BioNJ Targets Streamlined Therapeutic Development in Clinical Trials

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 BioNJ@BioNJ.org.

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.

BioNJ

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

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 Commercialization

Michael Nagy, Director, Office of the Senior Vice President and General Counsel

Terra Pfund Kroll, Corporate Contracts, Office of Research and Economic Development

Sheppard Mullin Richter & Hampton LLP

Blaine Templeman, Managing Partner of the NY office, Life Sciences Practice Head

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 Medicine

Sreekant Murthy, Ph.D., Chief Research Compliance Officer

Bristol-Myers Squibb

Cyclacel Pharmaceuticals

NPS Pharmaceuticals

Sanofi

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

BioNJ

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.