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Home > Events

Taking novel drugs from lab to clinic: Concepts and case studies

7-11 March, 5:30 PM New Delhi

Online webinar

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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

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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

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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

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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

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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

Watch the recording

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