16^th World Drug Delivery Summit September 06-07, 2023 London, UK

University of Chinese Academy of Sciences,China

Drug Delivery and Therapeutics

Faculty of Pharmacy, Pharmaceutical Technology Department Ege University Izmir

Pharmaceutical Technology

Kitty (Krithika) Rajagopalan, B.S (Pharm), MS, PhD is a visionary leader with over 23 years of operational experience in building and leading Global & US Health Economics, Pricing, Policy and Market Access function across drugs, devices, and biologics? industry. Her cross-therapeutic area Health Economics & Outcomes Research (HEOR) leadership expertise spans a wide spectrum of diseases and conditions including but not limited to psychiatry, neurology, oncology, cardio-pulmonary, respiratory, auto-immune and other rare diseases. She owns multiple copyrights for patient reported outcomes instruments and has published over 80+ manuscripts in peer-reviewed journals. She also has presented over 600 scientific papers at meetings and is an invited speaker at DIA, ISPOR and other forums on health care topics as diverse as global reimbursement, HEOR methodologies, Patient Reported Outcomes in Clinical trials, public policy issues with the emergence of ACOs and expanded role of HEOR. Her global experience also includes successful interactions and negotiations with FDA, EMA (Global Healthcare Regulatory) and payor (US and Ex-US) bodies in securing PRO label claims, and successful market access through the development of credible scientific evidence to support reimbursement guidance and health care decision-making. Kitty?s global geographic experience span includes US, Canada, Australia, Europe (including UK), Latin America and Asia, with specific emphasis on BRIC (Brazil, Russia, India, and China) Nations. Some of her notable successes include: First in class QoL and PRO label claims; Medicare ?New technology/pass-through reimbursement?; Positive reimbursement guidance from NICE, PBAC, other HTA bodies and US Public/Private payors and enabling device-related reimbursement legislation changes in Brazil.

Pharmaceuticals

Ashim K. Mitra received his Ph.D. in Pharmaceutical Chemistry in 1983 from the University of Kansas. He joined the University of Missouri-Kansas City in 1994 as Chairman of Pharmaceutical Sciences. He is also Vice Provost for Interdisciplinary Research, UM Curators? Professor of Pharmacy, Co-Director, Vision Research Center UMKC School of Medicine. He has 30+ years of experience in the field of ocular drug delivery and disposition. He authored and co-authored over 355 refereed articles, 67 book chapters in the area of formulation development and ocular drug delivery, 10 patents, and presented (along with his research group) well over 710+ presentations/abstracts at national and international scientific meetings. This work has attracted over six million dollars in funding from government agencies such (NIH) National Institutes of Health, (DOD) Department of Defense (DOD) and pharmaceutical companies.

