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12:00 PM (PT)
8:30 AM (PT)
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This is a three day course requiring attendance on all three days. "Advanced Business Development "(ABD) is a long-running course focusing on all key aspects of transactions in the biopharma industry. This course is ideal for professionals ranging from those with limited experience (2–3 years) looking to advance their skills; and highly experienced dealmakers or executives looking to hone their skills and network with other dealmakers. "Advanced Business Development" incorporates lectures from experienced dealmakers, review of example models, dissection of actual deals, interaction with other participants, and live Q&A. Also, the course includes a mock negotiation scenario when each participant is a member of a deal team assigned to negotiate a transaction involving a drug in development with another team using an actual valuation and deal structuring model. Takeaways: Business development practices Trends in BD transactions Valuation, analytics, and models Deal structuring Negotiation ...Course - Additional Fee
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This is a three day course requiring attendance on all three days. The Business Development Fundamentals in-person course provides a foundation of the key skills that are required to execute a licensing transaction. With a focus on the biopharma industry, the course is taught by senior executives who have personal experience and expertise in transactional and intellectual property law; business development – both sell and buy sides; finance; alliance management; negotiation, and university technology transfer. Previous attendees include professionals from many international institutions. A sample of companies include: - Alkermes - NIH - American Society of Hematology - Gilead - Amgen - Merck National Taiwan University - Baylor College of Medicine - Novartis - Bluebird Biosciences - Queensland University of Technology - Biogen - Pfizer - Chinese University of Hong Kong - Sanofi - Eli Lilly - Takeda - Evotec - US Army Medical Research - Genentech Course Price: BIO Member: $2,550 Non-Memb ...Course - Additional FeeFaculty
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8:30 AM (PT)
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This is a three day course requiring attendance on all three days. The Business Development Fundamentals in-person course provides a foundation of the key skills that are required to execute a licensing transaction. With a focus on the biopharma industry, the course is taught by senior executives who have personal experience and expertise in transactional and intellectual property law; business development – both sell and buy sides; finance; alliance management; negotiation, and university technology transfer. Previous attendees include professionals from many international institutions. A sample of companies include: - Alkermes - NIH - American Society of Hematology - Gilead - Amgen - Merck National Taiwan University - Baylor College of Medicine - Novartis - Bluebird Biosciences - Queensland University of Technology - Biogen - Pfizer - Chinese University of Hong Kong - Sanofi - Eli Lilly - Takeda - Evotec - US Army Medical Research - Genentech Course Price: BIO Member: $2,550 Non-Memb ...Course - Additional FeeFaculty
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This is a three day course requiring attendance on all three days. "Advanced Business Development "(ABD) is a long-running course focusing on all key aspects of transactions in the biopharma industry. This course is ideal for professionals ranging from those with limited experience (2–3 years) looking to advance their skills; and highly experienced dealmakers or executives looking to hone their skills and network with other dealmakers. "Advanced Business Development" incorporates lectures from experienced dealmakers, review of example models, dissection of actual deals, interaction with other participants, and live Q&A. Also, the course includes a mock negotiation scenario when each participant is a member of a deal team assigned to negotiate a transaction involving a drug in development with another team using an actual valuation and deal structuring model. Takeaways: Business development practices Trends in BD transactions Valuation, analytics, and models Deal structuring Negotiation ...Course - Additional Fee
8:30 AM (PT)
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This is a three day course requiring attendance on all three days. "Advanced Business Development "(ABD) is a long-running course focusing on all key aspects of transactions in the biopharma industry. This course is ideal for professionals ranging from those with limited experience (2–3 years) looking to advance their skills; and highly experienced dealmakers or executives looking to hone their skills and network with other dealmakers. "Advanced Business Development" incorporates lectures from experienced dealmakers, review of example models, dissection of actual deals, interaction with other participants, and live Q&A. Also, the course includes a mock negotiation scenario when each participant is a member of a deal team assigned to negotiate a transaction involving a drug in development with another team using an actual valuation and deal structuring model. Takeaways: Business development practices Trends in BD transactions Valuation, analytics, and models Deal structuring Negotiation ...Course - Additional Fee
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This is a three day course requiring attendance on all three days. The Business Development Fundamentals in-person course provides a foundation of the key skills that are required to execute a licensing transaction. With a focus on the biopharma industry, the course is taught by senior executives who have personal experience and expertise in transactional and intellectual property law; business development – both sell and buy sides; finance; alliance management; negotiation, and university technology transfer. Previous attendees include professionals from many international institutions. A sample of companies include: - Alkermes - NIH - American Society of Hematology - Gilead - Amgen - Merck National Taiwan University - Baylor College of Medicine - Novartis - Bluebird Biosciences - Queensland University of Technology - Biogen - Pfizer - Chinese University of Hong Kong - Sanofi - Eli Lilly - Takeda - Evotec - US Army Medical Research - Genentech Course Price: BIO Member: $2,550 Non-Memb ...Course - Additional FeeFaculty
9:00 AM (PT)
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This is a one day course requiring attendance for the entire course day. The "Product & Company Valuation" course is designed to teach a systematic approach to producing a valuation that can be used in investment rounds, mergers/acquisitions, licensing deals, or strategic development decisions in the pharma-biotech world. This introductory course is very valuable for pharma and biotech executives who are not familiar with compound and company valuations but need a thorough understanding of the valuation concepts and techniques that are commonly applied in the pharma and biotech industries. It goes beyond the number-crunching techniques of most consultants and includes difficult to define qualitative factors, which shape the risk profile of the company in question. This course optimally balances interactive lectures with practical group work exercises that are designed to help you practice the fundamental valuation tools & techniques taught throughout the day. Valuation is an inherently ...Course - Additional Fee
1:00 PM (PT)
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Company PresentationsCompany Presentations will take place in Theaters on the Exhibition Floor. Watch here for the detailed schedule, to be released in May. Find Presenting Companies in the Partnering system by filtering by the "Presenting Company" tag.Company Presentation Session
1:45 PM (PT)
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A longstanding priority for both Congress and FDA, there has been a significant evolution in recent years in the ways in which patients’ experiences and preferences have been incorporated into the drug development and regulatory review processes. Particularly when it comes to rare diseases for which natural history is often lacking, operationalizing learnings from the lived experiences of patients has become a critical goal for numerous stakeholders. In this session, we will discuss case studies and best practices in centralizing the voice of the patient/caregiver into the design of meaningful clinical trials (endpoints and methodologies), as well as ways patients can interact with FDA itself. In addition to biotech and pharma leaders in managing rare disease programs, the panel will include an FDA regulatory lawyer, with agency and congressional experience relating to patient-focused and rare disease drug development.Breakout Session 24BC
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Real world data (RWD) are increasingly relied upon to inform drug policy decisions at both the state and federal levels. For example, state Prescription Drug Affordability Boards (PDABs) are using all-payer claims databases (APCDs) to support decisions on drug affordability. Further, CMS is leveraging Medicare claims to select eligible drugs and set the maximum fair price (MFP) for drugs in the Medicare Drug Price Negotiation Program (MDPNP). A potential overreliance on claims-based data for these decisions highlights concerns such as unequal data access amongst stakeholders, data infrastructure gaps, and the need to utilize more patient-centric data. This panel will illustrate the current state of how RWD is being used in state and federal drug pricing decisions, discuss the limitations of current data, and examine opportunities and actionable solutions to address these and other challenges. Attendees will gain a better understanding of the way RWD can inform policy decision-making an ...Breakout Session 26AB
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Alzheimer’s disease is one of the greatest challenges facing patients, health systems, and society, affecting over 55 million people worldwide. At the intersection of a growing public health crisis, capital pressures, and profound economic burden, the field is at a pivotal inflection point. Addressing it will require diversified investment strategies and cross-sector collaboration that accelerate scientific progress across the full research and development continuum. This panel convenes leaders from biotech, pharma, and philanthropy to examine how innovative science, strategic investment, and collaborative models can unlock the next wave of Alzheimer’s breakthroughs and accelerate progress toward conquering this disease once and for all.Breakout Session 30ABC
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The healthcare ecosystem is experiencing an unprecedented transformation fueled by scientific, technological, geopolitical, economic, and demographic changes. Whilst breakthrough innovations are shaping the next generation of medicines, developers need to adapt smartly to remain competitive in a fast-changing global landscape. Policy makers need to keep up with the pace of change by providing an agile framework that accelerates access, enhances efficiency, and strengthens global competitiveness. This session explores the opportunities and challenges of platform technologies and novel licensing concepts, asking how industry, regulators, and healthcare systems can work together to turn breakthrough ideas into tangible health and economic value.Breakout Session 29C
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Our industry has faced a variety of geopolitical and economic issues that inject uncertainty into deal-making. We must now navigate an unprecedented wave of legislation, executive orders, and policies covering most favored nation pricing, tariffs, data sharing restrictions, and domestic manufacturing, among others. In this panel, speakers will explore strategies for how to allocate risk and close deals in the face of this uncertainty. These dynamics require organizations to adopt more agile negotiation frameworks, strengthen interdisciplinary collaboration, and anticipate shifting regulatory interpretations, ensuring that transactions remain resilient, competitive, and aligned with rapidly evolving global expectations as well as commercial realities and pressures.Breakout Session 25ABCSpeakers
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In vivo hematopoietic stem cell (HSC) engineering represents the next inflection point in genetic medicine - moving beyond transient delivery or ex vivo manipulation to direct, permanent reprogramming of the body’s own stem cells. By targeting HSCs in the body’s native bone marrow, emerging in vivo platforms such as viral-like particles, base and epigenetic editing, lipid nanoparticles, lentivirus and fusogen-based systems are advancing the therapeutic paradigm toward one-time, off-the-shelf treatments. This panel will convene thought leaders from this emerging field to explore scientific breakthroughs enabling in vivo HSC targeting, therapeutic opportunities across disease areas, challenges of delivery and safety, and the regulatory and commercial models needed for success. Attendees will leave with a stronger understanding of why this is one of the most important and emerging areas in therapeutic innovation.Breakout Session 31ABSpeakers
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This session brings together leaders from pharma, AI technology, life sciences platforms, CROs, and specialized biotech AI to cut through the noise and examine how artificial intelligence is delivering tangible value in biopharma today. Panelists will explore the evolution from AI pilots to scaled implementation, sharing concrete examples of where AI is meaningfully accelerating drug discovery, improving R&D productivity, and enabling new scientific approaches. The discussion will address current technical and organizational challenges, practical strategies for integrating AI into existing workflows, and near-future developments that will further transform the industry. Attendees will gain actionable insights into building effective AI capabilities, measuring ROI on AI investments, and preparing their organizations for the next wave of AI-powered innovation in biopharma.Breakout Session 28ABCDE
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Within the Asia Pacific Region, Google Health and Health2Sync have partnered with Taiwan's National Health Insurance Administration and AI to stratify diabetes patients at risk of complications and then provide personalized digital interventions to improve outcomes. In Singapore, both Google Health and Health2Sync are developing software that will help citizens better manage hypertension and pre-diabetes. In Japan, software and digital engagement are also deployed in corporate and municipality funded disease management programs. And in Korea, healthcare providers are starting to leverage evidence-based software tools for efficiency in achieving government sponsored population health. Speakers from Asia Pacific, including Taiwan, Singapore, Korea and Japan, will discuss their vision for better chronic disease management as well as the perspectives of economics with health technology assessment (HTA) as provided by solution providers and payers.Breakout Session 29ABSpeakers
