Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices

Date and Time: September 23 , 8:30 am  –  5:30 pm ,
September 24 , 8:30 am  –  4:20 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

Registration Now Open

Register here
Download the Agenda

Understanding the measurement of particle size distribution is crucial when developing methods for quality control and when demonstrating bioequivalence for complex generic drug products. However, development, optimization, and validation of these methods can be challenging due, in part, to the apparent and deceptive simplicity of particle size analysis.

This two-day workshop will include discussions during the performance of hands-on, step-by-step procedures demonstrating how techniques can be performed in a manner that considers all relevant perspectives and enhances our collective understanding on the topic.

Attendees will gain theoretical and practical knowledge relevant to performing particle size measurements across diverse and challenging products like emulsions and suspensions. In-person attendees will interact directly with academic experts, instrument vendors, and regulators to delve into use cases, best practices, and limitations of particle sizing methodologies. Specifically, the workshop will focus on common particle sizing techniques such as dynamic light scattering and laser diffraction, common deficiencies and challenges encountered during quality assessments, bioequivalence studies, and manufacturing process evaluations.

Choose your experience:

Virtual Attendees will have free access to all sessions of the workshop except the hands-on activities and 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
  • Enjoy free access to workshop recordings of presentations and panel discussions (not including the in-person only sessions)

In-person Attendees will enjoy all of the benefits of virtual attendance as well as interactive experiences featuring:

  • Hands-on activities with particle sizing systems from different manufacturers i.e., live particle size measurements of diverse and challenging products
  • Small group working sessions during which challenging scenarios will be simulated and guided exercises will illustrate how to navigate decisions during particle size method development and study design for challenging drug products
  • Collaborative discussion and learning opportunities with FDA, academic, and industry experts

Workshop Topics

  • Theoretical/conceptual understanding of common particle sizing methodologies
  • Regulatory perspectives on quality control and bioequivalence for complex generic drug products
  • Live demonstration of data acquisition and analysis procedures using dynamic light scattering and laser diffraction systems
  • Critical considerations for method development, validation, and reporting
  • Expert guidance and illustration of best practices for overcoming challenges

Audience

The workshop is designed for individuals seeking to enhance their understanding of particle size analysis and its critical role in ensuring the quality and efficacy of generic drug products. This workshop is ideal for professionals working in the pharmaceutical industry, particularly those involved in the development, quality control, and regulatory affairs of generic drug products. This may encompass roles such as formulation scientists, analytical chemists, quality control specialists, regulatory affairs specialists, and research and development professionals.

  • Virtual Attendance is optimal for an audience that would like to access workshop content from anywhere, eliminate travel time and expenses, and who would like to have the flexibility to attend dynamic sessions/presentations at preferred times.
  • In-Person Attendance is optimal for an audience that is interested in collaborative discussions and real-time engagement, immersive learning, interactive sessions, and group activities.

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” in order to register at this rate)

For in-person attendees, beverages and food for breaks will be provided; lunch is not included. A link will be provided closer to the event for ordering lunch each day.

For faculty and students from the University of Maryland, Baltimore; The Universities at Shady Grove; and University of Michigan, the workshop is free for in-person attendance. Other students, please email us for a reduced rate. Please contact us at (info@complexgenerics.org) and indicate which workshop you are interested in.

Continuing education (CE) credits will not be provided for attending this workshop. A certificate of attendance will only be provided to individuals attending the workshop in-person.

Introduction to the Workshop

This 2-day hybrid workshop addresses challenges in particle size characterization for complex generic drug products. It aims to enhance understanding of Dynamic Light Scattering (DLS) and Laser Diffraction (LD) techniques, tackle method development and validation issues, and provide hands-on experience with equipment. By bringing together industry experts, regulatory scientists, and instrument vendors, the workshop fosters collaboration to overcome hurdles in generic drug development, identify research needs, and improve regulatory guidance. Participants will gain valuable insights through theoretical presentations, practical demonstrations, and interactive discussions.

