Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends

The workshop will be held at the Universities at Shady Grove (USG).

Address: Ballroom (please follow signs in the hallway), 9630 Gudelsky Drive, Building II, Rockville, MD 20850

• The Traville-Gateway Garage is the closest parking garage, and recommended, to the venue (parking map).  Attendees can only park in the following locations:  Traville-Gateway garage parking (Levels 2-6), Lot 2, and the Shady Grove garage.  If you park in other areas, you may be ticketed.  CRCG will not cover parking tickets.

• Visitor Parking: Levels 2-6 of Traville Gateway Garage. PLEASE NOTE: The ground floor of Traville Gateway Garage requires a USG employee permit at all times.
• Guests are responsible for the cost of parking; parking will not be validated. Parking is $16 for all day.

Click for parking information from the USG website.

Directions and Transportation

• Travel from local airports to Rockville, MD (The Universities at Shady Grove (USG)) will require an Uber or Lyft, which is by far the best way to obtain car service.
• As there is road traffic in the region, the fastest way to the USG campus is the DCA airport, then taking the Metro subway from the airport to USG, then taking Uber or Lyft. Alternatively, fly into any WAS airport and take Uber or Lyft. If flying into BWI airport, we suggest taking Uber or Lyft to USG.
• The Metro subway serves DCA and IAD airports, which connects with the USG stop on the red line. If flying into IAD, taking the Metro will save some cost, but will probably take extra time, even if traffic is heavy.

Please click on the following “all transportation options” links to find transportation from the airport via subway, bus, taxi, car, and town car.

• Reagan National Airport (DCA): 21.1 miles from Rockville, MD (all transportation options from DCA) (train options from DCA)
• Dulles International Airport (IAD): 27.8 miles from Rockville, MD (all transportation options from IAD) (train options from IAD)
• Baltimore/Washington International Thurgood Marshall Airport (BWI): 37.5 miles from Rockville, MD (all transportation options from BWI) (train options from BWI)

Train tickets (Omio)

• Washington, DC to Baltimore: Approximately 35 minutes
• Penn Station Marc SB (Baltimore): Approximately 41 miles from campus

P.S. Transportation (Serving MD, VA, & DC) for reservations:  301-806-1717

Bob’s Limo Service (Email): 301-525-2525

B&B Executive Sedan (Email): 240-533-6262

East Coast Limousine (Email): 301-527-0413 or 240-793-8196

Uber: Baltimore, BWI Airport, Washington, DC, Dulles (IAD) Airport

Guests should mention they are attending a conference at The Universities at Shady Grove; most hotels offer discounts.

There are many hotels within a short driving distance to the USG campus including:

• Hilton Garden Inn Rockville-Gaithersburg (book using our reduced rate by September 24, 2025)
  14975 Shady Grove Road, Rockville, MD 20850 (0.6 miles from USG)
  240-507-1800
• Homewood Suites by Hilton Rockville-Gaithersburg
  14975 Shady Grove Road, Rockville, MD 20850 (0.6 miles from USG)
  240-507-1900
• Courtyard by Marriott Rockville
  2500 Research Boulevard, Rockville, MD 20850 (0.9 miles from USG)
  301-670-6700
• Sleep Inn Rockville
  2 Research Ct., Rockville, MD 20850 (1.2 miles from USG)
  301-507-8000
• The Rockville Hotel, a Ramada by Wyndham
  3 Research Ct., Rockville, MD 20850 (1.2 miles from USG)
  301-202-1098
• Spring Hill Suites by Marriott Gaithersburg
  9715 Washingtonian Blvd, Gaithersburg, MD 20878 (1.4 miles from USG)
  301-987-0900
• Sheraton Rockville Hotel
  920 King Farm Blvd, Rockville, MD 20850 (1.4 miles from USG)
  240-912-8200
• Courtyard by Marriott Gaithersburg Washingtonian Center
  204 Boardwalk Place, Gaithersburg, MD 20878 (1.6 miles from USG)
  301-527-9000
• Comfort Inn Shady Grove-Gaithersburg-Rockville
  16216 Frederick Rd., Gaithersburg, MD 20877 (2.2 miles from USG)
  301-330-0023 

