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Dr Jonathan Collins

MBBS, MRCP, MD, MBA, DipPharmMed

 

Professional Experience

[1] Managing Director, Medicines Development
& Licensing Ltd (2013- present)

  • Bringing first-hand regulatory authority knowledge of drug development and regulation to benefit clients

  • In-depth knowledge of successful strategies to obtain UK and EU regulatory approvals.

  • Providing independent expert drug development advice on:
    preventing common pitfalls in drug development; non-clinical data requirements and their assessment; all stages of clinical drug development (clinical development planning, strategy development and support, phase I-III study design including FTIM and paediatric planning, Good Clinical Practice, CRO liaison, data and documentation review); due diligence assessments; pre-empting regulatory problems through regulatory audit of drug development programmes to avoid common omissions and deficiencies in MA applications; predicting regulatory responses to development data; presenting at national and EU regulatory Bodies (licensing support meetings and Scientific Advice EU/FDA, EMA referrals)

  • Providing independent expert regulatory advice on:
    pre-MAA submission medical and regulatory project assessments and reports; advice and support of pre-MAA scientific advice; strategic safety planning e.g. risk management plans; regulatory strategic advice based on current EU and other authority regulations; credible review of regulatory turndowns; timely solutions to regulatory issues; planning and supporting EU and other regulatory authority requests for information and meetings; assistance to post-licensing pharmacovigilance activities.

  • Supporting legal work during licence development or post-licensing (competition claims), acting as Expert Witness in court.

 

[2] Managing Director, Drug Development and Licensing Limited (2005- 2013)

As above.  Company changed name with relocation.

 

[3] UK and EU Pharmaceutical Licensing & Regulation (9 years, 1996-2005)

  • Senior clinical assessor MHRA Licensing Division: CTAs, MAAs - new drugs, orphan drugs, abridged products (particularly topical drugs, anti-rheumatic, oncology (lead chemical drug assessor), respiratory (deputy lead assessor), dermatology, genitourinary, HRT, immunomodulators, musculoskeletal)

  • >500 UK marketing authorization applications assessed

  • >200 new drug CTAs assessed (many biotechnology products)

  • EU centralised procedures, orphan drugs, >100 mutual recognitions

  • >60 presentations of MAA turndowns to Committee on Safety of Medicines

  • Presentation to Medicines Commission

  • Frequent provision of MHRA scientific, medical, drug development and regulatory advice at Scientific Advice meetings

  • ‘In-house’ expertise:
    clinical pharmacology, respiratory, rheumatology, musculoskeletal, dermatologicals, oncology, immunomodulators, all topical developments; GCP; all major EU licensing procedures

  • EU expert for CPMP clinical scientific advice

  • Respiratory regulation: lectures to industry on asthma and COPD, major lecture to regulatory asthma conference, contributor to asthma, COPD and orally inhaled products guidelines


[4] Management (10 years, 1987-1996) and Business (15 years, 1993-2008)

  • Professional study (MBA) and practice; continuing education.

  • 10 years as department head; UK senior medical department management team; global phase I team; management team during two international mergers

  • 9 years professional management training including Ashridge Management College, MBA Open University Business School (OUBS)

  • National MBA alumni representative on OUBS Board and member of OUBS Advisory Board (to 2007)

  • Continuing education via Ashridge Management College, OUBS and AMBA

 

[5] Pharmaceutical Industry (11 years, 1985-1996 Hoechst, Hoechst Roussel, Hoechst Marion Roussel)

Extensive knowledge of non-clinical and clinical development.

 

Clinical development

  • International project team member of preclinical, clinical drug developments with Japanese, US, European, Canadian and S. African subsidiaries

  • Phase I investigator; early drug candidate selection, planning, surrogate pharmacodynamic method development in cardiovascular, respiratory, anti-ulcer, anti-infectives, analgesics, anti-rheumatics, anti-inflammatories

  • Manager international phase I unit and UK medical department

  • Leader, contributor of functional and project teams, member of several phase II & III project groups including respiratory, RA, dementia

  • Phase II & III study design, particularly asthma, dementia, rheumatoid arthritis and vascular disorders

  • Presenter to expert clinical advisory groups, clinical investigator meetings

  • Development of clinical & academic links to support product development

  • Chair of international project group to recommend drug discontinuation

  • Advancement of drugs to regulatory submission

  • Phase IV market support

  • UK and international strategic marketing

Regulatory submissions

  • In-house contributor to successful MA applications

  • Pre-submission presentations at FDA (pre-NDA), Health Canada and EU Member State Competent Authority meetings

  • Clinical expert report writing for subsidiary company

Presentations

  • Internally to influence commercial decisions; to internal and external audiences on a wide range of technical medical and managerial topics supporting products, company, industry and regulatory applications


[6] Clinical Hospital Medicine (27 years, 1977-2003)

  • Wide, general-physician training to Senior Registrar level (9 years); subsequent weekly hospital clinic commitment (18 years).

  • NHS hospital physician (1977→1985), MRCP, MD (cardiology, hepatology and virology of hepatitis C)

  • 1986-2003 weekly part-time, hospital clinical experience: cardiology (clinic + echocardiography); rheumatology clinic (particularly inflammatory arthropathies, osteoporosis)

  • Experienced practitioner in general medicine with broad experience in GI, respiratory, endocrinology, clinical pharmacology, renal and hepatic medicine; extensive experience in cardiology and rheumatology

  • Longstanding experience in asthma; as patient, pharmaceutical industry research and development, lecturer and presenter (to industry, MHRA and patient bodies)

[7] Professional Memberships

  • General Medical Council

  • British Medical Association

  • Member Royal College of Physicians

  • EMA Expert 2001

  • Ex-Fellow Faculty of Pharmaceutical Physicians

[8] Publications

  • Major papers in British Medical Journal / Lancet -  post-cardiopulmonary bypass pump jaundice; transmission of viral hepatitis C

  • Papers on pharmacokinetics, clinical cardiology, diabetes and hepatology

  • 2006 Critical Reader for BS811 ‘Strategic Management in Life Sciences and Healthcare’ (Open University Business School MBA in Life Sciences)


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