DiaMedica Announces Formation of Development Advisory Group for Its Diabetes Products
"We are pleased to welcome Dr. Cavagnaro, Dr. Gearing, and Mr. Johnson to our product development advisory group. They bring together significant industry experience in protein-based diabetes therapeutics from development, through regulatory approval and commercialization. They have all worked at or closely with the US Food and Drug Administration (FDA) with numerous biotechnology and pharmaceutical companies on successful drug approvals and are now guiding DiaMedica towards hitting its product development milestones," said Rick Pauls, Chief Executive Officer of DiaMedica.
Joy Cavagnaro, PhD, DABT, ATS. Pharmacology and Toxicology
Dr. Cavagnaro assists DiaMedica in the design and implementation of pre-clinical toxicology studies to access safety, tolerability and pharmacokinetics of protein-based therapies. Dr. Cavagnaro is President and Founder of Access BIO consultancy specializing in pre-clinical pharmacology and toxicology programs and science-based regulatory strategies to support Phase I clinical trials. She has over 25 years of experience in biotech. Previously, Dr. Cavagnaro served as Vice President of Regulatory Affairs at Human Genome Sciences, Inc. and spent close to a decade at the FDA Center for Biologics Evaluation and Research (CBER), including serving as Senior Pharmacologist & Director of Quality Assurance Office of the Center Director. While at the FDA, Dr. Cavagnaro was instrumental in establishing key policy, and guidance documents for biologic-based products and served as rapporteur for the "ICH S6 Guidance on Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals". Additional responsibilities included review of 100s of INDs and 6 licensing applications. Prior to the FDA, Dr. Cavagnaro was a Senior Staff Scientist, Department of Toxicology at Covance, overseeing pre-clinical pharmacology and toxicology client studies of biotechnology products. Dr. Cavagnaro is a Diplomate American Board of Toxicology and a Fellow Academy of Toxicological Sciences.
Patrick Gearing, PhD. cGMP Manufacturing and CMC Product Development
Dr. Gearing provides critical technical and regulatory advice on the manufacturing of cGMP quality biologic-based therapeutics to DiaMedica. Dr. Gearing has a well-established track record of working with clients to achieve successful process development and manufacture of cGMP protein therapeutics appropriate for clinical trials. Dr. Gearing routinely works with world-leading contract manufacturing organizations (CMOs), using his 19 years of industry experience to help clients overcome development and manufacturing challenges unique to each protein. Dr. Gearing has product development experience in several regulatory jurisdictions including the US, Europe, Japan, Canada and Australia, thereby being able to provide sound product development advice. Prior to founding Ridge Biotechnology, Dr. Gearing was Director of Pharmaceutical Development and Quality Systems at Seattle Genetics, Inc., helping to guide the development of their monoclonal cancer antibody pipeline. Additional industry experience also includes positions at Coulter Pharmaceutical, Inc., PDL BioPharma, Inc., and Immunex Corp. (Amgen).
Larry Johnson, MSc. Regulatory Affairs
Mr. Johnson provides expertise in the interaction with regulatory agencies, including the FDA, EMA, and Health Canada, to achieve clinical and marketing approvals. Mr. Johnson has over 35 years of experience in working with over 50 international and US-based pharmaceutical companies at all stages of product development (pre-clinical, clinical and market approval stages) to expedite development. This has included assisting with the filing of over 30 INDs, NDAs for drug products, and PLAs for biologic-based products. He has also participated in several hundred meetings with the FDA and other regulatory agencies on behalf of clients. Additionally, Mr. Johnson assists companies in the development of compliance procedures, standards and documentation (GLP, GCP, GMP) appropriate to the stage of product development. Previously, Mr. Johnson was Responsible Head and Director of Regulatory Affairs at Amgen, Inc., helping to obtain its first product approval; he continued working closely with the company for over 16 years as a regulatory consultant. Mr. Johnson has also been employed by Abbott Laboratories and the US Centers for Disease Control.