Controlled Release Society Indian Chapter organises
17th International Symposium on
Advances in Technology and Business Potential of New Drug Delivery Systems
Date: 1st & 2nd February, 2019
Venue: The Lalit, Sahar Airport Road,
Andheri (East), Mumbai 400059
Univ. Prof. Institute of Pharmacy, University of Innsbruck, Austria Chief Scientific Officer, ThioMatrix GmbH, Austria.
Associate Vice President, Ferring Controlled Therapeutics and External Technology, Scotland, UK
FRSC, FMASc, Alexander Von Humboldt Experienced Fellow. Professor, MAEER's Maharashtra Institute of Pharmacy, MIT Campus, Kothrud, Pune. Co-founder and Chief Scientific Officer, Actorius Innovations and Research (AIR), Pune, India.
Professor at Saarland University & Cofounder & Head, Department "Drug Delivery", Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Germany
Showalter Distinguished Professor of Biomedical Engineering, Purdue University, U.S.A.
Senior Lecturer and Director of the Buchanan Ocular Therapeutics Unit, Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand
Group Leader Nanomedicines and Translational Drug Delivery group, Institute of Biomedical Engineering/Institute for Investigation and Innovation in Health (INEB/i3S) and Assistant Professor at IUCS/CESPU, University of Porto,Portugal
Lead Investigator, Biopharmaceutics Department, Biocon Bristol-Myers Squibb R&D Centre (BBRC), Syngene International Ltd., Bengaluru, India
Senior Director, Translational Medicine and Clinical Pharmacology at Daiichi Sankyo, Pharma Development, Greater New York City Area, USA
Research Professor, Strathclyde Institute of Pharmacy & Biomedical Sciences, Glasgow, UK
Dr. Andreas Bernkop-Schnürch - Univ.-Prof. Institute of Pharmacy, University of Innsbruck, Austria Chief Scientific Officer, ThioMatrix GmbH, Austria
Since their introduction in the pharmaceutical arena thiolated polymers – designated thiomers - have attracted and inspired pharmaceutical scientists by their versatile properties. Due to the immobilization of thiol groups on well-established polymeric excipients such as alginate and chitosan various properties including mucoadhesive, in situ gelling, release controlling, permeation enhancing and efflux pump inhibiting properties are improved. The capability to form disulfide bonds within their structure, with mucus or tissues render them unique among biomaterials. These unique features of thiomers resulted in over ten clinical trials and numerous product developments so far. Due to their mucoadhesive properties thiomers can prolong the residence time of various types of drug delivery systems on mucosal membranes. As a consequence the local therapeutic effect of drugs can be prolonged. Thiolated alginate was used as coating material to enhance the mucoadhesive and drug release controlling properties for an intraoral metformin formulation for the management of periodontitis. Clinical studies on 20 subjects with this formulation indicated improvement of all clinical parameters post treatment. Furthermore, clinical studies focusing on the potential of polyacrylates to prolong the ocular residence time of a model drug showed a constant drug level in the lacrimal fluid over 8 hours with thiolated polyacrylic acid, whereas the corresponding non-thiolated polymer showed a rapid drug release and elimination already within the first hour. In another clinical trial mucoadhesive nanofibre mats with thiolated chitosan containing antimicrobial ingredients were shown to be higher mucoadhesive than the corresponding unmodified chitosan formulations. Furthermore, the potential of thiolated chitosan in treatment of dry eye syndrome was shown in various clinical trials. First product developments on thiolated chitosan such as Lacrimera® demonstrated that single-dose instillation for several days improves signs and symptoms in patients affected from dry eye disease from a variety of causes, who were refractory to standard treatment with lubricants. Thiolated hyaluronic acid was used as intraocular implant in patients with primary open angle glaucoma in a phase 1 study. As thiolated polymers exhibit biocompatibility, cellular mimicking properties and efficiently support proliferation and differentiation of various cell types, they are also used as scaffolds for tissue engineering. Furthermore thiolated polymers such as thiolated hyaluronic acid and thiolated chitosan were shown to exhibit wound healing properties. First products such as Hystem® (thiol-modified hyaluronan), Glycosil® (thiol-modified hyaluronan) and Gelin-S® (thiol-modified gelatin) have already entered the global market. All these clinical trials demonstrate the potential and safety of thiomers both as excipients for drug delivery and as active pharmaceutical ingredients. They are a helpful guidance for numerous further product developments based on thiomers.
