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

The Speakers

Dr. Andreas Bernkop-Schnürch
Dr. Andreas Bernkop - Schnürch

Univ. Prof. Institute of Pharmacy, University of Innsbruck, Austria Chief Scientific Officer, ThioMatrix GmbH, Austria.

Dr. Hitesh Doshi
Dr. Hitesh Doshi

Vice President - R&D, Sulphur Mills Limited., India

Dr. Janet Halliday
Dr. Janet Halliday - Key Note Speaker

Associate Vice President, Ferring Controlled Therapeutics and External Technology, Scotland, UK

Dr. Jayant Khandare
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.

 
Dr. Claus – Michael Lehr
Dr. Claus – Michael Lehr

Professor at Saarland University & Cofounder & Head, Department "Drug Delivery", Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Germany

Prof. Kinam Park
Prof. Kinam Park – Key Note Speaker

Showalter Distinguished Professor of Biomedical Engineering, Purdue University, U.S.A.

Dr Ilva Rupenthal
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

Prof. Bruno Sarmento
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

 
Dr. Ajay Saxena
Dr. Ajay Saxena

Lead Investigator, Biopharmaceutics Department, Biocon Bristol-Myers Squibb R&D Centre (BBRC), Syngene International Ltd., Bengaluru, India

Prof Clive Wilson
Prof Clive Wilson

Research Professor, Strathclyde Institute of Pharmacy & Biomedical Sciences, Glasgow, UK

Abstracts of Invited Talks

Thiolated Polymers: Lessons learned from Clinical Trials


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.

Circulating Tumor Cells as 'Liquid biopsy' - Polymeric Translations from Lab to Clinic.


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.

Drug Delivery Technologies for Combatting and Preventing Infectious Diseases


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.

Ocular Drug Delivery – Eye on Innovation


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.

Biopharmaceutics Considerations in Designing Modified Release Formulation


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.

Novel Agrochemical Formulations – The Unexplored Opportunity


Dr. Hitesh Doshi, Vice President - R&D, Sulphur Mills Limited., India

The pharmaceutical industry has grown tremendously due to the research work on new drug delivery systems and their subsequent commercialization. The ease of availability of trained man power from pharmacy schools and well qualified academic staff has contributed greatly to the development of the pharmaceutical industry. Significant amount of research has been done in the field of veterinary drug delivery also.

However, the agrochemical formulation industry has lagged behind. Although there are several agricultural universities and colleges in India and abroad, there is no formal training given on developing agrochemical formulations. New product development and improvisations to existing products have been very slow. The opportunities of formulation research in the agrochemical space is immense. As a trained pharmacist one can easily use his experience in creating value added products for the agrochemical industry. The freedom to use several excipients further makes the development work all the more interesting and provides an opportunity to build intellectual property.

In the presentation, the speaker will talk about the existing agrochemical formulations, newer trends and novel drug delivery systems in the agrochemical space.

Drug Delivery - Where Science meets Business


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.

The Future of the Drug Delivery Field: Time to Make Real Changes


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.

Functionalized Nanomedicines for Mucosal and Cell-driven Recognition Drug Delivery


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.

The Gut as a Beaker


Clive G Wilson, Research Professor, Strathclyde Institute of Pharmacy and Biomedical Sciences, Glasgow, Scotland, U.K.