My research interest includes ocular delivery system, transporter/receptor specific ligand based delivery to viral reservoir sites particularly the eye and brain. The brain parenchymal cells are protected by highly impermeable capillary cells (blood brain barrier). Similarly, the ocular blood vessels in the retinal choroid (blood retinal barrier) and the anterior segment-aqueous humor (blood-aqueous barrier) are barriers to drug delivery to the eye. Research interest can be categorized into two main areas: delivery and targeting of antiviral agents and development of noninvasive delivery systems for peptides and protein; serves on several National Institutes of Health Study Sections including AIDS and Related Research; editor of a book on "Ophthalmic Drug Delivery Systems" and a journal series on "Advanced Drug Delivery Reviews. In the area of antiviral drug delivery and targeting, work is in progress relative to retinal drug transport, metabolism and targeting of anticytomegalorivus agents like ganciclovir, cidofovir and foscarnet. A new ocular microdialysis technique has been employed for continuous vitreal sampling. Research is also being conducted to improved oral absorption of anti-AIDS agents like cosalane through prodrug modification. The other major research area of interest is the noninvasive delivery of peptides and proteins like calcitonin, insulin, human growth hormone, fibroblast growth factors pulmonary, nasal and buccal routes of delivery are being investigated. Poor mucosal permeability and rapid protease mediated degradation are the two major barriers to protein delivery. Prodrug modification, protease inhibition and various other approaches have been taken to improve protein absorption. Major area of research interest is to develop semi-invasive controlled delivery system for the treatment of posterior segment ocular diseases. Novel tailor-made pentablock (PB) copolymers have been developed and evaluated for the controlled delivery of macromolecules to back of the eye tissues (retina-choroid). PB copolymers were synthesized utilizing various FDA approved biodegradable and biocompatible polymer blocks (polyglycolide, polyethylene glycol, polylactide and polycaprolactone). Various PB copolymers have been optimized with respect to molecular weight and ratios of each block in order to successfully develop a macromolecular (lysozyme, BSA, IgG, and IgG Fab) drug delivery system. A comprehensive drug delivery systems comprising drug-loaded nanoparticles dispersed in thermosensitive gel have been investigated to achieve continuous zero order drug release at the target tissues (retina-choroid). Another major area of research interest is developing topical formulations (eye drops) that enable non-invasive delivery of drugs to back of the eye tissues (retina-choroid) with no/minimal systemic exposure. Drug loaded nanomicellar constructs are prepared with FDA approved polymers for ocular use. Nanomicellar constructs of hydrophobic drugs such as voclosporine, dexamethasone, rapamycin and others are being extensively studied and evaluated as potential drug carrier systems for retinal delivery. Nanomicelles aid to improve drug ocular permeability and deliver therapeutic levels of drug to back of the eye tissues. Research is being extensively conducted to improve posterior ocular drug bioavailability with nanomicelles as vehicles in a patient acceptable route of drug administration i.e. topical drop. This technology is expected to replace the current existing invasive, expensive and patient non-compliant route of drug administration methods (intravitreal and periocular injection, an injection into the eye). Also, this method helps to avoid complications associated with intraocular injections. Research is being conducted to develop nanomicellar formulations for hydrophilic drug molecules (DNA, RNA, protein, peptide) to deliver them to retina-choroid in a patient compliant and non-invasive route, topical drop administration. Recently my laboratory started working on targeted drug delivery to nuclei of cancer cells to overcome drug resistance. Besides gene mutations multidrug resistance proteins (MDR) or efflux pumps are major barriers for absorptions of 70% of drugs. Both MDR proteins and metabolizing enzymes are the major drawback in successful chemotherapy. Most cancer cells overexpress these MDR proteins. Consequently cancer cells receive subtherapeutic concentration of chemotherapeutic agents. It is difficult to eradicate cancer. I am in the process of developing a novel delivery system containing drug loaded nanoclusters conjugated with NLS peptide analogues in inhaler sustained formulation. Our discovery of novel nuclear localization signal (NLS) derived peptides appear to target plasma and nucleopore membranes of cancer cells only. Native NLS peptide sequences penetrate plasma membrane and nuclear envelope of both malignant and non-malignant cells. However our modified NLS sequence will enter specifically to nuclei of cancer cells avoiding non-malignant cells. NLS peptide is a prime facilitator for transport of large cargo into nucleus. To facilitate the process, NLS sequence requires to interact with importin alpha expressed on the nucleopore complex for translocation to nuclear DNA. This adenoviral fiber protein is capable of evading endosomal degradation. Our modifications of NLS peptides have potential to deliver nanocarriers specifically into nuclei of malignant cells. NLS peptides are modified by replacing specific amino acids in the native sequence. This optimized NLS peptides are conjugated to nanoparticles (NP) containing therapeutic agents. This formulation can be delivered via an inhaler device which will be very effective due to local sustained delivery for lung cancer. The drug delivery can provide more efficacious, cost effective, noninvasive and normal cells

Abdolarahim is from Iran

Drug Delivery Systems: Smart Stimuli-responsive Nano Materials, Mesoporous Nano Silica, Polymeric carriers, Nanofibers and Microfibers, Molecular Imprinting Polymers (MIPs), Natural polymers, Nanocomposite and nanohybrides, Ionic Liquids, Clays, Organometalics (Ferrocene), Diazo compounds, Graphen and Carbo Nano Tubes.

Degree in Pharmacy - Biochemistry Specialist in Industry - 1993. PhD in Biotechnology (Anhanguera University) ? Biomarkers in Alzheimer disease - 2016 Master of Pharmacy (Anhanguera University) - Clinical Research in Alzheimer's Disease- 2009 Postgraduate degree in hospital pharmacy - 1997. Extension in Clinical Research ? São Paulo University - 2012 Hospital Pharmacy - France - 1999. Clinical Pharmacy - United States -2000. Book Author: Hospital Pharmacy Management / Publisher Senac 2006 - 4rd edition Co-author of Hospital Pharmacy Book chapter: Hospital infection - their interfaces in healthcare - 2000. Co-author of the book: "Pharmaceutical Logistics General" / Publisher Contento - 2012

Alzheimer Dementia

Nirav R Soni has completed his MPharm from Gujarat Technological University (GTU) and he has taken Postgraduate Diploma Intellectual Property Rights (PGDIPR). He got “Best Teaching Award” and he has achieved award of “Best-Student of the year” for the year 2013. Recently, he got "National Award"- PEARL Foundation, “Best Assistant Professor Award in Pharmacy” for the year 2016. Also, the “International Young Leadership Awards-2016” - TIME Cyber Media Pvt. Ltd., and the “Best Upcoming Young Researcher in Ahmedabad” for the year 2016. He cracked GPAT (Graduate Pharmacy Aptitude Test-2013, AICTE) and got stipend from the Indian government. He has research experience in the Bioanalytical department and published thesis. Also, he has published books with ISBN. He has published research, review articles and letter to the Editors in reputed international journals. He has been serving as an Editorial Board Member as well as reviewers of reputes.

