King of Prussia, Pennsylvania, United States
Pharmaceutical Development Leader • More than twenty-year career with consistent and measurable achievements in drug development, and a proven track record of innovation with patents, publications, successful files, and marketed products. • Experienced in leading multidisciplinary CMC technical teams across different modalities (small molecules and biologics), covering physical product design, development, and manufacture to support programs lifecycle plans and development phases utilizing both internal and external supply organizations. • Ability to think strategically and communicate options to governance bodies. Demonstrated technical leadership and project management skills through bringing late-phase projects from R&D to Global Manufacturing and commercial supply organizations. • Significant experience in enhancing and implementing Quality by Design (QbD) principles in Product Development, spanning all product types and product device combinations, including input materials, formulation and process design, process development, scale-up and commercialization of the manufacturing process. • Successfully managed projects through file and launch ensuring that appropriate structures, systems, and controls are fully utilized to manage the scope, time, cost, risks to quality and resource elements for each project. • Core technical competencies include extensive experience in QbD, risk assessment tools, late-stage development and tech transfer, and excellent understanding of the products regulatory path across various modalities and markets. • Experienced in regulatory interactions, preparing documentation in support of early clinical phases and in a marketing authorization regulatory filings and global post market activities. Specialties: • CMC matrix team leadership across modalities of small and large molecules • Drug product development and in depth understanding of oral solid, liquid, and sterile manufacturing • Significant experience and understanding of a wide variety of analytical techniques • Risk assessment facilitation and QbD strategies in support of QbD files • CMC Regulatory experience across clinical files through marketing authorization • Good understanding of statistical designs in support control strategy • DP Process development, scale up and tech transfer • Experience in CMOs/CROs management
A single point accountable leader of CMC global matrix teams across R&D and Pharma Supply Chain, to define and lead the global CMC development and industrialization strategy and plan for new medicines across small molecules and biologics. Within this period, had the experience to lead a number of late-stage assets through various key milestones (starting from Ph2), through pivotal studies (Retosiban, Gepotidacin, aIL33r, Depemokimab), and through file and launch (Jemperli (dostarlimab)). Led the definition and implementation of the global CMC development and industrialization strategy and plan for a medicine, aligning with the global medicine development strategy and plan, the needs of the patient, the commercial intent for the medicine, the overall business context and the regulatory, compliance and manufacturing network requirements Provided options for CMC delivery to align with the project objectives, with recommendations based on sound judgement on both short- and long-term implications (risks, costs, resources, and time) for the global lifecycle of the medicine Experience in leading people and cross-functional multi-disciplinary CMC matrix team (~10+ core team members from R&D and Pharma Supply Chain encompassing technical, quality, regulatory, supply chain and manufacturing; ~50+ extended team members) to develop and execute the CMC project plans to accomplish the project aligned objectives to time, budget and resource forecasts. Worked as the voice of CMC on the medicine development project teams to align the teams on the physical product and supply chain influenced the medicine development and commercialization strategies and plans, ensuring appropriately gated commitment to, and investment in, CMC activities.
CMC Technical Leader for Retosiban; accountable for the delivery of technical activities within Product Development through leadership of a cross functional matrix team to develop late-stage assets. o Acting as the link with GMS management to discuss and clearly articulate technical risks and associated mitigation plans o Liaising with Commercial to ensure that the Commercial Image for the product is defined. o Ensuring that an appropriate pack range is established for the product o Ensuring that an appropriate supply chain is established for commercial supply o Leading the Pre-Approval Inspection (PAI) preparation and representing the product history at PAI audits o Delivery of successful product launch from GMS or third party manufacturing sites US QbD lead: o Support the development of the strategic direction and implementation of QbD in PD, aligned to the external environment and GSK’s experience. o Supported the successful NDA/MAA submissions of Eltrombopag® PfOS and Dutasteride for Alopecia submission to Japan PMDA as an author and reviewer and expert in QbD files format and requirements. o Supported Cabotegravir® process design by leading a team to make a decision on equipment sourcing to technical risk assessment on the process design at GMS site. o Supported the daprodustat (GSK1278863 Tablet) team to develop the principles on working with continuous processing and ensuring product quality and state of control is well defined. o As a QbD and SME in DP development worked with key late-stage assets (Eltrombopag PfOS, Dutasteride for Asia, Cabotegravir oral/injection, daprodustat (GSK1278863 Tablet), GSK2140944 and Retosiban) o Led key QbD-focused teams for the development of generic sterile product technical risks. o As a certified risk facilitator, ensured the technical risk assessment process is conducted at the right points in development, and to the required standards, for US based projects