Not too far back in our evolution, man was a nomadic hunter-gatherer and warrior, and food was distinctly unprocessed and fibre rich. The gut had to work hard to extract nutrients from a diverse matrix and protect the body against the occasional poisons from the seeds of berries and fruits which might be ingested. For many nutrients, absorption is an active process since the products of digestion are small and polar and the nature of the epithelium is a lipoidal barrier. In contrast, drugs have almost no nutritional value but are more easily absorbed passively. Mechanisms that help us to protect ourselves from poisons have evolved: specifically taste and the vomiting reflex have to be intentionally bypassed by disguise in a formulation. All the formulation work then has to be undone in the gut in a timely fashion to achieve the anticipated drug concentration -time exposure. Most drugs in the pipeline belong to Class to of the BCS or Class IIa or IIb of the DCS and therefore have limited aqueous solubility. This can limit the rate and extent of absorption, but is strongly influenced by formulation. Moving towards a robust in vitro test to predict performance is therefore a key step in the optimisation of an oral medicine. The task we face therefore is how to make continuous measurements in a murky media, whose composition changes along the gastrointestinal tract. Within the darkness of the gut, phenomena such as disintegration, super-saturation, precipitation and dissolution are occurring in unidentified segments. The simulated biological fluids that are used in pharmaceutical sciences are evolving recipes and much research is directed towards in silico prediction through better in vitro tests.

Our research programme within the OrBiTo program, in collaboration with other European universities and major pharmaceutical companies, has attempted to more closely define the influence of the composition of fluids in the gut in order to be able to improve the prediction of drug and formulation behaviour. This lecture will review some of the progress in this large initiative across the three feeder work packages.

Registration

Sponsors

Dupont - Colorcon Controlled Release Alliance
Ferring Pharmaceuticals
Sun Pharmaceutical Industries Ltd

 
 
PLATINUM SPONSORS
ACG Associated Capsules Pvt. Ltd
Bristol-Myers Squibb (BMS), USA
Hindustan Unilever Ltd

 
 
GOLD SPONSORS
Arihant Innochem Pvt. Ltd
Cipla Limited
Dupont - Colorcon Controlled Release Alliance
Idex India Pvt. Ltd
Lubrizol LifeSciences
Merck
Shin-Etsu Chemical Tylose Pvt. Ltd
Signet Chemical Corporation Pvt. Ltd
 
   
 
   
 
 
TECHNOLOGY SHOWCASE SPONSORS

Sponsorship Opportunities

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!

Sponsorship Modalities

Platinum Sponsorship Gold Sponsorship Technology Showcase Table Exhibit
(per day)
  • 5 Free Registrations
  • 1 Full page ad in Newsletter and on Website
  • 2 posters/ Table exhibit for 2 Days
  • Dinner with speakers (2 representatives)
  • 4 Free Registrations
  • 1 Full page ad in Newsletter and on Website
  • 1 poster/ Table exhibit for 1 Day
  • Dinner with speakers ( 2 representatives)
  • 20 minute podium presentation
  • 2 Free Registrations
  • Dinner with Speakers ( 2 representatives)
  • 2 Free Registrations on day of exhibit
INR 5,00,000/- INR 3,50,000/- INR 2,00,000/- Day1 INR 1,50,000/-
Day2 INR 1,00,000/-

Poster Presentations

Students, academicians and researchers are welcome to present their research related to the theme of the seminar at the poster presentation competition. Selection for the poster presentation is based on the abstracts submitted.

 

 

Programme

Day 1 Day 2

Friday, 1st February 2019



Saturday, 2nd February 2019


 
Dr. Andreas Bernkop-Schnürch
Univ. Prof. Institute of Pharmacy, University of Innsbruck, Austria Chief Scientific Officer, ThioMatrix GmbH, Austria.

Andreas Bernkop-Schnürch (born in Klagenfurt 6 December 1965) was educated in pharmacy and in microbiology and genetics at the University of Vienna, Austria, finishing his doctorate in 1994.
In 2003 he was appointed to a Chair in Pharmaceutical Technology at the University of Innsbruck.
He is author of over 300 research articles and reviews as well as editor and (co-)author of several books. As of November 2016 his publications have been cited over 13,500 and his Hindex is 61.
Andreas Bernkop-Schnürch is the founder of Mucobiomer Biotechnologische Forschungsund Entwicklungs GmbH (now part of the Croma-Pharma GmbH), Thiomatrix Forschungsund Beratungs GmbH and Green River Polymers Forschungs und Entwicklungs GmbH.

