Speakers 2022

20+ years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Devices, Technology Medicinal Delivery Platforms, Complex Generics, Companion Diagnostics, Digital Medicine, and Combination Product areas. Regularly provide AbbVie therapeutic franchise units regulatory counsel
and strategy to all aspects within the quality management system and regulatory affairs

INDUSTRY

• 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
• Represent AbbVie as the U.S Agent regarding FDA matters for international medical device facilities
• Actively participate in industry trade organizations and serve on standards committees.
• Member of various regulatory and quality work groups including DIA, RAPS, AAMI, ISPE Combination
• Products (CoP), OCRA, SDRAN, ASQ Orange Empire Section, and ASQ San Diego.
• Recognized international speaker, chair, and keynote at various regulatory symposia, Chairman of the
• DIA Combination Products Committee, and a moderator for various global regulatory panel
• discussions.
• Lecture various sections for the RAPS RAC Device Certification Prep Course - SDRAN
• Adjunct Assistant Professor at the University of Southern California (USC) – School of Pharmacy –
• Regulatory and Quality Sciences

• 2000 - BSc., Biology, Duquesne University
• 2002 - MHMS, Health Law and Policy, Duquesne University
• 2011 - Certificate, Health Law and Life Science Regulatory Compliance, Seton Hall University Law
• School - Center for Health & Pharmaceutical Law
• 2022 - Certificate, RAPS Executive Development Program, Northwestern University - Kellogg School
• of Management

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.

Yasmine Gomaa is a Senior Research Scientist and the Associate Director of the Laboratory of Drug Delivery at Georgia Institute of Technology, Atlanta, Georgia since April 2020. She earned a BA, MD and Ph D degrees in Pharmaceutical Sciences from Faculty of Pharmacy, Alexandria University, Egypt. Her research experience over the past 20 years has been in the delivery of drugs, vaccines and cosmeceuticals, especially via the transdermal and topical route. Early in her research career, she utilized drug delivery systems for skin delivery and recently microneedle based systems for skin and transdermal delivery of drugs and vaccines. She has a strong publication record, is a co-inventor for three pending patents and co-wrote several successful grants. She has worked in collaboration with industry, academic institutions, and several governmental, private and regulatory agencies as well as organizations such as CDC, WHO, UNICEF and Bill and Melinda Gates Foundation.

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.

Donna French, Ph.D. is Vice President of the Dosage Form Design and Development organization at AstraZeneca.  She is responsible for formulation sciences, drug product process development, drug delivery systems, and delivery device development for the biologics portfolio.  Prior to AstraZeneca, Donna was Senior Director of Device Development at Genentech and Executive Director of Drug Delivery Engineering at Amgen.  Donna has extensive experience developing and commercializing drug products, drug delivery systems and devices.  She has led the technical development and/or commercialization of numerous biopharmaceuticals with delivery devices worldwide.  Earlier in her career, she was a scientist researching novel formulations and formulation-based drug delivery systems for biologics.  Donna has a B.S. in Pharmacy from the Albany College of Pharmacy and a Ph.D. in Pharmaceutical Sciences from the University of Nebraska.  She is an elected member of the American Institute for Medical and Biological Engineering.

Will Forrest is a Principal Scientist at Merck Research Labs in the Sterile & Specialty Products division where he is responsible for the formulation and process development of biologic parenteral products, pipeline program leadership and Pharmaceutical Sciences IP lead.

Dr. Forrest has more than 8 years of experience in the drug product formulation/process development and analytical method development fields for a variety of parenteral modalities.

By training, he is a Chemist and holds a B.S. from Furman University, Ph.D. from Purdue University and Post-doctorate from the Massachusetts Institute of Technology

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 California Polytechnic in San Luis Obispo, CA. Eric performed his MS thesis research with Dr Jim Hedrick and Dr Robert Miller on the synthesis of polymers for drug delivery applications at the IBM Almaden Research Center in San Jose, CA. He then obtained his PhD in Chemistry with Prof. Oren A. Scherman at the University of Cambridge working on the preparation of supramolecular polymeric materials. Eris was awarded a Wellcome Trust Postdoctoral Fellowship to work with Prof. Robert Langer at MIT on the development of supramolecular biomaterials for applications in tissue engineering and drug delivery. Eric’s work at Stanford focuses on the development of biomimetic polymeric materials that can be used as tools to better understand fundamental biological processes and to engineer advanced healthcare solutions. His research has led to more than one hundred publications, 25 pending or granted patents, and formed the basis for two start-up companies. He has received a Margaret A. Cunningham Immune Mechanisms in Cancer Research Award and young faculty awards from the Hellman Scholars Fund, the American Diabetes Association, the American Cancer Society, and the PhRMA Foundation.

