Leveraging Early Investment at Discovery Interface to Accelerate the FIH Development of Complex Biologics

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Webinar Title: Leveraging Early Investment at Discovery Interface to Accelerate the FIH Development of Complex Biologics

Abstract:

Drug development is a long journey, and accelerating this process is essential to bringing life-saving medicines to patients faster. In early-stage development, shortening the preclinical timeline can enable faster readouts for new drug candidates, reduce cycle time, and allow more innovative medicines to be tested in the clinic.

One increasingly used approach to accelerate early-stage program development is parallel drug discovery and development. At Merck, we have established a CMC/Discovery interface team that is co-located with Discovery groups and actively engaged in developing the target product profile and designing molecules, as well as performing manufacturability assessments for candidate selection. This enables the selection of the most manufacturable molecule for preclinical development, helping avoid significant later-stage investment to address unexpected liabilities.

The team also develops production cell lines, processes, formulations, and analytical methods to accelerate FIH development. Pre-investment at the Discovery interface has been a key lever at Merck in enabling a 12-month timeline from preclinical candidate selection to FIH.

Speaker:

Dr. Ren Liu is a Senior Principal Scientist at Merck & Co., where he leads the Discovery Interface team in the Bioprocess Research and Development department and oversees the preclinical and clinical development of an early-stage oncology asset. He has more than 20 years of experience in early-stage biologics development, with expertise spanning protein engineering, cell line development, and process development. He has a strong track record of driving innovation and leading high-performing functional and cross-functional teams.

Dr. Liu earned his undergraduate degree from the University of Science and Technology of China and his Ph.D. in Biochemistry from the City of Hope National Cancer Center of the United States. He has published more than 50 peer-reviewed research articles and holds three patents. Prior to joining Merck, he led drug discovery and development at VasGene Therapeutics in Los Angeles. He also contributes actively to the scientific and environmental communities, serving as Associate Editor of Frontiers in Bioengineering and Biotechnology and as an advisory trustee of the California State Park Foundation.