DissoAmerica 2024 – Complex Drug Products

Speakers

• 

  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.

• 

  Payal Agarwal
  

  Payal Agarwal

  Payal Agarwal, Ph. D is currently a Biopharmaceutics assessor in the Division of Product Quality Assessment VI, in the Office of Pharmaceutical Quality (OPQ), CDER. Her responsibilities include biopharmaceutics assessment of NDAs (original and supplement), ANDAs (original and supplement), INDs, and Pre-ANDAs. Before joining the FDA, Dr. Agarwal served as a Senior Manager Advisory Services, Research Scientist I at Avalere Health. In this role she applied her comprehensive blend of expertise on multiple regulatory policy and strategy projects for diverse group of clients. She was engaged in providing regulatory policy advice and guidance based on legislative trends to Avalere’s internal and external stakeholders. Prior to Avalere Health, Dr. Agarwal was a tenured faculty and worked as an Associate Professor of Pharmaceutics and Biopharmaceutics in the Department of Pharmaceutical Sciences at the School of Pharmacy, Notre Dame of Maryland University for 12 years. Due to her exceptional dedication, knowledge and skills, and service to students, in addition to her caring and compassionate personality, Dr. Agarwal was awarded as the Teacher of the Year. Along with teaching, research, and mentorship roles, she held several leadership positions at the institution. She has been actively involved with many scientific organizations, served as an editorial board member and as a scientific reviewer for various peer reviewed journals, meetings abstract, and book chapters. She authored and edited the textbook “Pharmaceutical Calculations” for the PharmD curriculum. She has executed, managed, and led multiple scientific and regulatory projects.

  Dr. Agarwal has made significant contributions in the areas of oral delivery of proteins and peptide-based drugs. The novelty and significance of her research has been recognized and awarded by several scientific communities. Dr. Agarwal received her Ph.D. in Industrial Pharmacy from St. John’s University, NY, MS in Pharmacometrics from University of Maryland, Baltimore, MS in Pharmaceutics and Bachelor of Pharmacy from Dr. H.S. Gour University, India.

• 

  Ricardo Sosa
  

  Ricardo Sosa

  Ricardo Sosa obtained his PhD in Chemical and Biomolecular Engineering from the University of Houston in 2021. Upon graduation, he joined AbbVie as a Dissolution SME, leading the dissolution method development strategy for various oral drug products (including oral disintegrating tablets and oral biologics) in the pipeline. He leverages his training in engineering and experience in microscopy and flow through cell technologies to develop a holistic understanding of product performance for complex drug products using in-silico modelling and dynamic imaging, together with functionality assessment of excipients. He is involved in new dissolution vessel design to address issues related to artifacts associated with dissolution variability and inadequate hydrodynamics.

• 

  Andre Hermans
  

  Andre Hermans

  Andre Hermans is Executive Director in the Small Molecule Analytical Research and Development (SM-AR&D) Division at Merck and Co., Inc. in Rahway, NJ. He received his PhD in Analytical Chemistry from the University of North Carolina in Chapel Hill before joining Merck in 2007. During his time at Merck, Andre supported analytical method development and process development in the small molecule solid oral dosage area throughout all phases of drug development. In this function, he authored several IND and NDA applications with focus on oral formulations containing amorphous solid dispersion formulations, and various drug products in the HIV franchise. As an internal and externally recognized expert in dissolution technologies he significantly expanded Merck’s toolkit and understanding on modeling and prediction of both in-vitro and in-vivo dissolution of solid oral dosage forms.

  Andre is a member of the IQ dissolution working group, member of the USP expert panel for “New Advancements in Performance Testing”, and former chair of the AAPS In-vitro testing dissolution community. He is author of more than 30 publications mostly in the field of dissolution testing and clinical relevance.

• 

  Priti Jagani
  

  Priti Jagani

  Highly analytical and results-driven professional with 16+ years of experience executing and driving a full spectrum of continuous improvements with unequaled success across a broad range of analytical, In-Vitro Bioequivalence development, Regulatory strategies, and Project management of complex products. Well-versed in advancing research laboratories/partnerships to provide analytical capabilities and cultivate global collaboration. Documented success in supporting/leading 100 + qualified personnel and cross-functional teams as well as performing in-house innovations associated with product support from regulatory, analytical, and pre-formulation fronts. Impeccable record of spearheading lifecycle support of drug products activities from pre-formulation up until the commercial standpoint with remarkable success. Renowned for leading FDA inspections, 8+ FDA PAI, and In-Vitro Inspections as well as published one patent and engaged as an editorial member and peer reviewer for the International Journal for the Evaluation of Scientific Research Manuscripts. Led the project teams over first-to-file product submissions; delivered 25+ projects for timely FDA deficiencies/ investigations including Method Transfers, as well as efficiently headed data integrity assessments, evaluation and remediation activities, and gap Analysis of Quality Systems.

