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De-Risking Next Generation Biologics 2009
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2009 Agenda
Main Conference: Thursday | Main Conference: Friday
8:00
Registration and Coffee
9:00
Chairperson's Welcome and Opening Remarks
Ken Nicholson, Consultant, Therapeutic Area Strategy, Eli Lilly & Co.
Ken Nicholson, Consultant, Therapeutic Area Strategy, Eli Lilly & Co.
Opening Presentation
9:15
The Future of Biologics: The Complex Interplay of Innovative Molecules, Biobetters and Biosimilars
Biosimilars are poised to exploit the opportunity arising from expiring marketing exclusivity on the leading blockbuster biologics. However, the biologics environment is already facing increasing competitive and pricing pressures and the model of launching incrementally improved next generation molecules is likely over. Consequently, biobetters and truly innovative biologics must offer significant benefit to clinicians, patients and payers to be successful.
Jeffrey M. Bockman, Ph.D., Vice President, Defined Health
Biosimilars are poised to exploit the opportunity arising from expiring marketing exclusivity on the leading blockbuster biologics. However, the biologics environment is already facing increasing competitive and pricing pressures and the model of launching incrementally improved next generation molecules is likely over. Consequently, biobetters and truly innovative biologics must offer significant benefit to clinicians, patients and payers to be successful.
Jeffrey M. Bockman, Ph.D., Vice President, Defined Health
Strategies and Business Models to De-Risk Biologics Drug Development and Develop a Competitive Edge
9:45
Biobetters and Biosimilars: Similarities and Differences
Forums on biosimilars, or follow-on biologics, frequently touch upon the idea of biobetters. To some, biobetters represent the key differentiation of a biosimilar strategy, the competitive edge that distinguishes one biosimilar from the rest. To others, "biobetters" is merely a made-up word. Learn what biobetters are and where they fall in the continuum from biosimilar to innovative bioproduct. Discuss the roles of post-translational modifications, formulation techniques, and drug delivery technologies in defining biobetters. And consider the legal and regulatory implications of a biobetter drug.
Ken Nicholson, Consultant, Therapeutic Area Strategy, Eli Lilly & Co.
Forums on biosimilars, or follow-on biologics, frequently touch upon the idea of biobetters. To some, biobetters represent the key differentiation of a biosimilar strategy, the competitive edge that distinguishes one biosimilar from the rest. To others, "biobetters" is merely a made-up word. Learn what biobetters are and where they fall in the continuum from biosimilar to innovative bioproduct. Discuss the roles of post-translational modifications, formulation techniques, and drug delivery technologies in defining biobetters. And consider the legal and regulatory implications of a biobetter drug.
Ken Nicholson, Consultant, Therapeutic Area Strategy, Eli Lilly & Co.
10:15
Networking Refreshment Break
10:45
Development Strategies for Follow-on Biologics/Biosimilars and Biobetters
Development of follow-on biologics/biosimilars and biobetters requires an early understanding of the product candidate's molecular features and biological activities as well as the regulatory requirements in place (or under consideration) in the markets of interest. Development of these products requires significant technical expertise, investment and capabilities as well. This presentation will discuss Merck's view of the emerging product opportunity landscape in biologic drug development.
Kenneth G. Surowitz, Ph.D., Senior Director, Worldwide Regulatory Affairs, Merck Research Laboratories
Development of follow-on biologics/biosimilars and biobetters requires an early understanding of the product candidate's molecular features and biological activities as well as the regulatory requirements in place (or under consideration) in the markets of interest. Development of these products requires significant technical expertise, investment and capabilities as well. This presentation will discuss Merck's view of the emerging product opportunity landscape in biologic drug development.
Kenneth G. Surowitz, Ph.D., Senior Director, Worldwide Regulatory Affairs, Merck Research Laboratories
11:15
Business Models for Developing a Successful Follow-on Biologics Business - Opportunities and Pitfalls
By all projections, biologics drugs will continue to serve as the major driver for drug development in the foreseeable future. Successful biologics drug development, presents a formidable challenge when one considers the current knowledge boundaries that exist in the industry. However, there have been significant advances in recent years in analytical approaches, biologics production technologies, mechanism of action understanding, novel targets and clinical outcomes. Leveraging these advances with the evolving regulatory and market framework presents significant opportunities and challenges for developing a biologics business.
