- Elaine is a chemist with 25 years’ experience in biopharmaceutical Regulatory Affairs. Elaine started her career in the industry with Almirall, S.A. (Spain). She most recently held the post of Director, Regulatory Affairs (Oncology) for Amgen. She worked in Regulatory Affairs with Cortecs, an emerging biotechnology company, Chugai, a medium size Japanese pharma firm, and was Regulatory Director of BMS in UK. She was a principal partner with Gerry McGettigan in their consultancy firm, GMG BioBusiness Ltd, where she oversaw the successful completion of a range of projects and general management of the organization, including regulatory strategy and submissions. She was integral to the acquisition negotiations for GMG BioBusiness with the major US CRO, PRA International. Elaine has contributed to the successful development of small molecules and biotechnology agents in the fields of respiratory, oncology, haematology and GI diseases, and has particular expertise in biotechnology CMC issues. Elaine also has significant interest and experience in Emerging Markets.
- Gerry, a molecular biologist, has twenty five years’ experience in the biotechnology and pharmaceutical industries, in regulatory affairs, clinical development and business development, and in various Non-Executive Director roles. He has worked with large and ” extended_info=”medium pharma companies (Almirall, Spain and Glaxo, UK) and was Regulatory & Scientific Affairs Director of The Liposome Company, a US biotechnology firm.
He founded the European regulatory affairs and product development consultancy company, GMG BioBusiness Ltd, which was sold to a top 5 CRO in 2005. He also set up and was CEO of the Catalan biotechnology development agency, Biocat, based in Barcelona. Gerry has worked with many clients on projects ranging from early stage regulatory strategy and complex biotechnology products, to clinical development and registration of novel healthcare products.
Gerry has excellent relationships with top level business, science and governmental executives. Gerry has invested in several biotech / pharma companies. Gerry is Non-Executive Director of Syntropharma and Biopta.[/
Senior Regulatory & Strategy Consultant
- Alison has over 25 years experience in global Regulatory Affairs at major pharmaceutical companies such as Hoffman La Roche, Schering AG, Merck Serono and Shire in Switzerland, Germany and the UK. She has had leadership and senior managerial roles managing teams of regulatory professionals in the US, Switzerland and the UK. Her focus has been the preparation of regulatory strategies for global drug development and life cycle management for biologics and chemical products in diverse therapeutic areas such as oncology, neurology and dermatology. Areas of particular clinical interest are Multiple Sclerosis, AML, ALL and ADHD. Her experience spans the globe having particular focus on the USA, EU and Japan. She has lived in Germany and Switzerland for most of her career and came back to the UK in 2013 to build up a regulatory department for Jazz/EUSA Pharmaceuticals in Oxford. Alison has a comprehensive global regulatory experience including in the EU, Centralized procedures, DCP/MRPs, National approvals, MAA transfers, crisis management, Scientific Advice, Orphan Drug applications, HTA advice and CTAs. In USA, NDA submissions, advice meetings, Advisory Board preparation. In Japan, CTA submissions, Orphan Drug submissions, J-NDA preparation, submission and approval. Alison has substantial experience in mergers and takeovers and has a particular interest in due diligences. Alison’s role at Kinesys is as a Senior Consultant and she is based in the London area.