Session / Events List

Below is an alphabetical list of all sessions and events at BIO, April 22-25, 2013.

 

  • ACCINOV: A Unique Regulatory and Technological Environment for Biomanufacturing in France
    Biologics have resulted in new treatments that have helped advance medical care. While they have been hugely successful, they are also more


    Biologics have resulted in new treatments that have helped advance medical care. While they have been hugely successful, they are also more difficult and costly to manufacture than small molecule drugs. As the promise of biotherapeutics for the treatment of cancer, diabetes, and other diseases grows, so does the complexity of manufacturing and the reinforcement of regulatory constraints. Companies willing to develop a biomanufacturing capability need to anticipate the technological and regulatory constraints in order to assure safety, efficacy, quality and performance of new lifesaving biologics. This session will discuss these challenges and how ACCINOV, a biomanufacturing platform based in France, is supporting companies by offering a dedicated environment for addressing regulatory issues and promoting the development of enabling technologies for stronger quality control and new production process development.


    Learning Objectives:

    • Assess the technological and regulatory complexities of manufacturing biologicals
    • E-Coli platform: a cooperative project launched with the French Technological Research Institute
    • Discuss novel technologies that can help overcome quality control challenges in biomanufacturing

    Ability Level: All

    Session ID: 1947

    Day/Time:
    2013-04-24

    Track:
    International Market Briefings Track

    Location of Session:
    Building: S101A

    • Tags:
      • Biomanufacturing
      • Breakout Sessions
      • Education
      • France
      • International Market Briefings Track
  • Accountable Care Organization (ACO) Framework for Biopharmaceuticals
    Success in an ACO world is different from success in a capitated environment where the focus is only on managing costs. How does an ACO succeed in

    Success in an ACO world is different from success in a capitated environment where the focus is only on managing costs. How does an ACO succeed in this environment of dual responsibility for costs and quality, and how do biopharmaceuticals fit in? Biopharmaceuticals may be considered solely on the basis of cost and an ACO may be inclined to simply select the least costly options. However, there is much more to the story. For example, medications for heart failure are a relatively low-cost component of overall care, yet they play a large role in cost offsets and achieving quality benchmarks due to their impact on preventing re-hospitalization. In contrast, for rheumatoid arthritis (RA), biopharmaceuticals represent a large share of treatment costs, and quality measures related to RA are not being used by existing ACOs. This presentation will expand dialogue from the current high-level discussions to a more detailed exploration of how ACOs can best incorporate pharmaceuticals in their design and delivery of care.

    Learning Objectives:

    • Discuss the nuanced role of biopharmaceuticals in meeting quality benchmarks in the ACO environment
    • Review considerations for how ACOs can incorporate biopharmaceuticals in their design and delivery
    • Identify common gaps in ACO preparedness to optimize biopharmaceutical utilization

    Ability Level: All

    Session ID: 1881

    Day/Time:
    2013-04-22

    Track:
    Market Access and Commercialization Track

    Location of Session:
    Building: S401BCD

    • Tags:
      • Biopharmaceuticals
      • Breakout Sessions
      • Clinical
      • Drug Delivery
      • Education
      • Generics
  • Across the Great Divide: Creating and Managing Cross-Cultural Partnerships
    The alliance management profession has developed within the biopharma industry from nice-to-have to a necessity for navigating the risk-causing

    The alliance management profession has developed within the biopharma industry from nice-to-have to a necessity for navigating the risk-causing complexity and realizing the intended value within today’s deals. Some of that complexity comes from the global nature of the industry and partnering with companies from different national cultures, corporate cultures, and across many time zones. This session, featuring alliance professionals who will draw upon their specific experiences to provide rich examples, looks at how the role of the alliance manager is evolving, especially as it relates to cross-cultural partnerships. Topics covered include:
     
    •  Key aspects of a successful alliance management function given the complexity and global nature of many partnerships
    •  What deal makers need to know about implementing cross-cultural alliances – and the implications that has on negotiating the collaboration agreement
    •  How to create effective communication and alignment in a globally-dispersed, cross-cultural alliance team

    Moderator

    Janice Twombly, CSAP; President, The Rhythm of Business, Executive Committee Member, ASAP

