Grant S. Griffin, Drsc, Fraps, Rac Email and Phone Number
Grant S. Griffin, Drsc, Fraps, Rac work email
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Grant S. Griffin, Drsc, Fraps, Rac personal email
A regulatory affairs executive in the pharmaceutical and biotechnology industry with 18 years of health care experience, 14 years of experience in regulatory affairs, a Doctor of Regulatory Science (DRSc), and who is a Fellow of the Regulatory Affairs Professionals Society (FRAPS). Experience driving expedited regulatory approvals and expanded indications; building the company product pipeline and influencing the regulatory environment; and building collaborative relationships with health authorities, the CEO, and the Board of Directors to provide transformative therapeutics to patients in need.
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FellowNo Patient Left BehindChicago, Il, Us -
Griffin Regulatory LlcGreater Chicago Area -
Regulatory Affairs ConsultantTract Therapeutics, Inc. May 2023 - Present -
Medical Device Regulatory ConsultantOhio Medical Sep 2024 - Dec 2024Gurnee, Il, Us -
Executive Director, Regulatory AffairsEton Pharmaceuticals, Inc Apr 2024 - Jul 2024Deer Park, Il, Us -
Senior Regulatory ScientistCcs Associates, Inc. Nov 2023 - Mar 2024San Jose, Ca, Us -
Guest LecturerUniversity Of Southern California Oct 2023 - Oct 2023Los Angeles, Ca, Us"Clinical Trials of Drugs: History and Requirements," MPTX 511: Introduction to Medical Product Regulation -
Senior Director, Regulatory AffairsHarmony Biosciences Mar 2022 - Apr 2023Plymouth Meeting, Pa, UsRecruited to lead regulatory due diligence evaluations and support clinical development programs for an existing approved product, pitolisant.● Led regulatory due diligence evaluations of multiple drugs for rare neurological diseases to potentially expand the product pipeline, driving one of three pillars of the corporate growth strategy. ● Advanced existing development programs for pitolisant in idiopathic hypersomnia, Prader-Willi syndrome, and myotonic dystrophy, and potential development programs for HBS-102.● Established war room FDA inspection readiness. -
Regulatory Affairs ConsultantTract Therapeutics, Inc. Mar 2022 - May 2022Supported projects at the request of TRACT and with the permission of Harmony Biosciences. -
Director Of Regulatory AffairsTract Therapeutics, Inc. Jul 2019 - Mar 2022Recruited to serve as Head of Regulatory Affairs and lead the development of TRK-001, a cellular therapy that involves the selection and expansion of a patient’s own naturally occurring T regulatory cells (Tregs) for the prevention of graft rejection in solid organ transplant.● Qualified the company for incentives, including tax credits for qualified clinical trials, exemptions from user fees (e.g., $3,117,218 in Fiscal Year 2022), and a potential 7 years of market exclusivity after approval by obtaining Orphan Drug Designation.● Optimized development programs by generating internal product development plans (PDPs) that included potential expedited programs, including expedited development and review, intensive guidance from FDA, organizational commitment from FDA, rolling review, and a shorter review (6 months instead of 10 months) of a marketing application.● Positioned the company to raise capital to finance development through marketing approval by leading initial technology transfer of TRK-001.● Represented the company within the Alliance for Regenerative Medicine (ARM), advising that the US Government Relations and Policy Committee must collaborate with the US Regulatory Committee before pursuing changes to existing legislation that may impact FDA.● Established an initial company quality system to comply with FDA and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements. -
