Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Produc

Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products - The Center for Research on Complex Generics (CRCG)
Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products
Date and Time:
May 5
8:30 am
5:30 pm
May 6
8:30 am
5:30 pm
Co-hosts:
FDA and the Center for Research on Complex Generics (CRCG)
In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop
Agenda Now Available
Register here
Download the Agenda
The field of generic oral drug products continues to evolve leading to innovative bioequivalence (BE) approaches when conventional in vivo bioequivalence study designs may not be feasible. In response to these evolving complexities, this workshop is designed to address the latest advancements and regulatory challenges in the field, offering a unique platform to engage with all relevant parties, share knowledge, and contribute to the evolution of generic oral product development and regulatory assessment.
Attendees will gain valuable insights into the intricacies of developing generic oral products across diverse areas, including oncology drugs, unavailable reference listed drugs or reference standards, and drug products that are reformulated to mitigate nitrosamine risks. In addition to a series of expert-led presentations and panel discussions, in-person attendees will interact directly with experts from industry, consulting groups, academia and FDA in small group working sessions to deepen their understanding of current practices and challenges, regulatory expectations, and emerging trends. Specifically, the 2-day workshop will cover critical areas such as bioequivalence approaches for oral oncology products, risk assessment and regulatory decision making for nitrosamine-driven reformulation, demonstration of bioequivalence when a reference listed drug or reference standard is unavailable, biopredictive dissolution, and regulatory acceptance of innovative and alternative bioequivalence approaches for generic oral products. These topics reflect the most pressing challenges facing generic oral drug development today and the scientific innovations being deployed to overcome them.
Choose your experience:
Virtual Attendees
will have free access to all sessions of the workshop except the small group (in-person only) working sessions. Virtual attendees will be able to:
Attend all presentations and panel discussions
Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
Access a session summarizing the in-person only discussions
Enjoy free access to workshop recordings of presentations and panel discussions (not including the in-person only sessions)
In-person Attendees
will enjoy all the benefits of virtual attendance as well as interactive experiences featuring:
Interactive Small Group Working Sessions
with on key topics related to bioequivalence approaches for oral oncology products, risk assessment and regulatory decision making for nitrosamine-driven reformulation, demonstration of bioequivalence when a reference listed drug or reference standard is unavailable, biopredictive dissolution, regulatory acceptance of innovative and alternative bioequivalence approaches for oral products.
Collaborative Problem-Solving Exercises
, including real-world case studies and consensus mapping to identify priorities and actionable outcomes.
Direct Interactions with experts from industry, consulting groups, academia and FDA
for clarifying regulatory expectations and exploring insights into regulatory standards.
Networking Opportunities
designed to foster collaboration and advance regulatory science supporting bioequivalence innovations for generic oral products.
Workshop Topics
Regulatory pathways and insights for innovative and alternative bioequivalence approaches for generic oral drugs
when conventional in vivo BE studies are not feasible
Oral oncology products and BCS Class IV drugs
, where ethical, scientific, and feasibility constraints are most prominent
Biowaiver and alternative BE strategies
supported by biopredictive dissolution, absorption and PBPK modeling, and model-integrated evidence
Bridging challenges for discontinued products,
including unavailable reference standards
BE implications of nitrosamine-driven reformulation,
emphasizing risk-based regulatory approaches
Audience
The workshop is designed for professionals interested in advancing their understanding of regulatory science relating to innovative and alternative bioequivalence strategies for oral drug products. It is ideal for individuals involved with the product development, bioequivalence demonstration, and regulatory assessment of oral drug products. It provides an opportunity to address challenges and questions related to biowaivers, alternative BE strategies for oncology and BCS IV drug products and developing generics when a reference standard is unavailable, and to discuss the BE implications of nitrosamine-driven reformulation. This workshop is relevant to formulation scientists, analytical scientists, regulatory affairs specialists, quality control experts, biopharmaceutics, clinical pharmacology and R&D professionals from industry, consulting groups, academia, and FDA.
Virtual Attendance
is ideal for those who wish to access expert presentations and panel discussions remotely, eliminate travel requirements, and have the flexibility to engage with content in real time or on demand.
In-Person Attendance
is best for participants seeking high-level engagement through
collaborative small group working sessions, direct interaction with
experts from industry, consulting groups, academia and FDA
, and immersive learning focused on real-world challenges and problem-solving
Registration Fees:
This workshop is
FREE
for virtual attendees.
The combined cost for the two-day workshop in-person attendance and activities is:
$350, in-person attendees – general
$150, in-person attendees – government (must have an email ending in “.gov” to register at this rate)
For faculty and students from the University of Maryland, Baltimore, The Universities at Shady Grove, and University of Michigan, please contact CRCG (info@complexgenerics.org) regarding registration.
Continuing education (CE) credits will not be provided for attending this workshop.  A certificate of attendance will only be provided to individuals attending in-person, when requested.
For in-person attendees, beverages and food for breaks will be provided; lunch is not included.  Please see the tab
Ordering Lunch
to order lunch each day.  You can go to Dawson’s Market as well, located in Building III, first floor.  Hours are 9 AM-5 PM ET.  The cafe has additional food and beverage options there.  You are welcome to bring your lunch, as well.
Introduction to the Workshop
This two-day workshop will highlight bioequivalence (BE) approaches for generic oral drug products when conventional in vivo BE studies may not be feasible. The workshop will explore biowaiver pathways supported by bio-predictive dissolution, absorption modeling, and model-integrated evidence. The program will address BE strategies for oral oncology products, for bridging BE when designated reference listed drugs (RLDs) or reference standards are unavailable for discontinued products and when surrogate comparators are needed, and for the reformulation of nitrosamine-impacted drug products. Sessions will highlight scientific justifications and regulatory considerations for implementing these alternative BE strategies. Data integrity, reproducibility, model credibility, and well-defined criteria will be emphasized for establishing BE in complex and challenging generic oral drug development scenarios.
Participants will gain critical insights into the BE approaches described above as well as other related topics including biopredictive dissolution and strategies for regulatory acceptance of innovative and alternative BE approaches within the scope of generic oral products. Sessions will feature expert presentations, case studies, and interactive panel discussions.
In-person attendees will benefit from small-group working sessions focused on real-world challenges, best practices, and actionable solutions, offering a unique opportunity for direct engagement with regulators and thought leaders from industry and academia.
DAY 1
Session 1: Bioequivalence Approaches for Oral Oncology Products
Format:
Presentations and Panel Discussion (Virtual and In-Person Attendees)
This session will highlight how FDA and industry approach bioequivalence decision-making for oral oncology products when ethical constraints, patient feasibility, and limited study options require the use of alternative evidence and clearly defined decision thresholds.