Senior VP & Head of Clinical and Biopharmaceutics, Mankind Pharma

Dr. Tausif Ahmed is currently working as Sr. Vice President & Head-Clinical Research & Biopharmaceutics Department at Mankind Pharma Limited, Delhi, India. He is responsible for managing all Bioequivalence studies, preclinical Tox and Phase III clinical trials supporting domestic and global complex generic products across all dosage forms at Mankind. Prior to joining Mankind, Dr. Tausif worked as Sr. VP Bioequivalence and CT at Aizant Drug Research solution Pvt., Ltd. Hyderabad, India.  In past he has worked as Vice President & Head-Biopharmaceutics & Bioequivalence in the Global Clinical Management group, IPDO at Dr. Reddy’s Laboratories Limited (DRL), Hyderabad. He was responsible for managing all Bioequivalence studies supporting global complex generic products at DRL. He was also involved in PK/Modelling and Simulation activities supporting global generic development. Prior to joining DRL, he was Associate Director and Head-DMPK (preclinical discovery, Clinical dev., and Generic) & Dy. Test Facility Mgt. GLP toxicology dept. at Piramal Enterprises Limited, Mumbai. Dr. Ahmed has been associated with different pharmaceutical companies such as Dr. Reddy’s Research Foundation (DRF), Ranbaxy Research Laboratories, Sai Life Sciences Limited, and Piramal Enterprises Limited in the past. He obtained M.S. in Pharmaceutics from NIPER and Ph.D. in Pharmaceutical Medicine (specialization: Biopharmaceutics and PK/PD) from Hamdard University (Ranbaxy, now Sun Pharma Sponsored). He has been working in the field of drug discovery, development, phase I/II, and generic BA-BE studies for more than 23 years. His area of specialization includes DMPK, metabolite-ID, population PK, PK-PD modelling, and simulation, generic BA/BE studies and GLP bioanalysis. In recent years his focus is on use PBBM/PBPK modelling in generic drug development. He has extensive experience in outsourcing preclinical and clinical studies to CROs both in and outside of India. Dr. Ahmed has contributed to >15 IND filings, multiple ANDAs, and Phase I/II/III regulatory submissions, nationally and globally. He has co-authored two book chapters and over 50 papers and presentations. He is a reviewer for many international journals and is on the Editorial board of Int. J. Pharma Research. Dr. Ahmed is a guest faculty at Hamdard University, NMIMS (Mumbai), NIPER, and various other universities in India. He has also supervised many Master’s and Ph.D. students.   

Full Professor, University of Toronto; CEO and Co-Founder, Intrepid Labs Inc.

Dr. Christine Allen is CEO and co-founder of Intrepid Labs Inc., a company leveraging AI, automation, and deep pharmaceutical expertise to accelerate drug formulation and develop proprietary delivery technologies. Intrepid’s approach helps bring transformative medicines to patients faster, improving therapeutic outcomes and enhancing patient care. 

Christine is also a full professor at the University of Toronto (U of T), internationally recognized for her contributions to drug formulation and development, with over 180 peer-reviewed publications. She is a distinguished fellow of both the American Institute for Medical and Biological Engineering and the Canadian Academy of Health Sciences. Christine has held significant leadership roles, including President of both the Controlled Release Society and the Canadian Society for Pharmaceutical Sciences, and Editor-in-Chief of the Journal of Controlled Release. 

Her academic leadership includes serving as the inaugural Associate Vice-President and Vice Provost Strategic Initiatives and Interim Dean of the Leslie Dan Faculty of Pharmacy at U of T. 

Vice President QSP Software, Certara

Dr. Joshua Apgar is the VP, Head of QSP Software at Certara, and co-founder of Applied BioMath (acquired by Certara in Dec 2023). Prior to this, Josh was a Principal Scientist in the Systems Biology Group of the Department of Immunology and Inflammation at Boehringer Ingelheim Pharmaceuticals. His work leveraged physics-based models to: translate in vitro and in vivo data, assess target feasibility, understand drug mechanism of action, and predict human doses. The ultimate goal of this work was to reduce late stage attrition in drug development through a deep and quantitative interrogation of drug pharmacology and disease pathophysiology. 

 Josh received his PhD from MIT in Biological Engineering where he worked on experiment design for Systems Biology, focusing on the identification of tractable experiments that could allow for the estimation of unknown parameters and reveal complex mechanisms in signal transduction networks. Before that Josh worked at Avaki to develop a highly scalable software platform to support High Performance Computing, and Enterprise Information Integration in the Life Sciences, and Engineering. 

Lead Pharmacokineticist, DQMM, ORS, OGD, CDER, FDA

Dr. Andrew Babiskin is a Lead Pharmacokineticist in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs, CDER. He previously led the Locally-acting Physiologically Based Pharmacokinetic Modeling Team and the Quantitative Clinical Pharmacology Team in DQMM. Dr. Babiskin’s expertise lies in modernization of bioequivalence evaluation practices through model-integrated evidence. Dr. Babiskin received his B.S. degree from the University of Maryland (College Park) in Chemical Engineering and his M.S. and Ph.D. degrees from the California Institute of Technology in Chemical Engineering. He joined the FDA in 2012 as an ORISE postdoctoral fellow in the OGD Science Staff (now ORS) and became an employee within DQMM in 2014. 

