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John S. Finlayson (September 19, 1933 - June 2, 2020) is an American biochemist, one of the few senior US Food and Drug Administration (FDA) employees who had overseen the development of the Center for Biologics Evaluation and Research. He served at the FDA from 1958 to 2004. He retired from the position of Associate Director for Science, Office of Blood Research and Review, CBER, US FDA, known for his contributions to the safety of plasma derivatives products, including Albumin and Immune Globulins Products. He was awarded the FDA Distinguished Alumni Award in 2010, for his 51 years of distinguished service to the cause of public health, through research, regulation, and inspired mentoring of the current generation of CBER scientist-regulators.

Early life and education

Finlayson was born in Philadelphia, Pennsylvania on September 19, 1933. His father was a chemical engineer, specialized in pilot-plant work. His family had lived in many different places during his childhood to meet his father’s job needs. He had lived in New Jersey for less than a year before his family moved to Delaware. Soon after he began his school, his family moved to Virginia and then, later, back to Delaware, and from Delaware to New Jersey, and then his family moved again to Ohio, where he completed his high school training in 1949 and entered Marietta College. After graduating from Marietta College in Ohio in 1953, he went to the University of Wisconsin, where he got a master’s and Ph.D. in the Department of Biochemistry, College of Agriculture in 1957.

Career

Research

In 1957, Finlayson was awarded a National Cancer Institute postdoctoral fellowship to study in Sweden and set sail for Sweden on September 5th, 1957, right after he got married in the same year. In Sweden, He studied the pathway to synthesis of nucleic acids and protein turnover in tumor cells, and metabolism of cholesterol in obese dogs and dogs with various diseases.

On October 20th, 1958, Finlayson reported to work at the Laboratory of Blood and Blood Products, the Division of Biologics Standards (DBS) at the NIH. During the Cold War, he worked on plasma-derived albumin, the most abundant plasma derivative, which can be used as fluid resuscitation. The DBS was the regulatory agency responsible for biologics at that time, the function of which was transferred to CBER FDA in 1972.

In 1975, he was assigned as the chief for the Plasma Derivatives Branch. In the 1980s, he was invited to work at the Protein Research Institute of Osaka University and worked on the research related to the horseshoe crab (Limulus Polyphemus) for three months. The Limulus amebocyte lysate (an aqueous extract of blood cells) was widely used as the pyrogenic substance and is now used as a substitute for the rabbit pyrogen test.

Finlayson disagreed with what people said, “NIH does research and FDA regulates”, but emphasized that “If FDA, or at least CBER, doesn’t do its research, it’s dead. It cannot regulate effectively if it doesn’t have a viable research program”. Indeed, his research turned out to be extremely important in the decision making on the product safeties. His research helped understand the mechanism of the hypotensive episodes in 1977 where the kallikrein-kinin cascade pathway complicated, and solved the issues associated with the massive recall of immune globulin products related to the infection of the Hepatitis C in the 1980s. Now, his research continuously contributed to the understanding of product safety, such as, his article in 1980 predicted the activated clotting factor XI (FXIa) is a contaminant in immunoglobulin preparations that may lead to the thrombosis side effects. Further studies on this by others has concluded a clear link between FXIa and thrombosis adverse effects. Currently, FXIa has become a routine test for lot release of IGIV products.

During his tenure, he published 131 peer-reviewed articles, 6 chapters in books, 30 proceedings, and summaries of meetings, and 12 letters to the editor. His research interests included but were not limited to albumin, immune globulin, fibrinogen, coagulation factors. He was enthusiastic about science and continued to be an active scientist throughout his career. Hee said, “Research isn’t something that you do now and you write a paper and you go home and take a nap, it just has to keep on”.

Finlayson’s Research “Do’s” and “Don’ts”

These phrases have guided not just himself but to many others that have educated.

"Do's":

Base your conclusions on findings, not on fancy.

Draw the best conclusions – even if it’s bizarre or unpopular.

Be honest with yourself – you’re the one with the most to lose if you’re not.

Review your data and stance frequently – maybe even on paper (what are your current conclusions, and do they hold up?).

Use some discretion about proclaiming those conclusions as universal truths.

"Don’ts":

Disdain the easy experiment.

Avoid the hard experiment.

Fear to draw today’s best conclusions.

Ever stop cross-examining that conclusion.

Shoehorn data into that conclusion.

Sweep the anomalous result under the rug – give it a fair hearing.

Hesitate to alter or abandon conclusions if data warrant.

Rush into print.

Fear to be wrong if you’ve done all of the above.

Hesitate to admit it if, despite having [not] done all of the above, you were wrong anyway.

Gloat if, despite having done all of the above, you turned out to be right.

Regulation

Finlayson was one of the few senior FDA employees who had overseen the formation and development of CBER. He was a field inspector, decision-makers on the new products on IGIV, IGIM, Albumin products, many of which are life-saving products that have influenced and will continue to impact millions of patients in the United States.

