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
Angela established Spectrum Regulatory Solutions in 2005. She has nearly 40 years’ experience of the international healthcare industry, starting out as a microbiologist. For the past 16 years, Angela has worked in regulatory affairs and medical writing consultancy, gathering experience from over 100 healthcare companies across the EU and USA.
Angela has worked on a wide “spectrum” of documentation and regulatory submissions in many therapeutic areas, for pharmaceuticals, medical devices and biologics. She maintains a hands-on role in writing and project management.
Trevor contributes healthcare industry commercial experience spanning three decades. He leads the strategic direction of the business and market opportunity development. He is focussed on deep client understanding and leveraging Spectrum’s industry-leading experience, quality reputation and unique capabilities. His ultimate aim is to optimise regulatory approval time, enhanced safety, faster market access, medical writing delivery, and label management across pharmaceutical, biopharma, medical device, and functional food segments. Trained academically in bio-sciences, Trevor was active as a scientist in research before entering a career in commerce.
Beverly Barr, PhD
Beverly has more than 20 years’ experience in international healthcare spanning pharmaceuticals, biotechnology, medical devices and diagnostics. She has held senior positions in leading consultancies and communication companies, and currently leads a variety of projects including: due diligence, disease management, early evidence planning, evidence advisory panels, market access strategy and communications, health technology assessment, global value dossiers and toolkits, health policy/external affairs, patient access, payer research and global to local implementation of market access strategies.
Simon Thorn, PhD
Simon has a degree in medicinal chemistry, a PhD in organic chemistry, and over 17 years experience of the healthcare industry. He has worked in GSK’s global medical writing group, and also spent time in European Regulatory Affairs and finally as a Global Study Leader in Oncology Clinical Development. At Spectrum, Simon heads the regulatory writing group and works on documents to support both medicines and medical devices – protocols, clinical trial applications (CTAs), clinical study reports (CSRs), common technical document (CTD) components, pharmacovigilance (PV) reporting (e.g. DSURs and PSURs), risk management plans (RMPs), paediatric investigation plans (PIPs), and scientific advice briefing packs.
Gill Turnbull, PhD MICR
Senior Regulatory Writer
Following a degree in Biochemistry & Physiology, and a PhD in receptor biochemistry, Gill began her career in clinical research at GlaxoWellcome. Over 12 years she gained experience in all aspects of Phase I-III studies, from protocol design to submission for approval. She then moved to a Japanese company, focussing on early phase development. At Spectrum, Gill is mainly involved in the preparation of clinical components of regulatory submissions.
Jo Paul, PhD
Jo has a degree in toxicology and pharmacology and a PhD in oncology. She joined Spectrum in 2012 after six years as a medical writer in a large multi-national pharmaceutical company. She has experience of working in global teams writing a range of regulatory documents for clinical projects; clinical study reports, clinical summaries and overviews. Jo has worked across an array of therapeutic areas including respiratory, oncology, transplantation, orphan products, cardiovascular and metabolism.
Elaine Johnson, PgD (Pharmacovigilance), MRQA, MPIPA
Quality Assurance Manager
Elaine qualified as a Registered Nurse. Moving into industry in 1998, she worked principally in pharmacovigilance and gained a PgD in Pharmacovigilance from the University of Hertfordshire.
For the last six years, Elaine has worked in pharmacovigilance consultancy, with primary responsibility for the writing and quality review of procedural documents. She also brings three years’ experience of Quality Assurance. Elaine is responsible for the maintenance and development of the Company’s Quality Management System.
Charlotte Cunningham, BSc (Hons)
Charlotte has a degree in Environmental Protection. She has worked in administration for over 10 years within several diverse industries and has consequently developed a high level of versatility. Her achievements have included business growth in customer renewals, departmental management and the execution of key presentations to customers. At Spectrum, Charlotte provides strong administrative support, tracking multiple complex projects internally for the team. Charlotte manages the PIL readability testing programme.
Speak to us on +44 (0)1403 320 280 or enquire here.