Science Publications | Exploring the impact of ancestry on (cell) phenotypes

🔵 Ancestry matters: Building inclusivity into preclinical study design

Sophie Zaaijer and Amanda Capes-Davis | Cell 2021

Leveraging in Vitro Models for Clinically Relevant Rare CYP2D6 Variants in Pharmacogenomics

Sydney Stern, Paula L Hyland, Michael Pacanowski, Robert N Schuck | Drug Metab Dispos. 2024 Feb 14;52(3):159-170. 

An African perspective on genetically diverse human induced pluripotent stem cell lines.

Hurrell T, Naidoo J, Ntlhafu T, Scholefield. | J.Nat Commun. 2024 Oct 3;1

Toward Inclusivity in Preclinical Drug Development: A Proposition to Start with Intestinal Organoids

Julia Y Co, Jessica A Klein, Serah Kang, Kimberly A Homan* | Advanced Biology 2023 Dec;7(12):e2200333.

*Genentech

Model systems and organisms for addressing inter- and intra-species variability in risk assessment

Ivan Rusyn, Weihsueh A Chiu, Fred A Wright | Regul Toxicol Pharmacol. 2022 Jul:132:105197.

 

Hepatic Models in Precision Medicine: An African Perspective on Pharmacovigilance

Tracey Hurrell, Jerolen Naidoo, Janine Scholefield  | Front Genet. 2022 Apr 14:13:864725.

 

Ancestry of cells must be considered in bioengineering.

Erica Moore, Allen JB, Mulligan CJ, Wayne EC. | Nature Reviews Materials, 2022 Jan;7(1):2-4.

 

Greater genetic diversity is needed in human pluripotent stem cell models.

Sulagna Ghosh, Nehme R, Barrett LE. | Nature Communications, 2022 Nov 26;13(1):7301.

 

Ancestry-dependent gene expression correlates with reprogramming to pluripotency and multiple dynamic biological processes

Laura S Bisogno, Jun Yang, Brian D Bennett, James M Ward, Lantz C Mackey, Lois A Annab, Pierre R Bushel, Sandeep Singhal, Shepherd H Schurman, Jung S Byun, Anna María Nápoles, Eliseo J Pérez-Stable, David C Fargo, Kevin Gardner, Trevor K Archer | Science Advances,  2020 Nov 20;6(47):eabc3851.

🔵 An Interactive Resource to Probe Genetic Diversity and Estimated Ancestry in Cancer Cell Lines.

Dutil J, Chen Z, Monteiro AN, Teer JK, Eschrich SA. | Cancer Res. 2019 Apr 1;79(7):1263-1273.

 

Establishment of three novel cell lines derived from African American patients with colorectal carcinoma: A unique tool for assessing racial health disparity

Jenny Paredes, Ping Ji, Joseph F. Lacomb, Kenneth R. Shroyer, Laura A. Martello, and Jennie L. Williams | Int J Oncol. 2018 Oct; 53(4): 1516–1528.

 

Genetic Ancestry and Natural Selection Drive Population Differences in Immune Responses to Pathogens.

Nédélec Y, Sanz J, Baharian G, Szpiech ZA, Pacis A, Dumaine A, Grenier JC, Freiman A, Sams AJ, Hebert S, Pagé Sabourin A, Luca F, Blekhman R, Hernandez RD, Pique-Regi R, Tung J, Yotova V, Barreiro LB. | Cell 2016 Oct 20;167(3):657-669.e21.

Intersection of population variation and autoimmunity genetics in human T cell activation

Chun Jimmie Ye, Ting Feng, Ho-Keun Kwon, Towfique Raj, Michael T Wilson, Natasha Asinovski, Cristin McCabe, Michelle H Lee, Irene Frohlich, Hyun-il Paik, Noah Zaitlen, Nir Hacohen, Barbara Stranger, Philip De Jager, Diane Mathis, Aviv Regev, Christophe Benoist | Science. 2014 Sep 12;345(6202):1254665.

Scientific articles written by FDA officers

🔵 Racial/ethnic differences in drug disposition and response: review of recently approved drugs.