DAY 1:

Session 1:  DLS Theory, Practice, and Regulatory Perspectives

Format: Presentations (Virtual and In-Person Attendees)

  • This session provides a comprehensive overview of DLS technology, exploring its fundamental principles and practical applications in particle size analysis. Industry and regulatory scientists will delve into the current challenges associated with analyzing and assessing particle size studies, particularly in the context of characterization-based bioequivalence approaches. The session will also cover critical aspects of method validation and highlight common deficiencies observed in regulatory submissions, offering valuable insights for both researchers and industry professionals.

Session 2:  Vendor Perspectives for DLS

Format: Rapid fire presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)

  • In this dynamic session, seven DLS instrument vendors will present rapid-fire overviews of their latest technical developments and measurement best practices. These presentations will focus on innovative solutions to overcome common issues in particle sizing. Speakers will discuss critical considerations that guide users in selecting and operating DLS equipment effectively, providing real-world examples to illustrate the context of use. The session will conclude with an engaging panel discussion, allowing attendees to delve deeper into the topics covered throughout the morning.

Session 3:  DLS Equipment Demonstration

Format: Laboratory demonstration and discussion (In-Person Attendees Only)

  • This hands-on session offers in-person attendees a unique opportunity to work directly with DLS equipment from seven manufacturers. Participants will be divided into small groups, rotating through demonstrations of suitable particle size study procedures. Vendor representatives will guide attendees through the intricacies of method development, highlighting common pitfalls and how to avoid them. This practical experience will provide invaluable insights into the nuances of different DLS systems and their applications in complex generic drug development.

Session 4: Small Group Working Session

Format: Small group working session (In-Person Attendees Only)

  • In this collaborative session, attendees will work in small groups to tackle real-world challenges in particle size analysis. Guided by experienced moderators, participants will engage in in-depth discussions on multiple topics including measurement considerations, method development, method transfer, validation strategies, data analysis techniques and reporting.

DAY 2:

Session 5:  LD Theory, Practice

Format: Presentations (Virtual and In-Person Attendees)

  • This session provides a comprehensive introduction to LD technology, exploring its theoretical foundations and practical applications in particle size analysis. Expert speakers will delve into the current challenges associated with LD-based particle size studies, offering insights into best practices and potential pitfalls. Attendees will gain a deeper understanding of LD principles, enabling them to make informed decisions when selecting and implementing this technology in their research or industrial settings.

Session 6:  Industry Perspectives on Particle Size Measurement

Format: Presentations (Virtual and In-Person Attendees)

  • Industry experts will share their experiences and insights on the challenges faced in developing generic products, with a focus on particle size measurement. Speakers will discuss critical aspects such as technology selection, method development, and validation processes. The session will also explore the emerging role of artificial intelligence and machine learning in knowledge management for regulatory submissions. A key component of this session will be a discussion on potential hurdles in preparing submission packages and areas where additional FDA guidance could be beneficial.

Session 7:  Vendor Perspectives for LD

Format: Rapid fire presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)

  • This session mirrors the format of Session 2, focusing on LD technology. Four LD instrument vendors will deliver concise presentations highlighting their latest technical developments and measurement best practices. These talks will address common challenges in particle sizing and offer innovative solutions. Speakers will discuss critical factors that guide users in selecting and operating LD equipment effectively, providing practical examples to illustrate real-world applications. The session will conclude with a panel discussion, allowing attendees to engage with experts and explore the topics covered in greater depth.

Session 8:  LD Equipment Demonstration

Format: Laboratory demonstration and discussion (In-Person Attendees Only)

  • Similar to Session 3, this hands-on session provides in-person attendees with the opportunity to work directly with LD equipment from four leading manufacturers. Participants will rotate through small group demonstrations, gaining practical experience with various LD systems. Vendor representatives will guide attendees through suitable particle size study procedures, highlighting the strengths and considerations of each system. This session aims to deepen participants’ understanding of LD technology and its application in complex generic drug development.

