With patents for dozens of biologic drugs expected to expire within the next five years, the value of bringing biosimilar alternatives to the market has never been clearer for drug manufacturers. In the United States, the FDA has created an abbreviated licensure pathway for
biosimilars, but many pharmaceutical companies and biotech firms struggle in understanding how-to:
- Provide the pre-clinical and clinical data needed to demonstrate similarity
- The speed and complexity of advancing a biosimilar drug development project
- Design comprehensive clinical trials needed to prove safety and efficacy in humans
It's because of this that we're bringing you the 2nd Annual
Biosimilars Summit. This upcoming February, we'll be discussing some key insights from thought leaders into the biggest challenges in the analytical and clinical phases of
biosimilar drug development, from addressing current regulatory struggles, demonstrating the quality attributes needed to prove interchangeability, and successfully entering the market.
Is your company looking to streamline the processes for:
- Engineering quality attributes in your biosimilar to demonstrate chemical characterization.
- Proving product comparability at the In Vivo and In Vitro testing stages.
- Managing the additional bioanalytical data required by the FDA in the pre-clinical phase.
- Designing effective clinical trial protocols that move your product from Phase I to Phase III.
- Optimizing your operations for managing different clinical trial sites.
- Demonstrating effective parameters for safety, purity, effectiveness and potency to the FDA.
The summit's key presentations include such sessions as:
Pre-Clinical/Analytical- Testing the Molecule to Ensure Compatibility of Immunogenicity in the Human Body and the Drug
- Preparing For the BsUFA: US Regulatory Landscape for Approving Biosimilars
- Characterizing the Critical Quality Attributes of the Protein to Understand which Traits Are Imperative for the New Molecule
Clinical Study- Determining the Right Partnerships: Working Cohesively to Assess the Structure, Function and Bioanalytical Development to Prove an Accurate, Clean and Stable Molecule
- Populating Your Clinical Trial: Determining Patient Interaction, Physician Input and Branding Practices to Market the Trial
- Patient Selection: Picking the Right Patients for the Most Effective Clinical Trial
Market entry- Commercializing a New Product in an Emerging and Existing Market: What to Expect and How to Overcome the Regulatory Barricades
- Addressing the After Effect: Policy, Payers and Pharmacy - Ensuring a Sustainable Biosimilar Market in the US Market
- Educating the Market: Where do physicians fall and what are their concerns?
''Event was very informative; variety of presentation provided; good dialogue; information very relevant.''
AbbVie
2017 Speakers
- Edric Engert, Senior Vice President Biosimilars, Teva Pharmaceuticals
- Joseph McClellan, Vice President Biosimilars Development, Pfizer
- Amit Katiyar, Global Lead Biosimilars, Bristol-Myers Squibb
- Molly Burich, Associate Director, Public Policy- Biosimilars, Pipeline, Reimbursement, Boehringer Ingelheim
- Scott McGoohan, Director, Science and Regulatory Affairs, Biotechnology Industry Organization
- Rakesh Dixit, Vice President, R&D Global Head Biologics Safety Assessment, Pathology and, MedImmune
- Xiaolu Tao, Sr. Director, Clinical Pharmacology, Simere Pharmaceutical
- Bruce Leicher, SVP and General Counsel, Momenta Pharmaceuticals
- Stephan Krause, Director of QA Technical Support, AstraZeneca Biologics
- Elizabeta Zovko, Director of Clinical Development, Novartis
- Linglon Zou, Director of Experimental Immunology, Teva Parmaceuticals
- Penny Zhu, Associate Director Clinical Pharmacologis-Biosimilar Development, Sandoz
Advisory Board
- Edric Engert, Senior Vice President Biosimilars, Teva Pharmaceuticals
- Penny Zhu, Associate Director Clinical Pharmacologis-Biosimilar Development, Sandoz Inc.
- John Caminis, Head of Biosimilars, Shire
- Joseph McClellan, Vice President Biosimilars Development, Pfizer
- Paul Miller, Senior Director, Medical Affairs and Communications, Momenta Pharmaceuticals
Please fill in your name and email to receive the conference agenda of this event.
Pre-Conference Workshop Day - Monday February 20, 2017
- WORKSHOP A: Incorporating Current Public Policies to Better the Patient and Anticipate Potential Regulatory Inclusions in the Developmental Process of a Biosimilar
- WORKSHOP B: Testing the Molecule to Ensure Compatibility of Immunogenicity in the Human Body and the Drug
- WORKSHOP C: Commercializing a New Product in an Emerging and Existing Market: What to Expect and How to Overcome the Regulatory Barricades
Main Conference Day One - Tuesday, February 21, 2017
- Including: Morning Card Exchange Break, Networking Lunch Break, Afternoon Coffee Break
Main Conference Day Two - Wednesday, February 22, 2017
- Including: Morning Demo Drive, Lunch and Learn, Afternoon Coffee Break
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
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Venue
Venue to be confirmedPhiladelphia, PA
AccommodationMore information to follow...
Please note: We will never recommend, approve or appoint any third party rooming service to act on our behalf. Please be extremely wary if you are approached by any such companies. We will always endeavour to negotiate the best available rates for you so please use the Hotel's website link provided.
