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CASSS NorCal Regional Forum November 2019: Scientific Program
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To view the full program and agenda, click here.

Abstracts and speaker presentations (when available) are listed below.


Fast-to-Market CMC Strategies

Co-Chairs: Trevor Swartz, Genentech, a Member of the Roche Group and Shelley Suggett, Themistry, Inc.

Companies are driven by clinical development plans to rapidly bring drugs to patients. Efficient CMC strategy is a part of your company’s success! In this forum we will look at different perspectives and molecules, and evaluate the different deliverables required throughout development through initial licensure. CASSS is committed to bringing job-relevant education and regulatory trends for biopharmaceuticals to CASSS members through meeting programs Content may include information 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. 


Accelerated CMC Development and Strategies to Meet Fast to Patient Access
Tura Camilli,
Amgen Inc., Thousand Oaks, CA, USA
Click here to view speaker presentation.

Increasingly, Sponsors are pressured to expedite the availability of drugs for the treatment of unmet medical needs. Acceleration of drug development to meet clinical timelines often results in CMC becoming rate limiting to overall program development, prompting the need to develop appropriate risk-based solutions/strategies to ensure that CMC is not the limiting factor for new marketing applications. In this presentation, we describe some of the CMC acceleration challenges and present strategies considered to ensure fast to patient access.

Accelerated CMC Development for Polatuzumab Vedotin
Andy Lin, Genentech, a Member of the Roche Group, South San Francisco, CA, USA
Speaker slides not available.

Polatuzumab vedotin (POLIVY) is an anti-CD79b antibody drug conjugate used to treat B cell lymphoma . In order to bring POLIVY to the market as fast as possible after receiving positive Ph 2 clinical results, the team developed an accelerated filing strategy and successfully launched the product 2 years ahead of the original schedule. In this talk, we will describe streamlined validation opportunities, regulatory tools and the risks/benefits to be considered in developing an accelerated CMC strategy.

Leverage CMO’s Capacity, Technology and Flexible Facility Design to Support Speed-to-Market
Min Zhu, Boehringer Ingelheim Pharmaceuticals, Inc., Fremont, CA, USA
Speaker slides not available.

Innovative companies often apply an accelerated CMC strategy when surprised by remarkable clinical readouts. When internal resources and manufacturing capacity are limited, CMO can play an important role in supporting the company’s timeline. In this talk, we will describe how a pharmaceutical company can partnership with a CMO to co-develop an efficient CMC strategy, and leverage CMC’s capacity, knowledge, flexible facility design, as well new technology to support a fast-to-market strategy. 

Navigating the Unique Challenges of Allogeneic Cell Therapy Products
Farah Fawaz, Allogene Therapeutics, Inc., South San Francisco, CA, USA
Speaker slides not available.

Allogeneic CAR T products are emerging as a new modality in immunotherapy and may hold great promise to address unmet medical needs. In an environment where no precedents are available, we propose to leverage the CAR T Quality Target Product Profile (QTPP) as a tool early in development to help implement a robust process and enable modifications/optimizations throughout the product life cycle while supporting comparability strategies.

CMC Development Strategies for Expedited Gene Therapy Programs
Philip Ramsey,
Sangamo Therapeutics, Inc. Richmond, CA, USA
Click here to view speaker presentation.

There are numerous gene therapy product candidates in clinical development for rare diseases that offer an opportunity for accelerated approval. While clinical data may provide a rapid path to approval, there remains a huge challenge in providing a robust CMC package that supports this accelerated approval. In this talk, we describe challenges in implementing gene therapy programs including manufacturing capacity, formulation, analytical characterization, regulatory requirements, and the risks and benefits in pursuing an accelerated CMC strategy. 


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