Lead-Continuous Performance Improvement, Sandoz Development Center

Ms. Sridevi Challa is the Lead for Continuous Performance Improvement at the Sandoz Development Center (SDC), Hyderabad, where she drives strategic initiatives to elevate operational efficiency and lead transformation efforts aligned with the evolving needs of both Sandoz Development Center (SDC) and Sandoz Global Development (SGD). She partners closely with cross-functional teams to simplify processes, optimize scientific resource capacity, and reinforce Agile practices through robust governance and reporting frameworks. Her work is grounded in data-driven performance tracking and proactive improvement planning, ensuring SDC remains aligned with best-in-class benchmarks. Sridevi also plays a key role in identifying and implementing innovative technology solutions in collaboration with Sandoz Technology, while supporting change management and capability building across the organization. 

With expertise in formulation development, Sridevi previously served as Group Head at SDC Hyderabad, leading interdisciplinary teams in the development of complex drug products. Her technical strengths span QbD, PAT, process engineering, and digital twin approaches for smart formulation, with a growing emphasis on AI/ML applications in pharmaceutical R&D. A certified Master Black Belt and design thinking coach, she has led numerous Lean Six Sigma projects and capability-building initiatives. Her contributions have earned her multiple accolades, including Digital Ambassador, Curiosity Champion, and the Sankhya Conclave Award. A frequent speaker and panelist at global forums such as the FDA Scientific Research Workshop and Pharma IQ Conference, Sridevi holds a Master’s in Chemical Engineering and is currently pursuing her Ph.D. at IIT Bombay.   

Principal Scientist, Simulation Plus Inc.

Dr. Vladimir Chupakhin is a Principal Scientist at Simulations Plus Inc., focusing on AI data processing and new product development for pharmaceutical applications. With extensive experience spanning academia, industry, and startups — including positions at Janssen (Johnson & Johnson), Cellarity and GeneGo — he specializes in developing efficient pipelines that integrate AI and machine learning with cheminformatics, computational chemistry, and chemogenomics to accelerate drug discovery and support strategic decision-making. He earned his PhD in Chemistry from Moscow State University and completed postdoctoral research at the University of Strasbourg. His research has resulted in numerous peer-reviewed publications, and he has provided technical and strategic leadership to multidisciplinary teams and international research consortia. 

Associate Principal Scientist, Certara

Dr. James Clarke is an Associate Principal Scientist in the Certara Predictive Technologies Division. He works primarily in the field of Physiologically Based Pharmacokinetic (PBPK) modelling within the Simcyp Simulator Platform. Dr Clarke also has experience in Deep Learning model development and deployment, including computer vision, generative image AI models and QSAR development using Machine Learning approaches. Dr. Clarke is principal investigator for two ongoing FDA grants focused on developing models for complex topical formulations and is a team member in a further grant focusing on Long Acting Injectable IVIVC. 

Research Scientist, DPQR VI, OPQR, OPQ, CDER, FDA

Dr. Jayanti Das is a Research Scientist in the Office of Pharmaceutical Quality Research at the U.S. Food and Drug Administration (FDA). Dr. Das completed her Ph.D. in Mechanical Engineering from the University of California, Davis. Prior joining the FDA, Dr. Das worked at Intel Corporation as a Process Engineer. Her work is directly related to scientific investigation and research on advanced manufacturing for pharmaceutical product quality assessment and control, product image characterization, data analysis, and data visualization. 

Director, CMC Policy and Advocacy, GlaxoSmithKline

Dr. Katie Duncan is a Director of CMC Policy and Advocacy with Global Regulatory Affairs/CMC Excellence. Prior to joining GSK, Katie was a senior pharmaceutical quality assessor with the Office of Pharmaceutical Quality at the US Food and Drug Administration. She previously worked in small molecule drug discovery at a biotechnology company in San Diego, CA. She received her Ph.D. in organic chemistry from the Scripps Research Institute in La Jolla, CA and B.A. from Amherst College in Amherst, Massachusetts. 

Deputy Director, DQMM, ORS, OGD, CDER, FDA 

Dr. Lanyan (Lucy) Fang serves as Deputy Director of the Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards, Office of Generic Drugs (OGD), CDER/FDA. In this role, Dr. Fang oversees data analytics and leads the development of AI strategies for FDA’s generic drug program. She has established herself as a leading FDA expert in the application of modeling and simulation approaches for the review and regulation of generic drugs. 

