Jack Prior. At the interface of Biologics Manufacturing & AI/Data Science.

I work at the interfaces of biologics manufacturing. Between development and manufacturing, data science and manufacturing science. Today that work is mostly about AI. Getting the data ready is the way in, and agentic AI is finally making it real.

I lead process monitoring and data science/AI strategy across a global biologics manufacturing network, with nearly thirty years in biologics CMC and an Sc.D. from MIT, where I first put AI to work on biologics problems nearly forty years ago. More about me, or get in touch.

Upcoming

MIT Center for Biomedical Innovation event page for the CAACB Fall 2026 Workshop, a hybrid closed event November 17 to 19 at the Samberg Conference Center, Cambridge MA

MIT CAACB Fall 2026 Workshop, Cambridge November 19, 2026
Invited talk: "Are We There Yet? A Data Readiness Scorecard for Process Monitoring and AI, from Routine Variation to Contamination Events"

MIT Center for Biomedical Innovation's 2026 BioMAN Summit site: Artificial Intelligence, Sensing, and Automation in Biomanufacturing, December 9 to 10, Samberg Conference Center

MIT CBI BioMAN Summit, Cambridge December 9–10, 2026
Talk and discussion moderator: "BioMetre and AI-mAb: Tools to Evaluate Data and Agentic AI Readiness in Biologics Manufacturing"

IBioNe Webinar Series, UMass Lowell December 14, 2026, 11:00 AM ET
Webinar: "BioMetre and AI-mAb: Evaluating Data and Agentic AI Readiness in Biologics Manufacturing"

BILS 2027 promo: Jack Prior, keynote and panelist, Bio Innovation Leaders Summit, Hotel Palace Berlin

Bio Innovation Leaders Summit, Berlin February 10–11, 2027
Keynote and panelist: "Process Intelligence at Scale"

Pharma Manufacturing Summit USA 2027 speakers page, March 10 to 11 at the Sheraton Boston, with Jack Prior among the Sanofi speakers

Pharma Manufacturing Summit USA, Boston March 10–11, 2027
Case study: "From Data to Decisions"

BPI US West 2027 featured speakers: Michael Coolbaugh, Verzhiniya Aho, Jack Prior, Richard Braatz

BPI West 2027, San Diego March 16–18, 2027
Keynote: "Are We There Yet?"

Process Monitoring AI Projects

Readiness

BioMetre

A framework that scores how ready an organization's data is for AI, turning a vague question into a number you can track and improve. It anchors the "Are We There Yet?" digital maturity model I present, and I am working to establish it as an industry benchmark.

Build and test

AI-mAb

An open simulator that generates realistic biologics process data, so AI tools can be developed and stress-tested without waiting on scarce or proprietary datasets. Non-proprietary and available to the field.

Podcast, English edition

AI in Biopharma Manufacturing: Are We There Yet?

Season 1 reads the regulatory frameworks taking shape for AI in pharmaceutical manufacturing as they are written: EU GMP Annex 22, the FDA's AI credibility framework, the EU AI Act, the EMA reflection paper. One question per episode, thirty minutes, built for a walk. Nine episodes plus a trailer, each with a transcript and a fact-check against the source documents.

YouTube Apple Podcasts Spotify RSS feed

Podcast, édition française

On y est ? L'IA dans la production biopharmaceutique

L'édition française : les neuf mêmes épisodes, traduits ligne par ligne à partir des scripts anglais vérifiés et lus par des voix d'IA françaises, avec leur propre flux et leurs propres pages d'épisode. Sam et Sarah gardent leurs prénoms ; les documents gardent leurs titres officiels en français.

YouTube Apple Podcasts Spotify Flux RSS

Reference

AI-in-CMC Regulatory Map

My working notes on the rules of the road: an interactive map of the regulations, guidance, harmonised guidelines, standards and industry papers that govern AI in pharmaceutical development, manufacturing and quality — with a timeline, model-impact tiers, and the change-control instruments that connect them. Public sources only, updated as the landscape moves.

Job aid

Manage AI Risk in Five Steps

FDA, EMA, ICH, Annex 22, BioPhorum and GAMP each grade AI in their own vocabulary. Underneath, they all ask two questions: how much does the AI influence the decision, and what happens if it is wrong. A one-page job aid and infographic: define the context of use, grade on influence × consequence, identify weaknesses, layer the controls, monitor across the lifecycle. Every item attributed to its source.

Interviews and media

Other people's lens on the work: press interviews, conference coverage, and a podcast conversation.

Jack Prior in a taped interview with Lori Ellis of Open Door Salon at the AI Drug Discovery & Development Summit 2026, Boston

Implementing AI in Regulated Biomanufacturing

Taped interview with Lori Ellis of Open Door Salon: data readiness, turning process data into actionable insights, balancing AI innovation with IP protection, security, and regulatory compliance, and how to build an AI strategy when you don't yet trust your data. AI Drug Discovery & Development Summit, Boston, October 28, 2026. Full interview to follow.

