This AI-generated conversation explores the challenges of implementing AI in pharma accurately, reliably and safely, particularly given the stringent requirements of good practice (GxP) regulations and the need to enhance trust among stakeholders, including regulatory authorities, healthcare professionals, and patients. 

It is based on the BioPhorum publication Implementing AI systems in regulated pharma environments and key takeaways include: 

1. The whole AI lifecycle needs to be managed 
2. It's a risk-based approach with risk management throughout 
3. Setting clear objectives and scope creates the essential focus for success 
4. For reliable AI, data needs to be really well managed 
5. Algorithm selection and model design needs discipline to create assurance 
6. Deployment is about thinking of the whole system, which could include many AIs 
7. Data drifts, so ongoing monitoring and evaluation is essential 
8. Change control includes a much bigger challenge of version management 

You can also watch a 90-min webinar replay by nine of the (real-life) authors who illustrate each point from their experience.

In this episode of BioPhorum connect, we explore the newly published ASTM International standard guide 'Guide for Minimizing the impact of stability testing on batch yield of low yield biopharmaceutical products.'

This guide, authored by BioPhorum members, builds on a foundational BioPhorum publication developed through collaboration among 12 companies in the Advanced Therapy Medicinal Products (ATMP) space, particularly focused on gene therapies.

Simon Walker, Global Change Facilitator at BioPhorum, is joined by two key contributors to both the original BioPhorum deliverable and the ASTM guide:

1. Gael Debauve, Head of Gene Therapy Analytical Sciences at UCB
2. Madison Lee, Associate Director of CMC Program Management at Regeneron

Together, they discuss:

1. Why minimizing the impact of stability testing is critical for low-yield products
2. How the ASTM International guide expands the scope beyond gene therapies
3. The value of using a mock gene therapy product to quantify potential savings
4. Who in the industry will benefit most from this guidance
5. The collaborative advantage of working through BioPhorum

Whether you're in QC, QA, regulatory affairs, or CMC leadership, this episode offers valuable insights into improving efficiency and conserving product in early-stage development.

Join us for an insightful episode of the BioPhorum podcast, where we delve into the critical topic of cybersecurity in the biomanufacturing industry, which is now woven into the overall vision for digital maturity expressed in the Digital Plant Maturity Model. Hosted by Tim Horton, this episode features expert guests Anderson Goebel from Merck and Tom House from Rockwell Automation, who share their practical experiences and strategies for enhancing cybersecurity in their organizations.

Key topics discussed include:

1. The importance of IT and OT convergence for digital maturity and cybersecurity.
2. Practical steps for implementing cybersecurity frameworks and achieving consistency across organizations.
3. The impact of regulatory changes and validation challenges on cybersecurity practices.
4. The role of tabletop exercises in improving collaboration and risk management.

Don't miss this opportunity to gain valuable insights and learn from industry leaders.

Check out the resources mentioned in the podcast:

1. Digital plant maturity model v3
2. IT vs OT
3. Tabletop exercise to improve incident response

Our AI-generated podcast explores the transformative concept of managing data as a product, and discusses how adopting a data product mindset can revolutionize digital transformation in the pharmaceutical industry. 

Key takeaways include: 

• Understanding the importance of clear data ownership roles 
• Exploring different data architecture strategies like data mesh and data fabric 
• Realizing that a data product is more than just a dataset and what that means for ownership roles 
• Visualizing the lifecycle of a data product and the responsibilities involved.

This AI-generated conversation reviews the recently-published Playbook for digital integration of sponsor and contract organizations (DISCO). With the rise of external manufacturing in the pharmaceutical supply chain, managing numerous partners has become complex. Digital transformation is essential for visibility and flexibility. Practitioners have shared their experiences and practical solutions for moving to digital partnerships. The podcast covers challenges, digital integration, stages of developing partnerships, and crafting collaboration agreements - with a big emphasis on the human factors.

Also available is a public webinar 22 Jan 2025 by eight of the authors

In this episode, Soroosh and Soumen delve into the critical aspects of drug-device co-development, emphasizing the importance of early collaboration between teams to enhance patient safety and streamline processes. They discuss the vital role of biocompatibility testing, highlighting the need for early implementation to avoid delays and ensure regulatory compliance. The conversation also covers the complexities of regulatory challenges, including the variability in review processes across agencies like the FDA and EMA. Finally, Soumen introduces the concept of leveraging platform technology for biocompatibility testing, offering strategies for efficient integration in development programs. Tune in for valuable insights that can help navigate the intricacies of drug-device collaboration!

In this episode, we explore how AI is transforming product development and sustainability initiatives. Robin highlights the importance of leveraging company data throughout the product lifecycle to enhance decision-making and product development. We discuss AI's remarkable ability to synthesize extensive data sets, identify risks, and generate real-world evidence with unparalleled speed and precision. The potential of AI to streamline regulatory and quality documentation processes is also examined, envisioning a future where compliance is maintained effortlessly through automated updates. Soroosh and Robin address the challenges and benefits of data sharing for sustainability, emphasizing AI's role in analyzing sustainability data despite intellectual property and regulatory concerns. Finally, we delve into the future of AI in biopharma and medtech, advocating for a shift from traditional systems to process-oriented approaches, and exploring AI's potential to optimize critical documentation and business processes. Join us for an insightful discussion on the future of AI.

In this podcast, we explore the latest advancements in the cell and gene therapy (CGT) supply chain, focusing on the newly released CGT outbound supply chain tool. We had the pleasure of speaking with two key contributors, Maria and Kelly, who shared their insights on the tool’s usability and its effectiveness in educating stakeholders about the complexities of the CGT supply chain.

As the tool continues to evolve, Maria and Kelly also discuss the potential disruptions during therapy transportation and how addressing these in future updates is crucial for building greater resilience.

Creating this tool is just one of the many benefits of collaboration within the CGT Supply Chain workstream. We invite biomanufacturing and logistics industry representatives to join us for discussions, idea-sharing, and insights from top subject matter experts. Let’s work together to shape the future of CGT supply chains! Get in touch by emailing [email protected] and for more information about BioPhorum Supply Chain to Patient, visit our homepage.

Download the tool here.

Rashitha Jayasekara, Director of Digital & Technology at GSK introduces the BioPhorum Digital Integration for Sponsor and Contract Organizations engagement pack. Intended to be used with partners who are prime candidates for digital integration, it covers, very briefly, some guiding principles and vision, the value proposition, ambition, mechanisms and next steps.

Rashitha Jayasekara, Director of Digital & Technology at GSK

Join MediPhorum program manager, Victoria Ludlow, for a fireside chat with Susan Neadle, a recognized international Combination Products and Medical Device expert with >30 years industry experience.

Networked, published, highly active in numerous industry groups with links to teaching institutions, Susan brings deep knowledge and genuine passion for sharing that knowledge with others, and has been involved across several MediPhorum collaborations including device specification setting for EPRs, Risk Management and Global Regulatory programs.

Join us as she gives an industry update across developments across these three key topics.