Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Featured Sessions
Lifecycle Management Considerations for C&G Therapy
Oct 14, 2024 | 1015 - 1045
Presenter: FDA
This session will illuminate the challenges and opportunities inherent in the lifecycle management of cell and gene therapy products. From initial development stages to post-market considerations, attendees will gain invaluable insights into the regulatory pathways crucial for navigating the dynamic healthcare ecosystem.
Global AI Healthcare Regulations: Trends and Future
Oct 14, 2024 | 1300 - 1330
Presenter: Attrayee Chakraborty, Northeastern University
Artificial intelligence (AI) is rapidly transforming the healthcare sector. With over 520 AI medical algorithms cleared by the FDA and a growing number of AI-enabled devices, staying ahead of regulatory trends is crucial. This session will provide in-depth insights into the regulatory landscape for AI in the medical device industry worldwide.
Regulatory Considerations on Complex APIs' Sameness
Oct 15, 2024 | 1015 - 1045
Presenter: Maotang Zhou, FDA
Navigating the regulatory landscape for complex Active Pharmaceutical Ingredients (APIs) is a significant challenge. Complex APIs, often composed of multiple components with varying molecular weights, cannot be characterized using traditional analytical techniques. The FDA recommends a comprehensive “totality-of-the-evidence” approach to assess API sameness in generic drug products.
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Nikolai Makaranka
Mon, 14 Oct
Tue, 15 Oct
1045 – 1115
Digital Transformation
Nikolai Makaranka, Bristol Myers Squibb
There is a lot of buzz surrounding AI and its potential to revolutionize various industries, including pharma. However, despite the hype, the adoption of AI often lags, and its actual implementations remain limited to proof-of-concepts. This presentation will bridge this gap by showcasing an in-house-built AI solution that leverages the latest advancements in NLP for deviations analysis.The presentation will walk the audience through practical aspects of building and scaling an AI solution, focusing on key points such as preparing data and training a model. It will delve into the business impact of the solution and, whenever possible, demonstrate examples where the solution adds value. Specifically, it will demo search capabilities, similarity or recurrence analysis, and automated trending. Furthermore, the presentation will address a crucial aspect of building an AI solution -- assessing solution's performance. It will discuss what a validation protocol might look like for AI solutions to ensuring their reliability and effectiveness.Lastly, the audience will be guided through steps to kickstart the adoption of AI for Quality within their organizations. By the end of the presentation, attendees will have a clear understanding of how to leverage AI to reengineer and enhance quality processes.
1530 – 1700
Digital Transformation
Michael Schmeiszer, Sanofi
Nikolai Makaranka, Bristol Myers Squibb
Michael Crowthers, Deloitte & Touche LLP
Nick Armstrong, CAI
Brandi Stockton, The Triality Group, LLC
Nader Shafiei, Sanofi
1530-1600: Responsible Use of AI in a Regulated Environment by Michael Schmeiszer and Nade Shafiei
The rapid evolution of Artificial Intelligence (AI) brings immense opportunity to the pharmaceutical and biotech industries to boost drug discovery, accelerate development, and increase efficiency in manufacturing. At the same time the regulatory environment is still very much in flux and robust regulatory guidance does not yet exist.The combination of rapid innovation and uncertain regulatory context creates a high-risk environment for companies that want to adopt AI at scale across the value chain.We will discuss a framework to assess AI-related risks and implement appropriate controls in a pragmatic way, leveraging existing system life-cycle processes, to enable both innovative and responsible use of AI in a regulated environment.
1600-1700: AI Discussion Panel - Reflections on Past Missed Opportunities (QbD, PAT) and How to Navigate AI for Success
Join our expert panel as we reflect on missed opportunities in QbD and PAT, exploring how the biopharmaceutical industry can learn from past experiences to successfully navigate AI implementation. While AI holds immense potential to revolutionize the industry, adoption has been uneven. We'll delve into the challenges faced, including data quality, regulatory hurdles, talent shortages, and ethical considerations, discussing how to overcome these obstacles and leverage AI's transformative power in a rapidly changing technological landscape.
The rapid evolution of Artificial Intelligence (AI) brings immense opportunity to the pharmaceutical and biotech industries to boost drug discovery, accelerate development, and increase efficiency in manufacturing. At the same time the regulatory environment is still very much in flux and robust regulatory guidance does not yet exist.The combination of rapid innovation and uncertain regulatory context creates a high-risk environment for companies that want to adopt AI at scale across the value chain.We will discuss a framework to assess AI-related risks and implement appropriate controls in a pragmatic way, leveraging existing system life-cycle processes, to enable both innovative and responsible use of AI in a regulated environment.
1600-1700: AI Discussion Panel - Reflections on Past Missed Opportunities (QbD, PAT) and How to Navigate AI for Success
Join our expert panel as we reflect on missed opportunities in QbD and PAT, exploring how the biopharmaceutical industry can learn from past experiences to successfully navigate AI implementation. While AI holds immense potential to revolutionize the industry, adoption has been uneven. We'll delve into the challenges faced, including data quality, regulatory hurdles, talent shortages, and ethical considerations, discussing how to overcome these obstacles and leverage AI's transformative power in a rapidly changing technological landscape.
Michael Schmeiszer
Head, Digital Risk & Compliance, Strategy & Governance
Sanofi
Sanofi
Nikolai Makaranka
Director, Manufacturing Analytics
Bristol Myers Squibb
Bristol Myers Squibb
Michael Crowthers
Managing Director
Deloitte & Touche LLP
Deloitte & Touche LLP
Nick Armstrong
Sr Director, Digital Enablement
CAI
CAI
Brandi Stockton
Founder | Managing Partner
The Triality Group, LLC
The Triality Group, LLC
Nader Shafiei
Head, Digital Risk & Compliance – Data and SaMD
Sanofi
Sanofi
Hear From Top Industry Thought Leaders and Regulators on the Challenges and Solutions Impacting the Pharmaceutical Industry
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.