I am the Head of Device and MedTech Development within the Plasma Derived Therapies (PDT) business unit within Takeda and function within PDT’s R&D organization. My team is based in Lexington MA.

I hold a master’s degree in mechanical engineering and have been involved in medical device product development for over 18 years. My experience includes surgical implants, single-use devices, software enabled durable medical equipment and drug-device combination products across the entire product development lifecycle. In my current role I oversee development and post commercial activities for administration and site access devices, In-vitro diagnostics and Digital Health products.

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.

Sathya is currently leading the Biologics group as Director in Pre-Pivotal Drug Product Technology, Process Development at Amgen. Sathya has a PhD in Biochemistry/Biophysics from University of Zurich, Switzerland and postdoc from Stanford University, CA. She has more than a decade of experience in discovery and development of antibodies, nanobodies, fusion proteins, multi-specifics; She was employed at Boehringer-Ingelheim (2012-2017) and Janssen Biotherapeutics J&J (2017-2021). She has led projects in multiple therapeutic areas (Ophthalmology, Immunology and Oncology) and has five therapeutic drugs in clinical trials for indications such as Diabetic Retinopathy and Prostate Cancer. She owns several publications and patents.

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.

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.

Shrirang (Shri) Ranade is the Global Technical Lead for the Port Delivery System and has enjoyed working on the PDS program since he joined Genentech in 2012 as a Technical Regulatory Lead; transitioned to a technical development leader in 2015 and led the teams through HA submissions and FDA approval.

Prior to Roche/GNE, Shri held R&D positions in Boston Scientific and Johnson & Johnson, focused on the development of medical devices and drug-device combination products in Cardiovascular, Orthopaedics and ENT areas incorporating small & large molecule therapeutics. He is listed as an inventor on 17 issued US patents, an author on 6 book chapters and has 16 articles published in refereed journals.  Shri holds a B.Eng. from the University of Poona, an M.Sc. from the University of Manchester and a Ph.D. in Polymer Science from the University of Connecticut.

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.

Casey Dean joined Tolmar in November 2017 to establish the device development capabilities and build out an organization to support a growing innovation pipeline.  His group is responsible for parenteral devices that can deliver proprietary long-acting injectables. Within Tolmar, his group is engaged in technology development from early stage through late including innovation, development, clinical introduction, and scale-up for commercial manufacturing. A particular focus of his group is understanding user needs and business needs to engineer the right product for patients and health care providers. Prior to working at Tolmar, Casey was a Senior Device Engineer at Amgen and a Product Development Engineer in the Medical Systems Division of Parker Hannifin. Casey earned his MS and BS in Mechanical Engineering from Colorado State University.

Pete Sargent is an Engineering Advisor 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.

My Name is Shwetha Iyer, and I work as a Principal Scientist I in Novartis. My organization in Novartis is called Novartis Biologics Center (NBC) which is a part of NIBR here in Cambridge, MA. Within NBC, I am leading the formulation team for large biotherapeutics and other modalities such as gene therapy, Adeno-associated virus (AAV), Lentivirus (LV) etc. My group’s core responsibility includes but not limited to establishing developability assessments focusing on preformulation studies for large biotherapeutics in order to successfully lock down clinical service formulation for Phase I studies and in some cases, beyond Phase I. We work with high throughput, state of the art automation systems that enable us to determine the degradation mechanisms of the protein during stability and mitigate the risk to enable a successful liquid in a vial (LiVi) for clinical applications

Helen Hao a Principal Scientist in the Department of Small Molecule Pharmaceutical Sciences at Genentech.  In her current role, 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 in 2015, Helen worked at Amgen and AbbVie, specializing in development of oral solid dosage forms and sterile product for ophthalmology. Helen received my Ph.D. in Materials Science and Engineering from the University of Minnesota.

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

Pratik is an innovative leader with experience in matrix and line leadership roles. At GSK, he has held positions in areas of Early Development, Drug Product Design and CMC. In his current role, Pratik leads the Global Biopharmaceutics group in Drug Product Development that is responsible for integrated biopharmaceutics across dose forms. Pratik has 25 plus years of pharmaceutical industry experience, and is passionate about product design and performance. Prior to GSK, he worked at FMC Corp. and Schering-Plough in pharmaceutical drug delivery and formulation research. Pratik holds a Ph.D. in Pharmaceutical Sciences from University of Southern California.

