Since 2008, the BPI Theater, a 50-seat amphitheater located at the heart of the BioProcess Zone, has provided biopharmaceutical professionals with a dedicated destination to meet, network, listen and learn about the latest scientific and technology trends impacting biopharmaceutical research, development, and manufacturing.
In 2017, this live, three-day, complimentary event consisted of targeted panel discussions and individual presentations focusing on:
Emerging Therapies: ADCs, Recombinant Vaccines, Cell/Gene/Tissue, Bi-specifics, Fusion Proteins, Biosimilars, etc.
Emerging Techniques & Technologies: Continuous Processing, Contract Services, Single-Use Technologies, etc.
View the complete schedule of events and more detail in the myBIO Event Planner.
New Tools to Improve Cell Viability, Purity, and Recovery
11:00 am - 11:20 am
Speaker: Sean Kevlahan, PhD, Chief Executive Officer, Quad Technologies
The most promising areas of translational medical research today, such as CAR-T cancer therapies and stem cell-based regenerative medicine, require scientists to isolate and grow pure, healthy cell populations from complex starting materials such as blood and tissue. This presentation reviews how scientists are leveraging new technologies to improve cell viability, purity, and recovery.
Comparison of adherent cell technologies for the amplification of virus stocks and viral vectors
11:20 am - 11:40 am
Speaker: Yan Zhi, PhD, Program Design, Technical Lead, FUJIFILM Diosynth Biotechnologies
Production of high-titers of viral vectors for vaccine and therapeutic purposes proves difficult to transistion from the production scale at a small research laboratory to a larger manufacturing scale when working with adherent mammalian cell lines. This presentation presents a variety of adherent technologies that can be used for large-scale production of viral vectors.
Covering a Spectrum of New Product Development Technologies - From Cells to Cell Therapy
11:40 am - 12:00 pm
Speaker: Stewart McNaull, PhD, SVP, Business Development, KBI Biopharma, Inc.
By focusing on the science needed to develop emerging therapies, KBI Biopharma uses its experience and foundation of analytical characterization and formulation development, along with proven development and manufacturing capabilities to advance emerging therapy products including bi-specifics, Fc-fusion proteins, biosimilars, and cell therapy products.
Emerging Bio-Therapies and Their Manufacturing Challenges
12:00 pm - 1:00 pm
Emerging therapies using cell and gene therapy, RNAi, T-cell engagers and others, present new and unique manufacturing challenges for biopharmaceutical companies including:
Moderator: Patricia Seymour, Senior Consultant, BioProcess Technology Consultants, Inc.
Marc Better, Vice President Product Sciences, Kite Pharma
Richard Snyder, Chief Scientific Officer, Brammer Bio
Dave Watkins, Director Manufacturing Operations, Alnylam Pharmaceuticals, Inc.
Holger Wesche, Vice President Research, Harpoon Therapeutics, Inc.
Navigating the Road to Commercialization Together: From Development to Market Authorization Application
1:00 pm - 1:20 pm
Speaker: Dr. Cyril Peter, Senior Proposal Manager, Lonza Pharma & Biotech
Submitting a comprehensive file for market authorization application can bring challenges to drug owners who have chosen to collaborate with a CMO for their manufacturing needs. A foundation to a successful validation lifecylce approach can be created by complementing owner-specific know-how with Lonza's tailored solutions for data generation and extensive experience in the regulatory field.
Bio-CMOs: How Their Business Models Have Adapted to Meet the Challenges and Opportunities of the Protein-Based and Emerging Therapy Markets
1:20 pm - 2:00 pm
While the development and manufacture of emerging therapies follow a similar process as protein-based therapies, there are many unique equipment, technology, logistic, and scientific challenges that must be addressed early in the process to ensure greater chance for commercial success. As CMOs have enhanced their experience and capabilities in this niche, outsourcing development and manufacturing has now become a viable option for many companies.
Gil Roth, President, Pharma & Biopharma Outsourcing Association
John Foy, Vice President of Business Management for Biologics, Patheon
Kevin Orfan - Vice President Contract Manufacturing Services, Pfizer CentreOne
Michael A. Riley, VP/GM Catalent Biologics, Catalent
Vic Vinci, Vice President, Chief Scientific Officer, Cook Pharmica
Dr. Mark Wright, Site Lead, ADC, Piramal Pharma Solutions
Increasing cell productivity and quality in mAb production by focusing on a novel target
2:00 pm - 2:20 pm
Speaker: Adam Elhofy, Ph.D., Chief Science Officer, Essential Pharmaceuticals, LLC
The objective of lowering costs by achieving higher mAb titers typically comes at the cost of decreased efficacy. Increasing productivity without sacrificing quality is possible with novel bioprocessing approaches. Cell-Ess is an innovative approach to accomplish the previously contradictory goals of decreasing costs, increasing yield, while improving quality.
Cell, Gene, and Tissue Therapies: Applying Key Lessons from the Evolution and Commercialization of Protein-Based Therapiesg
2:20 - 3:30 pm
After many trials, errors, and milestones, regenerative medicine has become a mainstream part of the biologics industry, supported by at least 670 companies and clinics of all sizes. The purpose of this panel is to: (1) introduce and discuss what key lessons can be gleaned from the evolution of bioprocessing to support the optimal future development of regenerative medicines; (2) review the rapid changes in bioprocessing materials, operator specialization, and the changing utilization of processing rtechnologies shaping the current therapeutic development pathway; and (3) propose expectations of what may happen over the next decade of its maturation.
