Frank Casty, Md Facp Email and Phone Number
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Enterprise Physician Leader with extensive experience in large and mid cap global pharmaceutical companies across development, regulatory and medical affairs, business development and commercialization. Experience leading and executing successful drug development strategies in Rare Disease and multiple therapeutic areas including Pain, Respiratory, Cardiovascular, Lipid/Metabolism, Endocrinology, Oncology, Immunology and Critical Care. Track record of numerous regulatory interactions and filings from IND through NDA/MAA filings including having led key High Stakes Meetings such as FDA Advisory Committee meetings and Scientific Advice proceedings. Experience setting Medical Affairs strategies as well as launch and commercialization experience.Recognized for developing talent and high performing teams in a manner that maximizes value for the individual's development and for business outcomes. Experience leading through organizational change, developing new capabilities and working cross-functionally on complex business issues.Known for strong communication skills across a variety of audiences including press, scientific and business community, including public presentations and trade interviews. Recognized for identifying business development opportunities combining both technical and business perspectives. Currently serves as company advisor / mentor at Delaware Innovation Space providing startup companies with funds, mentoring and advisory support. Have served on other industry, academic and journal Boards. Open to Board positions.Email: frank.casty@gmail.com
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Advisory Board MemberMiist Therapeutics Feb 2023 - PresentMiist Therapeutics is a clinical stage pharmaceutical company focused on smoking cessation treatments by leveraging novel inhalation technology.
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Executive Vice President, Head Of Global R&D And Chief Medical OfficerMayne Pharma Jan 2023 - PresentSalisbury South, Sa, AuGlobal responsibility for Clinical, Regulatory and Medical Affairs, Quality and Pharmacovigilance. Our therapeutic areas of focus include Dermatology, ID and Women's Health. -
PrincipalLong Meadow Consulting Inc. Jan 2019 - Present
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Chief Medical OfficerOncoone Jun 2022 - Dec 2022Vienna, Austria, AtConsultant Interim CMO role -
Svp Head Of Drug And Device DevelopmentMallinckrodt Pharmaceuticals 2020 - 2021Dublin, Ireland, IeAccountable for all drug and device development across rare disease segments, critical care, hepatology, and burn therapeutics. Led clinical drug development, biostatistics, and operations organizations. Responsible for engineering technical reviews, planning, and operations. • Implemented organizational improvements, including a streamlined outsourcing model for drug development.• Benchmarked device organization and implemented organizational as well as strategic operational improvements. -
Senior Clinical Regulatory ConsultantNda Group Ab 2020 - 2020Upplands Väsby, Sweden, SeProvided full-time regulatory and clinical consultation services for rare disease, oncology, COVID therapeutics, and other therapeutic areas, with focus on regulatory submission reviews and key regulatory meeting strategies. • Provided clinical and regulatory strategic guidance for FDA Advisory Committee meeting preparations.• Supported products across multiple therapeutic areas, including Renal/Cardiovascular/Oncology.• Worked with a broad range of companies, from small to large cap companies.• Provided strategic review of briefing books, pre-IND and IND documentation, and NDA documents. -
Svp Head Global Medical Affairs, Product Safety And Risk ManagmentMylan 2014 - 2019Canonsburg, Pennsylvania, UsLed global team of approximately 500 providing medical and product safety support across branded, biosimilar, generic, and OTC products in NA, Europe, and Asia/emerging markets. Member of president’s operations leadership and performance management teams. Established global medical affairs department, including relevant policies, SOPs, and practices across NA, European, and emerging markets. Led biosimilar strategies for oncology and inflammation TA for Trastuzumab, Pegfilgrastim, Bevacizumab, Adalimumab, and Etanercept. Oversaw key therapeutic areas, including multiple sclerosis, oncology, respiratory, inflammation, women’s health, and HIV/hepatitis.• Performed due diligence and integrated acquired branded product businesses (Abbott European business, Meda, others), comprising approximately 50% of company portfolio.• Served as member of joint steering committee for joint venture product development with respiratory biotech company.• Led significant remediation efforts across global product safety organization in response to inspection findings. • Spearheaded inspection readiness plans globally and at country level (35 audits annually plus global health authority inspections).• Directed as medically responsible person for corporate support of quality issues, recalls, litigation, FDA, and other external communications. -
