Mr Mark DeStefano is the Director, Combination Products and Devices Research and Development for Teva Pharmaceuticals focusing on advanced technology identification and development for Teva pipeline and platform combination products. He is an experienced Device Development Professional with a demonstrated 32 yr. history of product innovation, design, development, and launch in many areas of the medical device industry from surgical devices to drug delivery devices and is the inventor / co-inventor on over 25 medical device patents. Mr DeStefano has spent the last 23 years in drug delivery device development, including 13 years in the development of insulin pumps and infusion sets for Type 1 Diabetes and 10 years in the development of injection devices for parenteral drugs. Mr DeStefano holds a Bachelor of Science in Mechanical Engineering from Drexel University.

Nick DiFranco, MEM, is the Global Market Segment Manager for Oral Drug Delivery and Novel Excipients at Lubrizol Life Science. 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.

Dr Anil Diwan is President & Executive Chairman of NanoViricides, Inc, a public company (NYSE-Amer.: NNVC; co-founded 2005). He co-invented a bio-mimetic drug delivery platform, nanoviricides™ polymeric micelles, enabling site-specific targeting, multi-point attack, & encapsulation. Orally available nanoviricide drug NV-CoV-2 is in Phase 1 for COVID and has shown strong pre-clinical efficacy in COVID and RSV, attesting to its broad-spectrum, reminiscent of antibiotics. Nanoviricides define a new paradigm “Re- Infection Inhibition,” going beyond antibodies and small chemicals. The platform further enables cures of viral infections by encapsulating orthogonal APIs ex: Remdesivir, Ribavirin, Cidofovir, etc. Dr Diwan was instrumental in designing and establishing the NanoViricides campus in Shelton that comprises R&D to Clinical Trial Drug Product Manufacturing facility of our nanomedicines. Dr. Diwan holds a PhD, (Bio)Chemical Engineering, Rice University and a BTech, Chemical Engineering, Indian Institute of Technology, Bombay (IITB).

With over 20 years of experience, Ryan leads the Small Molecule and Biologics Chemistry, Manufacturing, and Controls (CMC), Sterilization Engineering, Lab Operations, and Analytical Services Practice Areas for Kymanox. He is a seasoned, strategic leader in the areas of CMC Regulatory and Pharmaceutical Development.

Ryan’s expertise includes program and portfolio management, global CMC regulatory requirements and strategy, CDMO/CMO selection and management, product development (including formulation, process, and analytical), technology transfer (pre- and post-approval), and clinical supply manufacturing and distribution. He has a passion for identifying, developing, and delivering practical and innovative solutions for complex, non-conventional product formulations and drug delivery systems throughout a product’s lifecycle. Ryan also has extensive experience in the areas of Quality Operations and Management for manufacturing, release, and distribution of pharmaceutical, biologics, and combination products.

Before joining Kymanox, Ryan worked at Novan, GSK, Stiefel, and DSM Pharmaceuticals. Ryan holds a Bachelor of Science in Biochemistry from East Carolina University.

Dr. Duong has 15 years’ experience performing polymer and lipid nano/microparticle drug delivery research and experience building agile biomedical research teams with competitive intellectual property strategies. He has authored six peer-reviewed publications on nanoparticle delivery vehicles and coauthored a book chapter on nanoparticles for nucleic acid delivery. In the last year, he has led his teams to file >25 inventions in genomic technology and named on 13 patents, four have been granted.

He has authored multiple peer-reviewed publications for use of nanoparticles for vaccine applications including subunit vaccines, and host-cell directed therapeutics with mammalian cell and mouse models. His experiences in academia and industry have enabled a unique understanding of nanoscience combined with knowledge of patent landscape to form competitive intellectual property strategies.

At Battelle, he has served five years on leadership councils, three years on emerging scientists and engineering council, two years on the Technical Council advising leadership, driving growth strategy, and contributed to 10+ R&D programs, both as a researcher and an advisor.

Jason Durkin is the Vice President of Supply Chain at Windgap Medical having worked in the combination product industry for nearly 30 years. With experience in both injection and inhalation products, Mr Durkin has spent his entire career bringing life changing technologies to patients in need.

