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- FIXED-DOSE COMBINATIONS – Fixed-Dose Combination Products – What’s in the Clinic? (Part 3 – Pipeline)
Tugrul T. Kararli, PhD, MBA; Kurt Sedo; and Josef Bossart, PhD, believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and conclude this series of three articles, examining the past, present, and future of these products with the intent of understanding their whats and whys.
- SPECIAL FEATURE – Formulation Development & Manufacturing – CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs
Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.
Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.
- EXECUTIVE INTERVIEW – Vetter: Establishing a Successful Clinical Fill & Finish Manufacturing Site for Biologics
Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing the services of a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.
Harry A. Arena, MBA, President & CEO of TDT, Chris Kim, President & General Counsel, Viral Gene, Inc., and Dr. Scott Waldman, Professor & Chair of Sidney Kimmel Medical College’s Department of Pharmacology & Experimental Therapeutics at Thomas Jefferson University, discuss the unique characteristics of the vaccine, the patients who will benefit the most, and how a research team captured the attention of investors.
Zach Marks, MS, RPh, believes efficiency of vaccine use will be critical as the world population continues to grow and vaccine prices continue to rise, and ID administration can help reduce dose cost while potentially improving immunogenicity in traditional and hard-to-treat populations.
Jeffrey Bacha, MBA, says glioblastoma is one of the most common and fatal brain cancers, and new therapies to treat this disease are urgently needed. New approaches, such as vaccines and immunotherapies, have promising results, and to be most effective, will need to be used in combination with a chemotherapeutic.
Drug Development Executive: Donald E. Morel, Jr., PhD, Chairman and CEO, West, discusses how the company works closely with pharmaceutical and biotechnology companies to deliver life-changing therapies safely and effectively to patients.