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

Speaker Profiles

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Husain Attarwala, PhD, is Vice President of Bioanalytics, DMPK, Clinical Pharmacology, and Analytics at Aera Therapeutics, where he leads strategy across analytical sciences, drug metabolism, pharmacometrics, and clinical pharmacology, integrating bioanalytical and pharmacometric approaches to inform dose decisions across Aera's platform and pipeline. Previously, he was Head of Clinical Pharmacology and Pharmacometrics at Moderna, where he was instrumental in dose selection for Moderna's COVID-19 vaccine, using predictive models to guide clinical decision-making for mRNA vaccines and therapeutics. Earlier, as a Principal Scientist at Alnylam Pharmaceuticals, he contributed to dose selection for five novel siRNA therapeutics, guiding dose optimization through clinical development to global approval. Husain has also built agentic AI systems for biopharma — production workflows spanning regulatory report writing, competitive intelligence, and the automation of pharmacometrics and data analysis. He holds a PhD and MS in Pharmaceutical Sciences and Drug Delivery Systems from Northeastern University.

 

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Nathaniel Braman, PhD is the co-founder and VP of AI Research & Development at Picture Health, where he builds tools at the intersection of medical imaging, oncology, and drug development. He leads the development of Picture Health's multimodal PxPlatform, which extracts quantitative, biologically interpretable data from existing scans to provide guidance for clinical trials and care. He has built and validated medical image analysis tools in multiple care settings, which are being actively deployed in a number of clinical trials. As part of the Friends of Cancer Research (FOCR) ai.RECIST working group, his team is building and benchmarking AI tools to automate and accelerate standard imaging response assessment. His team additionally builds interpretable digital pathology measurements and models for precision oncology. He is most excited by the intersection of these technologies: fusing radiology, digital pathology, and molecular data to create medical AI that enables more informed and holistic clinical decision-making. Nathaniel holds a PhD in Biomedical Engineering from Case Western Reserve University, and has previously developed disease-detection and multimodal AI methods at IBM Research and Tempus Labs.

 

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John F. Conway is a scientist, entrepreneur, and strategic advisor with more than 35 years of experience at the intersection of life sciences, data, technology, and R&D operations. He is the founder and Chief Visioneer of 20/15 Visioneers, where he advises scientific organizations on AI and data strategy, laboratory modernization, research reproducibility, informatics, and organizational transformation. John has held senior scientific and technology leadership positions at Merck, GlaxoSmithKline, Accelrys, Schrödinger, LabAnswer, and AstraZeneca. This experience gives him a broad perspective spanning pharmaceutical R&D, scientific software, consulting, and executive strategy. As a founder of multiple ventures, John also brings practical experience building organizations, developing teams, and translating scientific innovation into sustainable business value. He advises startups on establishing scalable scientific operations, making sound data and technology decisions, and preparing for growth in an increasingly AI-enabled environment.

 

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Charlie T. Gombar, PhD is currently the ACDRS Director. He most recently served as Senior Vice President, Portfolio and Project Management, Pyxis Oncology. Prior to joining Pyxis, he served as Deputy Director, HIV Drugs, Bill & Melinda Gates Foundation. Previously he was Senior Vice President, Project Management at Endo Pharmaceuticals. Prior to Endo, he was Vice President, R&D Strategy and Business Improvement at Pfizer (formerly Wyeth Research) where he led a group whose purpose was to help define the strategic path forward in R&D to help Pfizer/Wyeth company thrive in the increasingly challenging environment and to drive process improvements in R&D. In addition, he led the team developing methylnaltrexone for treatment of opioid-induced constipation and post-operative ileus. He also served as Vice President, Project Management, responsible for all R&D projects in Neuroscience and Women’s Health & Bone, as well as drug development training for all project team members. In 2005 he co-led the Wyeth Research portion of the corporate-wide “Springboard” project. The key outcome of the R&D Springboard project was the implementation of the “Learn & Confirm” paradigm for pharmaceutical product development. Prior to joining Wyeth in 1997, he held positions in Project Management at SmithKline Beecham, Sterling Winthrop and Knoll Pharmaceutical. He spent several years in the Drug Metabolism Department at SmithKline before joining Project Management. He received his undergraduate degree in Chemistry from Pace University and his PhD in Pharmacology from Albany Medical College.

