DissoAmerica 2026

Speakers

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  Karunakar (Karu) Sukuru
  

  Karunakar (Karu) Sukuru

  Karunakar Sukuru (Karu) R.Ph., Ph.D. is the Global Vice-President of Product Development at Catalent Pharma Solutions. With over 29 years of experience in the pharmaceutical industry, he is a well-known leader in the development and manufacturing of various drug delivery systems and technologies. He has been responsible for P&L, product development, and execution of projects globally, making him a reliable and strategic thinker. Karunakar had technical oversight of products at over more than a dozen CDMOs worldwide while working at Endo Pharma. Currently, at Catalent, he works with 100s of pharmaceutical customers, including leading BioPharma companies globally. He has developed innovative CR platform technologies in softgel form (two granted patents) and has over 20 pending patent applications in the field of modified shell and fill suitable for capsules for enteric and colonic delivery and also in the lyophilization of biologics. After completing his Ph.D. in Pharmaceutics from IIT-BHU, India, in 1995, Karu began his career at Natco Pharma in India, where he developed a variety of oral dosage forms for two years. He then joined Banner Pharmacaps in India, where he worked on softgel and gel enrobed tablets. Karu joined Endo Pharma in 2006 and Catalent in 2016 as the VP of Product Development. He is also a Registered Pharmacist.

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  Stephen T Buckley
  

  Stephen T Buckley

  Dr. Stephen T. Buckley is Scientific Vice President in Drug Product Research at Novo Nordisk where he is responsible for a team of scientific experts tasked with identifying and evaluating novel drug delivery technologies. During his time at Novo Nordisk, Stephen has contributed to the development of multiple marketed drug products, including semaglutide, oral semaglutide, faster aspart and insulin icodec. He holds a degree in pharmacy from Trinity College Dublin (Ireland), and a Ph.D in biopharmaceutics and cell physiology from the same university. During this time, he also worked as a Visiting Fellow at the University of Southern California (USA). He is the recipient of honors and awards from the American Association of Pharmaceutical Scientists (AAPS) and the Scandinavian Physiological Society. He is (co-) author of 30+ articles in peer-reviewed journals (including Nature, Science, Science Translational Medicine and Nature Biotechnology), and has been invited to give numerous presentations at research institutions, international conferences and workshops.

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  Hardikkumar Patel
  

  Hardikkumar Patel

  Hardikkumar Patel, Ph.D., is currently a Senior Biopharmaceutics Assessor in DPQA XII, OPQA II, Office of Pharmaceutical Quality (OPQ), CDER, FDA. His responsibilities include risk-based biopharmaceutics assessment of NDAs, ANDAs, INDs, supplements, and pre-ANDA submissions. His areas of expertise include dissolution, IVRT, physicochemical characterization, and regulatory evaluation of drug product performance. Before joining his current role, Hardik was with the Office of Lifecycle Drug Products (OLDP), where he served as an ORISE fellow, a drug product assessor for oral drug products, and a drug product assessor for liquid-based drug products. He completed internships at GSK Consumer Healthcare as a bench scientist during the summers of 2012 and 2013. Hardik received his Ph.D. in Pharmaceutical Sciences and M.S. in Industrial Pharmacy from Long Island University, New York. He earned his Bachelor of Pharmacy degree from Nirma University, India.

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  Johannes Moes
  

  Johannes Moes

  Johannes is Scientific Director Dissolution Sciences at Johnson & Johnson Innovative Medicine. He leads global dissolution and in vitro performance strategies supporting drug product development and regulatory submissions across multiple modalities. His work focuses on using dissolution as a clinically and bio-pharmaceutically relevant performance test, enabling science based specifications, robust method development, and opportunities for biowaivers. Johannes brings deep expertise at the interface of formulation, process, biopharmaceutics, and regulatory science.

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  Kazuko Sagawa
  

  Kazuko Sagawa

  Dr. 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)

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  James Mullin
  

  James Mullin

  James Mullin is a Senior Principal Scientist at Simulations Plus, Inc. and has a graduate degree in Chemical Engineering. In his role at Simulations Plus, he contributes to modeling and simulation development and consulting activities across multiple programs including GastroPlus, MembranePlus, and DDDPlus. Most recently, James is participating in an FDA grant project to extend the capability of Gastroplus to predict local tissue concentrations by enhancing the model structure. Additionally, he has developed models to predict partitioning in pulmonary tissues and simulate inhalation of vapors for purposes of toxicological modeling and assessments. James has 19 years’ experience in PBPK modeling, computational fluid dynamics, and mathematical modeling.