Prior to her career at OGD, Dr. Fang worked as a senior clinical pharmacology reviewer in FDA’s Office of Clinical Pharmacology and as a senior pharmacokinetist at Merck. She earned her PhD in Pharmaceutical Sciences from The Ohio State University and is a graduate of the Excellence in Government Fellows program (2014-2015). 

Professor, School of Pharmacy and School of Medicine; Gyi Endowed Pharmapreneurship Professor; Professor, School of Pharmacy, Center for Translational Medicine, University of Maryland; Co-Founder, Vivpro Corp

Dr. Joga Gobburu is Professor with the School of Pharmacy and the School of Medicine, University of Maryland, Baltimore, MD, USA. He held various positions at the US FDA between 1998 and 2011. He has experience with overseeing the review of 1000s of Investigational New Drug Applications (INDs), over 250 New Drug and Biological Licensing Applications, numerous FDA Guidances and policies pertaining to drug approval and labeling. At the FDA, he was part of the committee responsible for 21st Review Process and provided input into PDUFA planning. He received numerous FDA awards such as the Outstanding Achievement Award and recognized with the Senior Biomedical Research Scientist appointment. He also received the Outstanding Leadership Award from the American Conference on Pharmacometrics (2008), the Tanabe’s Young Investigator Award from the American College of Clinical Pharmacology (2008) and Sheiner-Beal Pharmacometrics Award from the American Society of Clinical Pharmacology and Therapeutics (2019). He is also a Fellow of AAPS and ACCP. Dr. Gobburu is on the Editorial Boards of several journals. He has published over 100 papers and book chapters. 

Programme Manager, Digital CMC CERSI, University of Strathclyde 

Dr. Ian Houson is the programme manager for the Digital CMC CERSI led from CMAC, University of Strathclyde to accelerate and realise the full benefit of the adoption of digital tools in regulatory submissions. He has pioneered the use of Quality by Digital Design (QbDD) using physics-based and AI-driven modeling to enhance drug development workflows and worked on the translation of academic research for industrial impact. 

His previous roles in industry were in agrochemicals and pharmaceuticals process development, scale-up and manufacturing at an SME, a CDMO and large pharma in a range of technical, managerial and consultancy positions. The has authored numerous patents, papers and is the Editor of “Process Understanding for Scale-up and Manufacture” . Ian holds a DPhil in organic chemistry with Prof John Brown FRS, University of Oxford and a BScHons in Chemistry with Oceanography from the University of Southampton. 

Team Lead, DQMM, ORS, OGD, CDER, FDA 

Dr. Meng Hu received both his Bachelor of Engineering in Biomedical Engineering and Ph.D. in Physics from the Zhejiang University, China. He joined the FDA’s Office of Generic Drugs in 2015 and currently serves as a team lead in the Division of Quantitative Methods and Modeling under the Office of Research and Standards. His main research interests include the development and application of advanced data analytics tools (including AI/ML/LLM) to promote business and process intelligence in government, big data management, generation of real-world evidence, and quantitative methods to facilitate assessment for in-vitro bioequivalence study.  

Assistant Director, Data Science and AI Policy, OMP, CDER, FDA 

Dr. Gabriel Innes serves as the Assistant Director for Data Science and AI Policy in the Office of Medical Policy (OMP). Dr. Innes leads FDA’s artificial intelligence policy development initiatives and provides technical expertise on AI-enabled technologies, digital health technologies, and real-world data and evidence  (RWD/E) applications across CDER’s regulatory portfolio. He serves as Co-chair of the CDER AI Council’s Policy and Review Subcommittee and coordinates international collaborations with regulatory agencies including the European Medicines Agency (EMA) to harmonize AI regulatory approaches. His portfolio encompasses guidance development for AI and RWE, including leading the development of FDA’s Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products and Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products guidance documents. Dr. Innes manages PDUFA VII RWE reporting mandates. He has authored multiple peer-reviewed publications on RWE applications in regulatory decision-making. 

Gabriel brings extensive public health experience from his work at the CDC, USDA, and United Nations. He earned his VMD from the University of Pennsylvania School of Veterinary Medicine and holds a Ph.D. in Exposure Science and Environmental Epidemiology from Johns Hopkins School of Public Health, providing him with a unique interdisciplinary perspective on regulatory science and emerging technologies in healthcare. 

