# Paul Billings

Dr. Paul R. Billings is a distinguished American doctor, lecturer, researcher, professor, and consultant on genetic information. His research interests include the impact of genomic data on society, the integration of genomics with diagnostics in health and medical care, and individualised genomic medicine. He is the author of over 250 publications and has appeared on talk shows such as The Oprah Winfrey Show and 60 Minutes. He is currently the CEO and Director of Biological Dynamics.

## Biography

Dr. Billings is a board-certified internist and clinical geneticist known for his extensive expertise in genomics and molecular medicine that spans more than 40 years. Dr. Billings has helped many notable organisations, including roles with the Scientific Advisory Board of the Food and Drug Administration (FDA) and the Genomic Medicine Advisory Committee at the Department of Veterans Affairs. He also served as a member of the United States Department of Health and Human Services’ secretary's advisory committee on genetics, health, and society. He was formerly a director of the Personalised Medicine Coalition and a member of the IOM Genomics Roundtable, helping to make an impact on healthcare for broad populations.
Dr. Billings is the CEO and Director at Biological Dynamics, a company dedicated to improving global health outcomes by identifying early-stage disease through its proprietary exosome diagnostic technology. Its ExoVerita platform offers a simple and automated workflow to capture and analyse exosomes, powering advanced detection tests for myriad complex diseases. This technology utilises the ExoVerita platform to enable reliable surveillance and early cancer detection to increase the chance of survival for patients.
Prior to his CEO role at Biological Dynamics, Dr. Billings was the Chief Medical Officer at Natera, Inc., a leader in cell-free DNA testing. Prior to that, he completed an Executive-in-Residence programme at the California Innovation Centre of Johnson & Johnson, was a consultant for Quest Diagnostics Inc., and served as the medical director of the IMPACT Cancer Care Programme at Thermo Fisher Scientific (TFS). Dr. Billings also held key roles at MissionBio, Life Technologies Inc. (LIFE), and the Genomic Medicine Institute, located at El Camino Hospital, the largest community hospital in Silicon Valley.
Dr. Billings founded and led a number of companies focused on genetic and diagnostic medicine throughout his career, including Omica/FabricGenomics, GeneSage Inc., and Cellective Dx Corporation. He has held academic appointments at prestigious institutions, including Harvard University, the University of California, San Francisco, Stanford University, and the University of California, Berkeley. Notably, his work on genetic discrimination played a crucial role in creating and passing the federal Genetic Information Non-Discrimination Act of 2008. From 2003 to 2007, he was senior vice president for corporate development at Laboratory Corporation of America Holdings (NYSE: LH).
He served as a director of Ancestry.com (NASDAQ: ACOM) before their recent transactions, executive chairman of Signature Genomics Laboratories, LLC, and founder of the Cord Blood Registry, Inc. Previously, he served as a board director of TrovaGene, Inc., and CollabRX, Inc., both publicly traded personalised medicine companies in the United States. He also acts as the chief medical officer of Fabric, Inc. Additionally, Dr. Billings has held positions on various other for-profit and not-for-profit boards, including the Council for Responsible Genetics, Cancer Commons, and the Ronald McDonald House Charities (Bay Area).

## Background

Dr. Paul R. Billings has a diverse educational background, beginning at the Webb School of California in the 1960s. He pursued his undergraduate studies at the University of California, Santa Cruz, in 1970 before transferring to the University of California, San Diego, in 1972. While at UCSD, Dr. Billings had the opportunity to work as a student fellow at the Salk Institute of Biological Sciences under the guidance of adviser Dr. Martin Kagnoff. In 1973, he served as a student summer fellow at the American Gastroenterology Association, advised by Dr. Morton Grossman.
In 1974, Dr. Billings graduated summa cum laude from UC San Diego with an Artium Baccalaureatus (AB) Degree in History. He then continued his education at Harvard University, where he pursued medicine and immunology as a recipient of the Medical Scientist Training Grant Fellowship from the National Institutes of Health (NIH) and Harvard University. His research at Harvard earned him the James Tolbert Shipley Prize for best-published research in 1979. That same year, Dr. Billings obtained a Ph.D. in immunology and an M.D. degree.
During his time at Harvard, his Ph.D. supervisor was Baruj Benacerraf, who won a Nobel Prize the following year in 1980.
Following medical school, Dr. Billings began his residency at University of Washington-affiliated hospitals, which he completed in 1982. He then continued as a fellow in medical genetics under the guidance of Dr. Arno Motulsky until 1984. In subsequent years, Dr. Billings held teaching and tutoring positions at renowned institutions such as the University of California, Berkeley, Harvard University, the University of California, San Francisco, and Stanford University.
Dr. Billings’s research focuses on the intersection of ethics and medicine. He explores the societal impact of genetic information and biotechnology, the integration of genomics into healthcare, post-genomic health and identity, molecular biology, immunogenetics, their relationship to cellular differentiation, their application in cancer care, and human stem cell research in clinical medicine. Various organisations have funded his groundbreaking work, including the National Institutes of Health, the Robert Wood Johnson Foundation, and the Council for Responsible Genetics.