    Speakers

    Mark Noguchi, Global Head, Alliance and Asset Management, Roche Partnering
    Harm-Jan Borgeld, Head Global Alliance Management, Merck Serono - Merck KGaA
    David Thompson, Chief Alliance Officer, Alliance Management, Eli Lilly and Company
    Mary Jo Struttmann, Senior Director, Alliance Management, Astellas

    Ability Level: All

    Session ID: 2159

    Day/Time:
    2013-04-22

    Track:
    Business Development Track

    Location of Session:
    Building: N427BC

    • Tags:
      • Academic/University
      • Biopharmaceuticals
      • Breakout Sessions
      • Business Development
      • Business Development Track
      • Education
  • Advanced Business Development Course
    Take your skills to the next level by working directly with colleagues in a hands-on, practical course that is centered around a realistic business

    Take your skills to the next level by working directly with colleagues in a hands-on, practical course that is centered around a realistic business case!

    The Advanced Business Development Course is designed for executives and business development professionals interested in bringing their skills in valuation, deal structuring, due diligence, negotiation and contracts to the next level. During this intense, three-day workshop attendees will receive hands-on, advanced training from veteran business development professionals and legal advisers using real world case studies. In addition, attendees will be split into teams to conduct a mock negotiation over rights for a clinical stage compound.

    Since 2004, this course has been taught exclusively for life science business development professionals by the Biotechnology Industry Organization in collaboration with Licensing Executives Society. The faculty is drawn from among the most experienced business development professionals in the biotech drug development industry as well as big pharma, many of whom have been instructors in other programs, and all of whom have hands-on experience in the biotech industry.

    http://www.bio.org/events/conferences/bio-advanced-business-development-course 

    Who should attend?

    Although this course is recommended for business development professionals with approximately 3-5 years experience, people with less experience have taken it and benefited a great deal. It is designed for business development professionals who have most likely served as part of a business development or licensing team, but are now preparing to move to a senior manager level role within their organization.

    • Business development & licensing professionals
    • Alliance management professionals
    • R&D personnel who have significant interaction with business development
    • Intellectual property personnel involved in the licensing process
    • Biotech company CEOs
    • Professionals who are new to business development and licensing or who have limited deal experience

    Topics Covered in Advanced BD:

    The course will cover basic topics and skills crucial to every business development professional in the industry, including:

    • Valuation Concepts, Tools & Techniques
    • Value Sharing and Deal Terms Structuring
    • Types of IP and Issues in Due Diligence
    • Negotiation and Influence Strategies
    • Key Concepts of a Block Buster Deal
    • Current Trends in Licensing Deals

    *Time varies by day and is subject to change

    Session ID: 2146

    Day/Time:
    2013-04-19

    Track:
    Co-Located Events

    Location of Session:

    • Tags:
      • Advanced
      • Biotech Association
      • Biotech Specialties
      • Business Consulting
      • Business Development
      • Business Intelligence
  • Advanced Business Development Course
    Take your skills to the next level by working directly with colleagues in a hands-on, practical course that is centered around a realistic business

    Take your skills to the next level by working directly with colleagues in a hands-on, practical course that is centered around a realistic business case!

    The Advanced Business Development Course is designed for executives and business development professionals interested in bringing their skills in valuation, deal structuring, due diligence, negotiation and contracts to the next level. During this intense, three-day workshop attendees will receive hands-on, advanced training from veteran business development professionals and legal advisers using real world case studies. In addition, attendees will be split into teams to conduct a mock negotiation over rights for a clinical stage compound.

    Since 2004, this course has been taught exclusively for life science business development professionals by the Biotechnology Industry Organization in collaboration with Licensing Executives Society. The faculty is drawn from among the most experienced business development professionals in the biotech drug development industry as well as big pharma, many of whom have been instructors in other programs, and all of whom have hands-on experience in the biotech industry.

    http://www.bio.org/events/conferences/bio-advanced-business-development-course

    Who should attend?

    Although this course is recommended for business development professionals with approximately 3-5 years experience, people with less experience have taken it and benefited a great deal. It is designed for business development professionals who have most likely served as part of a business development or licensing team, but are now preparing to move to a senior manager level role within their organization.

