Elaine is a chemist with 30 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 a major US CRO. Elaine has contributed to the successful development of small molecules and biotechnology agents in the fields of respiratory, oncology, haematology and GI diseases, amongst others. Elaine also has significant interest and experience in Emerging Markets.
Gerry, a molecular biologist, has over 30 years' experience in the biotechnology and pharmaceutical industries, in regulatory affairs, clinical development and business development, as well as in various Non-Executive Director roles. He has worked with large and medium pharma companies (Almirall, Spain and GSK) and in 1990’s headed up the European Regulatory & Scientific Affairs function of The Liposome Company, a US biotechnology firm. With Elaine, he founded the European regulatory affairs and product development consultancy company, GMG BioBusiness Ltd, which was acquired by a top 5 CRO in 2005. He also set up and was the first CEO of the Catalan biotechnology development agency, Biocat, based in Barcelona. Gerry has worked with many EU, US and other clients on projects ranging from early-stage regulatory strategy for emerging biotechs to advising on strategy and operations for major developments of large pharma firms. Gerry has excellent relationships with top level business, science and governmental executives.
Gonzalo is a physician with broad experience advising pharma and biotech companies on regulatory and clinical development matters. For a number of years, he has been supporting Kinesys’ clients through our Advisory Board, in which Gonzalo is a key figure. He is currently Head of the Clinical Pharmacology Department at the Hospital Clinic, one of the major hospitals in Barcelona. He was CHMP member for Spain, and Clinical Assessor at AEMPS, for 10 years. Together with CHMP colleagues across the EU, he had responsibility for all decisions pertaining to new drug MAAs in the European Union.Gonzalo has held various other clinical and regulatory roles, including in pharmacovigilance. During his tenure at CHMP and AEMPS he chaired and participated in a number of EMA / CHMP working parties (cardiovascular, efficacy, and others), set up the Scientific Advice function at AEMPS, and assessed Scientific Advice Applications at EMA and AEMPS. Gonzalo was president of the European Association of Clinical Pharmacology and Therapeutics (EACPT) from 2011 to 2015.
Delphine joined Kinesys in 2018 and has over 15 years’ experience working in Global Regulatory Affairs across a number of therapeutic areas, product types and markets. Prior to joining Kinesys, Delphine worked at Amgen. In the early part of her career she was responsible for the development and implementation of regulatory strategies across Europe and Emerging Markets, for both small molecules and biotech products. Delphine also supported global clinical programmes and has extensive regulatory project management experience. Delphine provides regulatory expertise and leadership to clients on a range of projects including regulatory applications in Europe, US and EU National Competent Authorities (Scientific Advice, Orphan Drug Designations, Paediatric Plans, Expedited Development Pathways, MAAs) and advises clients on regulatory strategy for early to late-stage development assets. Delphine has experience in leading teams in executing regulatory submissions and regularly engages with Agencies. 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.
Graeme, a biomedical research professional, has over 10 years’ experience in regulatory affairs consultancy. He has significant experience in leading teams across a range of regulatory applications (Scientific Advice, Orphan Drug, Paediatric, CTD Modules, Expedited Development Pathways, Clinical Trial Applications) supporting the development of medicinal products across major global markets. His expertise also involves contributing to the regulatory strategy for product development in multiple therapeutic areas for companies spanning early-stage R&D up to late phase clinical development, and he regularly engages with Regulatory Agencies on behalf of clients. Prior to joining Kinesys, Graeme gained a PhD in Cardiovascular Pharmacology from the Faculty of Medicine at the University of Glasgow and worked in various academic positions in biomedical research (Cardiovascular, Neurology, Inflammation). He was co-founder and Research Director of Aurum Biosciences, a start-up Biopharmaceutical company developing a novel product for the management of acute ischaemic stroke, which has successfully progressed through preclinical development to the clinic.
A Pharmacist by training, Lola’s career in Regulatory Affairs spans 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.