Division Director, DHP, DHCE, CDRH, FDA

Dr. MiRa Jacobs is the Division Director for the Division of Digital Health Policy, which is part of the Digital Health Center of Excellence at the FDA. She has worked at the Agency since 2018, first as Lead Reviewer in the Office of Product Evaluation and Quality, where she provided support for software and cybersecurity review in addition to her work as a lead reviewer on the neurointerventional devices team. She joined the Digital Health Center of Excellence in 2020 and has since contributed to numerous programs and initiatives with a focus on developing and implementing policy for AI-enabled medical devices, the maturation of Predetermined Change Control Plans, and international harmonization on approaches to Software and AI-enabled devices. Prior to joining the FDA, Dr. Jacobs earned her Ph.D. in biomedical engineering from the University of Florida. 

CEO, Vivpro Corp

Dr. Pravin Jadhav is CEO of Vivpro Corp, a provider of R&D Intelligence Assistant (RIA) and AI enabled document writing platform. In the last 19 years of professional experience, Dr. Jadhav has help several key leadership positions at US food and Drug Administration (US-FDA), Merck and Otsuka. Most recently, Dr. Jadhav was Global Development Team Leader within Global Clinical Development at Otsuka Pharmaceutical Development and Commercialization (OPDC). Dr. Jadhav drove an integrated clinical development and commercialization strategy for a key asset. He has led multi-disciplinary team of data, information, and knowledge experts to create science-driven, technology-enabled solutions of clinical and economic utility. At US-FDA, he was Team Leader and Expert Regulatory Scientist in the Division of Pharmacometrics of the Office of Clinical Pharmacology (OCP). He has worked on more than 100 New Drug Applications and 150 Investigational New Drug applications. Dr. Jadhav received PhD in Pharmaceutical Sciences from the Medical College of Virginia Commonwealth University (VCU) and MPH from Johns Hopkins University, Bloomberg School of Public Health. 

Senior Scientific Reviewer, DB I, OB, OGD, CDER, FDA

Dr. Rajan Jog is a Senior Scientific Reviewer in the Office of Generic Drugs/Office of Bioequivalence/Division of Bioequivalence I in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration/White Oak Campus in Silver Spring, Maryland. He is an interdisciplinary scientist with over 14 years of diverse research and review expertise spanning regulatory, pharmaceutical industry, and academic environments. Dr. Jog completed his doctorate in Pharmaceutics and Drug Design in 2018 at the University of Connecticut, Storrs, CT, USA. His experience spans multiple facets of drug product development, including formulation science (pre-formulation and formulation development), pharmaceutical analysis, pharmacokinetics, bioequivalence, regulatory approval, and product lifecycle management processes. He has contributed numerous research publications in high impact factor journals, book chapters, and presentations to his area of expertise.

Senior Manager, Regulatory Affairs CMC, Amgen

Dr. J. Paul Kirwan is a Senior Manager, Regulatory Affairs CMC, with Amgen since 2018. Paul currently leads regulatory reliance procedures in conjunction with cloud-based regulatory submissions. He also leads the CMC Science and Strategy team which supports structured content and generative artificial intelligence authoring initiatives for regulatory CMC submissions, and manages the initial CMC and regulatory content included in module 3 for clinical and commercial submissions. In addition, he as actively engaged with several external professional associations, consortia, and trade associations. Prior to joining Amgen, Paul was a product quality CMC review chemist at FDA/CDER in the Office of Biotechnology Products and is also a former FDA Commissioner’s Fellow. Paul holds a Ph.D. in Biochemistry from the University of Colorado Anschutz Medical Campus, where he completed graduate and post-doctoral training in the laboratory of Robert S. Hodges. 

Director, ORS, OGD, CDER, FDA

Dr. Robert Lionberger serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD).  Dr. Lionberger leads OGD’s implementation of the Generic Drug User Fee Amendments (GDUFA) science and research commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission advice on complex generics through pre-Abbreviated New Drug Application (ANDA) meetings, product-specific guidance, and correspondence responses.    

He received his undergraduate degree from Stanford University in Chemical Engineering, and a Ph.D. from Princeton University in Chemical Engineering. After his Ph.D., he conducted post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA 18 years ago, Dr. Lionberger was an Assistant Professor of Chemical Engineering at the University of Michigan. 

