Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products

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

Parking

• The Traville-Gateway Garage is the closest parking garage 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.

• 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 UDG, 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 (link for reduced rate)

Book by November 4, 2025 to receive the reduced rate
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 Vice President and Head of Clinical Research & Biopharmaceutics Department, Mankind Pharma Limited

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. 

Senior Scientist, Pharmaceutical Development, Sandoz Development Center

Dr. Nemanja Aničić has a Ph.D. in the field of Nanoscience (research work in the field of biomaterials) and degree in chemical engineering.  Dr. Aničić has eight years experience in industry holding various positions within pharmaceutical development.   His expertise is in reverse engineering, physicochemical characterization of pharmaceutical products as well as data analytics utilizing mechanistic modelling approaches. 

Pharmaceutical Scientist, DPQA IV, OPQA I, OPQ, CDER, FDA

Dr. Megha Barot is currently a pharmaceutical scientist working at Office of Pharmaceutical Quality Assessment I (OPQA I), Office of Pharmaceutical Quality (OPQ), Center of Drug Evaluation and Research (CDER) at the FDA. She has more then 13 years of experience in the field of ocular drug delivery, reference standards and nanotechnology. In OPQ, she has been involved in quality assessment of variety of liquid and solid dosage forms, including complex formulations, extended-release injectables, peptides, and drug-device combination products. She executes CMC assessments for pre-marketing and post-marketing applications. She serves as a FDA liaison for the USP expert committee for Excipient Monograph. Prior to joining FDA, she worked as senior scientist and team lead at US Pharmacopeia Headquarter (Rockville, MD). She received her Ph.D. in Pharmaceutical Science and Chemistry from University of Missouri Kansas City. She obtained her Bachelor of Pharmacy and Master in Pharmaceutical Science from India.  

Pharmacologist, DTP I, ORS, OGD, CDER, FDA

Dr. Andre O’Reilly Beringhs is a pharmaceutical scientist with expertise in pharmaceutics and regulatory affairs. He earned his Ph.D. in Pharmaceutical Sciences from the University of Connecticut, after completing his Master’s and Bachelor’s degrees in Pharmacy at the Federal University of Santa Catarina, Brazil. His research and professional contributions focus on the development and regulatory evaluation of advanced drug delivery systems, including nanotechnology-enabled and ophthalmology therapeutics. 

 At the U.S. Food and Drug Administration, Dr. Beringhs serves as a Staff Fellow (Pharmacologist) in the Office of Research and Standards, Office of Generic Drugs. In this role, he applies his scientific and regulatory expertise to address complex challenges in the development and therapeutic performance of generic drugs, with a particular emphasis on ophthalmic drug products and nanoparticle-based injectables. His work supports the establishment of regulatory standards that advance access to safe, effective, and high-quality generic medicines. 

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

Dr. Hee Sun Chung is a Lead Pharmacologist in the Division of Bioequivalence I in the Office of Bioequivalence. She has more than 15 years of experience conducting bioequivalence assessment of generic drug related submissions, including, but not limited to, ANDA and ANDA supplements, pre-ANDA submission meeting requests, pre-ANDA product development meeting requests, controlled correspondences, protocols, as well as product specific guidance development requests. She has been involved in various multidisciplinary working groups addressing complex scientific and regulatory issues. Dr. Chung received B.S. in Chemistry and M.S. in Inorganic Chemistry from the University of Oklahoma, and Ph.D. in Pharmaceutical Sciences from the University of Michigan. 

Senior Advisor, DCR, OSCE, OGD, CDER, FDA

Commander Andrew Fine is the Senior Advisor in the Office of Generic Drug‘s, Office of Safety and Clinical Evaluation, Division of Clinical Review.  As part of the division management team, Commander Fine, provides clinical, regulatory, and process oversight for generic drug activities in the division.  Prior to his role as Senior Advisor, Commander Fine served as a team leader in the division for seven years where he led a team of physicians in their clinical work to support the Generic Drug Program.  He earned his Pharm.D. from the University of Illinois College of Pharmacy and completed a pharmacy practice residency at Northwestern Memorial Hospital.  Andrew is board certified in pharmacotherapy and earned a certificate in pharmacoepidemiology from the University of Pennsylvania.  Prior to joining the Office of Generic Drugs, CDR Fine spent 4.5 years as a safety reviewer in CDER’s Office of Surveillance and Epidemiology, Division of Pharmacovigilance where he led post marketing safety efforts for Multiple Sclerosis drug products.  

