Biographies

Angela Gisby, PhD CBiol MIBiol MTOPRA MICR
Director

Angela has more than 30 years' experience of the international pharmaceutical industry. Trained as a microbiologist with Beecham Research Laboratories in the 1970s, she was involved in the in vivo evaluation of novel penicillins and played a pivotal role in the development of Augmentin, the first penicillin-ß-lactamase inhibitor combination. Over more than 20 years, Angela acquired first-hand experience of almost all stages of the R&D process, and has seen several of SmithKline Beecham's anti-infective products grow from the test-tube to the marketplace. Her research interests centred on the pathogenesis of Chlamydia infection, and she is named as inventor on two patents. For many years, Angela was a reviewer for the Journal of Antimicrobial Chemotherapy and an advisor to its Editorial Board.

For the past 13 years, Angela has worked in the field of contract regulatory affairs consultancy and dossier preparation. Her experience covers a wide spectrum of documentation and regulatory submissions in many therapeutic areas, from nonclinical reports through clinical to post-marketing regulatory requirements. She also lectures internationally and writes research reports, technical documents, papers and book chapters, slides, posters and abstracts.

Angela established Spectrum Regulatory Solutions in 2005, bringing the experience of working with more than 70 pharmaceutical and biotechnology companies across the EU and USA.

Maria Mehlin, BSc(Hons) CBiol MIBiol MTOPRA
Operations Director, Regulatory Affairs

Maria's experience covers over 23 years in R&D, manufacturing, quality and regulatory affairs. A microbiologist by training, she has managed projects in numerous divisions, including pharmaceutical, medicinal, OTC, oral healthcare and animal healthcare. Maria has overall responsibility for the preparation, content and format of submissions to regulatory agencies (new submissions, agency responses and licence maintenance, including renewals and PSURs). Her main discipline is the CMC section of the CTD.

In addition to document preparation, Maria provides advice on regulatory submission strategy and timelines, and is responsible for tracking submissions, and critically reviewing documents for appropriate and accurate scientific rationale in all aspects of the dossier.

Maria also has experience of providing global support for labelling, and in the preparation of CTAs. Ensuring compliance with corporate policies and standards also fell within her industry remit. Maria's collaboration with multidisciplinary teams means that she has experience in a wide range of therapeutic areas.

Peter Blakeney, BSc (Hons) EurChem CSci CChem MRSC MTOPRA
Director, Drug Safety & Pharmacovigilance

Peter has over 27 years experience in the healthcare and pharmaceutical industries covering a variety of both National and International organisations, across ethical and generic sectors, dealing with a wide range of therapeutic areas and dosage forms, for both human and animal health. A chemist by training, he began his career as an analytical chemist in quality control before moving into regulatory affairs and also drug safety/pharmacovigilance matters. He has worked in various areas and, having operated directly in QC, QA, regulatory and drug safety/PV, has collaborated with other key associated disciplines and divisions on a cross-functional basis. His work in drug safety includes 4 years as Qualified Person for Pharmacovigilance (QPPV) at both local and EU level.

Peter has worked on most areas of dossier preparation, licence applications and associated activities throughout the life cycle management of products in global territories and has written and managed various aspects of the regulatory documentation, processes and projects. He has worked on and encountered most areas and aspects of drug safety, pharmacovigilance and medical information and has successfully managed a company Pharmacovigilance Inspection by the MHRA and the subsequent satisfactory close-out of actions. Peter has overall responsibility for the development and management of the drug safety and pharmacovigilance (DSPV) services.

Edward (Ed) Kuzniar, BSc LLB MBA MCIM
Business Development Director

Edward has more than 20 years experience in client based sales and marketing and the consultancy side of the pharmaceutical industry. Starting out as a Biochemical Pharmacologist specializing in drug metabolism and pharmacokinetics in academia and subsequently at Searle Pharmaceuticals in the UK, his first commercial role was with Philips as an international marketing specialist.

Following an MBA, specializing in strategic marketing management, Edward has held a number of senior National, European and International roles encompassing sales management, marketing, channel development, high level account management and product launch. Throughout his career Edward has worked with major pharmaceutical and biotech companies on a global basis to deliver projects ranging from early stage drug discovery through to clinical trials services across many therapeutic areas.

Since 1998, Edward has been working with pharmaceutical services companies, initiating, scoping and delivering high level solutions that have resulted in accelerating his pharmaceutical clients' drug discovery processes and reducing time to market. Edward has a keen interest in legislation and received an LLB(Hons) in 2005.

Gill Turnbull, PhD MICR
Senior Medical Writer, Regulatory Affairs

Gill has more than 15 years' experience within international clinical research, covering all aspects of clinical development. After obtaining a degree in Biochemistry and Physiology, followed by a PhD in neurochemistry and continued research in receptor biochemistry, she left academic research to start her career in clinical research at GlaxoWellcome. Over 12 years Gill gained experience in all aspects of conducting Phase I-III studies, from the design of concept protocols to reporting and submission of data, covering a wide range of therapeutic areas. She then worked for the European office of a Japanese company, responsible for the management of early phase development studies.

Gill is experienced in the interpretation of scientific data and subsequent preparation of documents ranging from clinical study protocols through to study summaries and reports, together with the development of supporting documents such as Investigator Brochures, and clinical components of the CTD.