Acting Deputy Director, ODES, OND, CDER, FDA

Dr. Jinzhong (Jin) Liu leads the Office of New Drugs (OND) Clinical Data Scientist (CDS) Staff and serves as the Acting Deputy Director of the Office of Drug Evaluation Sciences (ODES) within OND. Jin joined the FDA in 2014 to work on safety analyses of kinase inhibitors. As a clinical pharmacology reviewer in the CDER/Office of Translational Sciences (OTS)/Office of Clinical Pharmacology (OCP), Jin reviewed numerous INDs, NDAs, and BLAs for the treatment of solid tumors and hematologic malignancies. After joining CDER/OND/Office of Oncologic Diseases (OOD) as a clinical analyst, Jin supported safety reviews for numerous INDs, NDAs, and BLAs. In August 2018, Jin was reassigned to the OND Immediate Office (IO) to establish the CDS Staff. In September 2024, Jin began serving as the Acting Deputy Director for ODES. Jin obtained his PhD in Clinical Pharmacology from Indiana University School of Medicine. 

Associate Director for Innovation & Partnership, OCP, OTS, CDER, FDA

Dr. Qi Liu is the Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology (OCP)/ Office of Translational Sciences, CDER, FDA. She is a co-chair of CDER’s AI Council and the lead of CDER AI Review Rapid Response Team. She is a member of the FDA-Wide AI Policy Coordination and Planning Council. She is also on the executive board of CDER’s Quantitative Medicine Center of Excellence. She helped establishing the OCP Innovative Data Analytics Program (focusing on AI, real-world data and digital health) and AI review team, and serves as the lead. She had the experience leading OCP’s Physiological Based Pharmacokinetic Modeling and Simulation Oversight Board and co-leading Biologics Oversight Board. She was a co-lead initiating the Real-Time Oncology Review and Assessment Aid Pilot Programs. During her career at the FDA, she also contributed to over 200 NDA/sNDA reviews, 20 BLA/sBLA reviews, and numerous IND reviews to support drug development. She worked on working groups for FDA guidance documents and Manual of Policies & Procedures development. She is an Associate Editor of Clinical Translational Science and on the editorial board of five scientific journals. Before joining FDA, Dr. Liu was a senior pharmacokineticist at Merck & Co. Inc. She obtained her Ph.D. degree in Pharmaceutics and a concurrent Master’s degree in Statistics from the University of Florida in 2004. In addition, she has a Master’s degree in Pharmaceutics and a Bachelors’ degree in Clinical Pharmacy from West China University of Medical Sciences. 

Associate Director, Guidance & Scientific Policy at IO, OCP, OTS, CDER, FDA

Dr. Rajanikanth (Raj) Madabushi has over 15 years of regulatory experience as a Pharmacometrics Reviewer and Clinical Pharmacology Team Lead in the Office of Clinical Pharmacology, OTS/CDER/FDA. He currently serves as the Associate Director, Guidance and Scientific Policy in the Immediate Office of Clinical Pharmacology. Dr. Madabushi plays an instrumental role in FDA’s PDUFA MIDD initatives and is the CDER Point-of-Contact for the MIDD Paired Meeting Program. Dr. Madabushi is also involved in global harmonization activities as the Rapporteur for ICH M12 Expert Working Group – Drug Interaction Studies.  Dr. Madabushi received his Ph.D. in Pharmaceutical Sciences from Birla Institute of Technology and Sciences (BITS), Pilani, India. 

Chief Technology and Product Officer, A2-Ai

Dr. Devin Pastoor is the Chief Technology & Product Officer (CTPO) at A2‑Ai, where he partners with life‑science organizations to deliver end‑to‑end platforms for quantitative decision‑making. He specializes in connecting real‑world IT constraints with scientific workflows—standing up scalable, GxP‑compliant statistical computing environments; developing reproducible analytical tools and dashboards; and increasingly integrating generative AI to support clinical study reporting, code review, and SOP management.

Before A2‑Ai, Devin was a Principal Solutions Engineer at Posit helping pharma and biotech companies integrate R and Python for analytics and decision‑making and prior to that Senior Vice President at Metrum Research Group building technology solutions. He earned a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore.

Senior Epidemiology Expert, European Medicines Agency

Dr. Luis Correia Pinheiro is the Lead rapporteur for the Heads of Medicines Agency / European Medicines Agency’s Network Data Steering Group’s AI Workplan, Coordinates the EMA’s Health Data Lab, and is part of the leadership team of the European Specialised Expert Community Special Interest Area on AI and Data Science. He holds a Masters in Epidemiology and a Doctor of Pharmacy (PharmD). 

Director, OB, OGD, CDER, FDA

Dr. Partha Roy is a regulatory expert with 24 years of drug development experience in new and generic drugs. Dr. Roy currently serves as the Director of the Office of Bioequivalence in the Office of Generic Drugs, an FDA/CDER Office that oversees assessment of all bioequivalence (BE) data required to support Abbreviated New Drug Application (ANDA) applications. 

