HOSTED BY
DIGITAL CMC BASECAMP
Your journey towards high-performance drug development starts here
- TUESDAY, MAY 14TH 2024
- BOSTON, MA
Start the journey to tomorrow’s CMC
Every digital transformation story has a beginning. Coming to Digital CMC Basecamp is the first step for life science leaders interested in starting their journey. These exclusive events capture the energy and authenticity of the Digital CMC Summit, but in a smaller, more intimate setting where the life science community can speak freely and discover the innovative ideas, solutions, and strategies that will change drug development for the better.
World-class speakers
Hear from leaders who are spearheading drug development’s digital transformation.
Expert thought leaders
Share the air with some of the industry’s most renowned process, manufacturing, and innovation specialists.
Open forum
Join the kind of real, authentic conversation that can spark and sustain transformation.
Exclusive networking
See why Basecamp is perfect for making new connections, starting new discussions, and discovering fresh ideas.
What to expect at Digital CMC Basecamp
Come be part of the digital revolution in CMC: a movement that’s driving the operational, scientific, and analytical modernization of the drug development process.
Join your peers to take a fascinating, in-depth look at how CMC leaders are enhancing their risk management strategies, and creating unprecedented process intelligence.
Learn
Gather new strategies for breaking down CMC’s operational silos.
Connect
Share a unique deep-dive experience with fellow innovation experts.
Explore
Discover new approaches to enhancing productivity and mitigating risk.
Unlock
See how powerful CMC data can be with the right models and structures.
See what's in store
- Basecamp Schedule
Official Digital CMC Basecamp registration starts Tuesday afternoon.
The digital transformation of pharma is underway, and it’s a strategic priority for businesses and regulators. The audience here is leading the charge.
Speaker: Luke Guerrero, COO, QbDVision
Format: Speaking Session
Overview:
The future of CMC will be shaped by digitization and digitalization supported by structured data frameworks. This presentation will focus on how structuring your CMC data is foundational to the development of a vertically integrated knowledge base for lifecycle management. Specifically, key topics will be explored such as bridging the chasm between development and manufacturing and how a structured CMC framework can provide rich contextualization to data in data lakes and data warehouses. The advent of AI has created many opportunities to leverage the vast amounts of data generated by pharma and biotech companies. Explore how structured data can make the application of AI tools more robust.
Join us for discussions on:
- Structured Data Frameworks Fit for Pharma/Biotech Development
- Hierarchy of Taxonomies and Ontologies Supporting Structured Frameworks
- Building A Vertically Integrated Knowledge Base Using a Digital CMC Approach
- How Structured Data Will Support the Future of Regulatory Submissions
Presentation: How Structured Data Frameworks Will Support Successful Application of AI in CMC Workstreams
Speaker: Yash Sabharwal, Director, CEO, Co-Founder QbDVision
Format: Speaking Session
Overview:
Explore the transformative role of Digital CMC solutions and how they address the challenges faced by life science companies throughout pre-commercial development stages. Modern PLM and end-to-end lifecycle management technologies are revolutionizing how pharma and biotech deliver new therapies to patients. These tools have been shown to enhance operational efficiencies, streamline regulatory initiatives, and accelerate key workflows from R&D through commercial phases. Learn how these platforms contextualize data across multiple teams, systems and sites to provide a holistic view of development activities for commercial translation and regulatory compliance.
Join us for discussions on:
- How organizations are thinking about Digital CMC to drive operational and regulatory efficiency
- How organizations are addressing the challenges of bridging their development and manufacturing organizations
- Perspectives from organizations operating at different scales on their Digital CMC journeys
Moderator: Mike Stapleton, Board Director at QbDVision
Panelists:
Greg Troiano, Head of cGMP Strategic Supply & Operations, mRNA Center of Excellence, Sanofi
Pat Sacco, Senior Vice President Manufacturing, Quality, and Operations, SalioGen
Rachelle Howard, Director of Manufacturing Systems Automation and Digital Strategy at Vertex Pharmaceuticals
Matthew Schulze, Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering
Mark Fish, Managing Director, Accenture
Format: Panel Session
Break time! Beverages and Snacks will be provided. Socialize and network with speakers and attendees.
Overview:
The advent of newer technologies and advanced modalities has reinstated CMC as a critical enabler of life changing therapies. This incredible superpower to touch lives also comes with greater responsibility towards our scientists. How can CMC scientists be even more focused on science? How can we make their everyday work more meaningful? This talk will apply the lens of how standardization and digitalization across the value chain can make work more efficient and impactful for the scientists.
Join us for discussions on:
- Big trends defining the future CMC paradigm.
- Key opportunities for standardization and digitalization across the value chain from a biotech and big pharma perspective
- Making the workplace more exciting for the scientists of today and the future
Speaker: Vijay Raju, Vice President, CMC at Pioneering Medicines/Flagship Pioneering
Format: Keynote Speaking Session
Overview:
Explore the tangible impact of Digital CMC implementation through insightful conversations with industry trailblazers. Delve into their strategies for utilization, project deployment, integration with teams and systems, and other crucial aspects. Gain exclusive access to the firsthand experiences and valuable insights shared by the pioneers of Digital CMC.
Join us for discussions on:
- Opportunities for making the transition from legacy knowledge management to a modern digital CMC ecosystem
- Leveraging a Digital CMC approach to bring structure and context to primary data systems (e.g. ELNs, LIMS, Historians)
- Linking control strategy discussions with automation and control systems design
- Integration of Digital CMC technologies with downstream solutions (e.g. MES, ERP) to streamline the transfer into commercial operations.
Presentation: Data Strategies for CMC to Support Lifecycle Management
Moderator: Luke Guerrero, COO, QbDVision
Speakers:
Diana Bowley, Associate Director, Data & Digital Strategy, AbbVie
Chris Puzzo, Solution Architect, Digital & Data, Zaether
Victor Goetz, Ph.D, Executive Director, TS/MS New Modalities and Data Strategy, Eli Lilly and Company
Format: Presentations followed by live Q&A with Panel
Location: Glass House [Get Directions]
Featured speakers & moderators
KEYNOTE SPEAKER
Vijay Raju
Vice President, CMC Management, Flagship Pioneering
Vijay currently leads CMC activities to deliver on Pioneering Medicines portfolio. The portfolio is built on Flagship Pioneering’s bio-platforms covering multiple modalities (small molecules, biologics, cell & gene therapies). Vijay was previously in technical leadership roles at Novartis.
KEYNOTE SPEAKER
Vijay Raju
Vice President, CMC Management, Flagship Pioneering
Vijay currently leads CMC activities to deliver on Pioneering Medicines portfolio. The portfolio is built on Flagship Pioneering’s bio-platforms covering multiple modalities (small molecules, biologics, cell & gene therapies). Vijay was previously in technical leadership roles at Novartis.
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Basecamp
Request an invite to Digital CMC Basecamp
Welcome to Digital CMC Basecamp! Our events are currently exclusive and invite only.
If you’re interested in attending and believe you’d be a valuable addition to our community, please fill out the form on the right and tell us why you’d like to join us.