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  Sandra Klein
  

  Sandra Klein

  Prof. Dr. Sandra Klein is a pharmacist by training and obtained her license to practice pharmacy and her PhD from the University of Frankfurt, Germany. She was a Postdoctoral Fellow at Eastman Chemical Company in Kingsport, TN, USA and has been a Professor of Pharmaceutical Technology at the University of Greifswald, Germany since 2010. Since starting her PhD, she has been working on the development of biorelevant in vitro methods to assess the bioavailability of orally administered drugs and meanwhile has more than 20 years of experience with biorelevant dissolution assays. Her current research focuses on the development of biopredictive in vitro models to estimate the in vivo performance of drugs for different patient populations, as well as the development of oral dosage forms for special patient populations, particularly pediatric patients. The latter activities span the spectrum from formulations for poorly soluble drugs through taste-masked formulations to controlled-release dosage forms. Other research interests include the development of predictive and accelerated in vitro release methods for lozenges, vaginal and rectal delivery systems, and long acting injectables.
  Sandra is a member of the American Association of Pharmaceutical Scientists (AAPS), the European Paediatric Formulation Initiative (EuPFI), the German Pharmaceutical Society (DPhG) and the International Association of Pharmaceutical Technology (APV). She is currently also the President-elect of the APV, an Expert Member of the USP Expert Panel on New Advancements in Product Performance Testing, an Expert Member of the conect4children (c4c) Formulations Expert Group, and Editor-in-Chief of Pharmazie, An International Journal of Pharmaceutical Sciences.

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  Matthias G. Wacker
  

  Matthias G. Wacker

  Associate Professor Matthias G. Wacker works in the Department of Pharmacy at the National University of Singapore (NUS). After finishing his undergraduate studies in Pharmacy, he earned his doctoral degree in pharmaceutical technology from Goethe University in Frankfurt (Germany), where he also was a principal investigator and completed his habilitation under the guidance of Jennifer Dressman and Jörg Kreuter at the Institute of Pharmaceutical Technology. Before joining NUS, he headed the Department of Pharmaceutical Technology and Nanosciences at the Fraunhofer IME in Frankfurt. He serves on the editorial boards of several prestigious journals (e.g., European Journal of Pharmaceutics and Biopharmaceutics, Frontiers in Chemistry, Journal of Pharmacy and Pharmacology) and has been recognized for his research excellence with awards such as the Eudragit® Best Paper Award (2015) and the Phoenix Pharmaceutics Science Award (2017). He is a member of various committees and organizations, including the United States Pharmacopeial Convention‘s General Chapters – Dosage Forms Expert Committee and the Expert Panel on New Advancements in In-Vitro Product Performance Testing, as well as the International Organization for Standardization’s Technical Committee 229, which is responsible for developing nanotechnology standards. In his current research, he specializes in employing a quality-by-design approach to create and analyze advanced dosage forms, placing a strong emphasis on bio predictive release and computational techniques to establish in vitro-in vivo correlations. This enables improved formulation designs. Since 2022, he has been acknowledged as one of the World’s Top 2% Scientists by the Standford University Ranking. His work holds immense potential in refining the selection process for optimal formulation prototypes, enabling seamless translation from preclinical to clinical stages.

• 

  Rob Tzuchi
  

  Rob Tzuchi

  Dr. Ju is recognized for his in-depth knowledge and experiences in both formulation and dissolution method development, as his teams were directly responsible for the formulation development of 7 NDAs, dissolution method development of 8 NDAs/Phase III projects, including oral biologics and implants. At AbbVie, he established the Drug Release and Product Performance group with focuses on in-silico modelling, images and functional excipient release, and cross-functional alignment. He advocates in vitro release method development based on formulation design and release mechanism. Extensive interactions with global regulators on biowaiver, IVIVC, PBPK/PBBM modelling, and discrimination. Recognized expertise in biopharmaceutics, modified release formulations, pediatric formulations, amorphous solid dispersion, and FDC technologies for challenging molecules. Patents filings and litigation. Experiences with eye care products (implants and eye drops) and high-concentration biologics. Dr. Ju founded the Pediatric Working Group and chaired the Drug Product Leadership Group of IQ Consortium. He was inducted to the prestigious Vowiler Society within AbbVie, sat in the Scientific and Education Board of NIPTE, and was an Adjunct Professor of Roosevelt University. In leisure, Rob enjoys coaching sport teams, working out in the gym, and reading.

