Registration Now Open

 

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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

Goal: Identify and unpack critical challenges across focus areas

 

• 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 Recap & Closing Remarks (Day 1 Summary and Next Steps)

• 06:00-8:00 Group Dinner  (Details to follow)           

 

Day 2 – Synthesis & Opportunity Mapping
Goal: Review distilled input and define actionable project proposals

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• 08:30-09:00 Breakfast & Registration

• 09:00-10:00 Recap of Day 1 & Synthesized Problem Themes 

Facilitator-led readouts from Day 1’s sessions (Consolidated summaries will cover both in-person and remote boards for each of the three sessions)

• 10:00-11:15 Session 1:Opportunities & Proposals – CMC & Regulatory Submissions

• 11:15-11:30 Break

• 11:30-12:45 Session 2: Opportunities & Proposals – Digital Manufacturing

• 12:45-01:15 Lunch

• 01:15-02:30 Session 3: Opportunities & Proposals – Analytical Methods

• 02:30-02:45 Break

• 02:45-03:15 Prioritization, Next Steps

• 03:15-03:30 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.​