Massachusetts CRO/CMO Symposium

Monday, May 5 2014

Agenda

7:30 am                Registration and Networking Breakfast in Exhibit Hall

Sponsored by:  

  Toxikon

8:15 am                Welcome & Opening Remarks

Shelley Amster, Principal and Founder, ShelleyCO, LLC, Symposium Coordinator

Raj Rajur, Ph.D., President/CEO, CreaGen Biosciences, MassBio CRO/CMO Co-Chair

8:30 am                Improving the Next Generation Cluster

The Data Speaks Volumes: Summary of MassBio CRO CMO Survey & 2020 Report

Jeff Kiplinger, Ph.D., President & CEO, Averica Discovery Services

John Hallinan, Chief Business Officer, MassBio

Peter Abair, Director, Economic Development & Global Affairs

9:00 am                A Successful Massachusetts CRO – My Personal Journey

Barbara Osband, President & CEO, Cambridge BioMedical

9:15 am                The Virtual Model - Orchestrating Consultants and Distributed Research Organizations

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

Panelists:             Mary Lynne Hedley, Ph.D. President, TESARO

Doris Peterkin, CEO, ONCoPEP, Inc.

Pam Randhawa, CEO, Empiriko

Albine Martin, Ph.D., COO, Precision Biologics

10:00 am             Networking & Refreshment Break in Exhibit Hall

10:45 am             No Industry Standards – What is the Best Metric? Trends with Organizations

Moderator:        Cynthia Berger, Ph.D., Founder, VP, Pion, Inc.

Panelists:             Daniel Curran, MD, MBA, Vice President, Value Creation Therapeutic Area, Takeda Pharmaceutical Company Ltd

Richland Tester, Ph.D., Sr. Manager, Chemistry, Celgene Avilomics Research

James Tornos, Ph.D., Director of Procurement and Outsourcing, Pfizer

11:30 am              Case Studies - It Takes a Village

Case Study #1

Carolyn Green, President and Director, Atreaon, Inc. and Protein Therapeutics; COO, Stealth Peptides - Portfolio Firms of Morningside Technology Advisors

Masha Fridkis-Hareli, Ph.D., Founder and President, ATR, LLC, Co-Chair, Drug Discovery Working Group at MassBio

Michael Settles, Founder and President,   TGA Sciences, Inc.

Sheila G. Magil, Ph.D. Senior Consultant, BioProcess Technology Consultants, Inc.

Case Study #2

Michael S. Singer, MD, Ph.D., CSO & CMO, Topokine Therapeutics, Inc.

Judith Newmark, Ph.D., Program Manager, Toxikon Corporation

Facilitator:          Bhavishya Mittal, Ph.D., Scientist II (Formulation Sciences), Takeda Pharmaceuticals, and MassBio CRO/CMO Co-Chair

 

12:15 pm              Luncheon Networking in Exhibit Hall

Sponsored by:

PCI

1:30 pm               Roundtable Facilitated Discussions on Hot Topics in R & D

Join one of 16 small group discussions on hot topics in the industry. Each roundtable discussion will be led by an industry expert. Check out the list of Roundtable Options.

Facilitator:  Holly O. Coulter, MPH, President & CEO,  Ce3, Inc.

2:30 pm                Refreshment Break Networking in Exhibit Hall

3:00 pm                The Hybrid Model - Integrating Internal and External Resources 

Moderator:      Mukund S. Chorghade, Ph.D., CSO and Founder, THINQ Pharma    

Panelists:     Shengfang Jin, Ph.D., Sr. Director of Biology, Head of Strategic Outsourcing, Agios Pharmaceuticals

Jeff Saunders, Ph.D., VP Small Molecule Discovery, Ember Therapeutics

Margaret Porter Scott, Ph.D., Senior Director Lead Discovery, Epizyme

John D. Williams, Ph.D., Director of Chemistry, Microbiotix, Inc.

3:45 PM                Simplifying the Drug Development Journey From Research to Treatment - Fireside Chat

Emily Hickey, DVM, Ph.D., Corporate Vice President, In Vivo Discovery Research Services Charles River Laboratories

Mark Goldberg, President and Chief Operating Officer, PAREXEL International Corp

John Reddington, Ph.D., VP, Cambridge Biomedical (Facilitator)

4:30 pm                Closing Remarks

Robert Coughlin, President & CEO, MassBio

Shelley Amster, Principal and Founder, ShelleyCO, LLC, Symposium Coordinator

5:00 pm                Networking Reception in Exhibit Hall

 

 

 

ROUNDTABLE OPTIONS

Following the networking luncheon, attendees can choose to join one of 16 different Roundtable Discussions on industry hot topics. Each roundtable discussion will be led by an industry expert.

1.       The Benefits of Strong Relationships Between Technology Transfer Offices and CROs

Table Leader:  Monique Yoakim-Turk, Ph.D., Partner, Technology Development Fund, Associate Director, Technology and Innovation Development Office, Children's Hospital Boston

 2.       Government Grants and Contracts: CRO Support

Table Leader:  Edward H. Kislauskis, Ph.D., Consultant, Founder & General Manager, Nereus Life Sciences

 3.       CRO-CMO as a Grant Contractor, Collaborator, and PI

Table Leader:  Gary LWG Robinson Ph.D., Principal and Founder, PhaseDesign Research

 4.       Selecting the Right CRO to Conduct Preclinical Research in a Virtual or Semi-Virtual Company

Table Leader:  Katherine J. Turner, Ph.D., SVP Research, Scholar Rock LLC

 5.       Outsourcing CMC Analytics; Herding Cats           

Table Leader:  Roderic Cole, Ph.D., CEO, Blue Collar Scientific

 6.       The Value of Biomarker Development to Clients and How It Is Viewed by The FDA

Table Leader:  Peter Maimonis, Ph.D., Consultant, Bioscience International

7.       Vendor Selection for Small Sponsors

Table Leader:  Katie Walsh McCarthy, Principal Consultant, Halloran Consulting Group

8.       505b2 Submissions

Table Leader:  Nancy C. Motola, PhD, RAC, Motola Consulting           

9.       Regulatory Considerations for CMC Development

Table Leader:  Mark Moody, Ph.D.  Consultant

10.   Challenges Working with International CROs

Table Leader:  Tomasz H. Zastawny, PhD, DSc, MSc., CEO,  MTZ US Clinical Research

 11.    Legal and Contracting Strategies That Maximize CRO Partnerships and Ensure Success

Table Leader:  Colleen Surrette Sproul, JD, Principal, Contracts Associates, Inc.

 12.   The Value of a Qualified Program Manager

Table Leader:  Elena Chekhova, Ph.D., Biotine Consultancy

 13.   Drug Substance Outsourcing

Table Leader:  John Petersen, Ph.D., CSO, SynDevRx Pharmaceuticals             

 14.   Formation Development and Drug Product Outsourcing

Table Leader:  Indu Javeri, Ph.D., President, CuriRX  

 15.   The NDA Is In.  Are You Ready For That Audit?

Table Leader:  Sarah Silvers, RQAP-GCP, Associate Director, GCP Process Control and Compliance, Ce3, Inc.

16.   Fostering Collaborations Between Industry & Academia

Table Leader:  Sivappa Rasapalli, Ph.D., Assistant Professor, Department of Chemistry and Biochemistry, Biomedical Engineering and Biotechnology, UMASS Dartmouth

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