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  Sandip Tiwari
  

  Sandip Tiwari

  Dr. Sandip B. Tiwari is Head of Technical Services- Pharma Solutions North America at BASF and provides innovative solutions to (Bio) pharmaceutical companies to solve their formulation/ processing challenges. Prior to joining BASF, Sandip was a Fellow Manufacturing Science & Technology at Teva Pharmaceuticals, Davie FL where he led a team for development and commercial launch of complex oral modified release formulations. Sandip also worked at Colorcon Inc. as a Senior Manager, Global Technology Development focusing on innovation in modified release polymeric systems, and then as a Technical Director. Sandip did his post-doctoral fellowship from Northeastern University, Boston, MA exploring nanotechnology-based drug delivery systems. While in India, Sandip worked for Zydus Cadila in the area of novel drug delivery systems. He earned his PhD in Pharmaceutical Sciences from College of Pharmaceutical Sciences, Manipal, Karnataka, India. He has written one book, eight book chapters/ monographs and contributed more than 100 research publications, abstracts, and patents in the areas of dosage form design, new technologies, mathematical modeling, dissolution science and excipients.

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  Michael Hageman
  

  Michael Hageman

  Mike is a Distinguished Professor at the University of Kansas and has 30+ years of experience working in the pharmaceutical industry as a Research Scientist at Upjohn, Pharmacia, and Pfizer, and then as both Group Director and Executive Director of Discovery Pharmaceutics at Bristol-Myers Squibb. He obtained his BS in Pharmacy and PhD in Pharmaceutical Chemistry from the University of Kansas. Nine years ago, Mike took the position as the Valentino Stella Endowed Distinguished Professor of Pharmaceutical Chemistry at the University of Kansas. Mike also acts as the Director for the Biopharmaceutical Innovation and Optimization Center. His academic labs focus on Physical Pharmacy and Drug Delivery (P2D2) for PO, IP and SC delivery of poorly soluble and poorly permeable drugs, including the stabilization, formulation and processing of peptides and proteins. During his 30+ years in industry, he worked primarily in the preclinical and early clinical space, supporting Drug Discovery for molecular design and selection of developable small drug-like molecules as well as peptides and protein biologics. Significant emphasis was placed on providing physicochemical property characterization, including the design of preclinical dosage forms for enhanced bioavailability to enable successful progression of the drug candidates, all with a clear line-of-sight to a product dosage form. He was previously an adjunct professor at the Universities of Purdue, Kansas, and Utah. He was an editor for JPharmSci and chaired the Drug Delivery Advisory Committee for PhRMA Foundation. He is also an AAPS Fellow and has served as Chair of AAPS Physical Pharmacy and Biopharmaceutics Section. He currently serves on the Board of Trustees for the prestigious Madison and Lila Self Graduate Fellowships at the University of Kansas and the IAMI (Institute for Advancing Medical Innovation) Management Team at KU Medical Center.

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  Jenna Walker
  

  Jenna Walker
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  Vinod P. Shah
  

  Vinod P. Shah

  Dr. Shah is a pharmaceutical consultant. He retired from the US FDA (Food and Drug Administration) after serving for 30 years. While at the FDA, he developed several Regulatory Guidance for the Pharmaceutical Industry in the area of biopharmaceutics, including a guidance on the dissolution of IR and ER products. He is the author/co-author of over 330 scientific papers and co-editor of four books.

  Dr. Shah was the President of American Association of Pharmaceutical Scientists (AAPS) in 2003. He is a Fellow of AAPS and FIP. Dr. Shah is a recipient of FDA Award of Merit, FIP Lifetime Achievement Award in Pharmaceutical Sciences; IDMA Eminent Pharmaceutical Analyst Award (India); Honorary Doctorate from Semmelweis University, Budapest, Hungary; Honorary Doctorate from University of Medicine and Pharmacy Carol Davila Bucharest, Romania; SPDS Award of Excellence; AAPS Distinguished Pharmaceutical Scientist Award and AAPS Global Leader Award.