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The promise of cell and gene therapy is extraordinary - but so are the challenges of producing it at scale. Manufacturing remains the key barrier to delivering these life-changing therapies to patients globally. Now, a new wave of technologies is transforming that reality. Automation, AI, digital twins, and advanced analytics are driving consistency, speed, and scalability, while next-generation platforms are enabling closed, modular, and data-driven production systems. This session brings together experts across bioprocess engineering, CDMOs, and CGT innovators to explore how technology is redefining manufacturing economics and accessibility. Panelists will discuss integrating digital process control, predictive analytics, and smart automation to reduce cost of goods, improve reproducibility, and enable global supply at commercial scale. The conversation will also highlight partnerships that blend biotech innovation with tech-driven process excellence to build a sustainable, connected ...Breakout Session 32ABSpeakers
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In recent years, the US public health apparatus has weathered mounting fiscal stress, shifting political priorities, and deep cuts at the federal level. Proposed reductions to the Centers for Disease Control and Prevention (CDC), claw backs of COVID-era funding, and reorganization of health agencies threaten to hollow out core infectious disease surveillance, outbreak response, and health equity infrastructure. Meanwhile, threats from emerging pathogens, antibiotic resistance, and global disease spillover haven’t abated — indeed, many believe risk is rising. This panel will explore how stakeholders across the ecosystem are responding to this tension between rising biological threats and deteriorating public health support. What is being lost, what creative adaptations are underway, and where are the pressure points for emerging biotech innovation, local public health systems, and policy advocacy?Breakout Session 31CSpeakers
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Despite growing calls for pediatric inclusion, many clinical trials, especially in rare diseases, continue to exclude children or delay their enrollment until late stages. Yet, in many rare diseases, the point of maximal impact (PMI) occurs in childhood, when disease burden is highest and therapeutic windows are narrow. Excluding these patients not only delays access, but it also weakens trial validity, limits generalizability, and promotes off-label use in an evidence vacuum. This panel will challenge the outdated dichotomy of "adult-first" trial sequencing and instead propose scientifically grounded, ethically sound, and operationally feasible strategies for pediatric-first or concurrent inclusion. Attendees will leave with actionable strategies to confidently include pediatric patients in early-to mid-phase studies, supported by regulatory precedents, trial frameworks, and published outcomes.Breakout Session 23BCSpeakers
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2:00 PM (PT)
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The BIO Storytelling Stage is a showcase of the heart of BIO's priorities—sharing the stories of the biotechnology industry that show who we are, who we serve, what we do, and why we do it. You'll hear inspiring stories from researchers on the newest biotech advancements, perspectives from patients and caregivers on how biotech has affected their lives, and insights from company founders on their relentless pursuit to make the world a better place.Storytelling Stage Storytelling Stage (Booth #3035)
3:00 PM (PT)
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When Emerging Biopharma (EBP) companies consider globalization, what criteria guide their choice of markets to enter? In Japan, the evaluation of innovative new drugs has advanced significantly, creating an environment that is more open and attractive for startups and EBPs than ever before. Support from AMED, PMDA, and other government organizations has expanded, fostering new business opportunities through reforms in pharmaceutical regulations and drug pricing, improvements in clinical trial infrastructure, and increased opportunities for talent exchange and business matching. Japan now stands as a strategic gateway to Asia, especially for US and European startups. This session will share the latest updates and insights from Japan for entrepreneurs exploring opportunities in the Asian region.Breakout Session 29CSpeakers
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As technology evolves and AI requires more data, the question largely becomes how much do we need versus how much do we want and subsequently, what are the harmful consequences. The combination of web traffic data and voting records can easily manipulate societies. Adding patient data, whether it be from clinical trials or from a patient’s stored ChatGPT history, creates cybersecurity risks for societies that are unparallel. As we see geopolitical tensions rise and cybersecurity attacks increase, what is the industry’s responsibility to protect patient data? Attendees will hear from industry thought leaders as they explore these topics, questions, and more.Breakout Session 29ABModeratorSpeakers
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In biotech, success often hinges on spotting opportunities before anyone else does. Some of the industry’s most impactful companies have been built with smart business development regardless of their R&D bench that transforms their companies by advancing them into the next drug development stage, expanding their therapeutic areas to pursue other commercial markets, and creating favorable long-term financial positions. Hear from panelists who have made well-timed decisions, identified overlooked assets and in-licensing programs, and transformed them into successes with great science, grit, and a dedicated team. This panel will explore the art and science of intelligent business development, deals that are creative, how to recognize overlooked value, structure deals that create long-term growth, and build organizations around in-licensed innovation. Hear from leaders who turned unknown companies into industry players through sharp judgment, strategic vision, and a willingness to take cal ...Breakout Session 30ABCSpeakers
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HBO Max’s “The Last of Us" captivated audiences with its gripping portrayal of a post-apocalyptic world ravaged by a fungal infection. While fictional, the threat posed by fungal pathogens is real. Fungi are adapting to survive in extreme environments and developing resistance to the limited tools available, across human, animal, and environmental health. This panel brings together leaders from biotech, pharma, diagnostics and a venture capital fund to discuss how science, policy, and capital must align to advance antifungal innovation. Panelists will explore lessons learned from developing a novel antifungal class, the role of diagnostics, the value of strategic partnerships, and how One Health aligned strategies and innovative incentive mechanisms could reinvigorate the field.Breakout Session 31C
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Generative genomics, using generative AI models to create entirely new, high-fidelity genomic data, represents a major shift in how we understand and apply biology. Large-scale AI models trained on genomic and transcriptomic data enable researchers to predict biological behavior before running an experiment - accelerating discovery, improving clinical decision-making, and enabling more efficient development of new therapies. This session brings together innovators spanning the full AI-to-clinic pipeline to discuss how predictive biology is moving from theory to practice. The discussion will focus on how generative models improve biological predictability, optimizing trial design, and enabling faster, data-driven decision-making. Panelists will also explore emerging standards for validation, data integrity, and regulatory adoption to ensure clinical readiness.Breakout Session 28ABCDESpeakers
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Biomarker legislation is reshaping insurance and diagnostics policy across many US states, with more than 20 currently mandating coverage for biomarker testing under certain conditions. However, translating law into consistent practice remains complex. This session will bring together leaders from patient advocacy, diagnostics, legal policy, and industry coalitions to share real-world insights into implementation. Panelists will explore how states, payers, and laboratories are interpreting coverage mandates, navigating evidence requirements, appeals, and prior authorization, and uncovering practical challenges in aligning policy with operational reality. Attendees will gain a clear view of both the opportunities and potential pitfalls in biomarker legislation, leaving with actionable strategies for how stakeholders can collaborate to help ensure laws achieve their intended goal - improving patient access to precision testing in a sustainable, equitable, and affordable way.Breakout Session 26AB
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The financing and partnering environment for biotech has shifted significantly in recent years. Investors and partners have increasingly prioritized tangible, de-risked assets that offer compelling therapeutic differentiation and a product roadmap. As a result, the “product-first” model dominates, where clear positioning, validated biology, and a defined regulatory and commercial path are essential to secure financing or partnership interest. Yet companies that can balance a near-term, product-focused strategy with the broader potential of their pipeline are emerging as success stories. Attendees will hear how these companies show that a focused lead asset and a thoughtfully developed pipeline are not mutually exclusive but mutually reinforcing. Their ability to communicate both an immediate value proposition and a credible path to future growth is reshaping how investors assess risk and opportunity in early-stage and emerging biotech ventures.Breakout Session 25ABC
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The United States is making unprecedented investments to reshore biomanufacturing, strengthen supply chains, and enhance national security. As new facilities rise across the country, a critical question remains - how do we build the collaborative infrastructure needed to sustain growth and ensure long-term competitiveness? Industry-led Manufacturers Forums are emerging as a powerful model to meet this moment. North Carolina’s forum is widely viewed as the “gold standard,” while Oregon and Georgia represent newer models with strong industry leadership and early momentum. This panel will feature industry leaders and forum organizers from all three states, offering attendees an inside look at how these collaborations are structured and what makes them effective. The discussion will highlight the strategic value of industry-driven convenings in aligning partners around workforce, permitting, supply chain, and policy issues that are critical to scaling biomanufacturing capacity.Breakout Session 30DE
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For the first time in history, a patient has survived more than eight months following a gene-edited pig organ transplant, marking a pivotal moment as xenotransplantation moves from experimental promise toward clinical reality. With biotech companies now cleared by the FDA to initiate clinical trials, the field is advancing at unprecedented speed. This panel brings together scientific, clinical, and industry leaders to examine the data guiding first-in-human xenotransplant studies, how advances in genome engineering are addressing immune rejection and viral risk, and what it will take to translate early success into safe, scalable clinical practice. As transplantation enters a new era, the discussion will explore not only how xenotransplantation could alleviate the global organ shortage, but how it may ultimately redefine long-term patient care.Breakout Session 24BC
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The biotech and pharmaceutical sectors are undergoing rapid transformation, driven by advances in digital health, artificial intelligence, personalized treatments, and cell and gene therapies. These breakthrough innovations call for new collaborative approaches among developers, funders, and regulators to ensure timely patient access to cutting-edge treatments. In response, a range of public and public-private initiatives have been developed to strengthen mutual understanding of emerging trends, enhance regulatory preparedness, and foster dialogue between innovators and regulators. This session will explore insights gained from such initiatives in Europe and globally, highlighting how such strategic initiatives and early regulatory engagement with innovators can de-risk development programs, accelerate regulatory clearance, and shape future-ready regulatory frameworks.Breakout Session 23BCSpeakers
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4:15 PM (PT)
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As the biopharmaceutical industry strives to address areas of high unmet medical need, there is increasing reliance on novel endpoints to accelerate and support drug development. In rare diseases, traditional clinical outcomes may take too long to manifest, delaying access for patients with limited time and small populations. In chronic conditions, conventional endpoints can constrain innovation by overlooking meaningful aspects of disease that matter most to patients. This discussion will explore three critical areas for advancing the use of novel endpoints. First, optimizing sponsor submissions to clearly and persuasively present data supporting innovative endpoints. Second, strengthening FDA–sponsored collaboration to ensure comprehensive evaluation of disease manifestations and patient-relevant outcomes. Third and final, improving FDA transparency in documenting its rationale around endpoint acceptance, to facilitate learning for industry, clinicians, and patients.Breakout Session 23BC
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More than 10 million Americans live with osteoporosis. For decades, proving whether a new osteoporosis drug worked meant running massive clinical trials that followed thousands of people for 10–12 years. The Bone Quality Project brought together the largest dataset ever assembled on osteoporosis drug trials, analyzed bone mineral density (BMD), biochemical markers, and advanced imaging to find indicators (biomarkers) that predict fracture risk. Speakers will discuss these trials, and the lessons learned from the result - an increase in hip bone mineral density (BMD) after treatment strongly predicts a lower risk of fracture, so instead of waiting years to see whether a treatment prevents fractures, researchers can now use BMD changes as a trusted early signal of a drug’s effectiveness. As the first biomarker from the FDA’s Biomarker Qualification Program this approval will spur greater interest in development of treatments for osteoporosis, as well as accelerate interest in how biomark ...Breakout Session 30ABC