Previous and other positions
From 2006-2013 he served as dean of the Faculty of Chemistry and Pharmacy, University of Innsbruck, Austria.
Andreas Bernkop-Schnürch serves currently as CSO of Thiomatrix GmbH (www.thiomatrix.com).
He is founder and General Manager of Green River Polymers GmbH (www.green-river.eu).

Fields of expertise
Andreas Bernkop-Schnürch is a leading scientist of multifunctional polymers in the field of drug delivery and therapy. He invented and pioneered thiolated polymers – thiomers – as a new generation of bio- and mucoadhesive polymers. Various medicines based on thiomers have already successfully passed clinical trials and a first product for treatment of dry eye syndrome will soon reach the global pharmaceutical market.
He also pioneered zeta potential changing nanocarriers and contributed substantial basic knowledge to the field of self-emulsifying drug delivery systems (SEDDS) for mucosal delivery of macromolecular drugs. Furthermore, his research focuses on the development of oral, nasal and vaginal delivery systems for biologics including peptide and protein drugs as well as DNA- and RNA-based drugs.
Dr. Janet A Halliday PhD, FRPharmS
Associate Vice President, Ferring Controlled Therapeutics and External Technology, Scotland, UK

Dr Halliday has worked in Drug Delivery in pharmaceutical Research and Development for 30 years. Starting with a PhD in Pharmacy she has worked on a novel drug delivery technology that spun out from a University and ultimately reached the market, some technologies that never made it and some where efforts continue.

Janet’s role in Ferring is to scout out, evaluate and move along drug delivery technologies which support Ferring’s mission of Helping People Live Better Lives. Janet and her colleagues in Drug Delivery in Ferring work in partnership with University Technology Laboratories, startups and established drug delivery groups in the areas of Reproductive Medicine and Women’s Health, Urology and Gastroenterology. Her interest is in developing drug delivery solutions for small molecules, peptides and monoclonal antibodies.
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.

Education: Jayant Khandare is Masters in Pharmacy and Ph.D. in Chem. Eng. from National Chem. Lab., Pune, India. He worked in the capacity of postdoctoral research fellow with Prof. R. Kannan at Chemical Engg. Dept., and Children’s Hospital, Wayne State University, Detroit, and as a Research Associate with Prof. Tamara Minko, at The State University of New Jersey at Rutgers, USA. He is an Alexander Von Humboldt experienced researcher, Germany and was in a research group with Prof Rainer Haag.

Research: His research interests are at the interface of macromolecular chemistry, targeted drug delivery, 3D cancer cell scaffolds, and 3D surfaces. He was a senior research scientist, heading Polymer Chemistry Grp., in Drug Discovery Company- Piramal Healthcare Ltd India involved in New Chemical Entity- Drug Discovery.

Dr. Jayant Khandare has received several academic and industrial research grants from Dept. of Biotechnology and Dept of Science. He has published over 60 research papers, reviews, and book chapters. Dr. Khandare has filed 14 US/PCT patent applications. His PCT patent application on creating in vitro 3D cancer scaffolds of 2 mm size correlates in vivo- as a drug discovery tool. His research, Biofunctionalized Capillary Flow Channel Platform Integrated with 3D Nanostructured Matrix to Capture Circulating Tumor Cells, has been published in Advance Materials Interface. 2017 (cover page). He served as, Editor of special issue for targeted nano-delivery systems, Nanoscale, 2015. His, nano-rocket for cancer diagnosis was published in Nanoscale (2015) with Nature News and highlight in Economic Times and Times of India. His high peer reviews have been published in Chem. Society Reviews, highlight nano-therapeutics for leishmaniosis (Chem. Society Review, 2016) and Dendritic polymers in nanomedicine, Chem. Soc. Review (2012) (Impact Factor 40.182*).

