Before IND, Know: De-Risking Development Before Challenges Impact Your Program presented by Lonza
Before IND, Know: De-Risking Development Before Challenges Impact Your Program
The path from discovery to the clinic is filled with critical decisions that can significantly influence lead candidate selection, development timelines, resource requirements, and ultimately the success of a promising therapeutic. Challenges related to developability, manufacturability, product quality, immunogenicity, and regulatory readiness often emerge long before IND-enabling activities begin, yet are frequently identified only after they have become costly obstacles.
In this seminar, Bruno Nolasco, MD, Senior Principal Scientist, Early Development Services at Lonza, will share real-world case studies illustrating how early scientific insight can help identify, understand, and address development risks before they affect program progression. Attendees will explore how issues related to candidate selection, expression, product quality, and immunosafety were identified and successfully mitigated through targeted development strategies. Bruno will also highlight key immunogenicity considerations in mRNA development and approaches to evaluating and managing immune responses during early development, with a particular focus on factors relevant to vaccine and nucleic acid-based programs.
Building on these examples, the seminar will demonstrate how effective early de-risking can also help accelerate the path to the clinic. Tracy Yin, Associate Director, Business Development at Lonza, will provide an overview of Lonza's newly launched accelerated DNA-to-IND timelines across a range of biologic formats and discuss how early scientific understanding, informed decision-making, and proactive risk mitigation can help enable progression to IND in as little as six months.
Attendees will leave with practical strategies for proactively de-risking their programs, accelerating development readiness, and increasing confidence as they advance toward the clinic. A networking reception will follow from 4 to 5 PM, providing an excellent opportunity to continue the conversation with Lonza experts and fellow attendees.
Request a 1-on-1 Meeting
We have reserved a limited number of individual meetings with our guest speaker before and following the event. Attendees interested in being considered for a meeting should email tracy.yin@lonza.com with their organization, role, and topics of interest. Requests will be reviewed based on alignment with the speaker's expertise and available time.
Bruno Nolasco earned his MD from the National Autonomous University of Mexico and completed a post-doctoral fellowship at the Massachusetts General Hospital’s Center for Transplantation Sciences, where he studied mechanisms of allograft rejection and tolerance. He later joined Flagship Pioneering’s Generate Biomedicines, contributing to the development of the company’s pre-clinical immunogenicity risk assessment workflows. In 2024, he joined Lonza as part of the Immunology group, where he now supports the pre-clinical developability and immuno-safety portfolio within the Early Development Services division in Cambridge, Massachusetts. The Immunology group works across multiple business units to advance immunology programs for therapeutic proteins/peptides, mRNA therapies, vaccines, and cell & gene therapies. The team also provides support for regulatory filings, including the design and execution of studies for IND and ANDA submissions.
About Lonza
As a dedicated CDMO serving the healthcare industry, we bring life-enhancing and life-saving treatments to market for our customers and their patients. We are a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.
Founded in Switzerland in 1897, our company is the first and original CDMO. Today, we bring together a team of 20,000 colleagues across five continents to deliver integrated offerings that meet the complex needs of our global customer community.