Philip Huang Email & Phone Number

Paris, France, Fr

Reporting to Sanofi Global Medical Clinical and Country Quality Head (Dr. Catherine Marchese-Roland) and US Country Council Chair (Mrs. Carole Huntsman), responsible to:• Lead the regional integration of Quality Management Systems and Organization on all GxP and health-regulated activities to ensure compliance with regulatory requirements and company standards.• Provide Quality leadership across the US and Canadian organizations, including Medical, Regulatory and Pharmacovigilance Quality Councils• Lead and coordinate a network of professionals across the US and Canadian affiliates who are involved in GxP and health-regulated activities and empowered to address all matters related to Quality. • Define and implement oversight of quality standards and training, audits and readiness, product quality, and risk management; and partner with the business on targeted continuous process improvement ensuring quality by design.• Oversee regulatory interactions with Health Canada and FDA related to Product Quality, including management of the recall of Zantac, and products with nitrosamine impurities

Paris, France, Fr

Reporting to Sanofi US Chief Medical Officer (Dr. Charles Hugh-Jones) and US Chief Executive Officer (Mr. Jez Moulding), responsible to:• Lead the implementation and maintenance of the US Affiliate Quality System and Organization on all GxP and health-regulated activities to ensure compliance with regulatory requirements and company standards.• Lead and coordinate a network of professionals across the US Affiliate who are involved in GxP and health-regulated activities and empowered to address all matters related to Quality.• Oversee regulatory interactions with FDA related to Product Quality, including management of the recall of AuviQ.• Escalate and ensure aligned responses to Quality Events and Product Alerts (medical, regulatory, safety, etc.)

Paris, France, Fr

Reporting to the Chief Medical Officer (Dr. Charles Hugh-Jones), establish strategic planning operational excellence in NAMA as well as collaborating with our partners in R&D and Global Medical Operations to create robust transversal operational capabilities for the future. Lead Medical Project Management, Medical Training, NAMA Central Operations (Investigator Sponsored Studies, Medical Education Grants, and Publications), FDA Audit Readiness, Medical Compliance, Medical IT System Strategy, Medical Communications, and Medical Organizational Evolution Management.

Launched pharmaceutical and biotechnology consulting practice with project work focused on clinical and regulatory development; preparing and running FDA meetings; conducting health economics and outcomes research, developing medical affairs, commercial and business growth strategies; and building and managing relationships with Key Opinion Leaders (KOLs), advocacy groups, etc.

Reporting to the President, Merck Vaccines Division (Dr. Julie Gerberding), provided commercial strategy leadership to Vaccine Division's Executive Team to achieve global target of 10% annual growth in 2011-12 (to $4.4B) and projected revenue >$10B by 2020. Vaccines include Rotateq, Gardasil, Gardasil-9 (BLA submission), Varivax, Zostavax (BLA approval for expanded age indication and updated manufacturing process), Pneumovax 23, Pedvax HIB, Proquad, Recombivax, Vaqta, and Afluria (CSL). Led surveillance of external opportunities and risks to drive global vaccines business development.• Initiated/advanced six new product candidates and directed completion of four deals in 12 months to achieve development and commercial planning objectives. Led engagement of thought leaders on opportunities and unmet need to establish priority areas for vaccine improvements (immune senescence, improved delivery, etc.)• Led management of strategic alliances (Sanofi Pasteur, CSL, and Serum Institute) and engaged national organizations (ACIP, JCVI etc.) regarding new product positions and recommendations (revenue impact >$150MM).• Created four initiatives to improve market access and series completion and three partnerships around alternative sites of vaccination (pharmacy, travel kiosks, etc.) with revenue impact projected >$30MM• Fostered culture of innovation within vaccine base of >800 employees; sponsored initiatives around new delivery technologies (intradermal, oral, patch, etc.) and public solutions (combining human and animal health assets). Sponsored adoption of single-use technologies as low-cost modular platforms within manufacturing.• Completed special assignment to Merck's Chief Medical Officer (Dr. Michael Rosenblatt) to develop patient-centered growth strategy to demonstrate value under provisions of the Affordable Care Act, improving utilization and increasing data regarding clinical impact by moving from transactional to collaborative relationships.