He organized a workshop on immune globulins, immunoglobulins for intravenous application in 1979, a workshop on the albumin in Feb 1975. He experienced and tackled the issues associated with the product safety crisis of HIV and Hepatitis C in the 1980s.

Teaching

He taught introductory biochemistry for 25 years spread over 35 years starting from 1961. He was multilingual and fluent in English, Latin, French, German, Latvian and could speak Japanese.

After his retirement in 2004, he continued to teach the FDA employees in multiple ways for another ten years, such as group teaching, one-to-one coaching. FDA employees consulted him many submissions related to product safety, quality, identity, purity, potency, among other things.

He liked the phrase of Management by Walking Around (MBWA), which was what he had done when he managed the laboratory, branch, and office during his career. He spent his time listening to problems and ideas of their staff while wandering around an office.

Awards and honors

He received the FDA Distinguished Alumni Award in 2010.

References

1.      https://www.fdaaa.org/programs/fdaaa-awards/fda-distinguished-alumni-award-recipients/

2.      https://www.fda.gov/media/85940/download

3.     Finlayson, J. S.: Physical and biochemical properties of human albumin. In     Sgouris, J. T. and Rene, A. (Eds.): Proceedings of the Workshop on Albumin. DHEW Publication No. (NIH) 76‑925, US Government Printing Office, Washington, 1976, pp. 31‑56.

4.     Alving, B. M., Hojima, Y., Pisano, J. J., Mason, B. L., Buckingham, R. E., Jr., Mozen, M. M., and Finlayson, J. S.: Hypotension associated with prekallikrein activator (Hageman‑factor fragments) in plasma protein fraction. N. Engl. J. Med. 299:66‑70, 1978.

5.     Alving, B. M. and Finlayson, J. S. (Eds.): Immunoglobulins: Characteristics and Uses of Intravenous Preparations. DHHS Publication No. (FDA)‑80‑9005, US Government Printing Office, Washington, 1980, pp. 167‑172.

6.     Finlayson, J. S.: Which is the foreseeable future role of ethanol fractionation for the production of the main fractions albumin and immunoglobulins, as well as for the preparation of concentrates of trace proteins like coagulation factors? What is the evidence for a superior performance and practicability of other manufacturing procedures? Vox Sang. 40:48‑49, 1981.

7.     Smallwood, L. A., Tabor, E., Finlayson, J. S., and Gerety, R. J.: Antibodies to hepatitis A virus in immune serum globulin. J. Med. Virol. 7:21‑27, 1981.

8.     Gerety, R. J., Smallwood, L. A., Finlayson, J. S., and Tabor, E.: Standardization of the antibody to hepatitis A virus (anti-HAV) content of immunoglobulin. Dev. Biol. Stand. 54:411-416, 1983.

9.    Tankersley, D. L. and Finlayson, J. S.: Kinetics of activation and autoactivation of human Factor XII. Biochemistry 23:273-279, 1984.

10.  Finlayson, J. S. and Tankersley, D. L.: Availability of intramuscular immunoglobulin. Lancet 2:296-297, 1984.

11.  Tankersley, D. L., Preston, M. S., and Finlayson, J. S.: Immunoglogulin G dimer: an idiotype—anti-idiotype complex. Molec. Immunol. 25:41-48, 1988.

12.  Finlayson, J. S.: Risk of non-A, non-B hepatitis from intravenous immunoglobulin. Pediatr. Inf. Dis. J. 7:79, 1988.

13.  Finlayson, J. S.: Safety and efficacy of immune globulins. In Krijnen,

14.  Finlayson, J. S. and Tankersley, D. L.: Anti-HCV screening and plasma fractionation: the case against. Lancet 335:1274-1275, 1990.

15.  Finlayson, J. S. and Tankersley, D. L.: Immunoglobulin therapy. Lancet 338:893-894, 1991.

16.  Tankersley, D. L., and Finlayson, J. S.: Housedust mite allergens and IgG. Lancet 339:1364, 1992.

17.  Finlayson, J. S.: Regulation of plasma derivatives in the U.S.A. Dev. Biol. Stand. 81:277-281, 1993.

18.  Biswas, R. M., Nedjar, S., Wilson, L. T., Mitchell, F. D., Snoy, P. J., Finlayson, J. S., and Tankersley, D. L.: The effect on the safety of intravenous immunoglobulin of testing plasma for antibody to hepatitis C. Transfusion 34:100-104, 1994.

19.  Finlayson, J. S.: Blood testing: a regulatory perspective on strategies for donor, plasma and product screening. In Quality and Safety of Plasma Products. Medical Forum International, Zeist, The Netherlands, 1997, pp. 68-69.

20.  Alving, B. M., Reid, T. J., Fratantoni, J. C., and Finlayson, J. S.: Frozen platelets and platelet substitutes in transfusion medicine. Transfusion 37:866-876, 1997.