Speakers 2022

Over 19 years of experience in many facets of regulatory affairs, quality compliance and quality operations within the GxP regulated environment pertaining to Emerging Technologies and Combination Products.  Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system and regulatory affairs regarding CMC Global Dossiers/Global Device Regulatory Strategies, EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC), 21 CFR Part 3 and Part 4 - Combination Products, CE Marking, ISO 13485:2016/MDSAP, International Regulatory Affairs, Product Development - (Design Control, Risk Management and Human Factors Engineering), Acquisitions/Divestitures and represents AbbVie as the U.S Agent regarding FDA matters for international medical device facilities.

In addition, lectures at various symposia, is the Chairman of the DIA Combination Products Committee, chairs various global combination products conferences, participates in regulatory panel discussions within the industry and is an adjunct assistant professor at USC – School of Pharmacy - Regulatory Science Programs.

Ning Yu is Director, Head of Device Development at Biogen’s Product and Technology department.  Ning has been working in the field of drug delivery device for the past ten years, with broad experience on syringes, auto injectors, pen injectors, needle safety, wearable pumps, IV kit, intrathecal delivery device, ophthalmology, smart packaging and connected device etc.  Ning has worked on combination products from both the medical device and biopharma sides.  Prior to entering the drug delivery device world, Ning worked on orthopaedic implants and computer hard drives.  Ning has a BS in Mechanical and Electrical Engineering, MS and PhD in Mechanical Engineering from University of Illinois at Urbana-Champaign, and MBA from Boston University.

Dr. Burgess received her B.Sc. degree in Pharmacy from the University of Strathclyde, U.K. (1979) and her Ph.D. in Pharmaceutics from the University of London, U.K. (1984). She was a postdoctoral fellow at the Universities of Nottingham, U.K. (1984-1985) and North Carolina (1985). Dr. Burgess joined the faculty at the University of Illinois at Chicago in 1986 as Assistant and then Associate Professor and moved to the University of Connecticut in 1993. She was promoted to Professor in 1999, and in 2009 she was appointed Board of Trustees Distinguished Professor of Pharmaceutics at the University of Connecticut.

Dr. Burgess has been active in teaching, research and service throughout her career. Her students have recognized her with the Outstanding Teacher of the Year Award (2005 and 1992). She received the 2009 Distinguished Service award from the University of Connecticut, School of Pharmacy. In 2010, she became the first recipient of the CRSI (Controlled Release Society, India Chapter) fellowship award for outstanding contributions in drug delivery research. Dr. Burgess is the 2011 recipient of the Nagai APSJ International Women Scientist Research Achievement Award. Dr. Burgess also received the 2013 AAPS IPEC Ralph Shangraw Memorial Award for her outstanding research in the area of pharmaceutical excipients. In 2014, Dr. Burgess was recognized for her exceptional commitment in CRS, and was selected as the recipient of the Distinguished Service Award. She has over 130 refereed publications. She is the editor of two books. She has given over 330 research presentations, over 170 invited lectures, and 12 keynote addresses at major international scientific meetings; Dr. Burgess has served as major adviser for four M.S. and 22 Ph.D. graduates as well as 12 post-doctoral fellows. She is currently directing the research of seven Ph.D. students, two post-doctoral fellow, and two assistant research professors.

Dr. Burgess is a fellow of AAPS (American Association of Pharmaceutical Scientists) and of AIMBE (American Institute for Medical Biological Engineering). She served as elected President of AAPS in 2002 and CRS (Controlled Release Society) in 2009. She is a member of the USP Biopharmaceutics Expert committee and the USP Advisory Panel on Injectables. Dr. Burgess is editor of the International Journal of Pharmaceutics (2009 – to date). She was an editor for AAPSPharmSci (1999 - 2005) and editor of the Journal of Drug Delivery Science and Technology (2003 - 2008). Dr. Burgess serves on the editorial boards of seven international journals. Dr. Burgess has severed on NIH study sections on Drug Delivery and Biomedical engineering, Drug Delivery and Drug Discovery, Gene and Drug Delivery, and Nanomedicene as well as many special study sections for NIDA, NIDDK and NCI (2001- to date). In 2001 she undertook a sabbatical at the Office of Testing and Research at CDER, FDA. She consults for pharmaceutical, food, cosmetic and other industries.

Adithi graduated from the University of California, Davis with a degree in Biochemistry and Molecular Biology. Currently, she is a Technical Development Scientist at Genentech in the Pharmaceutical Development (Formulations) group. She has 8+ years of industry experience and has lead the formulation and drug product processing development of late stage molecules, authored multiple health authority filings and is an expert in low dose/concentration in-use administration.

