Dave is a microbiologist with over 40 years’ industry experience in the development of antibacterial, antifungal and antiviral agents and has an extensive range of skills and experience covering pre-clinical to post-marketing microbiology-related activities.
Dave joined Beecham Pharmaceuticals in 1976 and remained with the company through its various transformations eventually becoming GlaxoSmithKline. During this time, he spent 12 years in antibiotic discovery of ß-lactamase inhibitors and novel antibacterial agents, seven years in global clinical development and eight years in medical affairs and medical communications.
In 2004, Dave joined Chiron Biopharmaceuticals as European Director of Microbiology and was part of the team responsible for the approval and launch of daptomycin (Cubicin®) in Europe. He provided microbiology support to the European Marketing Group and local operating companies during the Cubicin® launch phase and provided microbiology expertise to the inhaled tobramycin development team. In 2006, Dave became an independent microbiology consultant providing consultancy services to Pharmaceutical and Biotech companies before joining tranScrip Partners in January 2010.
During his career, Dave has gained experience in the development of antibacterial agents for hospital and community use, including TB and C. difficile infection, topical agents for cSSTI and Bacterial Vaginosis, antiviral agents to treat HSV, VZV, Hepatitis B and C, and CMV infection and antifungal agents to treat systemic fungal diseases. He has designed and assisted with the implementation of microbiology plans to ensure submission readiness, including interpretation of PK/PD data to support dose selection and application of clinical breakpoints (including interacting with EUCAST) and has prepared the microbiology sections of several successful regulatory submissions, including responding to questions during the regulatory review process.
Dave has prepared or provided significant input into briefing documents for both FDA and EMA scientific advice meetings and has assisted with the preparation of Qualified Infectious Disease Product applications, Paediatric Investigational Plans, Product Monographs, Investigator Brochures, and product summaries for out-licensing and funding opportunities. He also has considerable experience with pre- and peri-launch activities, including congress-related activities (e.g., posters, symposia, and exhibits), advisory boards and scientific training of affiliate and sales staff.