Harvard Catalyst Profiles

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Jeffrey Way, Ph.D.


Available: 12/05/22, Expires: 12/05/23

We are currently developing therapeutic fusion proteins for prophylaxis of post-ERCP pancreatitis and also for chronic and recurring acute pancreatitis. Oversecretion of pancreatic trypsin, the digestive enzyme, leads to pancreatitis. Our treatment concept is based on SPINK1, a trypsin inhibitor protein that is naturally expressed in the pancreas. Our proteins are engineered forms of SPINK1 that have an extended plasma half-life. We have demonstrated efficacy in a mouse model of post-ERCP pancreatitis. The student would be part of a small team and would, depending on the student's interest, help with animal experiments, design of new engineered proteins, protein expression and purification from engineered cells, planning for clinical trials, and development of new therapeutic concepts. Pancreatitis is a terrible disease that has been largely ignored by the research community. This is an opportunity for a medical student to have a disproportionately large impact on an unmet need. The research would be pursued in the context of the HMS Systems Biology Dept., in Pamela Silver's laboratory, which focuses on synthetic biology and applied protein engineering.

Available: 01/01/23, Expires: 12/31/23

In addition to promoting red blood cell formation, erythropoietin protects neurons against hypoxia and other insults. Erythropoietin (EPO) ameliorates neural degeneration in animal models of ALS, multiple sclerosis, traumatic brain injury, and other neural disorders. Unfortunately, EPO also enhances blood clotting, which leads to heart attacks, stroke, and deep vein thrombosis. We are engineering forms of EPO that promote neuroprotection but do not cause thrombosis, have a long plasma half-life, have the potential for delivery by inhalation instead of injection, and for which anti-drug antibodies should not cross-react with endogenous EPO. This work will be carried out in the lab of Prof. Pamela Silver in the HMS Dept. of Systems Biology. The student work will involve protein design, protein expression, and testing in cells and mice.

Available: 01/01/23, Expires: 12/31/23

In addition to promoting red blood cell formation, erythropoietin protects neurons against hypoxia and other insults. Erythropoietin (EPO) ameliorates neural degeneration in animal models of ALS, multiple sclerosis, traumatic brain injury, and other neural disorders. Unfortunately, EPO also enhances blood clotting, which leads to heart attacks, stroke, and deep vein thrombosis. We are engineering forms of EPO that promote neuroprotection but do not cause thrombosis, have a long plasma half-life, have the potential for delivery by inhalation instead of injection, and for which anti-drug antibodies should not cross-react with endogenous EPO. This work will be carried out in the lab of Prof. Pamela Silver in the HMS Dept. of Systems Biology. The work will involve protein design, protein expression, and testing in cells and mice.

Targeted Erythropoietin Fusion Protein for the Treatment of Anemia
Part Time, 01/02/17 - 08/01/19
Fusion Protein Therapeutic for Pancreatitis
Soma Weiss, 07/01/18 - 07/01/19

Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
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PMC Citations indicate the number of times the publication was cited by articles in PubMed Central, and the Altmetric score represents citations in news articles and social media. (Note that publications are often cited in additional ways that are not shown here.) Fields are based on how the National Library of Medicine (NLM) classifies the publication's journal and might not represent the specific topic of the publication. Translation tags are based on the publication type and the MeSH terms NLM assigns to the publication. Some publications (especially newer ones and publications not in PubMed) might not yet be assigned Field or Translation tags.) Click a Field or Translation tag to filter the publications.
  1. Way JC, Burrill DR, Silver PA. Bioinspired Design of Artificial Signaling Systems. Biochemistry. 2023 Jan 17; 62(2):178-186. PMID: 35984429; PMCID: PMC9851155.
    Citations:    Fields:    
  2. Ng TL, Olson EJ, Yoo TY, Weiss HS, Koide Y, Koch PD, Rollins NJ, Mach P, Meisinger T, Bricken T, Chang TZ, Molloy C, Zürcher J, Chang RL, Mitchison TJ, Glass JI, Marks DS, Way JC, Silver PA. High-Content Screening and Computational Prediction Reveal Viral Genes That Suppress the Innate Immune Response. mSystems. 2022 04 26; 7(2):e0146621. PMID: 35319251; PMCID: PMC9040872.
