MA CRO/CMO Symposium

Monday, February 25 2013

Agenda

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

Moderator:

  • Timothy C. Atkins, Attorney at Law, Partner, Pepper Hamilton, LLP

Panelists:

  • 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 

Moderator:

  • Yael Schwartz, Ph.D., CEO, President & Director, Hygeia Therapeutics, Inc.; President & CEO, Canterbury Laboratories, LLC

Panelists:

  • 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

Moderator

  • Roger Frechette, Ph.D., Co-Founder and Partner, New England PharmAssociates, LLC

Panelists:

  • 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

Moderator:

  • Mark Trusheim, Principal, Co-Bio Consulting, LLC; Biomanufacturing Executive In Residence, UMass Dartmouth

Panelists:

  • 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

Moderator:

  • Louie Meyers, Partner, Ph.D., JD, Partner, Lando & Anastasi

Panelists:

  • 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)


 

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