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TransCelerate BioPharma Establishes Clinical Trial Comparator Network, Initiates First Transaction  
8/2/2013 8:56:02 AM

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PHILADELPHIA, Aug. 6, 2013 /PRNewswire/ -- TransCelerate BioPharma Inc. ("TransCelerate") today announced that it has reached its primary milestone in its Clinical Trial Comparator Network ("Comparator Network") initiative. Formed to establish reliable, rapid sourcing of quality drug products for use in clinical trials, the Comparator Network will enable accelerated clinical trial timelines and enhanced patient safety. In July 2013, a master service agreement (MSA), affirming a mutual commitment to offer secure and rapid supply of comparator drug products for clinical trials, was executed by several TransCelerate member companies. More importantly, the network is now active and the first network-based transaction has been initiated.

Currently, the mechanisms to acquire clinical trial comparator drugs and co-therapy drugs are inefficient and unpredictable. Unless a specific agreement is in place between biopharmaceutical companies, clinical trial sponsor companies frequently are unable to secure comparators and co-therapies directly from each other, and therefore must purchase on the open market. This leads to uncertainties regarding the ability to obtain an adequate and timely supply of necessary comparators and can result in supply disruptions. As newer and more sophisticated therapies enter the market, the current situation is likely to deteriorate. Difficulty in the sourcing of comparator drugs can result in substantial delays for a clinical study and delay availability of the drug to patients.

"The current process to source and manage comparator drugs and co-therapies can be challenging," said Dalvir Gill, PhD, Chief Executive Officer of TransCelerate. "Locating and accessing these comparators at the right time, in the right quantities and with the accompanying drug stability and regulatory information we need, doesn't always happen efficiently. This is further complicated by infiltration of the commercial drug supply chain by counterfeit drugs. With the activation of our Comparator Network the participating TransCelerate companies will be able to source these comparator drugs directly from each other, be able to secure supply when they need it in the quantities they need, have access to drug data and totally mitigate the risk of counterfeit drugs in that clinical trial."

Terry Walsh, RPh, MBA, head of the Comparator Network initiative for TransCelerate added, "We believe the Comparator Network will provide an infrastructure that improves the primary operating model for the comparator supply chain. Improved access to comparator drug stability and regulatory data will enable member companies to reduce waste by allowing for better management of temperature excursions and facilitate global trials. Member companies will also have the ability to receive detailed demand data, which will facilitate improved supply chain planning, and reduce the chance of supply issues for crucial products."

TransCelerate expects more companies to join the Comparator Network, as well as additional transactions to follow.

"For the first time, this TransCelerate initiative will allow industry-wide alignment and improved supply chain around comparator drugs for clinical trials that is so critical to enhancing patient safety and improving the efficiency of clinical trials," said Paul Stoffels, MD, Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals at Johnson & Johnson. "It is great to see the progress TransCelerate members have made in this area, working diligently to ensure something that was once just an idea is now a reality."

About TransCelerate BioPharma Inc.

TransCelerate BioPharma Inc. was formed in 2012 and is a non-profit organization focused on advancing innovation in research and development (R&D), identifying and solving common R&D challenges and further improving patient safety, with the goal of delivering more high quality medicines to patients. TransCelerate evolved from discussions at various forums for executive R&D leadership to discuss relevant issues facing the industry and solutions for addressing common challenges. Founding members include AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi, and all have representation on the Board of Directors. Additional members include Astellas Pharma Inc., Biogen Idec, Braeburn Pharmaceuticals, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.) and Onyx Pharmaceuticals.

Membership in TransCelerate is open to all pharmaceutical and biotechnology companies who can contribute to and benefit from these shared solutions. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com/.

Media Contacts:

Chair TransCelerate BioPharma Inc. Communications Committee
Seema Kumar
(908) 218-6460
skumar10@its.jnj.com

Shannon Caudill
(740) 281-3715 or (614) 378-9042
shannon.caudill@porternovelli.com

SOURCE TransCelerate BioPharma Inc.



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