Building a strong network for life science innovators
The Path to Pre-Clinical
Transitioning from R&D to Pre-Clinical Development
Program
At this in-person event, listen to lessons learned from experts and founders who have successfully gone through this phase of development and how to prepare for this critical milestone. Enjoy networking, heavy appetizers and refreshments after the panel.
AGENDA:
- Registration: 4-4:30pm
- Panel Discussion: 4:30-5:30pm
- Networking and Refreshments with heavy appetizers: 5:30-7pm
Panel
So you’ve completed the proof-of-concept studies, and the data is in. Congratulations, your start-up is ready for the next major phase in the commercialization journey: pre-clinical development. This pivotal step in a biotech’s progression demands careful planning as the requirements and necessary expertise of the company are changing and expanding beyond what was needed during the initial development of your asset.
During this transition, the organization shifts from skill sets needed for discovery (such as proof-of-concept studies and early-stage development) to specialized knowledge and proficiency in managing compliance, understanding regulatory standards, creating reproducible studies and preparing documentation for regulatory submission.
Speakers
Danielle Bogdanowicz, PhD, VP Business Ops and Strategy, BioLabs
Danielle is a biotech industry professional and entrepreneur who is passionate about life science innovation. She has experience working for early- and growth-stage biotech companies involved in orthopedic and cardiac tissue engineering, immuno-oncology, cardiovascular drug discovery and development, and implantable medical devices in strategy, operations, R&D, and consulting roles.
Stephen M. Perry, Founder & CEO, Kymanox
Stephen M. Perry is the CEO and Founder of Kymanox—a diversified and global professional services company solely focused on the Pharmaceutical, Biotechnology, Medical Device, and Combination Product industries. He has extensive CGxP experience as a Process Engineer, Technical Project Manager, Quality Auditor, and Regulatory Strategist. As a business executive, Stephen has successfully attracted growth capital from WestView Capital Partners and has further grown the unique Kymanox platform with the acquisition of four different companies.
Phillip Kim, PhD, MBA, President and CEO, Trutino BioSciences
Phillip brings over 20 years of integrated science / business experience in the biotechnology sector. Most recently, he served as VP of R&D and Experimental Medicine at Pierian Biosciences where he led the transformation of a research microarray-based immunoassay to a spectro-magnetic platform for downstream regulatory and commercialization strategy. Prior to Pierian Biosciences, he served as a Sr. Director at Prometheus Laboratories Inc. a Nestle Health Science Company overseeing R&D operations as well as medical affairs. He directed collaborative studies with pharmaceutical companies and academic institutions.
Nancy Hong, PhD, Venture Capital Investor
Nancy Hong has an extensive background in venture capital investing in both biopharmaceutical and medical device companies. Nancy was Managing Director at Rivervest Ventures from 2016 – 2023 and has served as a member of the Board of Directors for numerous start-ups including Scout Bio, Inc., Bluejay Therapeutics, Sequre Dx, and Biolinq, Inc, and Xilio Therapeutics.