Gautam Dalwadi
Senior Director @Prelude Therapeutics
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WORK HISTORY
Senior Director @Prelude Therapeutics
US
Led the end-to-end strategy, development, and clinical manufacturing of first- and best-in-class precision oncology molecules, advancing programs from discovery through IND-enabling studies to clinical trials. Enabled efficient CMC execution to cost-effectively transition oral and injectable molecules into the clinic.CMC & Formulation Expertise: Solved solubility/permeability challenges via polymorph/salt selection and formulation strategies, including roller compaction, dry blending, spray drying, HME, and nanomilling to enhance bioavailability and preclinical-to-clinic translation.Advanced Drug Delivery: Led feasibility studies for long-acting injectable protein degraders using LNPs, nanosuspensions, and microspheres, achieving extended SC/IV PK/PD profiles.Manufacturing & Tech Transfer: Successfully scaled up and transferred a 75 kg lyophilized injectable for Phase II between CDMOs.Biologics & ADC Development: Guided end-to-end formulation planning for ADCs from candidate selection through Phase I, collaborating across internal and external functions.CRO/CDMO Network Leadership: Built and managed a global network of 6+ University Collaboration, CROs/CDMOs, overseeing CDAs, MSAs, RFPs, SoWs, and delivery of oral and complex parenteral drug products.Device & Technology Due Diligence: Acted as SME for novel parenteral platforms including high-concentration nanosuspensions, Halozyme-enabled SC delivery, infusion pumps, and device compatibility.Regulatory Expertise: Authored and reviewed CMC sections of IND/IMPDs for FDA and EMA; led creation of batch records, tech reports, and quality documentation with Regulatory and QA.Cross-Functional & Regulatory Engagement: Represented Tech Ops in cross-functional and regulatory meetings, aligning development, quality, supply chain, and clinical execution.Strategic Budget Ownership: Managed technical operations budgets in coordination with Finance and Legal, ensuring efficient resource use and risk mitigation.
EDUCATION
Sardar Patel University
Bachelor of Pharmacy - BPharm
Curtin University
Doctor of Philosophy - PhD
The University of Kansas
Post Doctoral Researcher
Curtin University
Master in Pharmacy
ABOUT GAUTAM DALWADI
Novel drug delivery and formulation leader supporting private, public, and academic…
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