Applied Therapeutics Appoints Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer
Applied Therapeutics (Nasdaq: APLT) has appointed Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer. Dr. Baumgartner brings over 35 years of experience in regulatory, clinical development, and medical affairs roles, with a track record of leading 12 successful New Drug Applications and marketing authorizations.
As part of the executive leadership team, he will lead Applied's global regulatory strategy, particularly focusing on upcoming regulatory interactions regarding govorestat. Prior to this appointment, Dr. Baumgartner served as Senior Vice President of Global Regulatory Affairs at Ovid Therapeutics (2020-2024) and held senior positions at Acorda Therapeutics, Purdue Pharma, AstraZeneca, and Bristol-Myers Squibb.
Applied Therapeutics (Nasdaq: APLT) ha nominato Todd F. Baumgartner, MD, MPH come Chief Regulatory Officer. Il Dr. Baumgartner porta con sé oltre 35 anni di esperienza in ruoli regolatori, di sviluppo clinico e affari medici, con un comprovato successo nella guida di 12 domande di nuovi farmaci e autorizzazioni al commercio.
Come parte del team di leadership esecutiva, guiderà la strategia regolatoria globale di Applied, concentrandosi in particolare sulle prossime interazioni regolatorie riguardanti il govorestat. Prima di questa nomina, il Dr. Baumgartner ha ricoperto il ruolo di Senior Vice President of Global Regulatory Affairs presso Ovid Therapeutics (2020-2024) e ha ricoperto posizioni di alto livello presso Acorda Therapeutics, Purdue Pharma, AstraZeneca e Bristol-Myers Squibb.
Applied Therapeutics (Nasdaq: APLT) ha nombrado a Todd F. Baumgartner, MD, MPH como Director de Regulación. El Dr. Baumgartner aporta más de 35 años de experiencia en roles regulatorios, desarrollo clínico y asuntos médicos, con un historial de liderazgo en 12 solicitudes exitosas de nuevos medicamentos y autorizaciones de comercialización.
Como parte del equipo de liderazgo ejecutivo, liderará la estrategia regulatoria global de Applied, enfocándose particularmente en las próximas interacciones regulatorias relacionadas con el govorestat. Antes de esta designación, el Dr. Baumgartner fue Vicepresidente Senior de Asuntos Regulatorios Globales en Ovid Therapeutics (2020-2024) y ocupó cargos de alto nivel en Acorda Therapeutics, Purdue Pharma, AstraZeneca y Bristol-Myers Squibb.
Applied Therapeutics (Nasdaq: APLT)는 Todd F. Baumgartner, MD, MPH를 최고 규제 책임자로 임명했습니다. Baumgartner 박사는 35년 이상의 규제, 임상 개발 및 의학 분야 경험을 보유하고 있으며, 12개의 성공적인 신약 신청 및 마케팅 허가를 이끌어낸 경력이 있습니다.
그는 경영진 리더십 팀의 일원으로서 Applied의 글로벌 규제 전략을 이끌며, 특히 govorestat에 대한 향후 규제 상호작용에 집중할 것입니다. 이번 임명 이전에는 Ovid Therapeutics에서 글로벌 규제 업무 부사장(2020-2024)을 역임했으며, Acorda Therapeutics, Purdue Pharma, AstraZeneca 및 Bristol-Myers Squibb에서 고위직을 맡았습니다.
Applied Therapeutics (Nasdaq: APLT) a nommé Todd F. Baumgartner, MD, MPH au poste de Directeur Réglementaire. Le Dr Baumgartner apporte plus de 35 ans d'expérience dans les rôles réglementaires, de développement clinique et d'affaires médicales, avec un bilan de 12 demandes de nouveaux médicaments et d'autorisations de mise sur le marché réussies.
En tant que membre de l'équipe de direction exécutive, il dirigera la stratégie réglementaire mondiale d'Applied, en se concentrant particulièrement sur les prochaines interactions réglementaires concernant le govorestat. Avant cette nomination, le Dr Baumgartner a été Vice-Président Senior des Affaires Réglementaires Mondiales chez Ovid Therapeutics (2020-2024) et a occupé des postes de direction chez Acorda Therapeutics, Purdue Pharma, AstraZeneca et Bristol-Myers Squibb.
