Fred Ledley

Fred D. Ledley, M.D. is Professor of Natural & Applied Science and Management at Bentley University and the Founding Director of the Center for Integration of Science and Industry at Bentley University. An accomplished physician scientist, educator, and entrepreneur he is the author of >200 research papers in fields ranging from genetic medicine, cell biology, and biotechnology to strategic drug development and the financing of pharmaceutical innovation. He served previously on the faculties of the Howard Hughes Medical Institute and Baylor College of Medicine and was the founder of several biotechnology companies focused on gene therapy or personalized medicine, serving in the roles of Vice President, Research & Development or President and CEO. His current research focuses on advancing the translation of scientific discoveries for public value by promoting synergies between science, business, and public policy. Recent studies focus on the role of government in promoting pharmaceutical innovation, public and private sector investments in drug discovery and development, and influences on drug pricing and innovation. He has also published on integrating STEM subjects into business education. He has an M.D. from Georgetown University school of Medicine, completed training in Pediatrics and Genetics at Boston Children’s Hospital and Harvard Medical School, and was a post-doctoral fellow with Dr. David Baltimore at the Massachusetts Institute of Technology.

Education

• MD Georgetown University
• B.S. University of Maryland

Teaching Interests

Educating business students for leadership positions in the life science and healthcare industries.

Awards and Honors

• 2022, Presidential Citation, American Society for Head and Neck Surgery
• 2019, Mee Family Prize for lifetime research achievement, Bentley University
• 2018, Bentley University Award for Excellence in Scholarship, Bentley University
• 2014, Fellow of American Association for the Advancement of Science, American Association for the Advancement of Science (AAAS)
• 2012, Outstanding Scholarly Contribution, Bentley University
• 2008, BEN Scholar (Bioscience Education Network) National Science Digital Library and American Association for the Advancement of Science, 2008-2010

Publications

Journal Articles

• Shah, P., Vaughan, G., Ledley, F. D. (2023). Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms.. PLOS ONE.
• Cleary, E., Jackson, M. J., Zhou, E., Ledley, F. D. (2023). Comparison of research spending on new drug approvals by the US National Institutes of Health versus industry, 2010-2019.. JAMA Health Forum, (4(4):e230511) 4(4):e230511 4(4):e230511.
• Zhou, E., Jackson, M. J., Ledley, F. D. (2023). NIH Contribution to phased clinical development of drugs approved from 2010-2019. JAMA Health Forum. 4(7):e231921
• Ledley, F. D., Cleary, E. (2023). NIH funding for patents that contribute to market exclusivity of drugs approved 2010–2019 and the public interest protections of Bayh-Dole. PLOS ONE.
• Kiszewski, A. E., Cleary, E., Jackson, M. J., Ledley, F. D. (2021). NIH funding for vaccine readiness before the COVID-19 pandemic.. Vaccine. 39 2458-2466.
• Cleary, E., McNamee, L. M., de Boer, S., Holden, J., Fitzgerald, L., Ledley, F. D. (2021). Comparing long-term value creation after biotech and non-biotech IPOs, 1997-2016. PLOS Onre.
• Cleary, E., Jackson, M., Acevedo, A., Ledley, F. D. (2020). Characterizing the public sector contribution to drug discovery and development: the role of government as a first investor. Institute for New Economic Thinking.
• Cleary, E., Jackson, M. J., Folchman-Wagner, Z., Ledley, F. D. (2020). Foundational research and NIH funding enabling Emergency Use Authorization of remdesivir for COVID-19. medRxiv.
• Kiszewski, A. E., Cleary, E., Jackson, M. J., Ledley, F. D. (2020). The role of NIH funding in vaccine readiness; foundational research and NIH funding underlying candidate SARS-CoV-2 vaccines. medRxiv.
• McNamee, L. M., Zheng, S., Salim, U., Cleary, E., Ledley, F. D. (2020). Drug development in biotechnology companies with IPOs from 1997-2016.. Clinical Therapeutics. 43 156-171.
• Cleary, E., Ledley, F. D. (2020). NIH funding for research underlying new cancer therapies.. The Lancet. Oncology, (21) 6 755-757.
• Wernick NLB, ., Ledley, F. D. (2020). We Don't Have to Lose STEM Students to Business.. Journal of microbiology & biology education, (21) 1
• Ledley, F. D., McCoy, S. S., Vaughan, G., Cleary, E. (2020). Profitability of Large Pharmaceutical Companies Compared With Other Large Public Companies.. JAMA, (323) 9 834-843.
• Simon, S., Meldrum, H., Ndung'u, E., Ledley, F. D. (2018). Representation of industry in introductory biology textbooks; a missed opportunity to advance student learning. CBE Life Science Education, (17) 4
• Cleary, E., Beierlein, J. M., Khanukja, N., McNamee, L. M., Ledley, F. D. (2018). Contribution of NIH funding to new drug approvals 2010-2016. Proceedings of the National Academy of Sciences USA. 115.10 2329-2334.
• Beierlein, J. M., McNamee, L. M., Ledley, F. D. (2017). As technologies for nucleotide therapeutics mature, products emerge. Molecular Therapy: Nucleic Acid . 10.1016/j.omtn.2017.10.017.
• Beierlein, J. M., McNamee, L. M., Walsh, M. J., Kaitin, K. I., DiMasi, J. A., Ledley, F. D. (2017). Landscape of innovation for cardiovascular pharmaceuticals: from basic science to new molecular entities. Clinical Therapeutics, (39) 1409-1425.
• McNamee, L. M., Ledley, F. D. (2017). Modeling timelines for translational science in cancer; the impact of technological maturity.. PLoS ONE, (12.3, e0174538 )
• McNamee, L. M., Walsh, M. J., Ledley, F. D. (2017). Timelines of translational science: from technology initiation to FDA approval . PLoS ONE. 12.5 e0177371.