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This session will explore how quantum computing is poised to redefine the frontiers of drug discovery by solving complex molecular and optimization problems that exceed the limits of classical computing. Leading experts in AI-driven drug design, quantum algorithms, and computational chemistry will discuss how emerging quantum methods can accelerate target identification and compound optimization. Attendees can expect to hear about the practical challenges of integrating quantum computing into today’s pharmaceutical R&D pipelines and highlight early collaborations demonstrating how quantum advantage could shorten timelines and improve accuracy in the search for new therapies. Attendees will leave with a view of where quantum can create real R&D value in the near term, and what milestones must be reached to unlock breakthrough impact at scale.Breakout Session 28ABCDE
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This session will feature a Fireside Chat between the former CEO of Capstan Therapeutics, as they share firsthand experience leading Capstan through one of the marquee M&A deals of 2025, a $2B+ acquisition by Abbvie, as well as an M&A Partner and a Life Sciences Partner from Cooley. The conversation will explore the business and scientific factors that drive value in cell therapy, the strategic decisions behind building a company for acquisition, and the lessons learned from navigating a high-profile transaction. Attendees will gain unique insights into the evolving landscape of cell therapy M&A, including deal structuring, partnering strategies, and what it takes to achieve global impact in a rapidly advancing field.Breakout Session 30DE
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Clinical trials for large-population diseases face persistent challenges and remain the most complex and resource-intensive steps in drug development. Patient recruitment often lags, administrative bottlenecks delay study timelines, and operational inefficiencies that span into patient services and safety can hinder data quality and regulatory compliance. Agentic AI – intelligent systems capable of autonomous decision-making and task execution – offers transformative potential for the life sciences industry. This session will explore how agentic AI can streamline trial design, patient services, and execution across the entire study lifecycle.Breakout Session 29AB
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Influenza has long served as the backbone for the United States’ annual respiratory disease response and pandemic preparedness efforts. Unfortunately, the flu continues to claim hundreds of thousands of lives each year. Last season was the first in nearly a decade to be classified as high severity across all age groups in the US and resulted in a record 289 pediatric deaths. Meanwhile, flu vaccination rates have fallen for four consecutive seasons. Simply put, we are losing ground. Breakthrough innovations - from AI-powered vaccine design to at-home needle-free nasal vaccines to new preventatives and therapeutics - are reshaping how we fight the flu and our next pandemic response. This panel brings together leading researchers, biotech pioneers, and government officials developing next-generation vaccines, accessible home-based tools, and broadly protective treatments and preventatives to dramatically reduce the lives lost to influenza.Breakout Session 31CModeratorSpeakers
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For decades, the biotech innovation engine has produced extraordinary breakthroughs in cancer, rare diseases, and metabolic disorders. Yet across vast areas of medicine from preeclampsia to sarcopenia, dry eye disease, and neurodegeneration, progress has stalled. These are not rare conditions - they are common, costly, and catastrophic, affecting millions, but still without transformative therapies. Why? This session convenes leaders who have chosen to tackle diseases others abandoned as too complex or too commercially uncertain. Together, they will dissect where innovation has faltered in disease biology, technological advancements, or clinical application, and explore what’s finally changing that equation. Attendees will leave with a clearer view of where the biggest opportunities and the toughest roadblocks truly lie, and how new scientific and technological breakthroughs can help biotech reclaim the impossible.Breakout Session 24BC
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After two years of a quiet IPO window, the biotech markets are showing renewed signs of life. A growing number of companies are testing public waters again — but with tighter investor scrutiny, leaner balance sheets, and a renewed emphasis on clinical proof and capital efficiency. This panel brings together investors, bankers, and CEOs who have recently navigated or are preparing for the public markets. They will discuss what differentiates companies that can succeed in today’s IPO climate, how crossover financing is being used to de-risk listings, and what private biotech leaders should know as they plan for the next wave of market openings. Attendees will learn how macroeconomic forces, therapeutic focus areas, and valuation trends are shaping deal timing and investor appetite in 2026.Breakout Session 25ABCSpeakers
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The China-US relationship will have a huge role in shaping the future of global biotech. Yet, this relationship is increasingly defined by both interdependence and tension — with science, supply chains, capital, and talent moving through a landscape of heightened scrutiny and shifting trust. For many companies and investors, on both sides, navigating this landscape has become a strategic necessity rather than a theoretical risk. This high-level panel brings together influential voices to discuss how the biotech ecosystem can continue to thrive amid these realities. The discussion will focus on practical pathways to mutual success, including how to structure partnerships, manage risk, maintain scientific exchange, and identify areas where collaboration remains both viable and valuable in a rapidly changing environment.Breakout Session 29CModerator
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There’s no question that drug development is a risky endeavor with scientific, clinical, and commercial risk. Patients and society value advances in science that help people get well, stay healthy, and avoid more costly or burdensome settings of care. Policy choices have consequences, and they can either encourage innovation in tomorrow’s cures, or signal a belief that "we don't need any new treatments" and incentivize capital to invest elsewhere. The United States has been the world leader in innovation – but that isn’t an inalienable right. Session speakers will look to answer the following questions: What does the latest research reveal about the impact US policies like the Inflation Reduction Act have on investors? What can we learn from the impact of past policy choices in Europe or China? What should US leaders and policymakers know now?Breakout Session 26AB
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9:00 AM (PT)
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Gary Sinise, Actor-Humanitarian, and Founder of Gary Sinise Foundation, will be on the Main Stage on June 23, during "Driven by Purpose: Gary Sinise on Acting, Service, and Advocacy." In this featured program, Sinise will discuss how his work on stage and screen has inspired his service, philanthropy, and advocacy. His commitment to supporting veterans and first responders demonstrates how art can drive action and change lives.Featured Program Main Stage
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10:00 AM (PT)
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BioProcess Session BioProcess Theatre
10:15 AM (PT)
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• Contracting and Pricing • Demand Forecasting • Gross-to-Net • Pre-/Post- Deal Analysis • Accruals Management • Revenue ManagementBioProcess Session BioProcess Theatre
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10:30 AM (PT)
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Company PresentationsCompany Presentations will take place in Theaters on the Exhibition Floor. Watch here for the detailed schedule, to be released in May. Find Presenting Companies in the Partnering system by filtering by the "Presenting Company" tag.Company Presentation Session
11:00 AM (PT)
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Healthcare providers are often faced with the same set of challenges when diagnosing women with Alzheimer’s – debunking the stigma that has shaped the Alzheimer’s narrative for women and their families and removing the shame and misunderstanding so the disease can be diagnosed earlier. Oftentimes, these challenges lead to gaps in communication between women and their providers about memory, cognition, and brain health as well as provide obstacles for women in accessing screenings, care pathways, and clinical trials. This session looks to change the narrative and create change so that Alzheimer’s diagnoses in women can become a public health priority. Panelists will include a clinical expert, a researcher, a patient advocate, an industry innovator, and a policy leader as they look to flip the script from despair to empowerment and help redefine what it means to live with and prevent Alzheimer’s in women.Breakout Session 31C
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The next evolution of AI in biopharma is already here - systems designed not just to analyze data but to make decisions. These “agentic AI” models can set goals, adapt strategies, and generate hypotheses with a degree of autonomy that could reshape discovery and development. What is at stake is more than efficiency - it is a shift in perception. AI is no longer only a supportive tool but is beginning to be viewed as a potential teammate in scientific problem solving. The central question is whether these systems can be trusted to shape strategy. This panel will examine what standards of evidence are required before industry relies on autonomous input in hypothesis generation and experimental design, what safeguards are needed to ensure reliability and transparency, and how much human oversight will remain essential. Just as importantly, it will address how organizations will need to adapt their structures and mindsets if AI is to be treated as a collaborator rather than a calculator. A ...Breakout Session 31ABModeratorSpeakers
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The life sciences industry is built on innovation and driven by purpose. As competing for talent and earning public trust become critical business drivers, leading life sciences companies are investing beyond the lab to strengthen the communities where they operate. This session explores how strategic partnerships with nonprofits and community organizations are addressing urgent social challenges while strengthening talent pipelines, employee engagement, and corporate reputation. Speakers will share actionable strategies for designing meaningful partnerships, aligning internal culture with external impact, and evaluating outcomes. Attendees will gain practical insights and real-world examples for designing community investments that deliver measurable value for both business and society.Breakout Session 26AB
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As the next wave of patent cliffs loom, the pressure is on pharma to secure late-stage assets that deliver near-term value. Meanwhile, biotech leaders are navigating tighter capital markets and evolving deal structures, where milestone-heavy agreements delay returns and shift risk downstream. Join industry leaders as they share insights and advice on future-proofing partnerships in today’s complex, ever-changing landscape. Participants will learn what best-practice looks like when balancing value, risk-sharing and long-term asset potential, and how to harness complementary capabilities – scientific, operational, and commercial – to strengthen asset performance and drive better outcomes for patients.Breakout Session 25ABCSpeakers
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As major patent expirations loom, pricing pressures intensify and R&D productivity comes under strain, large pharmaceutical companies are accelerating dealmaking to fill therapeutic and clinical-stage gaps. From early discovery to late-stage clinical assets, the hunt for differentiated science has become more competitive. What are big pharma companies really looking for — and how can emerging biotechs align their science and timing to meet those needs? This session will explore where collaboration is fruitful across various therapeutic areas and stages of R&D, and what kinds of partnerships, licensing deals and acquisitions are most likely to define the next phase of biopharma innovation.Breakout Session 30ABCModerator
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This session will explore the critical journey of translating a scientific concept into a viable CNS therapeutic. Industry leaders will discuss the primary challenges and emerging solutions in neuroscience drug development, from initial discoveries to clinical application. Key topics to be discussed include developing disease models with translational relevance, identifying and validating causal therapeutic targets, leveraging biomarkers for patient stratification and defining meaningful trial endpoints, and innovating safe and efficient methods for drug delivery across the blood-brain barrier. Attendees will gain a comprehensive understanding of the current and emerging therapeutic landscape and future directions in bringing novel treatments to patients with neurological disorders.Breakout Session 24BC
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Europe is actively working to improve the clinical research environment, with particular emphasis on supporting biotechnology innovation and adapting to evolving scientific and societal needs. As new legislative initiatives such as the Biotech Act take shape, there is a growing focus on creating a more responsive and inclusive framework for clinical trials. This session brings together patients, regulators, and clinical trials’ sponsors to explore how the European Medicines Regulatory Network (EMRN) addresses these priorities. A central theme will be the importance of transparency and accountability, underscored by the recent introduction of EU-wide Key Performance Indicators (KPIs). The discussion will expand on the upcoming Clinical Research Investment Plan, to be launched under the European Commission’s flagship Life Science Strategy, as well as FDA’s efforts to support innovation in clinical research in the US. Participants will gain a clearer understanding of how clinical trial co ...Breakout Session 23BCModeratorSpeakers
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Messenger RNA (mRNA) medicines are increasingly recognized for their transformative power to improve patient health, as well as a strategic asset with implications for national and global security. The flexibility, speed, and scalability of mRNA therapeutics make them uniquely suited for rapid response to emerging threats - whether natural, accidental, or hostile. As such, governments should evaluate how mRNA fits into broader biodefense, pandemic preparedness, and supply chain resilience strategies. This panel will explore the intersection of mRNA innovation and national security, with perspectives from leaders in industry, government, and policy. Topics to be discussed will include the role of mRNA in future pandemic response, countermeasures for biological threats, and strategies for securing domestic manufacturing capacity. The discussion will also address the importance of global cooperation and the risk of falling behind strategic competitors in a field vital to public health and ...Breakout Session 29C
