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Hyatt Regency Bethesda

Sep 28, 2015 7:30 AM - Sep 29, 2015 4:30 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development

Engage with key regulators and partners in practical approaches to navigate regulatory requirements, enhance collaboration and accelerate combination product development.

Session 4: Collaboration in the Industry

Session Chair(s)

James A. Boiani, JD, MS

James A. Boiani, JD, MS

Partner

Epstein Becker & Green, P.C., United States

Winifred  Wu, MBA

Winifred Wu, MBA

President and Principal Advisor

Strategic Regulatory Partners, LLC, United States

Developing combination products often requires collaboration between drug, device, and biological product manufacturers. Partner relationships can range from joint development/joint ventures to working with key suppliers, to co-marketing. Business development professionals will share their best practices and challenges when collaborating with business partners. In this session, attendees will hear several scenarios of the diverse types of collaboration through presentations from multiple companies.

Speaker(s)

Aaron  Kemp

Collaboration in the Industry

Aaron Kemp

BD Medical, Pharmaceutical Systems, United States

Senior R&D Manager

Kirsten H. Paulson, MS, RAC

Coordinating Quality Systems with Partners

Kirsten H. Paulson, MS, RAC

Pfizer, Inc., United States

Brenda K. Schultz, MBA, RN

Managing Successful Partnerships: From Novel Therapy Development Through Commercialization

Brenda K. Schultz, MBA, RN

Medtronic, United States

Senior Principal, Strategic Alliance Management

Sandy  Koppenol, PhD, MS

Building Strong Technical Relationships: A Lifelong Commitment

Sandy Koppenol, PhD, MS

Gilead Sciences, United States

Senior Research Scientist II

Christopher J. Kurtz

Supplier Selection Process for Devices in Combination Products

Christopher J. Kurtz

AbbVie, United States

Vice President, Drug Device Industrialization

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