Applied Therapeutics (Nasdaq: APLT) hat Todd F. Baumgartner, MD, MPH zum Chief Regulatory Officer ernannt. Dr. Baumgartner bringt über 35 Jahre Erfahrung in regulatorischen, klinischen Entwicklungs- und medizinischen Bereichen mit und hat 12 erfolgreiche Anträge auf neue Arzneimittel und Marktzulassungen geleitet.
Als Teil des Führungsteams wird er die globale Regulierungsstrategie von Applied leiten und sich insbesondere auf bevorstehende regulatorische Interaktionen bezüglich govorestat konzentrieren. Vor dieser Ernennung war Dr. Baumgartner Senior Vice President für globale Regulierungsangelegenheiten bei Ovid Therapeutics (2020-2024) und hatte leitende Positionen bei Acorda Therapeutics, Purdue Pharma, AstraZeneca und Bristol-Myers Squibb inne.
- Appointment of highly experienced regulatory executive with track record of 12 successful drug approvals
- Strategic strengthening of regulatory expertise ahead of govorestat regulatory interactions
- Executive brings extensive rare disease and regulatory affairs experience from major pharmaceutical companies
- None.
Dr. Baumgartner will advance Applied’s preparation for upcoming regulatory interactions
NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the appointment of Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer. Dr. Baumgartner will serve as part of the Company’s executive leadership team and will be responsible for leading Applied’s global regulatory strategy.
Dr. Baumgartner joins Applied as an accomplished global drug development leader with over 35 years of experience in senior regulatory, clinical development, and medical affairs roles. He has held a diverse set of leadership roles over the course of his career, notably leading a total of 12 New Drug Applications and marketing authorizations through their approvals.
“We are delighted to welcome Todd to Applied as we continue to prepare for regulatory interactions regarding govorestat,” said John H. Johnson, Executive Chairman of Applied Therapeutics. “We believe that Todd’s wealth of development experience and strong track record with regulators will be valuable to Applied as we remain committed to our mission of addressing the unmet needs of patients with rare diseases.”
“I have been passionate about advancing important medical breakthroughs through clinical and regulatory development throughout my career, and I am excited to join Applied at this important time,” said Dr. Baumgartner. “I look forward to working with the Applied team as we seek to advance govorestat for the potential treatment of rare diseases.”
Prior to joining Applied, Dr. Baumgartner served as Senior Vice President of Global Regulatory Affairs, Pharmacovigilance and Biometrics at Ovid Therapeutics from 2020 through 2024, where he oversaw multiple development functions for several pipeline programs, including Regulatory Affairs, Pharmacovigilance, Biometrics, Program Management and Quality Assurance, and served briefly as acting Chief Medical Officer. Prior to that, Dr. Baumgartner served as Senior Vice President of Regulatory Affairs at Acorda Therapeutics, where he led the Regulatory Affairs and Clinical Operations organizations, heading up the regulatory development and garnering regulatory marketing approvals in the US and Europe for Inbrija™ for Parkinson’s OFF episodes. Previously, he served as Chief Medical Officer of Purdue Pharma and, earlier in his career, held various leadership positions of increasing responsibility at AstraZeneca Pharmaceuticals and Bristol-Myers Squibb. Dr. Baumgartner obtained an MPH from the University of California-Berkeley, an MD from the University of Missouri-Columbia, and a BA from Duke University.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company committed to the development of novel drug candidates against validated molecular targets in rare diseases. The Company’s lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Classic Galactosemia, Sorbitol Dehydrogenase (SORD) Deficiency and PMM2-congenital disorder glycosylation (CDG).
To learn more, please visit www.appliedtherapeutics.com.
Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding the strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” “predicts” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
Contacts
Investors:
Maeve Conneighton / Andrew Vulis
(212) 600-1902 or
appliedtherapeutics@argotpartners.com
Media:
media@appliedtherapeutics.com
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