Dr. Raman Iyer has 25+ years’ experience in drug product development in pharma industry. He began his career at Chelsea Laboratories followed by Whitehall Robins (c/o Pfizer) in OTC product development. He joined Hoffmann-La Roche in 2000 where he developed oral, nasal and other drug delivery systems for NCEs, from pre-clinical phase to technology transfer and scale-up. As a Senior Research Leader at Roche, Dr. Iyer led the development and launch of Zelboraf for metastatic melanoma, the very first amorphous solid dispersion (ASD) via a highly acclaimed novel co-precipitation technique, an industry first. He joined Novartis in 2013 where he has been involved in the development of age-appropriate formulations for pediatric indications. Dr. Iyer has authored several publications, patents and a few book chapters. He holds bachelor’s and masters’ degrees in pharmaceutical sciences and a doctoral degree from the University of Maryland at Baltimore.

David Lyon currently serves as a Sr. Fellow, Global R&D advising internal and external collaborations in bioavailability enhancement, inhalation, modified release and bioprocessing. He received his B.S. in Chemistry from Western Washington University and PhD in Inorganic Chemistry from the University of Oregon. Following a Post-Doctoral stint at the California Institute of Technology, David joined Bend Research as a Research Chemist in 1991. During his tenure at Bend Research, he held positions of increasing responsibility, culminating in the role of Senior Vice President, Research prior to the company’s acquisition by Capsugel and, subsequently, Lonza.

Dr. Fakhrul Ahsan is a University Distinguished Professor in the Department of Pharmaceutical and Biomedical Sciences at the California Northstate University College of Pharmacy (CNUCOP), Elk Grove, CA. Before joining CNUCOP in late 2020, Dr. Ahsan served as University Distinguished Professor and Director Graduate Studies at Texas Tech University Health Sciences Center School of Pharmacy in Amarillo, Texas (TTUHSC SOP), wherein he served at the faculty for 19 years. A pharmacist by training, he earned his pharmacy degree from the University of Dhaka in Bangladesh and received his Ph.D. in Pharmaceutics from Complutense University of Madrid. Dr. Ahsan’s research revolves around the development of novel formulations for the pulmonary delivery of small- and large-molecular-weight therapeutic agents for the treatment of pulmonary hypertension. He has also been deploying microfluidic chips for understanding the PAH pathophysiology and developing diagnostic markers for PAH. His research also involves 3D printing for customized dosage forms. He is a member of the Editorial Boards of the European Journal of Pharmaceutical Sciences and the Journal of Pharmacy and Pharmaceutical Sciences and was an Associate Editor of the Journal of Drug Targeting. Dr. Ahsan is an NIH-funded investigator and has been continuously funded since 2010. He also serves at various national level review panels of NIH and DoD.

Helen has over 15 years of formulation and product development experience within in pharmaceutical, biotech and agronomical industries. She has expertise in the formulation of poorly soluble and bioavailable, amorphous, and physically and chemically labile compounds. Prior to her role at Quotient Sciences, Helen managed numerous formulation development, plant scale up and R&D endeavours across multiple industries.

Dr. Karthik Vaideeswaran is an Associate Vice President of R&D in the Delivery, Device and Connected Solutions organization of Eli Lilly and Company. He leads an integrated science, technology and commercialization team comprising of surface, analytical and polymer scientists, biomedical, materials, mechanical and chemical engineers as well as experienced project management professionals who collaborate internally/externally to (a) develop and deliver the container closure systems and delivery device solutions for all the molecules in the Eli Lilly product portfolio, (b) pursue next-generation delivery device platforms for Lilly’s emerging delivery & device needs and (c) probe and understand the science & physiology of drug delivery and the underlying surface & interface phenomenon at a mechanistic level.

Dr. Steve Rumbelow, Croda’s Life Sciences Research Fellow, is responsible for developing partnerships and collaborations between the R&D team and external organizations, both in academia, research institutes and customers.  Prior to that he developed and managed the US Health Care R&D team, generating new high purity excipients and supporting performance claims data, specifically for the pharmaceutical and animal care industries. 