  3. Veling MT, Nguyen DT, Thadani NN, Oster ME, Rollins NJ, Brock KP, Bethel NP, Lim S, Baker D, Way JC, Marks DS, Chang RL, Silver PA. Natural and Designed Proteins Inspired by Extremotolerant Organisms Can Form Condensates and Attenuate Apoptosis in Human Cells. ACS Synth Biol. 2022 03 18; 11(3):1292-1302. PMID: 35176859; PMCID: PMC9651988.
    Citations: 1     Fields:    Translation:HumansAnimals
  4. Lee J, Vernet A, Gruber NG, Kready KM, Burrill DR, Way JC, Silver PA. Rational engineering of an erythropoietin fusion protein to treat hypoxia. Protein Eng Des Sel. 2021 02 15; 34. PMID: 34725710.
    Citations:    Fields:    Translation:AnimalsCells
  5. Hsu BB, Plant IN, Lyon L, Anastassacos FM, Way JC, Silver PA. In situ reprogramming of gut bacteria by oral delivery. Nat Commun. 2020 10 06; 11(1):5030. PMID: 33024097.
    Citations: 18     Fields:    Translation:AnimalsCells
  6. Stirling F, Naydich A, Bramante J, Barocio R, Certo M, Wellington H, Redfield E, O'Keefe S, Gao S, Cusolito A, Way J, Silver P. Synthetic Cassettes for pH-Mediated Sensing, Counting, and Containment. Cell Rep. 2020 03 03; 30(9):3139-3148.e4. PMID: 32130913.
    Citations: 6     Fields:    Translation:Cells
  7. Hsu BB, Way JC, Silver PA. Stable Neutralization of a Virulence Factor in Bacteria Using Temperate Phage in the Mammalian Gut. mSystems. 2020 Jan 28; 5(1). PMID: 31992629; PMCID: PMC6989128.
    Citations: 13     
  8. Lee J, Vernet A, Redfield K, Lu S, Ghiran IC, Way JC, Silver PA. Rational Design of a Bifunctional AND-Gate Ligand To Modulate Cell-Cell Interactions. ACS Synth Biol. 2020 02 21; 9(2):191-197. PMID: 31834794.
    Citations: 3     Fields:    Translation:HumansAnimalsCells
  9. Ziesack M, Gibson T, Oliver JKW, Shumaker AM, Hsu BB, Riglar DT, Giessen TW, DiBenedetto NV, Bry L, Way JC, Silver PA, Gerber GK. Engineered Interspecies Amino Acid Cross-Feeding Increases Population Evenness in a Synthetic Bacterial Consortium. mSystems. 2019 Aug 13; 4(4). PMID: 31409662; PMCID: PMC6697442.
    Citations: 13     
  10. Naydich AD, Nangle SN, Bues JJ, Trivedi D, Nissar N, Inniss MC, Niederhuber MJ, Way JC, Silver PA, Riglar DT. Synthetic Gene Circuits Enable Systems-Level Biosensor Trigger Discovery at the Host-Microbe Interface. mSystems. 2019 Jun 11; 4(4). PMID: 31186335.
    Citations: 13     
  11. Ziesack M, Karrenbelt MAP, Bues J, Schaefer E, Silver P, Way J. Escherichia coli NGF-1, a Genetically Tractable, Efficiently Colonizing Murine Gut Isolate. Microbiol Resour Announc. 2018 Dec; 7(22). PMID: 30533859; PMCID: PMC6284091.
    Citations: 2     
  12. Stirling F, Bitzan L, O'Keefe S, Redfield E, Oliver JWK, Way J, Silver PA. Rational Design of Evolutionarily Stable Microbial Kill Switches. Mol Cell. 2018 10 18; 72(2):395. PMID: 30340025.
    Citations: 1     Fields:    
  13. Kim S, Kerns SJ, Ziesack M, Bry L, Gerber GK, Way JC, Silver PA. Quorum Sensing Can Be Repurposed To Promote Information Transfer between Bacteria in the Mammalian Gut. ACS Synth Biol. 2018 09 21; 7(9):2270-2281. PMID: 30125499.
    Citations: 7     Fields:    Translation:AnimalsCells
  14. Spady ES, Wyche TP, Rollins NJ, Clardy J, Way JC, Silver PA. Mammalian Cells Engineered To Produce New Steroids. Chembiochem. 2018 09 04; 19(17):1827-1833. PMID: 29931794.