• 

  Mika Mast
  

  Mika Mast

  Mika Mast is a chemistry group lead in Lonza product development at the Bend site. She has over 17 years of industry experience across a wide range of technologies with a focus on multi-particulates. Her work encompasses formulation selection and analytical characterization of multi-particulates for taste-masking, enteric protection, controlled release, and bioavailability enhancement.

• 

  Annette Mullertz
  

  Annette Mullertz

  Anette Müllertz is professor in oral drug delivery and industrial relations at the University of Copenhagen, Denmark (UCPH) and head of Bioneer:FARMA, a business unit of Bioneer A/S, which is a research-based, non-for-profit service provider within the area of biomedicine and pharmaceutical development. She is heading the Physiological Pharmaceutics Research Group at UCPH, focusing on developing oral lipid-based drug delivery systems and predictive biopharmaceutics tools. She has >250 publications in international, peer-reviewed journals (H-index: 71, 15028 citations, (Google Scholar 26/3-24). She is / has been supervising 12 post docs, 54 PhD students and numerous master students, primarily at the University of Copenhagen, but also at other universities. She is a Fellow at the American Association of Pharmaceutical Scientists (2022), Fellow at the Controlled Release Society (2023) and recipient of the AAPS Lipid Based Drug Delivery Award (2005). She is editor of Journal of Drug Delivery Science and Technology (IF2023: 5.062).

• 

  Padma V. Devarajan
  

  Padma V. Devarajan

  Dr (Ms.) Padma V. Devarajan, President Society for Pharmaceutical Dissolution Science (SPDS) is Dean Research and Innovation, Professor in Pharmacy and former Head, Department of Pharmaceutical Sciences and Technology at the Institute of Chemical Technology, Mumbai, India. She is also a member of the Board of Governors and Head of the Incubator at the Institute of Chemical Technology. She has over 100 peer reviewed publications, many granted patents, has licensed technologies to industry and some products are commercialized in India and Europe. She is editor & author of two books on Targeted Drug Delivery, published by Springer. She was actively associated with the Controlled Release Society Inc., USA as Board Member and Member on the Board of Scientific Advisors and Chair of the Global Young Scientist Mentor Protégé Program. She is a Member on the Editorial board of the Asian Journal of Pharmaceutical Sciences and the European Journal of Drug Metabolism and Pharmacokinetics.

  Prof. Devarajan is a nominated Fellow of the Maharashtra Academy of Sciences, and Life Fellow of the Indian Chemical Society. She is a recipient of several awards and recognition for Research and Innovation, including the American Association of Indian Pharmaceutical Scientists Distinguished Educator and Researcher Award, the Bengaluru Nano Innovation Award, the Outstanding Woman Scientist Award of ICAR, Government of India and recently the Leading contributor and influencer in Academic Research & Industry Award.

• 

  Maureen Marsales
  

  Maureen Marsales

  Maureen Marsales holds a BS in biochemistry from Seton Hall University and is currently an Associate Principal Scientist in Merck’s Small Molecule Analytical R&D organization. Maureen has 19 years of experience in the pharmaceutical industry with a focus on the development and characterization of complex dosage forms. She has extensive experience working with inhalers, nasal sprays, nebulizers and subdermal implants. Most recently Maureen oversaw analytical activities for the Islatravir implant, an early phase candidate for HIV PrEP.

• 

  Christine Allen
  

  Christine Allen

  Dr. Christine Allen is a full professor at the University of Toronto (U of T) and an internationally recognized leader with more than 170 publications in drug formulation and development. She is a member of the Scientific Leadership Team of the Acceleration Consortium, a strategic initiative at the University of Toronto awarded $200M in funding from the Canada First Research Excellence Fund. She has received numerous awards and is a distinguished fellow of prestigious societies including the American Institute for Medical and Biological Engineering, and the Canadian Academy of Health Sciences.

  Christine is committed to the translation and commercialization of her research. She is a co-founder and CEO of Intrepid Labs Inc., a company that is accelerating pharmaceutical drug development through integration of AI, automation and advanced computing. She is also a co-founder and board member at Nanovista Inc. Her lab at U of T is deeply engaged in industry partnerships, playing a key role in advancing drugs from early-stage research to clinical trials.