## Government positions

Following is a partial list of Billings' government positions:
* Board Member of the Scientific Advisory Board of the Food and Drug Administration
* Board Member of the Genomic Medicine Advisory Committee at the Department of Veterans Affairs
* Board Member, HHS Advisory Committee, Genetics, Health and Society Office of Technology Assessment, United States Congress
* Contractor 1989 ("Genetic Testing in the Workplace")
* National Institutes of Health (NIH):
** Special Study Section 1989 ("The Human Genome Initiative")
** Member of Study Section on Cystic Fibrosis Screening for NIH Genome Center 1991
** Member of the Special Insurance Task Force on Insurance and Genetics 1991-1993 (NIH/DOE)
** Chair of NIH Special Task Force on Insurance and Genetic Information's Subcommittee on "Genetic Discrimination" 1991-1993
** Consultant for NIH/Food and Drug Administration Recombinant DNA Advisory Committee 1999

## Television appearances

* 60 Minutes – Season 28 Episode 32: Segment "Do You Really Want to Know?" (April 21, 1996)
* Barbara Walters Special: Segment “A Perfect Baby", July 1990
* "GM Foods May be Harmful " Associated Press, October 1999
* The Oprah Winfrey Show
* Today

## Selected publications
### Books

* Billings P (ed). DNA on Trial: Genetic Identification and Criminal Justice. Cold Spring Harbor Pubs, 1992.

