Precision for Medicine Adds Regulatory Expertise To Support Next Generation Medicines

CHEVY CHASE, Md., May 30, 2013 /PRNewswire/ -- Precision for Medicine, Inc., ("Precision"), the specialized scientific services company formed in 2012 to support next generation medical products, today announced the appointment of three key executives, significantly increasing the breadth of its regulatory and commercialization services. The addition of these executives and their teams expands and enhances Precision's ability to support life science innovators as they work to address value, effectiveness, and patient access for next generation medicines.  

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"Developers of diagnostic technologies – particularly companion diagnostics that support a new generation of biopharmaceuticals– are looking for a specific set of services as they work to guide their products to market," said Precision co-founder, Mark P. Clein. "The leadership team we have assembled at Precision for Medicine provides a unique combination of industry experience and scientific expertise to help guide all aspects of diagnostic and product development, from strategy to regulatory affairs, and from clinical trial design to commercialization."

Judi Smith, M.S., M.T. (ASCP) has been appointed Vice President, In Vitro Diagnostics Regulatory and Quality and will lead Precision's regulatory support services for diagnostic products, including companion diagnostics for next generation biopharmaceuticals. In this role, Ms. Smith will help clients guide diagnostics products from initial development through regulatory submission, review, and approval. Ms. Smith, who is currently the president of the Association of Medical Diagnostic Manufacturers, has worked in regulatory and quality sciences and clinical development for over 30 years. During that time, she has led successful regulatory submissions for a multitude of companion diagnostic assays, in vitro diagnostic products, and biological in vitro diagnostic assays to support quality control of diagnostic products. Ms. Smith earned a Masters of Science degree from the Medical College of Pennsylvania.

Merry Lee Bain, M.S., has been appointed Vice President, Medical Devices and will lead Precision's regulatory support services for medical devices. Ms. Bain guides strategic planning and implementation of regulatory strategies for clients developing products across a broad range of disciplines and therapeutic areas. Ms. Bain is a biomedical engineer with over 25 years experience in regulatory affairs for the medical device industry. She has been consulting for 10 years and held executive leadership positions in regulatory affairs at Cook Medical. Ms. Bain earned a B.S. in engineering and a M.S. in electrical engineering from Purdue University. 

Pia Maria Gargiulo, Ph.D. has been appointed Managing Director, Companion Diagnostics Solutions. In this role, Dr. Gargiulo will lead Precision's companion diagnostics programs with a focus on introducing novel technologies, and addressing the array of regulatory, clinical, and commercial requirements necessary to bring companion diagnostics to market. Before joining Precision, Dr. Gargiulo was the Vice President of companion diagnostic partnerships at Qiagen. During her tenure at Qiagen, Dr. Gargiulo worked with biopharmaceutical companies to establish successful drug-diagnostic collaborations and co-development programs. Prior to Qiagen, Dr. Gargiulo was a Therapeutic Brand Leader and Senior Regional Scientific Leader at AstraZeneca. Dr. Gargiulo earned a Ph.D. in cytogenetics from the Feinberg School of Medicine at Northwestern University.

About Precision for Medicine
Precision for Medicine (Precision), is a specialized scientific services partner dedicated to helping life science companies develop and commercialize next generation medical products.  Precision offers a unique combination of expertise, scientific infrastructure and organizational scale to help guide products from development, through regulatory review, to market introduction and commercial success. Best-in-class teams of scientists and industry expertise and a specialized portfolio of services help clients accelerate research, enable market adoption, enhance patient outcomes and realize the full commercial potential of innovative products. The company is headquartered in Chevy Chase, MD with offices in Boston, MA, Gaithersburg MD, and Frederick, MD.  For more information about Precision, visit www.precisionformedicine.com.

SOURCE Precision for Medicine, Inc.