 

 

 

Brandon W. Higgs, PhD is Chief Data Officer, Diagnostics, Danaher Corporation. He previously served as Vice President of Translational Data Sciences at Genmab which employs AI and advanced analytics to support precision medicine strategies for clinical programs. Brandon Higgs has over two decades of hands-on experience in data science and biomarker development. Prior to joining Genmab, he was Head of Translational Bioinformatics at Immunocore, where he led discovery of biomarkers for TCR-based bispecific treatments in oncology, specifically tebentafusp (Kimmtrak®). Before this, he developed the Translational Bioinformatics function at MedImmune/AstraZeneca supporting precision medicine strategies for drug programs in autoimmunity, respiratory disease, cardiovascular disease, and oncology, notably a type I IFN signature in lupus for anifrolumab (Saphnelo®) and blood-based tumor mutational burden for durvalumab (Imfinzi®) and tremelimumab (Imjudo®). Prior to this, he worked for a U.S. Department of Defense (DoD) institute, MITRE, deriving modeling approaches for the CDC and DoD for biothreat identification and syndromic surveillance. Earlier, he also developed predictive models in toxicogenomics at Gene Logic and conducted HIV/Hepatitis C sequencing at SRA Life Sciences. He is adjunct faculty at Johns Hopkins University where he has developed courses in the Advanced Academic Bioinformatics graduate program. Brandon received his BS from Indiana University, MSc from Johns Hopkins University, and PhD in Computational Biology and Bioinformatics from George Mason University. He has published >100 scientific articles and multiple book chapters.

 

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Glen Huang, MD is the Associate Director for Oncology Innovation in the Oncology Center of Excellence. He completed infectious diseases fellowship at UCLA and internal medicine residency at Wake Forest Baptist Medical Center and maintains board certifications in both internal medicine and infectious diseases. Dr. Huang has published on infectious diseases topics and actively contributes to FDA modernization efforts through his work on the MARS task force and as an Elsa Champion, developing AI solutions to enhance regulatory review efficiency.

 

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Andreas FR Hühmer, PhD is currently the Sr. Director for Scientific Affairs and Alliance Management at Nautilus Biotechnology in San Carlos, CA. Together with his colleagues he works on Nautilus’ next generation proteomics platform that promises to unlock the proteome and fuel a new era of scientific discovery. Before joining Nautilus, he directed both the day-to-day marketing business and long-term strategy for Proteomics, Structural Biology, and Metabolomics at Thermo Fisher Scientific. His work focused on democratizing mass spectrometry and supporting the adoption of innovative multi-omics methods in biological and clinical research. He also applied artificial intelligence and machine-learning tools to transform mass spectrometry workflows, enabling them to scale into more robust, automated, and high-throughput solutions. Dr. Hühmer holds a PhD (1997) and MS (1996) in Pharmaceutical Chemistry from the University of Kansas.

 

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Matt Klusas is an accomplished senior executive with a wide range of experience in strategy, sales, business development, and supply chain roles in multiple industries.  He brings a cross-disciplinary approach to solving challenges for mega-cap corporations, startups, and non-profits.  Most recently, Matt publishes independent research on vertical market failure in the magnetic data storage industry through his West Oxford Advisors shop.  Prior to West Ox, Matt served in both supply chain and hardware strategy roles at Amazon Web Services (NASDAQ: AMZN).  Initially hired by AWS to lead emerging storage technologies based upon a book he published on DNA digital storage, Matt served as the Global Commodity Manager for both hard disk drives (HDD) and magnetic tape, driving more than $1B in annual procurement for AWS.  He also led hardware strategy for the AWS S3 Glacier service.  Matt concluded his time at Amazon in the highly confidential Grand Challenge organization as the Head of Business Development for a medical device product.  

