A day-long national seminar on ‘Clinical Approaches to the Novel Drug Delivery systems and the Global Regulatory Requirements’, was conducted by Controlled Release Society Indian Chapter (CRS IC).
Held on October 15th, 2016, the aim of this seminar was to provide a forum for academic and industry researchers, clinical experts and regulatory professionals to discuss the latest scientific and clinical development for drug delivery system as well as the perceived regulatory concerns and challenges for submission and approval. The seminar was supported by SciTech Centre, Mumbai.
Controlled Release Society (CRS Inc) with over 4000 members worldwide is global scientific society. It is an international organisation for the promotion and development of novel drug delivery systems, with the headquarters in Minneapolis, Minnesota, USA and liaison offices in Geneva, Switzerland and Kawasaki, Japan. The Indian local chapter of Controlled Release Society (CRS-IC) was established in 1994 with headquarters at PERD Centre, Ahmedabad and regional office at SciTech Centre, Jogeshwari, Mumbai.
Dr. Anisha Pargal President CRS IC welcomed the participants and Dr. Parizad Elchidana chairperson, Scientific Committee coordinated the event. Several distinguished speakers from industry shared their views and experience.
Sushrut Kulkarni, senior vice president & head – Pharmaceutical Technology Center, Cadila Healthcare Ltd, Zydus Group of companies, Ahmedabad, covered clinical approaches for new drug applications (NDA) and abbreviated new drug applications (ANDA) and consideration of in vivo clinical end point BE studies during protocol development’. Clinical challenges and current approaches for orally inhaled products, transdermal patches and derma products were covered in detail. The steps taken by FDA under ‘Regulatory Science Initiatives’ to propose novel bioequivalence study designs for complex solid oral and non-solid oral drug delivery systems which have greatly helped industry to understand FDA perspective and to focus on critical aspects of development were discussed.
Dr. Shravanti Bhowmik, associate vice president-clinical development, Sun Pharma Advanced Research Company spoke on ‘Clinical trials for oral drug delivery systems- design and requirements’ with an excellent case study on the clinical requirements and formulation strategy for a drug most commonly used for spasticity. Gastro retentive innovative device technology was discussed with reference to clinical efficacy and safety studies and how clinicians can provide inputs into the QbD concepts of product design.
Dr. Mahesh Paithankar vice president – product development (NDDS) at Intas Pharmaceuticals Ltd., Ahmedabad, spoke on ‘Clinical development strategies for cancer nano – therapeutics’.
Dr. Paithankar, an expert on development of anticancer drug delivery system gave excellent insight into the concept of Bench to Bedside indicating that one should begin with the end in mind. A detailed discussion on nanaoaqualip technology was provided with appropriate case studies related to nano-therapeutic drug delivery systems on the key strategic aspects of clinical program like expected outcome, trial design, selection of primary endpoint, type of trial, selection of appropriate listed drug for 505(b)(2) program etc. Concepts like QALY – Quality Adjusted Life Year to measure health effectiveness and cost effectiveness for funding was also introduced.
Dr Ganesh Jadhav general manager (product innovation) at Sun Pharma, responsible for product innovation covered ‘Nasal drug delivery system: scientific, clinical and regulatory requirements for USA market’ as this non-traditional drug delivery route, offers a unique value proposition for drug developers to launch new products for the treatment of a range of acute and chronic conditions. The presentation provided a comprehensive view of various intranasal drug delivery technologies available in the market as well as in the development. The scientific, clinical, non clinical and regulatory requirements relevant for the US market concerning ANDA and 505(b)(2) NDA products were discussed extensively followed by a few case studies.
Dr. Ajaz S. Hussain a globally recognized leader in pharmaceutical quality and one of the most influential ‘Medicine Maker’ (named in the 100 Power list by the UK’s Medicine Maker magazine in 2015), currently president of the National Institute for Pharmaceutical Technology and Education, NIPTE, a collaboration among pharmaceutical science and engineering programs at 15 major universities in the USA, spoke on ‘Totality of evidence & therapeutic equivalence: lessons from a case study of bioequivalence evaluation of a locally acting nasal spray’.
Having worked with the FDA, Ajaz shared his personal experiences with complex generics with specific reference to metered dose Nasal Sprays approach, architecture and challenges encountered for the product approval. The topic of Pharmaceutical Equivalence with specific examples and key areas for consideration and steps to mitigate risk and create competitive advantage were also presented.
John DiBella, vice president – marketing & sales at Simulations Plus, Inc. in Lancaster, California, presented via a webinar on a very interesting concept of modelling and simulation. The topic of presentation was ‘Applying GastroPlus PBPK modelling & simulation to assist with pharmaceutical research and regulatory submissions’. Advanced compartmental absorption and transit model (ACAT) was presented along with physiologically-based pharmacokinetic (PBPK) models which can be parameterized using a combination of in silico, in vitro, and in vivo data, and their use, coupled with mechanistic absorption modelling (MAM). The encouragement and collaboration received from the regulatory agencies for the modelling approach along with which other areas where modelling can be helpful was also presented. Apart from oral, the applicability to dermal, ocular and pulmonary systems increased the level of interest within the pharmaceutical and generic industries as this technology helps to reduce R&D costs and regulatory burden.
CRS-IC will hold international conference series on “Advances in Technology and Business Potential of New Drug Delivery Systems” in Mumbai on February 17-18, 2017.
This conference brings together a galaxy of international scientists form industry and academia as well as CRS Inc office bearers.