πΊπΈ September 13 Β· Houston
Hilton Americas-Houston, Houston, TX
The day before posit::conf(2026) workshops begin. A full-day roundtable bringing together 80β100 pharma leaders and practitioners.
To attend without a conference pass, contact conf@posit.co
Want to join the advisory board? Contact us
Register βπ¨π October 5 Β· Basel
Novartis Pavilion, St. Johanns-Hafen-Weg 5, Novartis Campus, Basel, Switzerland
A smaller, focused event β capacity is limited.
Event Full β this summit is fully booked.
If you'd like to attend, join the waitlist and we'll notify you if additional spots become available.
Join the Waitlist βAI, Validation & Regulatory Readiness
Deep-dive sessions on reproducibility, governance, and submission-ready open-source workflows.
Connect With Pharma Leaders
Meet practitioners and decision-makers across CROs and top-tier pharma companies at each summit.
Vote on Roundtable Topics
Every roundtable is community-driven β browse, upvote, and pitch topics before the events.
SUMMIT DETAILS
EU Summit β October 5, Basel
Novartis Pavilion
St. Johanns-Hafen-Weg 5, Novartis Campus Β· Basel, Switzerland
Meeting Room: TBC
Agenda
| Time | Chair | Description |
|---|---|---|
| 9:00am | Satish Murthy (J&J) | Intro to day |
| 9:15β10:00am | Gregory Chen (MSD) | SUBMISSIONS The Analysis Results Standard Revolution β From Static Tables to Living, Machine-Readable Submissions |
| 10:00β11:00am | James Black (Novartis) | AI Validation and QC Reimagined β Trust, Testing, and the AI-Augmented Programmer |
| 11:00β11:15am | Bio-break | |
| 11:15β12:15pm | Aga Rasinksa (Atorus) | AI AI fireside chat: current status and workflow challenges, operational reality in regulated practice, and the operating model |
| 12:15β1:30pm | Lunch π΄ Lunch & Learn sessions TBC | |
| 1:30β4:00pm | Shannon Haughton (GSK) | ROUNDTABLE Round tables β Split into 2 Γ 1hr sessions with short break between. Attendance at each table is flexible. |
| 4:00β4:45pm | Mahmoud Hallal (Roche) & Round table chairs | Chairs report back notes, and any planned follow up |
| 4:45β5:00pm | Phil Bowsher (Posit) | Wrap up |
| 6:00β8:00pm | Posit Team | πΈ Social event β Posit Sponsored ApΓ©ro at Perron Basel, Vogesenplatz 1, 4056 Basel |
Hotel
Thereβs no hotel block for this summit β most attendees are local to the area. Note that BiotechX Europe is also in Basel around this time, so we recommend booking your hotel early if youβre traveling in.
SUMMIT DETAILS
US Summit β September 13, Houston
Hilton Americas-Houston
Houston, Texas, USA
The day before posit::conf(2026) workshops begin.
R/Pharma Workshops β Monday, September 14:
- Modern Clinical Reporting in R with the Pharmaverse β end-to-end clinical reporting (SDTM, ADaM, TLGs, ARDs) for clinical programmers & biostatisticians
- Administering & Orchestrating Next-Gen Statistical Environments β AI-integrated, GxP-compliant infrastructure, co-hosted by Pfizer & Posit
π A Saturday night pre-summit hangout is in the works β details and an invite email will be sent soon.
Agenda
π The agenda is still being finalized β speakers, exact timing, and the lunch session are subject to change.
