E176 | FDA Guidance on AI in Drug Development & Orphan Drug Development

In this episode, former FDA leader and current SVP of Regulatory and Quality at Ariana Data Intelligence, Dr. Frederico Goodsaid, shares cutting-edge insights on how artificial intelligence (AI) is reshaping the landscape of drug discovery and development — particularly in the treatment of rare and orphan diseases.

From breaking down the FDA's new guidance on AI to explaining why credibility now matters more than explainability, this conversation offers essential takeaways for professionals in biotech, pharma, regulatory affairs, clinical trials, and digital health.

In This Episode, You'll Learn:

• How the FDA defines and regulates AI tools in drug development
• The evolving concept of “credibility” in machine learning models
• Why AI is essential for rare disease research with small patient populations
• Challenges with black-box algorithms and how to overcome them
• How real-world evidence and genomic data are driving drug repurposing
• The FDA's stance on continuous learning AI systems
• Strategic advice for pharma companies adopting AI under regulatory scrutiny

About the Podcast:

AI for Pharma Growth  is a podcast focused on exploring how artificial intelligence can revolutionise healthcare by addressing disparities and creating equitable systems. Join us as we unpack groundbreaking technologies, real-world applications, and expert insights to inspire a healthier, more equitable future.

This show brings together leading experts and changemakers to demystify AI and show how it’s being used to transform healthcare. Whether you're in the medical field, technology sector, or just curious about AI’s role in social good, this podcast offers valuable insights.

AI For Pharma Growth is the podcast from pioneering Pharma Artificial Intelligence entrepreneur Dr. Andree Bates created to help organisations understand how the use of AI based technologies can easily save them time and grow their brands and business. This show blends deep experience in the sector with demystifying AI for all pharma people, from start up biotech right through to Big Pharma. In this podcast Dr Andree will teach you the tried and true secrets to building a pharma company using AI that anyone can use, at any budget.

As the author of many peer-reviewed journals and having addressed over 500 industry conferences across the globe, Dr Andree Bates uses her obsession with all things AI and futuretech to help you to navigate through the, sometimes confusing but, magical world of AI powered tools to grow pharma businesses.

This podcast features many experts who have developed powerful AI powered tools that are the secret behind some time saving and supercharged revenue generating business results. Those who share their stories and expertise show how AI can be applied to sales, marketing, production, social media, psychology, customer insights and so much more.

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