BioNJ Targets Streamlined Therapeutic Development with Clinical Trials Master Service Agreement Template

  BioNJ Targets Streamlined Therapeutic Development with Clinical Trials
  Master Service Agreement Template

 Collaborative Project with Rutgers University and Sheppard Mullin Richter &

Business Wire

TRENTON, N.J. -- February 25, 2014

Recognizing the strong need to streamline clinical trials,  BioNJ has
announced a Clinical Trials Master Service Agreement template designed to
support clinical trial facilitation in Phases 2 through 4. The form is
available to BioNJ members and the public by contacting BioNJ at

The project was a collaboration between BioNJ, Rutgers University and the law
firm of Sheppard Mullin Richter & Hampton LLP, and has been reviewed and
endorsed by Rutgers University and Rowan University.

“The purpose of the form is to reduce the negotiation time for translation
studies being conducted at New Jersey institutions,” said BioNJ President and
CEO Debbie Hart. “Our objective is to free up much needed resources and time
for research, accelerating the development of state-of-the-art therapeutics
and diagnostics emerging from research discoveries.”

“Translating scientific discoveries into therapeutic strategies at the bedside
of patients in need is quickly becoming the focus of all those with an
interest in the biotech and pharmaceutical communities,” said Spiro Rombotis,
President and CEO of Cyclacel Pharmaceuticals, Inc. and Chair of the BioNJ
Translational Institute of New Jersey Committee. “In a cost-constrained health
care environment, scarce resources will be allocated in favor of
translationally-designed therapeutics that can be utilized to meet very
specific patient needs. It is in the patient’s best interest if we can ease
and enable the clinical trial process through collaborations of this kind.”

The form is available at no cost from BioNJ. While some studies may require
modification to the form for a specific trial’s needs, the template provides a
reliable starting point for sponsors collaborating with New Jersey research
institutions. Although the form can be downloaded by anyone, guidance
documents to be developed over the next few months will only be available to
BioNJ members.

The guidance documents will help users better understand key issues raised in
the form. Future plans of the working group will include forms for Letters of
Indemnification, Guidance on Subject Injury and Sponsor Insurance Coverages.

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

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

Rutgers University
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
Michael Nagy, Director, Office of the Senior Vice President and General
Terra Pfund Kroll, Corporate Contracts, Office of Research and Economic

Sheppard Mullin Richter & Hampton LLP
Blaine Templeman, Managing Partner of the NY office, Life Sciences Practice
Sean Cornely, Associate and graduate of Rutgers

Rowan University
Julie Kligerman, Associate Counsel for Health Services
Carl Hock, Ph.D., Associate Dean for Research at Rowan School of Osteopathic
Sreekant Murthy, Ph.D., Chief Research Compliance Officer

Bristol-Myers Squibb
Cyclacel Pharmaceuticals
NPS Pharmaceuticals

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

Rutgers University
Rowan University

About BioNJ

With more than 300 member companies, BioNJ is focused on the growth and
prosperity of New Jersey’s life sciences cluster. Founded in 1994 by New
Jersey industry CEOs, BioNJ serves as the voice of companies located in New
Jersey, seeks to advance their economic growth and development and works to
encourage new and established companies from around the world to locate in New
Jersey. BioNJ represents companies engaged in biopharmaceutical, biomedical,
bioagricultural and bioremedial endeavors.


Bill O’Donnell
609-890-3185, Ext. 117
Yankee Public Relations
Fred Feiner, 908-425-4878
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