1. 1 Broadgate
Floor 2 Office 2
The Headrow
Leeds
LS1 8EQ
Phone +44(0)113 3502965
Mobile +44 771 2780442
E-mail
tony@informationchange.co.uk
Anthony (Tony) Lockett
Summary Tony Lockett has over 25 years of experience in the pharmaceutical and
medical devices industry. For the last 13 years he has been part of a
team of consultants advising clients on the regulatory and clinical
strategy for product development. He has also acted as a CMO for an
AIM listed company. He has recently started on a portfolio career, where
in addition to consulting on medical product development and acting as
an executive director, his company is co-developing re-positioned and
re-profiled products.
He is a member of the York Regional Ethics Committee.
He is a member of the finance committee for Ripon Cathedral.
Core Skills Therapy areas inflammation, infectious diseases and oncology.
Business skills company strategy, corporate governance, board
management.
Employment MEDQP Ltd
2003 – Date Consultant (MEDQP)
Consultant in pharmaceutical product development and pharmaceutical
medicine; advising clients in the creation of regulatory, clinical
development and project plans for products being in all stages of clinical
development.
Assignments include
• Advising venture capital companies on investment opportunities
• Writing development plans in new vaccine development
• Assisting clients with submissions for FDA and EU Competent
Authority meetings
• Assisting in the creation of Market Authorizations in the USA and
EU
• Creation of orphan drug strategies in renal disease and
nanotechnology
The consultancy adopts a commercial and regulatory perspective in
clinical development planning.
Achievements include;
2. • Part of a team submitting two successful MAA in 2012-2014 in
Ulcerative colitis and renal skin inflammatory disease
• 2 successful PIND meetings in 2015 in Chronic Inflammatory
Poly-Neuropathy and rheumatoid arthritis disease leading to
ongoing INDs diseases
• Clinical lead on a novel bowel cancer diagnostic currently in
clinical evaluation
• Successfully defended legal cases in the USA for the
interpretation of FDA guidances
• Submitted successful Special Protocol Assessments to the FDA
• Successfully challenged a EMA decision in a negative MAA
• Executive board member for two companies in immunology and
metabolic medicine
2015 – Date MEDQP Medical Director and Co-Founder Product
Development
Working in partnership with companies to employ a number of re-
development and re-positioning strategies to further the development of
products that have undergone some pharmaceutical development, or
already marketed, in new therapy areas.
Strategies employed include;
• Incorporation into fixed dose combinations
• Pharmacokinetic re-profiling using drug delivery systems
• Route of administration switches
• Drug device combinations
• OTC switching
• Biomarker driven re-profiling for the development of plans in new
therapeutic areas based on the results of biomarker evaluation
• Biosimilars including monoclonal antibodies
Ongoing investments/partnerships include
• Re-positioning a radio-sensitizing technology in head and neck
cancer
• Redeveloping a product for radiation mucositis
• Re-positioning a blood replacement product
• Re-positioning a cancer diagnostic into a hand held device
2013 - 2016 Retroscreen/hVIVO London
CMO/Senior Medical Director
CMO/Executive Board Member for an AIM listed infectious
disease/virology company. Role included
Taking part in Board meeting including creating strategic plans and
presenting them to the PLC board.
Leading clinical research into virus diseases including RSV, Influenza
3. Rhinovirus and Zika
Involved in fund-raising, investor presentations
Responsible for medical strategy of the company including the structure
of medical operations
Achievements
• Restructured the medical group
• Successfully conducted clinical trials on the role of infection in
Asthma
• Devised a strategy for identifying potential drug targets and
biomarkers in severe flu hospitalised pneumonia and sepsis
• Assisted in the follow-on fund raising for the company
2007-2010 Avecia Durham
UK
Medical Director
Medical director to the NIH anthrax and plague vaccine programs in the UK.
Part of an NIH team that controlled a $71 million budget
Achievements;
• Successful PIND meetings – leading to accepted IND
• Part of the FDA correlates of protection working party
• Successfully conducted First in Man studies
1999 - 2003 Covance Various
Translational Medicine Director , Covance Consulting
Leader of a consulting team writing product development/regulatory
plans for a range of pharmaceutical, biotechnology and technology
clients
Achievements included:
Successful clinical trials in artificial blood products and products for the
management of post traumatic shock and sepsis
1995 - 1999 Covance Various
Associate Medical Director/ Principal in Health Economics
Acting as a medical director for a range of clients
Part of the Safety group
Writing clinical development plans for phase 2-3 clients
Advising clients on health economics issues
Profit and loss responsibility for the health economics group
1993 - 1995 UK Department of Health
Head of Health Economics and Financial Planning
4. Head of economic and financial planning group of 4 responsible for
budget setting in an Heath Authority
Introduced new planning methods into an AHA
Manager of a team of 4 individuals
Part of the general management team
1993 Parke Davis/ Freiberg Germany/ Ann Arbor
USA
Physician Anti-infectives
Medical director responsible for all aspects of anti-infective development
phases 1-3
1990-1992 Marion Merrell Dow Various
Princeton New Jersey
Medical Director Anti-infectives
Medical director responsible for all aspects of anti-infective development
phases 3 and 4
1989-1990 London School of Tropical Medicine
Lecturer Microbiology/Immunology
Responsible for teaching clinical microbiology, and research into tropical
medicine. Visited east Africa and conducted research programmes.