Session 2: Nitrosamine-Driven Reformulation and Bioequivalence: Risk Assessment and Regulatory Decision-Making
Format:
Presentations and Panel Discussion (Virtual and In-Person Attendees)
This session examines how nitrosamine-driven reformulation should be evaluated within BE frameworks, emphasizing scientific justifications, risk-based assessment, and when alternative BE evidence is appropriate, particularly for BCS IV immediate release and modified release products.
Session 3: Discontinued RLDs and Unavailable Reference Standards: A Structural Barrier to Generic Access
Format:
Presentations and Panel Discussion (Virtual and In-Person Attendees)
This session frames discontinued RLDs and unavailable reference standards as a barrier to generic access, highlighting the public-health impact, regulatory constraints, and alternative approaches to resolve the problems.
Session 4: Small-Group Working Sessions
Format:
Interactive Working Session (In-Person Attendees Only)
In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, consulting groups and academic experts. In-Person Attendees will engage in discussions related to challenges and opportunities of bioequivalence approaches for oral oncology products, nitrosamine-driven reformulation and bioequivalence, and developing generic products when a reference standard is unavailable. Attendees will engage in guided discussions, consensus mapping, and reporting of actionable research or policy recommendations. Direct interactions with experts from FDA, industry, consulting groups and academia will be fostered.
DAY 2
Session 5: When Is Dissolution Truly Biopredictive?
Format:
Presentations and Panel Discussion (Virtual and In-Person Attendees)
This session highlights when dissolution data can credibly transition from a quality control tool to regulatory evidence for bioequivalence, focusing on biorelevant/predictive dissolution, discriminating capabilities of the testing media/method, integration with modeling, evidence sufficiency, and common dissolution-based BE arguments.
Session 6:
Regulatory Acceptance of Alternative Approaches
Format:
Presentations and Panel Discussion (Virtual and In-Person Attendees)
This session explores strategies for achieving regulatory acceptance when using alternative approaches to establish bioequivalence in challenging scenarios.
Session 7: Small-Group Working Sessions
Format:
Interactive Working Session (In-Person Attendees Only)
In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, consulting groups and academic experts. In-Person Attendees will engage in discussions related to the solutions (e.g., biopredictive dissolution and regulatory acceptance of alternative approaches) to address the challenges discussed on Day 1. Attendees will engage in guided discussions, consensus mapping, and reporting of actionable next steps. This session will foster direct interactions with experts from FDA, industry, consulting groups and academia.
The workshop will be held at the
Universities at Shady Grove (USG)
please follow signs
), 9630 Gudelsky Drive, Rockville, MD 20850
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 Shady Grove campus is the DCA airport, then taking the Metro subway from the airport to Shady Grove, 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 Shady Grove 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.
More links and information:
Directions and transportation options to USG
Public transportation
Campus map
The Traville-Gateway Garage is the closest parking garage to the venue (
parking map
Attendees may also park in Lot 2 and Shady Grove Garage but will need to allow more walking time to reach the event.
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.
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
Empire Sedan & Limo Services (empiresedan12@gmail.com):  240-988-1796
Washington Flyer Taxi:  703-572-TAXI or 706-853-6094
Regency Taxi:  301-984-1900
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 Universities of 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 your room (CRCG rate)
by April, 13, 2026)
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
EVEN by IHG Hotel Rockville
1775 Rockville Pike, Rockville, MD 20852 (5.5 miles from USG)
855-879-3836
For the May 5-6 workshop, you will need to pre-order your lunch for each day; lunch is not provided.
Lunch will be delivered to the main building where the workshop will be held (Building II, Ballroom) and labeled with your name.  You will pick up your ordered food at the registration desk, each day.
You can go to Dawson’s Market as well, located in Building III, first floor.  Hours are 9 AM-5 PM ET.  The cafe has additional food and beverage options there.  You are welcome to bring your lunch, as well.
The link for placing your order for Day 1 (May 5) is:
The link for placing your order for Day 2 (May 6) is:
Make your selection and Add to Order.  Once you have made your selection, you will then click on the shopping cart icon to check out.  If you want to purchase more than one item for the same day, you will need to place two separate orders.  You will Continue to Payment, where you can pay with Google Pay, Credit Card, or Cash App Pay.  Then hit Place Order.
During checkout, there is a spot for Note to Seller, to use when placing your order, if needed for modifications to your order.
The deadline for ordering lunch is
Monday, April 27
th
by 5 PM ET
Coffee, water, and pop will be available throughout each day in the conference room (Ballroom).
Food will be provided in the morning, and AM and PM breaks each day.
USG Lunch (Dawson’s Market)
Chicken Caesar Wrap $14.99
Includes chips, cookie, and choice of beverage
Turkey & Swiss Wrap $14.99
Includes chips, cookie, and choice of beverage
Tuna Salad Wrap $14.99
Includes chips, cookie, and choice of beverage
Grilled Vegetables & Hummus Wrap $14.99
Includes chips, cookie, and choice of beverage
Eggless Egg Salad Wrap (VEGAN) $14.99
Includes chips, cookie, and choice of beverage
You will have the option to remove tomatoes and/or cheese, if needed
Greek Salad $14.99
Includes romaine lettuce, tomatoes, onion, kalamata olives, bell peppers, feta cheese, pepperoncini peppers served with Dijon vinaigrette. Includes chips, cookie, and choice of beverage
Grilled Salmon Caesar Salad $15.99
Includes chopped romaine, house made croutons, shredded parmesan & Caesar dressing. Includes chips, cookie, and choice of beverage
Goat & Greens $14.99
Includes spinach, cranberries, pecans, tomatoes, goat cheese served with balsamic vinaigrette. Includes chips, cookie, and choice of beverage
Hot Items
Tomato Basil Soup  $6.99
Taco Bowl  $15.99
Your choice of [fajita chicken, ground beef, or vegetables] on a bed of rice with mixed greens, fajita vegetables, black beans, shredded cheese, and toppings on the side (guacamole, sour cream, and salsa)
Beverage Choice
Coke
Diet Coke
Sprite
Water
Just Tea-Mango White (additional $1.00)
Just Tea-Original Green (additional $1.00)
Just Tea-Half & Half (additional $1.00)
Dr. Browns-Cream
Dr. Browns-Black Cherry
Dr. Browns-Root Beer
Olipop-Grape (additional $1.00)
Olipop-Ginger Lemon (additional $1.00)
Olipop-Cherry Cola (additional $1.00)
Senior Vice President and Head-Clinical Research and Biopharmaceutics Department, Mankind Pharma Ltd.
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.
Director, Biopharmaceutics & Pharmacokinetics, Cipla Ltd.
