Jessica Carmen

2 months ago | outsourcedpharma.com | Louis Garguilo |Jessica Carmen |A Focus |GC Cell

Webinar: Who’s In Charge of Your Trial? How to Ensure Effective Oversight and LeadershipClinical trials in complex therapeutic areas require more than just a solid strategy—they demand proactive and engaged operational leadership from the sponsor side. Join our expert panel to discuss how an active and knowledgeable Clin Ops lead, in collaboration with an experienced outsourcing project lead, can drive informed decision-making, enhance efficiency, and ultimately ensure trial success.

Jan 14, 2025 | outsourcedpharma.com | Louis Garguilo |Jessica Carmen |A Focus |I Outsource

We’re ready to help usher your next drug into market! 2025’s first Outsourced Pharma Capacity Update provides a unique, virtual experience and the details necessary to find a CDMO for your specific timeline, volume, and production needs. Join us the last week of January as we draw the curtains on the industry’s best and give you complimentary VIP access to the resources available to support your success.

Sep 14, 2024 | bioprocessonline.com | Jon C. Strauss |Tim Sandle |Yadnyesh Patel |Jessica Carmen

AUGUST'S BEST FEATURED EDITORIAL9 Common Tech Transfer Pitfalls To AvoidMany issues can trip up a tech transfer process. Here are nine of them— plus ways to mitigate each. Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. RecommendationsICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.

Jun 26, 2024 | cellandgene.com | Jessica Carmen

By Jessica Carmen, PhD, Kincell Bio In the world of drug development, particularly in cell and gene therapy, costs can quickly spiral out of control. To combat this, drug developers often seek ways to cut expenses during the early stages of product development. One potential area for cost-cutting is the use of research-use only (RUO) leukopaks instead of the more expensive current Good Manufacturing Practice (cGMP)-grade leukopaks.