Ed has over 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 devices 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.
Karen has worked in the pharmaceutical industry since 1991, initially in Clinical Research and then since 2001 in Regulatory Affairs. She has undertaken a variety of roles within small biotech and large pharma companies and also Regulatory Consultancies working in the EU, AsiaPac and the US, and her roles have included both line management and project management responsibilities. Focusing on pre-marketing development, Karen has been responsible for regulatory applications ranging from ODD and PRIME designations, pre-INDs and Scientific Advice, INDs and CTAs through to MAAs and BLAs. Karen was responsible for the first CHMP Scientific Advice application and meeting for the AZ COVID-19 vaccine.
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 (CTD) sections for New Drug Applications (FDA) and Marketing Authorisation Applications (EMA), including Module 1 and 2; patient narratives; Investigator’s Brochures; briefing books for EMA and FDA Applications; 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 joined Kinesys Consulting in 2021 as Manager, Scientific and Regulatory Writing, and is now Senior Manager. 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 completed her PhD study in molecular biology at the European Molecular Biology Laboratory (EMBL), and University of Heidelberg. 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. She has published in several peer-reviewed journals and worked in highly international environments. Her writing and regulatory experience includes Paediatric Investigation Plans for EMA and FDA, Investigator’s Brochures, Agency briefing books, Risk Management Plans, expedited regulatory pathways such as PRIME (EMA) and Fast track designation (FDA), CTD sections for New Drug Applications (FDA), and Marketing Authorisation Applications (EMA), including nonclinical and clinical summaries and overviews. She has also authored Clinical Study Reports, lay summaries, patient narratives, clinical research manuscripts, and literature search reports. Claudia is a member of the American Medical Writers Association (AMWA) and the European Medical Writers Association (EMWA).
Becca recently joined Kinesys Consulting as a Senior Manager, Scientific and Regulatory Writing and is responsible for preparing a range of regulatory and clinical documentation for clients globally. She has over 6 years of experience as a medical writer and joined Kinesys Consulting from a senior role where she worked on the development of global market access materials across a broad range of therapeutic areas (oncology, CNS, nephrology, blood disorders). Becca has an MSci in Pharmacology from the University of Glasgow and obtained a PhD in Pharmacokinetics from the University of Manchester in partnership with AstraZeneca. Becca is a member of the American Medical Writers Association (AMWA).
Victoria joined Kinesys Consulting in September 2022 in a Scientific/Regulatory Writing Manager. Prior to this Victoria was 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. During that time, she employed the most up-to-date technology to study host response to infection, 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. Her writing and regulatory experience includes briefing documents for scientific advice (EU, UK and US), orphan drug designation and maintenance reports (EU, UK and US), Investigator’s Brochures, applications for early access pathway applications (PRIME (EU), ILAP (UK) and Fast track (US), common technical document sections in preparation for New Drug Applications (US) and Marketing Authorisation Applications (EU), including clinical patient narratives, written and tabulated summaries, risk management plans (EU), literature reviews, and preparation of slide decks for agency meetings. Victoria is a member of the American Medical Writers Association (AMWA) and European Medical Writers Association (EMWA).
Alison’s role at Kinesys is as a Senior 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, having worked 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 developments, including Japan, and life cycle management for biologics and NCEs in diverse therapeutic areas such as oncology, neurology and dermatology. Areas of particular clinical interest are Multiple Sclerosis, AML, ALL and ADHD. After working in Germany and Switzerland for most of her career she came back to the UK in 2013 to build up a regulatory department for Jazz/EUSA Pharmaceuticals in Oxford. Alison’s experience covers the EU Centralized procedures, DCP/MRPs, National approvals, MAA transfers, 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, and J-NDA preparation, submission and approval. Alison has substantial experience in mergers and takeovers and has a particular knowledge of due diligence and crisis management.
Reha has over 10 years’ experience in B2B business development and marketing, spanning 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.
