Clinical Trials Committee

The Vision

The objective of the Clinical Trials Committee is to engage the BioNJ Membership to work hand in hand with BioNJ leadership to further the mission of the organization by creating a vibrant clinical trials community and biotechnology industry in New Jersey, thereby, building upon a foundation of excellence here in New Jersey as a differentiating factor for the State. This Committee is to be a resource for all Members of BioNJ by helping the organization keep pace with changing trends, communicate industry successes and work to increase BioNJ and New Jersey’s reputation as a compelling and collaborative place for the industry to locate and prosper.

Distinguished Panelists at October 5, 2011 Clinical Trials Breakfast Briefing

Background

BioNJ released a Clinical Trials Master Service Agreement which is intended to enable, encourage and streamline the path for clinical trials Phases 2–4 by providing a template of an agreement between two entities. The purpose is to shorten the negotiation time for translation studies being conducted at New Jersey institutions, and as a result, freeing up much needed resources and time for research. Developed by a Working Group including BioNJ; Rutgers, The State University of New Jersey; and the law firm of Sheppard Mullin Richter & Hampton LLP, the agreement has been reviewed and endorsed by Rutgers University and Rowan University as well as a number of BioNJ’s Member companies.

The Form

The form is available by contacting BioNJ at BioNJ@BioNJ.org (use MSA in the subject line). While some studies may require modification to the form for a specific trial’s needs, the form provides a reliable starting point for Sponsors collaborating with New Jersey research institutions.

Suggestions for improvements to the form or questions regarding its’ provisions, should be submitted to BioNJ@BioNJ.org. They will be considered for future updates.

Continuing Efforts of the Working Group

The Working Group is continuing its efforts and will now turn to a Guidance Document that will help BioNJ Members and users of the form better understand key issues raised therein. Once the Guidance Document is complete, the Working Group will consider other forms, such as, forms for Letters of Indemnification, Guidance on Subject Injury and Sponsor Insurance Coverages. These documents will only be available to BioNJ Members.


Acknowledgments

BioNJ gratefully acknowledges the contributions of the following individuals and organizations in the development of this document.


BioNJ
Spiro Rombotis, President and CEO of Cyclacel Pharmaceuticals, Inc., Chair of the BioNJ Translational Institute of New Jersey Committee and BioNJ Board Member

Bristol-Myers Squibb

Cyclacel Pharmaceuticals

NPS Pharmaceuticals

Rowan University
Carl Hock, Ph.D., Associate Dean for Research at Rowan School of Osteopathic Medicine
Julie Kligerman, Associate Counsel for Health Services
Sreekant Murthy, Ph.D., Chief Research Compliance Officer
Sanofi
Rutgers University
Sean Cornely, Esq., Associate and graduate of Rutgers
Terra Pfund Kroll, Corporate Contracts, Office of Research and Economic Development
Michael Nagy, Director, Office of the Senior Vice President and General Counsel
Kathleen Scotto, Ph.D., Vice Chancellor for Research, Rutgers Biomedical and Health Sciences and BioNJ Board Advisor
Vince Smeraglia, Executive Director of the Office of Technology Commercialization

Endorsements

The following organizations have reviewed and endorsed the Clinical Trials Master Service Agreement.

BioNJ
Rutgers University
Rowan University

For more information, please click here to read a press release issued by BioNJ.

Upcoming Events

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Committee Members

Spiro Rombotis, BioNJ Board Member and Committee Co-Chair, Cyclacel Pharmaceuticals, Inc.
Ülo Palm, M.D., Ph.D., M.B.A., ASQ-CMQ/OE, Committee Co-Chair, Actavis, Inc.
Kim Joyce Baez, Senior Manager, Clinical Operations, Helsinn Therapeutics, Inc.
Andrew Brooks, Ph.D., Chief Operating Officer, RUCDR Infinite Biologics
Barbara Brown, Clinical Research Manager, Virtua Health
Denise Dennie, Pharm.D., R.Ph., P.M.P, Head, BD-Drug Disposition, Safety & Animal Research, Sanofi
Regina Dutkowski, Ph.D., Executive Director, D3 Medicine
Ron Librizzi, M.D., Chief, Maternal Fetal Medicine, Virtua Health
Michael Loftus, MPA, Executive Director, Business Development,  Integrium
John Morel, CPCU, ARM, Vice President, Business Devlopment, Berkley Life Sciences, LLC
Larry Morrell, Director, Business Development, Biomedical Systems
Sreekant Murthy, Ph.D., Chief Research Compliance Officer, Rowan University
Roomi Nusrat, M.D., Consultant, Aesclepius Sciences, LLC
Robert Ott, M.B.A., Director of Business Operations, ACT Oncology
Marie-Agnes Patrone-Michellod, Ph.D., Manager, Regulatory Affairs & Marketing, Cancer Genetics, Inc.
Jaime Rohrbach, Ph.D., Associate Manager Molecular Biology, GENEWIZ
Shana Russo, Counsel, Reed Smith LLP
Kathleen Scotto, Ph.D., Vice Chancellor of Research, Biomedical Health, Rutgers, The State University of New Jersey
Michael Trapani, Senior Consultant, Biologics Consulting Group, Inc.

If you are interested in participating in or supporting the BioNJ Clinical Trials Committee, please contact Kathleen Otto at KOtto@BioNJ.org or by phone at 609-890-3185.