    Citations: 1     Fields:    Translation:HumansCells
  15. Ziesack M, Rollins N, Shah A, Dusel B, Webster G, Silver PA, Way JC. Chimeric Fatty Acyl-Acyl Carrier Protein Thioesterases Provide Mechanistic Insight into Enzyme Specificity and Expression. Appl Environ Microbiol. 2018 05 15; 84(10). PMID: 29549102; PMCID: PMC5930381.
    Citations: 3     Fields:    Translation:Animals
  16. Stirling F, Bitzan L, O'Keefe S, Redfield E, Oliver JWK, Way J, Silver PA. Rational Design of Evolutionarily Stable Microbial Kill Switches. Mol Cell. 2017 Nov 16; 68(4):686-697.e3. PMID: 29149596; PMCID: PMC5812007.
    Citations: 28     Fields:    Translation:AnimalsCells
  17. Kuo J, Stirling F, Lau YH, Shulgina Y, Way JC, Silver PA. Synthetic genome recoding: new genetic codes for new features. Curr Genet. 2018 Apr; 64(2):327-333. PMID: 28983660; PMCID: PMC5849531.
    Citations: 8     Fields:    Translation:Cells
  18. Certain LK, Way JC, Pezone MJ, Collins JJ. Using Engineered Bacteria to Characterize Infection Dynamics and Antibiotic Effects In Vivo. Cell Host Microbe. 2017 Sep 13; 22(3):263-268.e4. PMID: 28867388.
    Citations: 16     Fields:    Translation:HumansAnimalsCells
  19. Lau YH, Stirling F, Kuo J, Karrenbelt MAP, Chan YA, Riesselman A, Horton CA, Schäfer E, Lips D, Weinstock MT, Gibson DG, Way JC, Silver PA. Large-scale recoding of a bacterial genome by iterative recombineering of synthetic DNA. Nucleic Acids Res. 2017 Jun 20; 45(11):6971-6980. PMID: 28499033; PMCID: PMC5499800.
    Citations: 26     Fields:    Translation:Cells
  20. Riglar DT, Giessen TW, Baym M, Kerns SJ, Niederhuber MJ, Bronson RT, Kotula JW, Gerber GK, Way JC, Silver PA. Engineered bacteria can function in the mammalian gut long-term as live diagnostics of inflammation. Nat Biotechnol. 2017 Jul; 35(7):653-658. PMID: 28553941; PMCID: PMC5658125.
    Citations: 88     Fields:    Translation:AnimalsCells
  21. Brown DM, Chan YA, Desai PJ, Grzesik P, Oldfield LM, Vashee S, Way JC, Silver PA, Glass JI. Efficient size-independent chromosome delivery from yeast to cultured cell lines. Nucleic Acids Res. 2017 04 20; 45(7):e50. PMID: 27980064; PMCID: PMC5397165.
    Citations: 9     Fields:    Translation:HumansAnimalsCells
  22. Noman N, Inniss M, Iba H, Way JC. Pulse Detecting Genetic Circuit - A New Design Approach. PLoS One. 2016; 11(12):e0167162. PMID: 27907045.
    Citations: 3     Fields:    Translation:Cells
  23. Liu X, Lopez PA, Giessen TW, Giles M, Way JC, Silver PA. Engineering Genetically-Encoded Mineralization and Magnetism via Directed Evolution. Sci Rep. 2016 11 29; 6:38019. PMID: 27897245.
    Citations: 10     Fields:    Translation:Cells
  24. Lee JW, Gyorgy A, Cameron DE, Pyenson N, Choi KR, Way JC, Silver PA, Del Vecchio D, Collins JJ. Creating Single-Copy Genetic Circuits. Mol Cell. 2016 07 21; 63(2):329-336. PMID: 27425413; PMCID: PMC5407370.
    Citations: 22     Fields:    Translation:Cells
  25. Boeke JD, Church G, Hessel A, Kelley NJ, Arkin A, Cai Y, Carlson R, Chakravarti A, Cornish VW, Holt L, Isaacs FJ, Kuiken T, Lajoie M, Lessor T, Lunshof J, Maurano MT, Mitchell LA, Rine J, Rosser S, Sanjana NE, Silver PA, Valle D, Wang H, Way JC, Yang L. GENOME ENGINEERING. The Genome Project-Write. Science. 2016 Jul 08; 353(6295):126-7. PMID: 27256881.
