July 31, 2019
Always present, rarely seen, and increasingly essential, the fast-growing area of Chemistry, Manufacturing and Controls (CMC) of pharmaceutical products is slowly emerging as a titan in its own right.
August 15, 2019
DSI to Showcase Progressive Drug Development Strategies and Products at the 2019 Biotech Week Boston
DSI will be attending Biotech Week Boston 2019, find us at BioPharm America on September 09-12th. Biotech Week Boston is dedicated to accelerating the business of biotechnology through new ideas, science, technology and partnerships to make a positive impact on patient health.
August 21, 2019
How to Avoid the End-of-Summer SlumpGetting your productivity back on track requires using your energy wisely, whether it's stockpiled from vacation or running on fumes. Here are a few ways to turn the end of summer into a springboard for a productive Autumn.
September 19, 2019
How would Bruce Lee develop a viable and effective chemistry, manufacturing and controls (CMC) regulatory strategy while focusing on ensuring a viable and effective clinical development strategy to keep the product moving forward, when the odds of clinical success were against him?
September 20, 2019
Drug Substance Development Expert, Dr. James Mencel, will be presenting “Expedited Filings and their CMC Implications: Considerations toward Better Planning”, sponsored by AMRI, a global contract research and manufacturing organization. Conference sessions will occur at AMRI’s Corporate Headquarters.
October 2, 2019
Ready to help, wherever you are! Google's version of Amazon's Alexa, Apple's Siri and Microsoft's Cortana is Google Assistant. It has made incredible progress since its 2016 launch and is probably the most advanced and dynamic of the assistants out there.
October 17, 2019
The landscape of chemistry, manufacturing, and controls (CMC) has continued to shift over time. Just a few decades ago, most drugs were developed from beginning to end by large pharma with well-defined systems of control. Today, this has significantly changed; much if not most early development (Pre-IND to Phase II) work is performed by small- to medium-size emerging biotech sponsors, many of which are virtual companies.
October 29, 2019
Here’s the problem: drug development managers must translate guidance into clear program objectives, identifying the data and information that needs to be produced, and prioritize resources and expenditures.
December 3, 2019
To ensure scientific and commercial success, it is critical to understand the drug development process and the myriad tasks and milestones that are vital to a comprehensive development plan.
Although the primary purpose of a well-designed regulatory strategy is to assure an efficient process for providing new, high quality and effective drugs for patients, it is also essential to effectively maximize the return on investment.
Each step along the path to commercialization is important and an effective chemistry, manufacturing and controls (CMC) strategy and ensuing communication plan plays an integral role in the overall success of a product.
December 19, 2019
A scientific review of the pertinent development data provides the necessary information to assure that informed decisions are made regarding the potential in-licensing of a development compound. By highlighting perceived risks and resource implications, the examination provides assurance that a given compound meets the requisite technical and quality elements.In advance of Biotech Showcase and the JP Morgan Healthcare Conferences next month, we are providing our complementary Drug Product Due Diligence Checklist. Send us a message if you would like a copy.
January 30, 2020
ncorporation of phase appropriate development strategies is becoming increasingly essential to manage the balance between speed, cost and completeness during development. The possibilities for both Chemistry Manufacturing and Control (CMC) development and filing approaches range from the minimalist style to a continuously supported style.
February 28, 2020
Looking for answers? Where are you at with your process and controls? Who is managing the operations? What bioassays are necessary for your product? When, where and how to validate your bioassay?