• Bouldin, R. M., Hall, G. J., Oches, E. A., Szymanski, D. W., Ledley, F. D. (2015). Connecting Business and STEM Education Through Undergraduate Research. Council on Undergraduate Research Quarterly, (35) 4 17-24.
• McNamee, L. M., Ledley, F. D. (2015). What does the current biotech stock market value? . Nature Biotechnology. 33813-4
• Beierlein, J. M., McNamee, L. M., Walsh, M. J., Ledley, F. D. (2015). Patterns of Innovation in Alzheimer's Disease Drug Development: A Strategic Assessment Based on Technological Maturity. Clinical Therapeutics, (37) 8 1643-1651.
• Wernick, N. L., Haughton, D. M., Ndung'u, E., Ledley, F. D. (2014). Positioning Genomics in Biology Education: Content Mapping of Undergraduate Biology Textbooks. Journal of Microbiology and Biology Education, (15) 2
• McNamee, L. M., Ledley, F. D. (2013). Translational Science by Public Biotechnology Companies in the IPO“Class of 2000”: The Impact of Technological Maturit. PLoS ONE, (8) 12 e82195.
• Ledley, F. D., McNamee, L. M., Uzdil, V., Morgan, I. W. (2013). Why commercialization of gene therapy stalled; examining the life cycles of gene therapy technologies . Gene Therapy.
• McNamee, L. M., Ledley, F. D. (2013). Making the biotech IPO work. Nature Biotechnology, (31) 969-970.
• McNamee, L. M., Ledley, F. D. (2013). Assessing the history and value of Human Genome Sciences. . Journal of Commercial Biotechnology, (19) 4 3-10.
• Ledley, F. D. (2012). Bridging the boundary between science and business through education. International Journal of Science in Society, (3) 3 171-194.
• Ledley, F. D., Holt, S. (2012). Learning Objectives and Content of Science Curricula for Undergraduate Management Education. Journal of Management Education.
• McNamee, L. M., Ledley, F. D. (2012). Patterns of technological innovation in biotechnology.. Nature Biotechnology, (30) 10 937-943.
• Ledley, F. D., Ndung'u, E. (2011). Use of genomic databases for inquiry-based learning about influenza. Journal of College Science Teaching. 40 70-76.
• Ledley, F. D. (2004). Can DTC deliver the health benefits of genomics to the public? . DTC Perspectives .
• Ledley, F. D. (2002). A Consumer Charter for Human Genetics. Nature Biotechnology. 20 767.
• Ledley, F. D. (1999). Can Pharmacogenomics Make a Difference in Drug Development?. Nature Biotechnology. 17 731.
• Ledley, F. D., Ledley, T. A. (1998). Pharmacokinetic Considerations in Somatic Gene Therapy. Advanced Drug Delivery Reviews. 30 133-150.
• Ledley, F. D., Housman, D. (1998). Why Pharmacogenomics? Why Now?. Nature Biotechnology. 16 492-493.
• Ledley, F. D., Rosenblatt, D. S. (1997). Methylmalonyl CoA Mutase. Human Mutation. 9 1-6.
• Rosenblatt, D. S., Ledley, F. D. (1996). A Molecular Study of Methylmalonic Aciduria: Structure-Function Correlations. Bulletin Academy National Medicine. 180 1553-1563.
• Adams, R. M., Wang, M., Crane, A. M., Brown, B., Darlington, G., Ledley, F. D. (1996). Effective cryopreservation and long term storage of primary human hepatocytes with recovery of viability, differentiation, and replicative potential. Cell Transplantation. 4 579-86.
• Ledley, F. D., Anderson, W. F. (1996). Gene therapy for cardiovascular disease: an introduction.. Marcel Dekker. 467-485.
• Ledley, F. D. (1996). Gene therapy in pediatric medicine. Advances in Pediatrics. 43 1-25.
• Drennan, C. L., Matthews, R. G., Rosenblatt, D. S., Ledley, F. D., Fenton, W. A., Ludwig, M. L. (1996). Molecular basis for dysfunction of some mutant forms of methylmalonyl CoA mutase deductions from the structure of methionine synthase. Proceedings of the National Academy of Sciences USA. 93 5550-5555.
• Ledley, F. D. (1996). Our Study is Man (and Woman). Human Gene Therapy. 7 1193-1195.
• Ledley, F. D. (1996). Pharmaceutical Approach to Somatic Gene Therapy. Pharmaceutical Research. 13 1595-1614.
• Ledley, F. D. (1996). Somatic gene therapy: applications in arthritis. Arthritis and Allied Conditions: A Textbook of Rheumatology.. .
• Ledley, F. D. (1995). After gene therapy: Issues in long term follow-up and care. Advances in Genetics. 32 1-16.
• Ledley, F. D. (1995). Assessing Risk (editorial). Human Gene Therapy. 6 551-552.
• Ledley, F. D. (1995). Gene transfer into the intestinal epithelium. Human Gene Therapy. . PubMed PMID: 8527472.. Sep;6(9):1145-51..
• Yovandich, J., O'Malley Jr., B. W., Sikes, M., Ledley, F. D. (1995). Gene transfer to synovial cells by intra articular administration of plasmid DNA. Human Gene Therapy. 6 603-610.
• Adams, R. M., Wang, M., Steffen, D., Ledley, F. D. (1995). Infection by retroviral vectors outside of their host range in the presence of replication-defective adenovirus. Journal of Virology. 69 1887-1894.
• Ledley, F. D. (1995). Non-viral gene therapies: the promise of genes as pharmaceutical products. Human Gene Therapy. 6 1129-1144.
• Ledley, F. D. (1995). When are genes investigational drugs?. Expert Opinion in Investigational Drugs. 4 781-782.
• Ledley, T. A., Ledley, F. D. (1994). A multicompartment, numerical model of cellular events in the pharmacokinetics of gene therapy. Human Gene Therapy. 5 679-691.
• Lovejoy Jr., F. H., Ledley, F. D., Nathan, D. G. (1994). Academic Careers: choice and activity of graduates of a pediatric residency program. Transactions of the American Clinical and Climatological Association. 54 180-197.
