Agenda – 2nd Biosimilar Market Access Strategies Summit

  • Day One
  • Day Two

Day One

 Monday, September 17

9:00AM – 9:15AM

Chairperson’s Opening Remarks
Nacer Hedroug, Director of Global Quality Assurance, Aseptic Vertical, Mylan

9:15AM – 10:00AM

CASE STUDY
Overcoming the Global Challenges of Biosimilar Development

Ruediger Jankowsky, Managing Director, CINFA BIOTECH

10:00AM – 10:45AM

The Biosimilar Business Case
Thomas Sachnik, Strategic Associate to the EVP Commercial Europe, Teva Pharmaceuticals

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

The Role of Biosimilar Pharmacovigilance Regulations
Dr. Niraj Chhaya, Risk Management, Biosimilars, BOEHRINGER INGELHEIM

12:00PM – 1:00PM

Luncheon

1:00PM – 1:45PM

Current Developments in Biosimilars Litigation and Their Impact on Market Access and Commercialization
Ryann M. Muir, Ph.D., Associate, STEPTOE & JOHNSON LLP
John J. Molenda, Ph.D., Partner, STEPTOE & JOHNSON LLP

1:45PM – 2:30PM

Optimize Pricing Strategies to Gain a Better Market Position
Jay Brown, Senior Director, Outpatient Pharmacy Support Services, NOVANT HEALTH

2:30PM – 3:00PM

Networking Break

3:00PM – 3:45PM

PANEL
Manage Payer and Provider Considerations for Market Entry

Sarfaraz Niazi, Adjunct Professor, Department of Biopharmaceutical Sciences, UNIVERSITY OF ILLINOIS AT CHICAGO, COLLEGE OF PHARMACY

3:45PM – 4:30PM

Navigate the Patent Dance and Other Legal Hurdles to Successfully Progress Biosimilars to the Market
Joanna Brougher, Adjunct Professor, CORNELL LAW SCHOOL

4:30PM –

End of Day One


Day Two

 Tuesday, September 18

8:00AM – 9:00AM

Continental Breakfast

9:00AM – 9:15AM

Chairperson’s Recap of Day One
Nacer Hedroug, Director of Global Quality Assurance, Aseptic Vertical, Mylan

9:15AM – 10:00AM

The Interchangeability Guidance, Recent Developments and Options for Seeking Approval of Interchangeable Biologics
Bruce Leicher, Sr. Vice President and General Counsel, MOMENTA PHARMACEUTICALS, INC.

10:00AM – 10:45AM

Recognize Specific Obstacles to the Adoption of Biosimilars
Aaron Hakim, Researcher, YALE UNIVERSITY SCHOOL OF MEDICINE

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

CASE STUDY
Initiate Biosimilar Medicine Trials in the NHS

Divya Chadha Manek, Head, Business Development, NIHR

12:00PM – 1:00PM

Luncheon

1:00PM – 1:45PM

Re-Evaluate Your Marketing Strategies Based on Competition, Risk Analysis and Mitigation
Nacer Hedroug, Director of Global Quality Assurance, Aseptic Vertical, Mylan

1:45PM – 2:30PM

Determine Specific Reasons to Distinguish the Better Option Between Biobetter and Biosimilar
Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MEDIMMUNE

2:30PM – 3:15PM

Discuss the Challenges When Obtaining Approval and Sustaining Market Success
Joseph P. Fuhr, Ph.D., Adjunct Faculty College of Population Health and Professor Emeritus Economics, WIDENER UNIVERSITY

3:15PM – 3:30PM

Summit Closing Remarks
Nacer Hedroug, Director of Global Quality Assurance, Aseptic Vertical, Mylan

3:30PM –

Summit Concludes