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President
CMC Drug Product Subject Matter Expert (SME)
Mr. Samawova is an accomplished biopharmaceutical professional with over twenty (20) years of extensive knowledge and experience providing technical and operational oversight for biopharmaceutical manufacturing across various drug platforms, from development through all phases of clinical and commercial manufacturing, within the pharmaceutical and biotechnology industry. His experience ranges from early-stage research and development for small and start-up firms to late-stage development and commercialization for mid-sized and large pharmaceutical companies, launching products in over 50 countries. He has been involved in priority review and fast track programs, as well as participated in Pre-approval Inspections (PAI) and enabling activities such as the design and execution of validation studies and evaluation of GMP systems. Additionally, he has authored and edited CMC sections for multiple filings in both the U.S. and the EU (IND/IMPD, BLA/MAA). Mr. Samawova has extensive experience in writing and reviewing Quality Overall Summary (QOS, CTD Section 2.3) and CTD Module 3 sections of pre-IND, IND, BLA, NDA, PAS, and Master Files in accordance with ICH M4Q.
Mr. Samawova possesses extensive expertise in numerous therapeutic areas, including oncology, immunology, immuno-oncology, and immunotherapies. His proficiency extends to infectious diseases and vaccines for medical countermeasures, with a focused emphasis on global health and biodefense. He has established collaborative partnerships with esteemed organizations such as the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI), the International Vaccine Institute (IVI), and the National Institutes of Health (NIH), as well as engaging in United States Government medical countermeasure drug development, which is supported by federal funds from entities like the Department of Defense (DoD), ASPR/BARDA, DARPA, among others.
In the realm of drug products development and manufacturing, Mr. Samawova’s areas of expertise encompass a wide range, including vaccines, immuno-oncology, DNA plasmids, viruses/live bacteria, antibody-drug conjugates (ADCs), monoclonal antibodies (mAbs), and other therapeutic proteins. He has been actively engaged in the development and implementation of CMC/regulatory strategies for both novel and biosimilar commercial products.
Through diverse projects within the pharmaceutical and biotechnology industry, Mr. Samawova has expanded his skill set in drug product development to encompass therapeutic proteins, including monoclonal antibodies, in both liquid and lyophilized forms, for both traditional and innovative delivery systems.
Mr. Samawova possesses extensive knowledge and experience in developing Supply Chain Risk Management programs. These programs entail monitoring risks and implementing mitigation strategies for commercial supply chains, often involving Contract Manufacturing Organizations worldwide. Additionally, he has hands-on experience in designing packaging and logistics solutions for cold chain products, catering to multiple markets.
In summary, Mr. Samawova broad technical and project management expertise is evident in areas such as Drug Product Development, Fill and Finish for Parenteral Drugs/Vaccines, Global Clinical Supply Operations, Gap analysis for regulatory filings, CMC sections of regulatory filings, Vaccine, Protein, Cell therapy and Viral vector process development, Technology transfer and scale-up, CMO selection and management, Temperature sensitive distribution strategy development and packaging design, Biosimilar development,
Risk analysis, FMEA workshops and process control strategies, Preparation for facility inspections, development, qualification, and validation of methods for raw materials, In-process testing, Lot release, Stability, and assessment of comparability and similarity, formulation strategy and development including the design of preliminary and later stage screening studies, application of biophysical techniques to evaluate formulation stability for short term studies, evaluation of stability profiles for lead candidate formulations in longer term studies, and evaluation of container/closure systems for drug product.
Mr. Samawova holds a Master of Business Administration Degree in Management, and a Bachelor of Science Degree in Biological Sciences from the State University of New York SUNY Empire.
PhD, MS, MBA, RAC
CMC Regulatory Subject Matter Expert (SME)
CMC Regulatory Subject Matter Expert (SME)
Dr. Kuate is an accomplished, strategy-focused, and US FDA-trained Regulatory Affairs Professional with over 24 years of experience in the development, manufacturing and regulation of biotechnology-based products including more than 12 years of unique combined experience as CMC reviewer at the Center for Biologics Evaluation and Research (CBER) and as CMC regulatory at several biopharmaceutical companies supporting the development, manufacturing and life cycle management of biologics/biotechnological-based drug products including biologics (NBRs and biosimilars), biologics and small molecule conjugates (e,g, ADC), immunoglobin intravenous (IVIGs), and gene/cell therapy products. Strong analytical skills and solid scientific background understanding and addressing regulatory CMC requirements through all phases of product development. More than 12 years of experience as research scientist in biotechnology product development with 23 scientific peer-reviewed publications and a book chapter. Experience communicating with regulatory authorities, leading regulatory advice meetings, and filing clinical and marketing applications with major regulatory authorities/regions including among others US, EU, Canada, and Japan.
Dr. Kuate has a Master’s of Science degree in Biochemistry from the University of Yaoundé I, Cameroon, a PhD in molecular Virology/Immunology from Ruhr-University Bochum, Germany, a Master’s of Science degree in Epidemiology/Biostatistics from the University of Bielefeld, Germany, and a dual degree Master’s degree in International Management (MIM) / Masters of Business administration (MBA) from the University of Maryland University College (UMUC), Maryland, USA. Dr. Kuate also has several professional certifications including the Regulatory Affairs Certification (RAC) and the Certified Clinical Research Professional (CCRP) certification.
Expertise:
CMC Quality Assurance Subject Matter Expert (SME)
Damola is a seasoned Pharmaceutical Quality Assurance and Compliance professional with over 15 years of experience in biopharmaceutical drug development and manufacturing. He has extensive knowledge and experience in effectively leading a global Quality organization supporting the development and commercialization of new products, including supply of materials for the clinical trial program, and life cycle management of existing products. His extensive experience also includes development and implementation of Quality Management Systems governing drug development activities within a Good Manufacturing Practices environment. He has a broad knowledge of pharmaceutical development and the expertise to lead and collaborate for the effective commercialization of quality pharmaceutical products.
Damola has an extensive background in the field of Cell and Gene Therapy (CGT), starting his career with Dendreon Corporation, where he helped the company receive the first FDA-approved therapeutic cancer vaccine, starting out in the Manufacturing Lab and then moving on to lead companywide continuous improvement efforts. He has since worked at PCT Cell Therapy Services, now Hitachi Chemical Advanced Therapeutics Solutions, LLC and Bellicum Pharmaceuticals, all staples in the field of Cellular Therapy. Damola has consulted for a number of startup Biotech who operate in the CGT space, as his passion is to more of these therapies on the market.
Damola received his B.A. in Biological Sciences from the State University of New York, in Plattsburgh, NY, and is an MBA from the C.T Bauer College of Business, where he also serves as an MBA Alumni Ambassador due to his outstanding leadership as an alumnus of the MBA program from the College.
Expertise:
Global Clinical and Commercial Supply Chain Management (SME)
Expertise:
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