Graduating from Leeds University with a PhD in 1982, Dr. Rumbelow started his career in the food and fine chemical industries, developing his skills in analytical chemistry ranging from trace analysis through to polymer characterization, during which he has worked with a combination of conventional and novel separation techniques to resolve complex problems.  Starting his career with Cadbury Schweppes in the UK, Steve joined ICI in 1995 before moving to the US division of Uniqema 1999 before joining the R&D team in Croda in 2007. Dr. Rumbelow has authored more than 40 scientific presentations, posters and articles and has been involved on several industry specific and technique-based groups and expert panels.

Giulio is the primary inventor of Cytimmune’s technologies. He left the company at the end of 2015, but returned in 2020 to lead Cytimmune’s R&D and manufacturing efforts. Giulio has won multiple National Institute of Standards and Technology (NIST) and Small Business Innovation Research grants for his work. He has also led product development for at least three therapeutics that have entered, or are preparing to enter clinical trials.

Dr. Panmai is currently working at WuXi STA as Vice President and Head of Early-phase Formulation Development, where he has been since 2017. He leads the formulation teams in Shanghai and Wuxi city, China, which are responsible for formulation development and clinical trial materials of new chemical entities from global clients (US, Europe and Asia).

Prior to joining WuXi STA, he worked at MSD in the US (PA/NJ) for 18 years in the Pharmaceutical Sciences group. He has extensive experience in formulation development and material characterization.

Dr. Panmai obtained his B.S. in Chemical Engineering from the University of California at Berkeley and Ph.D. in Chemical Engineering from Princeton University.

WuXi STA, a subsidiary of WuXi AppTec, is a leading CRDMO providing integrated CMC services including both API and drug product for small molecule, oligonucleotide, peptide and complex conjugate from discovery to development and commercial manufacturing.

WuXi STA has 13 R&D and manufacturing sites across Asia, North America and Europe. Our comprehensive drug product platform has a strong R&D team of 1200+ scientists with capabilities in broad oral and parenteral dosage forms. Our bioavailability enhancement technology platform includes spray-dried dispersion, hot melt extrusion, nano suspension, softgel & liquid filled hard capsules.

Keeth Jain is an Associate Director within the MS&T group at Generation Bio, Cambridge MA. In his current role, he is responsible for CMC development and manufacturing of innovative cell-targeted lipid nanoparticles-based drug product to create a new class of gene therapy utilizing a proprietary non-viral platform to provide durable, redosable treatments for patients living with rare and prevalent diseases. Prior to joining Generation Bio in 2021, Keeth worked at Shire and Takeda assuming different roles and was responsible for drug product development of multiple products across different modalities. Keeth earned his MS in Pharmaceutical Sciences from Northeastern University, Boston, MA.

PhD in human biology from the University of Marburg, Germany and a Master of Science (MS) in nutritional sciences form the University of Arizona, USA. 10+ years of experience in the medical device, pharmaceutical & in-vitro diagnostics industries (e.g. Alere – now Abbott, Siemens Healthineers) - in areas such as global business development, sales, key account management & marketing. Current position as international business development & sales manager at Gerresheimer AG for on-body drug delivery devices & autoinjectors for subcutaneous injection.

Dr. Nguyen Huu devised formulations for ocular drug delivery and studied mechanisms of age-related eye disorders during his time at the University of California, San Diego. He has extensive expertise in nanoparticle drug product optimization and development, as well as upstream and downstream workflows. Dr. Nguyen Huu currently serves as a Senior Field Application Scientist for Precision Nanosystems.

Jerzy Wojcik is currently the VP of Regulatory and Quality Services at EdgeOne Medical Inc. where he has provided quality and regulatory consultation using over 24 years of experience in medical device and combination product development.  Prior to EdgeOne Medical, he has held numerous leadership roles in regulatory and quality roles at BioLife Plasma, Baxter Healthcare, Avery Dennison, and has consulted for Delloite & Touche.  His experience ranges across more than 60 FDA product regulations of devices and includes product classifications Class I, II and III in US.  Jerzy has volunteered as a mentor on quality and regulatory topics to startup companies through Chicago Innovation Mentors and was previously an Adjunct Professor at Northwestern School of Law on Regulation of Medicine and Health.