Director, Experimental and Computational Biology, CFD Research Corp.

Dr. Carrie German is the Director of Experimental and Computational Biology at CFD Research Corporation (Huntsville, AL, USA). She received her Master’s and Ph.D. in Chemical Engineering from Oklahoma State University, combining in vitro and in silico modeling approaches to optimize tissue engineering efforts. She has continued her synergistic approach to research since joining CFD Research, focusing on applications in drug development and disease/injury/exposure modeling. In the ocular space, Dr. German has worked for the past 7 years on developing models and methods to support bioequivalence assessments. 

Senior Staff Fellow, DB II, OB, OGD, CDER, FDA

Dr. Yoriko Harigaya is a pharmacologist and staff fellow in the Division of Bioequivalence II, Office of Bioequivalence, within the Office of Generic Drugs (OGD), FDA. Prior to joining the OGD, she served as a clinical pharmacologist and staff fellow in the Office of Clinical Pharmacology, FDA. In her current role, she assesses a wide array of generic drug products. One of her key areas of focus is the assessment of complex ophthalmic drug products, and she serves as a subject matter expert in this area. She is also actively involved in leading controlled correspondence reviews related to acceptable levels of inactive ingredients, providing both regulatory and scientific guidance on generic drug development. 

Senior Director, Formulation R&D, Solaris Pharma

Mr. Romit Jani is the Senior Director and Head of Formulation R&D at Solaris Pharma, a company specializing in the development of complex generics. In his current role, he oversees the company’s Formulation R&D including product development, scale-up, and commercialization. He is also currently a member of the Portfolio Selection Team at Solaris, where he plays a key role in evaluating and selecting new projects. Before joining Solaris, Romit worked as a Research Scientist at Amneal Pharmaceuticals, where he was responsible for formulating and scaling up a variety of complex dosage forms, such as topicals, extended-release powders, and Ophthalmics. He holds a Master of Science in Pharmaceutical Manufacturing from Stevens Institute of Technology in Hoboken, NJ, and has more than 10 years of experience in the pharmaceutical industry, guiding products from concept to commercialization. 

Additionally, Romit has presented at and served as a member of the R&D panels for prestigious conferences, such as the CDR ( center (Center for Dermal Research) , Contract Pharma and CRCG (Center for Research on Complex Generics). He is also an active peer reviewer for a pharmaceutical journal.  

Senior Chemist, DPQA IV, OPQA I, OPQ, CDER, FDA

Dr. Young K. Jhon is currently a senior chemist working at Division of Product Quality Assessment IV (DPQA IV), Office of Product Quality Assessment I (OPQA I), Office of Pharmaceutical Quality (OPQ), Center of Drug Evaluation and Research (CDER) at the FDA.  He has more than 20 years of experience in the field of polymers, colloids (emulsions and suspensions), nanotechnology, drug-delivery system, implants, fluid mechanics, thermodynamics, and rheology.  In OPQ, he has been involved in assessment of complex dosage forms for oral, ophthalmic, parental, and topical routes, and in working groups for multiple guidances and research for complex drugs, including complex API sameness and the drug products that contain PLGA.  Also, he serves as application technical lead (ATL) for regulatory drug application assessments and as USP liaison for General Chapters.  Prior to joining FDA, he worked as an NRC fellow in Chemistry division at U.S. Army Research Office, RTP, NC.  He received a Ph.D. in Chemical Engineering from North Carolina State University, Raleigh. 

Postdoctoral Research Fellow, OPQR, OPQ, CDER, FDA

Dr. Coleman Johnson received his B.S. degree in Chemistry (magna cum laude) from the University of Oregon in 2019 and his M.S. degree in Polymer Sciences from the University of Oregon in 2020. He then joined Lonza Pharma and Biotech in Bend, OR, where his responsibilities included Chemistry Lead of a formulation and analytical development team. From 2022-2025, he earned his Ph.D. degree in Pharmaceutical Sciences from University of Texas at Austin under Dr. Feng Zhang. His Ph.D. dissertation was titled “Formulation development of melt-extruded biodegradable implants for intravitreal delivery” and he was the first author of three original research articles on topic. Coleman joined the FDA in September 2025 as a postdoctoral research fellow working under Dr. Xiaoming Xu in the Office of Pharmaceutical Quality Research. 

