Lee founded GRA and has a passion for developing medicines and improving lives by helping biotech companies succeed through guiding a product’s development to licensure.
Sam is a deeply experienced CMC analytical program leader who enjoys building client relationships and taking an adaptive, pragmatic approach to deliver tailored solutions to complex problems.
Andrew directs the APAC subsidiary, bringing deep experience in Medical Research and Life Sciences in microbiology, molecular and cellular biology, assay development, process development and CDMO management.
Extensive experience in the development of biological products across diverse disciplines, including regulatory experience in authoring CMC sections for clinical trials and commercial registrations.
Cora has over 30 years’ experience in biologics development with specific expertise in downstream process (DSP) development of processes.
Extensive experience in Process Development of mAbs, recombinant proteins, and adenoviral vectors. Expert in GMP Manufacturing up to 2,000 L bioreactor scale as well as providing regulatory support (CMC) for IMPDs and BLAs.
Andrew brings Analytical development, QC consultancy an Analytical support, specialising in biophysical methodology and supports biopharmaceutical clients.
A Scientific Leader with extensive experience of developing biopharmaceutical and gene therapy products, in the academic, public, and private sectors and through freelance consultancy.
Expert in immunology, immunogenicity and (bio)analytical sciences, across small molecules, biologics, vaccines, drug delivery systems, gene & cellular therapies - GMP, GLP, and GCP, non-clinical, and translational development
Expert commercial process scientist including biopharmaceutical development and technical transfer, mammalian and microbial cell upstream process development, data analysis and QbD.
Highly experienced Regulatory Professional adept at leading International Regulatory Agency submissions and interactions.
Accomplished senior regulatory professional with over 25 years of experience in research and development of biotechnical products in the pharmaceutical industry, supported by 10 years hands on research work.
Over 25 years experience in early stage biotech, biopharma and CROs across global programme leadership, clinical development & operations, medical and regulatory affairs from pre-clinical through life-cycle management.
Jim is a bioprocess and biopharmaceutical expert with 30 years of experience. Expertise includes manufacturing technical due diligence, technology assessment and company acquisition technical due diligence.
Alan is an experienced quality professional with over 40 years of experience in the pharmaceutical industry. He specialises in R&D and production facilities
BA strategic leader and expert in all aspects of Pharmaceutical CMC and QA, with over 35 years of relevant experience. Proficient in all dosage forms
30 year background in CMC encompassing discovery, development, manufacturing, quality systems, QRM, and process validation. QbD and DSP expert building process-oriented systems within CMC and quality departments.
Consultant Statistician, providing expertise aligned with the latest regulatory guidance. Focus includes shelf-life determination, method and process development, validation and specification setting.
Sota-san has >30 years Pharma/Biologics experience as an established CMC professional and consultant. He bridges Language and Regulatory gaps between Japan and rest of the world.
Mike is an established QA professional with Qualified Person status and extensive experience in the Life Sciences Industry. An interim QP/Auditor for Fisher who has consulted for more than 20 years.
Detail-oriented scientist with 25+ years’ experience with cGMP and GLP regulated products. Expert in development, optimization, qualification, validation, transfer, implementation, testing, and review.
Deep experience in academia, start-up/biotech, midsize and large Pharma. Excellent communication and track record of project management, scientific leadership, R&D lifecycle delivery and post-marketing initiatives.
Spiros is a biopharmaceutical business expert and deal-maker with over 20 years in biotech. His experience includes partnering, asset disposition, due diligence, technology scouting, business intelligence, valuations & revenue forecasting
Nearly 20 years CMC Manufacturing and Strategy experience in mammalian and microbial systems, plus QbD and six sigma black belt.
Steve has 14 years of industry experience in CMC product development of cell therapies and virus vaccines in analytical development and strategy, quality control, and CMC regulatory affairs at small biotech and big pharma companies.
A scientific leader with extensive experience in toxicology, pharmacology, immunology, pathogenesis & study design. Specializes in in-vivo models as well as PK/PD, biodistribution DART studies and assay development, including immunoassays, NAB assays, cell-based assays and molecular assays.