### Journal articles

* Billings P. Alert on Genetic Discrimination. Medical Tribune 1990; 31(12):15.
* Billings P. Biotechnology: Ethical Dilemmas. Biotech Monitor 1991; 1(2):2,4-6.
* Billings P. Rising Cost of Private Health Insurance. U.S. Congress Committee on Energy and Commerce. US Government Printing Office 1991; 11-58.
* Billings P. and Beckwith J., Genetic Testing in the Workplace. Trends in Genetics 1992; 8(6):198-202.
* Billings P. The Public Must Be Educated About the Limited Predictive Usefulness of Genetic Diagnoses. Genetic Engineering News 1992; 12(19): 4, 38.
* Billings P. Promises and Pitfalls of Genetic Testing. Bay Area BioScience Reports 1992; 3(4): 5,7.
* Billings P. Genetic Discrimination by Insurers: The Public Perception. J Insur Med 1993; 25(2): 184-91.
* Billings, P. Genetic Discrimination: What Can We Learn from History? (Commentary) Blatt, Miller and Haddow (eds). The Genetic Resource 1994; 8(1): 44.
* Billings P. A Study of Genetic Discrimination. (background paper and appendix). In: Genetic Information and Health Insurance: Report of the Task Force on Genetic Information and Insurance. NIH Publication 93-3686 1993.
* Billings P. and Hubbard R. Fragile X Testing: Who Benefits? GeneWatch 1994; 9(3-4):1-3.
* Billings P. comments on the social, legal, and policy issues arising from the genetic revolution. Testimony before the Senate Select Committee on Genetics and Public Policy on April 8, 1996. State of California Printing Office 1996.
* Billings P. Genetic information and privacy (a background paper). For the Record: Protecting Electronic Health Information. National Academy Press 1997.
* Billings P. comments on genetic research and privacy issues. Privacy Issues in Biomedical and Clinical Research. National Academy Press 1998.
* Billings P. "Wider impact? (letter)". HMS Beagle: The BioMedNet Magazine 1998; 42; Nov 13.
* Billings P. DNA data banks would taint justice. Boston Globe 1999; Jan 14 (A):19.
* Billings P., "Iceland, blood and the role of science". Am Sci 1999; 87(3):199-00.
* Billings P. Perspective on Medicine: Does life as a patient begin even before the patient is born? Los Angeles Times, 1999, Mar 11 (B):9.
* Billings P. Modified foods are like drugs. Boston Globe 1999; Aug 28 (A):19.
* Nadar C, Herbert M, Billings P, Bereano P, Hubbard R, King J, Newman S, and Stabinsky D. Redesigning Evolution? (letter). Science 1999; 285 (3):1491.
* Spinard P. with Billings P. ReadMe. Wired 2001; 9(12): 98.
* Billings P., Rothstein M., Faigman D., and Jones R. Cutting-edge issues in law and science. Proceedings of a 9th Circuit judicial conference panel presentation. In: Scientific Evidence Review Monograph 3 (Cwik C. and North J., eds.), 2001, ABA Publishing, Chicago, IL, pp. pp1–52.
* Beeson D, Billings P, Darnofsky M, and C Weiner. Ethics, genetic technologies, and social responsibility in the 21st century. 2001 Proceedings of a Townsend Center panel..
* Worthy K., Strohman R., Billings P. Conflicts around a study of Mexican crops. Nature 2002; 417:897.
* Billings P. A medical geneticist's view. World Watch 2002; 15(4):16.
* Billings, P. Your DNA computer: When machines and humans blend. IHealthBeat 2002: Sept. 6..
* Billings P. Iron revisited. Annals of Family Medicine 2004 Invited online commentary was posted 4/1/04 at.
* P.R. Billings and M.P. Brown. The future of clinical laboratory genomics. M.L.O. Dec. (2004), 8–15. (Published online Dec 1, 2004 at).
* Billings, P. CRG History A Chapter in Non-Governmental Politics, “Standards for Privacy of Individually Identifiable Health Information”, National Committee on Vital and Health Statistics, Subcommittee on Privacy and Confidentiality, January 12, 2005, available online at.
* Billings P. Stem cell research: dangerous territory? New Scientist. 2006;2576.
* Billings P., Personalized management of cancer using circulating tumor cells. The Personalized Medicine Report 2008, 11:18-21.