 

Prior to Amazon, Matt was the Chief Commercial Officer of OmniSeq, a Buffalo-based diagnostic startup focused on treatment decision support for cancer with an emphasis on immunotherapy.  He worked closely with the CEO to raise a Series B - including financial and strategic investors - leading to an acquisition by LabCorp (NYSE: LH). Before that, Matt held various roles at Thermo Fisher Scientific (NYSE: TMO) and legacy companies, including Life Technologies and Invitrogen.  As Chief of Staff and Head of Strategy for the Genetic Systems Division, he led the $725M acquisition and integration of Ion Torrent, a DNA sequencing company.  Matt began his professional career at McKinsey & Company, where he was a McKinsey Global Institute Fellow.  Prior to graduating, he held roles in financial services organizations including Deutsche Bank, the Chicago Board of Trade, and the Federal Reserve Bank of Chicago.  His writing is published in the McKinsey Quarterly, the Credit Union Journal, the Decadal Plan for Semiconductors, and the Journal of Commercial Biotechnology.  Matt studied at Magdalen College, University of Oxford and he received a BS from Illinois State University and an MSc from the London School of Economics.

 

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Christopher Langmead, PhD is Vice President of Molecular Design Technology at Danaher, where he defines the technical strategy for applying AI to molecular discovery across the company’s life sciences and diagnostics portfolio. His work focuses on translating advances in generative AI, predictive modeling, and automation into scalable capabilities for designing and optimizing proteins, antibodies, and mRNA.

 

Previously he was Executive Director of AI and Data at Amgen, where his team developed AI systems that impacted every therapeutic program. Before industry, he spent 18 years on the faculty at Carnegie Mellon University in the departments of Computer Science and Computational Biology.

 

 

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Corina J. Shtir, PhD is a biostatistician, precision medicine executive, and AI/ML leader with experience spanning academia, global life sciences leadership, and digital health innovation. Her work focuses on translating complex biological, clinical, and operational data into governed, interpretable systems that support better decisions in healthcare, life sciences, and public health.

 

As Global Head and Vice President of Precision Medicine at Thermo Fisher Scientific, Dr. Shtir led international programs in genomics, diagnostics, biobanking, clinical testing infrastructure, and precision medicine implementation, working with governments, academic medical centers, healthcare systems, and industry partners worldwide. Currently, as Chief Technology Officer at Dexwell, Inc., she leads the development of AI-driven platforms that combine machine learning, deterministic rules, scoring systems, graph reasoning, and workflow intelligence to support real-world decision-making. She is also CEO of Hopeful Life, a nonprofit organization focused on data-driven approaches to public health, youth mental health, and substance-abuse prevention.

 

Dr. Shtir is the author of AI and Machine Learning Unpacked: A Practical Guide for Decision Makers in Life Sciences and Healthcare, which helps leaders evaluate AI beyond technical terminology and understand when AI-generated outputs are reliable enough to inform meaningful decisions.

 

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Kenton Thibaut, PhD is Senior Resident China Fellow at the Atlantic Council’s Democracy + Tech Initiative. In this role, she serves as head of China research and serves as lead on projects related to China’s role in the global digital ecosystem. She helps governments, policymakers, and companies understand how China’s technology strategy, data governance regime, digital regulation, and approach to AI shape geopolitical risk, market access, international competition, and the global policy environment. Her work is grounded in deep China expertise and a comparative focus on the United States, European Union, and China. She combines policy research, strategic analysis, and engagement across government, industry, civil society, and multilateral institutions to assess how different governance models are shaping technology policy, AI strategy, and the international digital order.


Thibaut holds a PhD in Political Science from Georgetown University, where her doctoral research examined the drivers of regulatory fragmentation in cross-border data governance regimes and the implications for AI governance, with a focus on China. She also holds an MA in International Economics and China Studies from Johns Hopkins School of Advanced International Studies.

In addition to her professional work, she has held multiple competitive research fellowships, including a Fulbright Fellowship, Blakemore Freeman Fellowship, and Boren National Security Fellowship. She is a security fellow at the Truman National Security Project and a Term Member at the Council on Foreign Relations. Thibaut lived for more than five years in mainland China and Taiwan and is proficient in Mandarin Chinese. 

 

 

 

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