    • Business development & licensing professionals
    • Alliance management professionals
    • R&D personnel who have significant interaction with business development
    • Intellectual property personnel involved in the licensing process
    • Biotech company CEOs
    • Professionals who are new to business development and licensing or who have limited deal experience

    Topics Covered in Advanced BD:

    The course will cover basic topics and skills crucial to every business development professional in the industry, including:

    • Valuation Concepts, Tools & Techniques
    • Value Sharing and Deal Terms Structuring
    • Types of IP and Issues in Due Diligence
    • Negotiation and Influence Strategies
    • Key Concepts of a Block Buster Deal
    • Current Trends in Licensing Deals

    *Time varies by day and is subject to change

    Session ID: 2147

    Day/Time:
    2013-04-20

    Track:
    Co-Located Events

    Location of Session:

    • Tags:
      • Academic/University
      • Advanced
      • Co-Located Events
      • In-Licensing
      • Out-Licensing
      • Tech Transfer
  • Advanced Business Development Course
    Take your skills to the next level by working directly with colleagues in a hands-on, practical course that is centered around a realistic business

    Take your skills to the next level by working directly with colleagues in a hands-on, practical course that is centered around a realistic business case!

    The Advanced Business Development Course is designed for executives and business development professionals interested in bringing their skills in valuation, deal structuring, due diligence, negotiation and contracts to the next level. During this intense, three-day workshop attendees will receive hands-on, advanced training from veteran business development professionals and legal advisers using real world case studies. In addition, attendees will be split into teams to conduct a mock negotiation over rights for a clinical stage compound.

    Since 2004, this course has been taught exclusively for life science business development professionals by the Biotechnology Industry Organization in collaboration with Licensing Executives Society. The faculty is drawn from among the most experienced business development professionals in the biotech drug development industry as well as big pharma, many of whom have been instructors in other programs, and all of whom have hands-on experience in the biotech industry.

    http://www.bio.org/events/conferences/bio-advanced-business-development-course

    Who should attend?

    Although this course is recommended for business development professionals with approximately 3-5 years experience, people with less experience have taken it and benefited a great deal. It is designed for business development professionals who have most likely served as part of a business development or licensing team, but are now preparing to move to a senior manager level role within their organization.

    • Business development & licensing professionals
    • Alliance management professionals
    • R&D personnel who have significant interaction with business development
    • Intellectual property personnel involved in the licensing process
    • Biotech company CEOs
    • Professionals who are new to business development and licensing or who have limited deal experience

    Topics Covered in Advanced BD:

    The course will cover basic topics and skills crucial to every business development professional in the industry, including:

    • Valuation Concepts, Tools & Techniques
    • Value Sharing and Deal Terms Structuring
    • Types of IP and Issues in Due Diligence
    • Negotiation and Influence Strategies
    • Key Concepts of a Block Buster Deal
    • Current Trends in Licensing Deals

    *Time varies by day and is subject to change

    Session ID: 2148

    Day/Time:
    2013-04-21

    Track:
    Co-Located Events

    Location of Session:

    • Tags:
      • Academic/University
      • Advanced
      • Co-Located Events
      • In-Licensing
      • Out-Licensing
      • Tech Transfer
  • Advances and Emerging Trends in the Swiss Biotech Market
    Switzerland is a leader in biotechnology innovation. Its geographic position, industry and the variety of academia and non-profit organizations have


    Switzerland is a leader in biotechnology innovation. Its geographic position, industry and the variety of academia and non-profit organizations have helped the country forge a unique cluster for the development of a dynamic biotech industry. This presentation focuses on existing and new regulations in the Swiss biotech sector and provides an overview of the impact of ongoing regulatory initiatives on biotech development (statistics), technology transfer successes and regional case studies in a federalistic country.


    www.regenold.com


    Learning Objectives:

    • Develop an understanding of the Swiss biotech sector
    • Gain knowledge on technology transfer methods in Switzerland
    • Discuss the Swiss financing environment and stock exchange and how they impact the biotech sector