* Loupakis F., Sharma S., Derouazi M., et al. Detection of molecular residual disease using a personalized circulating tumor DNA assay in colorectal cancer patients undergoing resection of metastases. JCO-Precision Oncology, 2021, 5:1166-1177.
* Schneider J, Krainock M, Malashevich AK, et al. cDNA clearance and radiographic resolution of disease in response to dual checkpoint inhibition in metastatic microsatellite stable colorectal cancer with a high tumor mutation burden. Case reports in Oncology. 2021;14:849-853.
* Taniguchi H., Nakamura Y., Kotani D, et al. CIRCULATE-Japan: Circulating tumor DNA-guided adaptive platform trials to refine adjuvant therapy for colorectal cancer. Cancer Science. 2021;112:2915-2920.
* Magbanua MJM, Swigart LB, Wu H-T, et al. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Annals of Oncology. 2021;32(2):229-239.
* Kasi PM, Sawyer S, Guilford J, et al. BESPOKE study protocol: a multicentre, prospective observational study to evaluate the impact of circulating tumour DNA-guided therapy on patients with colorectal cancer. BMJ Open. 2021;11(9):e047831. Published 2021, Sep 24. doi:10.1136/bmjopen-2020-047831
* Weinberg BA, Winslow ER, Bayasi M, et al. Early detection of circulating tumor DNA postoperatively enables the discovery of resectable metastatic disease in a patient with colon cancer. Case Rep Oncol. 2021;14(3):1748–1753. Published 2021, Dec 10. doi:10.1159/000520743
* Kasi PM, Budde G., Krainock M., et al. Circulating tumor DNA (ctDNA) serial analysis during progression on PD-1 blockade and later CTLA-4 rescue in patients with mismatch repair deficient metastatic colorectal cancer. J Immunother Cancer. 2022;10(1):e003312. doi:10.1136/jitc-2021-003312
* Einstein DJ, Liang N., Malhotra M., et al. Assessment of Molecular Remission in Oligometastatic Esophageal Cancer with a Personalized Circulating Tumor DNA Assay. JCO-Precision Oncology. 2020;4:239-243.
* Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stage I to I Colorectal Cancer. JAMA Oncology. 2019;5(8):1124-1131.
* Christensen E., Birkenkamp-Demtröder K., Sethi H., et al. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients with Urothelial Bladder Carcinoma. Journal of Clinical Oncology. 2019; 37(18):1547-1557.
* Coombes C, Page K, Salari R, et al. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clinical Cancer Research. 2019;25(14):4255-4263.
* Halloran PF, Reeve J, Madill-Thomsen KS, Demko Z, Prewett A, Billings P, the Trifecta Investigators. The Trifecta study: comparing plasma donor-derived cell-free DNA levels with the molecular phenotype of kidney transplant biopsies. JASN, 2021. In Press.
* Qazi Y, Patel A, Fajardo M, McCormick S, Fehringer G, Ahmed E, Malhotra M, Demko ZP, Billings PR, Tabriziani H, and Gauthier P. Incorporation of donor-derived cell-free DNA Into Clinical Practice for Renal Allograft Management. Transplant Proc. 2021. 10:0041-1345(21)00710-7. doi:10.1016/j.transproceed.2021.09.027
* Mrug M, Bloom MS, Seto C, Malhotra M, Tabriziani H, Gauthier P, Sidlow V, McKanna T, and Billings PR. Genetic Testing for Chronic Kidney Diseases: Clinical Utility and Barriers Perceived by Nephrologists. Kidney Medicine (2021) do: https://doi.org/10.1016/j.kme.2021.08.006.
* Bunnapradist S, Homkrailas P, Ahmed E, Fehringer G, Billings P, Tabriziani H. Using Both the Fraction and Quantity of Donor-Derived Cell-Free DNA to Detect Kidney Allograft Rejection. J Am Soc Nephrol 2021:32 (10) 2439-2441; doi:10.1681/AS.2021050645
* Bunnapradist S, Datta N, Schaenman J, et al. Extremely High Cell-Free DNA Levels Observed in Renal Allograft Patient With SARS-CoV-2 Infection. Transplantation Direct. 2021;7(5).
* Peabody J., Billings P., Valdenor C, et al. Randomized clinical trial of a novel donor-derived cDNA test to detect rejection in CPV-simulated renal transplant patients. In Urol Nephrol. 2020; 52(8):1593-1601.
