MODIFIED RELEASE - Alternative Strategies for Development of Modified-Release Dosage Forms October 1, 2019

Andy Lewis, PhD, discusses a range of available formulation technologies, the challenges in MR formulation development, and the use of a design-space approach with on-demand manufacturing.

COMBINATION PRODUCT DEVELOPMENT - New Horizons in Development to Meet Emerging Demands October 1, 2019

Ed Trappler and John A. Merhige, MEM, believe it is no longer sufficient to put a product in a vial, and the future of healthcare products places increasing demands on the industry to provide innovations for delivering combination products.

2019 Analytical Testing in Drug Development eBook - Regulations Help Propel Testing Market September 6, 2019

This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services June 5, 2019

Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.

DEVICE DESIGN - Quality-by-Design Approach to Enable High-Dose Drug Delivery With Autoinjectors June 5, 2019

Patrick Le Gal explains how his company deployed a quality by design approach to manage all the unavoidable competing requirements and to propose a solution that balances performance, robustness, and usability.

BIOSIMILAR DEVELOPMENT - Approval of Biosimilar Medicines Through Totality of the Evidence June 4, 2019

Hillel Cohen, PhD, outlines the evolution of biosimilar approvals and describes the process of analytical and clinical testing followed in the development of a biosimilar, with use of data from the scientific literature.

SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development April 30, 2019

Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.

DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration April 30, 2019

Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.

TOPICAL DEVELOPMENT - Fast Tracking Your Way to Success April 29, 2019

Marc Brown, PhD, Jon Lenn, PhD, and Jeremy Drummond, PhD, believe it is essential the lead (and potentially a back-up formulation depending on any risk factors identified) has been optimized and characterized to demonstrate it will maintain its quality and performance as well as provide the best chance of measurable success in the clinical setting.

DRUG DEVELOPMENT - Softgel Technology for Fast-Tracked Development Programs April 29, 2019

Jeff Browne, PhD, and Ronak Savla, PharmD, PhD, believe given the accelerated timelines associated with expedited programs, lipid-based drug formulations, encapsulated in softgel capsules, provide an attractive option for addressing the challenges facing formulators.

FORMULATION FORUM - Formulation Development From Preclinical to First-In-Human April 29, 2019

Jim Huang, PhD, says when a compound enters preclinical development for a GLP tox study from the drug discovery stage, formulators have innovative options on how to develop a tox and clinical formulation that ensures the success of IND and first dose in human.

Angion Awarded $4.76-Million Department of Defense Grant for Drug Candidate April 3, 2019

DRUG DISCOVERY - Zebrafish in Preclinical Drug Development - A Small Fish With Big Returns April 1, 2019

Rafael Miñana, PhD, explores the benefits of preclinical outsourcing, the value of zebrafish as an alternative model, as well as the challenges and opportunities of managing a highly diversified portfolio and providing customized solutions.

RISK MANAGEMENT - FDA’s Quality Risk Management Approach to New Drug Applications April 1, 2019

Kaiser J. Aziz, PhD, explains how the FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.

PRODRUG TECHNOLOGY - Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs March 4, 2019

Travis Mickle, PhD, indicates key properties that prodrugs can potentially modify generally fall within one or more of the ADME categories, with the goal being the creation of an NCE that optimizes the performance, utility, and potential life-cycle management of the parent drug.

DRUG DISCOVERY - Validated Phenotypic Approach to Neuropsychiatric Drug Discovery March 1, 2019

Emer Leahy, PhD, reviews how the SmartCube platform represents a novel approach to discovering the next generation of breakthrough treatments for schizophrenia and other neuropsychiatric disorders.

MULTIPARTICULATE FORMULATIONS - Using Multiparticulate Technology to Develop Pediatric Drug Products February 28, 2019

Sven Stegemann, PhD, Matt Shaffer, Samantha Saville, and Jaspreet Arora, PhD, believe as pediatric formulations are expected to continue as a core research area in pharmaceutical technology, MP technologies have the potential to play a key role.

SPECIAL FEATURE - Outsourcing Analytical Testing: The Gateway to Drug Manufacturing January 10, 2019

Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.

TRANSLATIONAL PHARMACEUTICS - Accelerating Early-Stage Drug Development With Integrated CDMO & CRO Services January 9, 2019

Peter Scholes, PhD, describes the current challenges and questions faced by drug developers in accelerating molecules to POC and developing optimized and scalable drug products for patient trials.

HUMAN MICROBIOME - Advancing New Frontiers in a Rapidly Emerging Market November 12, 2018

Flo Orim, MD, PhD, focuses on biomedical aspects of research, development, and commercial endeavors in the human microbiome space, including essential background information, evolution of the field, and advances in basic research.