Scientific and business team

Former Scientific Director for a large CRO with 35+ years experience in infectious diseases.  Early experience gained researching the efficacy of combination drug treatments for resistant isolates of tuberculosis under the tutelage of Professor Denis Mitchison at Imperial’s Wolfson Institute before moving into mainstream clinical diagnostics.

Professional responsibilities have encompassed roles in both the public and private sector; overseeing and day-to-day running of pathology services (primarily microbiology and virology laboratories), tendering and managing major IM&T, diagnostic and related diagnostic testing services and leading teams in (e.g.) business development and change management within CROs.  

Latterly offering advice and services to public and private sector organisations with extensive experience in RCTs including Controlled Human Infection Modelling of URTIS and malaria. 

Founder of the consultancy group CHIMunomics Ltd. and Pathogenus Consulting Ltd. as well as acting as Chief Operating Officer for a small Biotech, IQ-IDM. 

Authored papers and many articles relating to HIV, Ethics and Viral Challenge, amongst others, and publishes a regular update on infectious disease threats and public health concerns.

Applied scientist with significant expertise in translational medicine and more than 125 articles in peer reviewed international journals on the subject. More than 25 years of experience consulting infectious disease specialist in a fourth line referral academic hospital, public health specialists and general practitioners on the diagnosis and treatment of endemic and emerging infectious diseases. As consultant to a CRO that was initiated as spin-off from his clinical diagnostic laboratory involved with over 80% of all influenza clinical trials ran between 2003-2015. During that time he was also responsible as operational principal investigator for the largest phase 4 global clinical trial on influenza with >4500 subjects included.

From 2016 till present independent consultant to numerous start-up biotech and larger pharma companies giving strategic advice on translating pre-clinical data into clinical development and interpretation of large complex datasets into comprehensive decision making.

Senior executive with 30 years of international, cross-cultural experience in diagnostic, medical devices and clinical trial industries (CRO). Proven managerial track record of establishing, developing, and strategically integrating companies with small, medium, and large operations and international sales, marketing and business development. Senior roles include full time and fractional positions as CEO, Managing Director, European Director, Director Business development and M&A for PE-backed, private and listed companies.  

Experienced medical professional with a unique blend of clinical, research, and strategic expertise in drug development in multiple therapeutic areas, including infectious diseases, respiratory, renal, autoimmune and oncology. Over 30 years of experience in senior clinical roles including medical practice, academic research, and pharmaceutical industry leadership. Author of 140 publications in peer-reviewed international journals.

Key areas of expertise:

• Strategic oversight and medical/clinical evaluation of assets in a broad range of therapeutic areas.
• Design and delivery of multiple, diverse clinical studies (PoC, Phases I-IV) in compliance with ICH GCP standards.
• Significant expertise in the virology of respiratory infections, including emerging and pandemic viruses and their epidemiology.
• Expert in anti-infective safety data, metabolic and other drug interactions including their relations with current regulatory requirements.
• Extensive knowledge and experience in the molecular design and chemistry of drugs and vaccines.
• Expert in anti-infective safety data, metabolic and other drug interactions including their relations with current regulatory requirements.
• Extensive experience in building public/private sector relationships with governmental bodies and health authorities.

Professional highlights:

• Designed and implemented the first ever clinical programme to demonstrate clinical      and virological efficacy and safety of a direct acting antiviral agent      against RSV bronchiolitis. 
• Medical Consultant and Lead at F. Hoffmann-La Roche, Switzerland.
• Founder and CEO of a number of healthcare-related companies.

Services and expertise:

• Development and implementation strategy.
• Regulatory strategy.
• Due diligence for asset licensing.
• Venture capital interface and liaison.
• Design and implementation of pre-clinical and clinical studies.
• Entrepreneurial      leadership in biotech and pharmaceutical companies.

A combination of medical expertise, scientific credentials and industry experience allows for comprehensive insights into drug development, from pre-clinical stages through to market approval and post-marketing surveillance.

Senior Executive with extensive pharmaceutical industry experience in companies such as CIBA-Geigy, Lundbeck and Hoffmann La Roche in Switzerland and he was co-founder of a contract research organization (CRO) based in UK, Germany and Switzerland and took the role of Research Director, offering clinical trial services to pharmaceutical companies from phase I to III. At Hoffmann La-Roche he worked on infectious disease projects covering antimalarials, antibiotics and the influenza antivirals Tamiflu and Xofluza. and had interactions with infectious disease experts, public health institutions WHO, CDC and ECDC as well as regulatory authorities, FDA and EMA.

James received a PhD in 1983 from London University in pharmacology and the Swiss Diploma for Pharmaceutical Professionals in 2002

Biotech executive with over two decades of experience in molecular biology, virology, and recombinant antibody development. Extensive expertise in research, business strategy, regulatory and leadership within the biotechnology sector. Proven ability to drive innovation, secure funding and develop breakthrough technologies in therapeutics and diagnostics. Passionate about advancing clinical assays, bacteriophages and antibody-based therapies.

Regulatory

Our regulatory experts have extensive experience in advising start-up and biotech companies on their global regulatory strategy in a wide range of therapeutic areas, ranging from infectious diseases to oncology and women’s health. They have worked with a spectrum of products, including vaccines, large and small molecules and biotech products. We are able to support clients in their interactions with the Food and Drug Administration (FDA), European Medicines Agency (EMA), Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and other national competent authorities in Europe or wider abroad. In addition, the team have actively participated in several international Scientific Advisory Boards.

Project Management

Our skilled project management team has extensive experience in the selection of Clinical Research Organisations, central and specialised Laboratories. Working from a Request For Information (RFI) / Request For Proposal (RFP), through to prequalification audits and selection of CRO and/or appropriate clinical sites. Inclusive of review, oversight and management during study conduct and study closure, with study budget review and feasibility works. The team are skilled in selecting and overseeing standard pathology as well as study specific laboratories, offering quality audits, responses to regulatory inspections and CAPA implementations.