Pierre Daublain works as Principal Scientist in the Discovery Pharmaceutical Sciences group at Merck Research Laboratories in Boston where he primarily supports Oncology research programs. His areas of expertise include physicochemical characterization and early formulation development of drug candidates, as well as development of informatics tools to model oral absorption and influence molecular design.

Dr. Daublain received an engineer diploma from CPE Lyon (France) in 1999. He obtained his Ph.D. in the laboratory of Prof. Martin Newcomb at the University of Illinois in Chicago in 2004, and his research focused on kinetic and mechanistic model studies of coenzyme B12-dependent rearrangements. He later conducted a post-doctoral fellowship at Northwestern University in the laboratory of Prof. Frederick Lewis, where he investigated electron transfer processes in DNA responsible for UV-induced damage.

Throughout his graduate and post-graduate studies, Dr Daublain published several papers in the field or physical organic chemistry and pharmaceutical sciences.

Ravi is the co-founder and CEO of Intact Therapeuetics, a venture-backed biopharma startup spun out of Stanford University, focused on targeted therapies for diseases of the gastrointestinal tract. Prior to Intact, he led marketing and medical affairs at Transcend Medical, working on a novel minimally invasive glaucoma implant, up until its sale to Alcon/Novartis for a total deal value of >$500 M. He began his career working in research and development for Guidant Corporation, developing best-in-class technologies for cardiac and vascular surgery. He received a BS in Mechanical Engineering, an MS in Management Science & Engineering, and fellowship training in Biodesign (biomedical innovation), all from Stanford University.

John received a BS in biochemistry from Albright College and his Ph.D. in synthetic organic chemistry from Brown University. After completing a Postdoctoral Fellowship at the Sloan-Kettering Cancer Institute in NYC in the departments of Positron Emission Tomography and Neurology, he joined the Medicinal Chemistry Discovery group at Johnson Matthey Biomedical. There he made several significant contributions to early research projects on new Pt- antitumor drugs and peptide-based diagnostic radio-imaging agents. After nearly a decade as a discovery med chemist, he moved on to drug development in positions of increasing responsibility at J&J and Sanofi-Aventis. He and his teams have specialized in the areas of drug delivery, solid state chemistry and biomaterials in relation to improving the bioperformance of therapeutic agents. Towards this end, he has led the successful implementation of a wide range of methodologies into drug discovery space including prodrug design for enhanced solubility/permeability, miniaturized polymeric amorphous dispersions and
nanoparticle technologies.

John currently is Executive Director of the Discovery Pharmaceutical Sciences
department at Merck’s Discovery Center in South San Francisco. In this
multidisciplinary role, he is responsible for oversight of the biopharmaceutical and drug delivery aspects of Merck’s discovery programs (small molecules, peptides, biologics) as well as the identification of new enabling technologies for burgeoning areas such as oral peptide and ophthalmic gene delivery. Over his over 32 year pharma career, he is co-inventor on 13 US Patents and author of numerous and diverse publications and book chapters in the fields of organic, solid state & medicinal chemistry and drug delivery.

John also currently serves as an Adjunct Associate Professor at the University of
Pennsylvania School of Medicine, where he regularly teaches classes in various
aspects of drug discovery and development.

Steve Persak is a Director of Device Development at Merck Research Labs. He is responsible for Device Innovation, Device Program Leadership, as well as other technical functions. Steve has more than 10 years of experience in the medical device and combination product sector, developing delivery devices for a variety of formulation types and delivery modalities. During his time at Merck, he has supported several programs, including Keytruda®, NuvaRing® and NuvaRing® Applicator, Nasonex®, Asmanex®, Simponi®, Nexplanon®, Implanon®, PegIntron®, and Lusduna®. By training, he is a Mechanical Engineer and holds bachelor’s and master’s degrees The Cooper Union in NY as well as an MBA from the NYU Stern School of Business.