* Peabody, J Billings P, Valdenor C, et al. Variation in assessing renal allograft rejection: a national assessment of nephrology practice. International Journal of Nephrology. Vol. 2019; Article DI 5303284, 6 pages.
* Altug Y., Liang N., Ram R, et al. Analytical Validation of a Single-Nucleotide Polymorphism-Based Donor-Derived Cell-Free DNA Assay for Detecting Rejection in Kidney Transplant Patients. Transplantation. 2019:103(12):2657-2665.
* Sigdel TK, Acosta Archila F, Constantin T, et al. Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR. J Clin Med. 2019;8(1):19.
* Mohan P., Lemoine J., Trotter C, et al. Clinical experience with non-invasive prenatal screening for single-gene disorders (NIPT-SGD). Ultrasound Obstet Gynecol. 2021 Aug 6. doi:10.1002/uog.23756 Epub ahead of print. PMID 34358384.
* Bratman, S.V., Yang, S.Y.C., Iafolla, M.A.J. et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab.Nat Cancer 1, 873–881 (2020). https://doi.org/10.1038/s43018-020-0096-5
* Jelsema R, Demko ZP, Billing, PR. Re: Clinical experience across the fetal-fraction spectrum of a non-invasive prenatal screening approach with a low test failure rate. Ultrasound Obstet Gynecol. 2020;56:467-473.
* Martin KA, Samango-Sprouse CA, Kantor V, et al. Detection of maternal x chromosome abnormalities using single nucleotide polymorphism-based noninvasive prenatal testing. Am J Obstet Gynecol MFM 2020;2:100152.
* Westmeyer M, Saucier J, Wallace J, et al. Clinical experience with carrier screening in a general population: support for a comprehensive pan-ethnic approach. Genetics in Medicine2020;22:1320-1328.
* Benn P., Martin K., McKanna T., et al. Combining the use of a fetal fraction-based risk algorithm and the probability of an informative redraw in noninvasive prenatal testing for fetal aneuploidy. J Genet Couns 2019,00:1-7.
* Hedriana H, Martin K, Saltzman D, et al. Cell-free DNA in twin gestations in single nucleotide polymorphism-based non-invasive prenatal screening. Prenatal Diagnosis 2020;40(2):179-184.
* DiNonno W, Demko Z, Martin K, et al. Quality Assurance of Non-Invasive Prenatal Screening (NIPS) for Fetal Aneuploidy Using Positive Predictive Values as Outcome Measures. Journal of Clinical Medicine 2019;8(9):1311.
* Norwitz ER, McNeill G, Kalyan A, et al. Validation of a Single-nucleotide Polymorphism-Based Non-Invasive Prenatal Test in Twin Gestations: Determination of Zygosity, Individual Fetal Sex, and Fetal Aneuploidy. Journal of Clinical Medicine 2019; 8(7):937.
* Ventura-Aguiar P, Ramirez-Bajo MJ, Rovira J, et al. Donor-derived cell-free DNA shows high sensitivity for the diagnosis of pancreas graft rejection in simultaneous pancreas-kidney Transplantation. Transplantation. 2022;106(8):1690-1697. doi:10.1097/TP.0000000000004088
* Stacey A. Cohen, Anup Kasi, Nicole Hook, Michael Krainock, Griffin Budde, Allyson Koyen Malashevich, Jeffrey Meltzer, Russ Jelsema, Perry Olshan, Paul R. Billings, Alexey Aleshin, Andrew S. Poklepovic, "The Utility of Circulating Tumor DNA (ctDNA) Monitoring in Cancer Patients Who Are Pregnant or Planning to Become Pregnant", Case Reports in Obstetrics and Gynecology, vol. 2022, Article ID 9412201, 5 pages, 2022. https://doi.org/10.1155/2022/9412201
* Dhakal, B. et al. (2022) ‘Assessment of molecular residual disease using circulating tumor DNA to identify multiple myeloma patients at high risk of relapse’, Frontiers in Oncology, 12. doi:10.3389/fonc.2022.786451
* Reusing, J.O. et al. (2022), ‘Association between total cell-free DNA and SARS-COV-2 in kidney transplant patients: A preliminary study’, Transplantation Proceedings, 54(6), pp. 1446–1454. doi:10.1016/j.transproceed.2022.02.027
* Azzi G, Krinshpun S, Tin A, et al. Treatment Response Monitoring Using a Tumor-Informed Circulating Tumor DNA Test in an Advanced Triple-Negative Breast Cancer Patient: A Case Report. Case Rep Oncol. 2022;15(2):473–479. Published 2022 May 2. doi:10.1159/000524324
