Hay Pharmaceutical Consulting, LLC

Specializing in Regulatory and Pharmaceutical Development Consultation

Douglas B. Hay, PhD, Principal

Ø 25 years experience in Regulatory Affairs and Pharmaceutical Development

Ø Specializing in developing regulatory strategies to

o support drug development

o maximize potential for product registration

o ensure optimal labeling for product promotion

Ø Preparation of concise and influential documentation in support of development, health authority meetings, and registration dossiers

Ø Expertise in regulatory due diligence associated with product review and acquisition

Ø Networked with highly experienced professionals for full service regulatory consultation and implementation

Contact Info: phone 267-733-5278

e-mail info@haypharmaconsulting.com

Douglas Hay, PhD Principal

Doug has 25 years of experience in the industry. Over this career, he has used expertise in regulatory affairs to proactively identify and lead regulatory and development strategies that maximize the opportunity for product registration and optimize approved labeling/promotion. His career has spanned drug development (Phase 1-4) in numerous therapeutic areas, including development of novel biologics in addition to numerous new chemical entities.

Doug recently led the global regulatory affairs groups at The Medicines Company and Shire Pharmaceuticals. He spent the majority of his career in the regulatory group at Bristol Myers Squibb. Prior to joining Squibb, he worked in contract toxiciology at Pharmakon Research Int’l.

At The Medicines Company, Doug was Vice President, Global Regulatory Affairs and Product Infrastructure. His responsibilities included oversight in defining and implementing company global regulatory strategy for critical care portfolio of products, including Angiomax, Cleviprex, cangrelor, and oritavancin. He lead a broad group responsible for shared services in support of development projects and marketed products including; EU Regulatory, Regulatory operations Drug Safety, Data Management, Compliance, Clinical Pharmacology, Nonclinical, and Statistics.

At Shire Pharmaceuticals, Doug was Senior Vice President of Global Regulatory Affairs. During his tenure, Shire filed NDAs/MAAs for novel therapies in ADHD, patients with end stage renal disease and ulcerative colitis. These included a successful first-line US approval of Daytrana (methylphenidate patch) for ADHD, overcoming a recommendation by the FDA reviewers and Advisory Committee for insertion of restrictive warning and use in subset of patients. Doug was actively involved in Shire’s task force that led to the reinstatement of Adderall XR to the Canadian market, reversing Health Canada’s product withdrawal.

At Bristol-Myers Squibb, Doug was Vice President of Global Regulatory Sciences with responsibilities including the direction of global regulatory strategies for all BMS drugs in early development and more focused leadership for global regulatory strategy and FDA Liaison for products in cardiovascular and immunology. This experience included involvement in drug development and registration programs in hypertension, heart failure, post-MI therapy, arrhythmia, hyperlipidemia, atherosclerosis, diabetic nephropathy, psoriasis, rheumatoid arthritis, solid organ transplant, oncology agents, antibiotics, antivirals and female hirsutism. These projects have included Pravachol for hyperlipidemia; Capoten for post MI and diabetic nephropathy; Monopril for hypertension and heart failure; Avapro for hypertension; Plavix for indications associated with atherosclerotic disease; Orencia for rheumatoid arthritis. Doug’s responsibilities also included leadership of regulatory support for due diligence activities associated with product licensing and acquisition and the integration of regulatory activities in the acquisition of Dupont Pharmaceuticals.

Doug received his A.B degree in Biology from University of California, Riverside, a MS in biology at California State University, Long Beach, and his PhD (physiology emphasis) from Northern Arizona University.