Dr. Liangfang Zhang is Joan and Irwin Jacobs Chancellor Professor of Nanoengineering and Bioengineering and Director of Chemical Engineering Program at the University of California San Diego. Dr. Zhang received his B.E. and M.S. degrees in Chemical Engineering from Tsinghua University, and his Ph.D. in Chemical & Biomolecular Engineering from the University of Illinois at Urbana-Champaign in 2006 under the supervision of Prof. Steve Granick. He was a postdoctoral associate in the laboratory of Prof. Robert Langer at MIT during 2006-2008. He joined the Department of Nanoengineering at UC San Diego as an Assistant Professor in 2008 and was promoted to Professor in 2014. Dr. Zhang’s research aims to create cutting-edge biomimetic nanotechnologies for various medical applications with a particular focus on biomimetic nanodelivery and biological neutralization. He has published 248 peer-reviewed articles and was among the Clarivate Analytics list of “Highly Cited Researcher” during 2017-2021. He is an inventor of 118 patents and patent applications worldwide.

Dr. MacKay, Ph.D. is the Gavin S. Herbert associate professor in Pharmaceutical Sciences at the University of Southern California School of Pharmacy. His research group explores recombinant protein-polymers, drug delivery, and pharmacokinetics. Dr. MacKay holds degrees in chemical engineering (S.B. 1999) and biology (S.B. 1999) from the Massachusetts Institute of Technology and bioengineering from the University of California at San Francisco and Berkeley (Ph.D. 2005). In 2008, Dr. MacKay joined the faculty at the University of Southern California in the Departments of Pharmacology and Pharmaceutical Sciences, Biomedical Engineering, and Ophthalmology. He is a full member of the USC Norris Comprehensive Cancer Center. Dr. MacKay is an executive editor at the journal Advanced Drug Delivery Reviews and a standing member of the NIH study section on Nanomedicine. His work has been supported by the US Army, NIH/NIGMS, NIH/NIBIB, NIH/NEI, StopCancer, USC Ming Hsieh Institute, and L.K. Whittier Foundation.

Yihong Qiu is currently Senior Research Fellow, Formulation Sciences at AbbVie. He has a broad knowledge and experience in different stages of drug product lifecycle, from preformulation, biopharmaceutics, drug delivery to product/process design & development, technology transfer, manufacturing trouble-shooting, and regulatory registration. During his 30-year tenure with Abbott/AbbVie, his work has resulted in marketed IR and MR products, patented drug delivery technologies, IVIVC’s and biowaivers. His research interests include modified-release delivery, enhancing dissolution and oral bioavailability, IVIVC and science-based regulations. He is an elected fellow of AAPS with over 60 publications in journals and books, > 35 patents granted or pending, and numerous invited presentations. He received BS in Pharmacy, MS. in Pharmaceutics from China Pharmaceutical University, and Ph.D. in Pharmaceutics from The University of Iowa.

Patrick Stayton serves as the Distinguished Career Professor in the Department of Bioengineering at UW.  He is the founding Director of the UW Institute for Molecular Engineering and Sciences.  His group develops new targeted prodrugs and drug delivery systems for infectious disease and cancer therapeutics. Dr. Stayton has a strong interest in translating the group’s research, has been awarded many patents, and is a co-founder of several startup companies, including PhaseRx Inc. that developed RNA therapeutics. Dr. Stayton has been elected as a Fellow of the American Institute for Medical and Biological Engineering, and has been the recipient of the Clemson Award from the Society For Biomaterials and the CRS-Cygnus Recognition Award from the Controlled Release Society. He served as Co-Chair of the GRC on Drug Carriers in Medicine and Biology in 2010.  He has also been awarded the Faculty Innovator Award, and the Distinguished Teacher and Mentor Award.

Chun-Wan received her Bachelor's degree from the Chemistry Department at National Taiwan University. She came to the USA for her Ph.D. degree from the Chemistry Department at Georgia Institute of Technology. After her Ph.D., she received the ORISE fellowship and started her postdoctoral training at the Massachusetts Institute of Technology. She started her industrial career at Merck Research Laboratory in 2015-2018. Currently, she is a Principal Scientist in the preformulation group at Genentech, and her pipeline support includes preclinical formulation development for the various dosing routes. She is interested in drug delivery for exotic modalities, including oligonucleotides, peptides, and mRNAs to support undruggable targets. Chun-Wan has published 20+ peer-review papers and two patents.

Dr. Peixuan Guo, a pioneer of RNA nanotechnology, has held three endowed chair positions at three different prestigious universities, and currently is the Sylvan G. Frank Endowed Chair in Pharmaceutics and Drug Delivery and the director of the Center for RNA Nanobiotechnology and Nanomedicine at The Ohio State University. He is the president of the International Society of RNA Nanotech and Nanomedicine. He received his Ph.D. from U Minnesota in 1987 and conducted his postdoc at NIH under Bernard Moss. He joined Purdue University in 1990, tenured in 1993 and became a full professor in 1997, honored as a Purdue Distinguished Faculty Scholar in 1998. He served as the Director of the NIH Nanomedcine Develoment Center (NDC) from 2006-2011, was the Director of NCI Cancer Nanotech Platform Partnership Program from 2012-2017. To date, Dr. Guo invented 70 patents (13 granted and 57 in Provisional and PCT).

