HOSTED BY
DIGITAL CMC BASECAMP
Your journey towards high-performance drug development starts here
- WEDNESDAY, SEP. 18TH 2024
- BASEL, SWITZERLAND
Start the journey to tomorrow’s CMC
Every digital transformation story has a beginning and Digital CMC Basecamp Basel is the first step for life science leaders interested in starting their journey.
Launched in 2022, the Digital CMC Summit connected CMC practitioners with digitalization experts to share ideas and showcase real-world advancements. Now our traveling Digital CMC Basecamp events expand this conversation, accelerating progress across the industry.
These exclusive, regionalized events capture the energy and authenticity of the Digital CMC Summit, but in a smaller, more intimate setting where the life science community can work collaboratively and discuss the innovative ideas, solutions, and strategies that are changing the way therapeutic breakthroughs come to market.
EVENT ABSTRACT
Accelerating Time-to-Market: Reducing Tech Transfer Times Through Digitalization
In the executive suites of most pharma and biotech companies, a key discussion taking place today is the need to significantly reduce the cycle times of drug development. One area of focus to achieve more immediate reductions in cycle time is the set of activities known as tech transfer. Traditionally a document-based process, but today digitalization presents an opportunity to significantly reduces times from the current 18-24 months to 3-6 months.
While the digital maturity of drug discovery and clinical activities have advanced over the past few years, the same cannot be said for the chemistry, manufacturing, and control (CMC) workstreams that are the foundation of pre-clinical to clinical translation and clinical to commercial translation. With 70%-80% of manufacturing data unstructured, the burden on users is high as time is wasted looking for information. And while AI can be a valuable tool, it will still require integrated knowledge that can be used to build process models supported by high-quality empirical data.
This exclusive, one day event, will focus on the digitalization of tech transfer workstreams with an emphasis on how data sitting in ELNs, LIMS, and other data sources can be contextualized and utilized for these activities. These discussions will focus on how companies are thinking about these problems and the technologies and practices that are being deployed to reduce cycle times so that patients can access novel therapies sooner rather than later.
What to expect at Digital CMC Basecamp
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 transforming the drug development lifecycle, powered by a community of CMC practitioners and digitalization experts focused on digitalizing and connecting the CMC ecosystem.
Join your peers to take a fascinating, in-depth look at how thought leaders in our space are advancing key objectives.
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 Wednesday morning.
Session Overview: Introduction & Welcome
Speaker: Luke Guerrero, COO, QbDVision
Format: Speaking Session
Keynote Session Overview:
Despite its importance in the process of developing innovative medicines, Chemistry, Manufacturing, and Controls (CMC) is often overshadowed by clinical development. Due to recent global industry trends, CMC leaders are now facing new challenges including unprecedented time and resource pressures. In this session, we’ll discuss key trends shaping the Pharma Technical Development space and latest perspectives on how digital CMC transformation can help address them.
Join us for discussions on:
- Trends shaping pharma technical development
- Vision for digitally enabled CMC development and key areas of digital adoption across top Pharma CMC organizations
- CMC industry success stories and learnings from outside of CMC
- Success factors and best-in-class approaches to digital transformations in Pharma R&D
Speaker: Paweł Póda, Pharma R&D Expert, McKinsey & Company
Session Overview: Learn what's in store for the Digital CMC movement.
Speaker: Mike Stapleton, Board Member, QbDVision
Format: Speaking Session
Food and beverages will be provided. Socialize and network with speakers and attendees.
Panel Session Overview:
In this panel discussion, we explore how Digital CMC optimizes documentation management, regulatory compliance, and tech transfer, while GenAI augments these processes with predictive modeling and analytics. We’ll delve into the regulatory and ethical considerations, proposing collaborative solutions to shape the future of pharmaceutical research and manufacturing.
Moderator:
Mark Fish, Managing Director, Accenture
Panelists:
Fran Leira, Global Head of Process Engineering CoE, CSL Behring
Chris McCurdy, Chief Architect of Healthcare and Life Sciences, AWS
James Maxwell, Life Sciences Innovation Lead, Accenture
Joschka Buyel, Director of Product Management, QbDVision
Grab a drink and socialize and network with speakers and attendees.
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.
Format: Speaking Sessions
15:15 | Case Study: Lower Cost Platform-Based Process Transfer Workflow Using QbDVision
The time needed to move CMC projects into clinical phases is a crucial performance indicator of CMC organizations. Amongst others, the scale-up and transfer of a manufacturing process from a non-GMP or GMP facility into another GMP facility can be a time-consuming path to BLA. At Bayer, process transfer requires the engagement of multiple SMEs to identify and assess process changes and facility gaps, which need to be reported and approved by quality assurance prior to being translated into site-specific batch records.
With Bayer, we took a new approach by leveraging the capabilities of QbDVision to define and govern our platform manufacturing process as a starting point for the process transfer of incoming CMC projects. With this approach, it was possible to drastically reduce the number of changes that needed in-depth discussion by relying on the platform knowledge, which was already built into QbDVision. This approach also provided the possibility to control, moderate, and trace back platform changes on a single parameter level. It’s estimated that by following this approach, we can reduce labor costs by up to 80%, depending on the unit operation.
Speakers: Florian Aupert, Lab Head, Biological Development, Bayer AG
Isabell Hagemann, Scientific Assistant, Biological Development, Downstream, Bayer AG
15:35 | Lighting Talk Overview: The Move Towards Structured Product Quality Submissions
The regulatory landscape is evolving as the FDA, EMA, and ICH move progressively towards structuring the CTD Module 3 submissions. This session will highlight an industry view on how ISO IDMP can serve as a foundational framework for structuring product and substance information by expanding it and combining it with the work done by FDA PQ-CMC and Accumulus PQ Industry, as well as discussing why a common standard data model for CMC information and international alignment of terminology and referential can enable interoperability in the pharma industry.
Speaker: Laurent Lefebvre, RA CMC Director, Novartis
15:55 | Lighting Talk Overview: Based on case studies, the talk will look at topics related to process, data, organisation, and technology that support a digital CMC strategy and delivery.
Speaker: Paul Denny-Gouldson, CSO, Zifo
16:15 | Panel & Audience Q+A
Moderator: Luke Guerrero, COO, QbDVision
Session Overview: Closing Remarks
Speaker: Luke Guerrero, COO, QbDVision
Format: Speaking Session
Join us at Movenpick for the Basecamp Afterparty and enjoy complementary dinner, drinks and networking.
Location: Movenpick | 4th Floor [Get Directions]
Featured speakers & moderators
Check back soon for more speaker announcements
KEYNOTE SPEAKER
Paweł Póda
Pharma R&D Expert, McKinsey & Company
A Pharmaceutical R&D expert specializing in Technical Development topics, Paweł has 13 years of experience supporting top pharmaceutical companies in their CMC and launch-related challenges. He currently co-leads the global CMC service line at McKinsey and hosts the McKinsey CMC Forum which has been convening CMC leaders from across the industry for the last 12 years.
KEYNOTE SPEAKER
Paweł Póda
Pharma R&D Expert, McKinsey & Company
A Pharmaceutical R&D expert specializing in Technical Development topics, Paweł has 13 years of experience supporting top pharmaceutical companies in their CMC and launch-related challenges. He currently co-leads the global CMC service line at McKinsey and hosts the McKinsey CMC Forum which has been convening CMC leaders from across the industry for the last 12 years.
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Afterparty
Hotel Mövenpick Basel | Executive Lounge | 4th Floor
Aeschengraben 25, 4051 Basel, Switzerlandat
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.
