NDA Partners in Conjunction with RJR Consulting and Intrinsik Supports Successful CTA Approval by Health Canada for First-in-Human Clinical Study

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NDA Partners Chief Executive Officer Earle Martin announced today that its client, Asahi Kasei Pharma (AKP), has successfully received approval of their Clinical Trial Application (CTA) from Health Canada to conduct a first-in-human study for a new therapy for patients undergoing posterolateral fusion (PLF) surgery. The safety and efficacy of the therapy are still under investigation and market authorization has not yet been obtained in any country. NDA Partners in conjunction with RJR Consulting, Inc. served as Asahi Kasei Pharma’s strategic regulatory advisor for the CTA submission.

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Asahi’s successful CTA approval allows for the start of clinical trials for a much needed therapy for patients undergoing PLF surgery. We were pleased to support Asahi’s efforts and congratulate them on this important milestone and step towards marketing approval in Canada.

NDA Partners Chief Executive Officer Earle Martin announced today that its client, Asahi Kasei Pharma, has successfully received approval of their Clinical Trial Application (CTA) from Health Canada to conduct a first-in-human clinical study for a new therapy for patients undergoing posterolateral fusion (PLF) surgery. The safety and efficacy of the therapy are still under investigation and market authorization has not yet been obtained in any country. NDA Partners in conjunction with RJR Consulting, Inc. served as Asahi Kasei Pharma’s strategic regulatory advisor and Intrinsik Corp. provided scientific and regulatory guidance into the preparation and electronic filing of the CTA submission.

Dr. David Feigal, Manager of NDA Partners’ medical device practice, praised Asahi on their accomplishment: “Asahi’s successful CTA approval allows for the start of clinical trials for a much needed therapy for patients undergoing PLF surgery. We were pleased to support Asahi’s efforts and congratulate them on this important milestone and step towards marketing approval in Canada.”

About NDA Partners
NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.

About Asahi Kasei Pharma Corporation
Asahi Kasei Pharma Corporation, headquartered in Tokyo, Japan, is a research-based health care innovator that discovers, develops, manufactures, and markets pharmaceuticals and diagnostic products. Asahi Kasei Pharma is a wholly owned business unit of Asahi Kasei Corporation, a US $20 billion technology company, that provides innovative, science-based solutions to a diverse range of markets including healthcare, chemicals and fibers, housing and construction materials, and electronics.

About RJR Consulting, Inc.
RJR Consulting, Inc. is a global life sciences Regulatory and Quality Consulting company founded in 2002 with the idea of bringing an international network of seasoned consulting professionals to businesses, organizations and government of all sizes. The company’s product quality and regulatory services broadly cover Pharmaceuticals (Human and Veterinary), Biologics and Biosimilars, Medical Devices and IVDs, Combination Products, Dietary Supplements and Cosmetics.

About Intrinsik Corp.
Intrinsik Corp., is a science-based consulting firm with over 35 years of experience and offices located throughout North America. As a recognized leader in the industry, our team of experts provide regulatory and scientific advice to help identify the most efficient drug development and registration pathways in a timely manner. We support the development of a wide range of human health products, including small molecules, biologics, natural health products, cosmetics, medical devices, and food additives and ingredients from the preclinical stage through to market and the post-approval phase.

Contact
Earle Martin, Chief Executive Officer
Office: 540-738-2550
MartinEarle@ndapartners.com

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