Anuradha Ramamoorthy, Pacanowski MA, Bull J, Zhang L. | Clin Pharmacol Ther. 2015 Mar;97(3):263-73.

Racial and Ethnic Differences in Drug Disposition and Response: Review of New Molecular Entities Approved Between 2014 and 2019

Anuradha Ramamoorthy, Hannah H Kim, Ebony Shah-Williams, Lei Zhang | J Clin Pharmacol 2022 Apr;62(4):486-493.

Race, pigmentation, and the human skin barrier-considerations for dermal absorption studies

Alec T Salminen, Prashiela Manga, Luísa Camacho | Front Toxicol 2023 Oct 11:5:1271833

Leveraging in Vitro Models for Clinically Relevant Rare CYP2D6 Variants in Pharmacogenomics

Sydney Stern, Paula L Hyland, Michael Pacanowski, Robert N Schuck | Drug Metab Dispos. 2024 Feb 14;52(3):159-170.

An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs).

Avila AM, Bebenek I, Bonzo JA, Bourcier T, Davis Bruno KL, Carlson DB, et al. | Regul Toxicol Pharmacol. 2020;114:104662.

 

Skin Pigmentation & Drugs

🔵 Implementing Differentially Pigmented Skin Models for Predicting Drug Response Variability Across Human Ancestries

Sophie Zaaijer, Simon C. Groen | Human Genomics, 2024: 18, 113 (2024)

Race, pigmentation, and the human skin barrier-considerations for dermal absorption studies

Alec T Salminen, Prashiela Manga, Luísa Camacho | Front Toxicol 2023 Oct 11:5:1271833

Development of a Phototoxicity Testing Strategy for Accurate Photosafety Evaluation of Pharmaceuticals Based on the Assessment of Possible Melanin-Binding Effects.**

Reinen J*, van Sas P, van Huygevoort T, Rubio L, Scase K, Wenker M. | Int J Toxicol. 2018;37:296–307.

*Charles River Laboratories

** this is based on animal models —> use 3D skin models instead aligned with the FDA Modernization Act 2,0. See tab “Pharma R&D” for vendors.

Understanding Molecular Drivers of Melanin Binding To Support Rational Design of Small Molecule Ophthalmic Drugs

Jakubiak P*, Reutlinger M, Mattei P, Schuler F, Urtti A, Alvarez-Sánchez R. | J Med Chem. 2018;61:10106–15.

*Roche

Establishment of an In Vitro-In Vivo Correlation for Melanin Binding and the Extension of the Ocular Half-Life of Small-Molecule Drugs

Paulina Jakubiak*, Carina Cantrill, Arto Urtti, Rubén Alvarez-Sánchez | Mol Pharm. 2019;16:4890–901.

*Roche

Pharmacokinetics and pharmacogenomics of clozapine in an ancestrally diverse sample: a longitudinal analysis and genome-wide association study using UK clinical monitoring data.

Pardiñas AF, Kappel DB, Roberts M, Tipple F, Shitomi-Jones LM, King A, et al. | The Lancet Psychiatry. 2023; 10:209–19.

Interrogating the relationship between rat in vivo tissue distribution and drug property data for >200 structurally unrelated molecules.

Harrell AW*, Sychterz C, Ho MY, Weber A, Valko K, Negash K. | Pharmacol Res Perspect. 2015;3:e00173.

*GSK

Clinical Trials

UCSF - Read status and details

Lead investigator: Suzaynn Schick, PhD

Summary

This is a pilot study of the effects of dermal melanin on dermal uptake and retention of nicotine. The initial hypothesis is that higher levels of dermal melanin will correlate with lower uptake and longer retention of nicotine in the skin and body.

Details

This is an interventional pharmacokinetic study comparing the uptake and metabolism of nicotine from smoke-exposed clothing in people with low high levels of dermal melanin and people with high levels of dermal melanin. The study will measure nicotine and metabolites of nicotine in the blood during exposure and in urine for 10 days after exposure.

Keywords

Healthy, Thirdhand tobacco smoke, Dermal, Exposure, Tobacco Smoke Pollution, Melanin, Nicotine, Wear clothing that has been exposed to cigarette smoke for 3 hours., Low melanin, High melanin