  Her leadership has been pivotal in several scientific societies, notably as President of the Controlled Release Society and the Canadian Society for Pharmaceutical Sciences. In academia, her roles have included the inaugural Associate Vice-President and Vice Provost Strategic Initiatives and Interim Dean of the Leslie Dan Faculty of Pharmacy.

  Christine’s commitment to equity, diversity and inclusion (EDI) goes beyond words. She actions EDI in her research and community engagement. In 2019, she founded the Women in STEAM: Leading and Reading book club to create a community that supports women as they advance in their education and careers.

• 

  Kruthika Harish Jain
  

  Kruthika Harish Jain

  Krutika Harish Jain graduated in 2021 from University of Minnesota with a PhD in developing an “Artificial Gut Simulator for Simultaneous Evaluation of Drug Dissolution and Absorption” specifically of oral BCS-II compounds under Prof. Ron Siegel. Krutika developed a novel small volume hollow fiber based module to be used in a UV spectrophotometer cuvette to elucidate the important processes such as supersaturation and precipitation that are impacted at physiologically relevant rates of absorption and determine the true efficacy of enabling oral formulations.

  She then joined Gilead Sciences in Foster City, CA to further her expertise in developing novel in vitro tools and in vivo PBBM models for complex long acting injectables. Recently she and her team published a paper in the Journal of Pharmaceutical Sciences outlining a novel 2-method in vitro release testing strategy to evaluate different phases of drug release from intramuscular single agent and combination long acting injectables. She is also an active member of the IQ dissolution working group and the LAI-focused sub team under this working group.

• 

  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.

• 

  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.

• 

  Sujata Sonti VP, Drug Product Development, GSK
  

  Sujata Sonti

  VP, Drug Product Development, GSK

  Sujatha Sonti is VP, Drug Product Development, GSK, based at the Upper Providence site in Philadelphia. In her current role she leads a global team of outstanding scientists across disciplines including formulation, packaging, biopharmaceutics, engineering, modelling, and process analytics to develop innovative and robust, patient centric medicines. This team is accountable for the design, development, and industrialization of drug products (Oral, Sterile and Inhaled) and their manufacturing processes for all GSK small molecule and biopharmaceutical products.

  Sujatha obtained a bachelor’s in pharmacy from the University of Mumbai, India and received her Ph.D. in Pharmaceutical Sciences from West Virginia University. Her graduate research focused on the delivery of large molecules: antisense oligonucleotides and gene therapy for the treatment of lung inflammation. Prior to GSK, Sujatha has previously worked at Avon Products, Inc, Ionis Pharmaceuticals, SkinMedica, Inc (a division of Allergan) and Medicis Pharmaceuticals, where she worked on the development of both prescription and consumer care products. Through these opportunities, she has gained over 24 years of product development experience and has had the incredible fortune of launching several Prescription/Cosmetic/OTC products.

• 

  Patrick Sinko Pharmacist and a Pharmaceutical Scientist at Rutgers
  

  Patrick Sinko

  Pharmacist and a Pharmaceutical Scientist at Rutgers

  Dr. Patrick J. Sinko is a Pharmacist and a Pharmaceutical Scientist at Rutgers, The State University of New Jersey. He is a Distinguished Professor and the Parke-Davis Endowed Chair in Pharmaceutics and Drug Delivery at the Ernest Mario School of Pharmacy. Dr. Sinko served as Chair of the Department of Pharmaceutics in the School of Pharmacy (1998-2008) and Associate Vice President for Research (2007-2018) in the Office of Research and Economic Development for Rutgers University. Dr. Sinko was elected Fellow in the American Association for the Advancement of Science (2011), the American Association of Pharmaceutical Scientists (2003), the Controlled Release Society (2017), and the National Academy of Inventors (2023). Dr. Sinko currently serves as the Immediate Past President of AAPS. He was also elected to the AAAS Council and the Board of Scientific Advisors of the Controlled Release Society. Dr. Sinko has served on numerous scientific advisory and review panels in the United States and Europe. He is the Editor of Martin’s Physical Pharmacy and Pharmaceutical Sciences (Fifth, Sixth, Seventh, and Eighth Editions) and is on the Editorial Advisory Board for numerous journals. He is the Editor-in-Chief for Pharmaceutics. Dr. Sinko has authored or co-authored over 540 publications, including research papers, abstracts, and book chapters (h-index = 67). He is the Principal Investigator of an active research laboratory focusing on biopharmaceutics, pharmaceutical formulations, and molecular-, nano-, and micro-scale drug delivery. The NIH has continuously funded his lab for over 30 years. During his career, Dr. Sinko has received several awards for his teaching and research, including the Rutgers University Board of Trustees Award for Excellence in Research and the highly selective National Institutes of Health FIRST and MERIT Awards.

