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CASSS NorCal Regional Forum Spring 2018: Scientific Program
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Program Abstract

Strategies on Shortening Process Development
Co-Chairs:  Michelle Frazier, Coherus Biosciences and Bryan Silvey, Kite, Gilead Company
The CASSS Northern California Regional Forum is committed to bringing job-relevant education and regulatory trends for biopharmaceuticals to CASSS members through meeting programs. The April forum will focus on strategies for shortening process development. The discussion will include content from other regional, national or international forums organized by CASSS and speakers from industry and FDA. The program will also provide a platform for networking with both peers and regulatory authorities.

The pharmaceutical development process for biological products is labor-intensive and time-consuming for companies and the patients that may ultimately benefit from these products. The advent of breakthrough therapy designations in the US and other global regions has certainly helped to bring important life-changing therapies to patients. However, development of robust manufacturing process for rapid development products often lags behind their rapid clinical programs. The recent entry of several cell and gene therapy products, often under rapid development, can also bring challenges to drug developers and regulators. This forum on rapid pharmaceutical development will provide a practical discussion on lessons learned in traditional breakthrough biologics products as well as cell and gene therapy programs from innovators and regulators alike.



Confirmed Speakers


Refining Cell Line Development Workflows for Enhanced Efficiencies from Transfection to Ph2 Onwards
Alice Chang, Five Prime Therapeutics Inc.

Process development timelines are constantly being pushed to bring potential therapies to the clinic as fast as possible while balancing the desire for a well-characterized, robust manufacturing process. Cell line development comprises a large fraction of this timeline and is an area with significant opportunity for cutting time from transfection to research cell bank. Here, we present our strategies, both prior and planned, for streamlining cell line development while maximizing late-stage readiness and reducing make-up work for Phase 2 onwards.

Accelerated Development: Challenges and Opportunities in a Rapidly Evolving World
Kin Tang, Genentech, a Member of the Roche Group

Scientific advancements have led to innovations in biomedical technology, novel therapeutic modalities, clinical study designs and regulatory sciences which present great opportunities for rapid development of innovative new medicines NMEs for patients with unmet medical need. However, this has also presented challenges to CMC scientists who must develop and deliver high quality products made by robust manufacturing processes within a significantly, compressed timeline. This presentation will review points for CMC development and regulatory considerations for accelerated development programs in a global setting.


Accelerated Late-Stage Process Development Strategies: Use of Prior Knowledge and the Registration Enabling Campaign
John Eschelbach,Genentech, a Member of the Roche Group

 Clinical development programs are increasingly designing trials and timelines with extra degrees of flexibility to allow for acceleration based on early positive data. This often places CMC activities on a critical path requiring a resource commitment at an early stage of clinical development when the likelihood of commercial launch remains low. The expectation from the health authority for accelerated programs, however, is to still deliver a CMC process with a detailed understanding of product and process knowledge to ensure patient safety and efficacy from a robust process. This expectation requires the sponsor to streamline the process validation study design, not simply eliminate or defer critical studies. 

In this presentation we explore a late-stage program that demonstrated both a low supply demand and limited clinical data, but also has the potential for a fast-to-market strategy gated to positive clinical results. We implemented the concept of a Registration Enabling Campaign (REC) conducted in parallel with a traditional Phase III supply campaign that would eliminate the need for a traditional PPQ campaign while still meeting the requirements for Registration Batches. We also explored strategies to streamline the process design through the use of prior knowledge. This approach allowed for the efficient execution of process validation in a compressed timeline without a significant expansion in resources.

We will present the strategy for required prospective studies needed to support a Registration Enabling Campaign, approached to leverage prior knowledge and overall risks associated with analytical quality control systems that must be leveraged at a very early phase in development.


more Calendar

7/10/2018 » 7/12/2018
Cell & Gene Therapy Products 2018

7/16/2018 » 7/17/2018
CMC Strategy Forum Summer 2018

9/9/2018 » 9/12/2018
CE Pharm and Mass Spec 2018

Featured Members
Linda O. Narhi, Amgen Inc.Visit the CASSS News page to get to know Linda Narhi!

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