Vice President R&D, Sun Pharmaceuticals Industries Limited

Dr. Ajay Jaysingh Khopade is a Vice President of R&D and Heading non-oral speciality division at Sun Pharmaceutical Industries Ltd (SPIL).  He has over 25 years of experience in Sun Pharma in pharmaceutical product development.  In his current role as VP-R&D, is responsible for the development of SPILs complex generic and specialty products.  Dr. Khopade was a recipient of a prestigious lifelong Humboldt post-doctoral fellowship under which worked at the Max Plank Institute of Colloids and Interfaces, Germany. He is also a recipient of a prestigious JSPS fellowship from the Ministry of Japan.  He is a board member of the European Union’s prestigious Marie-Curie Fellowship P4FIT programme. He is also on the academic board for MS University, NIPER, and various other colleges and institutes.  Dr. Khopade has participated as a CMC expert in the submission of a number of INDs, NDAs to USFDA and other regulatory Agencies. ​

​He is an inventor of a platform nanotechnology in the field of oncology (Nanotecton®), ophthalmics (GFR®, SMM® Trisurf® and TearAct®) protected by various IPs globally with over a dozen patents. Most of these technologies are commercialized.  He is a pharmaceutical and material scientist with an interest in understanding the physical chemistry of drug delivery system design. ​

Pharmacokineticist, DTP I, ORS, OGD, CDER, FDA

Dr. Shinae Kim is a Pharmacokineticist on the Device Evaluation Team in the Division of Therapeutic Performance at the FDA’s Office of Generic Drugs, where she evaluates complex drug–device combination products during the pre-ANDA phase and contributes to the development of product-specific guidances to support generic product development. Prior to joining the FDA, she spent more than nine years in research and academia developing medical diagnostic devices and novel technologies for real-time health monitoring and diagnosis. She holds a Ph.D. in Electrical Engineering and Computer Science from Seoul National University and completed postdoctoral research in chemical and biomedical engineering at the Georgia Institute of Technology. 

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

Dr. Bruce Lerman serves as a Lead Pharmacologist in the Division of Bioequivalence, in the Office of Bioequivalence – Office of Generic Drugs. He oversees a team of pharmacologists who evaluate clinical pharmacokinetic and in vitro studies, formulation, and safety data. He specialized expertise encompasses assessment of iron colloid injection products, narrow therapeutic drugs, and ophthalmic simple and complex dosage forms. He earned a B.S. from the University of Florida and obtained a Ph.D. from George Washington University. 

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. 

Professor, School of Pharmacy, University of Connecticut

Dr. Xiuling Lu, Professor at the University of Connecticut, Associate Director of Center for Pharmaceutical Processing Research, Past Chair of the National Institute for Pharmaceutical Technology & Education, received her Ph.D. in Biochemical Engineering from the Chinese Academy of Sciences. She was appointed as a Research Assistant Professor at the University of North Carolina at Chapel Hill from 2008 to 2011 prior to joining the School of Pharmacy at the University of Connecticut. Dr. Lu’s research is focused on innovative nanotechnologies for advanced drug delivery, optimization and evaluation of complex drug formulations and pharmaceutical processing, as well as the use of versatile imaging tools to improve pharmaceutical product quality. Dr. Lu has been active in both translating potential therapeutics to the clinic and commercializing nanomedicines.  One of her patents was licensed to a startup pharmaceutical company for commercialization. Her research is supported by NIH, American Cancer Society, NSF, FDA etc. Dr. Lu is an Editor of AAPS Open, serving on the editorial board of AAPS PharmSciTech, Pharmaceutical Research, International Journal of Pharmaceutics, and Drug Delivery and Translational Research. Dr. Lu received American Association of University Professors-UConn Excellence in Research and Creativity: Early Career Award in 2016 and Dean Robert L. McCarthy Faculty Service Award in 2019 as well as 2023 Research Advising Award. Dr. Lu was elected as the American Association of Pharmaceutical Sciences (AAPS) Fellow in 2023, received 19th Annual Women of Innovation Award in Research Innovation and Leadership, Connecticut Technology Council and Connecticut Center for Advanced Technology in 2024, elected as a member of Connecticut Academy of Science and Engineering in 2025, and Controlled Release Society Fellow in 2025, received 2025 Michael J. Pikal NIPTE Distinguished Scholar Award in Pharmaceutical Processing. 

