Simon John Topham BSc (Hons)

4 Maes Y Llan, Llanbedr, Gwynedd, LL45 2HL

Tel: 01341 241663 Email: Simon.J.Topham@googlemail.com

Mobile: 0776 7602096 Website : www.tophams-consultancy.co.uk

PERSONAL STATEMENT
A motivated professional consultant, with more than seventeen years experience in R
& D, ranging from academia to global pharmaceutical companies. The World expert for
in vivo Particle Mediated Epidermal Delivery (PMED). Experienced Study Director, &
Study Monitor (GXP auditing). Provided training and guidance for GLP studies & Ph1
clinical trials. Responsible for a research programme (21 research studies during a
twelve month period) which underpinned two Ph1 clinical studies as part of Pfizer’s
Influenza vaccine programme. Provided expertise in the design, conduct & governance
of all the preclinical studies performed at or on the behalf of PowderMed. I have a
proven ability to work dynamically & to meet extremely challenging project timelines.
Experience in multi functional project teams & also working individually, whilst
maintaining consistently high standards. Well developed interpersonal &
communications skills, applied during the interaction & training of colleagues,
collaborators & contract research organisations (CRO’s).

KEY EXPERIENCE

• Preclinical Specialist: in novel methods of drug delivery, DNA vaccines, drug

pharmacokinetics & dermatology, (especially acute dermal tolerability wound healing
& dermal resolution). The Official PowderMed in vivo trainer.
• Study Director, Study Monitor: Responsible for report, protocol & SOP writing &
reviewing (GLP). Working with CRO’s & study directors to help them improve their
standards of writing. Study monitor and auditor of external GLP and GCP studies,
including toxicology & reprotoxicology. Set up & improved the PowderMed preclinical
quality system to the standard of GLP. Completed the GLP for Study Directors,
training at BARQA.
• Auditing of GXP facilities and studies on behalf of PowderMed.
• Home Office Project Licence holder (2006-2008): Optimisation of Particle Mediated
DNA Vaccines & the Delivery Technology. The first and only non civil servant to hold
a Project License at the UK government’s Institute for Animal Health research
establishment. The PowderMed representative in meetings with consultants, ethical
review committees, collaborators & the Home Office Inspector. Actively developed
animal experimentation refinements to comply with the 3R’s.
• Home Office Personal Licence holder (1991-2008) with expertise in the following
species: chicken, chicken embryo, rabbit, guinea pig, rat, mouse & pig. Other species
occasionally worked with include dog, macaque, duck & turkey. Extensive experience
with large & small animal sedation & general anaesthesia, also small animal minor
surgery techniques including carotid artery cannulation.
• Scientific knowledge: of immunology pharmacokinetics and molecular biology
techniques.
• Test Item development: an understanding of the processes involved, enabling
progression from the early concept, through to the final use in the clinic.

ADDITIONAL MANAGEMENT ROLES

• Aquatic Toxicology Manager managing Severn Trent’s GLP facility.

• Line Manager of a small group of preclinical scientists.
• Supervisor of PowderMed’s Home Office personal license holders.
 • Laboratory & Facilities Manager, for a suite of laboratories at the Research Institute
(University of Oxford) based at the Churchill hospital.
• Supervised University of Oxford DPhil & final year students; collaborated with
the staff of the Medical Engineering Unit (MEU) developing in vivo techniques for their
novel technologies & the multiphoton microscope.