Preparing and Dispensing Drugs

Associate Professor (Instructor Class-B), Biomedical Engineering Department (Served as Head of BME Dept. from 15 Nov 2014 ? 12 April 2016), Military Institute of Science & Technology (MIST)Ph.D in Biological Chemistry

for Neuro-protection and Enzymatic Synthesis 1. Structure activity relationships (SARs),Quantitative Structure?Activity Relationship, Bioavailability, Drug Delivery methods, The Properties and Design of Drugs, Vaccines is Immunization, Nanoparticles for drug delivery, Drug and Therapeutic

Dr. Kasturi Pawar is a pharmaceutics professional with Doctorate in Pharmaceutics and over 6 years of research experience in the areas of topical, transdermal oral formulation development and drug delivery, microneedles- and iontophoresis-assisted delivery, biomaterial synthesis, and analytical method development and validation using HPLC. Dr. Pawar is currently employed with Valeant Pharmaceuticals International as a Principal Research Scientist in Formulation development department. Prior to Valeant Pharmaceuticals International, Dr. Pawar has also held Lead Formulation Scientist positions in her previous jobs at Tioga Research Inc. and G&W Laboratories. She has earned her PhD from Auburn University, AL in 2013, and her Masters and Bachelors from India in 2007 and 2005, respectively. Prior to coming to USA, she was working as a Research Scientist with Sandoz Pvt. Ltd in India. Dr. Pawar has extensive experience working with challenging formulations and providing innovative ideas to troubleshoot the challenges. She has worked in collaboration with groups across the country, and authored and co-authored 6 research papers and 2 review papers, and presented her research work in 13 poster and oral presentations in the several national and international conferences. She has won several awards and honors in her career. She is currently serving as an active reviewer at the Annual National Meetings of American Association of Pharmaceutical Scientists. She is also a peer reviewer for Journal of Controlled Release, International Journal of Pharmaceutics, Journal of Pharmaceutical Sciences, Current Drug Delivery, Dove Medical Press Articles and SciTechnol articles. She serves as an editorial board member for two journals, Journal of Innovations in Applied Pharmaceutical Science and Journal of Innovations in Pharmaceuticals and Biological Sciences.

Kasturi Pawar research interests are topical/transdermal formulation development and delivery using active permeation techniques, solubility improvement of insoluble drugs, percutaneous penetration enhancement techniques, Oral solid formulation development and delivery, biomaterial synthesis, nanoparticle drug delivery and tissue engineering.

Dr. Bo Michniak-Kohn is Academically appointed as Professor of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey.

Optimization of topical, transdermal and buccal drug delivery. Development of novel permeation models and computational modeling. Design and evaluation of novel dermal penetration enhancers and retardants & their structure-activity relationships. Design and testing of novel formulations for topical and transdermal drug delivery including creams, emulsions, gels and micro-and nano-carrier systems. Treatment & therapeutics for dermatological diseases such as atopic dermatitis, melanoma and psoriasis. Physical approaches to enhancing dermal drug delivery: iontophoresis, microneedles as well as formulation optimization. Visualization of drug transport pathways in skin using Raman, Fourier Transform Infra-Red spectroscopy, electron and confocal microscopy. Development of novel human tissue cultured skin equivalents for permeability testing. Computational approaches to predicting skin transport of drugs. Optimization of buccal drug delivery. Pharmacokinetics and ADME studies in animals and humans.

Dr. Roberts is a NHMRC Senior Principal Research Fellow, Professor of Therapeutics & Pharmaceutical Science at the University of South Australia and Professor of Clinical Pharmacology & Therapeutics at The University of Queensland. He is also Director of the Therapeutics Research Centre based in the Translational Research Institute at the Princess Alexandra Hospital in Brisbane and in the Basil Hetzel Institute at The Queen Elizabeth Hospital in Adelaide.

Therapeutics and Pharamceuticals

Dr. Stinchcomb received her PhD in Pharmaceutics from University of Michigan. She completed her Post-Doctoral Fellowship (Biopharmaceutics) from University of California, San Francisco. In 2010 she was honoured with "Kentucky Entrepreneur Hall of Fame" & "Springboard Portfolio Company - All Things Life Sciences". In 2011 as AAPS Fellow.