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The BIO Storytelling Stage is a showcase of the heart of BIO's priorities—sharing the stories of the biotechnology industry that show who we are, who we serve, what we do, and why we do it. You'll hear inspiring stories from researchers on the newest biotech advancements, perspectives from patients and caregivers on how biotech has affected their lives, and insights from company founders on their relentless pursuit to make the world a better place.Storytelling Stage Storytelling Stage - Booth 3035
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11:45 AM (PT)
11:50 AM (PT)
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Storytelling Stage Storytelling Stage - Booth 3035
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12:00 PM (PT)
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CDMO Capacity and Client Partnership Panel • How do you ensure your capacity planning aligns with actual client requirements rather than assumptions? • How do you balance multiple clients competing for the same capacity windows? • How do you build flexibility into capacity planning when client needs can change rapidly? • How do you maintain quality standards while maximizing capacity utilization? • How do you communicate capacity constraints to clients while maintaining strong relationships? • What contingency plans do you have for equipment failures, product issues, or unexpected downtime? • What makes a CDMO-client relationship successful over the long term?BioProcess Session BioProcess Theatre
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12:15 PM (PT)
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Super SessionThe biopharma industry has reached a critical inflection point. As it enters new scientific frontiers, it is simultaneously faced with increased budgetary pressures, looming patent cliffs, and—in the U.S.—structural distortions and renewed attempts to implement "Most Favored Nation" price setting. These dynamics could radically shift global leadership and patient access. This panel explores our industry's standing in a global economy where international competitors are rapidly scaling innovation and attracting capital. It will examine the U.S.’s future-readiness and discuss how to better establish biopharma’s vital role as a strategic national asset—essential for medical progress, economic strength, national security, and preparedness. Finally, the group will discuss proactive public policy ideas to move beyond defensive measures and solidify the U.S. position as a global leader.Super Session 28ABCDE
1:00 PM (PT)
1:45 PM (PT)
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Central Nervous System (CNS) disorders remain among the most complex and urgent challenges in global healthcare. This session will spotlight the latest advancements in CNS research and development, highlighting breakthroughs in areas that are revolutionizing our approach to these devastating diseases. Join a panel of leading experts from biotech, pharma, and the investor community as they share cutting-edge approaches and discuss how the convergence of technology accelerates the path from discovery to treatment. The discussion will cover disease-modifying approaches in neurodegeneration, translational precision in CNS R&D and how advances in platform technologies are enabling more efficient development of next-generation CNS therapies. This session offers a deep dive into the challenges and opportunities in the CNS landscape, providing a forward-looking perspective on the innovative strategies paving the way for a new era of brain health.Breakout Session 24BCSpeakers
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AI is redefining what’s possible across industries, and nowhere is the opportunity greater than in life sciences. But unlocking its full power requires more than algorithms — it demands bold new ways of building organizations that fuse cutting-edge AI with deep scientific expertise. Join founders, CEOs, and technologists who are leading this transformation at the intersection of AI and biotech. This panel will dive into how high-performing organizations are being designed for the future - cultivating adaptive cultures, harmonizing diverse skills, and forging strategic partnerships. Discover what it really takes to create agile, AI-powered companies that accelerate innovation and bring breakthrough science to life.Breakout Session 31AB
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Macroeconomic challenges that have hindered biotech IPO activity are subsiding and capital markets are expected to improve later in 2026, especially for early-stage biotech companies. Increased M&A activity by Big Pharma, anticipated interest rate cuts, and a backlog of companies with late-stage assets suggest an uptick in IPO activity in late 2026 and into 2027. Navigating strategic transactions like an IPO is complex, and preparation is critical, particularly as it relates to public company operations. CEOs and companies who can prioritize their strategic timeline and begin to build muscle memory around operating as a public company will find themselves in the best position to be successful and create organizational value. Preparation is key to capitalizing on potentially fleeting market windows with confidence. This panel will dive into lessons learned from past IPOs and how early-stage biotech’s can avoid common pitfalls.Breakout Session 25ABC
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Precision medicine has transformed oncology, but the next wave is unfolding in new therapeutic areas. The expansion into new areas promises enormous impact, yet the path forward is not straightforward. Outside of oncology, patient populations are more heterogeneous, biomarkers less validated, and regulatory and payor expectations less defined. Unlike oncology, where validated genetic drivers define patient groups, chronic and brain health conditions often lack clear biological anchors. This session will examine the big-picture opportunities and roadblocks for precision medicine’s expansion. Panelists will explore the evolving regulatory framework, payer readiness, and the tools - ranging from digital diagnostics to AI - that could enable precision care at scale. The discussion will draw lessons from oncology’s playbook while highlighting the unique considerations that must be addressed to translate precision into practice across new therapeutic domains.Breakout Session 29CSpeakers
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Rare diseases collectively affect more than 300 million people worldwide, yet fewer than 5% have an approved treatment. As cell and gene therapies (CGTs) progress from scientific aspiration to commercial and clinical reality, rare and ultra‑rare diseases remain at the center of the field’s most significant advances. This session brings together leaders representing biotech, regulatory agencies, payer organizations, investor communities, and patient advocacy to explore how CGTs are realistically being developed, delivered, and accessed today, with a focus on the latest clinical data shaping this next era. Panelists will examine real‑world evidence emerging from 2025–2026 clinical programs and discuss how adaptive trial strategies, single‑arm designs, and alternative data sources are enabling robust evidence generation despite small patient populations.Breakout Session 32AB
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This session will explore how pharma/biotech companies achieve pipeline diversity through portfolio strategy, strategic collaborations, and scientific rigor. The conversation will examine the processes behind diversification, including how companies identify emerging opportunities, leverage external innovation, allocate resources across modalities and disease areas, and adapt to evolving market and scientific landscapes. Panelists will discuss the tools and decision-making frameworks used to support sustainable innovation, balancing risk and reward for long-term impact. The session will also examine how collaboration accelerates diversification and influences investment decisions. Attendees will gain insight into how various organizational structures and partnering approaches shape pipeline development for resilience and relevance in the current healthcare environment.Breakout Session 30ABC
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Recent changes in FDA’s leadership and approach have caused some concern among industry leaders and patients about the stability, predictability, and reliability of our regulatory framework. While our existing framework is dependable, there have been concerns with it being slow and unwilling to embrace emerging regulatory science. The change in leadership’s perspective and approach, however, offers a unique opportunity to reform FDA and modernize our current regulatory paradigm. Concepts such as shifting to dynamic, real-time data exchange from current practice of static, paper-based reviews; de-risking by offering actionable feedback earlier in development and empowering patients by embracing transparency are all ideas that industry and patients can support. Speakers will examine how industry can seize the current moment as an opportunity to build a modern FDA that is patient-centric, technologically enabled, and scientifically sound.Breakout Session 23BCSpeakers
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Clinical trials in small populations, particularly those with progressive or degenerative rare diseases, face scientific and ethical hurdles that challenge traditional trial frameworks. High phenotypic variability, irreversible progression, and limited patient pools make randomized control trials (RCTs) often unfeasible or even inappropriate. Yet these trials are critical to accelerating treatments where time, function, and access are at stake. This session brings together trial designers, regulators, and rare-disease sponsors to explore strategies that improve the scientific rigor and regulatory viability of trials in these constrained settings. Panelists will discuss advanced trial designs, use of early functional biomarkers, and statistical models that embrace heterogeneity rather than eliminate it. Attendees will learn how to align study endpoints with disease trajectories, structure data collection to capture meaningful change, and design for power even when the patient population ...Breakout Session 31CSpeakers
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2:40 PM (PT)
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BioProcess International Theatre BioProcess Theatre
3:00 PM (PT)
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This session explores how patient preference studies (PPS) are transforming regulatory strategies in drug development, aligning with the upcoming ICH E22 guideline - the first international guideline related to Patient Experience Data. Our regulatory, industry, and patient panelists will discuss how systematically incorporating patient perspectives enhances trial design, benefit-risk assessments, and regulatory decision-making. Speakers will highlight the evolution from qualitative patient needs assessment to quantitative preference measurement, showcasing how these methodological advances support global development pathways. This panel will discuss how PPS can harmonize patient-focused approaches across regulatory frameworks, potentially accelerating approvals and improving access to therapies.Breakout Session 32AB
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Intelligence Precision Medicine cannot achieve its promise if entire populations remain underrepresented in the data that fuels it. As multiomic and real-world datasets expand, the next wave of therapeutic innovation will depend on how inclusively we capture and interpret human diversity. This session explores how inclusive health intelligence integrating genomic, transcriptomic, proteomic, and real-world evidence from underrepresented populations can drive discovery across the full translational pipeline. Panelists from leading research institutions, national programs, and data consortia will discuss how diversity in data enhances variant discoveries, strengthens model generalizability, and leads to more representative and effective precision medicine. Together, the panel will outline a vision for inclusive, interoperable, and trustworthy health intelligence that accelerates discovery for all populations.Breakout Session 29CSpeakers
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AI-enabled discovery and multimodal, human-centric datasets are reshaping how biopharma and digital health companies differentiate, partner, and scale. Rather than focusing on capital trends, this session will highlight practical approaches to monetizing proprietary data and AI platforms, meeting rising standards for data quality, privacy, and model transparency, and accelerating translational and clinical readiness. During this panel, venture investors, experienced operators, and regulatory, licensing and IP experts share a pragmatic playbook for building durable partnerships and navigating commercialization across global life science ecosystems — a conversation that will benefit both investors and AI enabled companies alike. Speakers will emphasize how investors and serial entrepreneurs can position AI driven ventures to stand out through deliberate licensing strategies, defensible data ownership and IP frameworks, and early alignment with global regulatory expectations.Breakout Session 31AB
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Women’s health is now a dynamic arena for innovation, data science, and strategic capital deployment. This session brings together leading investors to discuss where smart capital is flowing and how science, data, and market infrastructure are driving measurable returns. Speakers will outline how investors identify enduring value, structure partnerships, and capture growth across this rapidly maturing field.Breakout Session 25ABCSpeakers
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Clinical trials have too often failed to represent the communities they aim to serve - limiting the relevance, reach, and real‑world impact of medical innovation. The Robert A. Winn Excellence in Clinical Trials Award Program (Winn Awards) directly addresses this gap by cultivating community oriented clinical trialists (COCT) - physician scientists trained in community engaged trial design, effective patient recruitment, and equitable implementation. Attendees will hear from Dr. Robert Winn, a Winn CDA scholar alumna, and two pharmaceutical industry funding partners as they deepen their understanding of how training physician scientists in community‑oriented approaches strengthens equitable trial design and participation, while also gaining insight into how training and mentoring more clinical investigators can bring clinical trial opportunities to underserved communities, and walk away with actionable strategies for integrating meaningful community engagement into clinical research pr ...Breakout Session 26ABSpeakers