Head, Global Clinical Development Critical CareNovartis 2013 - 2014Basel, Baselstadt, ChLeadership across cardiovascular, metabolism, lipid, and cystic fibrosis therapeutic areas. Chair for franchise R&D review committee responsible for cross-functional critical document, data reviews, and FDA advisory committee preparations. Developed integrated, cross-functional business development strategies and performed due diligence and portfolio assessments of targeted assets. Served as R&D interface for commercial, regulatory, and global medical affairs alignment. • Improved employee engagement, talent management, and cross-functional collaboration.• Chaired franchise R&D committee responsible for top-line data reviews, study design, and drug development plans. -
Svp Chief Medical OfficerEndo Pharmaceuticals 2011 - 2013Malvern, Pa, UsProvided leadership across clinical development, medical affairs, biostatistics, drug safety, health economics, and medical communications covering rare disease, oncology, and pain portfolios. Oversaw key products including Valrubicin, Darolutamide, Histrelin, Testosterone, Octreotide, Lidoderm, and Opana. Led as responsible medical officer for corporate business units including branded, generics, and devices.• Developed payer-focused strategies, partnering field-based medical and health economic staff with commercial.• Led successful FDA Advisory Committee – joint meeting of reproductive health and safety/risk management. -
Vp, U.S. External Medical AffairsAstrazeneca 2009 - 2011Cambridge, Cambridgeshire, GbAccountable for leadership of US Health Economics, Medical Policy, Medical Education Grants and 26 strategic R&D alliances. -
Vice President, Head R&D Technical Evaluation, Business DevelopmentAstrazeneca 2009 - 2011Cambridge, Cambridgeshire, GbAccountable for 29 strategic R&D alliances, health economics, and medical policy. Established strategies focused on payers, managed markets, and collaborative R&D alliances. Appointed to Effective Health Care Program, Agency for Healthcare Research and Quality (AHRQ). Co-chaired Critical Path Institute committee, public-private R&D partnership for Alzheimer’s research. Completed two-product licensing deal, valued at up to $1.5 billion, with NEKTAR Therapeutics. Nominated for President’s Excellence Award.
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Vp, Global Medical Sciences, Global Clinical DevelopmentAstrazeneca 2007 - 2009Cambridge, Cambridgeshire, GbChaired global leadership of clinical research in oncology/infection, CV/metabolism, respiratory/inflammation, CNS therapeutic areas, discovery medicine, clinical pharmacology/PK, Clinical Pharmacology Unit (CPU), health economics, and medical education (600 staff). Led senior research review committees to review protocols and project progress and developed new capabilities to improve efficiency of drug development. Responsible for talent development and succession planning. Developed strategic assessment of global clinical pharmacology and CPUs, resulting in significant efficiencies.
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Vp, U.S. Strategic Drug DevelopmentAstrazeneca 2005 - 2007Cambridge, Cambridgeshire, GbAccountable for US Clinical Research and Medical Affairs activities (Phase 1-4). Leadership of 16 senior drug development team leaders across portfolio with clinical budget in excess of $150 million. Represented R&D on US Business Leadership Team responsible for P&L.
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Executive Director, U.S. Strategic Development, Emerging Products LeaderAstrazeneca 2003 - 2005Cambridge, Cambridgeshire, GbAccountable for 5 senior drug development team leaders of Phase 1 and 2 products across portfolio of CV/GI, Respiratory/Inflammation, CNS, Oncology/Infection. Established new AZ operating model focused on delivering an integrated US commercial and development strategy to business.
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Executive Director And Us Medical Leader, Respiratory / InflammationAstrazeneca 1999 - 2003Cambridge, Cambridgeshire, GbClinical Leader accountable for strategies and submissions across all phases of development. Led numerous FDA interactions including Pre-IND, End of Phase 2 and pre-NDA meetings.
Frank Casty, Md Facp Skills
Frank Casty, Md Facp Education Details
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The Robert Larner, M.D. College Of Medicine At The University Of VermontPulmonary / Critical Care Medicine -
Rush UniversityInternal Medicine Residency Program
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Temple University - Lewis Katz School Of MedicineDoctor Of Medicine - Md
Frequently Asked Questions about Frank Casty, Md Facp
What company does Frank Casty, Md Facp work for?
Frank Casty, Md Facp works for Miist Therapeutics
What is Frank Casty, Md Facp's role at the current company?
Frank Casty, Md Facp's current role is Executive Vice President, Head of R&D at Mayne Pharmaceuticals.
What is Frank Casty, Md Facp's email address?
Frank Casty, Md Facp's email address is ca****@****zon.net
What is Frank Casty, Md Facp's direct phone number?
Frank Casty, Md Facp's direct phone number is +1 724-514*****
What schools did Frank Casty, Md Facp attend?
Frank Casty, Md Facp attended The Robert Larner, M.d. College Of Medicine At The University Of Vermont, Rush University, Temple University - Lewis Katz School Of Medicine.
What skills is Frank Casty, Md Facp known for?
Frank Casty, Md Facp has skills like Clinical Development, Drug Development, Clinical Trials, Medical Affairs, Pharmacovigilance, Clinical Research, Pharmaceutical Industry, Fda, Cross Functional Team Leadership, Biotechnology, Oncology, Clinical Pharmacology.
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