Philip Johnson Email and Phone Number
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I have a total of 28 years of pharmaceutical drug development experience across a range of therapeutic areas and products. I am currently the Senior Vice President of Oncology Development for Lilly, where I lead the Project Leadership & Management, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Medical Writing, and Business Operation functions supporting oncology programs from through clinical development. I was previously the Vice President & Head of Regulatory Affairs & Medical Writing for Loxo@Lilly.Prior to joining Lilly, I was a Medicine Team Leader at Pfizer, where I led cross-functional medicine teams for Besponsa (inotuzumab ozogamicin) and Daurismo (glasdegib) to successful regulatory approvals in the US, Europe and the Rest-of-World. Prior to Pfizer, I was a Senior Director of Regulatory Affairs at Bayer, where I led a team of 6 US and European-based regulatory professionals focused on the global regulatory strategy for a portfolio of Bayer's oncology drugs. The global oncology portfolio under my management includes the marketed drugs Aliqopa, Nexavar and Stivarga, as well as compounds currently in development. I have led multiple regulatory filings for these compounds, obtaining priority review approval for each of these filings.Specialties: Oncology, Hematology, Cross-Functional Leadership, Regulatory Affairs, FDA, NDA, BLA, IND, Advisory Committees, Diagnostic Imaging, Diabetes/Metabolism, Rheumatology/Autoimmune, Virology, Anti-Infectives
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IpsenNew York, Ny, Us
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Senior Vice President, Oncology DevelopmentEli Lilly And Company May 2023 - PresentIndianapolis, Indiana, UsI lead the Early Oncology Development organization for Lilly, inclusive of Project Leadership & Management, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Medical Writing, and Business Operations functions, with responsibilities spanning from IND filings through NDA/BLA approvals and lifecycle development. -
Vice President / Head Of Regulatory Affairs & Medical WritingLoxo@Lilly Nov 2020 - May 2023Stamford, Ct, UsI led a team of 20 Regulatory and Medical Writing professionals supporting all Loxo@Lilly oncology programs from discovery through NDA/BLA approval. Key Regulatory responsibilities included IND filings and coordination of rest-of-world CTA filings, development and alignment of regulatory strategies with internal stakeholders and external regulators to support accelerated regulatory filings and approvals, NDA/BLA submissions, and regulatory policy. Key Regulatory Companion Diagnostics responsibilities included strategic CDx/Dx regulatory interactions including study risk determinations (SRD), IDEs, pre-sub consultation, and scientific advice, and partnerships with external Dx partners to align co-development activities.Key Medical Writing activities included development of all clinical documents including protocols, investigator brochures, protocol amendments, clinical study reports, Module 2 summaries, and Assessment Aids. -
Medicine Team Leader - OncologyPfizer May 2017 - Oct 2020New York, New York, UsAt Pfizer, I led the Medicine Team in the submission & approval of Daurismo (glasdegib) by FDA & EMA for acute myeloid leukemia, as well the approval of Besponsa (inotuzumab ozogamicin) by FDA & EMA for acute lymphoblastic leukemia, in addition to multiple life-cycle development programs for those medicines. I have also led an immuno-oncology program in head & neck cancer.As a Medicine Team Leader, I was accountable for driving the strategy, implementation and successful delivery of the integrated Medicine Plan for Oncology compounds in late phase development. Responsibility for these assets begins after achievement of Proof of Concept, and covered the period including pivotal registration development, subsequent registrations, post-approval trials & life-cycle management. I was responsible for ensuring timely execution and delivery of new and ongoing clinical trial programs that had a high likelihood of technical, regulatory and commercial success. I led the Global Medicine Team and aligned with associated subteams to ensure cross-functional alignment in support of the assigned assets. In this role I directly managed and was accountable for the medicine candidate and development budget, and I served as the steward for new medicine development plans at milestone / decision-point at internal governance meetings. -
Senior Director, Group Head, Oncology, Global Regulatory AffairsBayer Pharmaceuticals Jun 2016 - Apr 2017Leverkusen, North Rhine-Westphalia, DeResponsible for managing a team of 6 US & European-based regulatory professionals focused on the global regulatory strategy for a portfolio of Bayer's oncology drugs. The global oncology porfolio I managed included the marketed drugs Aliqopa (copanlisib), Stivarga (regorafenib), and Nexavar (sorafenib), as well as multiple oncology compounds currently in early development.I have also led multiple special projects within Bayer, including a multi-company FDA Advisory Committee meeting focused on Antimicrobials & Drug Safety / Risk Management, and multiple Global Meetings of 60 - 120 attendees. -
Director, Global Head, Oncology, Global Regulatory AffairsBayer Pharmaceuticals Mar 2013 - Jun 2016Leverkusen, North Rhine-Westphalia, DeResponsible for managing a team of 6 US & European-based regulatory professionals focused on the global regulatory strategy for a portfolio of Bayer's oncology drugs. The global oncology porfolio I managed included the marketed drugs Nexavar and Stivarga, the Pi3K inhibitor Copanlisib, as well as multiple oncology compounds currently in early development.I have also led multiple special projects within Bayer, including a multi-company FDA Advisory Committee meeting focused on Antimicrobials & Drug Safety / Risk Management, and multiple Global Meetings of 60 - 120 attendees.
