Michelle Howard Sparks
Senior Vice President, Product Development Elion TherapeuticsPharmaceutical Executive | Sr Consultant | CMC, Drug Delivery and Biopharmaceutics | Hands-on, flexible and risk-based approach to drug development
- Role
- Senior Vice President of Product Development at Elion Therapeutics
- Location
- Newton Centre, MA, US
- LinkedIn followers
- 500 followers
About Michelle Howard Sparks
Biotech Executive with 25 years of experience in global R&D CMC Leadership, spanning Preclinical Development through Commercial/Technical Operations under both in-house and outsourced business models. Proven success in the development of 5 commercial products, serving on the launch team of 2 commercial products. Experience authoring Module 3 (drug substance and drug product) and Module 2 (nonclinical) regulatory submissions, alliance management, asset valuation, expansion of patent portfolio and CMO management. Experience with large pharma, preference for biotech start-ups. Therapeutic areas: Ocular/Ophthalmology, Metabolic Disease, NASH/MASH, Oncology, HIV and Pain ManagementSpecialties: Small Molecule*Complex Formulation Development: Sterile implants and injectables, solid oral controlled release, semi-solids, inhalation, transdermal, controlled release vaginal rings, films, gels, soft gel caps and quick-dissolve tablets.*Biopharmaceutics and dosage form design for complex formulations.*Combination Drug Product/Device development for sterile injectables.*Global Phase 1 CMC/Clinical strategies for accelerating first-in-man studies in Australia and EU, extemporaneous compounding.*Polymer experience with Silicone, PU, PVA and EVA for controlled release applications and long duration implants.*Technical Operations: GMP manufacturing of sterile products, 21 CFR 820/210, ASTM, ANSI/AAMI/ISO, ICH.*Virtual Business Model: Selection and Management of CMO\'s/CRO\'s.
Experience
Senior Vice President of Product Development
Oct 2025 — Present
Education
University of Kentucky
Bachelor of Science (BS), Biology
1990 — 1993
Western Kentucky University
Pre-Professional
1986 — 1988
University of Kentucky
Doctor of Philosophy (PhD), Pharmaceutical Sciences, Medicinal Chemistry
1994 — 1999
Skills
- Edc
- Gmp
- Biotechnology
- Research and Development (R&D)
- Quality by Design
- Team Leadership
- Management
- Neurology
- Drug Delivery
- Corrective and Preventive Action (Capa)
- Drug Development
- Technology Transfer
- Analysis
- Glp
- Regulatory Submissions
- Pharmaceutical Industry
- Fda
- Oncology
- Validation
- Pharmaceutics
- Drug Discovery
- Capa
- Clinical Trials
- R&D
- Formulation
- Analytical Chemistry
- U.s. Food and Drug Administration (Fda)
- Quality Assurance
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