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TEAM
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.
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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.
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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.
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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.
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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.
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 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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