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  Clare Strachan
  

  Clare Strachan

  Clare Strachan completed a PhD at the University of Otago (New Zealand) in 2005 on Raman, terahertz and second harmonic generation for solid state analysis of pharmaceuticals. During this time she was also based at TeraView Ltd and the Cavendish Laboratory, University of Cambridge. She then transferred to the University of Helsinki, Finland for postdoctoral research in process analytical technology (PAT), and subsequently oscillated between Faculty positions in New Zealand and Finland. Since 2020 she is full Professor of Pharmaceutical Analysis at the University of Helsinki where she leads the Pharmaceutical Spectroscopy and Imaging research group, as well as the Helsinki Institute of Life Sciences (HiLIFE) Molecular Spectroscopy for Life Sciences (LifeSpec) infrastructure. Prof. Strachan’s current research focuses particularly on vibrational spectroscopy and imaging for pharmaceutical analysis, especially coherent Raman and complementary non-linear optical methods to enlighten microscale solid-state/phase behavior of pharmaceuticals during drug development. During her career, she has supervised about 25 PhD theses, published approximately 140 articles in international peer-reviewed journals, collaborated with and consulted for pharmaceutical industry, and accumulated over €6 million in competitive research funding. She is also currently an Editor of the European Journal of Pharmaceutics and Biopharmaceutics.

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  Aktham Aburub
  

  Aktham Aburub
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  Nupura Bhise
  

  Nupura Bhise
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  Vivek Shah
  

  Vivek Shah

  Vivek Shah is a highly accomplished scientist with an academic background in pharmaceutical sciences and chemistry. He received his Bachelor’s degree in Pharmaceutical Sciences from Ohio State University and then pursued a Master’s degree in Chemistry from Long Island University.

  After completing his studies, Vivek began his professional career at Merck. He contributed to the development of new techniques, Direct Drug Analysis in Polymeric Implants DESI-MSI Imaging and using Mixed Reality in Pharmaceutical Development. His expertise with the Apparatus 4 helped drive dissolution studies for many different programs including a program that used an in-line NMR cryoprobe with the Apparatus 4.

  Vivek’s expertise and contributions to the pharmaceutical industry have not gone unnoticed. He currently serves on the USP expert panel for In Vitro Product Performance and is an Executive Board member for the US Society of Pharmaceutical Dissolution Science, demonstrating his commitment to advancing the field of pharmaceutical sciences and his deep understanding of in vitro testing methodologies.

  Currently, Vivek is leading the Pharma Services team for SOTAX in Massachusetts, where he continues to demonstrate his leadership and scientific acumen. In his current role, he has helped develop and validate groundbreaking in-vitro methods for complicated drug release programs.

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  Arvind Bansal
  

  Arvind Bansal

  Dr Arvind Kumar Bansal is currently Professor, department of Pharmaceutics at National Institute of Pharmaceutical Education and Research (NIPER) – SAS Nagar, Punjab, India. He earned his M Pharm (Pharmaceutics) (1988) and Ph.D. (1993) from University of Delhi, India. Before joining NIPER, Prof Bansal worked as Senior Scientist and Group Leader in JK Pharmaceuticals and Ranbaxy Research Laboratories, for 8 years. Prof Bansal joined NIPER in 2000 and developed expertise in areas of pre-formulation and formulation development encompassing characterization and stabilization of the amorphous form, polymorphism, pseudo-polymorphism, particle engineering, screening salt forms, improvement of oral bioavailability and lyophilization. His research group works with the mission statement – ‘developing science based industrially viable pharmaceutical technologies’ and works closely with pharmaceutical industry to create opportunities for commercial exploitation of the products. Dr Bansal was conferred prestigious Fellow of American Association of Pharmaceutical Sciences in 2016. He was the first Indian, working in India, to be awarded this Fellow status. He has won prestigious awards like AAiPS Distinguished Educator and Researcher Award, Innocentive Award, OPPI Award and IPA-ACG Scitech Innovation Award 2018 for Best Innovative Development of Solid Dosage Form. Prof Bansal’s research group has completed more than 650 industry-sponsored projects, granted 12 patents, filed 27 patents, and published over 200 research and review articles. He has total citations of >13,200, with h-index of 62, in Google Scholar. He is an editorial board member of ‘Journal of Excipients and Food Chemicals’, ‘Drug Development Research’ and ‘Pharmaceutics’. He is also an Advisor to the editorial board of ‘Journal of Pharmaceutical Science’ and ‘Molecular Pharmaceutics’.

