Rapid Formulation Development Webinar Series – Hosted by FreeThink Technologies

26 March 2024, 3:00 PM GMT

Target Product Profiles

Jessica Kelly, FreeThink Technologies 

What you will learn: 

• The Target Product Profile (TPP) concept and its importance for clarifying objectives in the drug product development pipeline.
• Practical strategies for developing and maintaining an effective TPP throughout different development stages.
• How to leverage the TPP to speed decision-making and bring the drug product to market.

Jessica Kelly received her B.E. in Chemical Engineering from Stony Brook University, specializing in polymer engineering. Through her prior industry work, she gained expertise in the development of hydrogel and emulsion-based controlled release formulations. Since joining FreeThink Technologies in 2019, she has worked on developing diverse solid and liquid dosage formulations and has been an integral member of FreeThink’s proprietary osmotic capsule technology (OzmoCAP^®) development team. As a Senior Formulation Engineer, Ms. Kelly leads the development of formulations for customers. 

2 April 2024, 3:00 PM GMT

Solubilization Selection

Kenneth C. Waterman, Ph.D., FreeThink Technologies 

What you will learn: 

• The fundamental physical chemistry of drug solubility, its interplay with intestinal absorption and the role of different of mechanisms for solubilization.
• When particle size will improve drug absorption.
• The advantages of oil-based formulations including self-emulsifying dispersions.
• When amorphous solid dispersions (ASDs) are the right answer.
• Whether to use a spray dried (SDD) or hot melt dispersion (HME) for formation of an ASD.
• Stability of ASDs.

After receiving his B.S. (UCLA) and Ph.D. (UC Berkeley) in physical-organic chemistry, Dr. Waterman completed post-doctoral studies (Columbia University) in photochemistry. He spent 12 years at Polaroid (as a distinguished scientist) developing new imaging systems, then 13 years at Pfizer (as a Research Fellow) working in drug delivery, drug stability, biopharmaceutics, and prodrug development. In 2011, he founded FreeThink Technologies as both a laboratory and software company. He has successfully invented and commercialized a number of products and is the author of over 75 publications. 

9 April 2024, 3:00 PM GMT

Formulating for Stability

Maria Krisch, Ph.D., FreeThink Technologies 

What you will learn: 

• The advantages of using a tiered formulation approach combined with ASAPprime® for rapid and material sparing drug product development. 
• How a tiered formulation approach avoids common pitfalls associated with binary excipient compatibility studies. 
• Practical considerations for designing and executing a tiered formulation screen. 
• How to assess susceptibility towards oxidation and incorporate anti-oxidants into a screen. 

Dr. Krisch received her B.A. in chemistry from Swarthmore College and her Ph.D. in physical chemistry with a focus on molecular dynamics from the University of Chicago. She conducted post-doctoral research in physical chemistry at the University of California, Irvine, studying the surface structure and reactivity of liquids. Dr. Krisch served on the faculty and led a research group at Trinity College in Hartford, CT for eight years before joining FreeThink Technologies in 2017 where, as a Research Fellow in Physical Sciences, she is responsible for leading company projects focused on chemical and physical stability as well as training new users in ASAPprime® software. 

16 April 2025, 3:00 PM GMT 

Oral Controlled Release Formulations

Sheri Shamblin, Ph.D., Aleurites Consulting  

What you will learn: 

• Typical drivers for use of oral controlled release (CR) formulations. 
• An overview of standard oral CR technologies.  
• What CR technology is appropriate for your drug. 
• Tips and tools for formulation development and clinical evaluation. 

Dr. Sheri Shamblin received her B.A. in chemistry from the College of Wooster and her Ph.D. in pharmaceutical sciences from the University of Wisconsin-Madison and conducted post-doctoral research at Purdue University. She worked over twenty-five years at Pfizer and has extensive experience as a scientific leader in oral drug product development. Dr. Shamblin is a recognized expert in the development oral controlled release formulations and the use of enabling strategies to increase API solubility and in-vivo exposure. Throughout her industrial career, she has worked collaboratively with discovery and commercial asset teams to leverage drug delivery technologies (e.g., oral CR dosage forms, amorphous solid dispersions and multiparticulates) to achieve specific clinical objectives and bring new medicines to the market.

Moderated by Jennifer Chu, Ph.D., FreeThink Technologies 

Dr. Jennifer Chu received her B.S.E. (Princeton University) and Ph.D. (University of Texas, Austin) in chemical engineering performing research on polymer science. She previously worked at Pfizer and then several biotech and small pharmaceutical companies in formulation and process development. Prior to joining FreeThink  Technologies in 2018, she was Executive Director of Pharmaceutical Sciences for Achillion Pharmaceuticals. As head of Engineering and Formulation Sciences department she is responsible for leading formulation and new technology development at FreeThink.