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Translational Pharmaceutics and the Benefits of Real-Time Adaptive Manufacturing

Translational Pharmaceutics Seminar - San Diego, CA

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Title: Translational Pharmaceutics and the Benefits of Real-Time Adaptive Manufacturing


Date /Time Location

Wednesday, October 17th, 2018

Green Acre Nautilus*

3:00pm - 3:30pm - Registration

3:30pm - 4:30pm - Seminar

4:30pm - 6:00pm -  Cocktail and Appetizer Networking Reception

Nautilus B,

3535 General Atomics Ct,

San Diego, CA 92121

*Parking is available on all sides of the Nautilus 3 building and between buildings 2, 3, & 4.

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Seminar overview

Many pharma companies are seeking new ways of making drug development more efficient and cost-effective. This has led to an increase in the outsourcing of development activities to contract research partners who focus solely on disciplines such as clinical testing, formulation development and manufacturing. This in turn has created a siloed approach to drug development where there is a distinct lack of communication between the multiple vendors working on a particular drug molecule. For example, the Contract Development & Manufacturing Organization (CDMO) who is making the drug product, will seldom talk to the Clinical Research Organization (CRO) who is actually designing and performing the clinical trial.

This seminar series explains the benefits of Translational Pharmaceutics, a unique approach which integrates formulation development, real-time adaptive manufacturing and clinical research. The seminar will illustrate how, by breaking down the siloes and integrating horizontally, we can operate with more flexibility in the early phases of drug development, reducing costs and shortening timelines.

In addition, it will describe a different approach to drug product manufacturing, called real-time adaptive manufacturing and how it can help adapt to clinical trial requirements quickly and manufacture on demand the precise drug product required. The webinar will describe ways of maximizing flexibility around batch size, scale and product stability, whilst being truly responsive or “on demand” to the clinical trial requirements and the timing of product supply to any selected site, in response to emerging clinical data, or patient recruitment.

Key learning objectives:

  • Discover how an integrated approach enables a quick transition of molecules from first-in-human to POC;
  • Understand how drug product formulations and doses can be adjusted and manufactured real-time, often in response to emerging human data;
  • Learn how to save valuable API, through significant reductions in the amount of drug product manufactured;
  • Discover how to adapt to clinical trial requirements quickly and manufacture only the product your patients need;
  • Hear how this integrated approach can accelerate your drug development timeline.

If you are interested in registering for this event in other locations, please click here.

Drug product development

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