Full day: 9:00am β 5:00pm
| Time | Chair | Description |
|---|---|---|
| 9:00 β 9:30am | Phil Bowsher (Posit), Harvey Lieberman (Novartis) & Eric Nantz (Eli Lilly) | Welcome, introductions & kickoff β Phil Bowsher (Posit), Harvey Lieberman (Novartis) & Eric Nantz (Eli Lilly) |
| 9:30 β 10:20am | Joe Cheng (Posit) | REPRODUCIBILITY The State of Regulatory Reproducibility β Joe Cheng (Posit) on the state of reproducibility with R in regulated submissions: why Agency reviewers are asking harder questions, and the best practices that keep R code reviewable and trustworthy as coding practices continue to evolve with updates and AI |
| 10:20 β 10:30am | Break | |
| 10:30 β 11:20am | Eric Nantz (Eli Lilly) & Dilip Raghunathan (Regeneron) | PHARMA AI Pharma AI in Practice β lightning talks from Eric Nantz (Eli Lilly) and Dilip Raghunathan (Regeneron), followed by fireside discussion on AI application in pharma, pain points, and the submission side, including metadata-driven approaches |
| 11:30am β 12:30pm | Dror Berel & Eli Alexander Miller (Atorus Research) | Lunch presentation & networking β proposals from Dror Berel (Biostatistics R Developer, Shiny/Teal) on Pharmaverse/Teal & the public Teal Gallery Demos, and Eli Alexander Miller (Atorus Research) previewing R Consortium Submissions WG Pilot 8 β a proposal to demonstrate responsible, auditable use of AI agents in the submissions pipeline, building on Pilots 1β7 (20 min each, pending confirmation) |
| 12:30 β 12:40pm | Break | |
| 12:40 β 1:25pm | LIVE Q&A Open Floor β Live Executive Q&A (~30β45 min) | |
| 1:25 β 2:25pm | ROUNDTABLE Roundtable discussions β Session 1 (see the finalized topics below) | |
| 2:25 β 2:40pm | Break | |
| 2:40 β 3:40pm | ROUNDTABLE Roundtable discussions β Session 2 | |
| 3:40 β 4:40pm | Round table chairs | Roundtable summaries presented by session chairs |
| 4:40 β 5:00pm | Closing remarks | |
| 6:00pm | WU Consulting Group | πΈ Evening Mixer β hosted by WU Consulting Group at Reserve 101 (6-min walk from the hotel) |
π We need volunteer chairs! Each table needs a chair to guide the conversation and take notes to report back. If youβd like to volunteer for one of the six roundtables (details further down the page), let us know here β weβll follow up to confirm.
Featured Speakers
π€ Open Floor β Live Executive Q&A
Attendees submit written questions throughout the morning; a panel answers them live and unscripted β a fast-paced way to surface the topics the room cares about most. Panelists to be announced β check back as the agenda firms up.
πΈ Evening Mixer β 6:00pm
Following a well-received happy hour last year, weβre doing it again β join us for drinks at Reserve 101, a classy cocktail & whiskey bar just a 6-minute walk from the hotel (1201 Caroline St). Given our group size, expect a partial or full venue buyout. Questions for the venue: (713) 480-1579.
Hosted by WU Consulting Group
Hotel
π¨ The Summit is held at the Hilton Americas-Houston β the same hotel hosting posit::conf(2026) itself. In the heart of downtown, it offers sophisticated event spaces, upscale amenities, skyline views, and easy access to the cityβs dining and entertainment.
π Book your room online
US Summit Roundtable Topics
The topics below were finalized from the communityβs proposals in GitHub Discussions β thank you to everyone who proposed, upvoted, and commented. AI came up constantly across the proposals, so rather than splitting it thin across every table, we grouped it into two focused roundtables and kept the rest of the agenda open to the other topics the community cared about most.
π You can pick only one AI-focused table across your two rounds. There are two rounds and six tables β two of them are AI-focused (Trust & Governance, and AI Operations). Since AI is popular, weβre asking each attendee to choose at most one of the two AI tables so both stay focused and the other four topics get a fair mix of participants.
Trust, Safeguards & Governance for Agentic AI
As agentic AI moves into GxP-regulated workflows, teams need concrete patterns for trust, safeguards, and governance before deploying these tools in the creation or QC of GxP study code. This table tackles managing hallucinations and maintaining accountability, how to ground agents with the right context and guardrails, and how to evaluate whether AI-generated R code is actually readable and trustworthy β not just correct. The goal is a shared, practical view of what "trustworthy agentic AI" looks like in pharma.
AI in Practice: Automation, Cost & Skills
Beyond governance, teams are wrestling with practical questions: when deterministic automation beats AI-driven automation, how to benchmark agents and manage token cost as a proxy for spend (including where smaller, local, or open-weight models hold up just fine), and what IDE setups and upskilling paths actually work in a GxP-related context. This roundtable is about the operational side of AI adoption β cost, tooling, and training β comparing what's genuinely working today. We're glad to confirm Will L (trustedminiagents.dev) is joining to help ground the conversation in evaluating and benchmarking agent behavior in practice.
Reproducible Environments & Package Provisioning
Does renv make sense inside a Secure Computing Environment (SCE), and what does best-practice R package provisioning actually look like for GxP analyses? As more people bring AI and Python workloads onto shared SCEs, this table also digs into the operational side β how to scale infrastructure like Workbench to meet demand, and whether that demand is even the right use of AI. Attendees will leave with a clearer view of the options, and their limitations, for reproducible R environments in regulated pharma.
