John H. Email & Phone Number

Cambridge, Massachusetts, United States

Responsible for leading the global regulatory affairs oncology organization and ensuring innovative and progressive regulatory strategies are formulated and executed to advance Takeda’s portfolio of oncology assets.

Cambridge, Massachusetts, United States

Accountable for regulatory strategy across numerous oncology assets in all stage of development through leadership of a high performing team of regulatory strategists. Also responsible for providing regulatory leadership and input for all due diligence projects within oncology.

Tarrytown, New York

Tarrytown, New York

Global and US Regulatory Lead responsible for leading the regulatory team and driving regulatory strategy across the respiratory therapeutic area portfolio.

Princeton, New Jersey

• Serve as Global Regulatory Team Leader for a portfolio of numerous immuno-oncology and oncology early development (Phase 1 through Phase 2b) assets including small molecules and biologics. • Enable accelerated regulatory pathways to registration through providing strategic regulatory input to development teams regarding potential use of expedited health authority pathways (e.g. FDA Breakthrough Designation, Accelerated Approval) and adaptive trial designs• Provide regulatory input to all aspects of asset development through cross-functional discussions, governance interactions, and document reviews• Lead IND preparation including authoring and review of key documents, leading interactions with FDA, and driving preparation of responses to FDA information requests• Serve as FDA Liaison with responsibilities including leading and directing preparation for FDA meetings, information request response preparation, routine submission activities, and IND annual report preparation• Actively contribute to protocol and investigator brochure authoring and updating• Lead and coordinate preparation of responses to global health authority queries• Contribute to defining development strategy and potential registrational pathways for assigned assets• Provide regulatory input into assigned due diligence assessments of potential in-licensing opportunities

Wallingford, Ct

-• Provide guidance on regulatory issues to life cycle management development sub-teams for an marketed cardiovascular asset in role of regulatory representative • Influence the design of phase 3 and 4 clinical trials for a cardiovascular asset by providing regulatory guidance including analysis of precedent, interpretation of health authority guidance, interpretation of review documents including EPARs, FDA review documents, FDA Advisory Committee transcripts, and analysis of related products’ labeling.• Review draft clinical trial protocols and provide suggested revisions based on regulatory precedent and HA guidance in capacity as a regulatory reviewer for Immunology TA protocols • In collaboration with senior clinical development colleagues prepare detailed regulatory landscape documents detailing precedent and regulatory pathways for specific cardiovascular indications and providing recommendations for acceleration opportunities• Review and approve routine FDA submissions for a late-stage oncology asset including: protocol amendments, study reports, investigator information, and safety reports• Draft and coordinate review and revision of key strategic internal regulatory documents including Global Regulatory Plans, Regulatory Landscape Documents, and Global Regulatory Engagement Plans. • Develop and maintain global submission plans for assigned assets in collaboration with regional regulatory liaisons• Facilitate communication between alliance partners for a cardiovascular asset by serving as the BMS point of contact for regulatory matters• Manage global submission and approval tracking for assigned assets and prepare regulatory workload heat maps• Support the pediatric development sub-team for an oncology asset including EU PIP, discussions with global key opinion leaders, strategic planning, and timeline construction

Laboratory Leader with responsibilities including:- Led a fragment-based lead identification project by managing and deploying multiple lines of resources to rapidly advanced chemical matter from initial hits to potent leads- Managed a group of 3 high-performing associates- Served as a senior team member for a mid-stage discovery project influencing all aspect of project strategy and execution

Experience as a senior team member and Laboratory Leader on projects aimed at discovery of novel compounds to modulate diverse target types such as ion channels, enzymes, GPCRs, and NHRs within immunology and inflammation and cardiometabolic disease therapeutic areas. Responsibilities included design and synthesis of novel compounds, data analysis, assisting in setting chemistry strategy, and chemistry CRO management. Chemistry leader of two early-stage drug discovery projects with responsibility for jointly setting strategy and overseeing execution in conjunction with a biology leader. Responsible for managing and coaching a group of associate chemists.

Rahway, Nj

Ph. D., Organic Chemistry

Ph. D. awarded with distinction

Ba, Chemistry