Dr. Niren Murthy is a professor in the Department of Bioengineering at the University of California at Berkeley.  Dr. Murthy’s scientific career has focused on the molecular design and synthesis of new materials for drug delivery and molecular imaging.  The Murthy laboratory has been recently focused on developing non-viral delivery vehicles that can deliver Cas9 protein, gRNA and Donor DNA in vivo.  The Murthy laboratory is committed to translating research discoveries made in its laboratory. Several start-up companies and licenses have been generated from the laboratory, in particular, the start-up companies GenEdit, BioAmp Diagnostics and Microbial Medical were formed based upon research conducted in the Murthy lab.

Eric A. Appel is an Assistant Professor of Materials Science & Engineering at Stanford University. He received his BS in Chemistry and MS in Polymer Science from Cal Poly, San Luis Obispo. Eric performed his MS thesis research with Robert D. Miller and James L. Hedrick at the IBM Almaden Research Center in San Jose, CA. He then obtained his PhD in Chemistry working in the lab of Dr. Oren A. Scherman in the Melville Laboratory for Polymer Synthesis at the University of Cambridge. His PhD research focused on the preparation of dynamic and stimuli-responsive supramolecular polymeric materials. For his PhD work, Eric was the recipient of the Jon Weaver PhD prize from the Royal Society of Chemistry and a Graduate Student Award from the Materials Research Society. Upon graduating from Cambridge in 2012, he was awarded a National Research Service Award from the NIH (NIBIB) and pursued a Wellcome Trust Postdoctoral Fellowship at MIT working with Robert S. Langer on the development of supramolecular biomaterials for drug delivery and tissue engineering. During his post-doctoral work, he received a Margaret A. Cunningham Immune Mechanisms in Cancer Research Award. He recently received a Terman Faculty Fellowship from the School of Engineering at Stanford University.

Jim Leamon is a medical device and drug device combination product development leader, engineering director, manufacturing manager and he is experienced in working across functions and business groups in varying organizations. He has successfully brought new and effective products to market throughout the world, developed and implemented new engineering, quality control and manufacturing processes. He continuously provides leadership for many Product Development, and Engineering teams. He is engaged in current trends in the combination product space and in providing Jazz Pharmaceuticals the support to enhance various drug-device combination products and diagnostic devices.

Dr. Khaudeja Bano is the Executive Medical Director and Vice President of Combination Product and Device Safety at Amgen. She is responsible for the development and approval of next-generation combination products, drug delivery devices, and diagnostic instruments. She is highly regarded for directing strategic external outreach, championing product safety, and improving clinical infrastructure. Dr. Bano holds a Bachelor of Medicine, Bachelor of Surgery degree from Osmania University and has a Master’s degree in Clinical Research from the University of California, San Diego. Since immigrating to the United States in the early 90s, she has gone on to earn a Certification in Pharmaceutical Engineering from California State University, Fullerton and is a Certified Project Management Professional. Dr. Bano’s career spans more than 25 years’ and includes both clinical and safety leadership roles in various areas of development including medical devices, diagnostics, and pharmaceuticals. Outside of Amgen, she serves as the chair for the Post Marketing Safety group for the Combination Product Coalition (CPC) and mentors others foreign healthcare professionals advance their career

Dr. Stefan Yohe is the Director of Delivery & Device at Seagen, where his team focuses on enabling alternative routes of administration for the Seagen pipeline through novel formulations, delivery technologies, and devices. Dr. Yohe has over a decade of experience in delivery and device technology innovation, development, and commercialization with prior roles at Genentech and Bayer. He received his PhD in Biomedical Engineering and Pharmacology from Boston University, and his Bachelors in Material Science from The Pennsylvania State University.

Puneet Tyagi is an Associate Director with the Dosage Form Design and Development group at AstraZeneca, based in Maryland, USA. Puneet leads a team of scientists in the  area of biologics formulation development, with a focus on long acting formulations, transdermal delivery, and oral delivery of biologics. Puneet  received his bachelor’s and master’s degrees in pharmaceutical sciences  from India, and his PhD from the University of Colorado. Puneet Tyagi is co-inventor of several U.S. and international patents and has published extensively in the field of drug delivery.

