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.
Delphine recently joined Kinesys Consulting as an Associate Director Regulatory Affairs. She was most recently at Amgen, where she spent 10 years working in Global Regulatory Affairs. During her time at Amgen, Delphine worked in a number of roles including regulatory product lead in Europe, as well as in Emerging Markets. Her focus was primarily the development and implementation of regulatory strategies, including life-cycle management for biologics in both the oncology and non-oncology therapeutic areas. Delphine also supported global clinical programs, and her experience spans a number of EU regulatory procedures. Delphine has a PhD in Medicinal Chemistry from the University of Bath and has held post-doctoral research positions at Sanofi-Aventis and at the University of Oxford. She received her chemistry education in France and moved to the UK in 2000. Delphine worked briefly in a patent attorney practice and has a special interest in IP-related matters as well as in antibiotics research.
Graeme has over 15 years experience working as a biomedical research professional. Graeme's regulatory affairs experience with Kinesys is in a number of areas including biosimilars, scientific advice applications, CTAs and orphan product designations. He has also helped to design and now maintains the Kinesys Oncology & Orphan Products Database. As a researcher, Graeme has an impressive track record of developing and utilising preclinical disease models combined with imaging, in projects designed to improve understanding of disease mechanism and investigate novel diagnostic and therapeutic advances in areas of cardiovascular, pulmonary and neurological medicine.Graeme is a co-founder of a recently formed biopharmaceutical company, Aurum Biosciences Ltd where he advises on planning the current and future research and development programme required to support continued progression of the company's key technology through to a successfully translated product for acute stroke management. He is an integral member of the project management team responsible for development, regulatory and commercial planning.
A Pharmacist by training, Lola’s career in Regulatory Affairs expands over 20 years. She has held leading global roles in Biotech companies (ProQR Therapeutics, Antisoma) and mid pharma (Astellas) where she led the design and implementation of global regulatory strategies in all phases of development. Early in her career she worked as a Clinical Assessor at the Spanish Medicines Agency. Lola’s first consultancy role was with Gerry McGettigan and Elaine Murphy in their consultancy firm, GMG BioBusiness Ltd, where she contributed to the successful completion of a range of projects. Her experience covers a wide range of therapeutic areas (dermatology, ophthalmology, oncology, respiratory, urology, etc.) and product types (biologics, antisense oligonucleotides, small molecules). Lola has experience with EMA, FDA and EU National Competent Authorities, and has a particular interest in Orphan product development.
Ishbelhas 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.
Bonita has 15 years of experience in the pharmaceutical industry in companies such as Takeda, GSK, Amgen and Biomarin. Her experience covers most areas of Regulatory Affairs including a range of early and late stage development projects, Centralised / MRP / DCP MAAs, Orphan Drug Applications, CTAs, post-authorisation projects and labelling roles. Bonita has held Regulatory Lead and Regulatory Project Management positions, she is experienced in working in cross-functional teams, and she is knowledgeable in publishing and other systems. Bonita’s therapeutic experience covers Oncology and Rare Diseases, as well as generic products. Bonita has a degree in Pharmacology from the University of Auckland, New Zealand.
Ed has 15 years of experience directly relating to medical devices, spanning all aspects of the development life cycle, from initial concept to product maturity. He has worked on a broad spectrum of medical device and has extensive experience of providing consultancy for QMS and Regulatory compliance. His experience in medical device regulations and QMS requirements has allowed him to train notified body auditors on approved CQI (Chartered Quality Institute) and IRCA (International Register of Certified Auditors) courses. Product category experience includes – software, endovascular aneurysm repair systems, ophthalmology equipment, single use disposables, ventilators, and wireless patient monitoring. Prior to his career in medical devices, Ed worked in Research and Development at Reckitt, on Health and Homecare product ranges. He has a PhD in Materials Science from the University of St. Andrews, a first degree in Chemistry from the University of Strathclyde, and has published work in high impact factor peer reviewed journals.
Claire joined Kinesys Consulting in September 2021 in a Scientific/Regulatory writing role and is now Senior Manager. She came to Kinesys from a post-doctoral position at the University of Glasgow, where she worked on projects in immunology and parasitology. Claire has an MA in Natural Sciences from the University of Cambridge and a PhD in Molecular Biology from the John Innes Centre/University of East Anglia. Overall, she has over 10 years’ experience in biology research, across a breadth of fields. Claire’s writing experience includes common technical document sections for New Drug Applications (FDA) and Marketing Authorisation Applications (EMA), including Module 1 and 2; patient narratives; investigator’s brochures; briefing books; orphan designation applications; and MHRA applications for the Early Access to Medicines Scheme and the Innovative Licensing and Access Pathway. Claire is a member of both the European Medical Writers Association (EMWA) and the American Medical Writers Association (AMWA).
Claudia is a molecular biologist with 13 years’ experience as a biomedical researcher. After obtaining MSc. in Biomolecular Sciences and Technologies at the University of Pisa (Italy), she continued her training at the European Institute of Oncology in Milan. Claudia moved to Heidelberg in 2010, and completed her PhD study in molecular biology at the European Molecular Biology Laboratory (EMBL), and University of Heidelberg working on disorders of iron metabolism. In 2016 she was awarded a Novo Nordisk Postdoctoral Research fellowship at the Oxford Centre for Diabetes Endocrinology & Metabolism, where she spent 5 years investigating the molecular bases of type 1, and type 2 diabetes. As a researcher, Claudia has extensive knowledge of a wide range of molecular biology techniques, in vitro and in vivo experimental models and molecular mechanisms behind different diseases. She has published in several peer-reviewed journals and worked in highly international environments. Claudia joined Kinesys Consulting in August 2021 as Manager, Scientific and Regulatory Writing, and is now Senior Manager. Her writing experience includes paediatric investigation plans for EMA and FDA, investigator’s brochures, briefing books, risk management plans, clinical study reports, lay summaries, clinical research manuscripts, literature search reports, common technical document sections for New Drug Applications (FDA), and Marketing Authorisation Applications (EMA), including nonclinical and clinical summaries, overviews, and patient narratives. Claudia is a member of the American Medical Writers Association (AMWA) and the European Medical Writers Association (EMWA).
Victoria is a molecular biologist and immunologist with 18 years post-doctoral experience in the field of infectious disease. Having obtained her PhD at the University of Glasgow, she became a senior research scientist within the department of Parasitology. During that time, she employed the most up-to-date technology to study host parasite interactions, lectured undergraduate students, wrote grant proposals and peer reviewed manuscripts, and regularly presented her data at national and international conferences to a wide range of audiences. At Kinesys Victoria is responsible for preparing a range of regulatory and clinical documentation for clients in USA, EU and other global regions. Victoria is a member of the American Medical Writers Association (AMWA).
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.
Reha has over 10 years’ experience in B2B business development and marketing, spanning from executing marketing strategies and plans to lead generation and customer acquisition. Prior to being a professional marketer, she was a college teacher of communication and media as well as a researcher at University of Leicester, aiding with the in-depth analysis of the ever-evolving field of marketing. Reha has an MSc and BSc in Communications from the University of Leicester and holds a particular interest in the metrics behind every campaign.
