Biography:

Ashish Mungantiwar PhD, pharmacologist by profession. He is working as President Medical Services in Macleods Pharmaceuticals Limited. He heads various departments like Bioequivalence, Clinical trial and Pharmacovigilance. As Head of Bioequivalence he has served as Study Director for more than 2000 Bioequivalence studies. He has successfully handled more than 25 regulatory inspections from USFDA, WHO, EU and ANVISA. He has attended meeting with regulators of WHO and EU during approval process of the product. His passion for respiratory drug is seen from the fact that he has been awarded patent on device of Dry powder inhaler. In order to keep his academic temperament alive he works as PhD guide in industry and has already guided five PhD students. He is invited speaker in various international conferences.

Abstract:

Statement of the Problem: Respiratory dosage forms are at the forefront of asthma and chronic obstructive pulmonary disease treatments, two diseases that afflict worldwide populations. The global sales data estimates for asthma is approximately $15.9 billion. The US itself contributes 64% of the sales mainly due to much higher prices and lack of generic inhalers in the market. Introduction of generics is essential as pricing is barrier to patient care. However, regulatory approvals of these products by different agencies are demanding and are not harmonized.

Methodology & Theoretical Orientation: Current topic will cover US and EU requirement of bioequivalence and in-vitro performance studies. Understanding various study designs and challenges. Presentation will also cover current practice and precautions to be taken during the conduct of bioequivalence studies.

Conclusion & Significance: This presentation will critically review requirement and present future directions for clinicians, scientists, and regulators to consider optimizing the development and approval of drug products for respiratory dosage forms.

Biography:

Sudheendra K has his expertise in managing the GCP Quality Management Systems at Syngene Clinical Development in the conduct of Phase I, Bioequivalence, Bioavailability studies. He has hosted many international regulatory inspections such as US FDA, EMA, ANVISA, Thailand GLP at Syngene Clinical Development. He is a trained biochemist and has been associated with GCP QMS management for the last 14+ years. He has also audited many vendors and service providers who provide support for the contract research organizations for the conduct of early phase studies. He has also audited many complex clinical trials Phase II and Phase III trials have been conducted at different hospital sites. 

Abstract:

Clinical Research Organizations (CRO) supporting the biopharmaceutical and pharmaceutical Industry have seen a paradigm shift in how regulatory inspections are conducted.  The current expectations is that the CRO has to demonstrate Quality and data integrity (DI) in order to gain the trust of the regulatory investigators.  Adherence to DI standards have become one of the key areas of focus during regulatory inspections. The systems used in the research industry have become more complex in terms of metadata that is being generated across the companies. Metadata that is created in a clinical trial is quite voluminous and the inspectors are aware of the possible DI issues that can arise from time-to-time. The functions such as User Access, Delete Features Data Backup Policies, Audit Trail, role of the System Administrator etc. have become the focus of attention during inspections. ALCOA principles is applicable to both paper and electronic data, thereby to ensure that the DI standards as part of Good Documentation Practices (GDP) are followed uniformly by all personnel who generate clinical trial data. To ensure that the DI standards are maintained across the life cycle of the clinical trial, Quality Systems should be integrated and omnipresent in the operation to ensure the protocol, regulations and procedures are followed. Adherence to these standards will ensure that the clinical trial data generated will meet the applicable regulatory requirements. The current climate is such that, the DI requirements shall be more demanding and a primary focal point in clinical research. The focus of this presentation will highlight how we prepared the teams on the current global requirements to ensure a successful regulatory inspection. 

Biography:

Dr Muneesh Garg has completed his MD (Physician) from Dagestan State Medical Academy, Russia and MD (Pharmacology) from Goverment Medical College, Patiala, Punjab, India. He has more than 18 years of experience in academia, and clinical research. He is the principal investigator of Sitec Labs Pvt Ltd., Navi Mumbai, India, for more than 11 years and has completed about 1000 BA/BE studies. He has published many research papers in reputed journals.

Abstract:

Fluticasone propionate (FP), a topically active corticosteroid shows little or no systemic activity after oral administration is indicated for the prophylactic management of asthma of all severities. The aim of these studies was to determine the bioequivalence of test and reference formulations of fluticasone propionate HFA pMDI 250 mcg per actuation with and without a spacer device. Study-1 was a single dose, randomized, 4-period, 2-sequence, laboratory-blinded, crossover replicate design conducted in 32 healthy volunteers under fasting conditions without volumatic spacer. Study-2 was a single dose, randomized, 2-period, 2-sequence, laboratory-blinded, crossover design conducted in 28 healthy volunteers under fasting conditions with volumatic spacer. Both the studies had a washout period of 14 days. Blood samples were collected up to 36 hours post-dose for pharmacokinetic profiling. Safety evaluations included monitoring adverse events and vital signs as well as clinical laboratory assessments. Plasma concentrations of fluticasone propionate were determined using a validated LC-MS/MS method. The 90% CI of the difference between the test and reference for fluticasone propionate was 97.46-112.34 and 98.55-113.06 for C_max, and AUC_0-t respectively in study-1. The 90% CI of the difference between the test and reference for fluticasone propionate was 88.13-104.88, and 96.21-111.22 for C_max, and AUC_0-t respectively in study-2. Since the 90% CI of fluticasone propionate for C_max and AUC_0-t were within the 80–125% interval in both the studies, it was concluded that test and reference formulations of fluticasone propionate HFA pMDI 250 mcg per actuation are bioequivalent in their rate and extent of absorption with and without a spacer device.

Biography:

Dr Raja Mohamed has completed his PhD from Indian Institute of Technology (IIT) Delhi & Technical University, Dresden, Germany & a Post-Doctoral Fellowship. He worked as technical lead in Dept. of Science & Technology; Govt of India sponsored Research Project to Orchid Healthcare & IIT Chennai. He had been awarded prestigious DAAD fellowship to carryout research work in Germany. Currently he is heading Bio strategy Team @ Orchid Healthcare Ltd. He has guided several M. Pharm, B. Pharm & B. Tech graduates. He has published many research papers in reputed international and national journals.

Abstract:

Cancer is second most common cause of death in US & millions die world wide due to different types of cancers. Cancer is an uncontrolled division of abnormal cells and spreading of the same into surrounding tissues.  This phenomenon interferes with digestive, nervous, circulatory systems and alters the body function.  In many ways cancer cells are different from normal cells. Normal cells mature into very distinct cell types with specific functions, whereas cancer cells don’t. Cancer cells don’t follow the apoptosis process (programmed cell death), thus continue to divide into multiples. Cancer cells influence microenvironment, for example formation of blood vessels, over expression of certain receptors to have access to nutrients necessary for the growth. Predominantly anti cancer drugs are being used for the treatment of cancers. However, they do have dose-related cardio and neuro toxicities. Further they are mostly non specific to cancer cells. It means they not only kill the cancer cells but also the normal cells. These issues make the treatment difficult. Recently, researchers are employing different methods to maximize the drugs efficiency at the same time trying to reduce the adverse events caused by them. Classically drugs are being delivered to the tumors locally or targeted to the cancer cells. However, regulatory approval of such delivery systems becomes more stringent due to inherent toxicity raised from the drug delivery systems. Current study explains the different ways of targeting cancer cells using biodegradable/biocompatible delivery system to maximize the drug’s efficiency. In this study, hydrogels of biocompatible nature are being employed to deliver the drugs.