We are highly experienced educators and advisors in building and improving biopharmaceutical value-chains. We relish tackling tough challenges and seeking innovative ways for clients to build their brand reputation and value proposition.
THE CORE TEAM
Managing Consultant and Consultant in Strategic Supply-chain Management
Hedley founded PharmaFlow in 2005 and is managing consultant. He is also a passionate advocate of paradigm shifting modernisation in the life science industry, as well as being author of Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics, J Wiley & Sons, NJ 2011.
In his previous career, Hedley held senior positions at Bayer UK, British Biotech, Vernalis, Ortho-Clinical Diagnostics (previously J&J), and OSI Pharmaceuticals, (now Astellas). His early career was spent as an industrial engineer in the automotive, consumer durables and FMCG sectors.
He graduated from Cardiff University as a production engineer, holds a Diploma in Management Studies from the University of South Wales, and an Executive MBA from Cranfield University School of Management. Affiliations and qualifications include:
- Advisory Board Member International Institute for Advanced Purchasing & Supply (IIAPS).
- Member 2013 – 15 Expert Industry Panels for CPhI Worldwide.
- Editorial Board Member GMP Review.
- Former member UK BIAs Manufacturing Advisory Committee.
- Former Advisory Board Member of Marken, (now part of UPS).
Hedley regularly delivers podcasts, webinars and speaks at international conferences, and was co-chair of the highly regarded FDA/Xavier University sponsored PharmaLink Conference, held in Cincinnati annually, from 2011 to 2014.
Consultant in Advanced Therapy Manufacture and Quality
Chris has over 20 years operational experience in the life science industry, including roles in manufacturing, technical transfer, engineering, validation, and systems improvement.
His experience covers designing, developing, commissioning, and qualifying facilities, equipment, and processes. Whilst Chris has deep experience across the spectrum of life science value-chains, he specialises in advanced therapy medicinal products (ATMPs), including autologous (patient-specific) therapies.
Chris also has considerable experience in problem solving, process improvement and waste elimination utilising a variety of root cause analysis techniques, covering a number of therapeutic areas, including vaccine and cell & gene therapy manufacture.
Consultant in Pharmacy and Medical Writing
Michael is an MRPharmS qualified pharmacist with over 20 years’ experience working in community pharmacy and 5 years’ experience as a medical information pharmacist providing support on clinical, legal, and regulatory issues. His background is in learning and development, having spent many years developing and delivering training materials for a range of audiences.
He is a member of a pharmacy advisory panel and a multi-disciplinary steering group for the development of clinical resources for healthcare professionals.
Recent projects Michael has undertaken at PharmaFlow include an assessment of the pharmaceutical regulations relating to medicinal cannabis in the UK, and the competitive environment amongst major contract development and manufacturing organisations (CDMOs) globally.
Consultant in Management Systems and Compliance
Adele is a consultant in management systems, specialising in compliance with new & existing standards in advanced industry sectors.
Adele’s deep experience in business process analysis and technology was gained at Xerox and Johnson & Johnson (J&J). At J&J, she spent 6 years as Business Process Transport Lead, focusing on UK, IE and Nordics carriers, providing transport for the cross-sector Consumer, Pharmaceutical and Medical Device businesses. She held ISO 13485 Lead Assessor position for the UK Medical Device operations, and specialised in Transport auditing for shipments of Medical Devices and Pharmaceuticals.
Her expertise covers ISO Standards 13485, 9001, 14001, 45001, 27001, 27701, 22301, and Aerospace Standards (AS) 9100, 9120. Certifications include BSI Certified Lead Auditor (13485 and 9001), IRCA Lead Auditor (9001), AS9100/AS9120 Internal Auditor, Diploma in Quality Management, Diploma in Risk Management and cGMP/cGDP”
Consultant in Clinical Development and Patient Experience
Gareth is a consultant surgeon who after 28 years of clinical practice specialising in disease of the liver, pancreas, and biliary system, most recently at the Cleveland Clinic, has turned his attention to the development and supply of innovative new treatments for cancer.
He brings a passion for treating patients as individuals, and holistically, to new product development. As a practicing surgeon, he observed that in an era striving for personalised medicine, the majority of patients currently receive a generic approach, often with little efficacy.
Furthermore, in his clinical practice, he noted that current chemotherapies have a high incidence of unpleasant side-effects leading many to reduce their dose, change to a less effective option, or discontinue treatment altogether.
His specialist interest is in developing therapies for pancreatic cancer using various approaches, including targeting of previously untargeted pathways using natural molecules and combining the best of western and Ayurvedic approaches to maximize efficacy and minimise toxicity of hybrid combinations.
Gareth graduated from the University of Wales College of Medicine (MBBCh) and trained in the United Kingdom obtaining MD, MCh, and PhD research degrees. He also undertook training in France, Japan, and the United States. He is a Fellow of the Royal College of Surgeons of England and the American College of Surgeons.
Our principles are based on tried and tested approaches to researching and developing innovative new products and services, as practiced by advanced sectors such as semiconductor, aviation, aerospace, electronics and automotive.
The principles, outlined below, underpin every project assignment:
Value propositions can only be determined by talking with those end-users – understanding their needs, which often depend on the needs of end-users of their products and services.
Factor-in the unique regulatory, legal, and technical constraints, based on a deep, up-to-date understanding of the biopharmaceutical industry
Offer solutions that deliver on the client’s business objectives and strategic priorities.
We also have a strong network of trusted collaborators on hand to help when required:
We don’t shy away from a challenge
As a client, no matter where you are positioned in the biopharmaceutical value-chain, following these principles will allow you to build your own brand and value proposition.
Due to the bespoke nature of our services, projects can range from the relatively simple, such as sharing knowledge to technical specialists on good manufacturing and distribution practice (GMDP), to helping secure the launch of new molecular entities into global markets; and everything in between.
We don’t shy away from a challenge. Our breadth of knowledge and expertise means that we’re able to take on projects of all natures, no matter how big or small.