Wallingford, Connecticut, United States
Highly experienced clinical drug developer and matrix team leader for projects in several disease areas and across the spectrum of clinical development (PhIIa through lifecycle). Strategic thinker who prioritizes and integrates considerations across the full range of pharmaceutical development activities (scientific, clinical, regulatory, medical, commercial and manufacturing). Combines high-level perspective with the ability to dive deeply into technical issues, resulting in ad hoc assignments to resolve strategic or technical challenges for high priority or troubled assets. Project leadership accountability has included: • A commercial and strategic success (Baraclude: >$1.5 billion peak global sales; foundational asset for BMS’ presence in China) • Significant components of the NDA/MAA filings for Yervoy (ipilimumab), first monoclonal immuno-oncology agent • Diverse therapeutic areas (HIV, Hepatitis B and C [HBV/HCV], Immuno-Oncology, Idiopathic Pulmonary Fibrosis and NASH/fatty liver disease) Key Capabilities: • Strong matrix team leader with excellent cross-functional collaboration skills within Development and across broader organizational functions (e.g. Commercial, Business Development; Manufacturing) • Transparent communicator with strong stakeholder relationships • Skilled clinical regulatory strategist; effective communicator with Health Authorities • Experience in Asia, including China and Japan; and across small molecules (5) and biologics (2 ) Key Achievements: • Key participant in 3 primary NDA/BLA and MAA submissions across 2 Health Authority divisions (2 small molecules, 1 biologic). • Member of speaker team for FDA Advisory Committee and EMA Pediatric Sub-Committee Presentation (Baraclude). • Key accountability for more than 10 sNDA and equivalent Type 2 submissions. • Pediatric experience across 4 programs including successful US patent and EU SPC extensions • Speaker at plenary sessions for international liver disease meetings
September 2014 - January 2017: Strategic leadership of cross-functional team planning clinical development of assets across fibrotic diseases, with focus on liver (NASH) and lung (IPF); activities included due diligence, staff retention and early development team lead in IPF. Development Lead for HBV asset (Baraclude lifecycle) and led out-licensing of Lambda-Interferon. February 2013 - September 2014: Development Lead for Baraclude (completing post-approval commitments including pediatrics) and Lambda-Interferon cross-functional teams
Medical Lead progressing to Development Lead for the Baraclude (HBV) program. Led clinical team through completion of MAA filing and EMA approval; led design and clinical implementation of a large post-approval program (8 studies). This period included: two 6-month secondments in Immuno-Oncology first writing the CSR for the registrational trial for Ipilimumab (Yervoy) in melanoma, then leading the response team for clinical questions from the EMEA during review of that MAA; and a 3-month secondment to advise and assist Sustiva (HIV product) pediatric filing team resulting in successful exclusivity extension.
2005 - 2008: Group Director - Led Clinical team through approval of the Baraclude (HBV) MAA filing in the EU; clinical lead for on-site team at EMEA endorsement meeting. Led design and clinical implementation of a large post-approval program (including negotiation of EU pediatric obligation). 2002 -2005: Director - From 2003-2005 was Clinical Co-Lead during Phase 3 trial analysis and preparation of US and EU registrational filing documents. Clinical speaker at FDA Advisory Committee. From 2002-2003 was Clinical Lead for successful NDA and MAA applications for an HIV program with an Extended Release asset. Provided clinical support for pediatric exclusivity filings for 2 anti-HIV agents. 2000 - 2002: Associate Director - Medical Monitor for HIV extended release asset. Wrote clinical filing documents for NDA and MAA applications and authored two white papers for FDA.
Responsible for all in-patient HIV primary management and consultation, and for management of a dedicated outpatient clinic. Staff included 2 MDs, 2 PAs, 1 RN, 1 MSW, and 1 Nutritionist.