MA CRO/CMO Symposium
Monday, February 25 2013
7:30 AM Registration & Breakfast (Exhibit Hall)
8:30 AM Welcome & Opening Remarks
- Ed Price, President, PCI Synthesis
- Cliff Culver, Founder, OnDeckBiotech
Preview of the MA CRO CMO Gateway, a new online initiative to showcase our CRO and CMO community.
8:45 AM Fireside Chat
- Janice Bourque, MBA, Managing Director, Life Sciences, Hercules Technology Growth Capital
- Jose-Maria Fernandez Rodriguez, MBA, Laboratory for Financial Engineering, MIT SLOAN, Sloan Fellow on Innovation & Global Leadership
9:45 AM Recent Approaches in Sourcing
- Timothy C. Atkins, Attorney at Law, Partner, Pepper Hamilton, LLP
- Mark Benjamin, D.Sc., President & CEO, Galenea Corp.
- Sheila Dewitt, Ph.D., President, DeuteRx, LLC
- Mark E. Duggan, Ph.D., VP, Neuroscience, Research & Development, Innovative Medicines, AstraZeneca Neuroscience iMed
- Eileen E. Elliott, Ph.D., Executive Director, External Research R & D, Pfizer Pharmaceuticals
- Steven C. Gilman, Ph.D., Executive VP, R&D & CSO, Cubist Pharmaceuticals
10:15 AM Networking Break (Exhibit Hall)
11:00 AM Breakout Sessions
1. Discovery Through IND-Enabling Studies
- Yael Schwartz, Ph.D., CEO, President & Director, Hygeia Therapeutics, Inc.; President & CEO, Canterbury Laboratories, LLC
- Rod Cole, Ph.D., Director, Analytical Sciences, Cerulean Therapeutics
- Masha Fridkis-Hareli, Ph.D., Adjunct Professor, Graduate Biopharmaceutical Program, Emmanuel College
- Magdalena Leszczyniecka, Ph.D., President & CEO, STC Biologics
- Michael S. Marlow, Ph.D., Staff Scientist, Protein Biochemistry, Regeneron Pharmaceuticals
2. IND to Commercial Manufacturing
- Roger Frechette, Ph.D., Co-Founder and Partner, New England PharmAssociates, LLC
- Russell Doughty, Director, QA, Civitas Therapeutics
- Pete Leone, MBA, Chief Operating Offier/Vice President, Alvos
- Bhavishya Mittal, Ph.D., Scientist II, Formulation Sciences, Millennium: The Takeda Oncology Company
- David Reed, Ph.D., Director, Process Chemistry R&D, ArQule
12:00 PM Lunch in Exhibit Area
1:30 PM Breakout Sessions
1. IND Through Launch: Facilitated Round Table Discussions on 10 Hot Topics - Pick One & Join in on the Active Conversation!
Moderator: Holly O. Coulter, MPH, President & CEO, CE3 Inc.
Risk Based Monitoring
- Table Leader: Greg Dombal, COO, Halloran Consulting Group, Inc.
Evaluating Virtual Teams for Clinical Development
- Table Leader: Michael O'Meara, Executive Director, Clinical Operations, Constellation Pharmaceuticals
The Regulatory: 505 B (2) Process
- Table Leader: Nancy C. Motola, Ph.D., RAC, Principal Consultant, Pharma Regulatory Connection
Negotiations with the FDA About a Novel Target & a High Medical Need
- Table Leader: Christine Bunt, Founder, President & CEO, INTICA Biomedical
Pharmaceutical Development Risk Management – How to anticipate and mitigate risk throughout the development cycle.
- Table Leader: Patricia Seymour, MBA, CSCP, Senior Consultant, BioProcess Technology Consultants, Inc.
Accelerating the Clinical Route to NDA/BLA Submission
- Table Leader: Linda D. Bentley, JD, Member, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Program Management: Effectively Managing Outsourcing Relationships, from Both Sides
- Table Leader: Mary M. Sherman, Ph.D., Principal Consultant, Preclinical & Regulatory Consulting
“When – When is the right time to outsource? How – What to outsource? Hiring an individual vs. a team? Where – Where in the world is your CMO? Quality, Price, and Perception!”
- Table Leader: Eyal S. Ron, Ph.D., Principal, MADASH
Planning for Success - Planning Ahead – How to fit CROs and CMOs into your timelines
- Table Leader: Dennis Goldberg, Ph.D., President & Founder, Benu BioPharma, Inc.;l President & CEO, LipimetiX, LLC.
How might new pharmacogenomic tools and techniques improve new drug development and clinical trials?
- Table Leader: Michael Drues, Ph.D., President, Vascular Sciences
Setting your target product profile; Know what you’ve got & where you are going!
Table Leader: Gary Robinson, Ph.D., CEO, Phase Design Research
2. Early Formulation Development & CMC
- Mark Trusheim, Principal, Co-Bio Consulting, LLC; Biomanufacturing Executive In Residence, UMass Dartmouth
- Mark Moody, Ph.D., Vice President, Analytical Services, Merrimack Pharmaceuticals
- Andrey Peresypkin, Ph.D., Director of Pharmaceutical Chemistry, Vertex Pharmaceuticals
- Zahra Shahrokh, Ph.D., Chief Development Officer, STC Biologics, Inc.
2:30 PM Networking & Refreshment Break
3:15 PM Trends Towards & Best Practices for Use of Virtual Resources
- Louie Meyers, Partner, Ph.D., JD, Partner, Lando & Anastasi
- Abbie Celniker, Ph.D., CEO, Eleven Biotherapeutics
- Bob Linke, President & CEO, Embera NeuroTherapeutics, Inc.
- Albine Martin, Ph.D., COO, Precision-Biologics
- Manuel A. Navia, Ph.D., Entrepreneur-in-Residence, Oxford Biosciences; Founder, eXIthera Pharmaceuticals, LLC
- Alan Watson, Ph.D., M.B.A., Executive-in-Residence, Oxford BioSciences; CEO, Estabrook Pharmaceuticals, Inc.
4:15 PM Closing Remarks
- Robert Coughlin, President & CEO, MassBio
4:30 PM - 6:00 PM Networking Reception (Exhibit Hall)