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

Dr. Markham C. Luke serves as FDA Supervisory Physician (Dermatology) and Director of the Division of Therapeutic Performance I (DTP I) in the Office of Research and Standards, Office of Generic Drugs at FDA. 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. Markham has an M.D. and a Ph.D. in Pharmacology from Johns Hopkins University and completed his dermatology residency and fellowship at Washington University, St. Louis, MO and the  National Institutes of Health, Bethesda, MD. He is an Associate Professor at the Uniformed Services University of the Health Sciences, Bethesda, MD with research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products.  Markham has been at FDA since 1998 serving various roles, including as the Lead Medical Officer for dermatology drugs, Chief Medical Officer and Deputy Director for the Office of Device Evaluation in the Center for Devices and Radiologic Health, and as Acting Director for Cosmetics in the Center for Food Safety and Applied Nutrition.  

CEO, Franklin Biolabs

Dr. Vatsala Naageshwaran is currently the Chief Executive Officer and Board member at Franklin Biolabs, a leading genetic medicines contract research and manufacturing organization dedicated to advancing cell and gene therapies from discovery through market approval. She is an award-winning, results-driven biopharmaceutical executive with rich experience in creating robust strategies for scientific and business growth in the CRO/CDMO space. She has supported technical and commercial operations with a deep commitment to advancing innovative therapies for patients over a 20-year professional career.  

Vatsala was Chief Business Officer at Absorption Systems and following the acquisition by Pharmaron, became part of the Executive Management team for Pharmaron US Labs. In her role as Vice President, at Pharmaron, Vatsala was responsible for overall global strategy for biopharmaceutical services, supporting small molecules, biologics, cell, and gene therapies across preclinical and clinical phases of development in multiple therapeutic areas, including ophthalmology, neurodegenerative, cardiovascular, oncology, metabolic, and rare diseases and gene therapeutics supporting IND/NDA/BLA approvals. Prior to joining Pharmaron and Absorption Systems, Vatsala worked at Astex Pharmaceuticals and Myriad Genetics.   

Vatsala has an AM degree in Biochemistry and Molecular Biology from Mt Holyoke College, an M.S. degree in Pharmacometrics from the University of Maryland Baltimore and a Ph.D. in Ocular Drug Research from the University of Eastern Finland under the supervision of Professor Arto Urtti. She is the recipient of IDIQ and BAA grants from the US FDA. Her research has been featured at national conferences such as ARVO, AAPS, SOT and AACR and she has authored multiple publications submitted to peer-reviewed journals.  

Professor, Purdue University; President, Akina Inc.

Dr. Kinam Park and his team have been studying new analytical methods for the separation and identification of PLGA polymers from complex long-acting injectable formulations. In particular, his team has developed methods for analyzing branched PLGA, PLGA mixtures with different L:G ratios, and PLGA mixtures with varying molecular compositions and structures. 

Senior Staff Fellow, DTP I, ORS, OGD, CDER, FDA

Dr. Bin Qin is currently a senior staff fellow in the Division of Therapeutic Performance I, in OGD’s Office of Research and Standards. In his current role, Dr. Qin is responsible for the development of product-specific guidance for generic drug development, reviewing and responding to controlled correspondences, pre-ANDA meeting requests, and internal consults. Dr. Qin is also a project officer on multiple regulatory science research initiatives related to complex drug products, under the GUDFA regulatory science research program. 

