B07. Revolutionising pharmaceutical regulatory efficiency: Harnessing the power of AI and LLM

Tracks
Data, Technology and Informatics
Thursday, June 13, 2024
11:15 AM - 12:15 PM
C2.4

Chair & Speakers

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Mr Carl Bufe
Director
PharmOut

Chair: Revolutionizing Pharmaceutical Regulatory Efficiency: Harnessing the Power of AI and LLM

Abstract

In the ever-evolving pharmaceutical and medical device landscape, Artificial Intelligence (AI) and Large Language Models (LLM) have emerged as transformative forces. This presentation explores the pragmatic implications, current applications, and the future of AI in regulatory efficiency.

We delve into how these technologies advance regulatory practices, enhancing outcomes across audits, regulatory intelligence, and daily communications. Real-world AI and LLM applications showcase their pivotal role in streamlining operations and facilitating compliance with evolving regulations.

This is a thought-provoking discussion on the symbiotic relationship between technology and pharmaceutical regulatory practices.

Biography

Carl is a distinguished healthcare professional with over 20 years of experience in the pharmaceutical space, distinguished by unwavering commitment to the integration of artificial intelligence (AI). His multifaceted career encompasses roles in Pharmacovigilance, Regulatory Affairs, Clinical Trials, and Quality Management, where he uniquely combines his technical acumen with healthcare knowledge. Carl, a qualified pharmacist and auditor, boasts additional qualifications in commerce, risk management, and quality systems. He's not only worked alongside industry leaders and multinational corporations but has also been involved with startup organisations. His work transcends borders, collaborating with teams across the USA, UK, EU, China, and various ASEAN countries. As a regional contact in Pharmacovigilance and regulatory intelligence specialist, Carl's involvement has been instrumental in successful regulatory inspections by entities like EMA, TGA, and Health Canada.
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Navid Toosi Saidy
Chief Executive Officer
Propel Health AI

Reimagining Medical Affairs with Real-World Evidence and Generative AI

Biography

Dr Navid Toosi Saidy is the CEO and Co-founder of Propel Health AI, a healthcare data and Artificial Intelligence software platform company established with the mission to make real-world patient data more accessible and actionable. Propel Health AI is building a federated network for healthcare data and decision support exchange between healthcare providers and life sciences companies to enhance patient outcomes and the delivery of care. Navid holds a PhD in biomedical engineering and was previously the Digital Health Leader at a leading Australian Consultancy “Max Kelsen” which was recently acquired by Bain and Company. Drawing on years of experience in the MedTech, Digital Health and R&D sector, he is specialized in transformation of healthcare and life sciences companies towards data driven clinical, operational, and commercial decision making
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Saurabh Jain
CEO
Trialkey.ai

Future-Proofing Medicine: AI's Role in Predicting Clinical Trial Success

Biography

Saurabh Jain is a seasoned leader in the intersection of technology and healthcare, currently serving as the CEO of Opyl, a pioneering publicly listed company at the forefront of AI-assisted technologies for the biopharma and clinical research sectors. With a vision centered on leveraging AI to enhance clinical design, development, and delivery, he spearheads Opyl's mission to empower leading biopharma and health organizations with innovative solutions and expert guidance. His journey into the tech industry began as a software developer, where his passion for innovation and entrepreneurship enabled him to build a successful startup, leading to its acquisition by Telstra. Throughout his 20-year career, he has been a catalyst for change and progress, leveraging his expertise to drive strategic initiatives and foster growth in diverse organizations. His multidimensional experience encompasses senior leadership roles across various boards, where he has consistently demonstrated a knack for navigating complex landscapes and driving impactful outcomes. With a track record of success, a passion for innovation, and an unwavering dedication to advancing healthcare through technology, he stands as a visionary leader poised to shape the future of AI-assisted healthcare solutions at Opyl and beyond.
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