Main Conference One

7:45 AM - 8:45 AM Registration and Coffee

8:45 AM - 9:00 AM Chairperson Opening Remarks

9:00 AM - 10:00 AM Keynote: Diversifying Your Product and Marketing Strategy to Compete in a Highly Competitive Market

Edric Engert, Senior Vice President Biosimilars, Teva Pharmaceuticals


Edric Engert

Senior Vice President Biosimilars
Teva Pharmaceuticals

10:00 AM - 10:45 AM Addressing the After Effect: Policy, Payers and Pharmacy – Ensuring a Sustainable Biosimilar Market in the US Market

Molly Burich, Associate Director, Public Policy- Biosimilars, Pipeline, Reimbursement, Boehringer Ingelheim


Molly Burich

Associate Director, Public Policy- Biosimilars, Pipeline, Reimbursement
Boehringer Ingelheim

10:45 AM - 11:15 AM Morning Networking Break

11:30 AM - 12:15 PM Preparing For the BsUFA: US Regulatory Landscape for Approving Biosimilars

Kay Holcombe, SVP Science Policy, Biotechnology Innovation Organization


Kay Holcombe

SVP Science Policy
Biotechnology Innovation Organization

12:15 PM - 1:00 PM Perfecting the Balancing Act of Too Little vs Too Much: Alternative Approaches to designing Phase 3 Biosimilars Trials

Tim Clark, Clinical Development Consultant, ICON plc


Tim Clark

Clinical Development Consultant
ICON plc

12:45 PM - 1:45 PM Networking Lunch

3:45 PM - 4:30 PM Quality Attributes that Affect PK/PD and Utilizing Non- Clinical and Clinical PK/PD Data to Address the Residual and Uncertainty to Identify the Quality Attributes

Penny Zhu, Associate Director Clinical Pharmacologis-Biosimilar Development, Sandoz Inc.


Penny Zhu

Associate Director Clinical Pharmacologis-Biosimilar Development
Sandoz Inc.

2:30 PM - 3:30 PM Table 1: PK/PD to Support Biosimilar Development for Ocular Biologics

Xiaolu Tao, Sr. Director, Clinical Pharmacology, Simere Pharmaceutical


Xiaolu Tao

Sr. Director, Clinical Pharmacology
Simere Pharmaceutical

2:30 PM - 3:30 PM Table 2: The Need (or lack thereof) For in-vivo Toxicity Studies In Support of Biosimilars

Jean-Luc Tran, Senior Researcher, GSK


Jean-Luc Tran

Senior Researcher

2:30 PM - 3:30 PM Table 3: Improving Internal Capabilities to Assist Your Team

John Coelho, Global Medical Strategy Leader, Merck & Co


John Coelho

Global Medical Strategy Leader
Merck & Co

3:30 PM - 4:00 PM Afternoon Networking Break

4:00 PM - 5:30 PM Commercializing a Biosimilar: Should the Industry Bend the Fundamentals of Pharma Commercializing?

Saurabh Johri, Global Commerical Head-Biosimilars , Teva Pharmaceuticals


Saurabh Johri

Global Commerical Head-Biosimilars
Teva Pharmaceuticals

5:30 PM - 5:35 PM Chairperson Closing Remarks