Newsletter | November 12, 2025

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

SPONSOR

Webinar: Advancing Topical Formulations with Innovative Preclinical Models

In this webinar, experts will explore strategies to improve drug candidate success rates by integrating robust formulation development and predictive preclinical models. Learn how comprehensive drug characterization, in vitro/ex vivo testing, and systematic formulation approaches can identify promising candidates early, reduce development risks, and align with evolving regulatory expectations to streamline development and improve overall therapeutic outcomes. Click here to learn more.

INDUSTRY INSIGHTS

Optimizing Tablets For Even Splitting: The Pressure Sensitive Bisect Design

The pressure-sensitive bisect design allows accurate tablet splitting by maximizing facet width, optimizing angles, and balancing radius values for durability and user-friendly administration.

Continuous Flow Techniques For Fine Chemical Manufacturing

Explore the advantages and challenges of continuous flow processes and the concept of mini-monoplant technology, along with examples that demonstrate the versatility of continuous processing.

How To Evaluate CDMO Communication: A Framework For Biotechs

Determine a CDMO's communication strengths by assessing access, transparency, responsiveness, and scalability. Use the following framework to ensure your partner can endure through any challenge.

FEATURED EDITORIAL

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 on October 30, 2025.

Import Product Specifications And Drug Registration Testing For China

This overview and its recommendations are valid for drug registration testing (for marketing authorization applications in China) as well as for import testing (for commercial batches to be imported into China).

INDUSTRY INSIGHTS CONTINUED

Aligning Pediatric Patient Needs With Drug Development Success

Executive Director of Pharmaceutical Sciences Srinivasan Shanmugam, Ph.D., discusses pediatric patient compliance, regulations impacting trial access, excipients within formulations, and more.

Small Molecule Oral Delivery For Rare Diseases: Complexities As A CDMO

Developing therapies for rare diseases faces hurdles like high costs, small patient populations, and complex small-batch manufacturing. CDMOs offer crucial support, expertise, and flexibility.

Strategies For Enhancing Bioavailability Of Poorly Soluble Compounds

Poorly soluble compounds require targeted strategies to enhance bioavailability. Key methods include converting the API to an amorphous form, reducing particle size, and using lipid-based vehicles.

Orally Disintegrating Tablet (ODT) Vs. Standard Tablets (ST)

Review how Zydis® ODT compares against standard oral tablets, how the same molecule can produce a different outcome when utilizing Zydis ODT, and findings from over 20 published studies.

Spray Drying For Improved Solubility

Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.

SPONSOR

Webinar: Extrusion-Based ASD Scale-Up: Ensuring Performance Through Process Understanding

Boost your drug development success with Lonza’s upcoming webinar on amorphous solid dispersions (ASDs). Learn how hot melt extrusion (HME) can enhance bioavailability, cut costs, and scale efficiently—backed by real-world lab and pilot trials. Compare HME and spray drying while gaining exclusive insights into Lonza’s advanced capabilities and proven expertise in ASD manufacturing. Don’t miss it! Click here to learn more.

SOLUTIONS

Analytical Services: Method Optimization

We offer a comprehensive method optimization service to take early stage development methods with poor stability indication, excessive run time lengths, or legacy column chemistries and modify them.

End-To-End Pharmaceutical Solutions With A Softgel Specialty

Accelerate your pharmaceutical development with end-to-end support, global softgel expertise, and the strategic advantages of a New Zealand-based manufacturing partner.

Solvent-Free, Fusion-Based Amorphic Dispersion Process

Discover a solvent-free, fusion-based process that leverages frictional and shear forces to rapidly convert crystalline drugs and polymers into amorphous solid dispersions (ASDs).

Fine Chemical Manufacturing Services: R&D From Concept To Commercial

Our FCMS offers comprehensive research and development services and is equipped to handle all your product development needs, bringing your projects from concept to production.

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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