Dr. Jayant Khandare’s research on multicomponent nanosystem for capturing ‘Circulating Tumor cells (CTCs)’ has been published in Adv. Healthcare Mat. 2013 as a cover page, inside (Nature India Research Highlight). While, he published his work in ‘Small’ 2012 on enhancing surface interactions with colon cancer cells using transferrin-conjugated 3D nanostructured substrates. Recently, his research on fabrication of pH-tunable calcium phosphate nanocapsules via dendrimer-templated assembly for intracellular lysosomal release of drug has been published in ‘Particle’ 2013. With Prof. Haag, published a Critical Review in Chem. Society Review, 2012, titled as ‘Multifunctional dendritic polymers in therapeutics: opportunities and challenges’. His work on cellular imaging using biocompatible dendrimer-functionalized graphene oxide-based fluorescent probe anchored with magnetic nanoparticles was an Editorial choice of month cover in ‘Nanotechnology’ 2012 (highlighted as Editors/Publishers Pick for Sept 2012) (Research Highlight by Nature India).

Prof. Tamara Minko and work on receptor targeted polymers, dendrimers, liposomes: Which nanocarrier is the most efficient for tumor-specific treatment and imaging? was a cover page and the Editorial story in Journal of Controlled Release, 2008. During his Humboldt stint he worked with Prof. Rainer Haag, at Freie University, Berlin, Germany, he worked on nano-imaging of near infra-red-polyglycerol-dendrimer probes for cancer and inflammation imaging (Biomaterials 2009 and Small 2011). He was a research associate with Prof Tamara Minko, at The State University of New Jersey. Their research was published in Proc. Natl. Acad. Sci. USA, 2005 was focused on tumor-specific targeting of an anticancer drug delivery system by LHRH peptide. (Highlighted as Nature News, USA).

Jayant Khandare writes science blogs for 'Human Touch of Chemistry' and has been part of outreach events for Royal Society of Chemistry, West India. He has published 02 books on popularization of science.

Honors and awards: He was past Hon. Secretary-Royal Society of Chemistry, West India Section, for three years. Recently, he has been elected as a Fellow of Royal Society of Chemistry (FRSC) and a Fellow of Maharashtra Academy of Sciences (MASc). He is recipient of early Career Scientist, Royal Society of Chemistry-West India, 2012. He received ‘Best Scientist Award’ and citation from Asso. of Pharm. Teachers of India, 2015.


Technology platforms: His research based start-up, Actorius Innovations and Research (AIR) has clinically developed innovation platform OncoDiscover completed first Indian clinical trial in detecting early metastasis and prognosis in cancer patients. He is also a founder of Right to Research Foundation, a non-profit researcher’s entity in Pune. He has out licensed a pharmaceutical process technology in increasing patient compliance in diabetic and other therapies.

His technology, in reducing a Pharma Process and size of tablet as sustained release (SR) for type II diabetes has reached in market. His colon novel delivery system as delayed release (DR)-extended release (ER) capsules has completed the human study and is being out-licensed.

Dr. Claus – Michael Lehr
Professor at Saarland University & Cofounder & Head, Department "Drug Delivery", Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Germany

Claus-Michael Lehr is Professor at Saarland University as well as cofounder and head of the department "Drug Delivery" at the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), which was established as a branch of the Helmholtz Centre for Infection Research (HZI) Braunschweig in 2009. The Helmholtz Association of German Research Centers is the largest public research organization in Germany. Since October 2015, the institute is located in a brand new state-of-the-art research building on the university campus in Saarbrücken. Prof. Lehr has also been cofounder of Across Barriers GmbH and acts as CEO of PharmBioTec GmbH, a non-for-profit contract research subsidiary of Saarland University.

