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2025 July Allotrope® Connect Workshop

Companies and Organizations Registered to Attend:

Amgen • AWS • Bio-Rad • Brigham Young University • Bristol Myers Squibb • Continua Process Systems

Registration is now closed

 

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Please join us in shaping the future! The next Allotrope® Connect Workshop is taking place on July 8–9, 2025, in Philadelphia.  We invite industry and not-for-profit experts in lab informatics, digital transformation, regulatory science, technology, and manufacturing to collaborate on finding solutions for today’s pressing lab and manufacturing challenges.  In the workshop, we will bring together community experts to interactively explore real-world problem statements (see below) in the following areas with the goal of defining new pre-competitive project proposals that will combine the efforts across organizations to accelerate the pace of digital transformation.

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  • CMC and Regulatory Submissions

  • Digital Manufacturing

  • Analytical Methods

More information on the problem statements is available below and at the following link

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Attendees are welcome to share their perspectives in a brief document or slide, if they wish. These materials may be presented during the workshop and can optionally be submitted in advance to the event organizers for feedback.

 

Participation is open to the public, regardless of Allotrope membership, and is free to attend. While we hope you can join us in person, remote participation will be accommodated upon request. For assistance, please contact the event organizers info@allotropefoundation.org.

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Discovery Questions

To help maximize the value of our upcoming discussions, we encourage all participants to review the discovery questions in advance. The discovery questions document is available at link. These are designed to guide your organization’s thinking around key problems and challenges. Participants are welcome to submit their initial responses ahead of the meeting; any input shared in advance will be pre-loaded onto the discovery boards to help jump-start the conversation. Send you feedback to info@allotropefoundation.org

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Agenda

Day 1 – Problem Discovery & Exploration

  • 09:00-09:45 Breakfast & Registration

  • 09:45-10:00 Welcome & Introduction

  • 10:00-12:00 Session 1: Problem Discovery – CMC & Regulatory Submissions

  • 12:00-12:45 Lunch

  • 12:45-02:45 Session 2: Problem Discovery – Digital Manufacturing

  • 02:45-03:00 Break

  • 03:00-05:00 Session 3: Problem Discovery – Analytical Methods

  • 05:00-05:30 Closing Remarks - Getting Ready for Day 2

  • 06:00-08:00 Group Dinner  (Details to follow)           

 

Day 2 – Prioritization & Project Proposal

  • 08:30-09:00 Breakfast & Registration

  • 09:00-10:45 Session 1: CMC & Regulatory Submissions

  • 10:45-11:00 Break

  • 11:00-12:45 Session 2: Digital Manufacturing

  • 12:45-01:15 Lunch

  • 01:15-03:00 Session 3: Analytical Methods

  • 03:00-03:30 Next Steps & Closing Remarks

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​Workshop Location

Allotrope Secretariat Offices - Faegre Drinker Biddle and Reath, LLP
1 Logan Square
Philadelphia, PA 19103

 

​​​​​Problem Statements

Problem Statement #1 - CMC and Regulatory Submissions

Chemistry, Manufacturing, and Controls (CMC) information collected during pharmaceutical development often lacks seamless accessibility, contextual relevance, and integration. In an increasingly digital landscape, there is a critical need to transform this fragmented data into ready to use, structured, and connected knowledge with unambiguous materials and data genealogy. Without such transformation, the authoring, review, and submission of high quality regulatory filings will remain inefficient and slow processes which don’t serve the needs of patients, regulators, or innovators.

 

Problem Statement #2 - Digital Manufacturing

Application of digital solutions during manufacturing is important to consistently capture the materials, procedures, equipment, methods, and instruments planned in a process recipe, as well as the actual processing results obtained during batch execution. As manufacturing processes evolve and details change, results must be compared across process versions to feed quality data into reliable AI/ML predictions and form the basis of suitable control strategies. However, this is quite challenging with the current fragmented digital manufacturing ecosystem of solutions and inconsistency in data strategies across research and manufacturing operations. The end result is process transfers are slow, resource intensive, and prone to errors which impact right first time manufacturing objectives.

