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Press Release: Precision for Medicine Expands Regulatory and Commercialization Teams to Support Next-Generation Medicines

Industry Experts Will Support the Development and Commercialization of Medical Diagnostic and Device Products, Including Companion Diagnostics for Next-Generation Medicines

(Bethesda, MD) May 17, 2013 – Precision for Medicine, Inc., (“Precision”), the specialized scientific services company formed in 2012 to support next-generation medical products, today announced the appointment of 4 key executives, significantly increasing the breadth of its regulatory and commercialization services. The addition of these executives and their teams enhances Precision’s ability to support life science innovators as they address value, effectiveness, and patient access issues for next generation medicines.

“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 market access.”

David Parker, PhD, has been appointed Vice President, Market Access Strategy and will lead Precision’s market access consulting and advisory services to support biopharmaceutical, medical device, and diagnostic products. Dr. Parker’s expertise in personalized medicine, molecular, and advanced diagnostics, as well as medical devices complements a broad base of experience in biopharmaceuticals. Dr. Parker has been active in the healthcare industry for more than 25 years, including 16 years as a strategic consultant leading and coordinating product reimbursement, health economics, clinical science, and marketing strategy. Before joining Precision, Dr. Parker led the Washington office of Boston Healthcare Associates. Dr. Parker earned his PhD in Cell and Developmental Biology from the Massachusetts Institute of Technology, where he was a National Science Foundation Fellow.

Merry Lee Bain, MS, 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 of 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 her BS in engineering and MS in electrical engineering from Purdue University.

Judi Smith, MS, MT (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 diagnostic products from initial development through regulatory submission, review, and approval. Ms. Smith has worked in regulatory and quality sciences as well as 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 the quality control of diagnostic products. Ms. Smith earned her Masters of Science degree from the Medical College of Pennsylvania.

About Precision for Medicine
Precision for Medicine is a specialized company providing services and infrastructure to support life sciences companies as they develop new products in the age of precision medicine. Precision brings expertise, technology, and project execution to support innovative, patient-centric solutions from discovery through commercialization. The company is headquartered in Bethesda, MD.

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

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