Chemist, DPQR II, OPQR, OPQ, CDER, FDA

Dr. Nathan A. Reed is a Chemist at the Division of Pharmaceutical Quality Research Branch II (DPQR II), Office of Pharmaceutical Quality Research (OPQR), Office of Pharmaceutical Quality (OPQ), Center of Drug Evaluation and Research (CDER) at the FDA, a role he has held since July 2021. Prior to this, he served as an ORISE Fellow at the FDA from September 2019 to July 2021. His background includes managing a shared instrument and cleanroom facility at Washington University in St. Louis, which included analytical and microfabrication instruments. Dr. Reed’s expertise lies primarily in the physiochemical characterization, aerosol dynamics, and dissolution of complex drug products. He earned his B.S. in Integrative Biology from the University of Illinois-Urbana Champaign and his Ph.D. in Chemical Engineering from Washington University in St. Louis. 

Co-Director of CRCG, Professor of Pharmacy, Department of Pharmaceutical Sciences, Biointerfaces, College of Pharmacy, University of Michigan

Dr. Anna Schwendeman is a Professor in the Department of Pharmaceutical Sciences at the University of Michigan. Her research focus is on optimization of high-density lipoprotein (HDL) nanoparticles for treatment of atherosclerosis, sepsis, and drug delivery purposes. In 2016, she co-founded a company EVOQ Therapeutics (www.evoqtherapeutics.com) focused on the use of HDL Nanodiscs for delivery of personalized neoantigen cancer vaccines. Dr. Schwendeman received her B.S. from Moscow Institute of Physics and Technology and Ph.D. in Pharmaceutics from The Ohio State University. Prior to starting her academic career in 2012, Dr. Schwendeman spent 12 years in the pharmaceutical industry at Cerenis Therapeutics, Pfizer, and Esperion Therapeutics. She was involved in discovery and translation HDL drugs to clinical trials. She successfully submitted FDA INDs for seven different products including nanoparticles, liposome, recombinant proteins, peptides, and small molecules. Her laboratory’s research in regulatory sciences is focused on analytical characterization of liposomes, polymer microspheres, peptides, and biosimilar products. She is co-Director of FDA sponsored Center for Research in Complex Generics (http://www.complexgenerics.org). Dr. Schwendeman is an Associate Editor for Nanomedicine NBM and Eur. J. Pharm and Biopharm.

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

Dr. William C. Smith (Billy), is a Research Scientist in the Division of Pharmaceutical Quality Research working on complex drug formulations from topicals to injectables and implantable polymeric devices. Billy runs the DPQR Micromeritics “Particle Size” Lab working on the physicochemical characterization of nano- and micro-scale materials to support regulatory assessment and review, and evaluation of drug product quality. His work on complex and emerging issues in drug product formulations have been recognized for both fundamental scientific merit and impact on ongoing regulatory and policy assessments. He focuses on the characterization and performance evaluation of complex drug products for both the evaluation of advanced manufacturing processes and in the determination of bioequivalence. Billy received his B.S. degree in Chemistry from the Evergreen State College before finishing his Ph.D. in 2019 from the Colorado School of Mines under Dr. Kim R. Williams, in analytical chemistry, focusing on the development of advanced separations techniques for the characterization of complex polymers and colloidal nanomaterials. He currently acts as the young scientist representative to the steering board for International Symposium on Field- and Flow- Based Separations. 

Principal Scientist, Simulations Plus, Inc

Dr. Jessica Spires is a principal scientist at Simulations Plus, Inc. She is focused on physiologically based pharmacokinetic (PBPK) modeling of non-oral routes of administration, including dermal, ocular, and pulmonary administration, in the GastroPlus™ and MembranePlus™ software platforms. She has been a principal investigator on multiple FDA grants exploring the role of formulation properties on topical and ophthalmic drug delivery. She is a graduate of Case Western Reserve University with a Doctoral degree in biomedical engineering. 

Senior Pharmacokineticist, DQMM, ORS, OGD, CDER, FDA

Dr. Ming-Liang Tan is a Senior Pharmacokineticist in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD). In his current role, Dr. Tan’s responsibilities include managing research projects to support bioequivalence studies, addressing controlled correspondences and citizen petitions, providing response to pre-ANDA meeting requests and internal consults, and developing product specific guidance. His main research interests include the physiologically based pharmacokinetics (PBPK) modeling and simulations, with a focus on the area of locally acting complex products such as ophthalmic drug products. 

