Search Results for: CLINICAL TRIALS Its Time to
Peter Shaw and Yury Rozenman believe the pharmaceutical industry has reached a crucial inflection point, requiring access to new working methods and tools. But where should the pharmaceutical industry look for answers to these real-world challenges?
- 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.
- ADVANCED DELIVERY DEVICES – Wearable Bolus Injectors – A New Class of Patient-Friendly Drug Delivery Systems
Michael D. Hooven, MSME, indicates bolus injectors represent one of the most exciting new opportunities in the field of medical devices, and his company’s focus on developing innovative technology in combination with an intense emphasis on Human Factors has resulted in a system that is unique in a number of ways.
- SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise
Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.
- INTRAORAL DELIVERY – Utilization of Intraoral Administration for Enablement & Enhancement of Drug Delivery – Highlights of Recent Commercial Products
Zhen Yang, PhD, and Yunhui Wu, PhD, highlight several commercialized intraoral formulations from a clinical pharmacokinetic perspective and reveal its mechanism for enablement or enhancement of drug delivery via intraoral administration.
Robert A. Preti, PhD, discusses his company’s critical distinction from most other manufacturing partners, steady growth, and the primary challenges facing the cell therapy industry.
Robyn M. Barfield, PhD, and David Rabuka, PhD, say that despite challenges, there has been progress in advancing complex compounds through clinical trials and successfully treating patients, and these bioconjugate compounds include a subset of molecules known as ADCs.
- DISPOSABLE TECHNOLOGY – Use of Disposable Technology in Clinical Fill & Finish Manufacturing: Benefits & Considerations
Claudia Roth, PhD, reviews not only the benefits of using disposables, but the real-world variables to consider when converting to single-use technology. The pathway begins with the question, why use disposables?
John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.
- EXECUTIVE INTERVIEW – Array BioPharma: Steadily Moving to Late-Stage Development, Preparing for Commercialization
Executive Summary: Ron Squarer, Chief Executive Officer of Array BioPharma, talks about the company’s pipeline and evolution into a fully integrated, commercial-stage biopharmaceutical company.
Susan Rosenbaum, JD, and Irwin Hollander, PhD, present a unique and novel solution to this greatest challenge in medicine for brain disease treatment, considered the “Holy Grail of Neuroscience,” with their breakthrough innovation.
Kai Langel believes the remote research model and purpose-built technology offer the tools and the right process to help modernize clinical research and bring it closer to the high standard set by today’s consumer technologies.