Dr. Claus – Michael Lehr Claus-Michael Lehr, Professor at Saarland University & Cofounder & Head, Department “Drug Delivery”, Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Germany
The development of urgently needed novel anti-infectives is much limited by the difficult access to their site of action. While the receptors for most other drugs are located on the cell membrane and thus readily accessible for molecules from the blood plasma, anti-infective drugs often need to overcome some additional biological barriers.
In the context of pulmonary drug delivery, we recently succeed to establish the first human (hAELVi) and murin (mAELVi) alveolar epithelial lentivirus immortalized cell lines with AT-I like properies, which are now also commercially available.
Dr Ilva Rupenthal, Director at Large, CRS Inc., USA Senior Lecturer and Director of the Buchanan Ocular Therapeutics Unit, Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand
While the eye is readily accessible from the outside of the body, it is a rather isolated organ with a number of barriers and elimination mechanisms in place to protect it from the environment, rendering efficient drug delivery to the ocular tissues difficult. Various pharmaceutical strategies, such as novel formulations and physical force-based techniques, have been investigated over the years to transport therapeutic agents effectively to both the anterior and the posterior segments of the eye.
This presentation will give an overview of the research performed within the Buchanan Ocular Therapeutics Unit including the investigation of novel therapeutics and innovative drug delivery systems for the management of dry eye, uveitis, diabetic retinopathy and age-related macular degeneration. Topics will include specific tissue targeting approaches using cell penetrating peptides and coated nanoparticles, the use of physical forces such as ultrasound to overcome the physiological barriers as well as a number of in vitro, ex vivo and in vivo models to adequately test such systems.
Dr. Vijay Vashi Senior Director, Translational Medicine and Clinical Pharmacology at Daiichi Sankyo, Pharma Development, Greater New York City Area, USA
A broad overview of the role of Translational Medicine in drug development will be presented and will include the key role that biomarkers play in developing a target product profile and clinical strategy. Two specific examples of compounds that utilize these approaches will be presented. Key approaches and data from one compound currently in early clinical development specifically in the cardiovascular (CV) therapeutic area with a focus on thrombosis will be presented. The presentation on the CV compound will focus on the key drug development considerations especially related to potential biomarkers identified during the pre-clinical discovery stage that were then incorporated into the clinical drug development paradigm. PK, PD and safety results from the early clinical studies will illustrate the utility or the lack thereof of the biomarkers (identified in discovery) in clinical development decision making especially for studies leading to proof of concept in target patients. This specific example will also detail some of the biopharmaceutic considerations-specifically the utilization of i.v., oral and/or modified release dosage forms that then are evaluated as part of the clinical development program and become part of decision making on patient dosing regimens. A second example relates to a nephrology compound and will illustrate the importance of translating biomarkers identified in the discovery stage into the clinical development of the drug trials
Prof Clive Wilson Research Professor, Strathclyde Institute of Pharmacy & Biomedical Sciences, Glasgow, United Kingdom
Abstract Awaited...
Dr. Janet Halliday - Key Note Speaker Associate Vice President, Ferring Controlled Therapeutics and External Technology, Scotland, United Kingdom
Drug delivery technologies are developed to improve treatments for patients. Technology innovation can spring from academic and commercial innovation. However good the science is, it is only of value for the business if it can be translated into successful products.
Ferring has successfully developed drug delivery science into products to Help Patients Live Healthy Lives in the fields of Women’s Health, Reproductive Medicine, Urology and Gastroenterology. Examples will be shared of polymer controlled release PROPESS® vaginal system, long acting topical TESTAVAN® gel and bowel cleanser CLENPIQ® solution.
Ferring and other organisations continue to work on bringing new technologies closer to the market in on-going clinical trials. The international rules for clinical study publication allows these novel technology approaches to be shared with the scientific community at large. Examples will be shared of prolonged vaginal delivery, sustained release injectables and orally administered peptide. This provides global awareness of where science does meet business needs.
Dr. Jayant Khandare, FRSC, FMASc, Alexander Von Humboldt Experienced Fellow. Professor, MAEER's Maharashtra Institute of Pharmacy, MIT Campus, Kothrud, Pune. Co-founder and Chief Scientific Officer, Actorius Innovations and Research (AIR), Pune, India.