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As life sciences innovation becomes increasingly global, many emerging biotech ecosystems continue to face barriers to accessing the capital, infrastructure, and networks that define established hubs like Kendall Square. This session explores how structured “exchange” programs can create intentional pathways for international startups to integrate into leading biotech ecosystems, gain exposure to entrepreneurial best practices, and accelerate their growth. By enabling cross-border collaboration, these programs not only support international founders but also strengthen host ecosystems through new ideas, technologies, and partnerships. Attendees will hear from leaders actively building these global bridges and walk away with actionable insights on how to design, support, or participate in initiatives that drive sustainable global biotech innovation.Breakout Session 30ABC
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Even though orphan drugs currently account for almost 50% of all new medicine approved in USA and EU, many conditions still lack therapeutic options, and it has been estimated that 90-95% of the more than 7,000 known rare diseases do not have an approved treatment. This is particularly true for conditions which only affect very few individuals or where the underlying biology is poorly understood. Despite most major regulatory authorities having implemented legislation to stimulate and support development of medicines for rare diseases, several challenges persist. Generating robust evidence and managing uncertainty when dealing with small populations calls for global collaboration and regulatory alignment to agree on surrogate endpoints; external/historical controls; patient engagement in defining meaningful outcomes; and leveraging digital health technologies and decentralized clinical trials. This session will focus on how to leverage the evidentiary requirements to support global dev ...Breakout Session 23BCSpeakers
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Kickstart your journey in biotechnology by exploring the industry’s vast landscape and discovering where your skills and interests can make an impact. Experts will provide an overview of biotech across sectors (add in once I know who the speakers are) and share real-world experiences from the field, showcasing how their work is driven by people pushing boundaries, tackling the impossible, and improving outcomes for patients, public health, and the world.Breakout Session 29AB
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AI is becoming ubiquitous in biopharma, but no company can unlock its full potential alone. As the industry shifts from "tell me" to "show me," the pressure is on to move beyond the hype and use AI to fundamentally reshape how we discover and deliver medicines. Integrating AI "end-to-end" transforms the entire R&D journey—identifying targets, turbo-charging drug design, and optimizing clinical trials and manufacturing. However, real impact requires bringing together diverse expertise: biology, chemistry, clinical insight, and high-performance computing. Strategic partnerships with AI innovators are no longer optional; they are essential to scale discovery and streamline data management. This session explores the opportunities and challenges in building collaborations that move AI from a mere promise to tangible proof of impact across drug discovery and development.Breakout Session 30DE
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3:55 PM (PT)
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What manufacturing innovations have delivered the most significant cost reductions while maintaining product quality in your biologics operations? How are you balancing the capital investment required for continuous manufacturing against the long-term cost savings and efficiency gains? Which specific single-use technologies have provided the best combination of cost reduction and manufacturing flexibility in your experience? What strategies have most effectively reduced cold chain costs while ensuring product integrity during global distribution? How are you leveraging data analytics to identify and eliminate hidden cost drivers in your biologics manufacturing and distribution networks? What approaches have successfully reduced regulatory compliance costs without compromising quality or patient safety? How do you optimize the trade-off between centralized manufacturing efficiency and the cost benefits of regional production closer to end markets?BioProcess Session BioProcess Theatre
4:15 PM (PT)
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HHS secretary mandates NIH and FDA federal agencies to implement immediately the FDA Modernization Act which aims to establish a new roadmap to reduce animal testing in preclinical safety studies. Such recent legislative changes endorsed by Congress, and combined with some public sentiment support, encourage the use of alternative testing methods, or so-called New Approach Methodologies (NAMs), which encompass AI/ML computer modeling, organoids, and human organ-on-a-chip technologies. Although pharma and biotech companies are increasingly exploring and adopting NAMs in drug development, including for clinical studies, their readiness and widespread adoption are still evolving. To overcome these challenges, the panel of experts will discuss how to build a national framework leveraging current investment in NAMs with domains of expertise and infrastructure from academic and clinical institutions, and their industry partners, to ramp up technological scale-up access and quality manufactur ...Breakout Session 24BCSpeakers
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AI-enabled discovery and multi-modal, human-centric datasets are driving the next wave of biopharma partnerships. Collaborations are expanding rapidly, characterized by larger upfronts, equity-linked structures, and an increasing emphasis on data access, model co-development, AI validation, and cross-modality applications spanning small molecules, biologics, and emerging therapeutic areas. As this landscape evolves, the value proposition of these partnerships is shifting. This panel examines the emerging playbook for AI and data-enabled partnerships, with a focus on how deal structures unlock near-term value while compounding long-term strategic advantages. Using deal examples, the discussion will explore how companies structure data deals around multimodal and curated datasets, using access models such as federated approaches or data licensing, and how governance, quality standards, privacy, and deal terms are embedded into these collaborations.Breakout Session 25ABCSpeakers
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Since the first drugs were selected for “negotiation,” the Inflation Reduction Act (IRA) has been the target of litigation. Two strains of litigation emerged, with one focusing on the constitutionality of the IRA statute itself and the other focusing on various aspects of the IRA Implementing Guidance as issued by the Centers for Medicare and Medicaid Services (CMS). With a multitude of lawsuits filed, and over two years of active litigation, in many cases up to and including rulings by federal courts of appeal, what have we learned? What are the key issues and how has the litigation influenced price negotiations? It seems likely that the Supreme Court will be asked to weigh in, particularly with respect to the constitutional issues. How likely is the Court to take the case and, equally important, how are the individual Justices likely to weigh the competing legal, business, and public health concerns? This session will seek to answer these questions and more.Breakout Session 23BC
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With federal agencies commitments being uncertain and wavering, many researchers as well as emerging drug and device developers are struggling to find funding or to continue projects. At the same time, academia is struggling as federal funding is also being scaled back. States such as Maryland and Massachusetts are attempting to help bridge the gap by working with industry, investors, and academia to keep innovation going. This session will explore how academic institutions are attempting to not only do drug discoveries but also become clinical research sites. As the industry adapts to the new landscape, is collaboration between state, academia, and the industry the most viable way forward?Breakout Session 30ABCModeratorSpeakers
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The metabolic disease treatment landscape is transforming rapidly. While GLP-1 receptor agonists have demonstrated remarkable efficacy, addressing the full scope of metabolic dysfunction requires therapeutic diversity from the perspectives of mechanism, durability, and patient fit. This session examines complementary modalities, each offering distinct advantages. Small molecules - including neuroinflammation inhibitors, exercise mimetics, and metabolic modulators - provide mechanistic diversity with oral convenience. Genetic medicines enable durable upstream pathway modification with infrequent or one-time dosing. Protein therapeutics target growth factor pathways to optimize body composition and preserve lean mass. The discussion will address how mechanistically distinct approaches can work synergistically with incretin therapy - and with each other - to achieve outcomes beyond what any single modality delivers alone.Breakout Session 32AB
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Congress created the Rare Pediatric Disease Priority Review Voucher (PRV) program to incentivize the development of drugs for serious or life-threatening rare diseases in children. Vouchers are earned by companies that develop a rare disease drug for kids. The vouchers are transferable and entitle the holder to a priority FDA review for a subsequent product application. This incentive regularly faces legislative uncertainty, risking expiration when Congress does not act to renew its authority. The most significant lapse in the history of the program began in late 2024. This panel, convening patient advocacy and industry experts, will conduct a balanced assessment of the PRV program's outcomes, consider operational challenges, and explore whether legislative action is needed to ensure continued innovation for pediatric rare disease communities.Breakout Session 30DESpeakers
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Cancer immunotherapy has transformed oncology, yet many patients still don't respond or develop resistance to these treatments. Meanwhile, AI has generated unprecedented libraries of potential targets, but the ecosystem has become siloed. Discovery teams excel at identifying promising mechanisms but struggle with clinical prioritization, while drug developers want novel assets but lack visibility in the AI platform rationale. The result? Promising targets are left unused, clinical programs pursue the wrong targets, and money is wasted. The missing piece isn't more AI; it's multidisciplinary collaboration across the entire development continuum. This panel convenes leaders spanning discovery, development, diagnostics, business development, and investment to address a fundamental question - how do we build teams and partnerships that enable true end-to-end AI-driven drug development?Breakout Session 31AB
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As we approach 50 years of biotechnology innovation, a generation of female leaders are reshaping the industry at some of the most influential companies in biopharma, including as CEOs of Vertex and Alnylam. Women are spearheading some of the most transformative advances in therapeutics - from RNA and cell therapies to next-gen oncology and AI-led discovery. Yet, according to statistics, women still navigate persistent gender gaps in funding, board and C-suite seats, and executive visibility. This panel convenes leading women innovators - C-Suite and senior executives across pharma and biotech - to reflect on the evolving leadership landscape. Speakers will share personal lessons from their careers and pipeline triumphs, spotlight how they are shaping scientific strategies, and reveal the leadership approaches they deploy to shift culture, power access, and opportunity for those who follow.Breakout Session 26AB
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For years, therapeutic development for Alzheimer’s and other neurodegenerative diseases has focused on the pathologies within the brain such as, in the case of Alzheimer’s, amyloid plaques and tau tangles. While there is a neurobiological basis for the progression of these diseases, research clearly indicates that underlying neuroinflammation is critically important, and companies are looking to apply that knowledge to new therapeutics. In this session, biotech and pharma leaders in neuroinflammatory approaches to neurodegeneration will discuss why neuroinflammation has emerged as a powerful approach to neurodegeneration, the evolving landscape for therapeutic development and challenges, the state of clinical development, and opportunities facing the field.Breakout Session 24BC
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We are living in a golden age of biopharmaceutical innovation. Yet, too often, patients face barriers between them and the appropriate treatment they need across various cost-shifting programs. Payers often focus on drugs to manage healthcare costs, implementing programs such as copay accumulators, maximizers, and alternative funding programs. However, research shows that these are negatively impacting patient access and health. During this session, panelists will answer questions as to why the prevalence of high deductibles and patient cost-sharing is increasing, how high cost-sharing can negatively affect patient adherence, and what policies and/or regulations should be considered to protect patient access.Breakout Session 29C
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9:30 AM (PT)
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BioProcess Session BioProcess Theatre
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10:30 AM (PT)
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Company PresentationsCompany Presentations will take place in Theaters on the Exhibition Floor. Watch here for the detailed schedule, to be released in May. Find Presenting Companies in the Partnering system by filtering by the "Presenting Company" tag.Company Presentation Session
11:00 AM (PT)
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As diagnostics and precision medicine continue to advance, companies developing novel diagnostic technologies, analytical tools, and data-enabled testing solutions are reshaping how disease is detected, stratified, and monitored. Yet these companies often face unique challenges in capital formation. This session brings together investors, entrepreneurs, strategic corporate partners, and non-dilutive funding leaders to examine how financing strategies for diagnostics and precision medicine are evolving in response to these challenges. Panelists will explore how venture, strategic, and public capital assess diagnostic companies across stages, highlighting differences in capital efficiency, timelines, and risk profiles compared to drug development. Attendees will gain practical insights into how diagnostics companies are being financed today, what investors look for at different stages of growth, and how founders can navigate capital formation in a rapidly evolving innovation landscape.Breakout Session 26AB
