TransCelerate BioPharma Inc. Launches Two New Global Initiatives, Names Two New Board Members

PHILADELPHIA, June 16, 2014 /PRNewswire/ -- TransCelerate BioPharma Inc.  ("TransCelerate") is launching two new global initiatives enabled by broad participation and collaboration across the global research and development (R&D) community: develop a position on the best and most efficient methods for redacting privacy information found in clinical study reports and an approach for the anonymization of patient level data shared with the broader healthcare community; and develop a framework for a Quality Management System (QMS) specifically for clinical research to improve the quality and efficiency of clinical trials. These new initiatives, in addition to the current eight, will further the TransCelerate vision to improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies.

The newly launched global TransCelerate initiatives are:

• Clinical Data Transparency – In response to regulatory agencies' push for greater clinical data transparency and various industry responses, the Clinical Data Transparency initiative was created to explore developing a position paper on the best and most efficient methods for redacting privacy information found in CSRs. TransCelerate's initiative seeks to respond to other trade organizations' positions regarding this matter, including the positions set out in response to the EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing around sharing of CSRs. TransCelerate's members have worked to identify the instances and methods for redaction in order to preserve the privacy of patients, investigators and clinical trial staff. The approach was shared with senior representatives of the European Medicines Agency (EMA). The team will continue to work collaboratively to develop the principles for the writing of future CSRs, as well as an approach for the anonymization (and de-identification) of patient level data shared with the broader healthcare community.
• Clinical Research Quality Management System – Quality Management Systems are tools that are increasingly and successfully being used in other industries, as well as in pharmaceutical manufacturing, to control quality and improve performance in complex environments. Modern clinical research has become more complex due to globalization, higher regulatory standards and the nature of the diseases targeted. As Quality Management Systems used in manufacturing and other areas cannot be directly applied to clinical research, TransCelerate has decided to develop a framework for a QMS specifically for clinical research to improve the quality and efficiency of clinical trials, while further increasing patient safety. TransCelerate will work in close alignment with global regulatory agencies that are increasingly advocating a quality management system approach, not only for pharmaceutical manufacturing but also clinical research. The Clinical Research QMS framework will focus on common, recurring quality issues that health regulatory agencies have been pressuring the industry to resolve.

"With the launch of these new projects, we continue to tackle areas of R&D inefficiency and common need," said Dalvir Gill, PhD, Chief Executive Officer of TransCelerate. "The Clinical Data Transparency project is an excellent example of TransCelerate member companies working together in response to a common need rather than each addressing it individually. For this project, we will work closely with other stakeholders like EFPIA and PhRMA to ensure a coordinated effort. Overall, we are making significant progress with all our ongoing projects and we will continue to focus on delivering practical and actionable solutions to the clinical trials community."

In addition to launching these new initiatives, TransCelerate has filled two open seats on its Board of Directors: Iris Low-Friedrich, Executive Vice President, Biopharma Development Solutions, Chief Medical Officer and Member of the Executive Committee, will represent UCB; and Takuko Yamada-Sawada, Senior Executive Officer, Head of Global Development and Member of the Corporate Executive Committee, will represent for Shionogi & Co., Ltd.

More on each board member:

• Iris Low-Friedrich – Prof. Dr. Iris Low-Friedrich is responsible for the world-wide Clinical Development Organization, Global Medical Affairs, Global Regulatory Affairs and Project Leadership at UCB. In her role as Chief Medical Officer, she is passionate about bringing innovative therapies to patients, as well as ensuring the safety of the subjects in clinical trials. Iris championed the decision for UCB to join TransCelerate late last year to ensure that UCB could share its learnings and proactively collaborate with other member companies to help the biopharmaceutical industry identify and capture significant and much-needed efficiencies.
• Takuko Yamada-Sawada – Takuko Yamada-Sawada's responsibilities include development activities managed from offices in Osaka, Japan, Florham Park, NJ, USA and London, UK. Takuko has had a long interest in bringing innovative medicines to market, improving R&D efficiency and globalization. As a member of the TransCelerate Board she adds global diversity and brings an important perspective from the second largest pharmaceutical market in the world.

"Both Iris and Takuko are highly qualified to serve on TransCelerate's Board and will enhance our inclusive and globally diverse perspective," said Annalisa Jenkins, MBBS, MRCP, and Chairwoman of the TransCelerate Board of Directors. "We will glean important insights from the addition of UCB and Shionogi to TransCelerate's membership and Board – the viewpoint from these mid-cap companies will ensure the work of TransCelerate is pragmatic, relevant and valuable across our member companies, and ultimately for the biopharmaceutical ecosystem."

For more information on TransCelerate and the advances for both industry and patients it is providing through its initiatives, please visit www.transceleratebiopharmainc.com.

About TransCelerate BioPharma Inc.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organization's mission is to collaborate across the global R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of medicines. TransCelerate evolved from discussions at various forums for executive R&D leadership to debate current issues facing the industry and examine solutions for addressing agreed-upon common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Astellas Pharma Inc., Biogen Idec, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.), Medgenics, Inc., Shionogi & Co., Ltd. and UCB.

Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research and Development operations. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com/.

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