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.
BSc Hons Chemistry MRSC Qualified Person
I am a passionate quality professional that can lead and motivate cross-functional working teams and an articulate communicator across all levels within an organisation.
I have over 20 years’ experience working within two large Pharmaceutical and Medical Device multinational companies, and over two years’ experience in a consultancy capacity. From this I have gained a breadth of knowledge across the whole product lifecycle and across GCP, GMP, GDP and ISO Quality Management Systems and have a track record of turning regulatory expectations into practical working solutions.
I am able to offer a range of services as detailed below:
- Eligible to act as a Qualified Person via permanent provisions and have experience in batch certification of commercial and investigational medicinal products.
- Proactive Quality Manager and Pharmaceutical Auditor.
- Supporting clients with the development, implementation and effectiveness checks of Quality Management Systems.
- Deliver GxP and Quality Systems training courses.
- Assisting clients prepare, and host, regulatory inspections and audits.
- Providing bespoke technical consultation and guidance to support client requirements.
- Leading compliance projects and providing comprehensive and clear feedback to key stakeholders.
Dr Shona lang
Senior Consultant in Preclinical Evidence Synthesis and Systematic Review
Shona has over 10 years’ experience in consulting systematic reviews and evidence synthesis. Previous to this she worked for 15 years in cancer research, investigating tissue development and developing preclinical cell-based models.
Shona is an experienced manager with a demonstrated history of working in the research industry. She has been part of an Evidence Review Group for the assessment of health technology submissions to NICE and reviewed manuscripts for statistical analysis. She has worked in multiple disease areas and for a wide range of clients. Her current interest is precision medicine.
It is her belief that the application of systematic review methodology and evidence-based decision making will improve both investment in novel biotechnology and clinical translation and reduce scientific waste. She brings skills in evidence-based decision making, systematic review, epidemiology, risk of bias assessment and meta-analysis.