Overview - Day 1 - Day 2 - Download Brochure
MONDAY, APRIL 6
7:00am Registration and Morning Coffee
8:00 Chairperson’s Opening Remarks
Michael O’Brien, Ph.D., Assistant Vice President Chemistry Development, Wyeth Research
8:10 Keynote Presentation:
Strategic Chemistry Partnerships for Biotechs and Big Pharma - Past, Present & Future
Dinesh V. Patel, Ph.D., President and CEO, Protagonist Therapeutics Inc.
Running a company in the modern global and weakening economy presents unique and unprecedented challenges at the strategic, scientific, and operational level. The critical role of outsourcing chemistry in this context will be discussed. Specific examples encountered while managing outsourced R&D activities from various biotech companies (Affymax, Miikana, Arete, Protagonist) will be shared and analyzed. Future outsourcing trends and opportunities will be highlighted.
8:50 Using the Same Outsourcing Partner for Discovery and Process Chemistry: Opportunities and Challenges
Michael Kolb, Ph.D., Vice President Chemical Development, Wyeth
The talk will discuss a real-time example of outsourcing early-stage process chemistry and scale-up. Pros and cons for the option to use a partner who already works with Discovery are discussed. The presentation will also highlight internal experiences and describe in detail our approach, pitfalls and successes, towards the execution of this endeavor.
9:20 Outsourcing for Early Phase API Development
Bob Edmonston, Associate Director, API Development Sourcing, Alkermes, Inc.
This presentation will focus on how a medium-sized biotechnology company has developed a model for outsourcing API development to support early phase clinical programs. Some challenges of building an outsourcing strategy in uncertain conditions will be highlighted. The specifics of proposal development to vendor selection and chemistry evaluation will be discussed.
9:50 Networking Coffee Break
10:15 Panel Session: A Day in the Life of an Outsourcing Project Manager
Moderator: Dinesh V. Patel, Ph.D., President and CEO, Protagonist Therapeutics Inc.
Panelists:
Bob Edmonston, Associate Director, API Development Sourcing, Alkermes
Michael Kolb, Ph.D., Vice President Chemical Development, Wyeth Research
Anjali Pandey, Ph.D., Vice President Chemistry, Portola Pharmaceuticals
Sylvie K. Sakata, Ph.D., Senior Director of External Research Solutions, Pfizer La Jolla
Evaluating the chemistry
Partnering with the same outsourcing company for process and discovery chemistry
Daily challenges, such as answering your in-house chemist’s question: “What do you mean I don’t have the compound I asked for today?”
Practical issues: shipping samples, database integration and compatibility
Sponsored by
Chandra Rao, Executive Director, LAXAI
This talk will give a snapshot of the advantages of outsourcing to India including an overview of Laxai’s delivery capability and the flexible scalable models of engagement. It will cover Laxai’s strategy on IP protection, project management, communication and metrics.
11:30 Case Study: From Medicinal Chemistry to Phase I Clinical Batch
Andrew Henderson Ph.D., Business Development Manager, Onyx Scientific and Anjali Pandey Ph.D., Vice President, Chemistry, Portola Pharmaceuticals
12:00pm Luncheon Presentation
1:25 Chairperson’s Remarks
Jayshree Mistry, Outsourcing Associate, GlaxoSmithKline R&D Ltd.
1:30 The Day After: Team and Project Integration Once the Deal is Signed
Nailesh Bhatt, Managing Director, Proximare, Inc.
2:00 Panel Session: An Inside View -- Perspective of Chemistry Services Providers
Moderator: Nailesh Bhatt, Managing Director, Proximare, Inc.
Panelists confirmed to date:
Andrew Henderson, Ph.D., Business Development Manager, Onyx
Rob Maddox, President, PharmaCore Inc.
David Zimmermann, Chief Executive Officer, Kalexsyn, Inc.
Pat Noland, Vice President of Pharmaceutical Program Development, ABC Laboratories
Chandra Rao, Executive Director, LAXAI
Criteria and process for hiring staff chemists at outsourcing company
Elements from collaborations that worked well or did not
Chemist to Chemist communications
Changing project scopes/direction
Practical issues: shipping samples, database integration and compatibility
3:00 Sponsored Presentation
3:15 Networking Refreshment Break in the Exhibit Hall
4:00 Outsourcing of Chemistry Services for Early Phase Drug Discovery
Jayshree Mistry, Outsourcing Associate, GlaxoSmithKline R&D Ltd.
This presentation will focus on the outsourcing of chemistry services in the early phase of drug discovery. Effective means of communications, data exchange, and the metrics used to measure success will be highlighted. Specific areas of chemistry services outsourcing of current interest will be discussed.
4:30 Outsourcing Chemistry: Certain Legal Considerations
Anie Roche, Ph.D., Partner, IP Counseling and Patents, Wilson Sonsini Goodrich Rosati
This presentation will address certain key legal items that need to be considered while outsourcing chemistry projects. In particular, intellectual property issues will be discussed along with specific strategies to avoid potential loss of patent rights.
5:00 Session Q&A and Networking
5:30 Reception in the Exhibit Hall
6:30 End of Day One
For more information on speaking opportunities :
Anjani Shah, Conference Director
Cambridge Healthtech Institute
Phone: 917-509-9109
E-mail: ashah@healthtech.com
For Sponsor and Exhibit Information:
Suzanne Carol, Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5452
E-mail: scarroll@healthtech.com