LinkedIn preview post

BioPharm International: Q&A with Dr. Jack Prior, PDA/FDA Joint Regulatory Conference 2026

Q&A with Dr. Jack Prior: Is Your Process Data Ready to Act On?

Interview with Emily Schoenthaler after the PDA/FDA talk: what makes process data actionable, where AI adds value in process monitoring, and what to settle before AI supports manufacturing decisions. BioPharm International, September 17, 2026.

Read the Q&A

PDA/FDA 2026 panel: Bob Buhlmann of Gilead, Liatte Closs of FDA, and Jack Prior, with moderator Christopher Downey of FDA at the podium

FDA, Sanofi, Gilead Weigh AI Readiness and Validation Risk at PDA/FDA Conference

Feliza Mirasol's report on the session: the data maturity scoring model, FDA's foundations for digital transformation, the first warning letter citing AI misuse, and the panel on risk-based AI validation. BioPharm International, September 2026.

Read the coverage

PDA Week 2026 Interview

Two segments with Richard Jaenisch.

▶ Part 1: The Next Wave of Pharma AI ▶ Part 2: Measuring Data Readiness of AI

Bioprocessing Unfiltered Podcast

With William Whitford. Cambridge Healthtech Institute.

▶ Listen to episode ▶ Watch on YouTube LinkedIn post

Talks

"Your talk was super educational. You really are the OG of AI for bioprocess." Richard C. Willson, Huffington-Woestemeyer Professor of Chemical and Biomolecular Engineering, University of Houston

From Data to Decisions

Talk on data readiness for AI in biologics manufacturing, followed by the executive panel on unlocking data for manufacturing outcomes. AI Drug Discovery & Development Summit, Kisaco Research, Boston Marriott Copley Place, October 28, 2026.

Speaker page

Jack Prior delivering the plenary keynote at Bioprocess International 2026, Boston

Are We There Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence in Biologics Manufacturing

Plenary keynote. Bioprocess International, Biotech Week Boston, Hynes Convention Center, September 24, 2026.

Speaker page

BioPharma Webinars: Are We There Yet? Jack Prior, Sanofi, with Masaki Yamada, Invert

Are We There Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence in Biologics Manufacturing

Webinar, paired with Masaki Yamada of Invert on agentic AI for bioprocess decision support, followed by live Q&A. BioPharma Webinars, September 16, 2026.

▶ Watch on BrightTALK

Jack Prior speaking at the PDA/FDA Joint Regulatory Conference 2026, Washington DC

PDA/FDA Joint Regulatory Conference, Washington DC

"Is Your Process Data Ready to Act On?" in the session on advancing digital tools and data utilization in a CGMP environment, then a panel with FDA and Gilead moderated by Christopher Downey of FDA CDER. September 2026.

Event page

Jack Prior presenting at BioTalk US 2026

Are We There Yet? A Digital Maturity Model for Process Monitoring and AI in Biologics Manufacturing

Day Two keynote. BioTalk US 2026.

LinkedIn post

Bioprocessing Summit Europe 2026 plenary keynotes: Konstantin Konstantinov and Jack Prior

Process Data Readiness for AI in Biologics Manufacturing

Plenary keynote. Cambridge Healthtech Institute Bioprocessing Summit Europe, Barcelona.

LinkedIn post

Are We There Yet?

Recorded plenary talk. Pharma Manufacturing World Summit 2025.

▶ Watch on Vimeo LinkedIn post

AIChE PD2M organizing committee roster including Jack Prior

AIChE PD2M Conference

Organizing committee. At PD2M, hosted at Amgen, introduced former intern Jason Kelly, CEO of Ginkgo Bioworks, for his keynote on autonomous labs.

LinkedIn post

Jack Prior presenting at the National Academy of Sciences, February 2020

Opportunities and Challenges in Biologics Manufacturing Process Data Analytics Innovation

National Academy of Sciences, "Innovations in Pharmaceutical Manufacturing" workshop, Washington DC, February 2020.

An invited talk at a National Academies workshop convened to inform a committee writing a report for FDA on process data analytics technologies expected in biologics manufacturing.

▶ Watch on Vimeo Slides (PDF)

Panels

Regulators, industry, and me, on the record about AI and data.

Trust, not autonomy: Deploying agentic AI in GxP environments

Webinar panel, with Mike Branson of UCB, moderated by Reza Farahani of Katalyze AI. What an agent should be allowed to do, under what conditions, and what evidence is needed to trust the result: bounded tasks, grounding in controlled information, traceability, evaluation, and human oversight scaled to risk. Endpoints News, November 3, 2026.

Event page

Unlocking Data for Improved Manufacturing Outcomes

Executive panel, with Eric Hodgman of Bristol Myers Squibb and Nathan Moore, moderated by Ray Veeraraghavan of L7 Informatics. How pharma manufacturers are turning fragmented process and quality data into a strategic asset, and what it takes to translate better data access into measurable gains in yield, consistency, and speed. AI Drug Discovery & Development Summit, Boston, October 28, 2026.

Agenda