After over 35 years of working in the pharmaceutical industry in various technical and managerial positions at Johnson & Johnson and AstraZeneca Pharmaceuticals, Dr. Timko founded RhoTau Pharma Services to provide consulting expertise in the Pharmaceutical and Regulatory Sciences.
Dr. Timko’s focus is on assisting clients achieve their product goals of a fast submission and seamless approval, while assuring a cost effective product and secure supply chain.
Dr. Timko has worked across a variety of traditional and novel dosage forms and therapeutic groups and interacted with global Health Authorities on a diverse range of CMC topics. He is well versed in the technical and regulatory documentation requirements for INDs/IMPDs, NDAs/MAAs, and sNDAs/Variations. Dr. Timko is considered a subject matter expert with in-depth knowledge of Quality-by-Design, Process Analytical Technology, and Real Time Release in the current regulatory environment.
Dr. Timko has utilized his technical and managerial talents within cross- and multi-functional teams, mentoring colleagues and direct reports. He has had responsibility for both domestic and international senior staff, as well as well as supporting technical development and life cycle management of drug products.
Dr. Timko has been involved in preparing and/or reviewing more than 30 marketing applications either in a pharmaceutical development or regulatory capacity for innovator and generic compounds for a variety of small and large molecule dosage forms including but not limited to, immediate and extended release solid dosage forms, injectables, and liquids. He has hands-on experience in dosage form development, scale-up to commercial manufacture and production troubleshooting, preparing CMC briefing and regulatory documentation, preparing teams, and leading face-to-face meetings with Health Authorities. Additionally, Dr. Timko has provided technical expertise and served as subject matter expert witness on formulation development in patent litigation cases.
Dr. Timko was as a member of a PQRI cross-functional team of industry and FDA representatives who prepared a technical paper on “Current Best Practices Applied to the Development, Scale-up and Post Approval Change Control of IR & MR Dosage Forms,” published in the online journal, PharmSciTech. He holds several formulation patents, and has written and coauthored numerous articles for peer-reviewed journals and technical publications. He has also made presentations on formulation and process development and regulatory affairs topics as an invited speaker at association meetings and scientific conferences. He is a co-author of a book chapter on “High-Intensity Mixer Granulators” in Granulation Technology for Bioproducts.
Dr. Timko is an active member of the American Association of Pharmaceutical Scientists (AAPS), the International Society of Pharmaceutical Engineers (ISPE), the International Academy of Compounding Pharmacists (IACP) and the Pennsylvania Pharmacist Association (PPA). He is a Registered Pharmacist in New Jersey and Pennsylvania.
- Doctor of Philosophy in Pharmaceutical Science, Rutgers University
- Master of Science in Pharmaceutical Science, Rutgers University
- Bachelor of Science in Pharmacy, Rutgers University