Prior to his current role, Partha was Vice President in PAREXEL’s Regulatory and Access Consulting Global Business Unit, providing executive management, regulatory strategy and thought leadership focused on driving corporate growth and delivery. Following his Ph.D. from the University of South Florida, Tampa, Florida, Partha completed his Postdoctoral Fellowship in Drug Metabolism and Pharmacokinetics (DMPK) from Boston University, Boston, MA.  

Principal Product Manager, R&D, Digital & Process Excellence, Dr. Reddy’s Laboratories

Mr. Senthil Kumar is a seasoned researcher in drug discovery and development, with over 18 years of experience across leading pharmaceutical companies in India. He currently leads the Digital & Process Excellence team at Dr. Reddy’s Laboratories, focusing on API small molecules and biologics generics product development. His role involves integrating automation, digital technologies, and scientific tools across the value chain to enhance efficiency and innovation.

Prior to joining Dr. Reddy’s, Mr. Senthil contributed to novel drug discovery initiatives at organizations such as Biocon – Bristol Myers Squibb R&D Center, where he worked on therapies targeting immuno-oncology, fibrosis, and metabolic disorders. His core expertise spans in-vitro biology, translational research, data science, and lab automation, with notable contributions to regulatory submissions for generic drug products.

Mr. Senthil holds a B.Tech in Chemical Engineering from Anna University and an M.Tech in Biotechnology from VIT University, India. He is deeply committed to accelerating drug development through the strategic integration of artificial intelligence (AI) and machine learning (ML), in alignment with Dr. Reddy’s core mission: “Good health can’t wait.”

Vice President, Global Head Regulatory Affairs, Biocon

Dr. Anil Sachdeva is the Global Head of Regulatory Affairs at Biocon and a Certified Regulatory Affairs Professional (RAC) with over 31 years of global pharmaceutical experience spanning the U.S., China, and India. He holds an M.S. in Pharmaceutical Chemistry from New Delhi, India. 

An accomplished and results-driven regulatory executive, Anil has held leadership roles in top-tier generic pharmaceutical companies, where he has successfully led global regulatory strategies for complex sterile injectables, drug-device combination products, and oral/ophthalmic formulations across major markets including the U.S., EU, Canada, LATAM, and Asia. 

He has extensive experience managing the full lifecycle of pharmaceutical products—from development through post-approval—and is adept at guiding regulatory pathways for ANDAs and 505(b)(2) submissions. Anil has led large, cross-functional global teams of over 60 members and has been actively involved in due diligence assessments, strategic agency interactions, and formal negotiations with health authorities. 

Head of the Clinical Department, R&D PharOs Ltd

Dr. Volodymyr Stus is the Head of the Clinical Department at R&D PharOs Ltd., where he leads activities related to the design and conduct of BE and clinical studies. He is also supporting the AI transformation of PharOs Ltd. through the implementation and testing of AI-driven applications in Clinical, R&D, CMC, and IP processes. In his previous leadership roles at ZF Polpharma S.A., Dr. Stus’s responsibilities extended well beyond simple generics. He guided teams through planning and execution of pre-clinical studies, late-phase clinical trials (III-IV), and innovative Real-World Evidence (RWE) studies. His efforts supported the development of complex generics (such as DPIs and depot injections) and value-added products like new fixed-dose combinations and advanced ocular therapies. 

Dr. Stus has over 12 years of experience in the generic pharmaceutical industry and 19 years of overall experience in clinical studies. His work also involves the active exploration and application of AI technologies in pharmaceutical R&D. He is a published author in peer-reviewed journals on topics including statistics in BE studies and RWE. Dr. Stus received his MD with Honor from Dnipropetrovsk State Medical University, Ukraine. 

Assistant Professor, Center for Translational Medicine, University of Maryland, Baltimore, School of Pharmacy

Dr. Adarsh Subbaswamy is an Assistant Professor at the University of Maryland School of Pharmacy. Prior to this, he was a Staff Fellow (Regulatory Scientist) at the U.S. Food and Drug Administration (FDA) in the Office of Science and Engineering Laboratories (OSEL) at the Center for Devices and Radiological Health (CDRH). His research has focused on AI-enabled medical devices, including developing tools to quantify algorithmic bias, reduce performance differences among subpopulations, and evaluate the quality of medical data. More broadly he has worked on improving the reliability of machine learning models in healthcare through research on generalizability and causal machine learning. He completed his PhD in Computer Science at Johns Hopkins University where he was advised by Professor Suchi Saria. 