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  Xujin Lu
  

  Xujin Lu

  Dr. Xujin Lu is a Research Fellow at Bristol-Myers Squibb Company in the department of Drug Product Development, Global Product Development and Supply. With 30 years of experience in research and development in pharmaceutical industry, Dr. Lu currently focuses on in-vitro biopharmaceutics drug release and biorelevant dissolution for product development. Dr. Lu is active members of AAPS, ACS, and SAS, and a past Chair of the In Vitro Release and Dissolution Testing (IVRDT) Focus Group of AAPS. Dr. Lu also serves on the USP Expert Panel on New Advancements in Product Performance Testing, USP Expert Committee of Dosage Forms, and the Editorial Advisory Board of Dissolution Technologies journal.

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  Filippos Kesisoglou
  

  Filippos Kesisoglou

  Filippos Kesisoglou is a Scientific Associate Vice President at Merck & Co., Inc., (Rahway, NJ, USA) Pharmaceutical Sciences department. Filippos has over 20 years of experience in the fields of biopharmaceutics and formulation development, pharmacokinetics, PBPK and IVIVC modeling as related to clinical, drug product development and CMC regulatory applications, including establishment of clinically relevant specifications, across modalities. He has been a key contributor to several new drug applications across therapeutic areas. He has authored/co-authored 95 manuscripts/book chapters and more than 100 conference abstracts/podium presentations/webinars in several national/international meetings in the fields of biopharmaceutics, PBPK modeling, formulation development and drug delivery. Filippos has been involved over the years in several cross-industry and academia consortia including the IQ consortium and since 2023 has joined the ICH M13 (Bioequivalence Guideline) Expert Working Group. He is currently serving as an Editor for Journal of Pharmaceutical Sciences and on the Editorial Advisory Boards for the AAPS Journal and Pharmaceutical Research. He has been elected a Fellow of the American Association of Pharmaceutical Scientists (AAPS) and of the Americal Institute for Medical and Biological Engineering (AIMBE).

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  Deanna Mudie
  

  Deanna Mudie

  Deanna Mudie, Ph.D., is a Principal Scientist in Research and Development at Lonza. Her focus is on enabling bioavailability enhancing amorphous solid dispersions by developing dosage form platforms and in vitro dissolution methodologies to predict bioperformance. Deanna earned her Ph.D. in Pharmaceutical Sciences and B.S.E. in Chemical Engineering from the University of Michigan. She has seven years of pre-doctoral experience at two large pharmaceutical companies developing and manufacturing oral dosage forms from pre-clinical to commercial scale.

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  David Sperry
  

  David Sperry

  Dr. Sperry is a Sr. Research Advisor in Small Molecule Drug Development at Lilly Research Laboratories. He obtained a B.S. degree in chemistry from Indiana University, Bloomington, IN and a Ph.D. degree in chemistry from the University of Rochester, Rochester, NY. After receiving his degree, he took a postdoctoral research scientist position at Pharmacia & Upjohn where he developed an Artificial Stomach Duodenum model and studied its utility in drug development. Shortly thereafter, he accepted a research scientist position at Pharmacia (later Pfizer), working in the area of in vitro methods and biopharmaceutics. He then moved to Bausch and Lomb where he developed commercial ophthalmic formulations for late stage molecules. In 2007, Dr. Sperry joined Lilly Research Laboratories, where he created a group focusing on in vitro drug product performance techniques and predictions of in vivo performance. In 2013, Dr. Sperry joined a computational modeling group at Lilly. He now supports product development by using existing and creating new models to predict product performance and oral absorption of small molecule drug formulations.

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  Sanjaykumar Patel
  

  Sanjaykumar Patel

  Sanjaykumar Patel is Sr. Principal Scientist at Merck & Co., Inc. in Rahway, NJ. He has more than 22 years of experience in the pharmaceutical industry. His experience includes working on novel drug delivery formulations such as self-emulsifying drug delivery systems, amorphous solid dispersion, controlled release and gastroretentive, and parental formulation. His research interest is focused on developing predictive bio-relevant in-vitro methodologies to understand the in-vivo performance of oral and parental formulations. He has co-authored 18 scientific papers. He is an active member of AAPS and an immediate past Chair of the IVRDT (In Vitro Release and Dissolution Testing) community. He is a board member of the Society of Pharmaceutical Sciences-US Chapter in the area focusing on dissolution.