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Episode: 10 - Gene Therapy Analytics: How to Make the Right CMC Investments for Your Business

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Content provided by Evaluating Biopharma. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Evaluating Biopharma or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ro.player.fm/legal.

In this episode of Evaluating Biopharma, Mike Kelly, Senior Vice President at Atsena Therapeutics, shares his experiences and provides his advice on how your company can make proper CMC investments to reduce risk and maximize ROI, including: the make or buy decision, ensuring CMC investment to provide regulators what they need, scalability considerations, identifying technologies and assays to support your strategy, controlling COGS, and building a commercially feasible program profile. He also discusses factors that smaller businesses need to consider when choosing who to work with, such as fully understanding your needs and the compatibility between the sponsor and service provider in terms of technical capability, operational capability, management experience, and problem-solving tactics.
Links from this episode:
Evaluating Biopharma
Black Diamond Networks
Atsena Therapeutics

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

  continue reading

18 episoade

Artwork
iconDistribuie
 
Manage episode 371073006 series 3394448
Content provided by Evaluating Biopharma. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Evaluating Biopharma or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ro.player.fm/legal.

In this episode of Evaluating Biopharma, Mike Kelly, Senior Vice President at Atsena Therapeutics, shares his experiences and provides his advice on how your company can make proper CMC investments to reduce risk and maximize ROI, including: the make or buy decision, ensuring CMC investment to provide regulators what they need, scalability considerations, identifying technologies and assays to support your strategy, controlling COGS, and building a commercially feasible program profile. He also discusses factors that smaller businesses need to consider when choosing who to work with, such as fully understanding your needs and the compatibility between the sponsor and service provider in terms of technical capability, operational capability, management experience, and problem-solving tactics.
Links from this episode:
Evaluating Biopharma
Black Diamond Networks
Atsena Therapeutics

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

  continue reading

18 episoade

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