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The 36th edition of EY’s Beyond Borders Biotechnology Report provides an in-depth look at the US and European biotech industry as the operating and regulatory ecosystem is undergoing dramatic changes. There are tectonic shifts in pricing due to Most Favored Nation (MFN) pricing and IRA, FDA policy shifts, NIH funding uncertainties, and supply chain implications due to tariff policies. However, the industry is showing solid innovation, which fuels M&A alliances and venture capital investment. In 2025 the M&A value was $149B up 65% from 2024 and this momentum may carry forward in 2026. This session looks to explore all these topics, and more!Breakout Session 25ABCSpeakers
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The biomanufacturing workforce challenge is not national - it is global. No single country or stakeholder can solve it alone. The National Institute for Bioprocessing Research and Training (NIBRT) Program unites leading training and education organizations from Canada, the USA, Senegal, South Korea, Australia, and Ireland in a powerful international alliance. Together, these partners are collaborating, innovating, and scaling workforce development models to address the global skills shortage. By leveraging this network, members share expertise, align talent development with industry needs, and shape the future of a truly global biomanufacturing sector. Similarly, as demand for biomanufacturing talent increases within each country, no single stakeholder can meet the challenge alone. This session will highlight how partnerships between industry, academia, and training organizations bridge skills gaps and help ensure a sustainable talent pipeline.Breakout Session 31CSpeakers
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Overall survival (OS) remains the gold standard endpoint in oncology trials, but the FDA’s August 2025 draft guidance highlights new complexities in assessing survival in an era of highly effective therapies, longer patient lifespans, and confounding crossover or subsequent treatments. Recent high-profile cases where promising early efficacy endpoints masked OS detriments have catalyzed this regulatory evolution. The guidance now recommends that all randomized oncology trials collect and assess OS data, even when using surrogate endpoints as primary measures, thus fundamentally shifting trial planning expectations. OS is both an efficacy and safety endpoint in that it can measure both prolongation of life and reveal drug-related toxicities that may offset therapeutic benefits. The new guidance necessitates careful statistical planning, pre-specified analyses, and sensitivity assessments in clinical trials. This session will hear from industry leaders as they discuss how the FDA's guida ...Breakout Session 32AB
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New Approach Methodologies (NAMs) are playing an increasingly central role in biomedical and life-science research, while also breaking scientific and regulatory boundaries by moving beyond early adoption in drug development toward global implementation across health, agri-food, and environmental safety. This session will explore how cutting-edge human-relevant tools — from advanced in vitro systems and organ-on-chip platforms to AI-enabled digital twins — are transforming research, regulatory science, and product innovation across life-science and industrial ecosystems worldwide. Leading experts from regulatory agencies, industry, and the scientific community will demonstrate how NAMs are improving human relevance, accelerating discovery, and reducing development timelines, while opening new pathways for regulatory acceptance. Participants will gain insight into the rapidly evolving international landscape and the practical mechanisms needed to align validation, qualification, and dat ...Breakout Session 23BCSpeakers
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The role of vaccines in preventing and eradicating numerous infectious diseases is unparalleled; however, the past year has presented some new challenges for the industry, calling into question the scientific rigor behind these life-saving advances. This panel will highlight the importance of public support for scientific innovation, policies that can strengthen R&D and scientific discourse as well as how best to shore up confidence in science across the biopharma ecosystem. Panelists will explore vaccines as an example, the benefits versus risks, healthcare costs, and how to help rebuild trust to support global health with perspectives from industry, government, advocacy, research, and academia.Breakout Session 29CSpeakers
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AI has moved from concept to execution in drug discovery, but turning algorithms into actionable insights requires deep scientific alignment and cross-functional integration. This session brings together leaders from pharmaceutical and techbio companies to discuss how AI is redefining discovery, validation, and collaboration models across the biopharma ecosystem. Panelists will explore what it truly takes to make AI deliver measurable impact - building high-quality datasets, designing interpretable generative models, and translating predictions into experimentally validated outcomes. The conversation will also address how pharma and AI-native companies can collaborate more effectively, balancing innovation speed, data governance, and scientific credibility.Breakout Session 31ABSpeakers
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As the global biotech ecosystem becomes increasingly interconnected, in-licensing has evolved into a core growth engine, with US–Asia deal-making and NewCo formation continuing to accelerate as companies pursue capital-efficient paths to innovation and pipeline expansion. This session brings together executives, investors, and dealmakers shaping the next wave of cross-border collaboration to explore how the right assets are identified, regional rights are structured, and incentives are aligned across scientific, regulatory, and commercial stakeholders. Panelists will examine valuation trends, due-diligence best practices, and evolving partnership and NewCo models that are reshaping how biotech’s scale globally.Breakout Session 30ABCSpeakers
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This session is designed to provide students with the guidance and connections needed to enter the world of biotechnology after receiving their degree. Panelists will share their personal career journeys and insights, highlighting tips that helped them in the early stages of their careers.Breakout Session 29AB
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BioProcess Session BioProcess Theatre
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The BIO Storytelling Stage is a showcase of the heart of BIO's priorities—sharing the stories of the biotechnology industry that show who we are, who we serve, what we do, and why we do it. You'll hear inspiring stories from researchers on the newest biotech advancements, perspectives from patients and caregivers on how biotech has affected their lives, and insights from company founders on their relentless pursuit to make the world a better place.Storytelling Stage Storytelling Stage - Booth 3035
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1:40 PM (PT)
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BioProcess Session BioProcess Theatre
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1:45 PM (PT)
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Although artificial intelligence (AI) has existed for decades, recent advances in computational power, data availability, and machine learning models have significantly accelerated its development and expanded its practical applications. Nowhere is this rapid evolution more apparent than in the field of healthcare, where AI is transforming how we understand, diagnose, and treat medical conditions. Today, AI systems play an increasingly vital role in accelerating the discovery of new therapeutics and medical devices, streamlining clinical workflows, and enhancing the accuracy and timeliness of diagnoses and treatment recommendations. Panelists will discuss their contributions to the global regulatory AI framework, share insights from the regional AI evaluations, and explore the broader implications for global health governance. The session will also examine cross-cutting themes such as emerging regulatory trends, critical legislative gaps, and opportunities to harmonize policy approache ...Breakout Session 30DE
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Longevity science has entered its execution era. What once sounded speculative now rests on clearer biology, richer human datasets, and maturing toolkits that are pushing longevity from buzzword to buildable therapeutic category. This session brings together leaders from industry and investment to define what durable aging and healthspan means in practice. This panel will explore how to prioritize key pathways, select effective therapeutic approaches, and identify biomarkers and functional readouts that truly matter in the longevity space. Attendees will leave with a framework for distinguishing hype from substance and for understanding what it will take to move longevity science from promising experiments to scalable, real-world medicines.Breakout Session 31C
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Both Secretary Kennedy and Commissioner Makary have signaled that there will be a new era of “radical transparency” at the Food and Drug Administration (FDA). Regulatory transparency is generally desirable, particularly on matters of public health and the safety and efficacy of medicines for human use. As the FDA has undergone significant changes during the first year of the Trump administration, in the areas of personnel, organization, and interpretation of its mission, has the Agency lived up to its pledge? What has “radical transparency” looked like, and has it always been a good thing for patients and industry? Session speakers will examine such developments as the use of expert panels in lieu of advisory committees, the public release of Complete Response Letters (CRLs), and the award of preferential review timelines via the Commissioner’s National Priority Voucher program through a transparency lens and offer their conclusions.Breakout Session 29C
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The April 2025 Food and Drug Administration Roadmap to Reducing Animal Testing in Preclinical Safety Studies is a signature effort to shift the prevailing drug development paradigm. Aiming to reduce costs, time, and ethical burdens associated with animal studies and thereby streamline drug development pathways, the FDA Roadmap outlines a stepwise approach to reduce and replace animals via human-centered new approach methodologies (NAMs). It began with a three-year effort to explore existing data availability, develop an open-access data repository, encourage sponsors to submit NAMs data, and reduce the length of toxicology testing for mAbs. Many experts believe this paradigm shift is possible with the right investment, incentives, and clear guidance. Session attendees will hear updates from government panelists on progress and early successes, and discuss the kind of guidance, regulation, funding, and other incentives industry can expect. Panelists will discuss how academia and other c ...Breakout Session 32ABSpeakers
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The biopharmaceutical industry needs sources for more, and better prepared talent, and there is building enthusiasm for skills-based hiring. Over the past few years, the Registered Apprenticeship (RA) model of workforce development has been successfully deployed in a variety of life science related career pathways, predominantly for biomanufacturing technicians. However, misinformation, outdated assumptions, and lack of a nationally consistent model have hampered large-scale adoption of RAs by this industry. Efforts are currently underway to establish National Registered Apprenticeship Standards, starting with those for biomanufacturing technicians, which can be shared across the country to streamline development of new programs. These national standards will allow customization to meet local employers’ needs while ensuring site-to-site consistency regardless of location. By offering a 360º perspective this session will inform biopharma professionals on workforce development efforts in ...Breakout Session 26ABSpeakers
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Oncology continues to be the leading therapeutic area across the biopharma industry by almost all measures, including global drug sales, number of pipeline programs, venture capital dollar deployment, business development activity, and number of drug approvals. Innovation within the oncology pipeline continues to flourish, with novel mechanisms helping counteract the impending loss of exclusivity for several of today’s leading products. But where do industry leaders anticipate future investment to be heading? How are trends in discovery, development, commercialization, and business development impacting how large, mid-size, and small biopharma approach opportunities in oncology? A panel of experts will discuss what the industry can expect in oncology for the remainder of 2026 and beyond.Breakout Session 24BC
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This session focuses on shifting from reactive to preventative strategies in managing medicine shortages. Speakers will highlight supply chain resilience, harmonized processes and systems, and innovative solutions, while exploring how global partners collaborate to ensure medicine availability despite evolving legislative and geopolitical change.Breakout Session 23BCSpeakers
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This session will explore ARPA-H’s unique SBIR/STTR funding opportunities and the distinctive commercialization support designed to propel breakthrough companies forward. Attendees will hear firsthand from ARPA-H funded small business performers about their experiences leveraging tailored industry experts and acceleration services to drive their ideas from early-product to patient impact. The discussion will provide an insider’s view from investors on navigating market success in a rapidly evolving sector, including how to combine sources of capital in a challenging environment. Expect to leave with practical strategies and fresh perspectives on ARPA-H’s small business program, open funding opportunities, and the dynamic support ecosystem designed to maximize entrepreneurial impact in health innovation. This program provides an onramp to broader agency initiatives, seeding new ideas, and accelerating solutions that advance ARPA-H's mission.Breakout Session 30ABC
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In recent years, a confluence of global economic, market, and policy shifts have led to the abandonment of more than 1,000 promising treatments in development for rare diseases - many of which deliver meaningful results for patients. Patient communities, researchers, and clinicians have had to pivot and figure out bold new ways of advancing or repurposing innovative treatments that traditional biopharma companies can no longer support. Session attendees will hear from the changemakers - patients, parents, advocates, researchers, clinicians, and industry leaders who refused to accept there wasn't a better way. The paths they are forging are not only changing the landscape for rare disease but paving the way for precision medicines for larger disease areas that are increasingly being segmented into collections of distinct, less common, and rare conditions.Breakout Session 25ABC