    Citations: 56     Fields:    Translation:Humans
  26. Burrill DR, Vernet A, Collins JJ, Silver PA, Way JC. Targeted erythropoietin selectively stimulates red blood cell expansion in vivo. Proc Natl Acad Sci U S A. 2016 May 10; 113(19):5245-50. PMID: 27114509; PMCID: PMC4868492.
    Citations: 2     Fields:    Translation:HumansAnimals
  27. Liu X, Hicks WM, Silver PA, Way JC. Engineering acyl carrier protein to enhance production of shortened fatty acids. Biotechnol Biofuels. 2016; 9:24. PMID: 26839587; PMCID: PMC4736557.
    Citations: 8     
  28. Chen JS, Colón B, Dusel B, Ziesack M, Way JC, Torella JP. Production of fatty acids in Ralstonia eutropha H16 by engineering ß-oxidation and carbon storage. PeerJ. 2015; 3:e1468. PMID: 26664804; PMCID: PMC4675107.
    Citations: 11     
  29. Ford TJ, Way JC. Enhancement of E. coli acyl-CoA synthetase FadD activity on medium chain fatty acids. PeerJ. 2015; 3:e1040. PMID: 26157619.
    Citations: 7     
  30. Robinson-Mosher A, Chen JH, Way J, Silver PA. Designing cell-targeted therapeutic proteins reveals the interplay between domain connectivity and cell binding. Biophys J. 2014 Nov 18; 107(10):2456-66. PMID: 25418314; PMCID: PMC4241446.
    Citations: 2     Fields:    Translation:HumansCells
  31. Torella JP, Lienert F, Boehm CR, Chen JH, Way JC, Silver PA. Unique nucleotide sequence-guided assembly of repetitive DNA parts for synthetic biology applications. Nat Protoc. 2014 Sep; 9(9):2075-89. PMID: 25101822.
    Citations: 21     Fields:    Translation:Cells
  32. Sachdeva G, Garg A, Godding D, Way JC, Silver PA. In vivo co-localization of enzymes on RNA scaffolds increases metabolic production in a geometrically dependent manner. Nucleic Acids Res. 2014 Aug; 42(14):9493-503. PMID: 25034694.
    Citations: 46     Fields:    Translation:Cells
  33. Silver PA, Way JC, Arnold FH, Meyerowitz JT. Synthetic biology: Engineering explored. Nature. 2014 May 08; 509(7499):166-7. PMID: 24805338.
    Citations: 10     Fields:    
  34. Mattozzi MD, Voges MJ, Silver PA, Way JC. Transient gene expression in tobacco using Gibson assembly and the Gene Gun. J Vis Exp. 2014 Apr 18; (86). PMID: 24796418.
    Citations: 3     Fields:    Translation:Animals
  35. Way JC, Collins JJ, Keasling JD, Silver PA. Integrating biological redesign: where synthetic biology came from and where it needs to go. Cell. 2014 Mar 27; 157(1):151-61. PMID: 24679533.
    Citations: 76     Fields:    Translation:AnimalsCells
  36. Kotula JW, Kerns SJ, Shaket LA, Siraj L, Collins JJ, Way JC, Silver PA. Programmable bacteria detect and record an environmental signal in the mammalian gut. Proc Natl Acad Sci U S A. 2014 Apr 01; 111(13):4838-43. PMID: 24639514.
    Citations: 122     Fields:    Translation:HumansAnimalsCells
  37. Torella JP, Boehm CR, Lienert F, Chen JH, Way JC, Silver PA. Rapid construction of insulated genetic circuits via synthetic sequence-guided isothermal assembly. Nucleic Acids Res. 2014 Jan; 42(1):681-9. PMID: 24078086.
    Citations: 21     Fields:    Translation:Cells
  38. Voges MJ, Silver PA, Way JC, Mattozzi MD. Targeting a heterologous protein to multiple plant organelles via rationally designed 5' mRNA tags. J Biol Eng. 2013 Sep 08; 7(1):20. PMID: 24011257.