Dr. Yasvanth Ashokraj holds a
Master’s
degree and a Ph.D. in Pharmaceutics from NIPER, India, and has more than 20 years of experience in the generic pharmaceutical industry. He is currently working as Director, Biopharmaceutics and Pharmacokinetics at Cipla Ltd., India. He
is responsible for
leading technical teams
involved in
in vitro
evaluatory
method development, BA/BE studies, and PK/PD modeling and simulation across generics, complex generics, and 505(b)(2) products covering a wide range of dosage forms. He is presently focused on various applications of model‑based BE frameworks to address challenges related to bioequivalence. He has published over 25 research
and review
papers
and also
serves as a key contributor to the Education and Training Wing of the Society of Pharmacometrics and Health Analytics (SOPHAS), supporting the advancement of quantitative sciences in India.
Deputy Divison Director, DQMM, ORS, OGD, CDER, FDA
Dr. Andrew Babiskin is the Deputy Division Director of 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.
Team Lead, Biopharmaceutics, Dr. Reddy’s Laboratories Ltd.
Dr. Rajkumar Boddu received his Ph.D. from Jawaharlal Nehru Technological University (JNTU), Hyderabad, and his M. Pharmacy degree in Pharmaceutical Technology from Andhra University, Visakhapatnam, India.
He
is currently serving as
Team Lead in the Biopharmaceutics Department within the Global Clinical Management group at the Integrated Product Development Organization (IPDO), Dr. Reddy’s Laboratories Limited (DRL), Hyderabad.
He
is responsible for
biopharmaceutics evaluations through model-informed drug development, bioequivalence (BE) risk assessment, and BE predictions for both conventional and complex generic products.
Prior to joining DRL, he worked with organizations such as AET Labs,
Aizant
Research Solutions, and Hetero Drugs. With over 15 years of experience in biopharmaceutics and fo
rmulation development, Dr. Raj
is an accomplished pharmaceutical scientist whose core
expe
rtise
includes physiologically based b
iopharmaceutics
Model
ing
(PBBM) and physiologically based p
harmacokinetic
Modeling
(PBPK). These advanced
modeling
approaches are applied to oral solid dosage forms, long-acting injectables, topical formulations, and differentiated 505(b)(2) products.
He has extensive experience in regulatory justifications, including biowaive
rs, dissolution specifications
dissolution similarity evaluations
, drug-drug interactions (DDI)
supported by
physiological
modeling
techniques. Dr.
Raj
has authored or co-authored more than 30 peer-reviewed publications and serves as a scientific reviewer for several journals. He is also a sought-after speaker at international conferences, where he has delivered
numerous
talks on PBPK/PBBM applications in new drug and generic product development.
Lead Pharmacokineticist, DTP II, ORS, OGD, CDER, FDA
Dr. Heather Boyce serves as a Lead Pharmacokineticist for the Modified Release Oral Drug Products Team in the Division of Therapeutic Performance II (DTPII), Office of Research and Standards (ORS), Office of Generic Drugs, Center for Drug Evaluation and Research at the Food and Drug Administration
in White Oak, MD
Dr. Boyce brings 15 years of experience in the pharmaceutical industry with expertise in good manufacturing processes (GMP), pharmaceutical manufacturing and product development, clinical trial design and analysis, and clinical pharmacology.
Dr. Boyce received her Ph.D. in Pharmaceutical Sciences at the University of Maryland, Baltimore, School of Pharmacy where her research focused on excipient properties and formulation design of pharmaceutical drug products. She received her Bachelor of Science degree in chemistry with a minor in mathematics from Temple University of Philadelphia, PA.
Research Scientist, DQMM, ORS, OGD, CDER, FDA
Dr. Yi-Hsien Cheng is currently working as a research scientist at the Division of Quantitative Methods and Modeling (DQMM) within the Office of Research and Standards (ORS), Office of Generic Drugs (OGD) at FDA. She received her Ph,D, degree in Bioenvironmental Systems Engineering from National Taiwan University in 2013, where she completed her first postdoctoral fellowship. Before joining FDA in 2021, she completed her second postdoctoral fellowship in the Institute of Computational Comparative Medicine (ICCM) at Kansas State University.
Dr. Cheng’s work at the Oral PBPK Team in DQMM focuses on applying physiologically based pharmacokinetic (PBPK) modeling and simulation approaches to support bioequivalence (BE) assessment for oral drug products. Her work focuses on utilizing PBPK modeling and virtual BE simulations to evaluate the sensitivity of using parent vs. metabolite as analytes in BE assessment, assessing the impact of food-formulation variability on BE studies, evaluating the effect of non-comparable in vitro dissolution or alcohol dose dumping (ADD) results on BE evaluation, supporting single-sex study population justification in generic drug BE evaluations, and assessing the impact of reformulation on the bioavailability (BA) and BE of nitrosamine-impacted BCS-IV oral drug products.
Senior Vice President, Clinical Pharmacology, A2-Ai, LLC
Dr. Jack Cook joined A2-Ai in June of 2023 and is a Senior Vice President in the Clinical Pharmacology Department   Prior to that, Jack spent 33 years at Pfizer, Inc.  where he worked in a multitude of therapeutic areas.  Dr. Cook holds adjunct faculty positions at the Universities of Michigan and Florida Colleges of Pharmacy. He received B.S. degrees in Applied Mathematics and Pharmacy from Ferris State College, and his Ph.D. in Pharmaceutics from the University of Michigan. He has authored/co-authored over 85 peer-reviewed publications. He served as an industrial representative for the United States Food and Drug Administration’s Pharmaceutical Science and Clinical Pharmacology Advisory Committees from 2012 to 2019. He is a fellow of the AAPS. His current interests include improving therapy by
optimizing
drug delivery and the use of modeling and simulation to make rational decisions in the development of drugs.
Senior Pharmacologist, DB III, OB, OGD, CDER, FDA
Dr. Pamela Dorsey is a Senior Pharmacologist in the Division of Bioequivalence III. She is a secondary assessor for controlled correspondences and serves as a subject matter expert for the Generic Drug Structured Assessment-Bioequivalence development group and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, M13A guideline implementation group. Dr. Dorsey has extensive knowledge in the use of alternate comparator products for bioequivalence determination of generic drug products.
Prior to joining the FDA in 2014, Dr. Dorsey was a Cardiovascular Clinical Research Ruth Kirschstein Post-Doctoral Fellow at Boston University. Dr. Dorsey earned her Doctorate in Pharmaceutical Science from The University of Georgia, College of Pharmacy. In addition, Dr. Dorsey received a Bachelor of Science and Master of Science in Chemical Engineering from North Carolina Agricultural and Technical State University.
Division 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 Ph.D. in Pharmaceutical Sciences from The Ohio State University and is a graduate of the Excellence in Government Fellows program (2014-2015).