The research theme of Prof. Lehr's team is non-invasive drug delivery across biological barriers, in particular the epithelia of the gastrointestinal tract, the skin and the lungs. Recently, this has been expanded to microbial barriers, such as the bacterial cellular envelope, biofilms and host cell membranes. A substantial part of the lab’s activities is dedicated to innovative carrier systems, often based on nanotechnology, capable of safely and efficiently delivering drugs and vaccines across the barriers. In this context, the lab systematically investigates predictive cells and tissue models, preferentially human-based, to evaluate the safety and efficacy of novel therapeutic concepts and to facilitate their translation into the clinic.

Prof. Lehr is (co)author of more than 350 papers with >12.000 citations (h-index = 67). He is co-editor of the European Journal of Pharmaceutics and Biopharmaceutics and has been the initiator of the biannual International Conference and Workshop "Biological Barriers", which has recently taken place at Saarland University in August 2018 for the 12th time. Recently, the British magazine “The Medicine Maker” rated Professor Lehr, for the third time, as one of the top 100 most influencing drug researchers in the world.
Dr. Kinam Park
Showalter Distinguished Professor of Biomedical Engineering, Purdue University, U.S.A.

Kinam Park received his Ph.D. degree in Ppharmaceutics from University of Wisconsin in 1983. After postdoctoral training at the Department of Chemical Engineering of the same university, he joined the faculty of Purdue University in 1986. Since 1998, he has held a joint appointment in the Department of Biomedical Engineering, and became the Showalter Distinguished Professor of Biomedical Engineering in 2006. He has studied drug delivery systems for three decades with the research focus on the use of polymers for controlled release formulations. His current research focus is PLGA-based injectable, long-acting formulations. He is the founder of Akina, Inc. specializing in specialty polymers used in drug delivery systems and biomedical devices. He serves as the Editor-in-Chief of the Journal of Controlled Release.
Dr Ilva Rupenthal
Senior Lecturer and Director of the Buchanan Ocular Therapeutics Unit, Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand

Dr Rupenthal is currently a Senior Lecturer in the Department of Ophthalmology and the Director of the Buchanan Ocular Therapeutics Unit, which aims to develop and translate ocular therapeutic related scientific research into the clinical setting. Ilva received a BPharm from the Philipps-University of Marburg, Germany, in 2003 and completed a PhD on ‘Ocular delivery of antisense oligonucleotides’ with the School of Pharmacy and the Department of Ophthalmology, University of Auckland, in 2008. In 2010, Ilva was awarded a prestigious three-year New Zealand Science and Technology Postdoctoral Fellowship to establish an ocular pharmaceutics group within the New Zealand National Eye Centre. In 2013, she then received a prestigious $500,000 HRC Sir Charles Hercus Research Fellowship to continue her innovative research into stimuli-responsive ocular implants. Dr Rupenthal has received several awards including the 2016 HRC Celebrating Research Excellence Award and the 2014 University of Auckland Early Career Research Excellence Award, while also being a winner of the Spark Entrepreneurship Ideas Challenges in 2012 and 2014.
Dr. 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

Dr. Bruno Sarmento is Group Leader of the Nanomedicines and Translational Drug Delivery group at Institute of Biomedical Engineering/Institute for Investigation and Innovation in Health (INEB/i3S), University of Porto, Portugal and Assistant Professor at IUCS/CESPU.

His current research is focused on the development of functionalized nanomedicines and materials and their application in the pharmaceutical and biomedical fields. In particular, he is interested in the establishment of nanoformulations of advanced functional biomaterials and understand their interaction with cells and biological surfaces, with interest in diabetes, cancer and infectious diseases. He has also specialized in mucosal tissue engineering models to validate functionalized nanomedicines and to perform in vitro/in vivo correlation.
Dr. Ajay Saxena
Lead Investigator, Biopharmaceutics Department, Biocon Bristol-Myers Squibb R&D Centre (BBRC), Syngene International Ltd., Bengaluru, India

