DSI Introduces New, Hands-On Opportunity for Drug Sponsors to Learn from CMC and Regulatory Subject Matter Experts

DSI Introduces New, Hands-On Opportunity for Drug Sponsors to Learn from CMC and Regulatory Subject Matter Experts

CMC.Live provides a one-of-a-kind interactive experience focused on the critical Chemistry, Manufacturing and Controls real world issues

July 31, 2020 6:00 AM Eastern Standard Time

Phoenixville–(BUSINESS WIRE)—Design Space InPharmatics (DSI), an Industry Leader in Regulatory Drug Development, today announced its latest innovative offering for emerging biotech drug sponsors. CMC.Live is an interactive podcast where DSI’s team of subject matter experts and program managers watch the CMC and regulatory industry trends and discuss current hot topic areas. CMC.Live subscribers can listen to their conversations and ask questions (Ask the Experts).

This unique experience is another way that DSI presents exceptional educational value to drug sponsors at any stage of their developmental journey. Starting today, drug sponsors can access to see how they can incorporate lessons from CMC.Live in their own drug product development programs by going to: https://dsinpharmatics.com/cmc-live/ or subscribing on your favorite podcast platform

There is no better way to learn about the current CMC and Regulatory environment than to watch, listen and ask questions of subject matter experts as they are actively evaluating the regulations and guidance’s every day in their dealings with small emerging biotech

Ed Narke, Co-Founder at DSI and host of CMC Live’s team of experts.

Successful CMC regulatory strategies minimize compliance risk while maximizing global commercial opportunities for biotech and pharmaceutical sponsors.

Knowing how to develop an effective global CMC strategy is a requirement for regulatory professionals. Understanding the critical importance of monitoring and revising your strategy is perhaps even more vital

Narke

Narke will be joined by Meranda Parascandola, Head of Market Research and Business Development; Brian Lihou, Head of CMC Operations at DSI. This team does all the exploration and provides actionable strategic ideas backed by technical and fundamental analysis through real-world experience.

CMC.Live gives subscribers the experience of being in the room with subject matter experts for more than 30 minutes each week. Active drug sponsors get a first look at the week’s potential hot topics before or during their own internal strategic decision points, thru a dive deep with real-time reactions from CMC.Live guests.

Once subscribed, CMC.Live subscribers get unlimited access to upcoming and recent shows. CMC.Live broadcasts every Friday. If a subscriber misses an episode, he or she can watch a week’s worth of recent episodes at their convenience. Shows will be added to the CMC.Live archives shortly after the broadcast concludes.

To start your subscription to CMC.Live, please visit https://dsinpharmatics.com/subscribe and to learn more about all that DSI has to offer, go to dsinpharmatics.com.

About DSI

Design Space InPharmatics (DSI), is an Industry Leader in Regulatory Drug Development. ARE YOU DEVELOPING PRODUCTS WITH THE INTENTION OF MARKETING, LICENSING, OR DIVESTING?

DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.

Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.

© 2020 Design Space InPharmatics, LLC. All rights reserved. Corresponding logos are registered trademarks of Design Space InPharmatics, LLC

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Meranda Parascandola
Meranda Parascandola
Meranda Parascandola is a member of the DSInpharmatics team and has written a variety of blog posts which you can read here.