NDA Partners

NDA Partners congratulates Kaizen Bioscience on their preparations for NDA Submission in 2025. NDA Partners’ Expert Consultants, Alexander A. Vinks and Tomoyuki Mizuno helped support Kaizen’s lead program through model-informed drug development. #ndapartners #MIDD https://lnkd.in/eprFcY9Y

If you missed the LDT Industry Education webinar presented by the Reagan-Udall Foundation for the FDA on October 28th, you may watch the webinar recording here: https://lnkd.in/eSJV8xaG. Learn more about Medical Device Reporting, Corrections and Removals, and Quality System Complaint requirements from NDA Partners experts Julie Ballard, Bobbi Druyor-Sanchez, Alberto Gutierrez, and Donna Hartzfeld, Ph.D. #ndapartners #LDTs #qualitysystemcompliance #medicaldevicereporting

Meet The Expert: Joseph Toerner, MD, MPH, Expert Consultant, NDA Partners, A ProPharma Company Dr. Toerner is a board certified clinician with more than 25 years of experience working at FDA in CDER and CBER. He formerly served as Division Director, Division of Hepatology and Nutrition, Deputy Director for Safety, Division of Anti-Infective Products, and Lead Medical Officer in the Office of Antimicrobial Products in CDER, in addition to Medical Officer, Division of Vaccines and Related Product Applications in CBER. Throughout his FDA career, Dr. Toerner was responsible for managing the review of complex regulatory applications (INDs, NDAs, BLAs), post marketing safety issues, developing policy and guidance documents for new efficacy endpoints, and conducting the clinical review of regulatory applications. In addition to his regulatory roles, he has experience as a clinician-educator, principal investigator, and primary care physician. Dr. Toerner’s experience serving in regulatory roles, in addition to his clinical experience, will bring immense value to NDA Partners’ clients developing pharmaceutical products with a focus on infectious diseases and hepatology. Learn more about Dr. Toerner: https://lnkd.in/eGQiVztQ. #ndapartners #regulatorysciences #productdevelopment

Meet The Expert: Joseph Toerner, MD, MPH, Expert Consultant, NDA Partners, A ProPharma Company Dr. Toerner is a board certified clinician with more than 25 years of experience working at FDA in CDER and CBER. He formerly served as Division Director, Division of Hepatology and Nutrition, Deputy Director for Safety, Division of Anti-Infective Products, and Lead Medical Officer in the Office of Antimicrobial Products in CDER, in addition to Medical Officer, Division of Vaccines and Related Product Applications in CBER. Throughout his FDA career, Dr. Toerner was responsible for managing the review of complex regulatory applications (INDs, NDAs, BLAs), post marketing safety issues, developing policy and guidance documents for new efficacy endpoints, and conducting the clinical review of regulatory applications. In addition to his regulatory roles, he has experience as a clinician-educator, principal investigator, and primary care physician. Dr. Toerner’s experience serving in regulatory roles, in addition to his clinical experience, will bring immense value to NDA Partners’ clients developing pharmaceutical products with a focus on infectious diseases and hepatology. Learn more about Dr. Toerner: https://lnkd.in/eGQiVztQ. #ndapartners #regulatorysciences #productdevelopment

NDA Partners’ Alexander A. Vinks will be a panel member at the Duke-Margolis Institute for Health Policy virtual workshop on October 29th. The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, is convening a one-day public virtual workshop focused on sharing effective strategies for dose-finding and optimization in rare diseases and best practices for early-phase trial design. Join the discussion to learn more about Opportunities to Improve Dose-Finding and Optimization for Rare Disease Drug Development. https://lnkd.in/ejjpSdnS. #ndapartners #clinicaltrialdesign #modeling #drugdevelopment #pediatricdrugdevelopment

NDA Partners Experts Julie Ballard, Bobbi Druyor-Sanchez, Alberto Gutierrez, and Donna Hartzfeld, Ph.D. will be panelists on an October 28th webinar entitled "Record Keeping and Adverse Event Reporting: Medical Device Reporting, Corrections and Removals and Quality System Complaint Requirements" presented by the Reagan-Udall Foundation for the FDA. The 60-minute education webinar will be the part one of a series of webinars meant to help laboratories understand FDA’s expectations for a laboratory that offers LDTs. In this first seminar, the panelists will discuss how to comply with medical device reporting (MDR), correction and removal reporting, and complaint requirements beginning May 6, 2025 (Phase 1 of the phaseout policy). Register today to join the discussion: https://lnkd.in/e2xJMXnW. #ndapartners #LDTs #qualitysystemcompliance #medicaldevicereporting

