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Biosimilars North America

Building on previous success, SMi proudly announces the return of 3rd Annual Biosimilars USA conference to New Jersey in November 2016!

It's without doubts that the biosimilars market present lucrative opportunities for pharmaceuticals and biotech companies. Over the last 12 months, market participants have witnessed revolutionary steps in the US to facilitate commercialization.

It's now time for industry colleagues to act, and to act fast to seize such opportunities. The 3rd A nnual Biosimilars USA meeting will update you with the latest market developments and regulatory updates to ensure you stay at the forefront of this evolving market!


Day 1
8:00
Registration & Coffee
8:30
Chairman's Opening Remarks
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.
8:40
What to Expect? Regulatory Agency's Update on Biosimilars Application
Cindy Cao, Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals, Sandoz Inc
9:20
Regulatory Concerns for Interchangeability - Time to Define and Clarify
Brad Jordan, Director, Regulatory Affairs and R&D Policy, Amgen Inc.
10:00
Put Aside Your Status as a Generic, Biosimilar, Innovator or Sponsor? How Can You Beat the Big Guys? (Part 1)
Robin Chadwick, Principal, Schwegman Lundberg Woessner
10:00
Put Aside Your Status as a Generic, Biosimilar, Innovator or Sponsor? How Can You Beat the Big Guys? (Part 1)
Albin James Nelson, Senior Shareholder, Schwegman Lundberg Woessner
10:50
Morning Coffee & Networking Break
11:20
Biosimilars – Lessons Learned in Europe
Steinar Madsen, Medical Director, Norwegian Medicines Agency
12:00
The Emerging scenario by Biosimilars in Brazil
Andrew Simpson, Scientific Director, Orygen Biotechnologia S/A
12:40
Networking Lunch
13:50
Succeeding with Biosimilars in Canada
George Wyatt, Managing Director, Wyatt Health Management
14:30
Overview of Biosimilars Industry in China
Jianguo Yang, CEO, Abpro Corporation -- China
15:10
Afternoon Tea & Networking Break
15:40
Development of Biosimilars in South Korea
Kevin Kyumin Lee, Partner, Kim & Chang
16:20
Panel Discussion: Who's the Ultimate Winner? Biosimilars vs. Biobetters
17:00
Chairman’s Closing Remarks and Close of Day One
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.
9:10
Characterization of Innovator and Biosimilar Antibody Molecules
T. Shantha Raju, Senior Director of Analytical Sciences, MedImmune Inc.
9:50
The Importance of Early Immunogenicity and Product Quality Assessment (PQA) in Biosimilar Development
Laura Perry, Director of Scientific Affairs – Cell Line Development, Abzena
10:30
Morning Coffee & Networking Break
11:00
Why Successful Commercialization of Biosimilars is Important to Vizient
L. Ross Day, R.Ph. D.P., Director of Pharmacy, Sourcing Operations, Vizient Inc.
11:40
How to Build a Convincing Business Case and Sustainable Model for Biosimilar mAbs
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.
12:20
Networking Lunch
13:30
Biosimilars: Key factors for successful uptake in the market
Rodeina Challand, Director, Challand Biosimilar Consulting
14:10
Biosimilars – From Aspiration to Operations
Edric Engert, SVP Biosimilars, Teva Pharmaceuticals
14:50
Afternoon Tea
15:20
Considerations for Commercial Success
Molly Burich, Associate Director, Public Policy of Biosimilars, Pipeline, Reimbursement , Boehringer Ingelheim Pharmaceuticals, Inc
16:00
Panel Discussion: Marketing and Distribution – Keys to Success
16:40
Chairman’s Closing Remarks and Close of Day Two

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