    Ability Level: Advanced

    Session ID: 1948

    Day/Time:
    2013-04-22

    Track:
    International Market Briefings Track

    Location of Session:
    Building: S101A

    • Tags:
      • Advanced
      • Biopharmaceuticals
      • Breakout Sessions
      • Drug Discovery/Research & Development
      • Economic Development
      • Education
  • adVENTURES in Academic Partnering
    Pharma's holding tight to its belief that innovative research and major advances in drug discovery often occur within the walls of academia. How can

    Pharma's holding tight to its belief that innovative research and major advances in drug discovery often occur within the walls of academia. How can you best collaborate to allow research to scale the ivy-covered walls and make it to pharma's pipelines? This panel will explore how the pharma industry, academia and early-stage venture investors are experimenting with new business models that will provide the needed funding and flexibility to make these partnerships fruitful to all involved.

    Learning Objectives:

    • Gain perspective on the need for funding and collaboration from the pharma and venture capital (VC) communities
    • Evaluate Big Pharma’s and VC’s perspective on the challenges and benefits of collaborating with the academic community
    • Discuss how new models are translating early science into medicine and leveraging this in more labs

    Ability Level: All

    Session ID: 1932

    Day/Time:
    2013-04-23

    Track:
    Business Development Track

    Location of Session:
    Building: N427BC

    • Tags:
      • Academic/University
      • Breakout Sessions
      • Business Development
      • Business Development Track
      • Drug Discovery/Research & Development
      • Education
  • Affinity and Beyond: The Future of Separation Technologies
    Protein A has been a mainstay of downstream processing for MAbs for more than two decades. Its use with affinity chromatography was particularly

    Protein A has been a mainstay of downstream processing for MAbs for more than two decades. Its use with affinity chromatography was particularly effective in capturing product from supernatants when protein titers were low. With improvements in expression systems producing dramatically higher titers, increasing pressure to reduce costs, and the advent of single-use technologies, new approaches to MAb separations are emerging. This panel will review some of these methods and how they can compete with the legacy of Protein A, as well as discuss how Protein A manufacturers can adapt to a more competitive environment for antibody separations technology.

    Learning Objectives:

    • Review downstream processing landscape and role of Protein A
    • Examine emerging approaches to improved separations capacity and efficiency
    • Outline new technology challenges and barriers to adoption

    Ability Level: All

    Session ID: 1923

    Day/Time:
    2013-04-23

    Track:
    Manufacturing of Biologics and Drugs Track

    Location of Session:
    Building: S402B

    • Tags:
      • Biomanufacturing
      • Bioprocessing
      • Breakout Sessions
      • Education
      • Manufacturing
      • Manufacturing Of Biologics And Drugs Track
  • Affordable Care Act is Here to Stay
    The Patient Protection and Affordable Care Act (ACA) of 2010 includes key provisions that could lead to new and improved treatments, cures and cost

    The Patient Protection and Affordable Care Act (ACA) of 2010 includes key provisions that could lead to new and improved treatments, cures and cost savings for patients.  All of these changes will impact the biotechnology industry and the future of patient access to needed medicines.  This panel will address significant questions concerning the future of biotechnology under ACA and provide insights on what these changes mean for the industry, such as the impact of ACA on patient access to prescription drugs, biologics, and vaccines as well as implications of State decisions on Exchanges, benchmark benefit plans, and Medicaid expansion.  The role of industry in ACA on healthcare innovation and value-based initiatives will also be discussed.

    Session ID: 2089

    Day/Time:
    2013-04-24

    Track:
    Super Sessions

    Location of Session:
    Building: S406 AB

    • Tags:
      • Education
      • Hot Topic
      • Super Sessions
  • Allies in Innovation: Biologics and Cell Therapy Manufacturers Think Small for Big Value
    As biologic and cell therapies that open the door to more personalized and targeted medicine gain momentum, the bioprocessing and cell therapy

    As biologic and cell therapies that open the door to more personalized and targeted medicine gain momentum, the bioprocessing and cell therapy industries are advancing more cost-effective and flexible technologies for producing therapeutics in smaller batch sizes. Advances in the cell therapy industry will be especially relevant to developing biotherapies as cell titers continue to increase. This panel will explore how innovative technologies can bridge the gaps that currently constrain commercial-scale production. A shift in thinking about small-batch production will ultimately provide access to high-quality therapies at the lowest practical cost.

