Dr. Yan Ni | Pharmaceutical Research | Best Researcher Award

Executive Director, Passage bio, United States

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Researcher Evaluation for “Best Researcher Award”

Strengths for the Award:

Extensive Expertise in Drug Development: Yan G. Ni, PhD, has over 15 years of experience in drug development, particularly in small molecules, biologics, and gene therapies. His work spans several critical therapeutic areas, including neurological and cardiovascular diseases, immune-oncology, hematology, and rare diseases. His contributions to IND/CTA submissions and regulatory interactions further highlight his deep involvement in the field.

Leadership in Translational Biomarker and Precision Medicine: Dr. Ni has demonstrated significant expertise in integrating preclinical and clinical biomarker strategies, contributing to the successful design and execution of biomarker-based clinical endpoints. His role in implementing PK and immunogenicity strategies across different phases of studies showcases his ability to bridge the gap between research and clinical application, a crucial factor in modern drug development.

Proven Management Skills: Dr. Ni’s management experience is evident in his ability to build and lead high-performing cross-functional teams. His leadership roles in international professional organizations like the AAPS and SAPA, as well as his track record of mentoring and inspiring others, underline his effectiveness as a leader in both scientific and organizational contexts.

High Scientific Productivity: With over 35 peer-reviewed publications, several book chapters, and six U.S. patents, Dr. Ni’s scientific output is substantial. His contributions to industry white papers and his role as an organizer and invited speaker at national and international conferences further affirm his thought leadership in the field.

Recognition and Awards: Dr. Ni has received numerous prestigious awards, such as the Passage Bio High Impact Award, Regeneron High Impact Award, AAPS Excellence in Ligand Binding Assays Award, and Merck Award of Excellence. These accolades reflect his high-impact contributions to the field and recognition by peers and industry leaders.

Areas for Improvement:

Broader Impact Beyond Specialized Fields: While Dr. Ni’s expertise is well-recognized within specialized areas such as biomarkers, precision medicine, and drug development, expanding his influence into broader, interdisciplinary research domains could enhance his candidacy for a “Best Researcher Award.” For example, engaging in research that impacts public health or other critical global issues might increase his visibility and impact.

Further Innovation in Emerging Therapeutic Areas: While Dr. Ni has made significant contributions to established therapeutic areas, greater involvement in cutting-edge fields such as artificial intelligence in drug discovery or personalized medicine could position him as a pioneer in these rapidly evolving areas.

Enhanced Collaboration with Global Initiatives: Although Dr. Ni has demonstrated leadership in professional organizations and consortia, expanding his collaborative efforts to include global health initiatives or large-scale, multi-national research projects could further amplify his contributions and align with broader global research priorities.

Professional Experience

Passage Bio, Philadelphia, PA
Executive Director, Biomarkers and Precision Medicine
2021-Present
Senior Director, Head of Biomarkers and Precision Medicine
2020-2021

Built and led a high-performing team responsible for driving clinical biomarker, PK/biodistribution, immunogenicity studies, and supporting clinical operations.

Developed and implemented biomarker, PK, and immunogenicity strategies to inform decision-making for neurodegenerative disease portfolios.

Led biomarker and precision medicine support for IND/CTA submissions and global regulatory interactions.

Oversaw partnerships with external CROs and laboratories, and collaborated with Clinical Study Teams on biomarker inclusion in clinical portfolios.

Regeneron, Tarrytown, NY
Associate Director, Precision Medicine, Early Clinical Development & Experimental Sciences
2016-2020

Designed and implemented biomarker strategies to support dose selection and efficacy readings for complement-mediated rare diseases.

Provided strategic leadership for discovery and early cardiovascular programs, influencing biomarker-driven decisions on target validation, disease indication selection, and patient stratification.

Led multiple biomarker-focused natural history studies with academic and clinical centers.

Bristol Myers Squibb, Princeton, NJ
Senior Research Investigator II, R&D/PD/ABD/BAS-Biologics
2012-2016

Supported biomarker bioanalytical strategy implementation for immuno-oncology, immunology, and cardiovascular diseases.

Supervised biomarker method development and validation by internal staff and CROs.

Provided strategic and technical input on biomarker bioanalytical plans, resources, and timelines for FIH and PoC studies.

Merck & Co., Inc., Rahway, NJ
Senior Research Scientist, Cardiovascular Franchise Atherosclerosis Group
2007-2011

Led the development of a 2nd generation fully human monoclonal antibody for PCSK9.

Established ELISA-based pharmacodynamics and target engagement biomarker assays.

University of Texas Southwestern Medical Center, Dallas, TX
Research Assistant Professor, Internal Medicine Department, Cardiology
2001-2007
Research Scientist, Department of Pharmacology & Alliance for Cellular Signaling
2001-2007

Conducted research on cardiac hypertrophy, heart failure, and aging, focusing on Akt and FOXO transcriptional factors.

Education and Training

Persuasive Leadership Development: Wharton Business School, University of Pennsylvania

Postdoctoral Training: Yale University, under Professors Gary Rudnick and Eric Nestler

Ph.D. in Neuroscience: University of California, Irvine, under Professor Ricardo Miledi

M.S. in Pharmacology: Institute of Basic Medical Sciences, Beijing, China

B.S. in Biochemistry: Anhui University, Hefei, China

Professional Honors

Passage Bio High Impact Award (2021)

Regeneron High Impact Award and Multiple STAR Awards (2016-2020)

AAPS Excellence in Ligand Binding Assays Award (2015)

BMS R&D ROC Award and Multiple STAR Awards (2014)

Merck Award of Excellence (2007, 2008, 2009)

Professional Affiliations

American Association of Pharmaceutical Scientists (AAPS):

Founding Member and Chair of the Biomarkers and Translational Medicine Community

Founding Member and Chair of the Gene and Cell Therapeutic Products Community

Sino-American Pharmaceutical Professionals Association (SAPA):

Director for Public Outreach and Executive Committee Member

Publications

Yang, J., Mapelli, C., Wang, Z., et al. (2022). An Optimized Agonist Peptide of Protease-activated Receptor 4 and its Use in a Platelet Aggregation Assay to Monitor the Pharmacodynamic Effects of PAR4 Antagonists. Platelets. DOI: 10.1080/09537104.2022.2053091

Hays, A., Amaravadi, L., Fernandez-Metzler, C., et al. (2022). Is Incurred Sample Reanalysis (ISR) applicable in Biomarker Assays? AAPS J, 24:65. DOI: 10.1208/s12248-022-00708-y

Ni, Y.G., King, L., Fernández-Metzler, C. (2022). Recent Progress in Biomarker Bioanalysis and Target Engagement in Bioanalytical Aspects in Biological Therapeutics. ISBN: 9781119523215. Edited by Xu, X. & Xu, W.

Conclusion:

Dr. Yan G. Ni, PhD, is an outstanding candidate for the “Best Researcher Award” based on his extensive contributions to drug development, biomarker research, and precision medicine. His leadership, scientific productivity, and recognition by peers make him a strong contender for the award. However, expanding his research impact into broader and more emerging fields could further strengthen his profile for this prestigious recognition.