Your global leading partner in science for end to end CRDMO services
At the end of your discovery process and having selected your lead candidate, you now need pivotal TOX batches and GMP phase 1 material for IND submission. Medicinal chemistry is done at low gram scale and the focus is finding the right molecular architecture, whereas the scale-up phase requires kilo range amounts often a 100X factor up from MedChem.
Time is of the essence and as regulatory requirements are still forgiving in this early phase the temptation is to try and brute-force the ‘MedChem’ route. This can work with moderately complex routes but in recent years the majority of the candidates are the result of lengthy and complex synthetic schemes.
The result can be a significant time loss combined with excessive cost and impurity generation leading to a frustrating experience as the chemistry does not behave the way we want it to.
We will be discussing the transformation needed in decision-making, assessment and bringing in scale-up expertise earlier than typically done through PR&D scientists. In addition, we offer a platform for all attendants to share their best practices and experience so IND submission can be accelerated with better chemistry and technology decisions including the right focus on process impurities in human trials.
Common assumptions seen in practices:
Foreseeable Engineering & Technology aspect:
Foreseeable regulatory aspects:
Applicability of technology:
Final recommendation and discussion.
President – Drug Discovery Services & CDMO – Jubilant Biosys Limited
Marcel J. Velterop, as President Drug Discovery Services & CDMO will lead Jubilant Drug Discovery Services and Contract Development & Manufacturing Organisation (CDMO) to provide an integrated solution to our life science customers from drug development to scale-up and then commercial manufacturing designed for maximum speed and compliance.
Marcel brings over 25 years of business, pharmaceutical & CDMO experience and leadership to JDDS. He is a chemical engineering graduate from Delft University of Technology and has an in-house DSM course in Business Management from Rotterdam School of Management. He started his career with DSM in 1989 where he held various roles in Marketing, Logistics, Sales, Product Management & Strategy Development. He has also been associated with Dr Reddy’s where he held Senior Leadership roles for Europe, Japan & North America.
In a career spanning almost three decades, Marcel has had rich experience across diverse businesses and global markets. Prior to joining Jubilant, Marcel was associated with Sai Life Sciences Ltd., as Chief Commercial Officer, where he was responsible for strategizing and executing the company’s Growth Plan and ramping up the global discovery scale-up and commercial service business.
Dr. Vikas Shirsath
Senior Vice President – Synthesis – Jubilant Biosys Limited
Dr. Vikas Shirsath is a creative, result oriented medicinal chemist with broad experience in drug discovery operations including medicinal, synthetic chemistry, biology and IP management with major contribution in the area of CNS therapeutics.
During his 15 years of industrial experience with drug discovery services in India, he has led the science, operations, IP strategies and has mainly contributed to the growth of two start-up companies which grew to the critical mass of 250 team. At Zydus Research Center he worked on discovery of novel modulators for nuclear receptors. During his association with Suven Life Sciences, a start-up discovery group, he developed an integrated team for drug discovery and filed over 20 PCT applications in the area of CNS therapeutics in a short span of 4.5 years with a candidate in clinic for the mild to moderate cognition.
As Head of Medicinal Chemistry / CSO at Oxygen Healthcare Research, a Cambridge based start-up, he developed the effective and knowledge driven, customer centric teams. With a team of over 200 and annual growth rate of over 20% in 5 years, Oxygen Bio was acquired by Piramal Healthcare in 2011.
A Pharmacist by training from Pune University, he completed his Masters and Ph.D. with Medicinal Chemistry specialization from L. M. College of Pharmacy, Gujarat University.
Director – Scale-up Chemistry Operations – Jubilant Biosys Limited
Mr. Vandanapu has more than 26 years of experience in Process Development of New Chemical entity and Active Pharmaceutical Ingredients. He started his career from Neuland Laboratories Ltd, Hyderabad where he worked as a Junior Chemist. Post this he was associated with Pharmed Chemicals Ltd, Bangalore, Dr.Reddy’s Laboratories Ltd, CPS, Hyderabad, Glenamark Research Centre, Navi Mumbai, Sai Advantium Pharmaceuticals Ltd, Hyderabad and AstraZeneca India Pvt Ltd, GCD, Bangalore.
Before joining us he was associated with Sai Life Sciences Ltd, Hyderabad as Associate Director, Process R&D. Mr. Vandanapu has Master of Science in Chemistry (Industrial oriented), Regional Engineering College (NIT), Warangal, Affiliated to Kakatiya University, Andhra Pradesh, India and Bachelor of Science in Maths, Physics, Chemistry, Andhra Loyola College, Vijayawada, Affiliated to Nagarjuna University. He has many industrial awards and publications to his credit.