Ganesh Venkataraman, Ph.D., Co-founder and Chief Scientific Officer, Momenta Pharmaceuticals, Inc.
By all projections, biologics drugs will continue to serve as the major driver for drug development in the foreseeable future. Successful biologics drug development, presents a formidable challenge when one considers the current knowledge boundaries that exist in the industry. However, there have been significant advances in recent years in analytical approaches, biologics production technologies, mechanism of action understanding, novel targets and clinical outcomes. Leveraging these advances with the evolving regulatory and market framework presents significant opportunities and challenges for developing a biologics business.
Ganesh Venkataraman, Ph.D., Co-founder and Chief Scientific Officer, Momenta Pharmaceuticals, Inc.
11:45
Networking Luncheon
Development of Biobetters: Improved Versions of Existing Biologics
1:00
Biobetters in a Changing World: How Smart Follow-on Antibody Development Can Still Create a Glittering Future for Innovator Companies in the Antibody Space
The U.S. market is rightly regarded as the coliseum of new drugs, where competition is fiercer than ever, health spending is even tighter, and the future of generic competition in biologics is fast becoming a reality. How will these changes affect the business case for novel antibody development? Is it better to strive for improved function in a biobetter molecule, or simply to plan to copy an existing product? How will these developments, which may take many years to come into full existence, affect the business decisions we take now in respect of which programs to support?
Steve Bryant, Ph.D., Senior Director, Business Development, Genmab, Inc.
The U.S. market is rightly regarded as the coliseum of new drugs, where competition is fiercer than ever, health spending is even tighter, and the future of generic competition in biologics is fast becoming a reality. How will these changes affect the business case for novel antibody development? Is it better to strive for improved function in a biobetter molecule, or simply to plan to copy an existing product? How will these developments, which may take many years to come into full existence, affect the business decisions we take now in respect of which programs to support?
Steve Bryant, Ph.D., Senior Director, Business Development, Genmab, Inc.
1:30
Balancing Risk and Value in Antibody Pipelines
While antibody drug safety has come under the spotlight in recent times, statistically, most of the risk is in the target. Most, if not all, efficacy and toxicity seen with an antibody drug is on-target. The only way to offset this risk is to develop a me-too or me-better product against a clinically validated target and proven mechanism of action. Me-too or me-better approaches trade technical risk for commercial risk, but the profiles and processes for these two types of programs is completely different.
Kevin Johnson, Ph.D., Chief Executive Officer, PanGenetics, United Kingdom
While antibody drug safety has come under the spotlight in recent times, statistically, most of the risk is in the target. Most, if not all, efficacy and toxicity seen with an antibody drug is on-target. The only way to offset this risk is to develop a me-too or me-better product against a clinically validated target and proven mechanism of action. Me-too or me-better approaches trade technical risk for commercial risk, but the profiles and processes for these two types of programs is completely different.
Kevin Johnson, Ph.D., Chief Executive Officer, PanGenetics, United Kingdom
2:00
Alternative Scaffolds as Biobetters: A New Biotherapeutic Platform for J&J
Alternative scaffolds have unique properties that enable novel therapeutic applications. Their biophysical properties will allow these "biobetters" to be administered by novel routes, thereby increasing the number and types of druggable targets, and their stability and solubility allow the development of unique formulations. J&J plans to exploit these properties.
Steve Jacobs, Ph.D., Principal Research Scientist, Centyrex Venture, Johnson & Johnson
Alternative scaffolds have unique properties that enable novel therapeutic applications. Their biophysical properties will allow these "biobetters" to be administered by novel routes, thereby increasing the number and types of druggable targets, and their stability and solubility allow the development of unique formulations. J&J plans to exploit these properties.
Steve Jacobs, Ph.D., Principal Research Scientist, Centyrex Venture, Johnson & Johnson
Panel Discussion
2:30
Developing a Competitive Advantage in Biologics Drug Development
Steve Bryant, Ph.D., Senior Director, Business Development, Genmab, Inc.
