Constructing a Pharma Development & Manufacturing Project Plan: Steps to Evaluate Risk & Find Efficiencies

There are a variety of reasons why companies want to accelerate pharma development & manufacturing timelines: to produce drug products for a clinical trial, make products for compassionate use, or meet a management commitment to serve patients, etc. While the primary motivating factor may differ from company to company, each organization needs to balance the pressures of timeline objectives with the avoidance of risks that can affect the future of the program.

This webinar will recommend strategies to efficiently execute pharma development & manufacturing programs. The speakers will discuss a real-life example about how appropriate planning and judicious risk assessment favorably impacted a project timeline for a virtual pharmaceutical company. The speakers will share the successful tactics that shortened the project by performing tasks in parallel, allowing the client to maintain their commitments to their stakeholders. They will also identify what risks to the timeline should be avoided.

In this webinar, the speakers will:

• Present a general approach to layout a pharmaceutical development & manufacturing timeline and project plan
• Assess implications of the critical features of a drug product
• Discuss how to evaluate the risk of each step and identify opportunities to accelerate the project
• Examine how to approach adjustments when everything does not go as planned

Register for this webinar to learn about constructing a pharma development & manufacturing project plan with steps to evaluate risk & find efficiencies.

Speakers

Justin Lacombe, PhD, Chief Scientific Officer, Experic LLC

Justin Lacombe, PhD is Chief Scientific Officer at Experic. Justin leads the pharmaceutical development and engineering teams to provide expertise, insights and practical solutions that address many of the technical challenges that pharmaceutical companies encounter during drug and combination product development.

Justin’s focus is on robust scale-up and process development using Quality by Design and design controls principles. He has specialized expertise in manufacturing, combining small-volume powder dosing technology for powders with complex rheology, primary packaging development and formulation optimization. Based on his diverse experience, Justin has been a proponent of conducting powder filling studies earlier in the development process to avoid late-stage delays when scaling manufacturing processes to clinical and commercial quantities.

In previous roles, Justin was deeply involved in the development of inhaled pharmaceutical products, initially on metered dose inhalers at Catalent Pharma Solutions, and more recently and extensively on dry-powder inhalation products as Senior Manager, R&D, at Teva, from particle engineering to fill and finish. Justin earned his MS and PhD in chemical engineering from Rutgers University and has presented extensively on topics of manufacturing drug product interaction, process development optimization and drug-device combination products.

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Bruhal Shah, PhD, Director of Formulation, Experic, LLC

Bruhal Shah, PhD oversees formulation and process development activities at Experic and provides scientific leadership to client projects. With more than 10 years of diverse research experience in the pharmaceutical and biopharmaceutical fields, Bruhal has managed early- to late-phase development of clinical trial materials (CTM) and commercialization projects including the development of robust drug delivery systems with conventional and non-conventional technologies.

Bruhal’s focus is on pre-formulation, formulation/process development and optimization using a Quality by Design (QbD) approach. He has specialized expertise in the development and manufacturing of oral formulations (solid and liquid) and semi-solid dosage forms. He has worked extensively on various technology platforms to improve solubility of poor water-soluble drugs.

Prior to joining Experic, Bruhal held R&D scientific roles for Cambrex (formerly Halo Pharmaceutical). Bruhal received his PhD in pharmaceutics and drug design, and MS in pharmacology and toxicology from Long Island University (Brooklyn, NY). He has primarily presented on topics of solubility improvement strategies for poorly soluble molecules, drug delivery approaches for pediatric formulation development and Design of Experiments (DoE) approach during scale up activities.

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