The publications on this site are part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726

Informa
Skip to Page Content

Webinars

Biosimilars & Biobetters: Market Access Opportunities and Regulatory Challenges


Given the near-term loss of exclusivity for many best-selling biologics, global manufacturers are exploring the possibility of producing biosimilars or biobetters to extend product pipelines and increase availability of safe and effective lower cost products.

During this webinar, our panel of experts will explore the current regulatory, scientific and market access challenges facing industry engaged in developing biosimilars or biobetters.

They will focus on recent US legislation, emphasizing an abbreviated regulatory pathway yet to be defined by FDA, existing EU regulatory framework and new policies implemented by global public and private payers. They will also provide case studies on lessons learned from approval, pricing and uptake of biosimilar products.

In 90 minutes, you will:

  • Discover global investment opportunities for biosimilar and biobetter molecules
  • Discuss manufacturing and scientific challenges and strategies for the development
  • Discuss how "interchangeability" could impact approvals
  • Lessons learned from recent launches and analogs

For one low price, you and your entire team can take part in this fast-paced, insightful webinar. Best of all, you’ll be able to connect personally with our panelists when we open up the phone lines for live Q&A.

 


 

FEATURED SPEAKERS

Carolyn Finkle

Carolyn Finkle

Vice President of Regulatory Consulting, North America

Catalent Pharma Solutions

Ms. Finkle has over 25 years of scientific and industry experience including 15 years in management of drug and biologic development, quality and regulatory affairs for companies in the U.S. and Canada. Ms. Finkle holds a Master of Science in Chemistry from the University of Toronto, Canada and has a Bachelor of Science in Chemistry from the University of Ottawa, Canada. She has worked in research at Stanford University, the Toronto General Hospital and spent a year as a Foreign Researcher in Chiba University, Japan, prior to her industry managerial appointments.


Saurabh Aggarwal, PhD

Saurabh Aggarwal, PhD

Principal

Novel Health Strategies

Saurabh Aggarwal, PhD is a Principal at Novel Health Strategies. Mr. Aggarwal's expertise areas include pricing strategy, market access, HEOR, cost effectiveness modeling and comparative effectiveness research. He has led strategy projects on several blockbuster oncology, infectious disease, inflammation, cardiovascular and rare disease products. Previously, he was at Sanford Bernstein, IMS Health and Parexel, where he led international and U.S. based projects on drug and device products. Mr. Aggarwal has published articles on the biologics market including 'What's fueling the biotech engine' series in Nature Biotech. He holds a PhD from The Johns Hopkins University.


Microphone

Ronny Gal

Specialty Pharmaceutical Industry Analyst

Sanford C. Bernstein & Co., LLC

Aaron Gal (Ronny) is the specialty pharmaceutical industry analyst at Sanford C. Bernstein & Co., LLC, a leading independent research firm based in New York and London. Mr. Gal provides research and investment insight on specialty and generic pharmaceutical stocks to institutional clients around the world. His work has been recognized in third party surveys such as Institutional Investor and Greenwich Associates. Prior to joining Bernstein, Mr. Gal was spearheading Canon's business development in the life sciences business. Previously, he spent six years with the Boston Consulting Group, advising clients in the Pharmaceutical and health care delivery sectors. Mr. Gal was awarded a PhD from the Massachusetts Institute of Technology and holds a B.Sc from Emory University.

REGISTRATION

Audio CD & Transcript

Audio CD & Transcript

$349

Register

24/7 ENCORE Audio Presentation

24/7 ENCORE Audio Presentation

$349

Register

Cancellations: Webinar registrations may not be cancelled. Registrants may substitute the 24/7 ENCORE Audio Presentation for the Live Webinar at any time. Please contact Customer Care to make substitutions.