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CASSS Community News - September 27, 2018
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MEMBER SPOTLIGHT | NORTHEAST REGIONAL FORUM | WCBP/CMCWINTER | MIDWEST REGIONAL FORUM


 

 

Meet Bharat Dixit - CASSS Associate Director and
Member of the NERF & WCBP Committees
!

The CASSS Member Spotlight is an ongoing Q&A series focused on getting to know the CASSS Community.

After attending a few CASSS meetings, Bharat not only joined the WCBP organizing committee, but the new Northeast Regional Forum committee as well. Bharatsees CASSS as, "a great and unique organization for learning and networking."

In addition to his commitment to CASSS, find out more about Bharat and his photography hobby.



Be part of the discussion at the Northeast Regional Forum!

The roundtable sessions give attendees the opportunity to discuss hot topics, share best practices, and learn from one another. Topics will include:

Control Strategies for Accelerated Projects

Early Development of Potency Assays in Research with CMC Mindset

Leveraging Prior Knowledge to Accelerate CMC

Strategies to Transition Research Programs into Development Quickly to Reduce Time to First-in-Human

Authoring Regulatory Submissions with Limited Development and Manufacturing Experience

Analytical Development and Bridging to Enable Commercial Facilities Earlier in Development

Online Registration for this Program Closes Friday!


Be a part of the premier meeting for the biopharmaceutical community!

Start the week off right – don’t miss the CMC Strategy Forum this January on Monday, January 28. The CMC Strategy Forum features two tracks:

Continuous Manufacturing for Biologics

The Development of Patient-focused Commercial Specifications through Understanding of Clinical Relevance and Criticality of Quality Attributes

Registration is also now open for WCBP 2019.This year’s theme is Patient-Centric CMC Development: Rigor & Speed with Purpose

Session topics for 2019 will include:

Approval Success Stories: Trials and Tribulations Along the Way to the Goal

Clinically Relevant Specifications and Quality Standards

New Rapid Analytics and the Path to RTRT

New Technologies for New Modalities

Global Access through Transformative Technology



Midwest Regional Forum Program in Chicago – October 23
Work Smarter Not Harder - Leveraging Prior Knowledge to Accelerate CMC Programs

Preliminary program now available!

This Forum will explore strategies to speed delivery of material to the clinic for FIH trials by using prior knowledge and project platform approaches. Speakers will also discuss strategies about streamlining development studies to lock down process decisions earlier in the development cycle. Finally, we will discuss case studies on streamlining shipping studies, including exploring how to develop a simplified, rational package and shipping qualification program.


Upcoming CASSS Meetings


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