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For centuries, nature, and particularly the innate immune system, has encoded powerful mechanisms for disease control and repair. Today, artificial intelligence (AI) is reshaping drug discovery by revealing these signals with unprecedented resolution and by transforming how companies even run experiments, closing the loop between computation and the lab. Panelists will share their experience in learning directly from human-relevant biological data and how AI is enabling the discovery of antibody drugs, small molecules, and new therapeutic modalities that harness the body’s own regulatory systems. As experimentation becomes faster, more adaptive, and increasingly automated, these approaches are uncovering targets that have long eluded traditional R&D - accelerating discovery, reducing risk, and redefining how modern medicines are designed.Breakout Session 31AB
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2:30 PM (PT)
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As biopharmaceutical pipelines grow increasingly diverse — encompassing monoclonal antibodies, recombinant proteins, gene therapies, cell therapies, and other novel modalities — the pressure to streamline and optimize downstream processing (DSP) has never been greater. This panel brings together industry leaders and technical experts to discuss the latest innovations, strategic approaches, and critical pain points in downstream bioprocessing for both traditional biologics and advanced therapies. From advanced purification technologies such as chromatography, membrane filtration, tangential flow filtration (TFF), ultracentrifugation, and affinity-based methods tailored for proteins, viral vectors, and nucleic acids, to automation, real-time analytics, and platform strategies for scalable manufacturing, our panellists will explore how to improve yield, consistency, and scalability while controlling cost and ensuring product quality.BioProcess Session BioProcess Theatre
3:00 PM (PT)
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For 87 years, our industry had to operate under an uncomfortable truth: over 90% of cancer drugs that "cure" mice routinely fail patients in clinical trials. In 2022, the FDA Modernization Act 2.0 took the first historic step, lifting the animal testing mandate that had governed drug development since 1938. Then came the seismic shifts of 2025: in April, FDA launched a roadmap to phase out animal testing over the next 3-5 years and invited New Approach Methodologies (NAMs) data in INDs immediately. In July, NIH announced it would stop issuing new funding announcements focused exclusively on animal models, widening calls to prioritize human-relevant approaches. The policy infrastructure that propped up mouse models for nearly a century collapsed in months. This panel, led by industry trailblazers, will bring to light key differences among the types of NAMs, actionable strategies for adoption, avenues for making these accessible even to smaller biopharma companies, and the imperative for ...Breakout Session 24BCSpeakers
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This panel discussion addresses a critical paradox in biotechnology investment - while female-founded biotech’s demonstrate superior returns, they receive less than 3% of venture funding. This session features four pioneering founders currently building transformative "zero-to-one" companies - those creating entirely new market categories rather than competing in existing spaces. Panelists represent diverse biotech innovations spanning hibernation-based therapeutics, non-invasive vital sign monitoring, epigenetic gene therapies, and gravity-agnostic biotools. This session provides data-driven insights into the funding landscape while delivering actionable strategies for investors, a roadmap from the bench to the boardroom for scientists, understanding emerging technologies that could disrupt traditional approaches for industry veterans, and tactical advice to entrepreneurs from fellow founders building in the hardest environment.Breakout Session 30ABC
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For decades, autoimmune disease therapy has been defined by one trade-off - suppressing the immune system to relieve symptoms. That paradigm is now breaking. The 2025 Nobel Prize in Physiology of Medicine was awarded for discoveries illuminating how the body maintains immune balance, recognizing decades of research already embedded in novel breakthrough therapeutics in development. From cell therapies inducing drug-free remission in lupus to antigen-specific approaches reprogramming pathogenic memory, the science of immune tolerance - especially through enhancing Tregs - is rapidly shifting from theoretical ambition to a clinical reality. This panel will convene leaders across biotech, pharma, and venture capital to explore how the Immunology & Inflammation field is advancing toward tolerance, how the Nobel-recognized science of immune equilibrium is reshaping R&D strategy, and what investors and partners are watching for as new therapeutic approaches redefine the future of immune medi ...Breakout Session 31C
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Until recently, drug discovery has been limited by fundamental practical constraints such as the range of proteins that exist in nature or the availability of samples, time, and funding for experiments. Now, drug hunters are circumventing these limitations by using generative AI models to explore a vast chemical design space that extends far beyond the bounds of natural protein diversity, or to simulate complex biological experiments entirely in silico. This session will examine how leading drug developers are integrating AI-driven protein and gene-expression models with high-throughput experimental systems to navigate biological complexity. These approaches are increasingly demonstrating their ability to accelerate preclinical discovery timelines, uncover drug candidates that might be overlooked by traditional methods, improve the oral bioavailability of biologics, and design first-in-class therapies with no natural analogues. Drawing on the experience of biotech’s at the forefront of ...Breakout Session 31AB
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AI technologies are no longer a peripheral concept in drug discovery – these platforms are a driving force for innovative companies reshaping the way we identify targets, and design, optimize, and validate novel therapeutics. Panelists will share top tips and lessons learned from crafting and negotiating significant recent transactions, from both the biotech and pharma sides of the table, with a focus on how to ensure that early transactions are structured to allow the science to drive, preserving value in the core platform technology, while maximizing the company’s growth trajectory. This panel will discuss the when, the why, and the how of partnering AI-enabled drug discovery platforms, and how an early partnering approach can drive company value and trajectory, as well as how to approach deal structuring to reflect both technological value and therapeutic potential.Breakout Session 30DE
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As pricing pressures mount in the US, pharmaceutical companies are reassessing global launch strategies. This session looks to explore how geopolitical shifts - including US policy changes, EU pharmaceutical reform, and innovation agendas in the Middle East - are reshaping clinical development and access pathways for innovative therapies, with a focus on cell and gene therapies (CGTs), rare diseases, and personalized medicine. Regulators, industry leaders, and investors will examine evolving frameworks for clinical development, early access, health technology assessment (HTA), and pricing and reimbursement. Speakers will highlight early experiences with the EU HTA regulation and assess their implications for broader access strategies under legislative reforms in Europe, contrasted with emerging models in the Middle East.Breakout Session 29CModeratorSpeakers
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Biomanufacturing is at an inflection point. From the outside‑in, macro forces - significant near‑shoring investments over the next 3–5 years, costing pressures, and the need for regional, resilient supply chains - are reshaping where and how we make therapies. From the inside‑out, the need to increase speed to market, rapid advances in digitization including application of predictive and prescriptive maintenance, real‑time release, digital twins and AI, the drive to automated controls while reducing failure rates, along with advancements in new modalities are converging to redefine operations. Together, these forces demand a smarter, more adaptable approach to biomanufacturing. This session will explore the opportunities and hurdles to scale-up science, applying advanced technologies supported by reliable and sustainable supply chain strategies to optimize bioproduction.Breakout Session 32AB
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Inherited Retinal Diseases (IRDs) were once considered untreatable, leaving patients and families facing the certainty of progressive vision loss. Today, advances in gene therapy are changing that reality, offering new possibilities to preserve and restore vision. This session brings together leaders advancing ocular gene therapies alongside patients who have participated in or received investigational treatments, highlighting how scientific innovation and lived experience are converging to shape the next era of care. The discussion will explore emerging therapeutic approaches, durability and re-dosing challenges, manufacturing at scale, and - most importantly - the essential role patients play as partners in research, trial design, and the path toward treatments that meaningfully improve lives.Breakout Session 23BC
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4:15 PM (PT)
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The advances in technology over the past decade have yielded a broad range of biologics for cancer, each with unique attributes. This is great news for patients to have so many tools in the toolkit, but challenging for drug developers, and even for oncologists making treatment decisions. Today more than ever, the environment, whether prospective funders or partners, is much less forgiving of missteps in understanding the value proposition for each of these unique therapeutic modalities that are shaping the future standard of care for cancer. This session will hear from panelists as they engage in a clearsighted dialogue around the strengths, weaknesses, challenges, and opportunities of these various approaches as they highlight some of the key learnings in charting a course for the current and next generation of early-stage innovative modalities.Breakout Session 24BC
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Long-term post-marketing safety monitoring is crucial for understanding the risks of new therapies in real-world settings, yet current registries often create considerable burdens without delivering robust, actionable data in a reasonable timeframe. For registries like those in place for cell and gene therapies and pregnancy outcomes, fragmented drug-specific data collection, cumbersome follow-up, and inconsistent quality, limit effectiveness. Patients deserve safety strategies that protect them and provide timely and meaningful information. This session will highlight the need for harmonized approaches to safety monitoring that are disease or mechanism focused, rather than drug focused. Through stakeholder perspectives, this session will aim to elucidate pragmatic approaches to generating essential data necessary for safety monitoring. Case studies will be leveraged to demonstrate where low patient accrual led to innovative solutions to obtain data to inform patient safety.Breakout Session 23BCSpeakers
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Artificial intelligence (AI) has become a widely used label across biotech companies positioning platforms for drug discovery and development. However, what truly defines an AI-marketed platform today goes beyond the presence of advanced algorithms or biological claims. As the industry enters 2026, the central challenge is no longer whether AI can support innovation, but which AI platforms can demonstrate clear return on investment, commercial credibility, and scalability as services for biomedical development that customers are willing to pay for. This session will bring together AI-biotech founders, AI economics experts, and investors to examine what distinguishes successful AI platforms that are marketed and adopted as revenue-generating services rather than as internal programs. Panelists will explore the attributes that enable AI platforms to move from pilot studies to repeat customers, including validation of real-world performance, integration into existing R&D and clinical work ...Breakout Session 31ABSpeakers
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Europe's decades-long decline in pharmaceutical R&D and delay in patient access to medicines are the direct result of government policies designed to lower spending on innovative medicines, including direct drug price controls, antiquated comparators for health technology assessment (HTA), international reference pricing, revenue claw backs, and parallel trade. Even countries such as Denmark, with a budget surplus and GDP like the US, continues to institute policies that burden patients with delayed access to innovation. Under the Trump Administration, the US has said that it expects wealthy countries to shoulder their “fair share” of R&D investments and pay drug prices relative to US GDP. Our panel will argue that this is an opportunity for the EU to reorient its economy around biotech investment and economic growth. Furthermore, speakers will discuss global drug pricing and investment trends in the US, Europe, and China, and explore how companies and policymakers can work together to ...Breakout Session 25ABCModerator
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Death of expertise in the dawn of AI has been vastly overreported with no sign of its ability to displace creative and disciplined drug discovery teams. Citing Bernstein Research, the Financial Times notes: “from 2012 to 2022, adjusting for inflation, spending on pharmaceutical research and development increased by almost half to roughly $250bn, yet the number of novel drug approvals remained broadly flat.” AI holds the promise in shaping and hastening scientific discovery by winnowing therapeutic targets, sorting through large datasets, and flagging areas where assumptions need to be challenged. This panel will explore how AI and ML serve as force multipliers, especially for biotech’s with big ideas and small dedicated teams. The discussion will be a deep dive into how to position AI within a drug discovery team and create guidelines and guardrails for its adoption for maximum effect. Built on a working familiarity with what AI excels at now, this session will challenge assumptions ab ...Breakout Session 30DE