    Learning Objectives:

    • Consider the cost of goods and discuss successful process strategies to offset costs
    • Highlight new technologies that effectively and readily scale and integrate processes
    • Explore the innovation opportunities in existing and new technologies

    Ability Level: Advanced

    Session ID: 1921

    Day/Time:
    2013-04-22

    Track:
    Manufacturing of Biologics and Drugs Track

    Location of Session:
    Building: S402B

    • Tags:
      • Advanced
      • Antibody
      • Antigens
      • Australia
      • Biobased Products
      • Biologics And Immunochemical
  • Alzheimer's Forum
    BIO will host a one-day Alzheimer’s Forum on Wednesday, April 24, during the 2013 BIO International Convention.  The Forum will confront the issues

    BIO will host a one-day Alzheimer’s Forum on Wednesday, April 24, during the 2013 BIO International Convention.  The Forum will confront the issues and roadblocks to finding treatments and cures for this disease.  Panel discussions during the forum will focus on:

     

    -      Biosciences and future hope

    -      Regulatory Considerations and Challenges

    -      Societal and Economic Impact of Alzheimer’s

    Session ID: 1998

    Day/Time:
    2013-04-24

    Track:
    Special Programs

    Location of Session:
    Building: N426 C

    • Tags:
      • Alzheimer's Disease
      • Education
      • Special Programs
  • And Now for Something Completely Different: How Will Pharma Access External Early-Stage Innovation?
    Pharma faces hard realities: the FDA yearly approves enough “new molecular entities” to maintain a robust industry, mergers and acquisitions are

    Pharma faces hard realities: the FDA yearly approves enough “new molecular entities” to maintain a robust industry, mergers and acquisitions are shrinking the field of Big Pharma and large biotechs, and pressure to move late-stage projects through the pipeline is intense. The response? Shift resources to later-stage projects at the expense of higher-risk, early-stage programs. Who will fund early-stage innovation—essential to maintain the drug development pipeline—and how? Panelists representing Merck, Sanofi, and Johnson & Johnson will discuss differentiating themselves from their competitors, enhancing external resources to meet long-term demands, and what pharma may look like in 2018.

    Learning Objectives:

    • Discuss pharma's focus on late-stage drug development at the expense of early-stage drug discovery
    • Describe recent approaches pharma has initiated to leverage external innovation
    • Explore why drug discovery & development process has not progressed at the rate of technical advances

    Ability Level: Advanced

    Session ID: 1911

    Day/Time:
    2013-04-23

    Track:
    Drug Discovery and Development Track

    Location of Session:
    Building: S401A

    • Tags:
      • Academic/University
      • Advanced
      • Breakout Sessions
      • Drug Discovery And Development Track
      • Drug Discovery/Research & Development
      • Education
  • Assessment of PDUFA and FDASIA Implementation: How the Changes are Impacting the Work of Prescription Drug Regulatory Professionals
    The FDA Safety and Innovation Act (FDASIA) passed on July 9, 2012 and implementation started on October 1, 2012. Embedded within FDASIA is the


    The FDA Safety and Innovation Act (FDASIA) passed on July 9, 2012 and implementation started on October 1, 2012. Embedded within FDASIA is the Prescription Drug User Fee Act (PDUFA) Commitment Letter between industry and the FDA, which is intended to restore the FDA’s review performance by strengthening the scientific dialogue and transparency between the FDA and industry sponsors. Understanding the review management changes and regulatory science initiatives the agency has implemented can help biopharma executives get a realistic view of the agency's work streams and performance, which can help them more effectively navigate the regulatory review process. 

    Learning Objectives:

    • Identify FDA work streams being used to implement changes outlined in PDUFA
    • Appropriately assess the FDA’s performance compared to goals made in the PDUFA agreement
    • Discuss the impact of the changes on the overall efficiency and transparency of the review process

    Ability Level: Advanced

    Session ID: 1898

    Day/Time:
    2013-04-23

    Track:
    Achieving Regulatory Approval and Compliance Track

    Location of Session:
    Building: N426A

    • Tags:
      • Achieving Regulatory Approval And Compliance Track
      • Advanced
      • Biopharmaceuticals
      • Breakout Sessions
      • Education
      • Government
  • Association Marketing/Communications Professionals Meetup
    Please join your fellow marketing and communications professionals for a casual Meetup during the BIO International Convention in the Meetup Area,

    Please join your fellow marketing and communications professionals for a casual Meetup during the BIO International Convention in the Meetup Area, Booth #4800. This is a great opportunity to meet and strengthen relationships with those that are in your shoes across the world.