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  Suresh Bhojraj Pro-Chancellor of JSS Academy of Higher Education and former President of the Pharmacy Council of India
  

  Suresh Bhojraj

  Pro-Chancellor of JSS Academy of Higher Education and former President of the Pharmacy Council of India

  Dr. Suresh Bhojraj, Pro-Chancellor of JSS Academy of Higher Education and former President of the Pharmacy Council of India, is a visionary leader with over four decades of dedicated service in transforming education nationally and globally. During his tenure as President of the Pharmacy Council of India from 2003 to 2021, he pioneered initiatives such as the introduction of postgraduate “Pharmacy Practice” and Pharm.D. programs, revolutionizing pharmacy education and profession in India. As the founding Vice Chancellor of JSS Academy of Higher Education and Research for 11 years, Dr. Suresh propelled the institution to national and international acclaim, securing its position among the top 400 universities globally and top 50 universities in India. His emphasis on interdisciplinary research in medical and life sciences has led to numerous collaborations and accolades. Currently, as Director of the Technical Education Division at JSS Mahavidyapeetha, Mysuru, Dr. Suresh is elevating engineering and technological institutions across multiple locations. He also oversees JSS institutions in Dubai and Mauritius. Beyond his administrative roles, he contributes significantly to global pharmacy standards, serving as a delegate member of the United States Pharmacopeia Convention and Executive Member of the Commonwealth Pharmacists Association. Dr. Suresh’s contributions extend to numerous national and international committees, including the Scientific Committee on Problems of the Environment, where he collaborates closely with UN organizations. Recognized with prestigious awards and honorary doctorates, he is esteemed for his humane leadership and team-building skills. In addition to his prolific career, Dr. Suresh has authored numerous publications, delivered keynote addresses worldwide, and organized various conferences. His dedication to advancing education and healthcare underscores his enduring impact on society.

• 

  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.

• 

  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.

• 

  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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  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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  Nikoletta Fotaki Pharmacist, MSc, PhD, Centre of Therapeutic Innovation (CTI), Department of Pharmacy and Pharmacology, University of Bath, UK
  

  Nikoletta Fotaki

  Pharmacist, MSc, PhD, Centre of Therapeutic Innovation (CTI), Department of Pharmacy and Pharmacology, University of Bath, UK

  Dr Nikoletta Fotaki is a Reader in Biopharmaceutics at the University of Bath, UK. She graduated in Pharmacy from the National and Kapodistrian University of Athens in Greece and she holds an MSc in Toxicology and a PhD in Biopharmaceutics-Pharmacokinetics. She participated in several research projects in the School of Pharmacy of the National and Kapodistrian University of Athens and in Hoffman La Roche (USA) before her academic appointment at the University of Bath. She has also worked in the National Organisation for Medicines in Greece. Her expertise and research are focused on Biopharmaceutics Tools used in all stages of drug development, Physiologically Based Pharmacokinetic (PBPK) modeling/ Physiologically Based Biopharmaceutics modeling (PBBM), in vitro and in silico tools for predicting absorption in normal populations and in special populations, dissolution methods, IVIVCs and biowaivers. Her scholastic work includes more than 80 peer reviewed publications, one book, 5 book chapters, 86 published conference contributions and 2 patents. She is a reviewer and scientific advisor of several scientific journals. She was a Deputy Editor for AAPS Open and member of the editorial board of Journal of Pharmacy and Pharmacology, Dissolution Technologies and DiePharmazie. She is an Associate Fellow of the Higher Education Academy and has been involved in the evaluation of several research proposals. She is also an Adjunct Associate Professor in the University of Waterloo (Canada) and a visiting Lecturer in King’s College London. She is the vice chair of the Oral Biopharmaceutics and Absorption Modeling (OBAM) Community of AAPS and she has been the chair of the In Vitro Release and Dissolution Testing (IVRDT) Focus Group of AAPS. She is a member of a USP expert panel and of several scientific societies and has been an invited speaker at several conferences.

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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.