Rick is currently the SVP of CMC at QED Therapeutics, Origin Bioscences and Calcilytix Therapeutics all BridgeBio Companies. Prior to joining BridgeBio, Rick served as VP of Pharmaceutical Development Services at WuXi STA, where he provided scientific leadership in formulation development and GMP manufacturing. From 2004 to 2015, Rick was Global Head of Chemical and Pharmaceutical Profiling (CPP) at Novartis. His responsibilities included all small molecule therapeutics across the Novartis portfolio. He also lead and developed novel drug delivery technologies for small molecules and large molecules. Rick has also led R&D groups at Vertex Pharmaceuticals, Symbollon Pharmaceuticals, Biogen, and Bausch & Lomb. He received a Ph.D. in Chemistry from the University of Toronto and did a Post-Doctoral Fellowship at UCSB

Dr. Mohamed ElSayed is an accomplished leader with +25 years of experience spanning academia, biotechnology, and pharmaceutical organizations. He is a recognized expert in the development of small molecules, biologics, nucleic acids, and regenerative cell therapy.

Currently, he is the Oral Peptide Delivery Platform Leader at Eli Lilly & Company where he leads a cross-functional team of talented scientists that delivers the oral peptides portfolio. Prior to joining Lilly, Dr. ElSayed advised numerous pharmaceutical and biotechnology companies on challenging drug development programs while pursuing an academic career in parallel. He was a tenured professor at the University of Michigan where he established and led the Cellular Engineering and Nano-Therapeutics Laboratory. His research spanned multiple disciplines including biopharmaceutics, drug delivery, and material sciences with special emphasis on development of novel formulations for multiple therapeutic modalities. He constantly integrated technologies from disparate fields to develop innovative, robust, and scalable drug delivery platforms.

Dr. ElSayed received his B.Sc. and Ph.D. in Pharmaceutical Sciences from Cairo University, Egypt and the University of Maryland, Baltimore, respectively. He received +25 awards, contributed to 6 patents, co-authored +170 research articles and conference proceedings, and delivered +60 invited talks. Dr. ElSayed serves as chair of AAPS Pre-Formulation & Formulation Design/Development Community, a member of the Scientific Advisory Board of Boulder Peptide Society, and a member of the Editorial Office of Precision Nanomedicines and Journal of Pharmaceutical Sciences.

Charlie leads the Device and Packaging group in Genentech.  He and his group support end-to-end product development, from due diligence and early feasibility, through development, tech transfer into commercial and post-marketing product support.  He works with combination Devices such as pre-filled syringes and autoinjectors through advanced digital Devices and Ocular implants and smart packaging.  In addition to his normal end-to-end responsibilities, Charlie is focused on enhancing the working culture in his sphere, especially as it relates to speaking-up, challenging, and taking risk.  Prior to joining Genentech, he spent 20 years in the Medical Device Industry - mostly at start-ups, developing, and commercializing innovative products, including implants and electromechanical Devices.  He has managed various departments, including R&D, Mfg, Clinical, Regulatory, Operations, commercial, and Quality, culminating as CEO at his last company.  Charlie started his career designing cars for Honda Motor and enjoyed living in Japan for a year.  Outside work, he’s an avid cyclist, motorsports fan, and loves staying young with his two kids.

Vlad Muzykantov earned his MD (Internal Medicine) from the First Moscow Medical School in 1980, and PhD in Medical Sciences (Biochemistry) in 1986 from the National Cardiology Research Centre (Moscow), where he worked till 1993, when he moved to PENN, where he serves as the Founding Director of the Center for Targeted Therapeutics and Translational Nanomedicine and Vice-Chair of Department of Pharmacology. His research for last 40 years encompasses drug delivery and targeting in the vascular, respiratory and nervous systems. He published about 250 papers on this topic including Science, numerous Nature series, PNAS, ACS Nano, Blood, Advanced Materials and other high impact journals. In these collaborative studies his team pioneered targeting drugs and carriers to endothelial and blood cells, regulation of targeting and intracellular delivery of numerous drug delivery systems (DDS).

Nick DiFranco, MEM, is the Global Market Segment Manager for Oral Treatments at Lubrizol Life Science Health (LLS Health). In his role, Nick coordinates a multi-disciplinary team offering excipients and services for controlled release and solubility enhancement in oral solids and liquids, including Carbopol® and Apinovex™ polymers. Prior to this role, Nick held positions as an Applications Scientist and Market Manager at Lubrizol supporting long-acting drug delivery and CDMO services. Nick holds a B.S. in Biomedical Engineering (Biomaterials focus) and a Master of Engineering and Management degree from Case Western Reserve University.

