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BIOCOM Seminar | Are You Setting Your Molecule Up for Clinical Success?

Are You Setting Your Molecule Up for Clinical Success? 
How to Efficiently Bridge from First-in-Human Formulations to Scalable Dosage Forms for Proof-of-Concept Patient Trials

Cost, time, quality and dose flexibility are key considerations when developing first-in-human (FIH) dosage forms. Very often a simple pharmacy preparation may be sufficient to meet the requirements for Phase I clinical studies, but such products are likely to be unsuitable for Phase II patient trials which may take place at multiple clinical sites, in different countries and extend over a long period of time. Costly delays and budget overruns during product development and scale up can be prevented by carefully planning and integrating development activities and technology consideration from the outset. How do you develop a formulation that will be suitable for preclinical and FIH testing? How can you bridge from pharmacy preparations to GMP solid oral dosage forms that will be robust and scalable? How can you avoid common development pitfalls and ensure future success? 

Quotient Sciences and Catalent Pharma Solutions, two leading drug development and manufacturing organizations, are coming together to share their expertise on phase appropriate formulation strategies and selecting the best technologies that will successfully transition your molecule into FIH clinical trials and then on through to your POC milestone and beyond.

Key considerations and strategies that will be covered include:

  • Strategies on how to develop a phase-appropriate formulation
  • Bridging drug products from preclinical to first-in-human and scaling for your POC trials
  • Integrating pharmaceutical sciences & clinical testing to accelerate drug product development and reduces costs
  • Assessing the challenges of poorly soluble molecules in early development and what technologies are best suited to enhance bioavailability
  • Selecting scalable technologies to support your drug product’s needs and understanding the pros and cons

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Nikki Whitfield, Vice President of CDMO Services at Quotient Sciences
Nikki has 25 years’ experience in the pharmaceutical industry and has previously held technical leadership positions in Vectura, Quadrant Drug Delivery and Elan where she was responsible for the development, transfer and scale up of both early phase and late phase products for the European and U.S. markets. In her previous position as a Project Director at Vectura, she led the early phase product development for two inhaled, orphan indication products and the late stage development for a novel sterile topical product. Nikki’s current responsibilities at Quotient Sciences involve developing the global formulation and manufacturing capabilities.

Stephie Lee, Scientist, Catalent Pharma Solutions
Stephie Lee, M.S., is a Scientist at Catalent in San Diego. She has a broad background in preclinical and clinical formulation, process development and GMP manufacturing of small molecule candidates, with a focus on early phase strategies for bioavailability enhancement of poorly soluble compounds. Stephie has managed more than 60 oral formulation programs, including spray dried dispersion, fluid bed processing, and micronization projects. Prior to joining Catalent, Stephie was a researcher in Dr. Richard Kaner’s laboratory at University of California, Los Angeles (UCLA), where she focused her research on the effects of various reaction conditions on the morphologies of nano conductive polymers such as polyaniline, polypyrrole and the fabrication of free-standing thin films of these materials. She received her Masters of Science in Chemistry and her Bachelor of Science in Biochemistry from UCLA.

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