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ISCT addresses manufacturing standardization, a critical issue constraining the CGT development pipeline

  

ISCT addresses manufacturing standardization, a critical issue constraining the CGT development pipeline

Key insights published from ISCT 2022 Commercialization Signature Series

Vancouver, Canada, September 8, 2022 - The International Society for Cell & Gene Therapy (ISCT), the global society of clinicians, researchers, regulators, technologists, and industry partners dedicated to the translation of cell and gene therapy (CGT) into safe and effective therapies to improve patients' lives, today announces the publication of its key insights report from the 4th Annual ISCT Commercialization Signature Series event – an exclusive event for ISCT Patron Industry members to address critical manufacturing strategies driving commercial success in the CGT sector.

ISCT members and invited advisors, including prominent opinion leaders from across the value chain, unanimously agreed that the lack of standardization across manufacturing practices is a significant challenge that needs to be addressed urgently. The meeting held on May 3rd, 2022 in San Francisco, US, co-located with the ISCT 2022 Annual Meeting focused on three key themes:  Product development with end-stakeholder engagement, CDMO partnering best practices and the importance of integrating process analytics in your manufacturing strategy. The keynote presentation and panel discussions explored several key areas to address, which ISCT plans to use to help further conceptualize into standards and guidelines.

Commenting on the event's success, Anthony Ting, Chief Commercialization Officer, ISCT, said, "The mass-commercialization of cell and gene therapies is now a focus for the sector, and as a result, it is now a critical element of ISCT's activity. The 4th Commercialization Signature Series has established the link between key leaders working across the industry, and wider ISCT members, to make sure every ISCT member is able to share experiences and move forward in the same direction. The conversations facilitated at this year's event will play a crucial role in enabling everyone working across the supply chains to deliver therapies to patients suffering from a range of conditions more quickly and cost-effectively. ISCT is committed to continuing these conversations throughout the year during our monthly Industry member meetings and at next year's Signature Series event."

Alongside the Commercialization Signature Series, the Industry Committee hosts intimate monthly meetings for members to engage in topical, problem-solving conversations, network, share key learnings and develop educational resources to support the field.

The ISCT Industry Committee aims to be the global hub aligning key stakeholders in the industry, and actively liaises with Regulatory and Academia, to drive CGT Commercialization by building a community of engaged industry professionals to exchange knowledge.

The ISCT Industry Committee is set to reconvene in January 2023 for the next Commercialization Signature Series. For more information on how to attend and become an ISCT Industry member visit the ISCT website here.

The full 2022 Commercialization Signature Series report can also be found here.

ENDS

About ISCT Industry Membership

The ISCT Industry Community is comprised of member organizations across the globe and the CGT translation pipeline, as well as invited academic KOLs and regulatory experts. The ISCT Industry Membership Program was established to provide an intimate monthly discussion forum to network, educate and problem solve a range of topics constituting CGT manufacturing and commercialization. For more information or interested in joining the community, contact simone@isctglobal.org.

About the ISCT Commercialization Signature Series events

The Commercialization Signature Series is an exclusive annual event reserved for the ISCT Patron-level Member community and invited advisors to discuss state-of-the-art innovation and topical challenges in the CGT sector.

About the International Society for Cell & Gene Therapy

Established in 1992, the International Society for Cell & Gene Therapy (ISCT) is a global society of clinicians, regulators, researchers, technologists, and industry partners with a shared vision to translate cell and gene therapy into safe and effective therapies to improve patients' lives worldwide.

ISCT is the global leader focused on pre-clinical and translational aspects of developing cell and gene-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT offers a unique collaborative environment that addresses three key areas of translation: Academia, Regulatory, and Commercialization. Through strong relationships with global regulatory agencies, academic institutions, and industry partners, ISCT drives the advancement of research into a standard of care.

Comprised of over 2,700 cell and gene therapy experts across five geographic regions and representation from over 60 countries, ISCT members are part of a global community of peers, thought leaders, and organizations invested in cell and gene therapy translation. For more information about the society, key initiatives, and upcoming meetings, please visit https://isctglobal.org@ISCTglobal.


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