Panel Discussion: Optimising FR&D to expedite regulatory compliance

Panelists in this video:
+ Vinod Arora, Principal Advisor, Institute of Good Manufacturing Practices India (Moderator)
+ Dr Sajeev Chandran, Director, Adv. Drug Delivery Research & IVIVC/ Biopharmaceutics , Pharma R&D, Lupin
+ Dr Sukhjeet Singh, Chief Scientific Officer, Sentiss Pharma
+ Dr C Muthulingam, VP-Formulations, Mankind
+ Ravikumar N, Sr. Vice President, MSN Laboratories

Key Highlights:

● To enter new markets/countries, for e.g. China, ensure that all ingredients and excipients used for formulations are compliant with the pharmacopeias of these countries: Ravikumar N, Sr VP, MSN Laboratories

● An integrated and effective reverse engineering approach is key for successful formulation development of generics and to ensure their compliance with global regulations: Dr C Muthulingam, VP-Formulations, Mankind Pharma

● Formulation development should not be done in silos. FR&D scientists should get involved with different processes like dissolution to improve the efficiency of their formulations: Dr Sukhjeet Singh, Chief Scientific Officer, Sentiss Pharma

● Today, FR&D is being done through integrated and evidence-based strategies with cross-functional inputs to improve outcomes but certain blind spots need to be eliminated: Dr Sajeev Chandran, Director, Adv. Drug Delivery Research & IVIVC/ Biopharmaceutics, Pharma R&D, Lupin

● It is important to fix pharmacokinetic-pharmacodynamic (PKPD) parameters carefully, design your targets accordingly and then move into clinical studies: Dr Sukhjeet Singh, Chief Scientific Officer, Sentiss Pharma

● Molecule-based R&D approach in formulation development might offer greater advantages vis-à-vis market-based R&D approach, in enabling regulatory compliance across global markets: Vinod Arora, Principal Advisor, Institute of Good Manufacturing Practices India (IGMPI)