Carl Denny Email and Phone Number
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Vice President, Head of Regulatory Affairs - Abeona TherapeuticsExecutive Director - Regulatory Strategy at Sarepta Therapeutic Global Regulatory Leader for the review and approval of Casimersen by the US FDA.Experience in the submission and registration of AAV9 vector-based gene therapy treatment for spinal muscular atrophy. Served as Global Regulatory Leader for the submission, review and approval of Zolgensma in Japan.Have worked closely with regulators across multiple regions to support 7 submissions of the AAV9 gene therapy product, Zolgensma. 20 years of combined experience in CMC, US FDA and global regulatory affairs.Served as the US Regulatory Affairs Lead to prepare for, and execute, a successful US FDA Advisory Committee meeting.Experienced in the hiring and training of direct reports within regulatory affairs.Experienced in biologic and gene therapy drug registrations in the following regions: Latin America,Asia, Africa, Middle East, Japan, Canada, EU and US, Canada.Have conducted meetings with 11 regulatory agencies.In addition to the regulatory affairs experience mentioned above, have worked as an International Regulatory Consultant for Gilead Sciences for 3 years in the registration of antivirals in Latin America, Asia, Africa, and the Middle East.Specialties: Area of specialty/expertise in the following: Registration of gene therapy, mRNA products, and biologics. Experience in leading and managing regulatory teams.Regulatory Affairs Certified (RAC) in US FDA regulations
Abeona Therapeutics
View- Website:
- abeonatherapeutics.com
- Employees:
- 51
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Senior Vice President - Head Of Regulatory AffairsAbeona Therapeutics Jan 2024 - PresentCleveland, Oh, Us
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Vice President - Head Of Regulatory AffairsAbeona Therapeutics Aug 2021 - Jan 2024Cleveland, Oh, UsLead regulatory affairs organization to support regulatory activities for cell and gene therapy portfolio development.
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Executive Director - Regulatory StrategySarepta Therapeutics Jul 2020 - Jun 2021Cambridge, Ma, Us -
Sr. Director - Us Regulatory Affairs At Avexis, Inc.Avexis, Inc. Sep 2018 - Jul 2020
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Global Regulatory LeaderGe Healthcare Oct 2016 - Sep 2018Chicago, UsOversee the global regulatory activities for premarket regulatory submissions and new product development for assigned products. Responsible for the development and execution of global regulatory strategies. Close collaboration with Regional RA to support country specific regulatory activities and work plans. Interface with regulatory agencies globally to achieve strategic product goals. -
Director Of Emerging Market Regulatory AffairsTakeda Pharmaceuticals Apr 2014 - Sep 2016Tokyo, JpRegulatory Site Leader for Emerging Market Regulatory Affairs - Takeda Deerfield, Illinois Responsible for the development and execution of emerging market regulatory strategies to support product lifecycle, including product development and post-marketing activities in all non-US and EU countries. Primary focus on Emerging Markets including Asia, Latin America, Middle East and region Africa, as well as Russia, India, China and select Tier I countries (Australia, South Africa, etc.). Responsibility encompasses all therapeutic areas, biologics and small molecules. -
Director Of Regulatory Affairs, AmericasCatalent Pharma Solutions Jan 2014 - Mar 2014Responsible for the regulatory activities associated with the development, registration and maintenance of sponsor products. Provide regulatory assessment of pre-approval and post-approval commercial projects, regulatory strategy and responsibility for submission execution. Primary regions of responsibility are the Americas (Latin America, North America, and Canada), with additional responsibility as needed for Asia Pacific and the Emerging Markets.
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Associate Director Regulatory Affairs - Apac (Asia, Pacific, Russia, Cis) RegionAbbott Laboratories Aug 2012 - Dec 2013
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Associate Director Regulatory Affairs- Area & Affiliate Strategy (Cee & Russia)Abbott Laboratories May 2011 - Aug 2012In cooperation with regulatory affiliates and commercial colleagues, develop and support regulatory strategies for product registration in Central and Eastern Europe (CEE) and Russia.Support registration activities for assigned products in CEE & Russia region.
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Associate Director International Regulatory AffairsAbbott Laboratories Feb 2007 - May 2011
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Sr Regulatory AssociateEli Lilly And Company Apr 1998 - Jan 2007Indianapolis, Indiana, UsChemistry, manufacturing and Control - small molecules and biologics
Carl Denny Skills
Carl Denny Education Details
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Purdue UniversityChemistry -
Illinois State UniversityChemistry
Frequently Asked Questions about Carl Denny
What company does Carl Denny work for?
Carl Denny works for Abeona Therapeutics
What is Carl Denny's role at the current company?
Carl Denny's current role is Senior Vice President - Head of Regulatory Affairs at Abeona Therapeutics.
What is Carl Denny's email address?
Carl Denny's email address is ca****@****ott.com
What is Carl Denny's direct phone number?
Carl Denny's direct phone number is .224.554*****
What schools did Carl Denny attend?
Carl Denny attended Purdue University, Illinois State University.
What skills is Carl Denny known for?
Carl Denny has skills like Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, Fda, Regulatory Requirements, Ind, Chemistry, Clinical Trials, Clinical Development, Drug Development, Biotechnology, Biologics.
Who are Carl Denny's colleagues?
Carl Denny's colleagues are Olga Kourennaia, Grace Bizzell, Charles Burt, Jamie Phillips, Alysha Gonzales, Bernhardt (Bernie) Zeiher, Md, Fccp, Facp, Katharine Chambers.
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