Michelle Howard Sparks, Phd Email and Phone Number
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Pharmaceutical Executive with 25 years of experience in global R&D Leadership, spanning Preclinical Development through Commercial/Technical Operations under both virtual and non-virtual business models. Proven success in the development of 5 commercial products, serving on the launch team of 2 commercial products. Experience in cross functional leadership, alliance management, asset valuation, expansion of patent portfolio and CMO management. Experience in large pharma, extensive experience in pharma/biotech start ups in virtual and non-virtual environments. Therapeutic areas: Ocular/Ophthalmology, Metabolic Disease, Oncology, HIV and Pain ManagementSpecialties: *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*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*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 and use of Consultants as virtual employees
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President And FounderMichelle Howard-Sparks, LlcNewton, Ma, Us
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MemberChief Feb 2021 - PresentNew York, Ny, UsChief is a private network built to drive more women into positions of power and keep them there. Chief is the only organization specifically designed for senior women leaders to strengthen their leadership journey, cross-pollinate ideas across industries, and effect change from the top-down.
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Vice President, Product DevelopmentEyepoint Pharmaceuticals Aug 2019 - PresentLead R&D Groups relating to Formulation, Device Design and Preclinical strategy. -
Head Of Product DevelopmentZafgen, Inc. Jan 2014 - Aug 2019CMC lead responsible for development, manufacturing and supply/sourcing of all drug product, device and clinical trial components in preparation for approval and commercialization. Progressing NCE candidates (oral and parenteral) from nomination through commercial readiness. Provided strategic CMC input and corporate growth strategy from IPO to commercial launch planning. Worked closely with Quality to build Quality Systems for Combination Drug-Device development. Worked closely with Regulatory Affairs to support CMC related FDA, EMA and MHRA filings and interactions for Orphan Drug indication.
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Board MemberBritest Jan 2011 - 2016Daresbury, Cheshire, Gb -
Associate Director, Pharmaceutical SciencesMillennium Pharmaceuticals Mar 2010 - Jan 2014Cambridge, Ma, UsLead Formulation Group within the Pharmaceutical Technology Research and Development Lab Division, including a staff of 14 formulation development scientists in the development of oncology products. Responsible for ensuring departmental direction, achievement of goals and HR needs. Lead efforts toward the integration of global systems within CMC functions across Oncology, Immunology and Respiratory Therapeutic Areas. Served as Global CMC Lead for Oncology based therapeutic area. Responsible for maintaining business relationships with key CMO partners. Responsible for departmental budget, FTE resource planning, and progression of discovery candidates from First in Man through Phase III dosage form development, validation and commercialization. -
Director, Pharmaceutical DevelopmentInternational Partnership For Microbicides Mar 2008 - Mar 2010Silver Spring, Md, UsLead strategic and operational planning for global drug development efforts, including oversight of drug substance, drug product, pre-clinical testing, formulations and manufacturing. -
Associate Director, Pharmaceutical DevelopmentEndo Pharmaceuticals Jul 2006 - Mar 2008Malvern, Pa, UsCMC product lead responsible for all stages of NDA formulation and analytical development through validation. Authored, reviewed and created strategic direction within the CMC component of NDA regulatory submissions. Managed development activities with key partners organizations. Created NDA development plans. -
Manager, Technical OperationsEndo Pharmaceuticals Feb 2003 - Jun 2006Malvern, Pa, UsSelected and managed tech transfer R&D and commercial products between domestic and international manufacturing sites. Managed budgets, timelines and development activities with key partner organizations to ensure no commercial supply interruptions. CMC product lead on Phase III development projects and commercial products. Authored CMC sections. Responsible for staff mentoring and development. Created Cost of Goods and ROI analysis for portfolio valuations.
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Sr Scientist, Pharmaceutical DevelopmentEndo Pharmaceuticals Sep 1999 - Jan 2003Malvern, Pa, UsTechnical team leader responsible for pre-formulation, formulation, and process development of Schedule II narcotics. Lead tech transfer of NDA products to Phase I/II CMO. Managed pre-clinical and clinical supplies.
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Sales RepSouthwestern Company Jun 1989 - Aug 1992Nashville, Tn, Us
Michelle Howard Sparks, Phd Skills
Michelle Howard Sparks, Phd Education Details
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University Of KentuckyMedicinal Chemistry -
University Of KentuckyBiology
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Western Kentucky UniversityPre-Professional
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Apollo High School
Frequently Asked Questions about Michelle Howard Sparks, Phd
What company does Michelle Howard Sparks, Phd work for?
Michelle Howard Sparks, Phd works for Michelle Howard-Sparks, Llc
What is Michelle Howard Sparks, Phd's role at the current company?
Michelle Howard Sparks, Phd's current role is President and Founder.
What is Michelle Howard Sparks, Phd's email address?
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What is Michelle Howard Sparks, Phd's direct phone number?
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What schools did Michelle Howard Sparks, Phd attend?
Michelle Howard Sparks, Phd attended University Of Kentucky, University Of Kentucky, Western Kentucky University, Apollo High School.
What skills is Michelle Howard Sparks, Phd known for?
Michelle Howard Sparks, Phd has skills like Drug Development, Technology Transfer, Formulation, Pharmaceutical Industry, Validation, Management, Clinical Trials, Gmp, Regulatory Submissions, Biotechnology, Fda, R&d.
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