Session 9: Small Group Working Session

Format: Small group working session (In-Person Attendees Only)

  • This session includes vendor-led discussions on pre-workshop sample measurements, including cyclosporine ophthalmic emulsions, phytonadione injections, iron sucrose injection, triamcinolone injectable suspensions, and microcrystalline cellulose. Vendors will share challenges encountered during these measurements and propose solutions. Participants will then engage in small group discussions, collaborating on particle size method development, validation, data analysis and reporting.

Session 10: Waypoint Exercise

Format: Small group working session (In-Person Attendees Only)

  • The workshop will conclude with a comprehensive summary of key lessons learned and a forward-looking discussion on addressing identified challenges in the near future, setting the stage for continued progress in the field.

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

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

  • 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 (campus map).  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 USG, then taking Uber or Lyft. Alternatively, fly into any WAS airport and take Uber or Lyft. If flying into BWI airport, we suggest taking Uber or Lyft to USG.
  • The Metro subway serves DCA and IAD airports, which connects with the USG stop on the red line. If flying into IAD, taking the Metro will save some cost, but will probably take extra time, even if traffic is heavy.

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

Train tickets (Omio)

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

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:

 (book using our reduced rate by August 31, 2025)

14975 Shady Grove Road, Rockville, MD 20850 (0.6 miles from USG)
240-507-1800

 

Yousif Ayoub photo

Director, Head of Analytical Development, KFS R&D Global Analytical R&D Forum Leader, Teva Pharmaceuticals

Dr. Yousif Ayoub is a global expert in analytical development and solid-state characterization, with over 20 years of experience, 16 of them in pharmaceutical R&D. Currently he leads the Analytical Development Department at Teva’s Kfar Saba R&D and serves as the Global Analytical R&D Forum Leader, connecting analytical leaders across Teva’s global network. His expertise includes particle size distribution (PSD), polymorphism, spectroscopy, and complex analytical problem-solving, with significant contributions to regulatory submissions and inspections. 

Dr. Ayoub holds a Ph.D. in Physical Chemistry from the Hebrew University in Jerusalem. He has founded and led global scientific forums in PSD and Raman spectroscopy, and co-initiated AI-driven approaches to support regulatory work. He is passionate about science education, and he also co-founded Alrowad Academy to promote STEM among Arab youth. 

Dan Beach photo

Senior Field Application Scientist, Team Leader for the Small Molecule Pharmaceuticals group, Malvern Panalytical

Mr. Dan Beach holds a B.S. in Biochemistry and a Master’s in Business Administration.  Prior to joining Malvern Panalytical, Dan worked at a CMO focusing on method development and validation as well as working in pre-clinical R&D for a large pharmaceutical company.  Since joining Malvern Panalytical, he has held the role of Senior Field Application Scientist as well as being the Team Leader for the Small Molecule Pharmaceuticals group.  His background in small molecule drug development and method validation provides unique perspective while supporting laser diffraction and automated imaging customers. 

Jeff Bodycomb photo

Product Line Manager, HORIBA

Dr. Jeff Bodycomb is a product line manager at HORIBA.  He has spent decades analyzing particles and is responsible for technology improvement and providing technical support to customers.  Jeff has developed particle analysis instruments and analyzed materials with a variety of imaging and scattering techniques. He has worked with particle systems ranging from nanoparticles to coarse powders.  Dr. Bodycomb has experience with nanoparticle tracking analysis, dynamic light scattering, laser diffraction, and image analysis. His areas of interest are sources of error in measurement, scattering techniques, and microscopy.  Jeff earned his Ph.D. in Materials Science and Engineering from Rutgers University in New Brunswick, New Jersey, USA.   

Collin Britten photo

Field Application Scientist, Waters | Wyatt Technology

Dr. Collin Britten is a Field Application Scientist with Waters | Wyatt Technology, supporting applications for dynamic light scattering across materials sciences, biopharmaceuticals, and beyond. Collin received his Ph.D. in Chemical Engineering from the University of Oklahoma, focused on the synthesis and characterization of stimuli-responsive polymers and nanomaterials. In 2022, Collin joined Wyatt Technology, supporting light scattering users across the full spectrum of biopharma applications. 