- How to develop a competitive advantage in the changing biologics space?
- Can you play opportunistically in the biosimilars arena or is a fully committed strategy required?
- Biobetters vs. biosimilars - similarities and differences
- How to protect success of innovative products in the changing market?
- The role of new technologies in capturing value
Steve Bryant, Ph.D., Senior Director, Business Development, Genmab, Inc.
3:00
Networking Refreshment Break
Building Technology Capabilities as a Strategy to Share in the Growing Biologics Market
3:30
Enabling Biobetter Follow-on Products Using a Recombinant Polymer, rPEG: Amunix' Science and Business Strategy
Follow-on biologics provide an opportunity to improve on the characteristics of the original drug, differentiating the follow-on as a biobetter rather than a biosimilar. Amunix has developed rPEG technology which allows optimization of the PK/PD profile of a protein drug, as well as the potential to improve the safety, immunogenicity, route of administration, and manufacturing properties. This presentation will discuss our business model to leverage this technology and internal proprietary molecules
Josh Silverman, Vice President Product Development, Amunix
Follow-on biologics provide an opportunity to improve on the characteristics of the original drug, differentiating the follow-on as a biobetter rather than a biosimilar. Amunix has developed rPEG technology which allows optimization of the PK/PD profile of a protein drug, as well as the potential to improve the safety, immunogenicity, route of administration, and manufacturing properties. This presentation will discuss our business model to leverage this technology and internal proprietary molecules
Josh Silverman, Vice President Product Development, Amunix
3:55
Enhancing PK and Other Properties for Biobetter Antibodies: Xencor's Science and Business Strategy
Building enhancements into clinically validated antibodies to create biobetters offers a compelling alternative to the biosimilars approach. We have created and validated a suite of antibody Fc variants that enhance in vivo pharmacokinetics and/or cytotoxicity of targeted antibodies. These modifications have been shown to improve half-life and efficacy in mouse and cynomolgus monkey studies, and thus have the potential to confer commercially superior properties onto off-patent antibodies, including more convenient dosing, lower cost of goods, and improved efficacy.
John Desjarlais, Ph.D., Vice President, Research, Xencor
Building enhancements into clinically validated antibodies to create biobetters offers a compelling alternative to the biosimilars approach. We have created and validated a suite of antibody Fc variants that enhance in vivo pharmacokinetics and/or cytotoxicity of targeted antibodies. These modifications have been shown to improve half-life and efficacy in mouse and cynomolgus monkey studies, and thus have the potential to confer commercially superior properties onto off-patent antibodies, including more convenient dosing, lower cost of goods, and improved efficacy.
John Desjarlais, Ph.D., Vice President, Research, Xencor
4:20
Glyco-engineered Yeast for the Production of Novel and Follow-on Biologics
Abstract not available at time of print.
Natarajan Sethuraman, Ph.D., Senior Director and GlycoFi Site Head, Merck
Abstract not available at time of print.
Natarajan Sethuraman, Ph.D., Senior Director and GlycoFi Site Head, Merck
4:45
Development of "Biobetter" Monoclonal Antibodies Using RabMAbs
In this presentation, a technology overview will be combined with specific examples of therapeutic development and our business model for biobetter drug development. Rabbit monoclonal antibodies (RabMAbs) have picomolar affinities and recognize diverse epitopes. Therapeutic candidates more potent than clinical benchmarks were humanized using the proprietary mutational lineage guided humanization method. Two Humanized RabMAbs entered preclinical studies through partnerships and IND filing is expected in 18 months. Humanized RabMAbs against known targets therefore represent a novel class of "biobetter" therapeutic antibodies.
Guo-Liang Yu, Ph.D., Chairman and CEO, Epitomics, Inc.
In this presentation, a technology overview will be combined with specific examples of therapeutic development and our business model for biobetter drug development. Rabbit monoclonal antibodies (RabMAbs) have picomolar affinities and recognize diverse epitopes. Therapeutic candidates more potent than clinical benchmarks were humanized using the proprietary mutational lineage guided humanization method. Two Humanized RabMAbs entered preclinical studies through partnerships and IND filing is expected in 18 months. Humanized RabMAbs against known targets therefore represent a novel class of "biobetter" therapeutic antibodies.