Director, Biopharmaceutics & Statistics, Apotex Inc
Dr. Emilija Fredro-Kumbaradzi is Director of Biopharmaceutics and Statistics at Apotex. She is responsible for Biopharmaceutics aspects in the development of generic drug products. Her work spans dissolution science, in vitro comparisons, in silico modeling, and biowaiver justifications, ensuring alignment with global regulatory standards. She also oversees clinical research activities related to bioequivalence studies and clinical study design, with a focus on regulatory strategy and scientific integrity. With over 20 years at Apotex, Dr. Fredro-Kumbaradzi brings extensive experience in the biopharmaceutic evaluation of solid oral dosage forms. She holds a Ph.D. in Pharmaceutical Sciences from the University of Skopje, Macedonia, where she previously served as a Professor of Pharmaceutical Technology.
Lead Pharmacologist, DBIII, OB, OGD, CDER, FDA
Dr. Li Gong is a Lead Pharmacologist at the Division of Bioequivalence III (DB III) in the Office of Bioequivalence, within FDA’s Office of Generic Drugs. In this role, he leads a bioequivalence assessment team, conducting critical evaluations of in vivo & in vitro bioequivalence (BE) studies including abbreviated new drug applications (ANDAs), BE study protocols, Bio-INDs, controlled correspondences (CCs) and other regulatory submission for generic drug products. Dr. Gong earned an MD degree from Fudan University School of Medicine, and a Ph.D. degree in Neuropharmacology from Quillen College of Medicine, ETSU, TN. He worked as a house staff in the Dept. of Pathology &  Laboratory Medicine in Temple University for 5 years and also received a postdoctoral training in Clinical Pharmacology from Thomas Jefferson Medical School in Philadelphia, PA prior to his joining in the Agency in 2008.
Lead Pharmacologist, DQMM, ORS, OGD, CDER, FDA
Dr. Yuqing Gong
is currently
the
Team Lead
at the Quantitative Clinical Pharmacology Team in the Division of Quantitative Methods and Modeling
(DQMM)
, Office of Research and Standards
(ORS)
, Office of Generic Drugs
(OGD)
Center for Drug Evaluation and Research
(CDER)
FDA.
She
has led critical research priorities
utilizing
quantitative clinical pharmacology approaches and model-integrated evidence (MIE) to develop innovative study designs and methods supporting bioequivalence (BE) demonstrations for generics with complex in vivo study considerations.
Dr. Gong received her Ph.D. degree in Pharmaceutical Sciences at the University of Tennessee Health Science Center (Memphis, TN, US) in 2020. Her
Ph.D.
thesis work was to develop a
nanoform
lation
for antiretroviral drugs to suppress the viral load in the central nervous system across the blood-brain barrier.
Pharmacokineticist, DB I, OB, OGD, CDER, FDA
Dr. Min Guo is a Pharmacokineticist in the Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs at the FDA’s Center for Drug Evaluation and Research, a position he has held since April 2024. Previously, Dr. Guo served as a bioequivalence reviewer in the Division of Generic Animal Drugs at the FDA’s Center for Veterinary Medicine from 2019 to 2024. Prior to joining the FDA, Dr. Guo conducted postdoctoral research at the National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health (2015-2019), where he specialized in development and GMP production of C-11 and F-18 based PET imaging radiopharmaceuticals for studying substance abuse effects on the brain in clinical neuroimaging studies.
r. Guo earned his Ph.D. in Organic Chemistry and Biochemistry from the University of Maryland, College Park, and holds an M.S. and B.S. in Chemistry from Nanjing University, China.
Research Scientist, DQMM, ORS, OGD, CDER, FDA
Dr. Robert
Hopefl
is a Contractor working in the Quantitative Clinical Pharmacology team of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD). He joined the FDA as an ORISE Fellow in September of 2023. During his time as a fellow, he
leveraged
modeling and simulation approaches to investigate bioequivalence evaluation of topical products and carryover effects in products with a long
elimination
half-life. His current work focuses
on pharmacokinetics and clinical pharmacology to develop
guidances
to
facilitate
development of various
generic
drug products, including oral drugs, long-acting injectables, and orally inhaled drug products
. His research interests include quantitative modeling, pharmacokinetics, and innovative bioequivalence approaches. Prior to joining the FDA, Robert earned his PharmD from Larkin University.
Director, DTP II, ORS, OGD, CDER, FDA
Dr. Myong Jin Kim serves as Director of the Division of Therapeutic Performance II within the Office of Research and Standards, Office of Generic Drugs at CDER/FDA. Since joining the FDA in 2001, she has held several key positions, including Deputy Director of the Division of Quantitative Methods and Modeling and Team Leader in the Office of Clinical Pharmacology.
Dr. Kim earned her Bachelor of Science degree in Chemistry from the Georgia Institute of Technology. She went on to receive her Doctor of Pharmacy degree from Temple University School of Pharmacy and completed a two-year postdoctoral fellowship in clinical pharmacology at Bassett Healthcare, a major teaching affiliate of Columbia University College of Physicians and Surgeons, in New York.
Senior Manager, Formulation R&D, Orals, Sun Pharmaceuticals Industries Ltd.
Dr. Lalit Kumar Khurana holds a Ph.D. in Pharmaceutical Medicine from Jamia Hamdard Delhi and brings over 19 years of industrial experience in generic formulation development and clinical pharmacology. His expertise spans pharmacokinetic (PK) analysis, biopharmaceutic evaluations, and modelling and simulation to support formulation development, bioequivalence studies, and regulatory submissions. He has a proven track record in applying advanced PK principles, integrating in vitro–in vivo extrapolation (IVIVE) and mechanistic modelling for complex compounds, as well as implementing bridging strategies across global markets.
Lalit is highly skilled in PBPK modelling, with hands-on experience using platforms such as GastroPlus, PK-Sim, and SimBiology (MATLAB). His work includes developing and validating mechanistic models, interpreting clinical pharmacokinetic data, and supporting decision-making in both early and late-stage drug development.
Head, Bioavailability & BE Division, Sun Pharmaceuticals Industries Ltd.
Dr. Arshad H. Khuroo currently serves as the Head of the Bioavailability and Bioequivalence Division at Sun Pharmaceuticals, India. He holds a Ph.D. in pharmacokinetics and brings over 30 years of extensive expertise in the field. His professional strengths include deep knowledge of GCP/GLP guidelines, protocol design, biopharmaceutical evaluation, clinical operations, and regulated bio-analysis for pharmacokinetic and pharmacodynamic endpoint studies supporting ANDA/NDA 505(b)(2) filings.
