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ISCT Webinar: Risk Evaluation Management
Presented by the ISCT Commercialization Committee 

Date: February 6th, 2013 

Time: 9:00 AM Pacific, 11:00 AM Central, 12:00 PM Eastern, 6:00 PM CET (Europe) 

Chair: Wouter Van't Hof, PhD, Senior Director of Regenerative Medicine, Athersys, Inc. 

Speakers: Natalie Mount, PhD, Chief Clinical Officer, Catapult Limited, UK and Karin Hoogendoorn, Janssen Biologics BV, The Netherlands  

About the Webinar: 

Similar to the path for drugs, the development of cell therapy products (CTP) is a high risk and expensive endeavor. Regulatory expectations, development time and specific challenges for each development stage need to be taken into account. The Target Product Profile (TPP) concept provides an important mechanism for risk management and symbolizes the idea of beginning a development process with the ultimate product in mind. More specifically, as stated in regulatory guidance documents, "the TPP should represent the ideal version of what the sponsor would like to claim for product labeling, and the design, conduct, and analysis of clinical trials to maximize efficiency of program development”. Although commonly implemented for drugs, especially in big pharma, it appears the TPP concept has not yet been widely considered as a disciplined planning approach for CTP development. 

At its core, a well-utilized TPP is a communication tool that enhances efficient dialogue at various levels in the organization and through stages of development. This begins with internal program management by sponsors from discovery through development. It extends to discussions between sponsor and regulatory agencies and as such can minimize the risk of gaps in data becoming apparent at a late-stage, impacting overall development time and success. Furthermore, it is adaptable as a framework for discussion between academic discoverers, industrial developers/partnerships and investors.  

Functionally, the TPP enables advancement of the various development needs in parallel, integrating R&D, (non)clinical, regulatory, process and manufacturing, quality (QA/QC), commercial, labelling, and marketing needs. The document also incorporates flexibility to address the high likelihood for the need for change during product development, e.g. due to technical difficulties, clinical issues around safety and efficacy, changes in competition, IP landscapes and marketing.In this webinar we will discuss the TPP concept, the structure and utility of the document with specific emphasis on management of the unique risk profile for CTP development and highlight this by case presentation of the use of TPP in the development of an autologous and an allogeneic CTP.

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