• Qureshi, A. A., Crane, A. M., Matiaszuk, N. V., Rezvani, I., Ledley, F. D., Rosenblatt, D. S. (1994). Cloning and expression of mutations demonstrating intragenic complementation in muto methylmalonic aciduria. The Journal of Clinical Investigation. 93 1812-1819.
• Crane, A. M., Ledley, F. D. (1994). Cluster of mutations within methylmalonyl CoA mutase associated with mut- methylmalonic acidemia, intra-allelic complementation, and impaired adenosylcobalamin binding. American Journal of Human Genetics.. 55 42-50.
• Ledley, F. D. (1994). Designing clinical trials of somatic gene therapy. Proceedings of the New York Academy of Sciences. 716 283-293.
• Ledley, F. D. (1994). Development in somatic gene therapy. Expert Opinion in Investigational Drugs. 3 913-921.
• Ledley, F. D. (1994). Distinguishing genetics and eugenics on the basis of fairness. Journal of Medical Ethics. 20 157-164.
• O'Malley Jr., B. W., Adams, R. M., Sikes, M. L., Ledley, F. D. (1994). Gene transfer into human thyroid follicular cells. Laryngoscope. 5 837-44.
• Wilkemeyer, M. F., Andrews, E., Ledley, F. D. (1994). Genomic structure of murine methylmalonyl CoA mutase: evidence for genetic and epigenetic mechanisms regulating enzyme activity. The Biochemical Journal. 296 663-670.
• Sikes, M., O'Malley, B. W., Finegold Jr., M. J., Ledley, F. D. (1994). In vivo gene transfer into rabbit thyroid follicular cells by direct DNA injection. Human Gene Therapy. 5 837-834.
• Ledley, F. D. (1994). Non-viral gene therapies. Current Opinion Biotechnology. 5 626-636.
• Stankovics, J., Andrews, E., Crane, A. M., Wu, C. T., Wu, G. Y., Ledley, F. D. (1994). Overexpression of human methylmalonyl CoA mutase in mice after in vivo gene transfer with asialoglycoprotein/polylysine/plasmid complexes. Human Gene Therapy. 5 1095-1104.
• Ledley, F. D. (1994). Somatic gene therapy. Inherited metabolic disease. Diagnosis and treatment . 2nd 429-438.
• Ledley, F. D. (1994). The therapeutic promise of molecular genetics. Journal of Investigative Dermatology . 103(5 Suppl) 2-5.
• Abramowicz, M. J., Andrien, M., Dupont, E., Dorchy, H., Parma, J., Duprez, L., Ledley, F. D., Courtens, W., Vamos, E. (1994). Uniparental disomy of chromosome 6 involving the HLA region in a newborn with methylmalonic acidemia and diabetes mellitus. Journal of Clinical Investigation. 94 418-21.
• O'Malley Jr., B. W., Ledley, F. D. (1993). Applications of somatic gene therapy in head and neck surgery. Archives of Otolaryngology, Head & Neck Surgery. 119 1191-1198.
• Ledley, F. D. (1993). Are contemporary methods for somatic gene therapy suitable for clinical applications?. Clinical and Investigative Medicine. 16 78-88.
• O'Malley Jr., B. W., Finegold, M., Ledley, F. D. (1993). Autologous orthotopic thyroid follicular cell transplantation: a surgical component of ex vivo somatic gene therapy. Otolaryngology, Head, and Neck Surgery. 108 51-62.
• Stankovics, J., Ledley, F. D. (1993). Cloning of functional alpha propionyl CoA carboxylase and correction of enzyme deficiency in PCCA fibroblasts. American Journal of Human Genetics. 52 144-151.
• Sawada, T., Ledley, F. D. (1993). Correction of methylmalonyl CoA mutase deficiency in muto fibroblasts and constitution of gene expression in primary human hepatocytes by retroviral mediated gene transfer. Somatic Cell and Molecular Genetics. 18 507-516.
• Ledley, F. D., Adams, R. M., Soriano, H. E., Darlington, G. J., Finegold, M., Lanford, R., Carey, D., Lewis, D., Baley, P., Rothenberg, S., Kay, M., Brandt, M., Moen, R., Anderson, W. F., Whittington, P., Pokorny, W., Woo, S. L. (1993). Development of a clinical protocol for hepatic gene transfer: lessons learned in pre-clinical studies. Pediatric Research. 33 313-320.
• O'Malley Jr., B. W., Ledley, F. D. (1993). DNA and viral mediated gene transfer in follicular cells: progress toward gene therapy of the thyroid. Laryngoscope. 103 1084-1092.
• Ledley, F. D. (1993). Evolution and the Biologist's Daughter. Perspectives in Biology and Medicine. 36 281-288.
• Cholin, S., Tonoki, H., Hansen, T., Ledley, F. D. (1993). Expression of recombinant human Glutathione Reductase in Eukaryotic Cells after DNA Mediated Gene Transfer. Biochemical Medicine Metabolic Biology. 49 108-113.
• Andrews, E., Jansen, R., Crane, A. M., Cholin, S., MacDonall, D., Ledley, F. D. (1993). Expression of recombinant human Methylmalonyl CoA mutase in primary mut fibroblasts and Saccharomyces cerevisiae. Biochemical Medicine and Metabolic Biology. 50 135-144.
• Ledley, F. D., Lovejoy Jr., F. H. (1993). Factors influencing the interests, career paths, and research activities of recent graduates from an academic, pediatric residency program. Pediatrics. 92 436-441.
• Soriano, H. E., Lewis, D., Legner, M., Finegold, M., Ledley, F. D. (1993). Feasibility of hepatocellular transplantation via the umbilical vein in prenatal and perinatal lambs. Fetal Diagnosis and Therapy. 8 293-304.
• Ledley, F. D. (1993). Hepatic gene therapy: present and future. Hepatology. 18 1263-1273.
• Ledley, F. D. (1993). Prenatal Application of Somatic Gene Therapy. Obstetrics and Gynecology Clinics of North America. 20 611-620.
