Pleiad Europe is led by Helen Colquhoun and Julia Edgar, both of whom have extensive industry experience of successful medical product development, negotiations with Regulatory Authorities, project management and commercial partnering.

Helen and Julia have both worked with small, emerging and large multinational companies in the biotechnology and pharmaceutical industries since 1988. In particular, their strengths are:

• Extensive experience of successful product development planning and management
• Skilled in the development of regulatory, clinical and commercial strategies
• Excellent track record of problem solving
• Proven negotiation skills with regulators (including Europe and the USA) and potential commercial partners
• In-depth experience of biotechnology products and a variety of therapeutic areas
• Broad scientific and medical backgrounds
• Considerable senior management experience

JULIA EDGAR
Managing Director

Julia is a scientist (BSc, MSc) and an MBA graduate who has worked in the biotechnology and pharmaceutical industries since 1988. She has significant experience in taking transgenic products through clinical development, negotiating programmes with regulatory authorities and working in orphan indications. Julia’s key areas of expertise include clinical development (design and management of clinical studies, identification and management of Scientific Advisory Boards; interactions with regulatory authorities); programme management (formulation of global product development plans; and management of virtual project teams) and business development (market assessments, preparation of business plans, due diligence).

DR HELEN COLQUHOUN
Director

Helen is a pharmaceutical physician and has worked in the bio-pharmaceutical industry since 1988. She has particular expertise in product development planning, regulatory affairs, drug safety management and corporate development strategies. Helen worked for a large US pharmaceutical company as Associate Medical Director for several years. In 1995 she moved into consultancy and has worked with many clients from small, innovative biotechnology companies to large pharmaceutical corporations. Helen has led global drug development teams, successfully negotiated with the major regulatory authorities and managed important safety issues for clients. To keep her feet on the ground, Helen also continues to work one day a week as a part-time GP. The UK Government has recently recognised pharmaceutical medicine as a medical specialty and Helen will be part of the first group of physicians to obtain this specialist accreditation.

DR GILLIAN PRITCHARD
Medical Director

Gillian is a pharmaceutical physician with over ten years drug development experience. She has Phase I – III clinical research experience gained from academia (clinical pharmacology and cardiovascular medicine), contract research organisation (Phase I-II) and multinational pharmaceutical companies (Phase II-III). Prior to joining Pleiad, Gillian was Associate Director in Clinical Development at Pfizer and was part of the global development team with responsibility for the European Phase III diabetes programme. Gillian still maintains her interest in diabetes and has a regular diabetic clinic commitment. Gillian is currently completing her training to obtain specialist accreditation in pharmaceutical medicine.

GEORGINA SPENCE
Clinical Projects Manager

Georgina initially trained as a Nurse (RGN, SCM) and later graduated with a BA in Information Management: she has worked in both Data Management and Clinical Operations environments within the Pharmaceutical Industry across a broad spectrum of therapeutic areas. Prior to joining Pleiad, Georgina was a Clinical Team Manager for a large Global CRO with responsibilities for trial management, preparation of regulatory and ethical submissions, CRA training and mentoring, standardising clinical monitoring processes and co-ordinating project team communication both internal and external.

JILL HOWCROFT
Commercialisation Projects Manager

Initially Jill trained as a molecular biologist in a biotechnology company, before making a move in to the clinical development group where she worked as an assistant project manager. Two years of field experience as a CRA has given her a solid background in the practices of clinical research, from Phase I through to post marketing observational studies, supplemented latterly by an additional business development role. Jill undertakes the Pleiad commercialisation projects for Universities and Research Institutions as well as assisting with business development and clinical projects.

JENNIFER TRUELAND
Administration & Services Manager

Jen has worked in the fields of administration, office services and event management for 15 years and manages the admin support for the Pleiad team as well as ensuring the smooth running of the office. Prior to joining Pleiad she was Services Manager for Guinness UDV.

IAIN COLQUHOUN
Accounts Manager/Information Scientist/Medical Writer

Iain is an ecological scientist (BSc, PhD) with 16 years experience in Africa managing Government, World Bank and African Development Bank projects, and more recently in Scotland working in the private sector and for Scottish Natural Heritage. This has provided wide experience in writing scientific, project and situation reports for individuals, companies, governments and agencies. He now works as a medical writer and is a member of the European Medical Writers Association. For Pleiad he has responsibility for managing day-to-day financial matters and providing computer support. He also provides assistance as an information scientist - and anything else that may be required!!

KATHLEEN CRAIG
Administrative Assistant

Kathleen assists Jen and Iain with the general running of the office and book-keeping. Kathleen is our Clinical Trials Assistant and has responsibility for maintaining our clients' trial master files.

DR ISHBEL MACDONALD
Regulatory Consultant

Ishbel is an analytical chemist (BSc Hons, PhD) who has worked in research and development in academia and in the food and pharmaceutical industries since 1984. She is an independent consultant in Regulatory Affairs and a Visiting Lecturer at the University of Paisley. Prior to going freelance, Ishbel was Director of Regulatory and Clinical Affairs, Controlled Therapeutics Ltd, East Kilbride, UK. Her notable achievements include preparation and submission of a New Drug Application (NDA) with subsequent worldwide regulatory negotiation and approvals, successful appeal to UK Medicines Commission, successful management of a European mutual recognition procedure, establishment of agreements with trading partners, and drug safety management with responsibility for setting up a global safety database. Since going freelance in 2000, she has provided regulatory and technical advice to a wide range of pharmaceutical and food companies with more recent emphasis on Food Supplements and Medical Foods. She has also been involved in training in Regulatory Affairs and Product Development to small/medium sized pharmaceutical companies.

DR SUSAN ALEXANDER
Regulatory Consultant

Susan is a biochemist (BSc Hons, DPhil) who has worked in the pharmaceutical industry since 1992. She is a freelance regulatory affairs consultant with ’hands-on’ US and European experience in drug development, post licensing activities and medical devices. She has previously worked in small to medium biotechnology companies taking a key role in multidisciplinary drug development project teams. A particular area of her expertise is in quality assurance and manufacturing having been a Quality Assurance Manager for a small biopharmaceutical company. Susan has also provided regulatory support for world-wide clinical trials, prepared and co-ordinated regulatory submissions to the FDA, EMEA and national regulatory agencies for drugs and medical devices, and negotiated responses to regulatory agency questions during the review process.