Beth Negash is a Scientist III in the Solid Oral Formulation Development group at Catalent in San Diego, California. In this role, she largely focuses on pre-clinical to early phase drug product development of new molecules, often utilizing enabling technologies such as spray drying, as well as API sparing development tools including compaction simulation, to find solutions to various formulation and process challenges. She has over 7 years of experience in the pharmaceutical industry working on analytical, formulation, and process development. She holds a bachelor’s in chemistry from Jackson State University in Jackson, Mississippi, and a masters in chemical engineering from Purdue University in West Lafayette, Indiana.

Dr. Daniel Joseph Price leads the solid formulation excipients business of MilliporeSigma. Daniel and his team develop new products and technologies to be used in oral solid dosage forms. Prior to his transition to business and marketing, Daniel was a Marie Curie Fellow conducting research on solubility enhancement in drug formulation and has published extensively on the topic in peer reviewed journals. Daniel has Bachelor and master’s degrees in chemistry from the University of Leeds and a Ph.D. in pharmaceutical technology from Frankfurt Goethe University.

Lisa Caralli is Senior Director of Scientific Advisory at Catalent overseeing small molecule support for North America. She has over 30 years of industry experience in pharmaceutical research and development, with a focus on early phase approaches to the chemistry manufacturing and control of small molecules and peptides. Lisa has held previous product development positions at Ionis Pharmaceuticals, Amylin Pharmaceuticals and the Immune Response Corporation and holds a B.S. in Biochemistry from the University of California at Davis.

Dr. Ip is currently the Client Learning & Scientific Content Manager at Precision Nanosystems and has been serving in technical communication and training roles in PNI's commercial team since 2015. He combines his multidisciplinary background with an aptitude for communication to convey complex concepts to diverse audiences through various media. In his postdoctoral and doctoral research, he developed hybrid bio/inorganic nanomaterials for diagnostics applications. He has earned a Ph.D. in Chemistry and a B.A.Sc. in Engineering Science from the University of Toronto.

Harshal is part of our global medical division based out of Boston, with more than a decade of experience in medical device development, product life cycle strategy, and innovation management. He has significant expertise in oncology patient journey, economics of cancer care and innovations in oncology. He has a Bachelor of Mechanical Engineering degree from Nirma Institute of Technology in India, an MBA from Syracuse University, New York, and he recently completed a post graduate program in cancer biology and therapeutics development from Harvard Medical School.

Feng Zhang is an Associate Professor of Molecular Pharmaceutics and Drug Delivery at The University of Texas at Austin. Feng received his Ph.D. in Pharmaceutical Science at the University of Texas at Austin in 1999. He worked at PharmaForm and Gilead Sciences, prior to joining the College of Pharmacy at the University of Texas at Austin in Jan 2014.

His research interests include (1) formulation, processing, and characterization of melt-extruded long-acting implants, (2) investigation of process-induced transformation of API during twin-screw continuous granulation, and (3) simulation and modeling of melt extrusion for preparing amorphous solid dispersions to enhance bioavailability of BCS Class 2 and 4 drugs.

Feng has published over 80 papers in peer reviewed journals, supervised 6 students to their Ph.D. degree, and mentored 2 post-doc. He is the inventor of 15 patents.

Dr. Pedro Valente is the Director of Oral Drug Product Development at Hovione R&D specializing in formulation, particle engineering and process development of pharmaceutical drug products for oral delivery. Prior to joining Hovione as an R&D scientist in 2015, Pedro worked as an aero-thermodynamics engineer at Volvo Aero Corp. in Sweden (now GKN aerospace) and later on was an invited Lecturer and Researcher at the University of Lisbon covering the areas of Fluid Mechanics and Turbulence. Pedro Valente holds a Ph.D. from Imperial College London (U.K.) in Aeronautics and MScs from the U. Lisbon, Portugal (Mech. Eng.) and from Chalmers Technical University, Sweden (Fluid Dynamics and Turbulence).

Dr. Christopher P Worrall joined Nanoform as the Vice President of US Business Development in May 2021.  He is an expert in the area of crystallization and physicochemical modification, having spent the last 14 years specializing in the pharmaceutical solid form, including 13 years with Pharmorphix.  Dr. Worrall has been involved in the development of 7 commercial pharmaceutical products and is an inventor on numerous patents in the areas of liquid crystals, organic semi-conductors, and pharmaceutical solid form.  Prior to 2008, he held positions at SAFC and Merck KGaA focusing on developing organic syntheses for GMP production of active pharmaceutical ingredients and display materials.  He earned his PhD in synthetic organic chemistry from the University of Manchester, UK, and has multiple publications in the areas of atropisomerism and enantioselective synthesis.