Priya Singhal Email & Phone Number

Cambridge, Ma, Us

Cambridge, Ma, Us

I am delighted to be back at Biogen to lead Global Safety, Regulatory Sciences as well as Japan and China R&D. It is inspirational to be working alongside passionate global teams to bring medicines to worldwide patients who most need them.

Zafgen is a publicly traded, clinical-stage biopharmaceutical company. Zafgen has pioneered the study of MetAP2 inhibitors in both common and rare metabolic disorders and is currently advancing programs for type 2 diabetes, Prader-Willi syndrome and liver diseases. • Drive Zafgen’s preclinical programs into IND filing and Phase I development – including filtering among the many options, identifying the best opportunities, and resourcing them adequately so they can be realized.• Lead preclinical development strategy and communicate a vision and plan to translate discovery research into clinical development. • Serve as a member of the C-suite, contributing to overall corporate strategy, including but not limited to: long term business model, M&A, business development strategy and outreach, HR, regulatory, clinical and culture.• Establish and maintain relationships and serve as a key liaison between the Company and its external scientific advisors, public media, and the investment community.• Identify opportunities and lead collaborations to gain access to key capabilities.• Act as Site Head of the Boston office in the CEO’s absence.

Cambridge, Ma, Us

- Interim Global Co-Head, Global Development, Senior Vice President (2017-2018)- Global Head, Safety and Benefit-Risk (SABR), Senior Vice President (2016-2018)Oversight for five R&D functions: SABR, Regulatory Sciences, Biometrics, Clinical Trial Operations and R&D Quality Compliance: a total 580 FTEs across five functions and oversaw $300M budget• Successfully transformed a functionally-based organization to adopt a one team approach and enabled the achievement of ambitious organizational goals• Led the strategic planning, regulatory communication and execution of Zinbryta’s withdrawal from the market. Exceeded timelines by driving decision making, strategic planning and implementing key actions in all geographies• Steered Biogen through two Global GVP Inspections, achieving successful outcomes by strategic planning and personally mentoring teams• Renegotiated a diverse range of vendor contracts to deliver on a 30% savings ($7M) and better quality with a new risk mitigated approach and strategy• Successfully improved the gross underspend on budget of $300M to within 2% underspend and enabled timely funding of critical R&D projects

Cambridge, Ma, Us

Global Head, Safety and Benefit-Risk (SABR), Senior Vice President (2016 – 2018)Global Head, Safety and Benefit-Risk (SABR), Vice President (2013 – 2016)Accountable for global benefit-risk strategy and implementation across entire Biogen portfolio. Led 130 FTE and $70M budget• Turned around the SABR department to stabilize and improve annualized attrition rates from 45% to <10% in a 15 month period• Pioneering approach to address the organizational challenge of MD talent recruitment and retention. Recruited academic MDs and establishing an Industry leading model of the equipoised MD-PV Scientist model. This led to reversal of the MD: PV Scientist ratio of 2:1 to 1:2 while providing the right talent for the portfolio and providing the MD role with a growth track in-house leading to improved talent retention• Key contributor to five successful filings and launches• Initiated and advocated to internal leadership and DSMB regarding incremental steps to optimize benefit-risk in the design of the Aducanumab Phase 3 Program (lead Alzheimer program) – such as optimizing MRI monitoring, dose titration to minimize risk as well as enabling subjects with resolved risks to restart treatment safely• Led the evaluation of more than 75 due diligence opportunities to make a decision on the asset/company including significant contribution to designing a framework for multi-disciplinary diligence templates and defining parameters for Legal/Business alliance/ R&D roles and responsibilities across entities• Emergence of PML with Tecfidera: engaged with EMA over one year in several written exchanges; addressed two Scientific Advice Group (SAGs) and CHMP meetings to communicate my view and proposal with outstanding success and outcomes• Accountable for more than 100 safety/PV audits and inspections with successful outcomes• Led cross-functional company strategy to defend three Article 20 referrals by EMA (one for Tysabri, two for Zinbryta)

Cambridge, Ma, Us

Led a MD team to oversee all benefit-risk aspects of the pre-approval portfolio; promoted to Global Head, SABR in six months

Boston, Ma, Us

Vertex was founded in 1989 and was one of the first biotech firms to use an explicit strategy of rational drug design rather than combinatorial chemistry. Its product pipeline is focused on viral infections, inflammatory and autoimmune disorders, and cancer. Responsible for establishing an aligned Global Medical Affairs strategy including global publications and education plans for all compounds in the Vertex portfolio particularly the Hepatitis C and Cystic Fibrosis Portfolio. Responsible for a $5M budget.• Implemented Vertex initiated education programs, KOL engagement and publication plans to secure company’s position as a scientific leader across key therapeutic areas

Boston, Ma, Us

• Successfully presented at Telaprevir FDA Advisory Committee achieving unanimous Panel yes vote (18 to 0) in April ‘11. • Led HCV Disease Area Safety strategy and Global Patient Safety physician team• Directly managed four Safety physicians in Associate Director to Senior Director position• Collaborated across R&D, Medical and Commercial cross-functional groups for alignment on key HCV portfolio scientific data and interpretations• Collaborated on licensing Agreements and served as point lead for Partners and Affiliates including serving as Chair of cross-company Safety Oversight Working Group

Boston, Ma, Us

• Pharmacovigilance Franchise Safety Area lead for Vertex Hepatitis C Program including lead candidate in Phase III (protease inhibitor, telaprevir)• Led Pharmacovigilance Medical and acted as Vertex lead for Summary of Clinical Safety on NDA Clinical strategy team and Risk Management Plan team• Spearheaded strategy and implementation for external adjudication and consultations• Created effective and efficient risk management workflow models

Cambridge, Massachusetts, Us

Millennium was one of the world's leading biopharmaceutical companies, possessing a strong R&D pipeline in the oncology area. The company was a pioneer in the field of protein homeostasis research. Millennium was purchased in 2008 by Takeda.• Medical Lead for Velcade, represented Pharmacovigilance in GCP MHRA audit and GMP FDA audits• Provided leadership, oversight, and training for adverse event case management operations and medical review processes for internal staff, alliance partners and contract research organizations

Cambridge, Massachusetts, Us

• Responsible for operations and medical assessment process redesign.• Led Velcade risk management activities, including identification and presentation of cases representing potential signals, trends at weekly case-review meetings

Boston, Ma, Us

• Developed a model for pilot outsourcing program involving chest X-ray interpretation outsourcing to an Indian vendor. Resulted in cost reduction of 20%.

Master’S Degree, International Public Health

Doctor Of Medicine (M.D.), Mbbs & Internal Medicine Residency Program

Bachelor Of Medicine/Bachelor Of Surgery, Mbbs

Medical Externship, Department Of Pulmonary Medicine & Department Of Internal Medicine

Medical Externship, Department Of Internal Medicine