NDA Partners’ Dr. Alberto Gutierrez will be a panel member at the Food and Drug Law Institute (FDLI) Advertising & Promotion for Medical Products Conference on October 18th to discuss “Diagnostic Company Oversight”. Dr. Gutierrez will be part of a diverse panel of experts to review past enforcement trends and discuss prospective enforcement in the wake of phased LDT regulation. Join the discussion to hear more about the steps industry can take to align with the forthcoming standards. Dr. Gutierrez is a Partner with NDA Partners and has served in several executive roles at the FDA’s CDRH including, Director, Office of In Vitro Diagnostics and Radiological Health, and Director, Office of In Vitro Diagnostic Device Evaluation and Safety, and Deputy Director, New Product Evaluation, Office of In Vitro Diagnostic Device Evaluation and Safety. https://lnkd.in/esC8C2YR #ndapartners #regulatorysciences #regulatorystrategy #FDA #LDTs #diagnostics #laboratorydevelopedtests #FDLI

Dr. Stephen Weber, NDA Partners Expert Consultant, has co-authored an article entitled “Staying Out of Trouble: FDA Regulation of Orthobiologics and the Shoulder Surgeon” in the Journal of Shoulder and Elbow Surgery. Regulation of Orthobiologics by the FDA can be challenging to interpret for the non-regulatory scientist. However, understanding how regulations apply to clinical use of these orthobiologic products is critical, as there are both ethical and legal ramifications to using orthobiologics in conflict with regulations. Recent FDA guidances have attempted to clarify these issues, although some questions still remain. Read more about the regulation of orthobiologics here: https://lnkd.in/e7ZjRKqw or here: https://lnkd.in/ezwb6aGY. #ndapartners #orthobiologics #FDA #regulatorysciences

NDA Partners’ Dr. Daniela Drago will be a guest speaker at RAPS Convergence in Long Beach, California on September 18th hosted by Regulatory Affairs Professionals Society (RAPS). Dr. Drago will join a panel of regulatory experts to discuss “Emerging Regulatory Trends”. Join the discussion to learn more about the biggest innovations, pitfalls, challenges and trends impacting regulatory today – and in the future. Dr. Drago is a Partner with NDA Partners and has worked with the company since 2022. She is a regulatory affairs executive with a history of accomplishments spanning pharmaceutical, biotech, and academic roles. She has significant global expertise in the development of small molecules, biologics, cell and gene therapies, and combination products in multiple rare and common disease areas, including ophthalmology, neurology, immunology, and oncology. #ndapartners #regulatoryaffairs #regulatorysciences

We congratulate Dr. Vinod P. Shah on his accomplishment and honor of being awarded the Høst Madsen Medal by the International Pharmaceutical Federation (FIP). According to FIP’s announcement on September 1st, “Vinod P. Shah (USA) was today recognised for his contributions to the field of pharmaceutical science and regulatory research and their impact on policy and practice with an award of FIP’s Høst Madsen Medal. His work includes: establishing the scientific basis for the Biopharmaceutics Classification System for immediate release solid dosage forms and developing the classification system for topical drug products; developing a dissolution methodology for sparingly water-soluble drug products using a surfactant, which has been adopted by the US Food and Drug Administration (FDA) and the US Pharmacopeia; creating a procedure for comparing dissolution profiles by using similarity factor f2, which has been adopted globally by all regulatory agencies for dissolution profile comparison; and developing in vitro release methodology for semisolid dosage forms, now used in US FDA guidance.” Dr. Shah joined NDA Partners as an Expert Consultant in 2016. He has thirty years of experience at the FDA, working in different Divisions, until he retired as a Senior Research Scientist in the Office of Pharmaceutical Sciences in 2005. Learn more about Dr. Shah: https://lnkd.in/e_5CHUfk #ndapartners #pharmaceuticalscience #drugdevelopment #regulatorysciences