Open Source in Regulatory Submissions & Validation
Are the industry's long-standing concerns about using open source like R in regulatory filings actually solved heading into 2026 β including where hybrid submissions and ADRG/ADaM inclusion of R code stand today? Drawing on work from CAMIS, pharmaverse, and the R Consortium's submissions working group, this session builds a shared view of agency appetite, reviewer familiarity with R, and confidence in R-based outputs. A dedicated working-group update will also cover the latest on hybrid submissions, SCE considerations, and QC checking of R AI-augmented outputs, so expect input from people who have navigated real submissions.
The Future of Analysis Results Standards (ARD/ARS)
This is the community's most-discussed topic on GitHub β the architecture of parameterizable reporting and the case for standardized analysis results in a multi-technology, rapidly changing landscape. The roundtable digs into what a durable ARD/ARS standard needs to look like to survive shifting tech stacks, tooling, and the upcoming CDISC v2 migration. Given the interest already shown online, expect this table to be one of the most heavily attended.
Driving Adoption Beyond the Early Adopters
Most of us have lived this: "my colleagues still use Excel β now what?" This roundtable tackles the long tail of adoption β the change management behind org-wide migrations to open source and AI, and the judgment calls involved in bringing skeptical or resource-constrained colleagues along. It's a conversation about people and process as much as technology.
REGISTER
Registration
Register via posit::conf(2026) or contact conf@posit.co to attend without a full conference pass.
π conf.posit.co/2026/registration
Want to join the advisory board and help shape the event?
π Contact us here
GET INVOLVED
Roundtable Discussions
The roundtable topics feed into both summits and are shaped openly by the community. Please get involved before the events.
All proposed roundtable topics are collected on GitHub Discussions:
π github.com/rinpharma/rinpharma-summit-2026/discussions
- Browse proposed topics
- Upvote the ones that matter most to you
- Comment to add context or pitch a new topic
Notes and outcomes from past roundtables are shared at rinpharma.com/docs/summit/.
OUR STORY
Background
In 2018 and 2019, R in Pharma was in-person at Harvard University, focused on direct interaction between speakers and guests. Those connections have grown into many exciting areas of open source drug development β and into the summit series shown below. R/Pharmaβs virtual programming, which grew out of that same 2020β2022 shift, has since become its own large annual event drawing thousands of attendees a year β a great community in its own right, but a different experience from the smaller, face-to-face summits below.
πΊ R/Pharma Virtual 2026 is a separate event from the summits on this page. Workshops run September 28 β October 1 β 25 free workshops spread across timezones around the globe β with presentations on October 20β21. Register for R/Pharma Virtual here.
In 2026 weβre expanding for the first time to two events β bringing the R/Pharma Summit to both the US and Europe! π
WHY R/PHARMA
Purpose
Over the last five years weβve seen explosive growth in the use of R, Python, and other open-source technologies across drug development β with an accelerating focus on AI.
Bringing people into a room to start the conversations that matter.
The R/Pharma Summit provides an open, collaborative, and inclusive environment to foster in-person discussions on:
- AI in drug development
- Validated computing environments
- Scalable infrastructure
- Regulatory compliance and submissions
π Review the 2023β2025 roundtable summaries:
rinpharma.github.io/roundtables
Audience
These summits are for you if:
- You are an active contributor to the adoption of data science best practices across drug development
- You sponsor data science codebases
- You are an informatics professional designing and implementing GxP-conforming data science platforms
- You are interested in cross-pharma collaboration
Round Table Advisory Board
A mix of 50 people from pharmaceutical companies, CROs, and organizations supporting the advancement of open source for drug development and clinical reporting.
Organising Committee
The following committee organises the EU Summit. The US Summit is organised by a larger group through the non-profit Open-Source in Pharma, including representatives from several large pharmaceutical companies.
QUESTIONS
FAQ
What's the difference between the US and EU Summits?
Who should attend?
How do I help shape the roundtable agenda?
Can I attend both summits?
What does it cost to attend?
Endorsement
Endorsed & Supported By
This summit is under the umbrella of R/Pharma and Open Source in Pharma, supported by pharma partners Novartis and Johnson & Johnson. The EU event is hosted by Novartis and Posit.