Dr. Britten has extensive experience in developing DLS methods, including validation across different instrument platforms and orthogonal techniques. In his current role, Collin supports the development of light scattering methodologies in QA/QC, helping users to evaluate and implement dynamic and multi-angle light scattering to characterize the size, stability, and suitability of their products. 

Jeffrey Clogston photo

Principal Scientist, Physicochemical Characterization Section Head, Nanotechnology Characterization Lab, Cancer Research Technology Program (CRTP), Fredrick National Laboratory for Cancer Research, National Institutes of Health (NIH)

Dr. Jeffrey D. Clogston is a Principal Scientist and the Head of the physicochemical characterization section at the Nanotechnology Characterization Laboratory (NCL). In his role, Dr. Clogston conducts physicochemical characterization and standardization of nanoparticles, develops new analytical methodology for critical quality attributes, and assesses current instrumentation for nanoparticle characterization. Dr. Clogston has been with the lab for over 19 years. During this time, Dr. Clogston has helped to establish many protocols for nanoparticle characterization, working collaboratively with experts at the National Institute of Standards and Technology and standards organizations such as ASTM International and International Organization for Standardization. Throughout his tenure, Dr. Clogston has published nearly 60 manuscripts describing new analytical techniques for various nanoparticle platforms, keeping pace with the quick evolution of the nanomedicine field. 

Prior to joining the NCL in March 2006, Dr. Clogston received his Ph.D. in chemical engineering from The Ohio State University. His research dissertation was on the application of the lipidic cubic phase for drug delivery, wastewater remediation, and membrane protein crystallization. His areas of expertise include physicochemical characterization of and in vitro release from lipid- and polymer-based drug delivery systems, development of novel analytical methodologies to address characterization challenges and gaps, and protein and lipid biochemistry. 

Bernard Domnic photo

Director, Regulatory Affairs, Teva Pharmaceuticals, Inc.

Mr. Bernard Domnic works for Teva Pharmaceuticals, Inc., as Director, Regulatory Affairs managing the generics U.S. submissions and regulatory activities for multiple Teva sites across the U.S. and Europe. He has 26 years of experience in the Pharmaceutical Industry with 23 years in Regulatory Affairs and 3 years in Quality. The Regulatory role included working in Global Regulatory Affairs with submissions in more than 25 countries and working on several technologies with products across several dosage forms and routes of administration. Mr. Domnic have an M.S. in Drug, Device and Biologics Regulatory Affairs and currently is pursuing the licensing to become a registered pharmacist. 

Matt Elmer photo

Application Scientist, Microtrac, part of Verder

Mr. Matt Elmer is an accomplished engineer with extensive experience across multiple industries. With a strong foundation in materials science and engineering, Matt has built a career distinguished by product innovation, research and development (R&D), and technical customer service. He currently serves as a Microtrac Application Scientist, where he leverages his expertise to provide advanced solutions and technical support for customers. Matt holds an engineering degree from Penn State and a degree in Materials Science and Engineering from Alfred University. His technical acumen and problem-solving skills have enabled him to drive successful projects and collaborations, making him a valuable resource for both colleagues and clients. Matt’s broad industry background and commitment to excellence continue to shape his impactful contributions in the field of engineering and materials science. 


Jernej Grmaš photo

Head of Physical Analytics, Lek Pharmaceuticals d.d. (Sandoz) 

Dr. Jernej Grmaš is Head of Physical Analytics at Lek Pharmaceuticals (Sandoz), where he leads method development and strategic oversight for over 25 analytical techniques spanning material characterization, microscopy, rheology, and inhalation/nasal spray testing. His work focuses on supporting the development of complex generic products, including locally acting formulations and products requiring in vitro bioequivalence and characterization studies. 

 With more than 17 years of experience in pharmaceutical R&D in various roles, Dr. Grmaš has contributed to numerous product development programs and scientific publications. He is also experienced in digital transformation, having led the global rollout of a Digital Lab Platform within Sandoz. He holds a Ph.D. in Biomedicine and a Master of Pharmacy from the University of Ljubljana. 


