Meet the Partners

The Partners

  • Andy Baxter, Ph.D 
  • Geoff Kitson, BM BS, MFPM
  • Lorraine Jackson, BSc, CChem, MTOPRA
  • Peter Cozens, Ph.D.

Andy Baxter

Andy Baxter

Ph.D

In a career spanning over 35 years in the pharmaceutical industry, Andy has held senior technical and management positions in major pharmaceutical companies, emerging biotech companies and, most recently, small virtual pharmaceutical companies. Companies include, Pfizer, Chiroscience-Celltech, Arakis and Serentis.

A medicinal chemist by training, Andy has in-depth experience of the drug discovery process with a track record of leading programmes through lead generation, lead optimisation and candidate selection. Andy has a broad understanding of most therapeutic areas and has experience of many therapeutic targets. He is an inventor or co-inventor of over 60 patent applications.

In addition, Andy has more than 20 years of experience managing development programmes and has a broad technical and quality understanding of pre-clinical, chemistry, manufacture and controls (CMC) and regulatory; including Drug Substance development / procurement and GMP manufacture; and formulation development and manufacture of clinical supplies.

Andy regularly supports clients with the CMC sections of regulatory submissions for clinical trials in the UK, EU, Australia and USA. He has developed products as solid dose forms (including modified release), parental, topical (dermal and ocular), inhaled, intra-nasal, sub-lingual and transdermal patches. Andy has been successfully involved in both in-licensing and out-licensing projects and has managed collaborations between biotech and major pharmaceutical companies on a multidisciplinary level.

Geoffrey Kitson

Geoff Kitson

BM BS, MFPM

Geoff has gained a broad-based international perspective on drug development, from phase I to phase IV, experience of pre-clinical work, and regulatory requirements, since joining the pharmaceutical industry in 1988. He has been involved in the preparation of INDs, CTXs/CTAs, MAAs and other regulatory documents. He has experience in the development of individual clinical studies, clinical trial programmes, running multinational clinical trials and developing clinical strategies.

Geoff obtained his medical degree from the University of Nottingham and initially trained and worked in anaesthesiology and intensive care before joining the pharmaceutical industry with Syntex Pharmaceuticals Limited. In various roles at Syntex he worked in a number of therapeutic areas, primarily pain, but also including female health care and cardiology. He was instrumental in the approval of ketorolac in the UK and maintaining the approval throughout Europe. Prior to the takeover of Syntex by Roche Geoff worked in the USA, overseeing all ketorolac clinical trials worldwide, including planning the 16,000 patients “SAMM” study undertaken in Europe at the request of the CPMP. Geoff then joined Yamanouchi Pharma as the UK Medical Director. Wishing to move to earlier clinical development he moved to Head of Clinical Development at Chiroscience and then to Director of Exploratory Development World-wide at Medeva.

Over the last 20 years, consulting through ProPharma, Geoff has served as a consultant to start-up companies and academic institutions, offering services including, identifying target indications for products, developing clinical strategies from first in human through to licensure, developing and overseeing clinical trials and undertaking due diligence on products. Geoff’s work has largely focused on vaccines, anti-infectives and live biotherapeutic products in addition to other therapeutic areas such as pain.

Lorraine Jackson

Lorraine Jackson

BSc, CChem, MTOPRA

Lorraine is a highly experienced regulatory consultant with extensive knowledge of CMC regulatory affairs including CTD authoring of IMPD/IND and MAA/NDA/BLA’s.

Lorraine obtained a degree in chemistry at Leeds University. She has over 30 years’ experience gained in a variety of roles within a number of successful bio-pharmaceutical companies including Genzyme, Chiroscience, Celltech and UCB, initially training as an analytical chemist. Working within and managing multidisciplinary teams, Lorraine gained significant experience in selection and management of CMO / CRO’s for the purpose of generating data relating to tech transfer, method qualification/validation, QC testing, setting specifications, managing comparability and stability studies. Having worked in a Quality environment she has a good understanding of QMS and SOP’s relating to GMP activities. In 2007 the MHRA accredited the GLP facility in Cambridge which Lorraine was responsible for and managed with her team.

Lorraine left UCB in 2008 following the successful approval of Cimzia® in the EU and US, having played a key role in the submissions team. She moved into a full time regulatory role and during the last 13 years as a regulatory consultant supported numerous small and large bio-Pharma companies in many areas including regulatory strategy.

Lorraine provides regulatory support through the development pipeline including due diligence activities, scientific advice, Clinical trial applications, EMA/EU/USagency meetings and inspections. Lorraine has a wealth of experience in CMC including authoring of module 3 and QOS documentation, response to agency questions, preparing regulatory submissions, responses and variations with respect to National, DCP, MRP and Centralised Procedure submissions.

Peter Cozens

Peter Cozens

Ph.D

Peter Cozens formed ProPharma Partners Limited in 2000. He is a scientifically-qualified commercial development professional with broad international experience in both the biotechnology and conventional pharmaceutical sectors of the industry. Experienced in all facets of identifying, negotiating and managing third party agreements in all major territories to facilitate strategic business expansion. Additional responsibility in managing Patents and Trademark functions, including overseeing multinational patent litigation, some of which gave rise to seminal patent law, has provided valuable experience in contractual and intellectual property law. Experience also includes management of an export function responsible for sales outside Europe and the US and responsibility for strategic marketing/business information.

Peter obtained a PhD in molecular genetics from Leeds University and spent ten tears in pharmaceutical R&D, first at Ciba-Geigy (now Novartis) in Basel, Switzerland, then at Wellcome Biotechnology Ltd. where he led Wellcome’s cytokine programme. From 1987 to 1991, whilst still at Wellcome, he worked with Group Patents and Agreements on both patent litigation and licensing activities.

In 1991 he joined Medeva PLC where he became Executive Vice President, Business Development and Intellectual Property and a member of Medeva’s Executive Management Committee. Peter’s major achievement during this period was the building of Medeva’s development pipeline through a series of in-licensing and out-licensing deals and acquisitions. Peter also piloted the Biogen v. Medeva patent case through several courts culminating in a landmark House of Lords decision on the scope of patent claims. He is a member and former Chairman of the Intellectual Property Advisory Committee of the UK BioIndustry Association and a Non-Executive Director of iosBio Limited.

Expertise

  • Clinical Development
  • CMC Development
  • Medicinal Chemistry
  • Formulation Science
  • Regulatory Affairs