• Wilkemeyer, M. F., Stankovics, J., Foy, T., Ledley, F. D. (1993). Propionate metabolism in cultured human cells after over expression of recombinant methylmalonyl CoA mutase: Implications for somatic gene therapy. Somatic Cell and Molecular Genetics. 18 493-505.
• O'Malley, B. W., Jr.Adams, R. M., Sikes, M. L., Ledley, F. D. (1993). Retroviral mediated gene transfer into canine thyroid using an ex vivo strategy. Human Gene Therapy. 4 171-177.
• O'Malley Jr., B. W., Ledley, F. D. (1993). Somatic gene therapy; methods for present and future. Archives of Otolaryngology, Head & Neck Surgery. 119 1100-1107.
• Shevell, M. I., Matiaszuk, N., Ledley, F. D., Rosenblatt, D. S. (1993). Varying neurological phenotypes among muto and mut patients with methylmalonyl CoA mutase deficiency. American Journal of Medical Genetics. 45 619-24.
• Crane, A. M., Jansen, R., Andrews, E., Ledley, F. D. (1992). Cloning and expression of a mutant methylmalonyl coenzyme A mutase with altered cobalamin affinity that causes mut- methylmalonic aciduria. Journal of Clinical Investigation. 89 385-391.
• Vaden, S. L., Wood, P. A., Ledley, F. D., Cornwell, P. E., Miller, R. T., Page, R. L. (1992). Cobalamin deficiency associated with methylmalonic acidemia in a cat. Journal of the Veterinary Medical Association. 200 1101-113.
• Ledley, F. D. (1992). Current Status of Somatic Gene Therapy. Growth, Genetics, & Hormones. 8 1-5.
• Ledley, F. D., Soriano, H. E., O'Malley Jr., B. W., Darlington, L. D., Finegold, G. J. (1992). DiI as a marker for cellular transplantation into solid organs. BioTechniques. 123 581-587.
• Soriano, H. E., Gest, A., Bair, D., Vander-Straten, M., Lewis, D., Brandt, M., Finegold, M., Ledley, F. D. (1992). Hepatocellular transplantation (HCT) via the umbilical vein in fetal and newborn lamb. Transplantation Proceedings. 24 2964-2965.
• Ledley, F. D. (1992). Organ transplantation for genetic disease. Current Opinion in Pediatrics. 4 972-977.
• Crane, A. M., Martin, L., Valle, D., Ledley, F. D. (1992). Phenotype of disease in patients with identical genotypes of mut- methylmalonic aciduria. Human Genetics. 89 259-64.
• Ledley, F. D., Lovejoy Jr., F. H. (1992). Publication record of recent graduates from an academic, pediatric training program: assessing the development of academic physicians. Clinical and Investigative Medicine. 15 518-526.
• Soriano, H. E., Adams, R. M., Darlington, G., Finegold, M., Steffen, D. L., Ledley, F. D. (1992). Retroviral transduction of human hepatocytes and orthotopic engraftment in SCID mice after hepatocellular transplantation (HCT). Transplantation Proceedings. 24 3020-3021.
• Ledley, F. D. (1992). Somatic gene therapy in gastroenterology: approaches and applications. Journal of Pediatric Gastroenterology and Nutrition. 14 328-37.
• O'Malley Jr., B. W., Sikes, M. L., Adams, R. M., Finegold, M. J., Ledley, F. D. (1992). Somatic gene therapy targeted to the thyroid: DNA mediated and viral mediated gene transfer in animal models. Transplantation Proceedings. 24 2973-2974.
• Ledley, F. D. (1992). The application of gene therapy to pediatric practice. International Pediatrics. 7 7-15.
• Ledley, F. D., Brody, B., Kozinetz, C., Mize, M. (1992). The challenge of follow-up for clinical trials of somatic gene therapy. Human Gene Therapy. 3 657-664.
• Ledley, F. D. (1992). The quality of medical science. Clinical and Investigative Medicine. 15 513-517.
• Adams, R. M., Soriano, H. E., Wang, M., Darlington, G., Steffen, D., Ledley, F. D. (1992). Transduction of primary human hepatocytes with amphotropic and xenotropic retroviral vectors. Proceedings of the National Academy of Sciences USA. 89 8981-8985.
• Soriano, H. E., Lewis, D., Legner, M., Brandt, M., Baley, P., Darlington, G., Finegold, M., Ledley, F. D. (1992). Use of DiI marked hepatocytes to demonstrate orthotopic, intrahepatic engraftment following hepatocellular transplantation. Transplantation. 54 717-723.
• Ledley, F. D. (1991). Clinical application of genotypic diagnosis for phenylketonuria: theoretical consideration. European Journal of Pediatrics. 150 752-756.
• Ledley, F. D. (1991). Clinical considerations in the design of protocols for somatic gene therapy. Human Gene Therapy. 2 77-84.
• Wilkemeyer, M. F., Crane, A. M., Ledley, F. D. (1991). Differential diagnosis of mut and cbl methylmalonic aciduria by DNA-mediated gene transfer in primary fibroblasts. Journal of Clinical Investigation. 87 915-918.
• Raff, M. L., Crane, A. M., Jansen, R., Ledley, F. D., Rosenblatt, D. S. (1991). Genetic characterization of a MUT locus mutation discriminating heterogeneity in muto and mut- methylmalonic aciduria by intra-allelic complementation. Journal of Clinical Investigation. 87 203-207.
• Ledley, F. D., Woo, S. L., Ferry, G. D., Whisennand, H. H., Brandt, M. L., Darlington, G. J., Demmler, G. J., Finegold, M. J., Pokorny, W. J., Rosenblatt, H., Schwartz, P., Moen, R. C., Anderson, W. F. (1991). Hepatocellular transplantation in acute hepatic failure and targeting genetic markers to hepatic cells. (Text of clinical protocol for gene transfer into hepatocytes approved by Human Gene Therapy Subcommittee, Recombinant DNA Advisory Committee, and director of the NIH. Human Gene Therapy. 2 331-358.