1988.1989 PHLS London and Newcastle
Registrar Microbiology and Infectious Diseases
General hospital position, responsible for medical microbiology and
infectious diseases
1986-1989 NHS Newcastle Royal Victoria Infirmary
House Officer and Senior House officer appointments in general
medicine and surgery
Education
2016 IoD training in the role of the Director and Company Direction
2015 Medilink Ascend Skills Programme
Innovation and Business Strategy
2011 Eudravigilence training (revalidated in 2015)
2011 Keele University UK
Postgraduate Certificate in Medical Law
2008 London University UK
Postgraduate Certificate in Pharmacovigilance/Pharmacoepidemiology
5. 2002-3 Henley Management College UK
MBA with a specialist course in the management of Innovation
1993 - 1998 St Andrews University Scotland
Doctor of Philosophy
Thesis on the Role of Economics in Decision Making in Health Care
Regulation
1990 University of Wales UK
Certificate in Pharmaceutical Medicine
1987-1988 London University UK
Master of Science in Medicine (Microbiology and Immunology)
1980.1986 Newcastle Medical School UK
MBBS Bmed Sci(Hons)
Professional
memberships
Other
Interests
Member of the Faculty of Pharmaceutical Medicine
Licensed to practice with the GMC as a Pharmaceutical Physician,
revalidated 2015
Member of the York NRES ethics committee for the North East
Tutor on the MSc in Drug Development Kings College London
Member of the finance committee Ripon Cathedral
Cricket – Lords Taverner, qualified Umpire
Recent
Publications
An Ascending Dose Study to Assess the Safety and Tolerability of
an rPA Anthrax Vaccine, and Compare its Immunogenicity with
that of Anthrax Vaccine Adsorbed (AVA).
E Hugh Dyson1
, Marshall S Irving1
, Ronald Goldwater2
, Randall Stoltz3
,
Matthew Duchars4
, Anthony E Lockett4
& Andrew J H Simpson1
.DSTL,
Porton Down, UK. 2. PAREXEL Baltimore CPRU, Baltimore, MD. 3.
Covance GFI Research, Evansville, IN. 4. Avecia Ltd, Manchester, UK.
Published as ICCAC abstract October 2006
6. Two Phase 1 Clinical Trials of a Recombinant F1 and V Plague Vaccine
M. Irving1
, P. Packer1
, J. Miller1
, T. J. Brooks1
, R. Fuhr2
, R. Goldwater3
, A. E.
Lockett4
, H. Dyson1
, D. Williamson1
, A. J. Simpson1
;
1
DSTL, Salisbury, UNITED KINGDOM, 2
PAREXEL Institute of Clinical
Pharmacology, Berlin, GERMANY, 3
PAREXEL CPRU, Baltimore, MD,
4
Avecia Ltd, Manchester, UNITED KINGDOM.
Published as ASM abstract October 2007
Repeat-dosing of oral insulin (Capsulin) in persons with type 2 diabetes
T.P. Broke-Smith, S.D. Luzio, A. Lockett, R.R. New, D.R. Owens, United
Kingdom
Published as ESAD Abstract May 2009
The glucose lowering effect of an oral insulin (Capsulin) during an
isoglycaemic clamp study in persons with type 2 diabetes.
Luzio SD, Dunseath G, Lockett A, Broke-Smith TP, New RR, Owens DR,
Diabetes Obes Metab , Volume 12 , 1 (January 2010) pp.82-87
Viral Induced disease in mild atopic asthma: dynamics of pulmonary
function change, symptom onset in Human Rhinovirus-16 (HRV)
Inoculated volunteers.
Alex j Mann & Ganesh Balaratnam, Jane Gunter, Pawel Rucki,
Chris Poll, Martin Johnson, Tony Lockett,
hVIVO Services Ltd,. Poster Presentation at the American Thoracic
Society December 2015
7. Two Phase 1 Clinical Trials of a Recombinant F1 and V Plague Vaccine
M. Irving1
, P. Packer1
, J. Miller1
, T. J. Brooks1
, R. Fuhr2
, R. Goldwater3
, A. E.
Lockett4
, H. Dyson1
, D. Williamson1
, A. J. Simpson1
;
1
DSTL, Salisbury, UNITED KINGDOM, 2
PAREXEL Institute of Clinical
Pharmacology, Berlin, GERMANY, 3
PAREXEL CPRU, Baltimore, MD,
4
Avecia Ltd, Manchester, UNITED KINGDOM.
Published as ASM abstract October 2007
Repeat-dosing of oral insulin (Capsulin) in persons with type 2 diabetes
T.P. Broke-Smith, S.D. Luzio, A. Lockett, R.R. New, D.R. Owens, United
Kingdom
Published as ESAD Abstract May 2009
The glucose lowering effect of an oral insulin (Capsulin) during an
isoglycaemic clamp study in persons with type 2 diabetes.
Luzio SD, Dunseath G, Lockett A, Broke-Smith TP, New RR, Owens DR,
Diabetes Obes Metab , Volume 12 , 1 (January 2010) pp.82-87
Viral Induced disease in mild atopic asthma: dynamics of pulmonary
function change, symptom onset in Human Rhinovirus-16 (HRV)
Inoculated volunteers.
Alex j Mann & Ganesh Balaratnam, Jane Gunter, Pawel Rucki,
Chris Poll, Martin Johnson, Tony Lockett,
hVIVO Services Ltd,. Poster Presentation at the American Thoracic
Society December 2015