Dr. Stinchcomb’s research is focused on transdermal prodrugs, microneedle-enhanced delivery, and translational research models for public-private partnerships.

Dr. Boudinot received his PhD. in Pharmaceutics from State University of New York in 1985. In 1979 - 1980 he worked as a Research Technician, Clinical Pharmacokinetics Laboratory at Millard Fillmore Hospital. In 1980 - 1985, He joined as Graduate Assistant, Department of Pharmaceutics, School of Pharmacy, State University of New York at Buffalo. In 1985 - 1990 He moved to University of Georgia to join as Assistant Professor of Pharmaceutics, College of Pharmacy. In 1986 - 2002 He was promoted to Faculty of Gerontology, University of Georgia Gerontology Center. From 2002 to present he was promoted to several posts such as Associate Professor, Head of Department, Associate Dean & Senior Associate Dean. He was also a part of Faculty of Interdisciplinary Graduate Program in Toxicology, University of Georgia. Currently He is the Dean of Graduate School, Virginia Commonwealth University.

Dr. Boudinot's research focuses on pharmacokinetics, biopharmaceutics, drug metabolism and pharmacodynamics in drug discovery and development. Research involves characterizing physicochemical properties of novel therapeutic agents, developing bioanalytical methodologies, conducting preclinical pharmacokinetic studies and developing pharmacokinetic models for interspecies scale up. Current work is focused on the pharmacokinetics of large molecular weight polyanionic compounds and characterization of physiological mechanisms involved in drug distribution and elimination.

Dr. Yihua Bruce Yu is an Associate professor of Pharmaceutical sciences and Bioengineering at the University of Maryland. Prior to joining the University of Maryland, he was assistant professor at the University of Utah. He received his Ph.D. in molecular biophysics from the Johns Hopkins University and conducted postdoctoral work at the University of Alberta in peptide chemistry. His current research interest includes biomaterials engineering and imaging agent development. He received the 2004 Kimmel Scholars Award for his work on imaging agent development and the 2005 Presidential Early Career Awards for Scientists and Engineers for his work on biomaterials.

Dr. Bruce Yu's research has two main thrusts: biomaterials engineering and imaging technologies. In the biomaterials area, our current focus is the link between molecular chirality and material mechanical properties, exploiting chirality to create biomaterials with novel mechanical properties for cell growth and differentiation. In the imaging area, we develop imaging agents for multi-color F-19 MRI. He is also working a MRI technology to evaluate the mechanical properties of soft materials and biological tissues.

Dr. Tahseen Mirza is an accomplished scientist and leader with over twenty years of industrial and regulatory experience in the areas of generic and branded pharmaceutical development. He holds a Ph.D. in Pharmaceutical Sciences from University of Cincinnati. In his current job, Dr. Mirza is Division Director of the FDA Office of Manufacturing and Product Quality’s (OMPQ) Division of Policy, Collaboration and Data Operations (DPCDO). Prior to joining OMPQ, Dr. Mirza was the Deputy Director of the Division of Product Quality Research (DPQR), within The Office of Pharmaceutical Science’s (OPS) Office of Testing and Research (OTR). Before joining the FDA, he was a Director in the Technical R&D department of Novartis Pharmaceutical Corp, East Hanover, NJ. During his career, Tahseen has led groups of chemists and Ph.D. level scientists in various R&D and QC/QA departments and is well versed in both early and late phase product development. He has enabled the transfer of manufacturing processes and analytical methods globally between R & D and manufacturing and contract manufacturers. He has also worked in various capacities for Sanofi Aventis, Merial/Merck and the United States Pharmacopeia. At the USP he served as a USP Liaison between FDA, industry and three USP Expert Committees; Dissolution and Bioavailability (Biopharmaceutics), Pharmaceutical Dosage Forms and Biostatistics he coordinated the efforts towards establishing sound analytical methods and compendial monograph standards. He has lectured and trained industry and FDA scientists in Manufacturing Science, Biopharmaceutics and Dissolution. He has moderated national and international conferences and workshops on variety of topics such as drug release, dissolution, QbD and PAT. Dr. Mirza has lectured and trained industry and FDA scientists in Manufacturing Science, Biopharmaceutics and Dissolution. He has co-authored more than 30 research articles. He has moderated national and international conferences and workshops on variety of topics such as drug release, dissolution, QbD and PAT. Dr. Mirza is the founding Chairman of the AAPS focus group, In Vitro Release and Dissolution.

Dr. Tahseen's interest lies in Regulatory research Projects.