Moderator: Dr. David Brindley, University of Oxford and Harvard University
David Backer, MBA, Head of Commercial Development, Gene Editing & Novel Modalities, MilliporeSigma
Lynne Frick, Vice President, Business Development, IsoPlexis
Robert Preti, President & CEO, PCT ( A Hitachi Company)
Morrie Ruffin, Managing Partner, Alliance for Regenerative Medicine (ARM)
The Process of and Business Considerations for Innovation in Biomanufacturing: Supplier and End-User Perspectives
11:00 am - 12:00 pm
Due to the omnipresent demands to improve development speed, reduce costs and improve product quality, the biopharmaceutical industry has an ongoing need to evaluate and adopt new technologies in the manufacture and testing of our products. Nevertheless, in addition to the development costs and resources required to implement new technologies, there are significant regulatory, technical and timeline risks, which are amplified in the pharmaceutical industry and act as a brake on innovation. This panel will explore the business considerations for adopting new technologies and the processes used by industry leaders to ensure successful implementation, including perspectives from both suppliers and end-users.
Moderator: Tom Ransohoff, Vice President, BioProcess Technology Consultants, Inc
John Bonham-Carter, Director, Repligen Corporation
Bernard Huyghe, Senior Director, Pfizer
Stewart McNaull, PhD, SVP, Business Development, KBI Biopharma, Inc.
Todd J. Menkhaus, Co-Founder, Nanopareil
Single-Use and Process Development Technologies: Making the Right Choices for Your Process
12:00 pm - 1:00 pm
There is no debate - single-use and process development technologies have become essential, main-stream tools to lower cost and time to market, extended the viability of smaller indication products, and provide flexibility as to where and how products can be manufactured. The question now is: with so many options available, what technologies are best suited for your bioprocess?
Our panel provides answers to how they made their technology decisions; the factors behind their decisions; and using 20/20 hindsight, would they have made a different decision. In addition, the panel discusses how the advent of SUT’s impacted ‘barrier to entry’ or changed their strategy to manufacture in-house or outsource to a CMO.
Moderator: Susan Dexter, Managing Director, Latham Biopharm Group
Magnus Schroeder, Director, Downstream Process Development, CMC Biologics Deborah Harris, Vice President, Operations, Abzena
Stephen Lam, Vice President, Operations, Patheon (Invited)
Advancing the Monoclonal Antibody Therapies of Tomorrow
1:00 pm – 1:20 pm
Developers of cell culture-based therapies need reliable and proven partners with the development and manufacturing experience to support the delivery of therapies to patients. FUJIFILM Diosynth’s Saturn mAb Platform provides regulatory compliant processes, facilities and systems with the potential for providing earlier access to mAb cGMP manufacturing and disposition, allowing our partners to meet critical timelines in their CMC journey.
Speaker: Dr. Thomas Page, Vice President, Engineering and Asset Development, FUJIFILM Diosynth Biotechnologies USA, Inc.
Platforms Everywhere! How to differentiate your vaccine platform in a competitive market
1:20 pm - 2:30 pm
Platform approaches to vaccine drug substance manufacturing play a key role in accelerating the product development cycle time. The benefits are clear in that the patients have earlier access to the treatment and product sponsorinvestments are de-risked from regulatory and manufacturing perspectives.
Vaccines present unique challenges for manufacturing platform development due to the diverse nature of vaccine components. Vaccines may be composed of inactivated whole viruses and bacteria, recombinant proteins, subunit particles, nanoparticles, live attenuated infectious agents, and may include the use of adjuvants. As a result, there are a plethora of techniques available to produce the antigens and ultimately the vaccine. This panel will discuss the practical implementation of a platform approach to vaccine manufacturing, when
platforms are appropriate for vaccines, potential risks, key milestones in platform acceptance and the long-term value of platform approaches.
Moderator: Joshua Speidel, Managing Director, Commercial Practice Team, Latham Biopharm Group
Patrick Lucy, Interim Chief Executive Officer, President and Secretary, Pfenex Inc.,
Bill Taylor, Vice President of Business Development, Protalix BioTherapeutics
Career and Personal Paths to the Corporate Boardroom
11:00 am – 12:00 pm
Women In Bio (WIB) will present a panel of Board Room Ready program graduates for a discussion of the career and personal paths each followed to achieve her goal of sitting on a corporate board.
Among the questions our panelists will discuss are:
When did you consider being on a board?
What advice would you give women in the early to middle stages
of their careers who want to sit on a board?
What do you know now that you wish you had known earlier in your career?
How did you become an accomplished leader in your field?
Moderator: Dawn Hocevar, WIB President
Jennifer Carver, Chief Operating Officer, La Jolla Pharmaceutical Company
Susan Dexter, Managing Partner, Latham BioPharm Group
Theresa Matkovits, Senior Vice President, Head of Drug Development, ContraVir Pharmaceuticals