Manager, Regulatory Affairs, Global Regulatory Strategy, Us And CanadaAbbvie Sep 2015 - Jul 2019North Chicago, Illinois, UsPromoted to lead pediatric and post-approval FDA regulatory strategy, support pre-approval FDA regulatory strategy, advise Health Canada regulatory strategy, and manage Investigational New Drug (IND) and New Drug Application (NDA) submissions and timelines for MAVYRET® (glecaprevir/pibrentasvir) for the virologically curative treatment of patients with chronic hepatitis C virus (HCV) infection. Also assigned on a part-time basis to analyze the impact of evolving regulations and guidance for internal stakeholders and help establish company positions on regulatory policy topics at trade associations.● Obtained New Drug Application (NDA) approval 11 days prior to the Priority Review Prescription Drug User Fee Act (PDUFA) date. From 2017-2019, Mavyret (glecaprevir/pibrentasvir) was prescribed to approximately 100,000 patients with chronic HCV in the US and generated approximately $3.36B in revenue.● Obtained FDA Priority Review and sNDA approval and Health Canada Priority Review for adolescent patients. Advised pre-sNDS meeting teleconference to gain agreement with Health Canada. Nominated for AbbVie Inc. President’s Award. Obtained an early sNDA approval with safety and efficacy data from the HCV/HIV-1 coinfection study and liver and renal transplant study.● Qualified the company for incentives, including tax credits for qualified clinical trials, exemptions from user fees (e.g., $2,588,478 in Fiscal Year 2019), and a potential 7 years of market exclusivity after approval.● Qualified the company for pediatric exclusivity, which attaches 6 months of additional exclusivity to all dosage forms and all indications with the same active moiety as the drug studied and attaches to the end of all existing marketing exclusivity.● Advanced the regulatory policy positions of the company at the outset of Prescription Drug User Fee Act (PDUFA) VII negotiations. -
Regulatory Affairs Contractor, Us And Canada Area And Affiliate Strategy, OncologyAbbvie Aug 2015 - Sep 2015North Chicago, Illinois, Us -
Regulatory Affairs Contractor, Submission Operations And PublishingAbbvie Jan 2013 - Aug 2015North Chicago, Illinois, Us -
Regulatory Affairs Contractor, Development RegulatoryAbbott Jul 2010 - Dec 2012Abbott Park, Illinois, Us -
Clinical Research CoordinatorChicago Institute Of Neurosurgery And Neuroresearch Aug 2007 - Jul 2010
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Patient Care TechnicianEvanston Northwestern Healthcare May 2006 - Aug 2007Evanston, Il, Us
Grant S. Griffin, Drsc, Fraps, Rac Skills
Grant S. Griffin, Drsc, Fraps, Rac Education Details
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Harvard Law SchoolLaw -
Harvard Medical SchoolAnd Immunology (50 Weeks) -
University Of Colorado Law SchoolMini Law School (14 Weeks) -
University Of Southern CaliforniaRegulatory Science -
University Of Southern CaliforniaRegulatory Science -
University Of IowaRussian (With Honors) And History (With Honors)
Frequently Asked Questions about Grant S. Griffin, Drsc, Fraps, Rac
What company does Grant S. Griffin, Drsc, Fraps, Rac work for?
Grant S. Griffin, Drsc, Fraps, Rac works for No Patient Left Behind
What is Grant S. Griffin, Drsc, Fraps, Rac's role at the current company?
Grant S. Griffin, Drsc, Fraps, Rac's current role is Fellow.
What is Grant S. Griffin, Drsc, Fraps, Rac's email address?
Grant S. Griffin, Drsc, Fraps, Rac's email address is gr****@****vie.com
What schools did Grant S. Griffin, Drsc, Fraps, Rac attend?
Grant S. Griffin, Drsc, Fraps, Rac attended Harvard Law School, Harvard Medical School, University Of Colorado Law School, University Of Southern California, University Of Southern California, University Of Iowa.
What are some of Grant S. Griffin, Drsc, Fraps, Rac's interests?
Grant S. Griffin, Drsc, Fraps, Rac has interest in Clinical Trial Data Disclosure, Entrepreneurship, Regulatory Affairs, Education, Foreign Languages, Science And Technology, Arts And Culture, Neuroscience, Health.
What skills is Grant S. Griffin, Drsc, Fraps, Rac known for?
Grant S. Griffin, Drsc, Fraps, Rac has skills like Writing, Regulatory Intelligence, Clinical Trials, Medical Writing, Planning, Allied Health, Strategist, Chemistry, Draft, Students, Clinical Research, Processors.
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