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  4.  » The Road to IND: Accelerating Development & Manufacturing of Oral Small Molecules

The Road to IND: Accelerating Development & Manufacturing of Oral Small Molecules

Date: April 4, 2023
Time: 9:00 a.m. – 1:30 p.m. PCT
Location: JLABS – San Diego
3210 Merryfield Row
San Diego, Calif. 92121

In collaboration with:


In today’s environment, it is important to make the right R&D choices, especially considering the various pressures on developers such as time, resources, and funding. Short term thinking can lead to long term problems leading to missed timelines, escalating costs, and even regulatory issues in later phases. Fortunately, innovators can employ various data driven scientific approaches to make key early development decisions right the first time.

This event will focus on several key considerations for developing the best small molecule drug product for patients:

  • Adopting novel technologies to discover targets, identify lead compounds, and assess pre-clinical safety and efficacy
  • Analyzing and addressing biopharmaceutical challenges
  • Integrating preclinical data to design better clinical trials.



09:00 am – 09:30 am

Registration and Networking Breakfast

09:30 am – 09:40 am

Welcome Note

Ronak Savla, Pharm. D., Ph.D., MBA
Director, Strategic Ventures,
Catalent Pharma Solutions


Nick Mourlas, Ph.D.
Regional Head, JLABS San Diego,
Johnson & Johnson Innovation

9:40 am – 10:25 am

Using Artificial Intelligence in Discovery and Development of Pharmaceutical Products

Michael Bemben, Ph.D.
Director, Data Science External Innovation,
Johnson & Johnson

10:25 am – 11:10 am

Preformulation and Formulation Development Strategies for Early Phase Small Molecule Programs

Lisa Caralli
Sr. Director, Scientific Advisory
Catalent Pharma Solutions

11:10 am – 11:20 am

Coffee Break

11:20 am – 12:05 pm

Precision HUMANOIDs: Designed to Support Phase ‘0’ Trials-in-a-Dish

Pradipta Ghosh, M.D.
Professor, Departments of Medicine and Cellular and Molecular Medicine
Founding Director, Institute for Network Medicine {}
Founding Director, HUMANOID™ Center of Research Excellence (CoRE)

12:05 pm – 12:50 pm

Translating Discovery into Proof of Mechanism: Clinical Trial Considerations

Michael Howell, Ph.D.
Galileo Biosystems

12:30 pm – 01:30 pm

Networking Lunch & Meet the Experts



We are passionate about helping healthcare startups succeed, and that means more than providing state-of-the-art lab space and equipment. Our resident companies have access to a wealth of Johnson & Johnson resources and internal expertise in pharmaceuticals, medical devices and consumer products— and across all of our therapeutic areas. And because it’s a “no-strings-attached” model, companies gain access to the broader Johnson & Johnson Family of Companies and expertise while retaining intellectual property and decision-making freedom. JLABS is designed to remove hurdles to success and empower life science innovators through infrastructure, community and specialized expertise. Our resident startups build the confidence to reach their entrepreneurial goals and make a lasting difference in the lives of patients. We exist to support you.