• Hinds, M., Deisseroth, K., Mayes, J., Altschuler, E., Jansen, R., Ledley, F. D., Zwelling, L. A. (1991). Identification of a point mutation in the topoisomerase II gene from a human leukemia cell line containing an Amacrine-resistant form of topoisomerase II. Cancer Research. 51 4719-4731.
• Ledley, F. D., Crane, A. M., Klish, K., May, G. (1991). Is there methylmalonyl CoA mutase in Aspergillus nidulans?. Biochemical and Biophysical Research Communications. 177 1076-1081.
• Shapira, S. K., Ledley, F. D., Rosenblatt, D. S., Levy, H. L. (1991). Ketoacidotic crisis as a presentation of "benign" methylmalonic acidemia.. Journal of Pediatrics. 119 80-84.
• Ponder, K. P., Gupta, S., Leland, F., Darlington, G., Finegold, M., DeMayo, J., Ledley, F. D., Chowdhury, J. R., Woo, S. L. (1991). Mouse hepatocytes migrate to liver parenchyma and function indefinitely after intrasplenic transplantation. Proceedings of the National Academy of Sciences USA. 88 1217-21.
• Ledley, F. D. (1991). The physician scientist's role in medical research and the mythology of the intellectual tradition. Perspectives in Biology and Medicine. 34 410-420.
• Zwelling, L. A., Mayes, J., Deisseroth, K., Hinds, M., Grant, G., Pathak, S., Ledley, F. D., Vyas, R., Hittelman, W. (1990). A restriction fragment length polymorphism for human topoisomerase II: Its possible relationship to drug-resistance. Cancer Communications. 2 357-61.
• Ledley, F. D. (1990). Clinical application of somatic gene therapy in inborn errors of metabolism. Journal of Inherited Metabolic Disease. 13 597-616.
• Sifers, R. N., Ledley, F. D., Reed-Fourquet, L., Ledbetter, D. H., Ledbetter, S. A., Woo, S. L. (1990). Complete cDNA sequence and chromosomal localization of mouse alpha1-antitrypsin. Genomics. 6 100-104.
• Jansen, R., Ledley, F. D. (1990). Disruption of phase during PCR amplification and cloning of heterozygous target sequences. Nucleic Acids Research. 19 5153-56.
• Ledley, F. D., Crane, A. M., Lumetta, M. (1990). Heterogenous alleles and expressionof methylmalonyl CoA mutase in mut methylmalonic acidemia. AmericanJournal of Human Genetics. 46 539-547.
• Jansen, R., Ledley, F. D. (1990). Heterozygous mutations at the mut locus in fibroblasts with muto methylmalonic acidemia identified by PCR cDNA cloning. American Journal of Human Genetics. 47 808-814.
• Threadgill, D. W., Wilkemeyer, M. F., Womack, J. E., Ledley, F. D. (1990). Localization of the murine methylmalonyl CoA mutase (Mut) locus on chromosome 17 by in situ hybridization. Cytogenetics and Cell Genetics. 53 112-114.
• Sertic, J., Vincek, V., Ledley, F. D., Figueroa, F., Klein, J. (1990). Mapping of the L-methylmalonyl CoA mutase gene to mouse chromosome 17. Genomics. 6 560-564.
• Ledley, F. D., Grenett, H. E., Dunbar, B. S., Woo, S. L. (1990). Mouse phenylalanine hydroxylase: homology and divergence from human phenylalanine hydroxylase. The Biochemical Journal. 267 399-406.
• Ledley, F. D., Jansen, R., Nham, S. U., Fenton, W. E., Rosenberg, L. E. (1990). Mutation eliminating mitochondrial leader sequence of methylmalonyl CoA mutase causes muto Methylmalonic Acidemia. Proceedings of the National Academy of Sciences USA. 87 3147-3150.
• Ledley, F. D. (1990). Perspectives on methylmalonic acidemia resulting from molecular cloning of methylmalonyl CoA mutase. Bioessays. 12 335-340.
• Wilkemeyer, M. F., Crane, A. M., Ledley, F. D. (1990). Primary structure and activity of murine methylmalonyl CoA mutase. The Biochemical Journal. 271 449-455.
• Nham, S. U., Wilkemeyer, M. F., Ledley, F. D. (1990). Structure of the human methylmalonyl CoA mutase (MUT) locus. Genomics. 8 710-716.
• Jansen, R., Kalousek, F., Fenton, W., Rosenberg, L. E., Ledley, F. D. (1989). Cloning of full-length methylmalonyl-CoA mutase from a cDNA library using the polymerase chain reaction. Genomics. 4 198-205.
• Ledley, F. D., Koch, R., Beaudet, A., O'Brien, W. E., Bartos, D. P., Woo, S. L., Jew, K. (1989). Phenylalanine hydroxylase expression in the liver of a fetus with phenylketonuria. Genetic Counseling and the Outcome of Phenylketonuria. Journal of Pediatrics. 113:463-467. 113(3):463-8..
• Jansen, R., Ledley, F. D. (1989). Production of high specific activity DNA probes by the polymerase chain reaction. Gene Analysis Techniques. 6 79-83.
• Cheng, S. V., Martin, G. R., Nadeau, J. H., Haines, J. L., Bucan, M., Kozak, C. A., MacDonald, M. E., Lockyer, J. L., Ledley, F. D., Woo, S. L., Lehrach, H., Gilliam, T. C., Gusella, J. F. (1989). Synteny on mouse chromosome 5 of human loci linked to Huntington's Disease. Genomics. 4 419-426.
• McDonald, J. D., Cotton, R. G., Jennings, I., Ledley, F. D., Woo, S. L., Bode, V. C. (1988). Biochemical defect of the hph 1 mouse mutant is a deficiency of GTP cyclohydrolase activity. Journal of Neurochemistry. 50 655-657.