Nicholas Holtgrewe photo

Chemist, DPQR II, OPQR, OPQ, FDA

Dr. Nicholas Holtgrewe has been a Chemist at the FDA Division of Pharmaceutical Quality Research II (DPQR II) since April 2019. His research at the FDA focuses on inhalation drug characterization, particle sizing, X-ray powder diffraction (XRPD), and spectroscopy and his expertise is in optics, X-ray diffraction, and Raman spectroscopy. He received a B.S. degree in Chemistry from Truman State University in 2008 and a Ph.D. degree in Chemistry from Washington University in St. Louis in 2013.

Darby Kozak photo

Deputy Director, OGD, FDA

Dr. Darby Kozak is the Deputy Director for the Office of Generic Drugs (OGD) where he serves as a senior agency advisor in the development and implementation of FDA policies and long-range objectives for generic drug scientific programs and activities, including the development of a strategic plan for the Generic Drug Program. Dr. Kozak started his FDA career in April 2015 as a reviewer, team lead, and then deputy division director in OGD’s Office and Research and Standards where he helped develop new analytical methods and equivalence evaluation methodologies for complex generic drug substances and parenteral, ophthalmic, otic, and inhalation formulations. Prior to joining the FDA, Dr. Kozak was Chief Scientist for Izon Science and Research Fellow at The University of Queensland’s Australian Institute for Bioengineering and Nanotechnology. Dr. Kozak has a B.Sc. in Chemical Engineering from the University of Washington (Seattle, WA) and Ph.D. in Chemistry from the University of Bristol (United Kingdom). 

Director of Product Management, Unchained Labs 

Dr. Kevin Lance directs product management globally at Unchained Labs. His expertise includes biophysical characterization of viral vectors, lipid nanoparticles, proteins, nucleic acids, and small molecules. Prior to Unchained Labs, his research experience covered the fields of sustained antibody delivery and nanotechnology. He earned his Ph.D. in Bioengineering from the joint UC Berkeley – UCSF Bioengineering Graduate Program. 

Headshot of Robert Lionberger

Director, ORS, OGD, 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. 

Matthew McGann

Applications, Product Management, and Marketing Specialist, Bettersize Instruments

Mr. Matthew McGann is an Applications, Product Management, and Marketing Specialist at Bettersize Instruments, where he leverages his deep expertise in analytical technologies to support cutting-edge research across the life sciences sector. With a strong background in particle analysis instrumentation and a passion for empowering scientists and engineers, Matthew plays a key role in bridging technical product knowledge with customer success, helping labs worldwide optimize their material characterization workflows. 

Jonathan Mehtala photo

Senior Application Scientist, Malvern Panalytical

Dr. Jonathan Mehtala is a Senior Field Application Scientist for Malvern Panalytical supporting the Zetasizer, NanoSight, PEAQ ITC, and PEAQ DSC products.  He has over ten years of experience in multiple application areas, including nanoparticles, proteins, exosomes, viral vectors, and RNA-LNPs for gene therapies and vaccines. 

Jonathan studied Chemistry at the University of Massachusetts Amherst, and joined the Field Application Scientist team at Malvern Panalytical in 2014 after completing his Ph.D. in Chemistry at Purdue University.  During his doctoral studies at Purdue, he developed drug delivery systems using gold nanorods and self-assembled protein nanoparticles. 

Kiwan Park photo

Sales Manager, Bettersize Instruments

Mr. Kiwan Park is a technically driven business leader with a strong foundation in chemistry and advanced scientific instrumentation. With extensive hands-on experience in analytical instrumentation, particle sizing, and materials characterization, Kiwan has built a career grounded in scientific expertise and precision measurement technologies. Currently serving as Sales Manager at Bettersize Instruments, he leverages over a decade of technical knowledge in particle characterization to drive client success and technical partnerships.

