Marlborough, Massachusetts, United States
Ph.D. in inorganic chemistry/materials science with 20 years of experience in pharmaceutical industry Strategic leader with a background in physical, colloidal, and analytical chemistry, pre-formulation and formulation development, and nanomedicine. Expertise in small molecules, peptides, and RNA conjugates. Playing a key role in interdisciplinary discovery and drug development teams. Developed formulations for several leads and 2 compounds in Ph2/Ph3 stage. Innovative and creative scientist with analytical and critical thinking skills for data interpretation, information integration, and decision making. Relationship builder and mentor recognized for establishing and maintaining effective collaborations with internal and external stakeholders. Areas of strength include: Drug Delivery Systems Analytical Chemistry Discovery/ Formulation Development Process Development/ Form Selection Solid State Characterization Polymorph, Cocrystal, Salt Screening CRO/ Team Management IND/IMPD filing Coach/ Mentor Presentations/ Publications/ Patents
• Developed new CMC strategies for NCE and ATMP projects to accelerate drug development. • Collaborated with external partners to identify and execute non-traditional CMC strategies. • Achieved successful implementation of alternative CMC strategies resulting in streamlined drug development processes.
Results-driven consultant with in-depth analytical and formulation drug development leadership in small molecules and drug conjugates (peptides, proteins, ADCs, oligonucleotides), and various drug delivery systems (polymeric nanoparticles and self-assembled drug nanocarriers). Recognized for strength in managing and driving programs across technical and business needs. Key areas of expertise: • Drug development (discovery, clinical development, and commercialization) • Lead selection • CDMO Management • Analytical method transfer and validation • Analytical and process support for Manufacturing and Technical operations • Investigations/Deviation Systems and Management, CAPAs and root cause analysis • Specifications - drug substance (DS) and drug product (DP) • Drug delivery systems/Nanoparticles – formulation and physicochemical characterization • Regulatory filings (IND/BLA) • Solid state characterization/Form Selection & Control • Coaching/Mentoring
Leads analytical development activities across the Immunogen portfolio on monoclonal Antibody Drug Conjugates (ADCs) at all stages of development. Works closely with Immunogen process/bioprocess development, clinical, quality, regulatory teams, and external partners to ensure and support the progression of clinical programs and enable late-stage and commercial manufacturing.
• Managed development strategies and analytical activities for drug substance (DS) and drug product (DP). • Designed and managed GMP stability studies/trend analysis (DS and DP) at vendors to deliver clinical supplies. • Led Ph3/commercial formulation development strategies for PEN-866 (lyophilized Injectable DP) - prototype formulation patented – DP formulation composition evaluation ongoing. • Led Ph3/commercial formulation development strategies for PEN-221 (injectable frozen formulation) - four formulation prototypes selected – accelerated and long-term stability ongoing. • Evaluated and expanded the drug substance manufacturing capacity and provided technical support for new vendor. - approve validation protocols/reports, analytical IPC, release methods – new batch successfully manufactured/released. • Managed Specification Review Committee meetings and activities between CMC, Analytics, QA. - ensured FDA and ICH Regulations Compliance for specifications of starting materials, intermediates, DSs, and DPs. • Coordinated and successfully resolved Investigations and CAPAs. • Established and managed GMP Reference Standard (RS) program. • Built, mentored, and coached highly effective teams (2-3 members).
• Managed formulation, analytical, and quality control activities for two discovery programs for 5 years. - oversaw formulation development/dose verification for in vivo studies (PK, efficacy) at CROs and in-house. - supervised analytical method development, purity assessment, and screening for in vitro and in vivo testing. • Developed 2 prototypes (patented) and selected the clinical formulation for the first lead of Pentarin platform. - Routinely interfaced with internal key resources, CROs, consultants to manage manufacturing and analytical activities for multiple development batches and GMP batches. - Executed analytical method transfer and method validation at CROs. - Collaborated on drug product development strategies (clinical manufacturing and regulatory submissions). • Authored DS and key DP sections and assisted in FDA/MHRA submissions for two clinical candidates. • Led physicochemical characterization of API to support CMC activities (salt/polymorph screening and recrystallization process for DS manufacturing). - Identified crystalline forms, support manufacturing and implemented new storage requirements at CROs. • Built, mentored, and coached highly effective teams (2-5 members).
Developed and evaluated prototype formulation for Tarveda clinical candidate - phase 1/2a Managed a broad range of R&D activities and processes to support chemistry and in vitro/in vivo studies for two Tarveda’s platforms. Developed HPLC Methods: assay purity, physicochemical characterization (logP, particle size (DLS)), solubility/stability in organic & aqueous solvents, Developed formulations to support in vivo studies (in house and at CROs) - Screened compounds and different surfactants/emulsifiers to developed IV formulations - Provided stability data, solubility, PS, pH sensitivity, and freeze/thaw stability for key formulations. - Set up protocols for dose verification and ensured work is documented and reported Set up solubility/stability studies for Lead drug conjugates Led analytical development efforts for polymeric nanoparticle (NP) development for drug delivery - Developed analytical methods to test potency (encapsulation) and chemical stability of drug in NP - Identified and developed methods to screen and characterize NP (physical stability, freeze/thaw stability, drug encapsulation, drug release methods) - Designed studies and provided analytical support for NP development and characterization (solubility in solvents, stability, potency, composition, drug release methods based on dialysis and centrifugation) Led Physicochemical Characterization of Nanoparticles Team (members of analytical and formulation groups) - Defined the purpose, goals, and objectives for the team - Organized and facilitated meetings - Developed new techniques and strategies to accelerate NP formulation development and platform understanding (NP stability, free/encapsulated drug ratio, polymer/drug interaction, NP composition, drug release methods based on novel solid state extraction (ACE) method) Manadge direct report and consultant