TransCelerate BioPharma Inc. Grows, Strengthens Novel Effort to Accelerate Drug Development

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Company News Release

TransCelerate BioPharma Inc. ("TransCelerate") today announced that six new pharmaceutical companies have joined as members of the independent non-profit entity formed to assess, refine and create processes to bring innovative new medicines to the public faster. The addition of the new members to TransCelerate marks a major milestone since the organization's founding by ten healthcare and pharmaceutical companies in September 2012. The new member companies include Astellas Pharma Inc., the first member of TransCelerate headquartered in Japan, Biogen Idec, Braeburn Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.) and Onyx Pharmaceuticals.

By joining TransCelerate, each of the new companies will contribute financial and other resources, including personnel, to solve industry-wide challenges in a collaborative environment. With these six new members, combined with the ten original founding members, total membership in TransCelerate now stands at 16 companies.

"We are thrilled to expand the membership of TransCelerate BioPharma with these six new companies, we welcome them as members and we look forward to working with them," said Dalvir Gill , PhD, Chief Executive Officer of TransCelerate. "With the addition of these new members, TransCelerate extends its ability to impact global R&D and advance healthcare solutions worldwide."

As initial areas of focus, TransCelerate seeks to provide the following solutions: development of risk-based site monitoring approach and standards, development of a shared user interface for investigator site portals, mutual recognition of study site qualification and training, development of clinical data standards, and establishment of a comparator drug supply model.

"Together, we are leading the effort to develop shared industry solutions to simplify and accelerate the delivery of innovative products to patients – enabled by broad participation and collaboration across the global research and development community," said Dr. Gill.

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