Kiwan holds a Bachelor of Science in Chemistry (Cum Laude) from Walla Walla University, and an MBA from the University of California, Irvine. His core strengths include scientific instrumentation, analytical methods, and technical sales consulting, combined with strategic operations leadership. 

Senior Staff Fellow, DTP I, ORS, OGD, 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. 

Alan Rawle photo

Emeritus Expert in Particle Sizing and Analysis

Dr. Alan Rawle has a degree in industrial chemistry and a Ph.D. in supported alloy catalysts both acquired at Brunel University, London, UK.  From 1990 to 2024, Alan was with Malvern Instruments (now Malvern Panalytical) and was the Applications Manager based in Westborough, MA, USA since 2003 until his retirement in May 2024. 

Dr. Rawle had spent many years working with the ISO TC24/SC4 (Particle Characterization) standardization committee assisting with the writing of documentary standards in light scattering, small angle x-ray scattering, image analysis, zeta potential, and dispersion as well as his own interest in the theory and practice of sampling.    

Dr. Rawle was (2005 – 2022) CoChair of E 56.02, the Characterization SubCommittee of the ASTM E56 Committee on Nanotechnology.  In 2023, Alan was the recipient of an ASTM Award of Merit (and is thus a Fellow of ASTM; FASTM).  He was the Technical Author (i.e. writer) for ASTM standards in particle sizing, zeta potential, size distribution calculation among others.  Dr. Rawle is also a Fellow of the Royal Society of Chemistry (FRSC), and a Distinguished Fellow of the International Engineering and Technology Institute (DFIETI). 

Rama Subba Reddy K photo

Analytical Expert, Advanced Characterisation Lab – Polymorphism & Nanosizing, Dr. Reddy’s Laboratories Ltd.

Mr. Rama Subba Reddy K, an accomplished Analytical Expert with 15+ years of experience, specializes in advanced characterization techniques, offering expert guidance in x-ray diffraction, light scattering, and thermal analysis. He plays a pivotal role in solving complex scientific challenges and ensuring analytical strategies align with evolving regulatory standards. Designing and executing characterization strategies tailored for complex generic products. 

Rama blends technical depth with strategic foresight, continually enhancing the analytical landscape of pharmaceutical science. Prior to Dr. Reddy’s Laboratories, he served in the R&D organization of global pharmaceutical companies such as Viatris Inc., and Aurigene Discovery Technologies Limited. Rama received master’s degree in chemistry from Andhra University, India. 

Prashun Roy photo

Application Scientist, Microtrac, part of Verder

Dr. Prashun G. Roy is an Application Scientist at Microtrac (part of Verder). He earned his Ph.D. from the City University of New York, where his research focused on polymer-based drug and protein delivery, as well as the synthesis of mesoporous materials. Dr. Roy has published nine research papers in peer-reviewed journals. He also served as a postdoctoral researcher and adjunct professor at the College of Staten Island. 

Carl Schuurmans photo

Associate Director, Applied Process Analytical Technologies, Inprocess-LSP

Mr. Carl Schuurmans has previously worked at Philips research, Utrecht University, and Harvard.  Carl is currently an associate director at InProcess-LSP leading the applied process analytical technologies group. His research interests are pharmaceutical technology and process analytics, mainly focused on in-process particle size measurements using spatially resolved dynamic light scattering (SR-DLS). 

Headshot of Anna Schwendeman

Co-Director of CRCG, Larry and Ann Hsu Professor of Pharmacy, Department of Pharmaceutical Sciences, Biointerfaces, College of Pharmacy, University of Michigan

Dr. Anna Schwendeman is a Larry and Ann Hsu Collegiate 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.

William Smith photo

Research Scientist, DPQR V, OPQR, OPQ, 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.

 

Xiaoming Xu photo

Director, DPQR V, OPQR, OPQ, 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 established FDA’s particle size measurement facility and pioneered the agency’s internal training program on particle size analysis, which has trained more than 200 staff across regulatory and research functions. Dr. Xu is an editorial board member of the International Journal of Pharmaceutics and an elected Fellow of the Controlled Release Society (CRS). 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.