Catalyst Insights

A Catalyst Clinical Research Newsletter?

Welcome to the latest edition of the Catalyst Clinical Research newsletter! We are thrilled to share some of the latest updates from our dedicated team of experts. Read about what's been happening since our last issue and explore opportunities to connect with us.??

A Week Until...

Webinar: The New Era of Project Optimus: Implications for Oncology Development Strategy?

Register to join us next week for “The New Era of Project Optimus: Implications for Oncology Development Strategy” webinar at 1 p.m. Eastern, 25 September. Xtalks will host as our panelists discuss real-world examples and case studies, highlighting how drug development has evolved in the Project Optimus era. Discover lessons learned, best practices, and more about the shifting regulatory landscape. ?

?The expert panel includes:???

• Andrew Zupnick, PhD, Vice President, Oncology Drug Development, Catalyst Oncology, Moderator?

• Meredith Manuel, Executive Director, Consulting, Catalyst Oncology?

• Gilles Gallant, BPharm, PhD, FOPQ, Chief Development Officer, Mythic Therapeutics?

• Joe Shan, VP ClinOps, Adcentrx Therapeutics?

Visit the webinar landing page to register, or if you prefer LinkedIn Live, sign up here: https://www.dhirubhai.net/events/7231379478000660484/about/?

ESMO Connections

ESMO 2024 wrapped up and our team had many unforgettable experiences, including one with Kalida, which supports patients and their families through their cancer journeys. We hosted an event and learned more about the organization.

Subscribe to us and follow Catalyst Oncology for more ESMO 2024 highlights!?

Catalyst Flex: Unlocking Success One Metric at a Time?

Catalyst Flex has achieved a 100% team retention rate since 2021. Our successful track record in team retention is evident across all of Catalyst with a 97% corporate retention rate and an 89% project assignment completion rate. Learn more about our unique approach and discover how we can help support your clinical trial goals. ?

Blog: FDA Finalizes Project Optimus: Guidance for Dosing and Expectations for First-in-Human Oncology Trials?

With the publication of the final Project Optimus initiative guidelines, a Catalyst Oncology expert shares how to incorporate the FDA’s recommendations on dose optimization and patient-centric approaches to maximize the efficacy of new cancer treatments while minimizing toxicity. Learn more from Meredith M., Executive Director, Catalyst Oncology Consulting, as she highlights items that changed from the draft.?

Upcoming!?

Looking ahead, don’t miss the chance to connect with our experts from Catalyst Flex and Catalyst Oncology at our upcoming webinars and events. Contact us at [email protected] to schedule a meeting with our experts.?

Webinar: Leveraging Functional Service Providers for Enhanced Efficiency in Drug Development??

Register today for our upcoming Catalyst Flex and XTalks webinar, “Leveraging Functional Service Providers for Enhanced Efficiency in Drug Development” at 1 p.m. (Eastern) on 31 October. You won’t want to miss this discussion on how FSPs are?transforming the clinical research landscape.??

The expert panel includes:??

• Craig McIlloney, SVP Catalyst Flex, Catalyst Clinical Research??

• Rob Petrie, CIO, OrciMed Life Sciences??

• Elisha Talley-Roithner, Head of Operations, Launch Therapeutics??

• Melissa Church, SVP, Strategy & Solutions, Catalyst Clinical Research, moderator??

Conferences?

• Connect with Catalyst Flex at?PHUSE?SDE 2024?on?September 21?in?Chennai, India. Our team looks forward to engaging with industry leaders and discussing the latest insights and advancements in clinical data science.?

• Next, join us from?September 22 to September 24?at?SESUG 2024?in?Bethesda, Maryland! Don’t miss Nathan Riley, Statistical Programmer II, Catalyst Flex, presenting on “Efficient Way to Create Adverse Event Summary Tables by System Organ Class and Preferred Term using PROC SQL in SAS.”?

• Join a Catalyst Oncology team in?San Francisco?on?September 24?for?Immuno-Oncology hubXchange 2024. Meredith Manuel, Executive Director, Catalyst Oncology Consulting, will host a roundtable discussion on "Project Optimus – The Impact on Protocol Designs and Requirements” to ensure your early phase oncology trials are Project Optimus ready.?
• We’ll also be at the?Society for Clinical Data Management (SCDM) annual conference?from?September 29 to October 2. Visit us at booth #607 to discuss your challenges and explore how we can support your unique clinical research needs.?