• Chair of the PD Formulation Strategy Team that helps create and implement new harmonized ways of working within the global PD organization and created compound development strategies that are effective and efficient in use of time, personnel, and budget. • Single point of accountability for project teams and a technical team leader for several key company assets and multidisciplinary Pharmaceutical Development Project Teams. • Quality by Design Lead and site Champion : Developed and evaluated manufacturing processes to support dosage form development utilizing QBD (Quality by Design) and DFM (design for manufacturing) principles. • Developed a novel formulation approach for a bio-enhanced LOVAZA® product that in-turn was evaluated and have shown superior efficacy in clinical studies with 12 – 15X fold increase in exposure (AUC). • Redesigned and optimized the LOVAZA® manufacturing process at a third party CMO by conducting the appropriate process understanding studies and risk assessments to ensure commercial process robustness. • Designed and implemented an innovative manufacturing process that significantly simplified the industrialization of second generation LOVAZA® product utilizing engineering principles and data simulation and by applying QBD principles to ensure process robustness. • Developed a new drug delivery system for an oral-to-topical delivery of a protein product (domain anti body dAb) in support of a Biopharm Discovery unit and drafted a roadmap for the program to enable the progress to clinical studies. • Facilitated the acquisition of another company’s PD actions into GSK and took over management of different CROs and CMOs and transferred all the clinical supply chain operations and development activities to GSK without interruption to any clinical studies or commercial supplies.
• Designed and performed studies on dosage formulation development for chemical entities to support discovery and clinical studies through PPQ batches and commercial batches, including scale-up strategies. • Led a project through approval and launch of Neurontin®ST (smaller tablet) for Japan market. (>90% drug load formulation) • Successfully led the tech transfer team to transfer the process to a Pfizer Japan facility which required the conversion of fluid bed dryer to a granulator using modeling data and process understanding. • Authored CMC file parts in support of regulatory filings (CTD) and supported the team in responses to regulatory authority questions. Involved in drafting of CMC section for several IND submissions. • Developed oral immediate release/controlled release formulations and fixed combination tablets for projects through Phase IIa,b. • Developed formulations using conventional and enabling technologies to support early preclinical and Phase I studies. Designed a self-emulsifying drug delivery system (SEDDS) to improve the absorption of a water insoluble compound and was able to significantly improve bioavailability. • Served as a lead formulator on pharmaceutical sciences project teams; contributed by leading sub-teams engaged in troubleshooting; worked as deputy of team leader/project manager when necessary. • Engaged as an active member of a global “science-of-scale” team responsible for developing process understanding and lead global efforts on fluid bed granulation. o Lead a global team to establish a “right first time” strategy for fluid bed granulation process. Developed predictive tools that helped scale up process parameters • Co-led a team responsible for evaluation of potential for use of Direct Compaction based on knowledge of material mechanical properties. • Formally supervised two scientists, and a post-doctoral research fellow. Provided guidance to several other scientists on various project activities and matrix teams.
• Worked as a lead formulator and drug product team leader for a project involving tablet dosage form of a high dose drug with poor mechanical properties. • Developed sustained release and enteric-coated pellets using fluid-bed rotor pelletization, extrusion/spherenization and aqueous polymer coating technologies. • Supported a team developing oral formulations for a low solubility drug using Hot-Melt Extrusion (solid dispersion) technology. Evaluated and developed solid matrix system to improve apparent solubility which resulted in more bioavailability. • Developed oral immediate release solid dosage forms and liquid filled soft-gelatin/hard-gelatin capsules for lipid-based formulations including self-emulsifying drug delivery systems (SEDDS). • Led global effort toward fluid bed granulation process understanding within Pfizer
I worked to as a lab technician for undergraduate program labs, graded exams and lectured undergraduate students in different subjects. As a research assistant worked on different industry contract projects where I gained experience on preformulation of different drugs, formulation of different dosage forms. Experience in solid dosage form design and unit processes including; optimized mixing process to ensure uniformity, evaluated granulation and direct compression methods, tested formulation flow properties and added excipients to improve tablet formulation for flow and evaluated final formulation performance