issues

September 2022

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COVER

SPECIAL FEATURE – Injection Devices: Three Trends Influencing Development & Delivery

Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.

FEATURES

SPECIAL FEATURE – Injection Devices: Three Trends Influencing Development & Delivery

Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.

SOLUBILITY ENHANCEMENT – How Microparticles are Opening Doors to New Solutions for Oral Drug Delivery

Jessica Mueller-Albers, PhD, Yiming Ma, PhD, Alexander Bernhardt, PhD, and Michael Damm review the use of microparticles for solubility enhancement of oral small molecules and how this approach can address the challenges in pharmaceutical formulations.

GENERATIVE AI TECHNOLOGY – Generative Machine Learning Can Construct Smooth Chemical Search Spaces for Efficient Drug Discovery

Jason Rolfe, PhD, and Ali Saberali, PhD, and Mehran Khodabandeh, MSc, explain how Generative ML promises to efficiently optimize more accurate estimates of binding affinity and other pharmacological properties over the entirety of drug-like chemical space.

GENE THERAPY – Developing Affordable Point of Care CAR-T Therapies: Expanding Efficacy & Impact

Rimas Orentas, PhD, and Boro Dropulić, PhD, MBA, believe the future belongs to those who will be able to innovate rapidly, maintain regulatory confidence, and drive down costs to make CAR-T cell and other engineered cell therapies available to all who would benefit.

EXECUTIVE INTERVIEW – Emergent CDMO: A Molecule-to-Market Partner for Complex Biologics

Bill Hartzel, Senior Vice President and Head of CDMO Business, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.

DRUG DEVELOPMENT STRATEGIES – Marrying Target Product Profile, Regulatory & Partnering Strategies for Long-Term Product Success

Chris Rojewski believes given the costs, time, and risks associated with contemporary drug development, it’s time this fundamental aspect of successful development be brought as close to the program as possible — the CDMO tasked with executing drug strategy in the first place.

LIVE BIOTHERAPEUTIC PRODUCTS – Not All Microbiome Approaches Are Created Equal

Duncan Peyton says in comparison with other therapeutic classes, such as antibodies or gene therapy, the progress that has been made with LBPs to date has been rapid, and for the field to maintain this rate of progress and to establish LBPs as a mainstay in the treatment of patients across a variety of diseases, a number of key questions need to be addressed.