Guo-Liang Yu, Ph.D., Chairman and CEO, Epitomics, Inc.
5:10
Innovative Manufacturing: The True Key to COGS Reduction for Biosimilars and Biobetters
For high-volume products such as monoclonal antibodies, it will be difficult for biosimilar developers using traditional cell culture processes to compete with the COGS enjoyed by innovator companies operating at capacities that offer significant economies of scale. Transgenic production provides a low-risk route for the development and manufacture of high-volume biosimilar and biobetter products such as monoclonal antibodies. This presentation will discuss GTC's strategy to capitalize on the biologics market through development of innovative technology and an internal product line of biobetters and biosimilars.
Ashley Lawton, Ph.D., Vice President, Business Development & GM, Biosimilars, GTC Biotherapeutics
For high-volume products such as monoclonal antibodies, it will be difficult for biosimilar developers using traditional cell culture processes to compete with the COGS enjoyed by innovator companies operating at capacities that offer significant economies of scale. Transgenic production provides a low-risk route for the development and manufacture of high-volume biosimilar and biobetter products such as monoclonal antibodies. This presentation will discuss GTC's strategy to capitalize on the biologics market through development of innovative technology and an internal product line of biobetters and biosimilars.
Ashley Lawton, Ph.D., Vice President, Business Development & GM, Biosimilars, GTC Biotherapeutics
5:35
Close of Day One
Main Conference: Thursday | Main Conference: Friday
7:45
Coffee
8:15
Chairperson's Remarks
Aaron (Ronny) Gal, Ph.D., Senior Research Analyst, Sanford C. Bernstein
Aaron (Ronny) Gal, Ph.D., Senior Research Analyst, Sanford C. Bernstein
The Evolving Market Landscape of Biosimilars
8:30
Eight Thoughts on Biosimilars
Biosimilars are now moving from the concept stage to the pipeline stage - targets are defined, business plans gain substance, budgets are put together and time to market/ revenue goal are (gulp) being committed to. In this talk, we will attempt to put some boundaries around the likely shape of the business. What are the challenges in coming to market, what will be the marketplace challenges, how will the competition shape up and what will be the likely economics of the business?
Aaron (Ronny) Gal, Ph.D., Senior Research Analyst, Sanford C. Bernstein
Biosimilars are now moving from the concept stage to the pipeline stage - targets are defined, business plans gain substance, budgets are put together and time to market/ revenue goal are (gulp) being committed to. In this talk, we will attempt to put some boundaries around the likely shape of the business. What are the challenges in coming to market, what will be the marketplace challenges, how will the competition shape up and what will be the likely economics of the business?
Aaron (Ronny) Gal, Ph.D., Senior Research Analyst, Sanford C. Bernstein
9:00
No Man's Land Revisited: Evolving Investment Patterns and Business Models
A review of recent industry developments in the context of the previous paper, "Avoiding No Man's Land: Potential Unintended Consequences of Follow-on Biologics" will be discussed. How have biotech investment patterns changed during 2009? What new business models are being explored? What could this mean for the future shape of the industry?
Terri Hisey, Vice Chairman, US Lifesciences Leader, Deloitte LLP
A review of recent industry developments in the context of the previous paper, "Avoiding No Man's Land: Potential Unintended Consequences of Follow-on Biologics" will be discussed. How have biotech investment patterns changed during 2009? What new business models are being explored? What could this mean for the future shape of the industry?
Terri Hisey, Vice Chairman, US Lifesciences Leader, Deloitte LLP
9:30
Analysis of Healthcare Reform, Evolving Business Models and the Revenue/Cost Implications for Biosimilars and Biobetters
This presentation will discuss the emerging environment for healthcare reform and our analysis of the potential impact on the development of biosimilars and biobetters, as well other ramifications for drug developers.
