Dr. Joseph Sinkule
Vice President, Regulatory Affairs
Dr. Joseph Sinkule is an experienced life sciences professional focused on medical product development and regulatory approvals. He has over 27 years of pharmaceutical and biotechnology management experience in the research, development, manufacturing and commercialization of drugs, medical devices, and biologics.
Dr. Sinkule's therapeutic areas of experience include oncology, infectious disease, drug delivery, immunology (vaccines, monoclonal antibodies and cytokines), extracorporeal liver assist devices, wound-healing, and biotechnology (stem cell and gene therapy products). His expertise in the areas of drug development strategies, project management, licensing and business development, regulatory project management, FDA and EU regulatory affairs, pre-clinical and clinical research (GCPs/GLPs), process development and manufacturing (GMPs), quality assurance and quality control in the pharmaceutical/biotechnology industry makes him uniquely qualified and highly capable as a consultant and advisor.
Dr. Sinkule has been directly responsible for or involved in the preparation of over 35 INDs, 3 Drug Master Files, 3 NDAs, 2 BLAs (PLA/ELA), 2 PMAs, six 510(k) and many other regulatory submissions for literally dozens of drugs, devices, vaccines and other biologics, as well as devising, directing and/or reviewing medical product development and manufacturing plans, performing GCP, GMP and GLP compliance assessments, outsourcing contracts, technology and product licenses and material transfer agreements, and coordinated client meetings with CBER, CDER, CDRH and other regulatory authorities.
In addition to authorship of several clinical and regulatory documents, he has authored and co-authored more than 25 peer-reviewed journal articles and book chapters in the fields of oncology, clinical trials, pharmacokinetics, biotechnology product development, cancer immunotherapy and vaccines.
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