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Meet the partners

James Chubb, Ph.D.

James Chubb, Ph.D. is broadly experienced in operational management, strategy and financing of biopharmaceutical companies, as well as possessing extensive pharmaceutical product development experience.

As a senior executive at Glaxo with more than 12 years of experience, Dr. Chubb was responsible for directing the filing of more than 15 NDA's and ANDs for anti-bacterial and anti-fungal drugs, beta agonist bronchodilators and inhaled steroids for asthma, topical steroids for dermatological indications and serotonin antagonists for cancer induced nausea and vomiting. As President and Chief Executive of Triplex Pharmaceuticals and its successor, Aronex Pharmaceuticals, for 8 years, Dr Chubb raised over $65 million in financing, and established several corporate partnerships. He built a strong management team and over saw advancement of three cancer drugs and an anti fungal into clinical trials. Dr. Chubb was subsequently founder and principal of ProPharma International Partners, Inc, a consulting and advisory service company to biotechnology companies, with locations in the San Francisco Bay area and London, UK.

Dr. Chubb received his Ph.D. in Pharmacology from the University of Arizona College of Medicine and completed a cardiovascular research fellowship at Michigan State University.

Peter Cozens, Ph.D.

Peter Cozens has worked for more than 27 years in the pharmaceutical industry. 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, many cases 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. A molecular geneticist by training on completion of his PhD, in 1978 Peter joined Ciba-Geigy (now Novartis) in Basel, Switzerland as a research scientist. In 1981 he moved to Wellcome Biotechnology Ltd. to work as a senior scientist in Molecular Biology and became leader of 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. He was responsible for a series of in-licensing and out-licensing deals and acquisitions including partnerships with Janssen, Connetics Corporation, Targeted Genetics, Peptide Therapeutics, SmithKline Beecham, ML Labs, Aviron, Mayo Medical Ventures, Eurand and Chiroscience. Peter also piloted the Biogen v. Medeva patent case through several courts culminating in the landmark House of Lords decision on the scope of patent claims. He is Chairman of the Intellectual Property Advisory Committee of the UK BioIndustry Association and a Non-Executive Director of Eden BioPharma Limited.

Geoffrey Kitson, M.D.

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. In the last few years he has taken 5 products through to first in man studies, and progressed products through to Phase II/III.

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 take over 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 he 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.

Before joining ProPharma, Geoff served as a consultant to start up companies offering services in clinical trial development and possible clinical strategies and identifying therapeutics areas for products.

Lorraine Jackson

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 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 10 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.

Paulo Rangel, MBA.

Paulo S. Rangel concentrates on working with biopharmaceutical and medical device companies on worldwide in- and out-licensing.

Mr. Rangel was a Founder, President & CEO of Lasercure Sciences, a medical device start-up focused on the use of lasers to treat diabetic foot ulcers and pain. Mr. Rangel completed the financing, a diabetic foot ulcer clinical study, two collaborations, and filed two patents (an inventor on both).  Before Lasercure, Mr. Rangel was a Founder and Chief Business Officer of 5i Sciences, a start-up focused on a new approach to treat sleep apnea.  As CBO, Mr. Rangel is responsible for the company’s intellectual property, finance and general strategy.

Mr. Rangel was the head of Business Development at Arizeke Pharmaceuticals, a respiratory company, from December 2000 to August 2006.  While at Arizeke, Mr. Rangel completed license agreements, renegotiated existing agreements and was responsible for intellectual property, business planning, evaluation of new product opportunities and certain financial projects.  Prior to joining Arizeke, Mr. Rangel was Director of Business Development at Universal Preservation Technologies from September 1998 to December 2000.  Between 1990 and 1998, Mr. Rangel was in the finance department at Hybritech, Inc. and was also involved in the start-up of four biotechnology companies, two of which were successfully acquired by large companies.  Earlier, he was at Amgen Inc., focused on the process scale-up of erythropoietin.

Mr. Rangel received a B.A. in chemistry/biochemistry from the University of California at San Diego and an M.B.A. from Duke University.

Andy Baxter, Ph.D.

In a career spanning 25 years, 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. Andy has in-depth experience of the drug discovery process 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 many years of experience managing development programmes and has a broad technical and quality understanding of pre-clinical, chemistry, manufacture and controls (CMC), regulatory and early clinical operations. He has developed products as solid dose forms (including modified release), parental, topical, 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.

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