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Interim Head, Asia Pacific, Global Regulatory AffairsBayer Pharmaceuticals Aug 2014 - Jan 2015Leverkusen, North Rhine-Westphalia, DeManaged team of 55 regulatory professionals including direct line management of 12 Asia-Pacific Country Heads plus 3 Regional Regulatory Strategists. Responsible for Bayer’s development and market portfolio in Asia-Pacific to obtain health authority approvals with competitive labeling while maintaining optimal regulatory compliance.Ensured alignment of regulatory staff in the Asia Pacific region strategically and operationally to support the regional business objectives and accountable for interactions with national regulatory authorities through the local regulatory representatives. Represented Asia-Pacific region to Global Regulatory Affairs Management Team and provided budgetary oversight to meet financial targets.
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Deputy Director, Regulatory Affairs - Oncology, Diagnostic ImagingBayer Pharmaceuticals Oct 2009 - Feb 2013Leverkusen, North Rhine-Westphalia, DeLed multidisciplinary team in preparing and filing multiple New Molecular Entity NDAs, obtaining 1st cycle NDA approvals. Led all interactions between Bayer and FDA, including labeling negotiations and responses to clinical and pre-clinical questions. Led meetings with FDA for lifecycle development opportunities.Led 30-member team and coordinated with 3 external vendors to prepare for FDA Advisory Committee; received unanimous vote for approval. Led team in developing Bayer Advisory Committee Best Practices guidance. Recognized with Bayer Leadership award for work on NDAs.
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Associate Director, Regulatory AffairsHoffmann-La Roche Jun 2008 - Oct 2009Switzerland 🇨🇭 , Ch -
Senior Program Manager, Regulatory AffairsHoffmann-La Roche Jun 2005 - May 2008Switzerland 🇨🇭 , Ch
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Program Manager, Regulatory AffairsHoffmann-La Roche Sep 2003 - May 2005Switzerland 🇨🇭 , Ch
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Manager, Regulatory AffairsSchering-Plough Healthcare Products Dec 2001 - Sep 2003
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Senior Regulatory Affairs AssociateSchering-Plough Healthcare Products Jan 2000 - Nov 2001
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Regulatory Affairs SupervisorPharmaceutical Formulations, Inc. Jun 1998 - Dec 1999
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Regulatory Affairs AssociatePharmaceutical Formulations, Inc. Jul 1997 - Jun 1998
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Regulatory Affairs AssistantPharmaceutical Formulations, Inc. May 1996 - Jul 1997
Philip Johnson Skills
Philip Johnson Education Details
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Rutgers Business SchoolManagement Of Science And Innovation -
Northwestern University - Kellogg School Of ManagementRegulatory Management
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Brown UniversityChemistry
Frequently Asked Questions about Philip Johnson
What company does Philip Johnson work for?
Philip Johnson works for Ipsen
What is Philip Johnson's role at the current company?
Philip Johnson's current role is Senior Vice President, Oncology Development at Lilly.
What is Philip Johnson's email address?
Philip Johnson's email address is ph****@****zer.com
What schools did Philip Johnson attend?
Philip Johnson attended Rutgers Business School, Northwestern University - Kellogg School Of Management, Brown University.
What skills is Philip Johnson known for?
Philip Johnson has skills like Regulatory Affairs, Fda, Oncology, Ind, Medical Imaging, Regulatory Strategy, Pharmaceuticals.
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