Newsletter | December 8, 2025

12.08.25 -- Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads

FROM THE EDITOR

Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads

Part one of a two-part series on FDA Commissioner Martin Makary, M.D.'s comments at the Gailen Forum in New York City.

INDUSTRY INSIGHTS

Why Biotech CRO Partnerships Are Essential For Clinical Trial Success

For early-stage biotech companies, the road from discovery to market is fraught with challenges, and in this environment, strategic partnerships with CROs have become a cornerstone of clinical success.

Take Action On PFAS To Protect Your Critical Processes

PFAS restrictions are tightening, but a full ban could disrupt critical industries lacking alternatives, such as pharmaceutical manufacturing. Learn where PFAS use remains indispensable.

Delivering Successful Cell And Gene Therapy Trials

These trials present unique logistical hurdles. Success requires a meticulous operational framework, strategic site specialization, and a patient-centric design for smooth execution.

Harnessing R Shiny Dashboards For Statistical Programming, Data Visualization

Empower your teams to move beyond static reports by leveraging R Shiny to transform data into interactive, real-time insights that drive smarter, faster decisions.

Striking A Balance Of Speed And Quality To Deliver Next-Gen Therapeutics

Successful delivery of a bispecific antibody therapeutic to patients necessitates a manufacturing strategy that can accommodate the unique size, structure, and complexity of these molecules to ensure quality.

Novartis To Invest $771M In RTP, Creating Up To 700 Biologics Jobs

A $771 million expansion will bring new biologics and small molecule manufacturing capabilities and create hundreds of jobs. Learn how this investment positions the Research Triangle for future growth.

Retention Begins With Recruiting The Right-Fit Patients

Recruiting the right patients into a clinical trial is only half the battle. To combat attrition, sponsors must also institute measures that ensure patients remain comfortable and confident throughout the trial.

Introducing 2 New Highly Effective ADC Payloads For Cancer Therapeutics

Unlock the potential of antibody-drug conjugates (ADCs) by exploring our novel payloads, designed for easy access and evaluation, to accelerate your ADC drug development with proven efficacy and safety.