As Test Facility Manager, Dr. Khuroo ensures GLP compliance in the conduct of pre-clinical studies. Over his distinguished career, he has successfully navigated more than 100 regulatory inspections worldwide. He has authored or co-authored over 100 scientific articles published in leading international journals.
Beyond his scientific contributions, Dr. Khuroo is also an accomplished author of two books—
Echoes of Experience: 30 Insights from Life’s Journey
and
Perceivable Interactions
—both of which have been well-received by readers globally.
Vice President & Head, Biopharmaceutics, Dr. Reddy’s Laboratories Ltd.
Dr.
Sivacharan
Kollipara
is currently working as
Vice President &
Head
, Biopharmaceutics
department
in the Global Clinical Management group, IPDO at Dr. Reddy’s Laboratories Limited (DRL), Hyderabad. He
is responsible for
biopharmaceutics evaluation, bioequivalence risk assessment
and bioequivalence prediction for conventional as well as complex generic products at DRL. He is also involved in PK modeling and simulations activities supporting generic drug development of various immediate release, modified release
and complex products at DRL
and involved in
utilizing
novel PBPK and PBBM modeling approaches for regulatory justifications for various markets
. Prior to joining DRL,
Dr
. Kollipara
was Principal Scientist (Global Pharmaceutical Development) at Novartis Healthcare Pvt Ltd., Hyderabad.
Previously
he also has been associated with Ranbaxy Research Laboratories, Gurgaon (Metabolism and Pharmacokinetics).
He obtained Masters in Pharmaceutical Sciences from BITS, Pilani, Rajasthan
India
and
Ph.D.
in Biopharmaceutics
Dr
. Kollipara is also
Chair Person
, Scientific Planning Committee for
SOPHAS (Society of Pharmacometrics & Health Analytics)
, India
Overall
Dr
. Kollipara
has an experience of 1
years in the field of drug discovery, development and generic product development, bioanalytical method development and validation, PK data
modelling
and simulations. He has authored/co-authored
more than
peer-reviewed publications
and is
scientific
reviewer for many peer-reviewed journals
. His research interests include PBPK/PBBM modeling,
biowaivers,
virtual bioequivalence simulations, IVIVC/R, drug-drug interactions, dissolution/bioequivalence safe space, bio-predictive dissolution methodologies, biowaivers
alternative BE approaches, pharmacometrics and
novel statistical tools for dissolution similarity analysis
and food effect evaluations.
Dr. Kollipara has been invited as speaker
in
various international conferences and delivered
numerous
scientific talks on PBPK, PBBM approaches in new drug and generic product development, use of model integrated bioequivalence approaches and biowaivers.
Head Clinical Innovation, Clinical Pharmacology M&S, Sandoz Global Development
Dr. Dejan Krajcar holds a Master’s degree in Pharmacy and a Ph.D. in Biomedicine from the University of Ljubljana, Faculty of Pharmacy. He has over 16 years of experience in clinical development, including clinical trial strategy, clinical pharmacology, pharmacometrics, IVIVC, biostatistics, study planning, execution and oversight. His development experience spans a wide range of products, including oral solid dosage forms, nasal, topical, respiratory, and injectable products.
His work focuses on bioequivalence (BE) strategy and data-driven decision-making for complex and challenging development programs. He has authored publications related to machine learning driven bioequivalence risk assessment and has contributed to peer-reviewed work involving physiologically based pharmacokinetic (PBPK) modelling.
Since 2023, he has led a team in Sandoz dedicated to model integrated drug development, with a particular focus on innovative and regulatorily acceptable approaches when conventional clinical study designs are not feasible.
Assistant Professor, University of Maryland Baltimore
Dr. Brooke Langevin is an Assistant Professor in the Center for Translational Medicine at the University of Maryland School of Pharmacy. She received her Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore. Her work focuses on applying quantitative and model-informed approaches to support decision-making in drug development and clinical practice, with a particular emphasis on data-limited settings. This work spans applications in rare disease, pregnancy, and bioequivalence, where limited data require alternative quantitative strategies for regulatory evaluation.
Associate Director for Science, OB, OGD, CDER, FDA
Dr. Bing V. Li is the Associate Director for Science in the Office of Bioequivalence within the Office of Generic Drugs at the U.S. Food and Drug Administration (FDA). In this role, she provides scientific leadership and
expertise
in the assessment of bioequivalence (BE) studies
submitted
through Abbreviated New Drug Applications (ANDAs) and oversees
the
scientific initiatives
within the Office of Bioequivalence.
Dr. Li is
an
Expert Pharmacologist at the FDA, specializing in the bioequivalence of aerosolized drug products. Before joining the FDA in 2004, Dr. Li was a Research Investigator at Bristol-Myers Squibb. She earned her Ph.D. in Pharmaceutical Sciences from the University of Wisconsin–Madison in 2001, and her bachelor’s degree in Medicinal Chemistry from Peking University, China, in 1990.
Pharmacologist, DTP II, ORS, OGD, CDER, FDA
Dr. Hyelim
Lim is a
Pharmacologist
in
the Immediate Release (IR) Team
in
DTP II as a Visiting Associate (
Staff Fellow
).
She works on regulatory activities including product-specific guidance (PSG) development, controlled correspondence review, and pre-ANDA for IR oral drug products
The
DTP
II
is
proactively developing PSGs for suitability
petition-enabled generic products.
Her research includes administration methods for chewable products, baseline correction for bioequivalence studies of endogenous compounds, and translating pharmacokinetic science for locally acting gastrointestinal products. She serves as Project Officer for research on Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drugs (RFA-FD-009).
Hyelim
presents her research at scientific meetings including the American College of Clinical Pharmacology and American Society for Clinical Pharmacology and Therapeutics.
Before joining the IR team,
Hyelim
was an ORISE fellow in the Modified Release Team in DTP II, where she conducted research supporting PSG development
Hyelim
received a PharmD from
University
of Wisconsin – Madison.
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
Associate Director, DTP II, ORS, OGD, CDER, FDA
Dr. Dongmei Lu obtained her Ph.D. degree in Pharmaceutical Sciences from University of North Carolina at Chapel Hill. Her extensive industry experience includes pre-formulation and formulation at GlaxoSmithKline, Wyeth, and Pfizer. Dr. Lu served as a reviewer and team leader in the Office of Bioequivalence within the Office of Generic Drugs before transitioning to the Office of Policy for Pharmaceutical Quality in OPQ. There, she developed numerous policies, notably the guidance for nitrosamine-impacted products. Currently, Dr. Lu oversees the research portfolio and activities on oral dosage forms in bioequivalence perspective in DTP II/ORS.
