TransCelerate BioPharma Launches Three New Initiatives and Expands Membership

TransCelerate
BioPharma Inc., a non-profit dedicated to streamlining and
accelerating the research and development of innovative new therapies,
today announced it has committed to an expansion of its clinical and
drug safety portfolio, revealing the following new initiatives:

• The Common
  Clinical Serious Adverse Events (SAE) Fields Initiative intends
  to conduct a feasibility assessment, develop best practices relating
  to identifying the most critical SAE fields, and work with an industry
  standard setting organization to promulgate standards in this area,
  all with the intent of increasing the quality of what is reported and
  creating efficiencies for sites, CROs and regulators.
• The Modernization
  of Data Analytics for Clinical Development Initiative aims
  to analyze methods for considering and validating novel statistical
  computing platforms to propose to Health Authorities and better enable
  them to support these platforms.
• Due to the success of the Interpretation
  of Guidances and Regulations Initiative launched in
  drug safety in 2018, the initiative has expanded in scope from
  strictly pharmacovigilance to include clinical guidances and
  regulations. For its first deliverable, the workstream is creating a
  Quality Tolerance Limits Framework to help facilitate clinical
  trial compliance. The framework will propose interpretations of
  clinical regulations and seek to foster harmonization across health
  authorities by proactively sharing recommendations that reduce the
  amount of duplicative efforts and audit findings.

“These three new initiatives are fully aligned with our strategic
priorities and future roadmap. We expect these deliverables to enhance
our prior investments and to deliver quick and tangible value to our
members and other stakeholders,” said Janice Chang, Executive Vice
President, TransCelerate BioPharma Inc. “Furthermore, as multiple
stakeholders adopt our work globally, we have significantly ramped up
our engagement with health authorities who are increasingly eager to
collaborate with TransCelerate to solve common problems. Broader global
adoption of our work is complemented by Member Company networks in over
30 countries that apply regional, cultural and regulatory implications
to our initiatives.”

Echoing Ms. Chang’s sentiment, Badhri Srinivasan, Head, Global
Development Operations, Novartis noted, “One of the strengths of
TransCelerate is that it engages key groups across the Research and
Development landscape to find opportunities for streamlining. This
includes getting the right input from patients, investigative sites,
academic researchers, clinical research organizations and health
authorities to incorporate into collaborative approaches. Since joining
TransCelerate less than two years ago, we have been very active
contributors in multiple successful initiatives as well as adopting a
number of solutions.”

Expanding Its Regulatory Reach

The TransCelerate clinical and drug safety portfolio now consists of 30
initiatives supported by significant in-kind resource contributions from
TransCelerate members. The drug safety team recently met with several
health authorities to inform thinking for upcoming deliverables.
Specifically, TransCelerate’s Value of Safety Information Data Sources
initiative has met with the Food & Drug Administration, the Medicines
and Healthcare Products Regulatory Agency and presented to the
Pharmaceuticals and Medical Devices Agency in Japan and the European
Medicines Agency’s Operation of European Union Pharmacovigilance
industry stakeholder platform meeting. Additionally, it has written two
position papers for journal publication: “Patient Support Programs,
Market Research Programs, and Social Media Provide Limited Value to
Patient Safety” and “Issues with Pooling Reports from Solicited Sources
Together with Spontaneous Reporting.”

TransCelerate Welcomes Prominent Industry Member

Regeneron,
a leading U.S. biotechnology company, has joined TransCelerate as its 20^th
member. Regeneron’s seven FDA-approved medicines are designed to help
patients with eye diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, neuromuscular diseases,
infectious diseases and rare diseases.

David Weinreich, MD, MBA, Senior Vice President, Global Clinical
Development at Regeneron commented, “We applaud the organization for its
work in streamlining drug development. By sharing its work publicly,
TransCelerate benefits the entire ecosystem as we look to modernize drug
development to achieve our shared mission of getting innovative
therapies to patients faster. Regeneron looks forward to working
alongside TransCelerate’s other members to lend our expertise and solve
the most pressing issues affecting R&D today.”

About TransCelerate BioPharma, Inc.

TransCelerate BioPharma Inc. is a non-profit organization dedicated to
improving the health of people around the world by streamlining and
accelerating the research and development (R&D) of innovative new
therapies. The organization’s mission is to collaborate across the
global biopharmaceutical R&D community to identify, prioritize, design
and facilitate implementation of solutions intended to drive the
efficient, effective and high-quality delivery of new medicines. The
vast majority of TransCelerate solutions are publicly available.
Headquartered in Philadelphia, TransCelerate has 20 member companies and
30 initiatives focused on improving the patient and site experience,
enhancing sponsor efficiencies and drug safety and, as appropriate,
harmonizing process and sharing information.

Membership in TransCelerate is open to pharmaceutical and biotechnology
companies with R&D operations. For more information, please visit http://www.transceleratebiopharmainc.com,
https://twitter.com/TransCelerate,
or https://www.linkedin.com/company/transcelerate-biopharma-inc-/.

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