- 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 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.
Executive Director Regulatory Affairs
- Ishbel has been working in the Pharmaceutical industry for over 30 years, starting as an analytical chemist and with 25 years in Regulatory Affairs. She previously worked with Wyeth (now Pfizer), Controlled Therapeutics (now part of Ferring Group) and her own consultancy company, MacDonald Regulatory. Prior to becoming a consultant in 2000, she was Director of Regulatory and Clinical Affairs at Controlled Therapeutics Ltd, responsible for worldwide regulatory negotiation and approvals. Ishbel has provided regulatory advice and been involved in many types of regulatory applications in development, licensing and post-licensing / life cycle management for a wide range of pharmaceutical and food supplement companies in Europe, US and Far East. She has been responsible for most types of Regulatory Applications including Scientific Advice, Orphan Designations, CTAs, PIPs and MAAs. Ishbel specialises in working with Start-ups and SME’s on regulatory strategy, gap analysis, regulatory agency meetings, lifecycle management and regulatory due diligence.