Dr. Lu’s expertise is recognized widely, as evidenced by her role as an FDA Expert supporting ICH M13A and 13B global harmonization efforts. She is also a member of the FDA Biopharmaceutic Classification Systems Committee. Additionally, Dr. Lu contributes to several professional organizations, serving as a member of the PQRI Biopharmaceutics Technical Committee, FDA Liaison for USP nitrosamine and relevant research areas, and as an Editorial Advisory Board Member for the journal of
AAPS Open.
Senior Principal Scientist, PBPK R&D, Simulations Plus, Inc.
Dr. Deanna Mudie
is a Senior Principal Scientist in PBPK R&D at Simulations Plus
, where she leads development of
Physiologically Based Biopharmaceutics Mode
ls
PBBMs
, designs
mechanistic software features, and serves as technical lead and consultant
on
biopharmaceutics related
projects.
Deanna has over
twenty
years of experience
in the pharmaceutical field
spanning diverse roles in
academia, large pharma, CDMO, and software companies.
In addition to
PBBM, Deanna has
led
projects in
formulation development for
oral
bioavailability enhancement, biorelevant in vitro methodologies, and solid oral dosage form manufacturing
. She is a recognized leader
and
has
publications
in physiological parameters
impacting
oral delivery
biopredictive
dissolution testing
and mechanistic modeling
and design and evaluation of
amorphous solid dispersions
Deanna
earned
her
BSE in Chemical Engineering
and
her
Ph.D. in Pharmaceutical Sciences
at the
University of Michigan
Director, Global Clinical Operations, Gx-Pharmacokinetics, US, Teva Pharmaceuticals
Ms. Suparna Mukherjee is Director of Global Clinical Organization at Teva Pharmaceuticals, bringing over 20 years of experience in generic drug development. She is an expert in designing and executing bioequivalence (BE) studies, shaping clinical strategy, and leading regulatory interactions. Her work spans biopharmaceutics, PK/IVIVR, CRO oversight, and agency engagement across the entire product lifecycle—from early development through commercial launch.
She holds a Master of Pharmacy (MPharm) from Jadavpur University, India, and a Bachelor of Pharmacy from N.M.V.P.S. College of Pharmacy, Pune University.
Pharmacokineticist
, DQMM, ORS, OGD, CDER, FDA
Dr. Arindom Pal is a Pharmacokineticist in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs at the U.S. Food and Drug Administration (FDA). Dr. Pal earned his Ph.D. in Pharmaceutical Sciences from the University of California, Pacific in 2019. Following his doctoral studies, he completed a three-year postdoctoral fellowship at Johns Hopkins University School of Medicine, where he contributed to the DMPK group within the Johns Hopkins Drug Discovery Center.
Dr. Pal joined the FDA in 2023 as an ORISE Fellow and transitioned to his current role as Staff Fellow in 2024.
His research
expertise
encompasses
physiologically-based
pharmacokinetic (PBPK) modeling, drug
metabolism
and pharmacokinetics (DMPK), and targeted drug delivery systems. At the FDA, Dr. Pal focuses on oral PBPK modeling and simulations to support regulatory reviews and advance research initiatives within DQMM. His multidisciplinary training in biopharmaceutics, pharmaceutical chemistry, and pharmacology provides
a strong foundation
for his contributions to pharmaceutical science and regulatory science.
Ralph F. Shangraw/Noxell Endowed Professor, Industrial Pharmacy and Pharmaceutics, University of Maryland; co-Director, CRCG
Dr. James Polli is Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption, involving laboratory and clinical research. He has served as the advisor to 26 Ph.D. graduates. He is co-Director of the Center for Research on Complex Generics (CRCG). He is Director of the online M.S. in Regulatory Science program. He is a fellow of the American Association for Pharmaceutical Scientists (AAPS) and served as an editor of Pharmaceutical Research for 12 years. He is the 14th recipient of the American Pharmacists Association Takeru Higuchi Research Prize. He was the recipient of the 2024 American Association of Colleges of Pharmacy Volwiler Research Achievement Award, the 2022 AAPS Global Leadership Award, and the 2021 TOPRA Education Award. He is a member of the University of Maryland General Clinical Research Center Advisory Committee and the University of Maryland institutional review board (IRB).
Group Head Analytics, Sandoz Global Development, Sandoz
Dr. Blaž Robnik is a Group Head in Analytical Development at Sandoz, based in Ljubljana, Slovenia. He leads a team focused on mechanistic understanding of drug product stability, impurity formation, and the development of robust control strategies for standard and specialty generics.
He holds a Ph.D. in Biomedicine (Pharmacy) from the University of Ljubljana, where his doctoral research focused on reactions of amine
containing active ingredients with reactive excipient impurities, work that laid the foundation for his continued focus on degradation pathways and nitrosamine risk. He played a key role in the application of kinetic and predictive modeling to drug product development, enabling early risk identification, sensitivity analysis, and data
driven formulation decisions.
Research Fellow, Drug Product Design & Supply, Pfizer Global R&D
Dr. Kazuko Sagawa is a Research Fellow at Pfizer Research and Development in
Groton,
Connecticut
As a member of a multidisciplinary team within Pfizer, she has been involved in developing biopharmaceutics strategy for drug product development
The work includes biopharmaceutics risk assessment, PBPK model development, and clinical bioequivalence risk assessment
Dr. Sagawa received her
B.Sc
in Pharmacy from Tokyo University of Pharmacy and Life Sciences (Tokyo Japan) and her Ph.D. in Pharmaceutical Sciences from the University of New York at Buffalo (Buffalo, NY)
Global Head, Global Clinical Management, Dr. Reddy’s Laboratories Ltd.
Dr. Anuj Kumar Saini is the Global Head – Global Clinical Management at Dr.
Reddy’s Laboratories Limited, Hyderabad, India. He leads global preclinical and
clinical development strategy and operations, with oversight across
biopharmaceutics, clinical operations, immunogenicity, biostatistics and data
management, medical writing, program management, bio-innovation, and
external collaborations.
With over 22 years of experience across the pharmaceutical industries and
contract research organizations, including 17 years in senior leadership roles, Dr.
Saini brings deep expertise in the development of small molecules, peptides,
biosimilars, complex injectable and drug-device combination products,
respiratory therapies, topical, and transdermal formulations. His work spans
preclinical through late-phase clinical development, with strong strengths in
PK/PD, immunogenicity, PBPK modelling, and global regulatory submissions.
Dr. Saini is passionate about delivering data-driven development strategies that
enable efficient global product approvals while meeting the highest scientific and
regulatory standards.
Team Head, Biopharmaceutics (CPP), Sun Pharmaceuticals Industries Ltd.