As Senior Advisor to Dr. Michael Kamarck (Head of Biologic Operations and MBV Groups), provided operational leadership to both Executive Teams that governed progress of eight internal biosimilar product development teams (over 600 employees).• Rationalized global manufacturing network for Biologics (Therapeutic Proteins, Biosimilars, and Vaccines) following merger with Schering-Plough. Developed plan to deliver >$500M in projected annual savings by 2015. Ensured that strategy was compliant with jurisdictional requirements across 22 countries.• Led due diligence and business development activities to accelerate rate of approvals from MBV pipeline. Directed cross-divisional planning for R&D pipeline and required manufacturing capacity (organic and inorganic), resulting in two key strategic partnerships as well as an acquisition and a divestiture. • Established need for strategic clinical operational partners to develop biosimilar products. Negotiated unique performance-based partnership with a CRO (PAREXEL) to achieve competitive advantage.• Engaged medical / scientific KOLs, reimbursement policymakers, and patient advocacy groups in order to inform and develop Merck's policy positions around standards of data required to establish biosimilarity and interchangeability; engaged legislative staff / government regulators to successfully advance Merck's positions. • Chaired DIA's first biosimilars forum. Reinforced Merck brand as scientific leader within biotechnology industry. Advocated that clinical studies for follow-on biologics should leverage existing innovator trial data with supplemental research requirements based on established safety profile.

As founding member of MBV leadership team, led assessments and strategic planning to develop business case supporting pursuit of emerging biosimilar opportunity. Delivered pipeline targeting 12 key molecules in inflammation, oncology, and other therapeutic areas. Operationalized new business unit with 80+ employees within first six months.• Led 28-person multi-divisional team to design and implement new operational processes critical and unique to MBV’s accelerated end-to-end development (from basic research through manufacturing to clinical development and commercialization). Prioritized capabilities gaps for development of critical CRO and CMO partnerships.• Engaged design firm IDEO to partner on novel delivery devices and platforms for biosimilar products.• Collaborated with clinical, scientific, and regulatory thought leaders to understand and define key issues surrounding development and use of biosimilar products (especially monoclonal antibodies and other multifunctional macromolecules).

Led MRL Special Projects Team (reporting directly to Dr. Peter Kim, President MRL and Joanne Lahner, VP & Assistant General Counsel) to provide scientific and medical basis of VIOXX litigation defense to achieve landmark settlement (26,600+ cases).• Testified as expert witness and delivered depositions on clinical trial design and execution as well as use and limitations of observational studies.• Engaged external scientific and clinical thought leaders, as well as public constituencies, to understand and represent landscape of thinking around inflammation, cardiovascular disease, and COX-2 inhibition. • Created R&D "SWAT" team that included staff from clinical, regulatory, and post-marketing product functions. Established innovative ability to respond consistently and expeditiously to any requests related to VIOXX (within one hour standardly; one day maximum). Instituted processes and systems to manage special projects.

Provided strategic regulatory oversight for coxib franchise (rofecoxib, nitric oxide releasing coxib, and etoricoxib) to Global Regulatory Leadership Team. Also served as product development team lead for special pathogen products (Isentriss, a first-in-class anti-HIV integrase inhibitor with 2012 revenue of $1.5B).• Established medical and commercial priorities for Isentriss development program. Designed clinical trials; oversaw scientific / medical engagement and launch strategy. • For both R&D franchises, reviewed and modified clinical development plans to meet clinical, regulatory, and commercial needs. Led preparation, review, and submission of regulatory documents to FDA.• Negotiated agreements with FDA regarding requirements for coxib drug development programs (e.g., final labeling language and promotional claims). Led planning and preparation for FDA advisory committee meetings related to Benefit Risk Considerations for COX-2 Selective Inhibitors.• Interacted with worldwide thought leaders to guide development of consensus strategic positions in two therapeutic areas (Arthritis / Immunology and Anti-Infectives).• Medical representative to review committees overseeing approval of promotional materials, medical educational programs, investigator sponsored studies, and publications process.

Oversaw worldwide regulatory product teams and product development teams for second and third generation COX-2 inhibitors and neuropharmacology products (pain, sleep, general anxiety disorder, schizophrenia, and Alzheimer’s disease). Developed and refined clinical development plans to meet clinical, regulatory, and commercial needs.• Directed clinical regulatory team evaluating GEM polymer extended release delivery device, securing FDA clearance for use in Phase II and Phase III studies.• Led planning and preparation for FDA advisory committee meetings: Trial Design and Endpoints for Acute Gout and Clinical Trial Models and Classifications for Pain.• Medical representative to review committees overseeing approval of promotional materials, medical educational programs, investigator sponsored studies, and publications process.

Us

Attending Physician, General Medicine Service, with teaching and supervisory responsibility for attending rounds with residents, interns, and medical students, Brigham and Women’s Hospital, Boston, MA

Boston, Ma, Us

Medical resident, with teaching and supervisory responsibilities for interns and medical students, Medical Services, Massachusetts General Hospital, Boston, MA

Boston, Ma, Us

Intern in Internal Medicine

Mba, Marketing, Finance, Strategy

Md, Internal Medicine

Ba, Chemistry

Education record