EXPERT REPORT by HEDLEY REES, PHARMAFLOW, DATED 17th DECEMBER 2021 - PART I
EXPERT REPORT by HEDLEY REES, PHARMAFLOW, DATED 17th DECEMBER 2021 - PART I
Written for PJH Law to be used in a letter before action against MHRA
More Education for Paid Subscribers
What follows is part of an expert report written for PJH Law in a case against the MHRA. It went nowhere, of course, as in December 2021 the locks were well and truly down. As more and more folk wake up to the perils of these injections, me thinks some cold hard facts will be in order. Here you go:
EXPERT REPORT
Prepared By
Hedley Rees Managing Consultant at PharmaFlow Limited, 17th December 2021
CONTENTS
Title
Curriculum Vitae
Glossary of Terms
Summary
Safety of Final Product and Supply chain
Non-compliance with GMDP
Conflicts of Interest and lack of experience in the MHRA
Steps for MHRA to take
STAGES INVOLVED IN DEVELOPING A NEW MEDICINE
GLOBALLY HARMONISED PROCESS FOR DEVELOPING A NEW MEDICINE
ADVANCED THERAPY MEDICINAL PRODUCTS
THE PROCESS OF LICENSING
Supply Chain for Distribution of SARS-COV-2 Injections
SUMMARY OF GMP OBLIGATIONS OF A CLINICAL TRIAL SPONSOR (CTS) OR MARKETING AUTHORISATION HOLDER (MAH)
TRANSFER OF OWNERSHIP TO THE DISTRIBUTION CHANNEL
INITIAL FURTHER ASSESSMENT OF ISSUES AND CONCERNS
Annex 1: Profiles of MHRA Board Members
Declaration and Signature
Full CV available upon request
Name:
Hedley Rees
Present Appointment:
Hedley Rees is the Managing Consultant at PharmaFlow Limited, a UK based consultancy specializing in supply chain management within the pharmaceutical and life science sectors. Clients range from large pharmaceutical companies to emerging biotech, and also include investors, lawyers, other consultancies, facility design & build specialists and third-party logistics providers (3PLs). Assignments span preclinical, clinical, and commercial supply chains up to complex multi-product networks covering global territories.
Qualifications:
B. Eng. (Tech) Hons Production Engineering, University of Wales;
Executive MBA, Cranfield University School of Management.
Previous Appointments:
Senior positions at Bayer UK, British Biotech, Vernalis, Ortho-Clinical Diagnostics and OSI Pharmaceuticals (now Astellas).
Affiliations and qualifications:
· Author, Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics, Wiley, 2011
· Advisory Board Member, International Institute, Advanced Purchasing & Supply (IIAPS).
· Editorial Board Member GMP Review (GMP = Good Manufacturing Practice).
· Former consultant to Oxford BioMedica on UK Government funding call Advanced Manufacturing Supply Chain Initiative (AMSCI), resulting in funding of £7.1M.
· Former Advisory Board Member to Marken, 2011 - 2012 (now a UPS company).
· Founding Member of Expert Industry Panel for CPhI Worldwide (UBM plc)
· Former member of the UK Bio-Industry Association’s (BIA) Manufacturing Advisory Committee, 2007 – 2011
Conference Speaking Engagements:
“Why patient-specific (autologous) therapies need hospitals to manufacture; and how to go about it”, National Healthcare Expo, ARENA MK, Milton Keynes, 26th November 2019
“How Whole Systems Thinking Will Transform the Pharma Supply Chain”, Making Pharmaceuticals, Coventry Ricoh Arena, April 30th, 2019.
“Building Robust Advanced Therapy Value Chains with Rapid Prototyping and Systems Thinking”, Making Pharmaceuticals, Coventry Ricoh Arena, April 25th, 2018
“A practitioners view on supply chains in Pharma & Biotech”, Pharmaceutical Licensing Group (PLG), at Fasken & Martineau LLP, London, October 23 2014
“A Provider Perspective on Building Patient-Centric Supply Chains”, UPS EU Healthcare Annual Conference, Hungarian Academy of Science, Budapest,
October 1 2014
“De-risking the Pharma Supply Chain from Day 1…” Jardine Lloyd Thomson (JLT) Insurance Annual Conference, Windsor, UK May 16 2014
“Implementing QbD like other industries – successfully!” FDA/Xavier University PharmaLink Conference, Cincinnati, March 13th 2013.
“Is the Pharma Supply Chain a Lost Cause?” QUMAS CONNECT, Tampa, Florida, Feb 4th 2013.
“The Power of Integrated Supply Chains, by Design” 36th International GMP Conference, University of Georgia March 14th 2012.
“Good Distribution Practices: What do they mean to you?” International Society for Pharmaceutical Engineering (ISPE) Annual Conference, San Francisco, November 14th 2012.
“Building, Managing and Continuously Improving Clinical Supply Chains”, IQPC Clinical Trial Supply Europe, Basel, February 1st 2012.
“The Power of Integrated Supply Chains, by Design” FDA/Xavier University Global Outsourcing Conference, Cincinnati, October 4th 2011.
“Building Supply Chain Transparency and Pedigree”, FDA/Xavier University Global Outsourcing Conference, Cincinnati, June 16th 2010.
“The Importance of Quality by Design in Biotherapeutic Development”, BioIndustry Association, London June 4th 2009.
“Building, Managing and Continuously Improving Outsourced Value Chains in Biotech”, Next Generation Pharmaceutical Summit, Evian, Lake Geneva, May 7th 2008.
“Building, Managing and Perfecting Supply Chains in Pharmaceuticals”, The ManuPharma European Summit, Noordwijk aan Zee, Netherlands, 18th May 2005.
Publications:
Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics, J Wiley & Sons, Hoboken, NJ 2011
What Patients Need to Know About Pharmaceutical Supply Chains, KDP, March 2021
Various journal articles on supply-chain management and industry modernisation published in:
· Chemistry Today
· GMP Review
· Industrial Pharmacy
· Pharmaceutical Technology
· Pharmaceutical Journal (PJ),
· Pharmaphorum
· European Biopharmaceutical Review
Background:
Hedley’s skill set covers the range of competencies from strategic procurement, production and inventory control, distribution logistics, information systems and improvement. His early career was spent as an industrial engineer in the automotive, consumer durables and FMCG sectors.
As an expert in production systems and industrial improvement methods, Hedley is a zealous advocate of the regulatory modernization frameworks of FDAs 21st Century Modernization and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidances Q8 – Q12.
Hedley regularly delivers podcasts, webinars and presentations at international conferences. He was co-chair of the highly regarded FDA/Xavier University sponsored PharmaLink Conference (formerly FDA/Xavier Global Outsourcing Conference) held in Cincinnati annually, from 2011 - 2013.
He is focusing his time now on developing and delivering digital education programmes for various stakeholders in the pharmaceutical industry, believing education is the only route to long term, sustainable resurgence for the industry.
GLOSSARY OF TERMS