Jon Glaudemans, Senior Vice President, Avalere Health
This presentation will discuss the emerging environment for healthcare reform and our analysis of the potential impact on the development of biosimilars and biobetters, as well other ramifications for drug developers.
Jon Glaudemans, Senior Vice President, Avalere Health
10:00
Networking Refreshment Break
10:30
Legislating an Abbreviated Approval Pathway for Follow-on Biologics
This presentation will discuss the ongoing debate regarding proposals to generate an abbreviated approval pathway for follow-on biologics. In addition to presenting his own research on the optimal period of market protection for originator drugs, the presenter will review the important economic, legal and scientific research informing this discussion.
Alex Brill, CEO, Matrix Global Advisors; Former Senior Advisor and Chief Economist, House Ways and Means Committee
This presentation will discuss the ongoing debate regarding proposals to generate an abbreviated approval pathway for follow-on biologics. In addition to presenting his own research on the optimal period of market protection for originator drugs, the presenter will review the important economic, legal and scientific research informing this discussion.
Alex Brill, CEO, Matrix Global Advisors; Former Senior Advisor and Chief Economist, House Ways and Means Committee
11:00
Physician and Payer Perceptions of Biosimilars: Barriers and Opportunities
While biosimilars may seem financially compelling to some parties, cost savings will not be fully realized without physician acceptance. Year-over-year, Decision Resources' primary research has shown a trend toward both awareness of and reluctance to prescribe biosimilars among physicians. This presentation will examine evolving physician and payer perceptions and how these changes affect forecast sales of brands and biosimilars.
Michael J. Malecki, Ph.D., Product Manager, New Products, Decision Resources
While biosimilars may seem financially compelling to some parties, cost savings will not be fully realized without physician acceptance. Year-over-year, Decision Resources' primary research has shown a trend toward both awareness of and reluctance to prescribe biosimilars among physicians. This presentation will examine evolving physician and payer perceptions and how these changes affect forecast sales of brands and biosimilars.
Michael J. Malecki, Ph.D., Product Manager, New Products, Decision Resources
11:30
Lunch on your own
12:45
Afternoon Chairperson's Remarks
Blair Fraser, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.
Blair Fraser, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.
Regulatory and Commercial Experiences in Different Markets
12:50
Overview of the US Regulatory Landscape for Biosimilars
Many scientific and regulatory issues continue to litter the US landscape for biosimilars. Introduction of these follow-on versions of protein products has been impeded by the lack of a clear regulatory path, a lack that may be remedied by pending legislation. Even with a path forward, the quality, safety, and effectiveness of protein products continue to be a concern of the Food and Drug Administration.
Blair Fraser, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.
Many scientific and regulatory issues continue to litter the US landscape for biosimilars. Introduction of these follow-on versions of protein products has been impeded by the lack of a clear regulatory path, a lack that may be remedied by pending legislation. Even with a path forward, the quality, safety, and effectiveness of protein products continue to be a concern of the Food and Drug Administration.
Blair Fraser, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.
1:15
European Hands-on Experience with Biosimilars: Lessons Learned
Many companies have developed follow-on versions of biologics. But, only a handful of those companies have succeeded in getting their products approved in the EU under stringent biosimilar guidelines and then subsequently launched into this highly regulated market consisting of 27 member states. We will evaluate the guidelines in place, the biosimilars approved, as well as those rejected by the EMEA so far. Furthermore, we will address the clinical and market experience in the EU as well as the potential influence for the US market.
Mateja Urlep, Founder & CEO, TikhePharma; Former Global Head of Marketing and Medical, Sandoz Biopharmaceuticals, Slovenia
Many companies have developed follow-on versions of biologics. But, only a handful of those companies have succeeded in getting their products approved in the EU under stringent biosimilar guidelines and then subsequently launched into this highly regulated market consisting of 27 member states. We will evaluate the guidelines in place, the biosimilars approved, as well as those rejected by the EMEA so far. Furthermore, we will address the clinical and market experience in the EU as well as the potential influence for the US market.
Mateja Urlep, Founder & CEO, TikhePharma; Former Global Head of Marketing and Medical, Sandoz Biopharmaceuticals, Slovenia
1:45
Comparability Exercise during Monoclonal Antibody Biosimilar Development: How Similar is Similar?
