21-22 February, 2017

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