* Rosenheck JP, Ross DJ, Botros M, et al. Clinical Validation of a Plasma Donor-derived Cell-Free DNA Assay to Detect Allograft Rejection and Injury in Lung Transplant. Transplant Direct. 2022;8(4):e1317. Published 2022, Mar 25. doi:10.1097/TXD.0000000000001317
* Wojas, A. et al. (2022), 'Clinician-reported chorionicity and zygosity assignment using single-nucleotide polymorphism-based cell-free DNA: Lessons learned from 55,344 Twin pregnancies’, Prenatal Diagnosis, 42(10), pp. 1235–1241. doi:10.1002/pd.6218
* Kasi PM, Chakrabarti S, Sawyer S, et alBESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumoursBMJ Open 2022;12:e060342. doi:10.1136/bmjopen-2021-060342
* Bleyer AJ, Westemeyer M, Xie J, et al. Genetic Etiologies for Chronic Kidney Disease Revealed through the Next-Generation Renal Gene Panel. Am J Nephrol. 2022;53(4):297-306. doi:10.1159/000522226
* Halloran PF, Reeve J, Madill-Thomsen KS, et al. Combining donor-derived cell-free DNA fraction and quantity to detect kidney transplant rejection using molecular diagnoses and histology as Confirmation. Transplantation. 2022;106(12):2435-2442. doi:10.1097/TP.0000000000004212
* Halloran PF, Reeve J, Madill-Thomsen KS, et al. Antibody-mediated Rejection Without Detectable Donor-specific Antibody Releases Donor-derived Cell-free DNA: Results From the Trifecta Study [Published correction appears in Transplantation. 2023 Jan 1;107(1):e43]. Transplantation. 2023;107(3):709-719. doi:10.1097/TP.0000000000004324
* Kim PJ, Olymbios M, Siu A, et al. A novel donor-derived cell-free DNA assay for the detection of acute rejection in heart transplantation. J Heart Lung Transplant. 2022;41(7):919-927. doi:10.1016/j.healun.2022.04.002
* Miyo M, Kato T, Nakamura Y, et al. DENEB: Development of new criteria for curability after local excision of pathological T1 colorectal cancer using liquid biopsy. Cancer Sci. 2022;113(4):1531-1534. doi:10.1111/cas.15226
* Kasi PM, Fehringer G, Taniguchi H, et al. Impact of Circulating Tumor DNA-Based Detection of Molecular Residual Disease on the Conduct and Design of Clinical Trials for Solid Tumors [published correction appears in JCO Precis Oncol. 2022 Apr;6:e2200193]. JCO Precis Oncol. 2022;6:e2100181. doi:10.1200/PO.21.00181
Billings on "Genetics news (www.geneletter.com)":
* Homecooked eugenics. GeneLetter 2000; 1 (Feb); 1)
* New heights of compatibility. GeneLetter 2000; 1 (Feb); 1)
* Understanding the EEC split. GeneLetter 2000; 1 (Feb); 1)
* Thinking in neurofibromatosis type 1. (GeneLetter 2000, 1)
* Constructing new genetics. GeneLetter 2000; 1 (Feb); 1)
* Wherefore art thou disease genes? GeneLetter 2000, 1(Mar; 2)
* Genetic for all. GeneLetter 2000, 1(Apr; 3)
* Following up. GeneLetter 2000, 1(May; 4)
* A gene therapy death. GeneLetter 2000; 1 (Jun); 5)
* Gene therapists beware: lessons from GM food. GeneLetter 2000; 1 (Jun); 5)
* Mutation: the good, the bad, and the ugly. GeneLetter 2000, 1(Jul; 6)
* Biotechnology's albatross. GeneLetter 2000, 1(Aug; 7)
* A genomic failure. GeneLetter 2000, 1(Aug; 7)
* Warp speed genetics. GeneLetter 2000, 1(Sep; 8)
* Questioning the question: the role of opposites. GeneLetter 2000, 1(Sep; 8)
* On crooks, adverse selection, and insurance genetics. GeneLetter 2000, 1(Oct; 9)
* Art and genetics: asking the right questions. GeneLetter 2000, 1(Oct; 9)
* Practicing responsible genetic medicine. GeneLetter 2000, 1(Nov; 10)
* Genetic hygiene: public health anew? GeneLetter 2000, 1(Dec; 11)
* Applying genetic advances: where do we go from here? A report from GeneSage's “Genetic Issues Survey of Managed Care Executives”. GeneLetter 2000, 1(Dec; 11)
* Paying for the genetic revolution. GeneLetter 2001, 1(Jan; 12)
* Hemochromatosis imbroglio. GeneLetter 2001, 1(Jan; 12)
* Happy Birthday, GeneLetter! GeneLetter 2001, 2(Feb; 1)
* The disappearing gene. GeneLetter 2001, 2(Mar; 2)
* Where things stand. GeneLetter 2001, 2(Apr; 3)
* Human genetic complexity. GeneLetter 2001, 2(May; 4)
* Genetic screening anew. GeneLetter 2001; 2(Aug; 5)