There is much interest in analytical testing and characterization for demonstrating comparability of biosimilars to the reference product. A case study will be presented about the comparability studies of a monoclonal antibody biosimilar, which includes in-depth physicochemical and biological analyses to define the development target, continuous comparison and a final comparability exercise for confirmation of achieved similarity.
Zheru Zhang, Ph.D., Director, Analytical Development, Celltrion, South Korea
There is much interest in analytical testing and characterization for demonstrating comparability of biosimilars to the reference product. A case study will be presented about the comparability studies of a monoclonal antibody biosimilar, which includes in-depth physicochemical and biological analyses to define the development target, continuous comparison and a final comparability exercise for confirmation of achieved similarity.
Zheru Zhang, Ph.D., Director, Analytical Development, Celltrion, South Korea
2:15
Networking Refreshment Break
Global Experiences in Biosimilar Development: Translating Success to the US and European Markets
2:45
Developing High-Quality Etanercept in China per ICH Standards: Science and Business Strategy of Translating Biosimilars in China into US/EU Markets
Many companies have established products such as EPO or interferon approved in different countries such as China and India. Successful launch of these products in less-developed countries is a good start point for biosimilar development. However there are many more hurdles to developing these products as biosimilars for the US/EU market. In this talk, our strategy of developing biosimilars for US/EU markets are highlighted.
Chris Chen, Ph.D., Chief Operating Officer, Shanghai Celgen Biopharmaceuticals, China
Many companies have established products such as EPO or interferon approved in different countries such as China and India. Successful launch of these products in less-developed countries is a good start point for biosimilar development. However there are many more hurdles to developing these products as biosimilars for the US/EU market. In this talk, our strategy of developing biosimilars for US/EU markets are highlighted.
Chris Chen, Ph.D., Chief Operating Officer, Shanghai Celgen Biopharmaceuticals, China
3:15
Translating Experiences in Emerging Markets to Success in the US and Europe
This presentation will discuss Dr. Reddy's experiences in developing biosimilars in emerging markets, and how we aim to translate these lessons learned into successful product launches in other geographic regions. It will also discuss our view of the emerging global landscape of biosimilars and the role that Dr. Reddy's plans to play in the future.
Raghav Chari, Ph.D., Senior Vice President, Dr. Reddy's Laboratories, Inc., India
This presentation will discuss Dr. Reddy's experiences in developing biosimilars in emerging markets, and how we aim to translate these lessons learned into successful product launches in other geographic regions. It will also discuss our view of the emerging global landscape of biosimilars and the role that Dr. Reddy's plans to play in the future.
Raghav Chari, Ph.D., Senior Vice President, Dr. Reddy's Laboratories, Inc., India
3:45
Biosimilars in China: Opportunities and Challenges
To meet with the challenging healthcare demand for safer, less expensive and efficacious drugs, biosimilar product development is attracting worldwide attention. This presentation will provide a brief overview of the current Chinese biosimilars market as well as the SFDA regulatory guidelines in dealing with the development of biosimilar drugs. It will also discuss the efforts of 3SBio in developing biosimilars for the world market.
Yingfei Wei, Ph.D., Chief Scientific Officer, 3SBio, Inc., China
To meet with the challenging healthcare demand for safer, less expensive and efficacious drugs, biosimilar product development is attracting worldwide attention. This presentation will provide a brief overview of the current Chinese biosimilars market as well as the SFDA regulatory guidelines in dealing with the development of biosimilar drugs. It will also discuss the efforts of 3SBio in developing biosimilars for the world market.
Yingfei Wei, Ph.D., Chief Scientific Officer, 3SBio, Inc., China
4:15
Hypes and Hopes: The Opportunities and Challenges for the Development of Biosimilars in China
Abstract not available at time of print.
Yining Zhao, PhD., Associate Research Fellow, Strategy Management Group, Pfizer, Inc.
Abstract not available at time of print.
Yining Zhao, PhD., Associate Research Fellow, Strategy Management Group, Pfizer, Inc.
4:45
Close of Conference
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