Executive Summary
Dr. David Krause is a broadly experienced pharmaceutical executive, board certified in internal medicine with added qualifications in geriatrics. Across more than 30 years in pharmaceutical research and development and medical affairs, he has led clinical development and medical affairs teams at large and medium-sized public companies as well as small private start-ups, and has successfully filed multiple BLAs and NDAs.
As a Senior Partner at The Bracken Group, David advises biotech, pharma, and start-up clients on clinical development planning, medical affairs strategy, and regulatory pathways — drawing on a career that spans global therapeutic areas at SmithKline Beecham and GlaxoSmithKline, where he also headed North America vaccine clinical development, and three Chief Medical Officer appointments. At Vicuron Pharmaceuticals he completed development of a parenteral anti-infective and an injectable antifungal for invasive fungal disease, filing both NDAs before the company’s USD 1.9 billion sale to Pfizer. At Tarsa Therapeutics he submitted a 505(b)2 NDA for an oral calcitonin product for osteoporosis, and at Genomind he led medical affairs, regulatory affairs, and new product development in pharmacogenetics and mental health.
Earlier in his career at SmithKline Beecham Biologicals, David completed development and submitted BLAs for multiple vaccines — hepatitis A, hepatitis A/B, DTPa, and DTPa-Hep B — and ran an 11,000-patient Phase 3 trial of a Lyme disease vaccine that led to publication in the New England Journal of Medicine and US licensure. A Fellow of the American College of Physicians and author of dozens of scientific publications and numerous abstracts, he has served as a consultant to the Department of Defense and sits on Genomind’s Scientific Advisory Board. Clients engage David when a program needs a physician-executive who can connect clinical strategy, medical affairs, and regulatory filing into one credible path.
Areas of Expertise
Clinical Development Leadership
Building and leading clinical development organizations across global pharmaceutical companies, mid-sized public entities, and venture-funded start-ups, from early phase through registration.
Medical Affairs
Medical affairs strategy and team leadership spanning multiple therapeutic areas — including scientific advisory boards, publication planning, and post-approval medical strategy.
Regulatory Strategy, NDAs & BLAs
Multiple BLA and NDA filings, including 505(b)2 submissions and vaccine biologics licence applications, with direct experience partnering with the FDA.
Vaccines & Anti-Infectives
North America vaccine clinical development, large-scale efficacy trials including an 11,000-patient Lyme disease programme, and development of parenteral anti-infective and antifungal therapies.
Pharmacogenetics & Precision Medicine
Pharmacogenetic testing and medication management in psychiatry and CNS — test-guided treatment trials, consultation services, and real-world application of PGx data.
Business Development
Transaction and partnering support informed by CMO-level diligence, including a company sale to Pfizer and ongoing scientific advisory work across biotech and start-up boards.