Disc Medicine Expands Leadership Team with Appointment of Industry Veteran Steve Caffé, MD as Chief Regulatory Officer
Disc Medicine (NASDAQ:IRON) has appointed Steve Caffé, MD as Chief Regulatory Officer. Dr. Caffé brings over 25 years of experience in global product development and regulatory affairs, with expertise in hematology, oncology, and rare diseases. He previously served as Head of Regulatory Affairs at CRISPR Therapeutics, contributing to the approval of Casgevy® for sickle cell disease and beta thalassemia.
Dr. Caffé's appointment comes at a important time for Disc Medicine as it transitions to a late-stage hematology company. His extensive experience, including contributions to over 40 new drug approvals worldwide, is expected to be valuable as Disc prepares for significant trial initiations across its portfolio in the coming year.
As part of his appointment, Dr. Caffé received an inducement equity award, including stock options and restricted stock units, subject to vesting conditions.
Disc Medicine (NASDAQ:IRON) ha nominato Steve Caffé, MD come Chief Regulatory Officer. Il Dr. Caffé porta oltre 25 anni di esperienza nello sviluppo di prodotti globali e negli affari regolatori, con competenze in ematologia, oncologia e malattie rare. In precedenza ha ricoperto il ruolo di Responsabile degli Affari Regolatori presso CRISPR Therapeutics, contribuendo all'approvazione di Casgevy® per la malattia falciforme e la beta talassemia.
La nomina del Dr. Caffé avviene in un momento importante per Disc Medicine, che si sta trasformando in una compagnia di ematologia in fase avanzata. La sua vasta esperienza, che include contributi a oltre 40 approvazioni di nuovi farmaci a livello mondiale, si prevede sarà preziosa mentre Disc si prepara ad avviare prove significative nel prossimo anno.
Come parte della sua nomina, il Dr. Caffé ha ricevuto un premio di equity di induzione, comprendente opzioni su azioni e unità di azioni vincolate, soggette a condizioni di maturazione.
Disc Medicine (NASDAQ:IRON) ha nombrado a Steve Caffé, MD como Director Regulador. El Dr. Caffé aporta más de 25 años de experiencia en el desarrollo de productos globales y asuntos regulatorios, con especialización en hematología, oncología y enfermedades raras. Anteriormente, se desempeñó como Jefe de Asuntos Regulatorios en CRISPR Therapeutics, contribuyendo a la aprobación de Casgevy® para la enfermedad de células falciformes y la beta talasemia.
El nombramiento del Dr. Caffé llega en un momento importante para Disc Medicine, ya que está en proceso de transición a una compañía de hematología en etapa avanzada. Se espera que su amplia experiencia, que incluye contribuciones a más de 40 aprobaciones de nuevos medicamentos a nivel mundial, sea valiosa mientras Disc se prepara para iniciar ensayos significativos en su cartera durante el próximo año.
Como parte de su nombramiento, el Dr. Caffé recibió una compensación en forma de capital, que incluye opciones sobre acciones y unidades de acciones restringidas, sujetas a condiciones de adquisición.
Disc Medicine (NASDAQ:IRON)은 Steve Caffé, MD를 최고 규제 책임자로 임명했습니다. Caffé 박사는 25년 이상의 글로벌 제품 개발 및 규제 업무 경험을 보유하고 있으며, 혈액학, 종양학 및 희귀 질환에 대한 전문 지식을 갖추고 있습니다. 그는 이전에 CRISPR Therapeutics의 규제 업무 책임자로 재직하며, 겸형 적혈구병 및 베타 지중해빈혈 치료를 위한 Casgevy® 승인에 기여했습니다.
Caffé 박사의 임명은 Disc Medicine이 후기에 진입하는 혈액학 회사로 전환하는 중요한 시기에 이루어졌습니다. 그의 방대한 경험은 전 세계적으로 40개 이상의 신약 승인에 기여한 이력이 있어, Disc가 내년 중에 포트폴리오 전반에 걸쳐 중요한 시험을 시작하는 데 있어 매우 유용할 것으로 기대됩니다.
임명 일환으로 Caffé 박사는 주식 옵션 및 제한 주식 단위를 포함한 유도 자본 보상을 받았으며, 이는 조건에 따라 발효됩니다.
Disc Medicine (NASDAQ:IRON) a nommé Steve Caffé, MD au poste de Chief Regulatory Officer. Dr. Caffé apporte plus de 25 ans d'expérience dans le développement de produits mondiaux et les affaires réglementaires, avec une expertise en hématologie, oncologie et maladies rares. Auparavant, il a occupé le poste de Responsable des affaires réglementaires chez CRISPR Therapeutics, contribuant à l'approbation de Casgevy® pour la drépanocytose et la bêta-thalassémie.
La nomination du Dr. Caffé intervient à un moment important pour Disc Medicine, qui se transforme en entreprise d'hématologie de stade avancé. Son expérience extensive, y compris sa contribution à plus de 40 nouvelles approbations de médicaments dans le monde, devrait être précieuse alors que Disc se prépare à des lancements d'essais significatifs dans son portefeuille au cours de l'année à venir.