Senior Chemical Engineer, DQMM, ORS, OGD, CDER, FDA

Dr. Ross Walenga joined the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. He is currently a Senior Chemical Engineer at the Division of Quantitative Methods and Modeling at the Office of Research and Standards. He began his career at Virginia Polytechnic Institute and State University (Virginia Tech), where he earned a Bachelor Science in Aerospace Engineering. He later earned his Ph.D. in Engineering (mechanical track) from Virginia Commonwealth University in 2014, where he also spent seven months as a postdoctoral fellow prior to joining the FDA. His research interests include computational fluid dynamics modeling of orally inhaled, nasal, ophthalmic, and dermal drug products to answer questions pertaining to bioequivalence. 

Chief AI Officer, OC, FDA

Deputy Director, DTP I, ORS, OGD, CDER, FDA 

Dr. Yan Wang is the Deputy Director in the Division of Therapeutic Performance I (DTP I), Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). DTP I is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Yan has been at the U.S. Food and Drug Administration since 2013. Prior to her current role, Yan served in various roles, including as the subject matter expert in the area of complex long-acting drug products, and as the Team Lead for the Complex Drug Substance and Complex Formulation Team in ORS/DTP-1. Yan has research interests in developing new analytical methods, in vitro characterization, and drug release testing methodologies for complex drug products. She specializes in complex parenteral, ophthalmic, otic, intravaginal, and intrauterine formulations. 

Senior Research Scientist, OPQR, OPQ, CDER, FDA 

Dr. Daniel Willett is a Senior Research Scientist at the FDA’s Office of Pharmaceutical Quality Research in St. Louis, MO, where he develops spectroscopic and imaging-based approaches integrated with machine learning and multivariate data analysis techniques for physicochemical analysis of pharmaceutical products across nano and macro scales. His expertise particularly focuses on machine learning approaches for Process Analytical Technology (PAT) applications in pharmaceutical quality assessment. Dr. Willett serves as a Government Liaison for USP’s Process Analytical Technology Expert Panel and as Chair of the ASTM E55.14 Measurements and Analysis subcommittee, contributing to the development of analytical standards for the pharmaceutical industry. He received his B.S. in Chemistry from Murray State University and Ph.D. in Analytical Chemistry from Clemson University, bringing expertise in both fundamental analytical science and regulatory applications of modeling and AI technologies to pharmaceutical quality research. 

Master Pharmacologist, DB I, OB, OGD, CDER, FDA

Dr. Zhen Zhang is a Master Pharmacologist in the Division of Bioequivalence I, Office of Bioequivalence, within the FDA’s Office of Generic Drugs (OGD). His extensive expertise includes data analysis, modeling and simulation, dissolution studies, and topical product evaluations. Dr. Zhang leads efforts to modernize data analysis tools within the Office of Bioequivalence, significantly enhancing the efficiency of bioequivalence reviews. He also co-leads OGD’s Oral PBPK Expert Committee. Over the course of his career, Dr. Zhang has addressed complex bioequivalence challenges and played a key role in the development of several FDA general guidances. For his significant contributions, Dr. Zhang has received many individual and group awards at both the FDA and CDER levels. Dr. Zhang earned his Ph.D. in Pharmacology from the University of Wisconsin-Madison. 

Professor & Vice Chair, Department Bioengineering & Therapeutic Sciences, School of Pharmacy & School of Medicine, University of California San Francisco

Dr. Liang Zhao is currently a professor and director for the center of regulatory science at the School of Pharmacy, University of California San Francisco (UCSF).  Prior to joining UCSF, he had served as the Director of Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs, CDER/FDA between 2015 and 2024. He has demonstrated excellence and leadership in drug development and regulatory science for new and generic drugs during his 19–year professional tenure including in Pharsight as an associate consultant, BMS as a research investigator, MedImmune as an Associate Director, and FDA as Clinical Pharmacology reviewer, Pharmacometrics Team Leader, and Division Director.  Dr. Zhao and his team have introduced a broad array of innovative tools in the realm of drug deliveries, bioequivalence assessment, and big data tools including machine learning to pharmacometrics. They have also implemented the Model Integrated Evidence (MIE) Industry Meeting Pilot to support regulatory communications between generic applicants and the FDA and proposed a regulatory mechanism of using Model Master File to support regulatory submissions. Liang currently serves as the Chair of the FDA ModSim WG for the Modeling & Simulation community cross FDA centers and offices. He has published over 120 peer reviewed publications and 8 book chapters. He received the 2023 Gary Neil Prize for Innovation in Drug Development from ASCPT in recognition to his contribution to clinical pharmacology and pharmacometrics.