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The FDA’s new guidance supporting non-animal testing methods is reshaping preclinical drug development, creating unprecedented opportunities for biotech innovation. This session brings together biotech CEOs, translational scientists, and platform leaders using organoids, organ-on-chip systems, and other human-based models to improve predictability, reduce cost, and accelerate development. Panelists will share real-world case studies on how companies have successfully navigated the new FDA framework, particularly in the antibody and biologics space, to cut preclinical timelines and move candidates into the clinic faster. Attendees will gain insights into how next-generation, human-relevant models are transforming R&D strategy, regulatory interactions, and the future of drug discovery beyond animal testing.Breakout Session 29C
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Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) establishes how regulated industry fees support the human drug review program at the Food and Drug Administration (FDA) and associated Agency performance goals, programs and processes. The law must be renewed every five years, including a negotiation between industry and the FDA and reauthorization of the law by the U.S. Congress. This session will explore the changes we can anticipate during PDUFA VIII (effective Oct. 2027) and potential implementation considerations for biopharmaceutical developers. The panel will include PDUFA and BsUFA negotiators from FDA, industry and BIO. We will also discuss renewal of the Biosimilars User Fee Act (BsUFA).Breakout Session 29AB
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Back by popular demand, this high-impact session returns to BIO and will guide health and science executives through a proprietary framework developed by LaVoieHealthScience: The LHS Fifteen-Slide Presentation®, a disciplined structure that drives clarity, focus, and momentum. These methodologies are designed to help companies clearly articulate the company value proposition, market problem, value solution, competitive differentiation, regulatory approach, and financial vision within a concise 15-slide structure.Breakout Session 30ABC
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Heart disease remains the leading cause of death in the United States, with a person dying every 34 seconds from cardiovascular disease, claiming almost one million American lives every year and accounting for one in every three deaths. For decades, treatment has centered on symptom management and slowing disease progression rather than reversing damage. But the next generation of innovative approaches is challenging the notion that cardiac injury is irreversible, showing that the heart can be repaired, not just supported, by addressing the genetic and molecular drivers of disease itself. This discussion will spotlight the science, novel approaches and new targets driving the next generation of cardiovascular therapies, where the goal is not merely to extend life, but to restore the vitality and resilience of the human heart.Breakout Session 31CSpeakers
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Venture capital funding specifically for women’s health biotech and pharmaceuticals has undergone a significant transformation since 2023. While the broader "Women's Health" category is often dominated by "Femtech" (apps, digital platforms, and medical devices), the women’s health biopharma sub-sector is seeing results and advancing assets into the clinic. Join this session to hear about exciting developments in women’s health therapeutics, new partnership models and challenges developers face when researching some of the toughest challenges in women’s health.Breakout Session 26AB
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9:00 AM (PT)
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Long before immunotherapy took center stage, it lived on the margins of oncology. Those pursuing it were often politely dismissed as “dreamers,” relegated to the back rooms at ASCO as well-intentioned, but unrealistic in their belief that the immune system could be trained to fight cancer. Rather than abandon the idea, they chose to stay on the path less travelled. This panel brings together members of that original community of quiet architects who helped turn scientific curiosity into a life-extending standard of care. Their conversation will reflect on the moments of uncertainty, the small signals that kept them moving forward, and the collaborations that gave early observations room to grow. Lastly, panelists will explore the future they envision - new immune pathways, next-generation combinations, and emerging tools that may help uncover deeper and more durable responses.Breakout Session 24BCSpeakers
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The biopharmaceutical industry faces persistent misinformation campaigns targeting patent practices, with myths about patent thickets, evergreening, and excessive patent filings driving misguided policy proposals. This session presents evidence-based analysis directly contradicting these narratives using USPTO data, empirical research, and economic studies. Panelists will examine how organizations propagate flawed methodologies that inflate patent counts by including abandoned applications and non-Orange Book patents, creating misleading impressions of the patent landscape. Distinguished experts from industry, law firms, and global jurisdictions will demonstrate how robust patent protection enables both innovation incentives and timely generic competition, while debunking claims that follow-on innovations represent trivial evergreening. Attendees will gain crucial insights into defending evidence-based patent policy against activist narratives threatening the innovation ecosystem that ...Breakout Session 29C
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This session brings together leaders from early-to-late-stage biotech’s and the investment community to explore practical frameworks for transforming early-stage discoveries into development-ready therapeutic assets. Panelists will share concrete examples of early scientific work that has successfully evolved into new biotech companies, illustrating how thoughtful program design, early validation strategies, and milestone-driven execution can bridge the translational gap. The discussion will highlight how effective collaboration models and clear development roadmaps help reduce scientific, operational, and investment risk. Attendees will gain actionable insights into de-risking early-stage science, structuring productive partnerships, and aligning innovation with the expectations of industry and investors to accelerate the path from discovery to real-world therapeutic impact.Breakout Session 29ABSpeakers
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Novel manufacturing technologies can help rapidly scale manufacturing capabilities, increase supply chain resilience, bring manufacturing closer to the patient, and support greener manufacturing. On a global scale, regulators are actively supporting the adoption of advanced manufacturing technologies through early engagement channels. This session will present regulatory perspectives on efforts to implement innovation in medicines development, manufacturing and control, and the latest initiatives at ICH and ICMRA level. Industry representatives will share case studies and best practices and discuss how the interactions with regulators have supported their implementation journey. The discussion will focus on the opportunities offered, the remaining challenges, and the priority areas for industry and regulators to work collaboratively to promote and facilitate the implementation of novel manufacturing technologies globally.Breakout Session 23BC
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In an increasingly selective capital environment, a handful of biotech CEOs have managed to defy the odds—closing $100 million-plus financing rounds that fueled major growth, platform expansion, and pipeline acceleration. What separates these companies from the rest? What messages, metrics, and milestones resonate most with investors in today’s market? This session brings together biotech CEOs who have each raised $100M+ rounds to share the behind-the-scenes stories of how they did it—what worked, what didn’t, and what they’d do differently next time. From crafting a compelling narrative and building investor confidence to navigating syndicate dynamics and valuation pressure, the discussion will offer actionable insights for founders preparing their next raise.Breakout Session 25ABC
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Colorado’s life sciences community is relentlessly focused on patients. In this interactive panel, Colorado BioScience Association President & CEO along with the other panelists, will share real-world practices for embedding patient perspectives into product development, education, and access strategies - building trust and transparency through advocacy partnerships and ensuring that policy discussions reflect the patient voice. The conversation will include lessons learned from a National Dialogue on Schizophrenia that united advocates, clinicians, and policymakers for collaborative problem-solving, and a Colorado BioScience Association Day at the Capitol with patients that highlighted how patient perspectives can inform balanced approaches to state-level policy. The discussion will draw on real-world examples of cross-sector collaboration among advocates, clinicians, industry leaders, and policymakers. We will also examine how strong advocacy partnerships help the ecosystem navigate ...Breakout Session 26ABSpeakers
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10:00 AM (PT)
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Company PresentationsCompany Presentations will take place in Theaters on the Exhibition Floor. Watch here for the detailed schedule, to be released in May. Find Presenting Companies in the Partnering system by filtering by the "Presenting Company" tag.Company Presentation Session
10:15 AM (PT)
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Cell and gene therapies have become invaluable modalities in the medicine toolkit. Following recent safety concerns with AAV vector technology, experts will look increasingly toward new vectors and delivery methods. In terms of patient access, political action on drug pricing casts the cost considerations of CGT in a new light. Manufacturing innovations can reduce costs to some degree, but payer incentives within the broader healthcare industry must be aligned with these often one-and-done treatments. Building on a panel discussion featured at BIO 2025 about the innovation needed in manufacturing processes, this session will focus on how those advances must come hand in hand with improvements across the entirety of the cell and gene therapy ecosystem - from the design of the therapies themselves to their delivery to patients.Breakout Session 23BCModerator
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Europe is taking bold steps in transforming its biotech industry, from strengthening biotech ecosystems, simplifying regulatory framework, and accelerating trial authorizations, to creating better funding opportunities and supporting market uptake and expansion. This panel will bring together public and private funders, industry leaders, clinical trials networks, and entrepreneurs to explore how Europe’s evolving ecosystem is reshaping opportunities for biotech innovation. Speakers will compare experiences, highlight best practices, and discuss how new EU-level actions are supporting growth of biotech innovations. Attendees will gain a clear view of the new opportunities, incentives, and support mechanisms emerging across Europe — and how they can position their organizations to thrive in a more competitive and innovation-friendly European biotech environment.Breakout Session 25ABCSpeakers
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The path from academic discovery to patient impact has never been more complex. Federal funding shifts, market turbulence, and evolving expectations for commercialization are challenging traditional models of university tech transfer. Yet these pressures are also driving fresh approaches to how institutions partner, de-risk early science, and connect with industry and investors. This session convenes leading translational and academic innovation experts to share how top universities are reimagining models of partnership and entrepreneurship to ensure innovation thrives despite uncertainty. Panelists from MIT, Penn, Yale, and Brown will explore strategies for aligning institutional incentives, strengthening university–industry collaboration, and building regionally connected ecosystems that move discoveries from lab to market faster.Breakout Session 29AB
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Antibody–drug conjugates (ADCs) reshaped cancer treatment by combining the precision of targeted antibodies with the potency of cytotoxic therapies, but as the field matures, the focus is shifting toward making ADCs not only more effective, but safer and more tolerable for patients. This session brings together leaders in oncology, R&D, bioconjugation chemistry, and translational medicine to examine how next-generation ADCs - through smarter linkers, novel payloads, improved selectivity, and more patient-friendly dosing strategies - are redefining targeted therapy. Panelists will discuss advances aimed at reducing off-target toxicity, improving durability of response, and leveraging biomarkers and combination approaches, asking whether the next wave of ADC innovation can fully realize the promise of precision medicine by delivering powerful cancer therapies with less burden on patients.Breakout Session 24BC
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Intellectual property rights remain the foundation of innovation in the life sciences. Today, that foundation is facing sustained and coordinated pressure from all sides. Insurers, pharmacy benefit managers, and hospital systems -- groups that historically stayed out of IP policy -- are now actively campaigning to erode patent protections. At the same time, misguided legislative proposals framed around "patent abuse," threats to the Bayh-Dole framework, and growing trade pressures on regulatory data protection are converging to weaken the incentives that power biomedical discovery. Featuring leaders from industry, academia, and policy advocacy, this panel will examine how we arrived at this inflection point -- and outline a strategy to defend, modernize, and strengthen the IP ecosystem that underpins breakthroughs.Breakout Session 29CModerator
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Sponsors routinely collect patient experience data (PED) to better understand disease areas and ensure development programs meet patient needs. To advance patient-focused drug development effectively, early alignment on PED collection activities between industry, patient advocacy groups, and regulators is essential. This alignment supports the identification of what is clinically meaningful to patients, ensures the generation of fit-for-purpose data, informs regulatory decisions, and facilitates the inclusion of PED in labeling and patient-facing resources. Although regulators encourage early and frequent engagement regarding PED, industry stakeholders often face uncertainty about the timing and content of such interactions. This lack of clarity can hinder the ability to obtain actionable regulatory feedback at the appropriate time points. To facilitate strategic and timely discussions on the use of PED in product development and regulatory decision-making, resources including framewor ...Breakout Session 29AB
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