The talk will highlight the ‘seed and soil theory’ of cancer metastasis, detection, and enumeration of circulating tumor cells (CTC) from cancer patients blood . The detection and enumeration of CTCs offer the utility with respect to prognosis in epithelial origin cancers, example, breast, colorectal, head and neck, and prostate cancers etc. The CTC analysis is highly implicated for the detection of early-stage metastasis with prognostics value, monitoring relapse, and in personalized cancer therapy. CTC monitoring is a non-invasive ‘real-time liquid biopsy’. Enumeration of CTCs sustain immense challenge in their capture due to low abundance in the peripheral blood (1 CTC per million other blood cells). CellSearch technology was clinically developed and approved by USFDA. This technology is an unmet need in India and is prohibitively expensive for many cancer patients especially for lower economic strata of society. The talk will detail ‘OncoDiscover’ platform consisting magneto-polymeric nanosystem. The talk will feature- CTC enumeration and imaging of cancer cells using clinical blood samples for monitoring disease progression. OncoDiscover, technology has been clinically validated with regulatory permissions in India. OncoDiscover ‘Liquid Biopsy Technology’ is set to be available with affordability for overall survival monitoring to cancer patients in India.
Prof. Kinam Park – Key Note Speaker Prof of Pharmaceutics & Showalter Distinguished Prof of Biomedical Engineering, Purdue University & Founder & President Akina Inc., USA
The modern drug delivery technology is only 60 years old. During the first 30 years many breakthrough formulations were developed helping patients deal with various diseases effectively. The progress in the last few decades, however, has been slow, and many important drug delivery problems have not been resolved. The field has been overwhelmed by nanotechnology, nanomedicine, and many nano-sized drug delivery systems. The drug delivery field is at the strategic inflection point, and it is time for us to find new ways of developing effective drug delivery systems. The future of this field depends on nurturing talented young scientists with purpose, passion, and the conviction of doing meaningful science. The progress will be accelerated, if all of us achieve enlightened mindset embracing paradoxes and diverse ideas.
Prof. Bruno Sarmento Group Leader Nanomedicines and Translational Drug Delivery group, Institute of Biomedical Engineering/Institute for Investigation and Innovation in Health (INEB/i3S) and Assistant Professor at IUCS/CESPU, University of Porto, Portugal
In drug delivery field, bioavailability and specificity are key challenges in the establishment of advanced products. Nanoparticles have been proposed by our group as valid approaches to provide successful systems to deliver drugs to their site of action. Besides the proper control of nanoparticle matrix to provide a suitable release of drug payload, the surface of nanoparticles has a major impact on the interaction with biological barriers and cell membranes. We have studied thoroughly the interaction of nanoparticles with cells and mucus regarding their adhesive properties that modulates their mucoadhesive behaviour, ultimately related with passive targeting to mucosae. Understanding how nanosystems interact with individual mucin chains and the 3D structure of mucus is paramount, as a passive functionalization of nanoparticles may concern, exploring different biomaterials as mucus-modulators. Our active targeting approach for nanoparticles has been focused on ligand molecules attached to the surface of nanoparticles to increase the probability of binding to unregulated cell membrane receptors in key local effector sites. New and less - explored receptors are being targeted in engineered nanosystems, providing enhanced local and intracellular levels of drugs, without compromise the safety of the systems. In this talk, application of nanosystems for mucosal delivery of drugs with physiological and social impact, developed in our research group, will be presented. The surface modification of nanomaterials with targeting moieties, from biological biomacromolecules to biopolymers, has been successfully attained.
Dr. Ajay Saxena Lead Investigator, Biopharmaceutics Department, Biocon Bristol-Myers Squibb R&D Centre (BBRC), Syngene International Ltd., Bengaluru, India
Modified release formulations have been traditionally developed on the basis of targeted PK profile and deconvoluted in vitro drug release profile, overlooking the physiological hurdles faced by the product. Focus is shifting in utilizing an integrated in vitro (microdissolution), in silico (GastroPlus™ simulation) and in vivo (pre-clinical and clinical) approach to understand the underlining physiological challenges. This presentation will unveil Biopharmaceutics approach in providing a scientific rationale to design a modified release formulation targeting a robust clinical performance.
We invite you to attend and participate in India’s largest gathering of drug delivery scientists!
A unique opportunity to meet and listen to the leading scientists of the world in person, to hear of the latest advances in the science of drug delivery from the inventors and innovators themselves and develop partnerships & collaborations!
Interact with energetic and enthusiastic young researchers and scholars who present their innovative ideas, often with unique protocols, for frugal product development!
| Platinum Sponsorship | Gold Sponsorship | Technology Showcase | Table Exhibit (per day) |
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| INR 5,00,000/- | INR 3,50,000/- | INR 2,00,000/- | Day1 INR 1,50,000/- Day2 INR 1,00,000/- |