COMPANY

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 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.

Consultant in Medical Governance and Regulatory Strategy



Angeliki is a physician-scientist and molecular pathologist who after more than three decades in medicine and science, nineteen of them at Pfizer, where she chaired benefit-risk and where the final medical judgement on its medicines rested with her, has turned her attention to how medicines are developed, manufactured, and supplied.



She brings a discipline formed where medical, regulatory, commercial and legal considerations converge: the patient comes first, and in her experience that safeguards the enterprise as reliably as it safeguards the patient.

Holding decision authority over manufacturing, reformulation, recall and supply, she observed that in an industry striving for resilience, the decisions determining whether a medicine reaches a patient are taken long before anyone is watching.



Furthermore, in directing the medical strategy when regulators mandated action on carcinogenic impurities, she noted that the failure was rarely scientific. Programmes stall, and supply fails, because decisions taken early, in nonclinical development and CMC, are treated as regulatory hurdles rather than the design phase they are. By the time the consequences reach the patient, the cost of correcting them has multiplied many times over.



That conviction shaped her work on supply resilience. She built Pfizer’s global Medically Necessary Products strategy, created the medical list classifying every product by necessity when the pandemic overwhelmed hospitals, and co-led Pfizer’s representation in the EU Critical Medicines Alliance, whose work informed the Critical Medicines Act.



Her specialist interest is the governance of evidence, and increasingly how AI-derived findings are validated and defended. She was building machine-learning models for oncology outcomes prediction long before “AI in medicine” had a name, work that returned a withdrawn lung-cancer therapy to patients through a companion diagnostic. She is also co-founder of Oncolyze Inc., developing oncolytic therapy for leukaemia.

Angeliki graduated in medicine from Democritus University of Thrace and completed her pathology residency and PhD in molecular pathology at Aristotle University of Thessaloniki. She also trained in Switzerland and the United States. She is an inventor on eight patents in machine-learning diagnostics for oncology.