Professor, Biopharmaceutics, University of Eastern Finland

Dr. Arto Urtti is Professor of Biopharmaceutics at University of Eastern Finland.  Previously, he has been working as Professor of Biopharmaceutics at University of Helsinki and as visiting Professor at University of California San Francisco.  

Prof. Urtti’s research is focused on ocular drug delivery and pharmacokinetics in preclinical setting. His research spans formulation of nanomedicines and controlled release systems, physical-chemical and preclinical biological testing of drugs and delivery systems in cultured cells, tissues and animal models. The experimental research is supported by computational studies.  

His research has been published in more than 400 peer-reviewed articles that have been cited > 26,000 times (H-index = 83; ScholarGPS). He is co-inventor in 25 families of patents and patent applications. His research is funded by Finnish Government Sources, European Union, U.S. FDA, and several international pharma companies (both SMEs and big pharma). Prof. Urtti has received various awards for his research activities in Finland, European Union, United States and Japan.  

Chemical Engineer, DPQR VI, OPQR, OPQ, CDER, FDA

Dr. Michael VandenBerg joined FDA OPQ’s Office of Pharmaceutical Quality Research in June 2023 after finishing his Ph.D. at the University of Notre Dame in Chemical Engineering. Dr. VandenBerg’s doctoral studies focused on soft materials engineering and supramolecular chemistry, with a focus on “smart” drug delivery systems comprised of dynamic covalent crosslinking polymers and self-assembling small molecules. Dr. VandenBerg has authored 18 peer-reviewed scientific publications, and is currently involved in research areas spanning continuous manufacturing of nanomaterials to characterization of complex drug products, contributing his expertise in rheology, mechanical analysis, polymer chemistry, formulation, and semi-solid materials to FDA review and research programs. 

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 I. 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. 

Director, DPQR V, OPQR, OPQ, CDER, FDA

Dr. Xiaoming Xu serves as Division Director in the Office of Pharmaceutical Quality Research (OPQR) at the U.S. Food and Drug Administration (FDA). In this role, he oversees multiple regulatory science initiatives focused on complex formulations, nanomaterials, and advanced manufacturing. Dr. Xu plays a leading role in the implementation of the Generic Drug User Fee Amendments (GDUFA) III, serving as co-lead of the Complex Product-Specific Guidance (PSG) Working Group, where he promotes the integration of regulatory research into PSG development for complex drug products. He is an active member of the FDA Nanotechnology Task Force and leads international collaborations and standards development in the area of nanotechnology-enabled products. Dr. Xu is an editorial board member of the International Journal of Pharmaceutics and a Fellow of the Controlled Release Society (CRS) and American Association of Pharmaceutical Scientists (AAPS). He holds a B.S. and M.S. in Pharmaceutics from China Pharmaceutical University and earned his Ph.D. in Pharmaceutical Sciences from the University of Connecticut. 

Senior General Physical Scientist, DPQR II, OPQR, OPQ, CDER, FDA

Dr. Huzeyfe Yilmaz is a senior scientist in the Office of Pharmaceutical Quality Research (OPQR). Dr. Yilmaz leads several research projects on development of advanced analytical methods for characterization of complex drug products and medical countermeasures and serves as a spectroscopy subject matter expert. Dr. Yilmaz received his Ph.D. in Materials Science and Engineering from the Washington University in St. Louis. 

Founder and CEO, digiM Solution LLC

Dr. Shawn Zhang is founder and CEO of digiM. Shawn and his digiM team are passionate about the combined power of experimental measurements and computational physics simulations (thus I2S – digiM’s flagship image to simulation software platform). With over hundreds of publications, patents, and software products, Shawn leads digiM to becoming a trusted partner in the characterization, institutionalization, and democratization of microstructure science across multiple industries. Shawn graduated from Rutgers University with a Ph.D. in Computational Physics and a minor in Computer Engineering. Before starting Boston-based DigiM, Shawn held senior positions at leading CAE software company Fluent (now Ansys) and leading electron microscopy company FEI (now ThermoFisher). Learn more about Shawn’s work in Google Scholar or LinkedIn.