    Citations: 4     
  39. Torella JP, Ford TJ, Kim SN, Chen AM, Way JC, Silver PA. Tailored fatty acid synthesis via dynamic control of fatty acid elongation. Proc Natl Acad Sci U S A. 2013 Jul 09; 110(28):11290-5. PMID: 23798438.
    Citations: 59     Fields:    Translation:Cells
  40. Robinson-Mosher A, Shinar T, Silver PA, Way J. Dynamics simulations for engineering macromolecular interactions. Chaos. 2013 Jun; 23(2):025110. PMID: 23822508.
    Citations: 4     Fields:    Translation:HumansAnimalsCells
  41. Mattozzi Md, Ziesack M, Voges MJ, Silver PA, Way JC. Expression of the sub-pathways of the Chloroflexus aurantiacus 3-hydroxypropionate carbon fixation bicycle in E. coli: Toward horizontal transfer of autotrophic growth. Metab Eng. 2013 Mar; 16:130-9. PMID: 23376595.
    Citations: 22     Fields:    Translation:Cells
  42. Ducat DC, Avelar-Rivas JA, Way JC, Silver PA. Rerouting carbon flux to enhance photosynthetic productivity. Appl Environ Microbiol. 2012 Apr; 78(8):2660-8. PMID: 22307292.
    Citations: 84     Fields:    Translation:Cells
  43. Agapakis CM, Niederholtmeyer H, Noche RR, Lieberman TD, Megason SG, Way JC, Silver PA. Towards a synthetic chloroplast. PLoS One. 2011 Apr 20; 6(4):e18877. PMID: 21533097.
    Citations: 21     Fields:    Translation:AnimalsCells
  44. Ducat DC, Way JC, Silver PA. Engineering cyanobacteria to generate high-value products. Trends Biotechnol. 2011 Feb; 29(2):95-103. PMID: 21211860.
    Citations: 121     Fields:    Translation:Cells
  45. Kosuri S, Eroshenko N, Leproust EM, Super M, Way J, Li JB, Church GM. Scalable gene synthesis by selective amplification of DNA pools from high-fidelity microchips. Nat Biotechnol. 2010 Dec; 28(12):1295-9. PMID: 21113165.
    Citations: 89     Fields:    Translation:HumansCells
  46. Aldaye FA, Senapedis WT, Silver PA, Way JC. A structurally tunable DNA-based extracellular matrix. J Am Chem Soc. 2010 Oct 27; 132(42):14727-9. PMID: 20925350.
    Citations: 13     Fields:    Translation:HumansCells
  47. Niederholtmeyer H, Wolfstädter BT, Savage DF, Silver PA, Way JC. Engineering cyanobacteria to synthesize and export hydrophilic products. Appl Environ Microbiol. 2010 Jun; 76(11):3462-6. PMID: 20363793.
    Citations: 67     Fields:    Translation:Cells
  48. Agapakis CM, Ducat DC, Boyle PM, Wintermute EH, Way JC, Silver PA. Insulation of a synthetic hydrogen metabolism circuit in bacteria. J Biol Eng. 2010 Feb 25; 4:3. PMID: 20184755.
    Citations: 30     
  49. Taylor ND, Way JC, Silver PA, Cironi P. Anti-glycophorin single-chain Fv fusion to low-affinity mutant erythropoietin improves red blood cell-lineage specificity. Protein Eng Des Sel. 2010 Apr; 23(4):251-60. PMID: 20083493.
    Citations: 7     Fields:    Translation:HumansCells
  50. Way J, Super M. The potential for cancer combination therapy with multi-targeted, single-protein pharmaceuticals. Expert Opin Drug Discov. 2008 Feb; 3(2):147-52. PMID: 23480218.
    Citations: 1     Fields:    
  51. Savage DF, Way J, Silver PA. Defossiling fuel: how synthetic biology can transform biofuel production. ACS Chem Biol. 2008 Jan 18; 3(1):13-6. PMID: 18205286.
    Citations: 26     Fields:    
  52. Silver PA, Way JC. Molecular systems biology in drug development. Clin Pharmacol Ther. 2007 Nov; 82(5):586-90. PMID: 17637784.