    The BIO International Convention is the year's best opportunity to connect with industry, government, association, and academic bioscience professionals. By attending this Meetup, we hope you'll further develop long-term contacts with other professionals, share ideas, discuss marketing struggles/tactics, talk about new media, etc.

    If you have a suggestion or questions about this Meetup, please email George Goodno at ggoodno@bio.org.

    The Meetup is free to attend but you will need a registration to the BIO International Convention.

    Visit this event on our Meetup website.

     

    Session ID: 2208

    Day/Time:
    2013-04-23

    Track:
    Networking and Evening Events

    Location of Session:
    Building: Meetup Area, Booth #4800

    • Tags:
      • BIO Party List
      • Corporate Communications/Media
      • Meetup
      • Networking
      • Networking And Collaboration
      • Networking And Evening Events
  • Austerity vs. Growth: Will the Life Sciences Be the Next European Bailout?
     Under the weight of Europe’s sovereign-debt crisis, politicians and economists are intensely debating the merits of austerity and fiscal

     Under the weight of Europe’s sovereign-debt crisis, politicians and economists are intensely debating the merits of austerity and fiscal responsibility versus stimulus and collective liability. The current dynamics are taking a heavy toll on the biopharmaceutical industry as governments are implementing austerity measures that include price cuts and rebate reforms for innovative therapeutic products in order to generate savings. The impact for developers, which spend billions annually on R&D, extends far beyond individual markets due to the practice of international reference pricing. Additionally, in some EU countries the outstanding debts to the industry are growing rapidly and may ultimately contribute to drug supply shortages as companies are increasingly forced to take more drastic measures.

    This panel convenes experts from academia and industry to explore the impact of Europe’s economic crisis and resulting austerity programs on the competitiveness of the biopharmaceutical industry.

    Moderator: Joseph Damond, Senior Vice President, International Affairs, BIO

    Speakers:
    Øyvind W. Brekke, Senior Advisor / Senior Vice President, International Healthcare, DNB Bank
    Didier Malherbe, Vice President, Public affairs, UCB
    David A. Talbot, Director, International Government Affairs, Eli Lilly and Comapny

    Ability Level: All

    Session ID: 2132

    Day/Time:
    2013-04-23

    Track:
    International Spotlights & Policy Track

    Location of Session:
    Building: S102A

    • Tags:
      • Breakout Sessions
      • Education
      • International Spotlights & Policy Track
  • Automatic Substitution of Biologics: Who Decides and with what Criteria?
    The first approval of a biosimilar product in the U.S. could happen this year, but how this new category of products will be incorporated into the

    The first approval of a biosimilar product in the U.S. could happen this year, but how this new category of products will be incorporated into the U.S. health care system remains unclear. U.S. biosimilar law is unique in that it permits designation of biological products as interchangeable. However, it is not clear what this will mean in practice and, in particular, whether and under what circumstances automatic substitution, which is widely practiced for small molecule drugs, would be permissible for biological medicines. Although the federal statute defines what can be designated as interchangeable, state law generally governs pharmacy practice and the extent to which pharmacists can substitute a different medicine for the one prescribed. What should a substitution policy include to ensure patient safety while also maximizing savings? How can inappropriate substitutions be avoided?

    Learning Objectives:

    • Raise awareness of the role states play in the implementation of the biosimilar law
    • Review the difference in safety considerations for small and large molecules
    • Consider the criteria that should be applied to ensure automatic substitution is safe for patients

    Ability Level: All

    Session ID: 1879

    Day/Time:
    2013-04-24

    Track:
    Market Access and Commercialization Track

    Location of Session:
    Building: S403B

    • Tags:
      • Biologics And Immunochemical
      • Biology
      • Biopharmaceuticals
      • Biosimilars
      • Breakout Sessions
      • Education