Global Regulatory, Clinical Development and Operations Strategist and Advisor

Over a period of almost 4 years, delivered 6 INDs, rare disease/orphan drug designation and POC/EOP2 for global pipeline. Reporting to the President of MTDA, Dr. Day led the global clinical development for Mitsubishi Tanabe. The creation of this role aligned with Mitsubishi Tanabe’s medium term strategy of shifting key global drug development leadership roles from Japan to the US in the areas of project management, stage gate governance, and certain development functions including clinical science, operations, finance, regulatory and vendor management in order to optimize the development and commercialization of the company’s expanding portfolio.KEY RESPONSIBILITIESManaged Clinical Science, Clinical Operations, Data Science, Medical Writing Clinical Finance and Project Management functions.Working closely with the US President and other colleagues in the US, the EU and in Japan, served as a key contributor to the implementing organizational vision for Global Development.Directed and managed Early Development Team Leaders (EDTLs) and clinical operation team leaders (COTLs) supporting clinical development, clinical operations, drug safety and regulatory affairs.Directed the execution of clinical development from preclinical through late stage development globally. Key deliverables included development of clinical development plans, creation of clinical protocols, overseeing clinical operations, data science, finance and budgets, project management and medical writing.Develop the organizational capability to support global clinical development.Chaired the Protocol Review Committee (PRC).

Providing Consulting Services in the following: Regulatory :• Specializing in creation of 505(b)(2) and fixed-dose combination (FDC) strategy for purposes of designing stream-lined drug development programs and supporting pre-IND meeting planning. • NDA /MAA planning and writing, • US and EU advisory committee meeting preparation and conduct, • Complex global health authority communication and negotiations.Clinical: • Specializing in early to late stage clinical trial design, strategy, operations, large trial design and global trial management. Regulatory Safety and Pharmacovigilance: • Safety strategy and assessment in global development programs• Development of risk management plans, complex safety issue management, pharmacovigilance, and health authority communication and negotiation. Clinical/Regulatory Documentation - • Specializing in complex medical writing and messaging, including pivotal regulatory submissions such as IND, IB, briefing documents, eCTD development and writing - modules 1, 2, 4 and 5.

Most senior Executive team member responsible for global non-clinical and clinical research/development/operations/submissions and associated functions, including regulatory strategy. Served as the most senior scientific/clinical leader for the company regarding external presentations, health authority interactions or analyst meetings. Responsible for global clinical research and development organization and all clinical trials from pre-clinical to Phase III/IV and commercialized products including oversight and management of clinical data management functions. Oversaw the clinical research activities including design and conduct of clinical trial protocols, data management strategies and systems, development of required reports and regulatory filings to gain product approval. Developed operational plans for managing clinical research activities, including activities to be performed in-house or through third-party relationships, and clinical trials according to the strategic plan to support product approval in US and EU. Interacted with various groups within the company, and external to the business, in the execution of clinical research/development activities. Managed strategic level decisions regarding regulatory strategy and negotiations worldwide regarding all aspects of clinical development and approval submission processes. Served as primary moderator and presenter for Qsymia FDA Advisory Panels (July 2010 and Feb 2012) and was recognized as the “architect” behind the novel complex clinical program supporting this product’s approval. Qsymia and Stendra named by Forbes as 2 of top 7 new drugs of 2012. Extensive product launch support with commercial/marketing and medical affairs involving market access, payers, training, interaction with, KOLs, analysts/investors. Major accomplishments include:• NDA Evamist –Approved 7/2007• NDA Stendra –Approved 4/2012• NDA Qsymia – Approved 7/2012 • MAA Stendra – Approved 6/2013• sNDA Stendra – Approved 9/2014

Graduate student advisor and course instructor for PhD and PharmD level courses including drug development, toxicology, and pharmacology and therapeutics for metabolic disease, cardiovascular, ophthalmology and oncology.

Dr. Day held a variety of positions with Pfizer, Inc. from 1993 until his departure in October 2005. Most recently, Dr. Day was the Senior Director/Therapeutic Area Head - Oncology and Ophthalmology in Risk Evaluation and Documentation/Worldwide Regulatory Affairs - from September 2003 until his departure. Prior to this position, Dr. Day served as the La Jolla Site Head and Senior Associate Director, for Safety Risk Management in Worldwide Regulatory Affairs from August 2001 to 2003, Associate Director II, Global Safety Leader in Worldwide Regulatory Affairs from 2000 to 2001. Prior to joining Worldwide Regulatory Affairs, Dr. Day was a clinician in Clinical Development - Associate Director I - responsible for phase 2 and phase 3 clinical programs from 1999 to 2000 and, Senior Clinical Research Investigator leading metabolic disease and women's health clinical programs from 1997 to 1998. Dr. Day started his career in Drug Discovery running a pharmacokinetics/ADME lab - Senior Research Scientist from 1995 to 1997 and Research Scientist from 1993 to 1994.