Our People

All members of our core project management team have worked in global pharmaceutical companies and have extensive backgrounds in the industry. Our staff and our network of consultants have deep expertise in their chosen specialism, allowing us to assemble high quality teams tailored to the needs of our clients. CVs are available upon request. The core team is supported by Finance, Administration and IT functions.

Our Core Project Management Team

Angela Gisby, PhD CBiol MSB MTOPRA MICR
Managing 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.

Trevor Brett
Commercial Director

As Commercial Director at Spectrum Regulatory Solutions, Trevor leads the strategic and tactical direction of business unit relationships and market opportunity development. He is strongly focused on deep client understanding and leveraging Spectrum's industry leading experience, quality work reputation and unique capabilities. This in support of timely sponsor regulatory approvals and faster market access -towards pharmaceutical, biotechnology, veterinary health, medical device and functional food service segments.

Trained academically in Applied Biology, majoring in biotechnology and clinical sciences, Trevor was active as a scientist in Bioresearch for a duration, before entering a career within commerce.

Trevor's commercial experience spans 2 decades based on increasing business model contributions and senior management responsibility, joining the Spectrum team from a background with international Contract Research Organisations. His serial achievements include targetted sales revenue growth and sponsor awards, working throughout clinical and non-clinical development services.

Maria Mehlin, BSc(Hons) CBiol MSB 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.

Simon Thorn, PhD
Senior Regulatory Writer

Simon has more than 15 years experience working in the pharmaceutical industry, across a wide range of disciplines. After obtaining a degree in medicinal chemistry, followed by a PhD in organic chemistry, and continued post-doctoral research on catalytic antibodies, Simon left academia to join the discovery medicinal chemistry group at Organon Laboratories working primarily in the CNS therapeutic area. After 5 years, Simon left the bench to spend time working in various writing roles, including within intellectual property drafting patent applications and within a medical communications agency before joining the global medical writing group at GSK.

Over an eight year career at GSK Simon also worked in European Regulatory Affairs and Oncology Clinical Development. During this time Simon gained extensive experience of many aspects of late stage clinical development including design, execution and reporting of clinical trials (eg CTA/IMPD preparation, protocol, statistical analysis plans and CSR writing) and preparation and agency review of MAA and NDA submissions.

In addition, Simon has also worked on preparation of requests for scientific advice, preparation of paediatric investigational plans, and responses to regulatory agency and ethics committee questions.

Gill Turnbull, PhD MICR
Senior Regulatory Writer

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.

• Download brochure
• Spectrum News