Dans le cadre de sa nomination, le Dr. Caffé a reçu une prime en actions d'incitation, comprenant des options d'achat d'actions et des actions restreintes, soumises à des conditions d'acquisition.
Disc Medicine (NASDAQ:IRON) hat Steve Caffé, MD zum Chief Regulatory Officer ernannt. Dr. Caffé bringt über 25 Jahre Erfahrung in der globalen Produktentwicklung und im regulatorischen Bereich mit, mit Fachwissen in Hämatologie, Onkologie und selteneren Erkrankungen. Zuvor war er Leiter der Abteilung für regulatorische Angelegenheiten bei CRISPR Therapeutics und trug zur Genehmigung von Casgevy® für die Sichelzellenanämie und Beta-Thalassämie bei.
Die Ernennung von Dr. Caffé erfolgt zu einem wichtigen Zeitpunkt für Disc Medicine, da das Unternehmen sich zu einer fortgeschrittenen Hämatologie-Unternehmung entwickelt. Seine umfangreiche Erfahrung, einschließlich der Beiträge zu über 40 neuen Arzneimittelzulassungen weltweit, wird voraussichtlich von großem Wert sein, während Disc sich auf bedeutende Studieninitiativen in seinem Portfolio im kommenden Jahr vorbereitet.
Im Rahmen seiner Ernennung erhielt Dr. Caffé eine Anreizaktie, einschließlich Aktienoptionen und eingeschränkter Aktien, die an Vesting-Bedingungen geknüpft sind.
- Appointment of highly experienced Chief Regulatory Officer with 25+ years of expertise
- Dr. Caffé's track record includes contributions to over 40 new drug approvals worldwide
- Timing aligns with Disc Medicine's transition to a late-stage hematology company
- Strengthens leadership team for upcoming significant trial initiations across the portfolio
- None.
Dr. Steve Caffé is an accomplished industry executive with over 25 years of expertise in global product development and regulatory affairs
WATERTOWN, Mass., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced the appointment of Steve Caffé, MD as the company’s Chief Regulatory Officer. Dr. Caffé is an experienced biotech executive with significant expertise in global regulatory leadership across a wide range of therapeutic areas, including hematology, oncology, and rare diseases.
“We are excited to welcome an executive as accomplished as Steve to Disc, where his depth of regulatory expertise and experience in global product development will be integral to the company’s growth,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “Steve’s track record of successful drug approvals across multiple disease areas and geographies will be a significant advantage for Disc as we move into the later stages of development across our portfolio.”
“I am excited to be joining Disc at this pivotal moment in the company’s transition to a late-stage hematology company,” said Dr. Caffé. “With significant trial initiations coming in the next year for all three pipeline programs, I look forward to leading global regulatory interactions to support Disc’s mission of delivering novel treatments to patients with high unmet need. I am excited to work with the talented team at Disc and build on the excellent work done to date.”
Dr. Caffé has more than 25 years of experience in global product development and regulatory affairs, having held senior leadership positions at several top biotechnology companies. Most recently, he served as Head of Regulatory Affairs at CRISPR Therapeutics where he was involved in the development and approval of Casgevy® (exagamglogene autotemcel) for sickle cell disease and beta thalassemia. Prior to joining CRISPR, Dr Caffé was the Senior Vice President leading Regulatory Affairs, Pharmacovigilance, Quality, and Patient Advocacy at Ra Pharmaceuticals. Before this, Dr. Caffé held senior-level regulatory positions at a number of other biopharmaceutical companies, including Sucampo Pharmaceuticals, AMAG Pharmaceuticals, MedImmune (Biologics Division of AstraZeneca), Baxter, Sanofi-Aventis and Merck. Across these experiences, Dr. Caffé has contributed to over 40 new drug approvals and major new indications worldwide in a wide range of therapeutic areas. Steve received his M.D. at the Université Pierre et Marie Curie in Paris, France.
In connection with Dr. Caffé’s appointment, on September 16, 2024, Disc granted to Dr. Caffé an inducement equity award outside of Disc’s Amended and Restated 2021 Stock Option and Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4), comprised of (i) an option to purchase 55,000 shares (the “Option Award”) of Disc’s common stock (“Common Stock”), at an exercise price equal to the closing price of the Common Stock on the date of grant, and (ii) a restricted stock unit award for 36,666 shares of Common Stock (the “RSU Award” and, together with the Option Award, the “Inducement Award”). The Option Award shall vest
About Disc Medicine
Disc Medicine (NASDAQ:IRON) is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. For more information, please visit www.discmedicine.com.
Disc Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Disc’s expectations with respect to the chief regulatory officer position, upcoming trial initiations in the next year, and Disc’s clinical development plans and related regulatory interactions. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “look forward,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” or the negative of these terms and other similar words or expressions that are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Disc’s current beliefs, expectations and assumptions regarding the future of Disc’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Disc may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and investors should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of a number of material risks and uncertainties including but not limited to: Disc’s expectations regarding the chief regulatory officer position; Disc’s expectations regarding leadership and future growth; Disc’s expectations regarding its research and development programs; Disc’s expectations of entering late-stage development; and the other risks and uncertainties described in Disc’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2023, and in subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement speaks only as of the date on which it was made. None of Disc, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law.
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