• Zoghbi, H., O'Brien, W. E., Ledley, F. D. (1988). Linkage relationships of the human methylmalonyl CoA mutase to the HLA and D6S4 loci on chromosome 6. Genomics. 3 396-398.
• Ledley, F. D., Ledbetter, S. A., Ledbetter, D. H., Woo, S. L. (1988). Localization of mouse phenylalanine hydroxylase locus on chromosome 10. Cytogenetics and Cell Genetics. 47 125-126.
• Ledley, F. D., Lumetta, M. R., Zoghbi, H. Y., VanTuinen, P., Ledbetter, S. A., Ledbetter, D. H. (1988). Mapping of human methylmalonyl CoA mutase (MUT) locus on chromosome 6. American Journal of Human Genetics. 42 839-846.
• Ledley, F. D., Lumetta, M., Nguyen, P. N., Kolhouse, J. F., Allen, R. A. (1988). Molecular cloning of L-methylmalonyl CoA mutase: gene transfer and analysis of mut cell lines. Proceedings of National Academy of Science. 85 3518-21.
• Peng, H., Armentano, D., Graham, L., Ledley, F. D., Woo, S. L. (1988). Retroviral-mediated gene transfer and expression of human phenylalanine hydroxylase in primary mouse hepatocytes. Proceedings of the National Academy of Sciences USA. 85 8146-8150.
• Ledley, F. D., Grenett, H. E., Bartos, D. P., vanTuinen, P., Ledbetter, D. H., Woo, S. L. (1987). Assignment of human tryptophan hydroxylase locus to chromosome 11: gene duplication and translocation in evolution of the aromatic amino acid hydroxylases. Somatic Cell and Molecular Genetics. 13 575-580.
• Ledley, F. D., Grenett, H. E., Woo, S. L. (1987). Biochemical characterization of recombinant human phenylalanine hydroxylase produced in E. Coli. Journal of Biological Chemistry. 262 2228-2233.
• Guttler, F., Lidsky, A. S., Ledley, F. D., DiLella, A. G., Sullivan, S. E., Woo, S. L. (1987). Correlation between polymorphic DNA haplotypes at phenylalanine hydroxylase locus and clinical phenotypes of phenylketonuria. Journal of Pediatrics. 110 68-71.
• Grenett, H. E., Ledley, F. D., Reed, L. L., Woo, S. L. (1987). Full length cDNA for rabbit tryptophan hydroxylase: functional domains and evolution of aromatic amino acid hydroxylases. Proceedings of the National Academy of Sciences USA. 84 5530-5534.
• Marvitt, J., DiLella, A. G., Brayton, K., Ledley, F. D., Robson, K. J., Woo, S. L. (1987). GT to AT transition at a splice donor site causes skipping of the preceding exon in phenylketonuria. Nucleic Acids Research. 15 5613-5628.
• Woo, S. L., DiLella, A. G., Marvit, J., Ledley, F. D. (1987). Molecular basis of phenylketonuria and potential somatic gene therapy. Cold Spring Harbor Symposium in Quantitative Biology. 51 395-401.
• Woo, S. L., DiLella, A. G., Marvit, J., Ledley, F. D. (1987). Molecular Basis of Phenylketonuria and recombinant DNA strategies for therapy. Enzyme. 38 207-213.
• Guttler, F., DiLella, A. G., Ledley, F. D., Lidsky, A. S., Kwok, S. C., Marvit, J., Woo, S. (1987). Molecular Biology of Phenylketonuria. European Journal of Pediatrics. 146(sup1) 11-May.
• Bao, J. J., Sifers, R. N., Kidd, V. J., Ledley, F. D., Woo, S. L. (1987). Molecular evolution of serpins: homologous structure of the human alpha1 antichymotrypsin and alpha1 antitrypsin genes. Biochemistry. 26 7755-7759.
• Ledley, F. D., Woo, S. L. (1987). P chlorophenylalanine does not inhibit production of recombinant human phenylalanine hydroxylase in NIH3T3 cells or E. Coli. Biochemical and Biophysical Research Communications. 142 302-308.
• MacDonald, M. E., Anderson, M. A., Lockyer, J. L., Milstein, S., Hobbs, W. J., Kaufman, S., Faryniarz, A. G., Ledley, F. D., Woo, S. L., Gusella, J. F. (1987). Physical and Genetic Localization of the quinonoid dihydropteridine reductase gene (QDPR) on the short arm of chromosome 4. Somatic Cell and Molecular Genetics. 13 569-574.
• Ledley, F. D., Woo, S. L. (1987). Prospects for somatic gene therapy of phenylketonuria. Amino Acids in Health and Disease, New Perspectives. UCLA symposia on molecular and cellular biology New Series. Alan R. Liss, (55) 565-580.
• Ledley, F. D., Darlington, G. J., Hahn, T., Woo, S. L. (1987). Retroviral gene transfer into primary hepatocytes: implications for genetic therapy of liver specific functions. Proceedings of the National Academy of Sciences USA. 84 5335-5339.
• Ledley, F. D., Grenett, H. E., Bartos, D. P., Woo, S. L. (1987). Retroviral mediated transfer and expression of human alpha1-antitrypsin in cultured cells. Gene. 61 113-118.
• Ledley, F. D., Hahn, T., Woo, S. L. (1987). Selection for phenylalanine hydroxylase activity in cells transformed with recombinant retrovirus. Somatic Cell and Molecular Genetics. 13 145-154.
• Ledley, F. D. (1987). Somatic gene therapy for human disease: a problem of eugenics?. Trends in Genetics. 3 112-115.
• Ledley, F. D. (1987). Somatic gene therapy for human disease: background and prospects (Part I). J Pediatr. 1987 Feb; PMID: 3100752 [PubMed - indexed for MEDLINE]. 110(2):167-74.
• Lockyer, J., Cook, R. G., Milstein, S., Kaufman, S., Woo, S. L., Ledley, F. D. (1987). Structure and expression of human dihydropteridine reductase. Proceedings of the National Academy of Sciences USA. 84 3329-3333.