Ajay is Lead Investigator in Biopharmaceutics (BPH) department at Biocon Bristol-Myers Squibb Research & Development Centre (BBRC), Syngene International Ltd., Bengaluru. His research group is engaged in pre-formulation and formulation development for new chemical entities, supporting preclinical and IND enabling toxicology, Phase 1 and Phase 2a studies through oral & parenteral routes of administration. He has deep interest in formulating oral bioavailability enhancement strategies by modulating either Drug substance properties like amorphous solid dispersion and lipophilic salts or by utilizing novel drug delivery systems like nanosuspension, microsphere and SMEDDS. He is skilled with biopharmaceutics risk assessment for drug substance (Neat form, Salts, Prodrug, Spraydried dispersion) and drug product (solution, suspension, tablet & capsules) to craft mitigation strategies using in vitro (microdissolution), in silico (GastroPlusTM Simulation using compartmental and PBPK models, Material Studio) and in vivo tools. Ajay has been with BBRC since 2009. He received his doctoral degree in Pharmaceutics from University of Bradford, and pursued Post-Doctoral Research at University of Minnesota.

He has been felicitated with several awards for his contributions; is a co-author for several research articles in international peer-reviewed journals.
Dr. Hitesh Doshi, PhD.
Vice President - R&D, Sulphur Mills Limited., India

Hitesh completed his Ph. D. in Pharmaceutical Technology from the B. V. Patel PERD Centre under the able guidance of Prof. H. L. Bhalla. He then worked with companies like Sun Pharma, Franco-Indian, IVAX (now Teva). At Franco-Indian he was responsible for redevelopment of the company's flagship product and market brand leader "Dexorange Syrup". At Sun Pharma and IVAX, he was responsible for development of generic products for US and EU.

In the year 2005 he joined the Nordic Group’s India office. He was responsible for setting up of a state-of-the art solid oral R&D facility with pilot plant. Under his guidance, his team developed several generic and value added generic products for EU. The pilot plant was later used for manufacturing products for Europe and faced three EU GMP inspections, all of which were cleared without any objectionable observations. He also enrolled for an Executive MBA program in 2013 and stood first in the batch.

In 2018, Hitesh ventured out into the Agrochemical formulation business to try his formulation skills in a new field, by joining Sulphur Mills Ltd as Vice President – R&D.

He has always liked to be in touch with academics and has been a referee for the Masters and Ph. D. thesis for five national universities. He has been an active member of the CRS Indian Chapter right since its inception and has been a member of the Executive Committee since 2009.

He has five granted patents to his credit and many more are in the application stage.
Prof Clive Wilson
Research Professor, Strathclyde Institute of Pharmacy & Biomedical Sciences, Glasgow, UK

Clive Wilson is a Research Professor at Strathclyde University and recently retired as the J.P. Todd Chair in Pharmaceutics. He remains an active member of staff and was offered the post of Research Professor for the next four years. He is heavily involved in global pharmaceutics projects in the USA and Europe across industry and academic groups. He is a past-president of the European Union Federation for Pharmaceutical Sciences (EUFEPS). He serves on Senate of EUFEPs with interests in European training policy and education and on the EU COST action UNGAP management board. In August this year, he was invited to become Chief Scientific Officer of ReVana, a Queen’s University Belfast spinout concerned with developing ocular implants for treatment of glaucoma and wet AMD.

Major areas of research have been the study of the behaviour of drug formulations in man. With John Hardy in Medical Physics at Queen’s Medical Centre and later Professor Davis in Pharmacy at Nottingham, he pioneered applications of scintigraphy in the study of drug absorption following oral, nasal, pulmonary and ophthalmic delivery.. He has published more than 180 papers, seven books and over 100 reviews and book chapters and has supervised 64 Ph.D. and 1 M.D. student. He was made a Fellow of the Controlled Release Society in June 2010 and an Eminent Fellow of the Academy of Pharmaceutical Sciences in September 2011. In November 2017, he was awarded doctor honoris causa of Semmelweis University, Budapest, Hungary for work on oral drug absorption.