    Citations: 7     Fields:    Translation:HumansAnimalsCells
  53. Drubin DA, Way JC, Silver PA. Designing biological systems. Genes Dev. 2007 Feb 01; 21(3):242-54. PMID: 17289915.
    Citations: 44     Fields:    Translation:HumansAnimalsCells
  54. Way JC, Lauder S, Brunkhorst B, Kong SM, Qi A, Webster G, Campbell I, McKenzie S, Lan Y, Marelli B, Nguyen LA, Degon S, Lo KM, Gillies SD. Improvement of Fc-erythropoietin structure and pharmacokinetics by modification at a disulfide bond. Protein Eng Des Sel. 2005 Mar; 18(3):111-8. PMID: 15820978.
    Citations: 8     Fields:    Translation:HumansAnimalsCells
  55. Kau TR, Way JC, Silver PA. Nuclear transport and cancer: from mechanism to intervention. Nat Rev Cancer. 2004 Feb; 4(2):106-17. PMID: 14732865.
    Citations: 176     Fields:    Translation:HumansCells
  56. Way JC. Covalent modification as a strategy to block protein-protein interactions with small-molecule drugs. Curr Opin Chem Biol. 2000 Feb; 4(1):40-6. PMID: 10679371.
    Citations: 8     Fields:    Translation:Cells
  57. Wolf FW, Hung MS, Wightman B, Way J, Garriga G. vab-8 is a key regulator of posteriorly directed migrations in C. elegans and encodes a novel protein with kinesin motor similarity. Neuron. 1998 Apr; 20(4):655-66. PMID: 9581759.
    Citations: 24     Fields:    Translation:AnimalsCells
  58. Ono M, Wada Y, Wu Y, Nemori R, Jinbo Y, Wang H, Lo KM, Yamaguchi N, Brunkhorst B, Otomo H, Wesolowski J, Way JC, Itoh I, Gillies S, Chen LB. FP-21399 blocks HIV envelope protein-mediated membrane fusion and concentrates in lymph nodes. Nat Biotechnol. 1997 Apr; 15(4):343-8. PMID: 9094135.
    Citations: 5     Fields:    Translation:HumansAnimalsCells
  59. Silver PA, Way JC. Eukaryotic DnaJ homologs and the specificity of Hsp70 activity. Cell. 1993 Jul 16; 74(1):5-6. PMID: 8334705.
    Citations: 64     Fields:    Translation:Cells
  60. Way JC, Wang L, Run JQ, Wang A. The mec-3 gene contains cis-acting elements mediating positive and negative regulation in cells produced by asymmetric cell division in Caenorhabditis elegans. Genes Dev. 1991 Dec; 5(12A):2199-211. PMID: 1684166.
    Citations: 30     Fields:    Translation:AnimalsCells
  61. Sadler I, Chiang A, Kurihara T, Rothblatt J, Way J, Silver P. A yeast gene important for protein assembly into the endoplasmic reticulum and the nucleus has homology to DnaJ, an Escherichia coli heat shock protein. J Cell Biol. 1989 Dec; 109(6 Pt 1):2665-75. PMID: 2556404; PMCID: PMC2115965.
    Citations: 96     Fields:    Translation:AnimalsCells
  62. Way JC, Chalfie M. The mec-3 gene of Caenorhabditis elegans requires its own product for maintained expression and is expressed in three neuronal cell types. Genes Dev. 1989 Dec; 3(12A):1823-33. PMID: 2576011.
    Citations: 118     Fields:    Translation:AnimalsCells
  63. Way JC, Chalfie M. mec-3, a homeobox-containing gene that specifies differentiation of the touch receptor neurons in C. elegans. Cell. 1988 Jul 01; 54(1):5-16. PMID: 2898300.
    Citations: 154     Fields:    Translation:AnimalsCells
  64. Way JC, Davis MA, Morisato D, Roberts DE, Kleckner N. New Tn10 derivatives for transposon mutagenesis and for construction of lacZ operon fusions by transposition. Gene. 1984 Dec; 32(3):369-79. PMID: 6099322.
    Citations: 401     Fields:    Translation:Cells
  65. Morisato D, Way JC, Kim HJ, Kleckner N. Tn10 transposase acts preferentially on nearby transposon ends in vivo. Cell. 1983 Mar; 32(3):799-807. PMID: 6299577.
    Citations: 64     Fields:    Translation:Cells
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Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR002541.