ACDRS Workshop: AI in Drug Development: From Discovery to Regulatory-Ready Impact

This one-day hybrid workshop will introduce participants to the most relevant AI applications across the drug development lifecycle.

Details

About

Workshop Introduction

Drug development is changing rapidly with the advancement of artificial intelligence (AI). Across the R&D lifecycle, AI is beginning to reshape how organizations identify biological targets, design and optimize molecules, automate laboratory workflows, select patients, model dose and exposure, design and monitor clinical trials, prepare regulatory submissions, and generate post-market evidence. At the same time, AI introduces new expectations for validation, governance, workforce readiness, change management, and responsible implementation.

This one-day hybrid ACDRS workshop will introduce participants to the most relevant AI applications across the drug development lifecycle, with emphasis on practical use cases, scientific and regulatory considerations, and the organizational capabilities required to move from experimentation to scaled impact.

 

Learning Objectives

By the end of the workshop, attendees should be able to:

  1. Describe high-value AI applications across discovery, preclinical, translational, clinical, regulatory, and commercial phases. 
  2. Distinguish near-term operational AI use cases from longer-horizon frontier AI opportunities.
    Identify key scientific, regulatory, quality, and governance considerations for AI-enabled drug development
  3. Understand how AI may reshape clinical trial design, monitoring, regulatory interactions, evidence generation, and post-market lifecycle strategy.
     

Program

Workshop will take place in Washington DC and times below are eastern.

TimeStageTopicSpeakers
9:00 am ET Welcome and Framing for the Day from the Workshop ChairCharlie T. Gombar, PhD, ACDRS Director; and Brandon W. Higgs, PhD, Chief Data Officer, Diagnostics, Danaher Corporation
9:10 amDiscov. to Transl.AI Across Drug Development: From Models to Decision-Grade Evidence Corina J. Shtir, PhD, CTO, Dexwell Inc.
10:00 amPreclinical / Molecular DesignIn Silico Biologics, Protein Design, and the Lab of the Future Christopher J. Langmead, PhD, Vice President of AI-Driven Molecular Design, Danaher
10:50 am Networking Break 
11:00 amTranslationalMultimodal Translational AI: Biomarkers, Radiomics, Diagnostics, and Patient Selection Nate Braman, PhD, Vice President, AI Research & Development / Co-founder, Picture Health
11:50 amClin. Pharm. / Early Dev.AI in Clinical Pharmacology, PK/PD, ADME, and Dose Optimization Husain Attarwala, PhD, VP Clinical Pharmacology & DMPK, Aera Therapeutics
12:40 pm Lunch 
1:20 pmClinical DevelopmentAI-Enabled Clinical Trials: Emulation, Operations, and Real-Time Monitoring Andreas Huhmer, PhD, Senior Director Scientific Affairs and Alliance Management, Nautilus Biotechnology
2:10 pmRegulatoryRegulatory-Grade AI - From FDA AI Tools to Reviewer Simulation and AI-Ready Submissions Glen Huang, MD, Assoc Director of Oncology Innovation (OCE), US Food and Drug Administration 
3:00 pm Networking Break 
3:10 pmCommercial / LifecycleThe Model Was Never the Moat - AI, Data, and Value Creation in Drug Development: What the Deals Returned, and How to Structure the NextMatthew Klusas, Managing Director, West Oxford Advisors
4:00 pmEnterprise TransformationAI and Digital Transformation in Drug Development: Workforce, Change Management, and Scaled AdoptionJohn Conway, Founder & Chief Visioneer Officer, 20/15 Visioneers
4:50 pm Closing Synthesis and Next StepsBrandon Higgs

Registration

  • Each year, in addition to its course, ACDRS also presents a workshop that is open to all interested parties. 
  • The registration fees for this course are shown below. 
  • The option to attend in-person or virtually via Zoom must be selected at time of registration.
  • All registration fees are non-refundable. Registrations may be transferred to another individual if you are unable to attend.
  • Program details and schedule are subject to change.
  • Enrollment is limited. 
  • Join interest list to be notified when registration opens.
  • Deadline to register: Tuesday, October 13, 2026 11:59 pm PT
Registration CategoryRegistration Fee
General Admission$400.00 
Discounted fee for ACDRS alumni (industry): $250.00
Discounted fee for Govt/Academia/Nonprofit: $50.00

For additional details, contact [email protected] .