• Ledley, F. D., Woo, S. L., Grenett, H. E. (1987). Structure of aromatic amino acid hydroxylases. Amino Acids in Health and Disease: New Perspectives. New Series. Alan R. Liss. UCLA symposia on molecular and cellular biology, (55) 267-284.
• Ledley, F. D. (1987). Somatic gene therapy for human disease: background and prospects (Part I). J Pediatr. PMID: 3100752 [PubMed - indexed for MEDLINE]. 110(2):167-74..
• Ledley, F. D., Levy, H., Woo, S. L. (1986). Molecular analysis of the inheritance of phenylketonuria and mild hyperphenylalaninemia in families with both disorders. New England Journal of Medicine. 314 1276-1280.
• Ledley, F. D., Woo, S. L. (1986). Molecular basis of alpha1 antitrypsin deficiency and its potential therapy by gene transfer. Journal of Inherited and Metabolic Disease. 9(suppl 1) 85-91.
• DiLella, A. G., Kwok, S. C., Ledley, F. D., Marvit, J., Woo, S. L. (1986). Molecular structure and polymorphic map of the human phenylalanine hydroxylase gene. Biochemistry. 25 743-749.
• Ledley, F. D., Grenett, H. E., McGinnis Shelnutt, M., Woo, S. L. (1986). Retroviral mediated gene transfer of human phenylalanine hydroxylase into NIH3T3 and hepatoma cells. Proceedings of the National Academy of Sciences USA. 83 409-413.
• DiLella, A. G., Ledley, F. D., Rey, F., Munich, A., Woo, S. L. (1985). Detection of phenylalanine hydroxylase messenger RNA in PKU liver biopsy samples from patients with phenylketonuria. Lancet. 19 160-161.
• Lidsky, A., Ledley, F. D., DiLella, A. G., Kwok, S. C., Daiger, S. P., Robson, K. J., Woo, S. L. (1985). Extensive restriction site polymorphisms in the human phenylalanine hydroxylase locus and application in prenatal diagnosis of phenylketonuria. American Journal of Human Genetics. 37 619-634.
• Ledley, F. D., Grenett, H. E., DiLella, A. G., Kwok, S. C., Woo, S. L. (1985). Gene transfer and expression of human phenylalanine hydroxylase. Science. 228 77-79.
• Ledley, F. D., DiLella, A. G., Kwok, S. C., Woo, S. L. (1985). Homology between phenylalanine and tyrosine hydroxylases reveals common structural and functional domains. Biochemistry. 24 3389-3394.
• Ledley, F. D., DiLella, A., Woo, S. (1985). Molecular biology of phenylalanine hydroxylase and phenylketonuria. Trends in Genetics. 1 309-313.
• Kwok, S. C., Ledley, F. D., DiLella, A. G., Robson, K. J., Woo, S. L. (1985). Nucleotide sequence of a full length cDNA clone and amino acid sequence of human phenylalanine hydroxylase. Biochemistry. 24 556-561.
• Woo, S. L., Güttler, F., Ledley, F. D., Lidsky, F. D., Kwok, A. S., DiLella, S. C., Robson, K. J. (1985). The human phenylalanine hydroxylase gene. Medical Genetics Past, Present, Future. Alan R. Liss, New York. . 123-138.
• Ledley, F. D., Levy, H. L., Shih, V. E., Benjamin, R., Mahoney, M. J. (1984). Benign methylmalonic aciduria. New England Journal of Medicine. 311 1015-1018.
• Wang, J. Y., Ledley, F. D., Goff, S., Lee, R., Groner, Y., Baltimore, D. (1984). The mouse c abl locus: Molecular cloning and characterization. Cell. 36 349-356.
• Ledley, F. D. (1983). Recombinant DNA and the Copernican world view. Perspectives in Biology and Medicine. 26 245-260 .
• Ledley, F. D. (1982). Evolution and the human tail, a case report.. N Engl J Med.; PMID: 7070433 [PubMed - indexed for MEDLINE]. 306(20):1212-5.
• Habig, W. H., Ledley, F. D., Grollman, E. F., Meldolesi, M. F., Aloj, S. M., Hardegree, M. C., Kohn, L. D. (1978). Tetanus toxin interactions with the thyroid: decreased toxin binding to membranes from a thyroid tumor with a thyrotropin receptor defect and in vivo stimulation of thyroid function. Endocrinology. 102 844-851.
• Meldolesi, M. F., Fishman, P. H., Aloj, S. M., Ledley, F. D., Lee, G., Bradley, R. M., Brady, R. O., Kohn, L. D. (1977). Separation of the glycoprotein and ganglioside components of thyrotropin receptor activity in plasma membranes. Biochemical and Biophysical Research Communications. 75 581-588.
• Ledley, F. D., Lee, G., Kohn, L. D., Habig, W. H., Hardegree, M. D. (1977). Tetanus toxin interactions with thyroid plasma membranes: implications for the structure and function of tetanus toxin receptors and potential pathophysiological significance. Journal of Biological Chemistry. 252 4029-4055.
• Ledley, F. D., Mullin, B. R., Lee, G., Aloj, S. M., Fishman, P. H., Hunt, L. T., Dayhoff, M. O., Kohn, L. D. (1976). Sequence similarity between cholera toxin and the glycoprotein hormones: implications for structure activity relationships and the mechanism of action. Biochemical Biophysical Research Communications. 69 852-859.
• Mullin, B. R., Fishman, P. H., Lee, G., Aloj, S. M., Ledley, F. D., Winand, R. J., Kohn, L. D., Brady, R. O. (1976). Thyrotropin ganglioside interactions and their relationship to the structure and function of thyrotropin receptors. Proceedings of the National Academy of Sciences USA. 73 842-846.
• Mullin, B. R., Lee, G., Ledley, F. D., Winand, R. J., Kohn, L. D. (1976). Thyrotropin interactions with human fat cell membrane preparations and the finding of a soluble thyrotropin binding component. Biochemical and Biophysical Research Communications. 69 55-62.
