Search Results for: COMBINATION CORNER How to Approach
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COMBINATION CORNER - How to Approach OTS Devices for Your Combination Product May 3, 2016
Lilli Zakarija, MSME, MBA, cautions that while OTS devices are already “developed” and on the market, they should still go through the device development design control process from the perspective of the combination product, and then let the design control process determine if the device meets the specific requirements of the CP.
COMBINATION CORNER - Keys to Avoiding Common Pitfalls in the Development of Product Requirements for Drug Combination Products February 28, 2017
Jerzy Wojcik says it is more important than ever to bring the right team together early in a project to capture product requirements correctly. The cost of missing needs or requirements goes up exponentially as development proceeds, and many of these requirements can be identified early in the project if the right individuals are at the table.
COMBINATION CORNER - Keys to a Robust Combination Product Design Verification & Validation June 30, 2016
Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.
SPECIAL REPORT - Outsourcing Formulation Development and Manufacturing: An Early Approach Saves Time and Money March 31, 2013
In this Special Report, Contributor Cindy H. Dubin asks many of the leading companies in this sector what challenges pharma currently faces in formulation and manufacturing and how they, as third-party providers, are helping to alleviate those burdens.
Processa Successfully Identifies Next-Generation Capecitabine Dosage Regimens for Phase 2B Trial November 1, 2022
Processa Pharmaceuticals, Inc. recently announced positive results from its ongoing Next-Generation Capecitabine (NGC) Phase 1B trial. The data collected has...PEPTIDE THERAPEUTICS - Oral Peptide Therapeutics – Opportunities Abound as Barriers Fall August 31, 2020
John S. Vrettos, PhD, says numerous technologies are currently in development that are designed to enable the oral delivery of peptides. Though each has its unique set of properties and capabilities, all must overcome key obstacles to successfully deliver peptides via the oral route.
TriSalus Life Sciences & Roger Williams Medical Center Announce Initiation of Phase 1 Clinical Trial for a Novel Delivery Technology February 14, 2020
TriSalus Life Sciences recently announced the initiation of a new clinical trial assessing the safety and feasibility of an innovative new treatment that combines its…..
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.
INTRATUMORAL DELIVERY - Arming the Immune System; Turning Cold Tumors Hot August 29, 2019
Daniel J. O’Connor believes a trigger mechanism that can turn cold tumors hot can help researchers set their focus on delivering potentially life-saving drugs directly to core of a cancerous tumor.
CHECKPOINT INHIBITORS - Novel Targets & Global Markets April 29, 2019
Laurie L. Sullivan and Cheryl L. Barton, PhD, say as manufacturers expand the clinical utility and healthcare professionals become more familiar with their efficacy and safety profiles, the checkpoint inhibitor market will continue to expand, becoming the cornerstone of many cancer treatment regimens.
ONCOLOGY DIAGNOSTICS - Advancements Paving the Way for More Tailored Drugs November 20, 2017
Divyaa Ravishankar, MS, says pharmaceutical companies have been subjected to a wide variety of external forces compelling them to get innovative about development of new platforms, liaise with new partners, leverage big data toward precision and predictive diagnosis, and identify new markers.
Allergan to Acquire Tobira Therapeutics, Expanding Global GI R&D Pipeline & Taking a Leading R&D Position in NASH September 25, 2016
Allergan plc recently announced it has entered into a definitive agreement under which Allergan will acquire Tobira for an upfront...SPECIAL FEATURE - Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality June 2, 2016
Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.
ANTIGEN-SCREENING SYSTEM - Perfecting the Promise of T Cell Therapies for Infectious Disease & Cancer May 31, 2016
THE EVOLUTION OF IMMUNOTHERAPIES The human body is armed with an efficient and elegant immune system that fights pathogens and...7/18/2012 July 12, 2012
Prokarium Acquires Key Oral Vaccine Technology Prokarium Ltd recently announced it completed a key technology acquisition from Emergent BioSolutions Inc....5/16/2012 May 14, 2012
Mucosis Announces Positive Data for Mimopath Platform Mucosis B.V. recently announced Phase I clinical data providing proof-of-concept that Mimopath-based mucosal...9/27/2011 September 25, 2011
Thermo Fisher Scientific Introduces New Imaging ATR Accessory Thermo Fisher Scientific Inc., a world leader in serving science, recently announced...