As Chief Operating Officer of R&D and Cofounder of Pendant Biosciences, Dr Elmquist is transforming the way the pharma market uses polymers (starting with whether they’re using them at all). He received his PhD in Chemistry at Vanderbilt University, where his research focused on oligonucleotide synthesis containing site-specific food mutagens. He continued his cancer research as a Postdoctoral Fellow at MIT in the Department of Biological Engineering where his research focused on the role of inflammation and endogenous DNA damage as drivers of carcinogenesis and age-related diseases. He currently holds a seat on the board of BioTN Foundation, Tennessee’s leading non-profit focused on STEM in education, workforce development, and entrepreneurship. He previously held a scientist role at BioMimetic Therapeutics developing therapeutic products with platelet-derived growth factor, followed by a Business Development Role at the Cool Springs Life Sciences Center.

Rick Fitch, PhD is the Senior Director Nonclinical Research and Development at Xeris Pharmaceuticals, Inc. He has worked in the pharmaceutical industry for over 25 years in the areas of pharmacology and toxicology and for over 10 years in the development of novel drug delivery technologies such as nanoparticles and XeriJect. Dr Fitch has a PhD in Physiology from the University of California at Davis.

Matthew Fordham has more than 10 years’ experience developing products for a wide range of markets; from industrial machinery and consumer electricals to wound care and diagnostics devices and sterile injectables. Over the past 5 years, he has focused exclusively on developing products in the medical and healthcare space. Mr Fordham has led major projects in wound care and parenteral drug delivery for some of the global leaders in the medical device and pharmaceutical industries; including mechanical development from concept to clinical trial units for a negative pressure wound care device, design and development of a novel pen injector platform mechanism and device, execution of design verification testing of an autoinjector platform device, design and development of a novel orally administered drug delivery device. Mr Fordham has a master’s degree in aerospace engineering, specializing in the aerodynamics of subsonic, sonic and hypersonic airflows within the context of aircraft, spacecraft and wind energy systems. After graduating, he spent several years training other engineers to design effectively, using 3D CAD systems and computational numerical modeling systems. He is a keen sportsman and fitness enthusiast, which parallels his passion for developing products in the medical, healthcare and wellbeing markets.

Reenal Gandhi is Global Business Development Director within Aptar Pharma’s Prescription division, where she is responsible for driving the assessment of potential new opportunities, with a specific focus on new technologies. Ms Gandhi has over 15 years’ experience in both the drug delivery device and pharma industries, developing and commercializing drug delivery solutions for biotech, vaccines and pharma. Throughout her career, Ms Gandhi has been active in business development activities related to nasal devices and injectable devices such as pre-filled syringes and autoinjectors. Her interest lies in developing combination products with drug delivery devices, balancing formulation, technology, and commercial potential. Before joining Aptar Pharma in 2020, Ms Gandhi worked for drug delivery device company and global pharma/Rx company with a focus on licensing and acquisition of innovative and generic products.

Sudhakar Garad, PhD, received his PhD from the Bombay College of Pharmacy, University of Mumbai, India in 1998 in Pharmaceutical Drug Delivery Technology with Dr M S Nagarsenker. Soon after completion of his PhD, he worked with Pfizer, India for less than a year in clinical research. Taking into consideration his excellent credentials during his PhD, he was selected as a postdoctoral fellow at the University of Connecticut to understand micro-environmental properties above dissolving surface of the polymers with Dr Robin Bogner. After his post-doctoral fellowship, Dr Garad worked with Vertex Pharmaceuticals for a period of three years as Senior Investigator in the formulation development group. After Vertex, he joined Novartis as a Group Head. Dr Garad worked with Novartis for 9 years and joined as a Director of formulation development at Cubist Pharmaceuticals/Merck for 2.5 years. Currently Dr Garad is working as a Global head of Chemical and Pharmaceutical profiling (Discovery Pharmaceutics/Novel Drug Delivery) and Disease Area Head (New Indications) at Novartis. His primary role is to collaborate with research colleagues and build the right biopharmaceutical properties into new chemical entities, if not enable them via solubility/dissolution enhancement technologies to expedite molecules into tox and clinical studies. He is also responsible for enabling research, clinical and commercial molecules via novel delivery technologies (Brain targeting, permeability enhancement, TI improvement etc). He has many publications, book chapters and patents. In last 20 years of his career he has taken more than 200 new chemical entities in clinical studies across dozen disease areas ( CVM, Oncology, ATI, MS, Respiratory, NS, GI, Antibacterial, Tropical diseases, HCV etc), via oral, parenteral, inhalation and transdermal route of administration.