• Ledley, F. D., Wilson, J. B. (1974). Computer analysis of ultrasound cardiograms. Computers in Biology and Medicine. 4 27-41.

Books

• Ledley, F. D. (2011). Sputnik's Child. 334. CreateSpace

Book Chapters

• Ledley, F. D., Oches, E. A. (2013). Business Education in an age of science and technology In Everett, D., and Hardy, G., (Eds.) Shaping the Future of Business Education: Relevance, Rigor, and Life Preparation. . Palgrave Macmillan (Link)
• Ledley, F. D. (2009). Visions of a Source of Wonder In Proctor, J., (Eds.) Envisioning Nature, Science, and Religion. 379. Pennsylvannia, USA: Templeton Press (Link)
• Ledley, F. D. (1994). Hepatic Gene Therapy. In Cheng, P., (Eds.) Somatic Gene Therapy. 61-72. New York: CRC Press
• Ledley, F. D. (1994). Pharmacokinetic Considerations In the Use of Genes as Pharmaceuticals In Wolff, J.A., (Eds.) Direct Gene Therapy. 235-244. New York: Birkhauser
• Ledley, F. D. (1990). Molecular Cloning and Characterization of Human Methylmalonyl CoA Mutase. Cobalamin '88, Proceedings of the First International Symposium on Biomedicine and Physiology of Vitamin B12 In Linnell, J.C., Bhatt, H.R., (Eds.) Cobalamin '88, Proceedings of the First International Symposium on Biomedicine and Physiology of Vitamin B12. 333-342. London: Children's Medical Charity
• Leadlay, P., Ledley, F. D. (1990). Primary sequence homology between methylmalonyl CoA mutase from Propionibacterium shermanii and Homo sapiens In Linnell, J.C., Bhatt, H.R., (Eds.) Cobalamin '88, Proceedings of the First International Symposium on Biomedicine and Physiology of Vitamin B12. 343-354. London: Cobalamin '88, Proceedings of the First International Symposium on Biomedicine and Physiology of Vitamin B12. Children's Medical Charity
• Ledley, F. D. (1990). Prospects for somatic gene therapy in the management of inborn errors of metabolism In Fernandes, J., Bremer, H.J., Saudubray, J.M. , (Eds.) Inherited metabolic disease. Diagnosis and treatment.. 671-680. Springer-Verlag
• Ledley, F. D. (1989). Human gene therapy In , (Eds.) Biotechnology, a comprehensive treatise. 399-461.. Weinheim: VCH Verlagsgesellschaft.
• Ledley, F. D. (1989). Molecular Genetic Studies in Methylmalonic acidemia. UCLA symposium on gene transfer in animals. In A.L. Beaudet, R. Mulligan, I.M. Verma, (Eds.) Gene Transfer and Gene Therapy. 335-344. New York: Alan R. Liss
• Armentano, D., Peng, H., MacKenzie-Graham, L., Shen, M., Seh, ., Ledley, F. D., Darlington, G. J., Woo, S. L. (1989). Retroviral-mediated gene transfer of human PAH into mouse primary hepatocytes. In A.L. Beaudet, R. Mulligan, I.M. Verma, (Eds.) Gene Transfer and Gene Therapy. 355-363.. New York: Alan R. Liss
• Ledley, F. D., Woo, S. L. (1988). Reconsidering the genetics of phenylketonuria. Dietary Phenylalanine and Brain Function. In Wurtman, R.J. and Ritter-Walker, E., (Eds.) Dietary Phenylalanine and Brain Function. 228-237. Boston/Basel: Birkhauser
• Ledley, F. D., Woo, S. L., DiLella, A. G. (1986). Molecular biology of phenylalanine hydroxylase and phenylketonuria In Y. Tsukata, (Eds.) Molecular Genetics in Developmental Neurobiology. 201-214. Tokyo: Japan Scientific Societies Press (JSSP). The Ninth International Symposium on Brain Sciences. Molecular Genetics in Developmental Neurobiology.
• Ledley, F. D., Woo, S. L., Güttler, F. (1985). Cloning and expression of the human phenylalanine hydroxylase gene In Bickel, H., Wachtel, U., (Eds.) Inherited Diseases of Amino Acid Metabolism. 37-50. Georg Thieme Verlag, Stuttgart, New York.
• DiLella, A. G., Ledley, F. D., Woo, S. L. (1985). Prenatal Diagnosis and Carrier Detection of Phenylketonuria by Gene Mapping In H. Koprowski, S. Ferrone, and A. Albertini, (Eds.) Biotechnology in Diagnostics. 295-307. Rome: Biotechnology in Diagnostics. Elsevier Science Publishers
• Ledley, F. D. (1984). Metabolic disease In Graef, J.W., Cone, T.E. , (Eds.) Manual of Pediatric Therapeutics, third edition. 341-350. Boston, MA: Little, Brown and Company
• Kohn, L. D., Consiglio, E., DeWolf, M. J., Grollman, E. F., Ledley, F. D., Lee, F. D., Morris, N. P. (1980). Thyrotropin receptors and gangliosides. Structure and Function of Gangliosides. In Svennerholm, L., Mardel, P., Dreyfus, H., Urban, P.F., (Eds.) Structure and Function of Gangliosides. 487-504. New York: Advances in Experimental Medicine/Plenum Press
• Hunt, L. D., Ledley, F. D., Dayhoff, M. O. (1979). Hormones and active peptides In Dayhoff, M.O., (Eds.) Atlas of Protein Sequence and Structure. Washington, D.C.: National Biomedical Research Foundation
• Kohn, L. D., Lee, G., Grollman, E. F., Ledley, F. D., Mullin, B. R., Aloj, S. M., Meldolesi, M. F. (1977). Membrane glycolipid and their relationship to the structure and function of cell surface receptors for glycoprotein hormones, bacterial toxins, and interferon. In Harmon, R.E., (Eds.) Cell surface carbohydrate chemistry. . Academic Press, San Francisco.