July 02, 2020 - 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 a 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:
• Why lose time on a new route? “We need it fast, let us make it this way”
• “My route is better”
• Medicinal chemists have been seen to be satisfied with their route in 70 % of the cases (what is the source of this statement?)

Foreseeable Engineering & Technology aspect:
• Need for Column chromatography
• Use of SFC – rather an avoidance of it
• Isolation issues and other purification aspects

Foreseeable regulatory aspects:
• The solvents & catalysts being used
• Impurities
• Use of cleanroom

Applicability of technology:
• Use of flow/photochemistry

Analytical aspects:
• Level of details in the qualification of API – what assay level is best?
• Techniques needed for the qualification of material
• Setting up the limits for impurities, metals, OVI, moisture
• Solid-state characterization – when to do it?

Final recommendation and discussion

Webinar Speakers:

1. Marcel Velterop
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.

2. Dr. Vikas Shirsath
Senior Vice President – Global Operations – 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 contributions 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 teams.

3. Purushotham Vandanapu
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, Glenmark Research Centre, Navi Mumbai, Sai Advantium Pharmaceuticals Ltd, Hyderabad and AstraZeneca India Pvt Ltd, GCD, Bangalore.

About Jubilant Biosys Limited:
Jubilant Biosys, a subsidiary of Jubilant Life Sciences Limited, is a Contract Research Organization with its R&D centers in India and business offices in Asia and North America. Jubilant Biosys specializes in comprehensive drug discovery services for the global pharmaceutical industry.

In order to be the preferred collaborator in the drug discovery domain, Jubilant Biosys is committed to comply with and continually improve its quality systems. With having strong clinical development, Jubilant Biosys has risen as a fully integrated contract research organization in India and headquartered at Bengaluru with end-to-end solutions.

Jubilant Biosys Limited
Bengaluru Research Site:
#96, Industrial Suburb 2nd Stage,
Yeshwantpur Bangalore - 560 022
Karnataka India.
Tel: +91-8066628400

For more info: www.jubilantbiosys.com/webinar/

Contact Information
Jubilant Biosys
Jubilant Biosys
#96, Industrial Suburb 2nd Stage
Yeshwantpur, Bangalore, Karnataka, India
560022