EMPLOYMENT HISTORY
After working in the Molecular Parasitology Department of the Institute for Animal Health
laboratories at Houghton & Compton, I joined a small start-up company, Oxford Biosciences
in 1997 that utilized a needle free drug delivery technology developed at the University of
Oxford. Flotation on the stock market led to the company changing its name to PowderJect,
which became the leading vaccine manufacturer in the UK. PowderJect was acquired by
Chiron Vaccines in 2003. PowderMed was then formed in 2004 as a spin out company from
Chiron, & was subsequently acquired by Pfizer in 2006. In 2008 I started my own consultancy
company. Roles held during throughout my career include:

2009 Aquatic Toxicology Manager at Severn Trent’s GLP facility in Runcorn.

2008 - Owner of Topham’s Life Science Consultancy Ltd.
2006 - 2008 Senior Study Director, Study Monitor & Project License Holder at PowderMed
(Pfizer). Preclinical & Clinical Immunology Department.
2004 - 2006 Senior Scientist & Study Director at PowderMed Ltd (Preclinical Research,
GLP Study Monitoring, the official PowderMed trainer). Deputy Project
License holder, Preclinical Department.
2003 - 2004 Scientist Ι Ι at Chiron Vaccines, Facilities Manager at the Research
Institute in Oxford. Deputy Project License holder, Preclinical Department.
1997 - 2003 Research Associate at PowderJect Pharmaceuticals PLC, Oxford, Preclinical
R&D. Facilities Manager & Deputy Project License holder.
1991-1996 Scientific Officer at the Institute for Animal Health Compton Laboratory, Nr
Newbury. Molecular Parasitology Department.

EXTERNAL CONSULTANCIES
2004-2008 Official PowderMed trainer, travelled extensively in the UK, USA & Canada,
training CRO’s, university staff, clinicians & the US Army.

OTHER POSITIONS OF RESPONSIBILITY

• DEFRA import license holder for PowderMed.

• A member of biological safety & Genetically Modified Organism (GMO) committees.
• Fire warden, first aider, COSHH & H&S representative.

EDUCATION
1997-2007 Home Office, modules 1-5, Physiology Department University of Oxford,
Pfizer PGRD & the Institute of Biology.
1988.1991 BSc (Hons) Ι Ι i Applied Zoology (Pest Science), U.C.N.W. Bangor.
PUBLICATIONS

J.M.Bumstead, S.J.Topham & F.M.Tomley Inhibition of the development of Eimeria

tenella in cultured bovine kidney cells by a soluble factor produced by peripheral
blood lymphocytes from immune chickens. Parasitology (1998) 117: 39-47

Longridge, D.J., Sweeney, P.A., Topham, S.J., Burkoth, T.L. & Bellhouse, B. (1998)
Effects of payload per unit area on Dermal PowderJect delivery of testosterone to
conscious rabbits. Proc.Int.Symp.Cont.Rel.Bioact.Mater. 25:595-596.

Sweeney, P.A., Topham, S.J., Zuurbier, R.J., McCrossin, L.E., Muddle, A.G. &
Longridge, D.J. (1999) Effects of dose escalation on Dermal PowderJect delivery of
salmon calcitonin to conscious rabbits. Proc.Int.Symp.Cont.Rel. Bioact.Mater.
26:188-189.

Sweeney, P.A., Topham, S.J., Zuurbier, R.J., McCrossin, L.E., Muddle, A.G. &
Longridge, D.J. (1999) Effects of formulation on Dermal PowderJect delivery of
salmon calcitonin to conscious rabbits. Proc.Int.Symp.Cont.Rel. Bioact.Mater.
26:407-408.

Dempster, A.C., Topham, S.J., Johnson, M-J. Hickey, P.L. & Longridge, D.J. (2000)
Comparison of epidermal thickness to skin response in various species following
systemic drug delivery with a dermal PowderJect particle delivery system.
J.Pharm.Pharmacol 52 (Suppl): 49.

Topham, S.J., Sweeney, P.A. & Longridge, D.J. (2000) The relationship between
transepidermal water loss & particle penetration, following drug delivery by a dermal
PowderJect particle delivery system. J.Pharm.Pharmacol 52 (Suppl): 43.

Sharpe M, Lynch D, Topham S et al (2007) Protection of mice from H5N1 influenza

challenge by prophylactic DNA vaccination using Particle Mediated Epidermal
Delivery. Vaccine 25. 6392-6398.

References & Training Record are available upon request.