DNDi, the Indian Society for Clinical Research (ISCR), and BIRAC Regional Bio-Innovation Centre (a joint initiative of BIRAC and Venture Center) are hosting five days of virtual workshops titled ‘Taking novel drugs from lab to clinic: Concepts and case studies‘.
This event is an exciting opportunity to hear from national and international experts as they walk you through the path of translational research for small molecules.
Programme
Framework for successful lead optimization
Date: Monday, 7 March 2022
Time: 5:30-7:30 PM IST
Session chair: Monalisa Chatterji, Co-founder, Director, Sekkei Bio Pvt Ltd
| Introduction to the webinar series Kavita Singh, Director DNDi South Asia Regional Office Sanish Davis, President, Indian Society for Clinical Research (ISCR) Premnath Venugopalan, Director, Venture Center |
| Overview of lead optimization Ben Perry, Discovery Open Innovation Leader, DNDi |
| Lead optimization explained through case study 1 Ian Gilbert, Head of Division of Biological Chemistry and Drug Discovery, University of Dundee |
| Lead optimization explained through case study 2 Kirandeep Samby, Consultant, Medicines for Malaria Venture |
| Lead optimization explained through case study 3 Lori Ferrins, Research Associate Professor, Northeastern University |
Pharmaceutical development
Date: Tuesday, 8 March 2022
Time: 5:30-7:30 PM IST
Session chair: Amit Antarkar, Head, OSD R&D India, Mylan Laboratoris Limited (A Viatris Company)
| Impact of API physicochemical properties on product development Ravinder Kodipyaka, Head, Formulation R&D, Aurigene Pharmaceutical Services |
| Formulation strategies for accelerating oral drug candidates to Phase I clinical trials Vivek Kumaravel, Senior Group Leader, Pharmaceutical Development, Syngene International |
| Quality requirements for Phase I investigational products Stephen Robinson, Pharmaceutical Development Director, DNDi |
PK-PD relationship and safety pharmacology
Date: Wednesday, 9 March 2022
Time: 5:30-7:30 PM IST
Session chair: Shridhar Narayanan, CEO, Foundation for Neglected Disease Research (FNDR)
| Principles and modeling of PK-PD relationships Ayman El-Kattan, Head of DMPK, IFM Therapeutics |
| Understanding PK/PD using pre-clinical models: Lessons for efficacy studies Anirudh Gautam, Senior Director R&D (Proprietary Products), Dr Reddys Laboratories |
| Introduction to Safety Pharmacology; Interpretation and translatability in Clinic/FIH studies K. S. Rao, Subject Matter Expert (SME), Eurofins Advinus |
Toxicology and toxicokinetics
Date: Thursday, 10 March 2022
Time: 5:30-7:30 PM IST
Session chair: Nitin Shetty, Chief Technical Officer, Bioneeds
| Introduction to GLP Toxicology Senthilkumar Mariappan, Toxicology Project Lead, Bayer Pharmaceuticals |
| Important considerations for bioanalytical method development/ validation; Interpretation of toxicology studies in context of toxicokinetic parameters and implications Venkata Mukkavilli, Director, Technical Operations, Absorption Systems |
| Planning toxicology development roadmap: Case study 1 Nigel Roome, Independent expert in Toxicology and Toxicologic Pathology |
| Planning toxicology development roadmap: Case study 2 Stephanie Braillard, Non-Clinical Development Senior Manager, DNDi |
Goalpost: First-in-human clinical trial
Date: Friday, 11 March 2022
Time: 5:30-7:30 PM IST
Session chair: Jaideep Gogtay, Global Chief Medical Officer, CIPLA
| Practical and Technical approaches to determining First in Human Dose Jean-Yves Gillon, Head of Translation Sciences, DNDi |
| Planning study design: Principles behind dose escalation models Jörg Taubel, CEO, Richmond Pharmacology |
| Risk assessment and risk mitigation strategies while planning Phase I trials and critical reasons for delay when conducting IND/CTA enabling studies: Case study 1 Henri Caplain, Senior Advisor and Consultant in Clinical Development and Risk Management Plans |
| Risk assessment and risk mitigation strategies while planning Phase I trials and critical reasons for delay when conducting IND/CTA enabling studies: Case study 2 Sumati Nambiar, Senior Director, Child Health Innovation and Leadership Department, Johnson & Johnson |