Ms. Pradnya Shahapure currently serves as Team Head – Biopharmaceutics within the Clinical Pharmacology and Pharmacokinetics department at Sun Pharmaceutical Industries Limited, Gurugram, India. In her role, she leads the development and implementation of modeling based strategies for Virtual Bioequivalence (VBE) assessments to support clinical study waivers. She also provides mechanistic, model informed insights to guide formulation development, leveraging advanced in silico tools and biopharmaceutics modeling approaches.
Ms. Shahapure earned her Master’s degree in Pharmacy (Biopharmaceutics) from Shivaji University, Kolhapur. With more than 23 years of experience in the bioequivalence domain, she has contributed extensively across multiple functional areas, including bioanalysis, quality control, and oversight of clinical and bioanalytical phases of BE studies.
Associate Director of Clinical Safety, DTP II, ORS, OGD, CDER, FDA
Dr. Jihong Shon possesses extensive scientific and regulatory expertise spanning clinical pharmacology, clinical trials, and drug safety assessment. Since 2020, Dr. Shon has held the position of Clinical Assessor in the Clinical Safety and Human Research Team and currently serves as Associate Director of Clinical Safety, DTP-II, ORS, OGD. He also serves as Co-Chair of the Generic Drug Development Safety Committee (GDDSC) at OGD. He previously served as a Senior Clinical Pharmacology Reviewer in the Office of Clinical Pharmacology (OCP), the Office of Translational Science (OTS), CDER.
Dr. Shon earned his degrees from Inje Univ. College of Medicine in Korea. Throughout his research career, he participated in more than 80 early-phase clinical trials as either primary or sub-investigator, including bioavailability/bioequivalence studies in healthy subjects and patient populations for new and generic drug development programs. He served as a committee member and secretary for the IRB and Pharmacovigilance Unit at Busan Paik Hospital, Korea. Dr. Shon also held a teaching faculty appointment at Inje Univ. College of Medicine in Korea.
Head, Global R&D and Technical Quality, Viatris
Dr. Dan Snider received his Doctor of Philosophy degree in Chemistry from West Virginia University in 1995 and soon thereafter began his career at Mylan Pharmaceuticals in Research and Development. Dan is currently the Head of Global R&D and Technical Quality at Viatris. Dan has worked on several initiatives with Industry and U. S. FDA such as Polymorphism in Generic Drug Products and Quality by Design as well as various other Chemistry Manufacturing Controls related topics.
Global Head, Regulatory Strategies Center of Excellence, Simulations Plus, Inc.
Dr. Sandra Suarez-Sharp’s academic journey began with Industrial Pharmaceutical Chemistry studies at the National Polytechnic Institute of Mexico City. After gaining practical experience at Johnson and Johnson in Mexico, she earned her Ph.D. in Pharmaceutical Sciences from the University of Florida in 1997. Her postdoctoral research at Chapel Hill University focused on Pulmonary Drug Delivery and Pharmacokinetics. Dr. Suarez-Sharp’s tenure at the U.S. FDA commenced in 1999, where she held diverse roles, including reviewer positions within the Office of Clinical Pharmacology and  scientific advisor within the Division of Biopharmaceutics, Office of Product Quality. Her expertise extended to in vitro-in vivo correlations/relationships (Safe Space), clinically relevant drug product specifications, real-time release testing, and physiologically based biopharmaceutics modeling (PBBM). Notably, she contributed to key industry guidance documents (eg., PBBM guidance) and represented the FDA at multiple scientific events.
Joining Simulations Plus as Vice President of Regulatory Affairs in 2020, Dr. Suarez-Sharp now leads the Regulatory Strategies Center of excellence, a team of talented scientists applying advanced modeling and simulation techniques for strategic planning, decision-making, and risk management in drug development to support regulatory decision making. Her extensive publication record and contributions have significantly influenced pharmaceutical sciences and regulatory practices.
Master Mathematical Statistician, DB VIII, OB, OTS, CDER, FDA
Dr. Wanjie Sun is a Master Mathematical Statistician at the FDA/CDER/OTS/Office of Biostatistics/DB8. She was the 2024 President of the 2024 FDA Statistical Association. Wanjie joined the FDA in 2013 after working in industry for a couple of years and spending twelve years at George Washington University as a Principal Investigator, Co-Principal Investigator, and Lead Research Scientist. She received her PhD degree in Biostatistics from the George Washington University.
Wanjie is actively engaged in regulatory research and has contributed to multiple ICH and FDA guidance. She has received numerous FDA awards recognizing her contributions to regulatory research, scientific communication, and leadership. She has authored/co-authored 60+ publications and serves as an Associate Editor for
Pharmaceutical Statistics
Senior Scientific Advisor, Head of Mechanistic Oral Absorption Modeling, Certara Predictive Technologies UK Ltd. (Simcyp Division)
Dr. David Turner’s
main role
at Certara Predictive Technologies lies in the development
and application of mechanistic
oral absorption model
embedded in PBPK platforms
including tools for virtual bioequivalence assessments and
safespace
identification. In addition, I am a strong advocate of the mechanistic modelling of
in vitro
biopharmaceutic experiments (the digital twin concept) to better parameterise and add confidence to PBPK models. I
joined
Simcyp
in 2004
prior to which I
worked in a Computational Chemistry Group (
Synt:em
SA,
Nîmes
, France) focussed
mainly upon
high throughput
in silico
discovery and virtual screening projects
. I have a PhD in
QSAR modelling
and am
author or co-author on
46
peer-reviewed papers
mostly
in the area of
PBPK modelling.
Senior Pharmacologist, DQMM, ORS, OGD, CDER, FDA
Dr. Fang Wu is a senior pharmacologist reviewer and scientific lead for oral
Physiologically
based
Pharmacokinetic modeling in Division of Quantitative
Methods and Modeling
(DQMM)
, Office of Research and Standards
(ORS)
, Office of Generic Drugs
(OGD) in FDA
. Dr. Wu has been with FDA for more than
years.
She
is responsible for
using modeling and simulations tools for reviewing pre-abbreviated new drug
applications (pre-ANDA) meeting packages, ANDA
consults
and controlled
correspondences. Prior to joining DQMM, Dr. Fang Wu was a
biopharmaceutics reviewer for more than 4 years and responsible for
NDA
and
ANDA reviews. She has been a principal and co-principal investigator for multiple
FDA research projects and
involved
in several guidance working groups and grant review panels.
Division Director, DPQA XII, OPQA II, OPQ, CDER, FDA
Dr. Hailing Zhang serves as Division Director of the Division of Product Quality Assessment XII (DPQA XII) in the Office of Product Quality Assessment II (OPQA II), Office of Pharmaceutical Quality (OPQ). Dr. Zhang earned her Ph.D. in Organic Chemistry and Physical Organic Chemistry from Emory University in Atlanta, Georgia. Prior to joining the FDA in 2014, she was an Associate Professor of Pharmaceutical Science in the College of Pharmacy at Mercer University in Atlanta, Georgia. In her current role as Division Director of DPQA XII, Dr. Zhang leads a team of accomplished
pharmacokineticists
who provide biopharmaceutic assessments and approvals for various submissions under the GDUFA and PDUFA programs.
