Archives: Speakers

Kara is responsible for setting the strategic direction and overseeing all pipeline activities for sourcing, selection, screening, onboarding, optimizing and tracking the portfolio across JLABS globally. Kara joined the JLABS team in 2012, shortly after the flagship JLABS site opened at Janssen R&D in San Diego. In her previous role, Kara executed on external engagement, sourcing innovation, portfolio management, operational excellence, educational programming, and P&L for the JLABS in San Diego site. Kara also serves as an Instructor for the I-Corps at NIH program, a program aimed at commercializing biomedical technologies, where she serves as Domain Expert in Therapeutics for NIH SBIR recipient companies. Kara came to JLABS from Galapagos NV in Belgium, where she had various roles of increasing responsibility, including business development, marketing, investor relations and medical communications at a time when the company grew from 60 to more than 800 employees and completed its initial public offering on Euronext. Kara holds a BS in Chemistry from the University of North Carolina at Chapel Hill and a PhD in Biochemistry from the University of Texas at Austin.

Matt has 25 years of experience in the life science industry conducting clinical trials across all phases. His experience spans roles at sponsors, sites, and the NHS, and he has extensive experience in site management and expanded use of oncology therapies. He is passionate about building effective relationships between industry stakeholders to drive innovation and patient access.

Dr.Lingling Rogers is a Senior Director of Regulatory Affairs CMC at Urovant Sciences, Inc. in San Diego, CA. She has more than 20 years of experience in the pharmaceutical industry, including 14 years in regulatory affairs CMC. Her expertise includes serving as the company liaison for interactions with global regulatory health authorities; providing regulatory oversight for drug development of small/large molecules and drug device combination products; and leading global regulatory submissions in support of clinical studies, marketing applications, as well as lifecycle management. She has also served on cross-functional due diligence teams conducting critical reviews of third-party regulatory dossiers for potential in-license opportunities. Dr. Rogers holds a M.S. degree in Organic Chemistry from University of San Francisco and a Ph.D. degree in Medicinal Chemistry and Pharmacognosy from Purdue University.

Qiu has over 10 years’ experience in Clinical Study development and execution. He started clinical research journal from Pfizer, which involved in the global clinical trial resulted the successful launch of Viagra (Sildenafil), followed by leading couple of clinical trials in Beijing Novartis Pharma Co., Ltd. Dr. Qiu then switched his gear to clinical validation of diagnostic platforms in academics and IVD industry, including Beckman Coulter and Leica Biosystems. Under his leadership, Leica Biosystems’ Digital Pathology system AT2 DX has been awarded FDA 510(k) clearance 90 days after submission.

Dr. Martin Mendoza serves as the lead for extramural research for the Office of Minority Health and Health Equity (OMHHE), Office of the Commissioner, FDA.  In this capacity, Dr. Mendoza oversees all OMH extramural research which includes projects in the FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) cooperative agreements with Johns Hopkins University, the University of Maryland, Stanford University, the University of California San Francisco, Yale University, and Mayo Clinic. Dr. Mendoza has spoken before Congress in support of OMH’s programs and mission, has authored numerous Congressional response letters and reports, and is also the primary author for OMHHE’s recent FDA guidance document Collection of Race and Ethnicity Data in Clinical Trials.

Prior to joining the FDA, Dr. Mendoza spent several years in the Office of Clinical Research at the National Institute of Neurological Disorders and Stroke (NINDS), NIH.  There, he was part of programmatic management for all NINDS-sponsored clinical trials and oversaw the institute’s extramural human subjects protections activities and the Congressionally-mandated reporting of women and minorities in clinical research.  Previously, Dr. Mendoza was an active researcher within the NIH intramural research program, conducting laboratory-based research at the National Cancer Institute, the National Institute on Aging, and the National Human Genome Research Institute where he served as a genetic mapper for the Human Genome Project.  Dr. Mendoza is a graduate of the University of Maryland Baltimore County and received his doctorate in cancer biology from Johns Hopkins University.