Joey Glassco, MBA, is the Senior Global Market Manager for Parenteral Drug Delivery at Lubrizol Life Science Health (LLS Health).  Joey has served as Marketing Director for CDMO division since 2017 and has been involved in pharmaceutical excipient new business development since 2013. Prior to joining the LLS Health, she spent nearly 15 years in marketing roles in various Lubrizol business units. Joey also has over 10 years of experience in finance at Lubrizol, Ford Motor Company, and The Franklin Mint. She received Bachelor of Science degrees in Finance and Accounting from Juniata College and her M.B.A from the Smeal College of Business at Pennsylvania State University.

Marika Nespi obtained her MS degree in Pharmaceutical Science with Organic Chemistry major at the University of Parma (Italy). After moving to the US, Marika started her career in the pharmaceutical industry working as a medicinal chemist at Genentech in 2000, and then at Plexxikon in 2002. While at Plexxikon, she became a formulation researcher in 2013, and then joined the pre-formulation group at Genentech since 2018. She gained strong knowledge of pharmaceutics fundamentals (including solid state and different dosage forms) along with deep understanding of ADME/DMPK. She is currently a Senior Principal Scientific Researcher (SPSR) and supports the pipeline in pre-clinical formulation development. Her interest is in Amorphous Solid Dispersion (ASD) approach for drug delivery, and her focus is specifically on spray-dry dispersions (SDD) development for supporting pre-clinical toxicology assessment.

Shuang Chen is currently a senior principal research scientist at AbbVie. He received his Ph.D. degree in chemistry from the University of British Columbia, Canada. Before joining AbbVie’s Process Research & Development team in 2006, he was a postdoc researcher in the School of Pharmacy of the University of Wisconsin at Madison where he focused his research on the polymorphism and crystallization of organic crystals. At AbbVie, his job responsibilities and experience include assessment of developability of candidate drug molecules, discovery and selection of API solid forms for pharmaceutical development, development of drug substance process for scale up and commercialization, and characterization and improvement of API physical properties for drug product development.

Pete Sargent is an Associate Senior Consultant Engineer in the Delivery, Device, and Connected Solutions Department at Eli Lilly and Company. He earned his B.S. in Chemical Engineering from Rose-Hulman Institute of Technology and his M.S. in Biomedical Engineering from Purdue University.

He is responsible for the development of primary packaging container closure systems for use with parenteral drug product and drug substance.

Pete has 15+ years of experience in the medical device and pharmaceutical fields. He’s led numerous projects for the development of drug substance and drug product container closure systems in support of Chemistry, Manufacturing, and Control content for Regulatory submissions for large molecule drugs.

His current responsibilities include senior technical oversight for the development and advancement of platform container closure systems for parenteral drug products and drug substance.

Dr. Helen Hou joined the Department of Small Molecule Pharmaceutical Sciences at Genentech (South San Francisco, California) in 2015. In her current role as a Senior Scientist, she is responsible for drug product development to allow fast-entry into human and the definition of market-image formulation/process. Prior to joining Genentech, Helen worked in several industrial positions at Allergan (2013 –2015), AbbVie (2008 – 2013), and Amgen (2006 – 2007), specialized in development of oral solid dosage forms and sterile product for ophthalmology. Helen received her Ph.D. in materials science and engineering from the University of Minnesota in 2006, where she did research in development of novel intranasal formulation for the treatment of epilepsy. Her primary research interests include understanding the effect of solubilizing additives on the manufacturability and release behaviour of high-energy solids, and designing in vitro models for the prediction of in vivo performance of supersaturating solid dosage forms.

Pavan Handa has 25+ years of experience in Business Development, Strategic Planning, Venture Management in the global pharma industry with both drug delivery and specialty pharma. Former SVP for Antares Pharma, senior management roles at various organization including Enzon, Kashiv, Noven, & Union Carbide.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com

Dipen Desai has 15+ years of experience in Complex Product R & D in top companies like Roche, Kashiv & Amneal and key specialization area includes formulation, processes, drug delivery technologies for NCE molecules, 505b2 & complex generics. Was responsible for development of platform technologies like BIOMAXX, GRANDE & KRONOTEC and is an Inventor on 30+ Patents.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com