Deputy Director, ORS, OGD, CDER, FDA
Dr. Lei Zhang serves as the Deputy Director of Office of Research and Standards within Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She oversees the Generic Drug User Fee Amendments (GDUFA) science and research program to ensure the therapeutic equivalence of generic drug products. Dr. Zhang was previously Senior Advisor for Regulatory Programs and Policy in the Office of Clinical Pharmacology at CDER, FDA.  Dr. Zhang is an accomplished professional with more than 2
years of combined
experiences
in the areas of drug research,
development
and regulatory review and approval. She has contributed to
numerous
guidance development and research projects focused on science-based regulatory decision making. Before joining FDA in 2002, she worked at Bristol Meyers Squibb as a Research Investigator and Preclinical Candidate Optimization Team Leader. Dr. Zhang is an Adjunct Professor in the Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco (UCSF), Schools of Pharmacy and Medicine. Dr. Zhang received her Ph.D. in Biopharmaceutical Sciences from UCSF.  She is currently the Rapporteur for the ICH M13 Expert Working Group that is developing harmonized guidelines on bioequivalence (BE) for immediate-release solid oral dosage form drugs including M13A, M13B and M13C. Dr. Zhang was inducted American Association of Pharmaceutical Scientists (AAPS) Fellow in 2013. She received the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Malle
Jurima
-Romet Mid-Career Leadership Award in 2023. She is a member of ASCPT, ISSX, AAPS, and ACC
P.  She
serves/
has served
various
volunteer
and leadership
roles in these
organizations
She has published more than 140 peer-reviewed papers and book chapters.
Lead Pharmacologist, DTP II, ORS, OGD, CDER, FDA
Dr. Qi Zhang is the Team Lead for Immediate Release Drug Products in the Division of Therapeutic Performance II, Office of Research and Standards at the U.S. Food and Drug Administration. In her current role, she leads regulatory reviews, product-specific guidance development, and research initiatives addressing critical gaps in generic drug development and approval.
Since joining the FDA in 2014, Dr. Zhang has served in various roles across the Office of New Drug Products, Office of Pharmaceutical Quality, and Office of Generic Drugs. She has evaluated biopharmaceutics
and clinical pharmacology sections for new and generic drug applications
supporting multiple clinical divisions, as well as inter-center
consults
. A primary focus of her work has been her leadership of the ICH M13A Implementation, where she developed
risk-based
frameworks and mitigation strategies for vulnerable populations (including oncology
pediatric
, and
nitrosamine-impacted
products)
, n
ew and alternative methodologies for high-risk products
, and r
egulatory frameworks for products where reference standards are unavailable.
Dr. Zhang specializes in complex drug products, oral complex generics, Biopharmaceutics Classification System (BCS), biowaiver and bridging strategies, and clinically relevant dissolution/drug release.
Regulatory Officer, DTP II, ORS, OGD, CDER, FDA
CDR Yi Zhang holds a Ph.D. in Pharmacology and Master’s and
Bachelor’s
degrees in Pharmaceutical Sciences. She is a subject matter expert in bioequivalence (BE) standards and approaches for diverse drug dosage forms to promote generic drug development and approval.
She
pioneered and
established
the first Product-Specific Guidance (PSG) program while serving as BE Director in the Office of Bioequivalence (OB). She has led multiple teams in the Office of Research and Standards (ORS), including the PSG Development Team, Dermatological and Topical Product Team, and Immediate Release Oral Solid Dosage Forms Drug Team. Her leadership has
expedited
international harmonization on generic drug guidance and fostered collaboration with external stakeholders to develop automated assessment tools that improve efficiency and accuracy through artificial intelligence and machine learning applications.
CDR Zhang also leads multiple research projects addressing critical regulatory scientific issues in generic drug
development and
approvals, with particular focus on Biopharmaceutics Classification System (BCS) Class III-based biowaivers, locally acting gastrointestinal products, and challenges related to unavailable reference listed drugs (RLD) and reference standards (RS).
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
numerous
complex bioequivalence challenges and played a key role in the development of several FDA general
guidances
. Dr. Zhang earned his Ph.D. in Pharmacology from the University of Wisconsin-Madison.
Research Scientist, DTP II, ORS, OGD, CDER, FDA
Dr. Gang Zhao joined the Division of Therapeutic Performance (DTP) II within the Office of Research and Standards (ORS) as an ORISE fellow in November 2023. As a member of the Immediate Release (IR) Team, he conducts risk assessments for complex oral drug formulations and supports ICH M13A guidance implementation. His work includes developing and revising product-specific guidances (PSGs) for IR oral drug products, reviewing controlled correspondence on bioequivalence study design, and evaluating the impact of critical excipients and formulation strategies on drug absorption and bioequivalence.
Prior to joining the FDA, Gang served as a senior scientist at Ensign Pharmaceutical, where he led preclinical pharmacology studies and specialized in polymeric prodrug delivery systems for poorly soluble drugs and long-acting therapeutics. He earned his B.S. in Biotechnology from Jilin University and Ph.D. in Pharmaceutical Sciences from the University of Nebraska Medical Center.
Senior Research Pharmacologist, DPQR V, OPQR, OPQ, CDER, FDA
Dr. Ahmed Zidan is a Senior Research Pharmacologist in the Division of Pharmaceutical Quality Research (DPQR V), Office of Pharmaceutical Quality Research (OPQR), within the Office of Pharmaceutical Quality (OPQ) at the U.S. Food and Drug Administration (FDA). He received his Ph.D. in Pharmaceutics in Zagazig University through a scholarship at Howard University, where his training focused on drug delivery, biopharmaceutics, advanced manufacturing, and formulation science, providing a strong foundation for his work in oral drug product performance and regulatory science. His work focuses on the mechanistic understanding of oral drug product performance and the development of regulatory science frameworks integrating biopredictive dissolution, in vitro–in vivo correlation (IVIVC), and physiologically based pharmacokinetic (PBPK) modeling to support bioequivalence assessment.
Dr. Zidan has led and contributed to multiple FDA translational and research programs addressing complex generic drug development, including modified-release formulations and products where conventional bioequivalence approaches are challenged. He has authored numerous peer-reviewed publications and scientific reports and has delivered invited presentations at national and international scientific conferences on biopharmaceutics and other regulatory science. He has also received several FDA recognition awards for his contributions to advancing the additive manufacturing and regulatory sciences.