 

Problem Statement #3 - Analytical Methods

Analytical methods are typically manually captured in either electronic documents or as structured tabular information in a software application. Manual entry is subject to mistakes, inconsistencies, and incomplete information that is unintentionally passed on to future users of the method during transfers. To meet today’s digital challenges, methods instead should be machine-readable instructions that interact directly with software to improve data integrity, and linked to results to simplify interpretation and troubleshooting.​

Problem Statements

Participants Sharing Space

In preparation for the July 2025 Connect Workshop, we’ve added a Participants Sharing Space to this event page to highlight profiles, solutions, and relevant contributions from participants and their organizations. If you’d like to be included, please send the following to the Allotrope Product Team: amnon.ptashek@allotropefoundation.org Please include the following information:

  • Organization name

  • Participant name and email

  • Subject/title of the shared information

  • Short! 1–2 sentences with description

  • A link to the relevant resource (e.g., company profile, solution overview, publication, or another related artifact)

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Shared Artifacts Space

Shared Artifacts Space

1. Digital Manufacturing Perspective: Link​​

Shared by: Gene Tung, Hailio Technologies​

 

2. Developing Framework for Accelerating Digital Tools use in Regulatory CMC Submissions: Link

Shared by: Dr Ian Houson, Digital CMC CERSI

The Digital CMC CERSI is a Centre of Excellence for Regulatory Science and Innovation (CERSI) formed to accelerate the adoption of digital technologies in regulatory processes to ensure faster, more efficient delivery of medicines to patients with reduced environmental impact.  Working collaboratively with a consortium of partners, it will drive the integration of technologies such as AI, machine learning, and hybrid models in regulatory frameworks for Chemistry, Manufacturing, and Control (CMC). â€‹â€‹

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3. Data & AI Driven Digital Labs - Applying FAIR principles to Life Sciences Data Capture, Management, and Analysis

Shared by: Lee Tessler, PhD, Principal Tech Strategist, Life Sciences, Amazon Web Services

Background: AWS works with biopharmas to build next-generation connectivity foundations, data platforms, and AI solutions to host scientific algorithms and workflows.

Customer signals: Standard metadata and standard measurement data, including ASM, are of increased interest by biopharmas, and the ability to have that integrated with AWS services will benefit the biopharmas deploying these new ecosystems.

Opportunity: As the Allotrope Foundation continues to identify and prioritize their needs in this problem space, there are several AWS Services that we can potentially bring to the table and work to match with those needs.

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4. Lab of the Future – Summary: Link​​

Shared by: ​Sean Ruane, PhD, Principal Scientist – Data Science, CPI

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5. SciY - Digitalization, Automation and AI Readiness from R&D to Manufacturing (Please refer to the links below)

Shared by: Anna Codina, Ph.D, Senior Director Strategy & Business Development, SciY

Designed to support your digitalization journey, the SciY Digitalization Suite integrates a wide range of best-in-class technologies and capabilities originally developed by Mestrelab, Optimal, ZONTAL, Arxspan and LOGS, now harmonized within the Bruker ecosystem.

•  www.sciy.com

•  SciY solutions overview brochure: Link
•  Webinar "Enhance Processes from R&D to GMP Manufacturing: synTQ and ZONTAL Integration" Form Process Control to True Digitalization
•  Peer Review Article: The Pistoia Alliance's methods database project: Instrument, chromatographic data system, and vendor-agnostic digital transfer of machine-readable high-performance liquid chromatography-ultraviolet methods using the allotrope data format
•  Newsletter (including Mnova to Allotrope ASM): Business Continuity and Growth: From Legacy ELNs to Real-Time, Data-Driven Decisions
•  Flyer: Post-Merger Data Confidence: Unlocking the Ful Value of Acquired ELNs: Link 

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6. End to End Digital Twins for CMC innovation: Link

Shared by: Dr Christoph Herwig, Senior Scientific Advisor, Körber Pharma Austria

We provide a cloud-native software platform for the pharmaceutical and biotech industry, providing seamless integration of end-to-end data management, AI, and digital twin capabilities within a single platform. This includes End to End Digital Twins for CMC innovation, such as holistic control strategies and real time release

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7. Use of AFO and ASM: Link

Shared by: Amnon Ptashek, Allotrope Foundation

A light introduction to the Allotrope Foundation Ontology (AFO) and Allotrope Standard Model (ASM), both designed to support FAIR (Findable, Accessible, Interoperable, Reusable) data in laboratory environments. AFO offers a federated, modular, and extensible ontology structure to harmonize terminology and context across systems. ASM complements this with a modular, consistent, and scalable data model for capturing and structuring scientific data. Together, they enable seamless data integration, as illustrated by examples such as the Plate Reader use case. Allotrope Framework products built on AFO and ASM standardize data capture, flow, and analytics across diverse instruments and platforms, supporting efficient data reuse, interoperability, advanced analytics, automation, and data-driven applications in both research and manufacturing.

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