Duncan H. Whitney, Ph.D.
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`25 Channel Center St., Boston, MA 02210; duncanhwhitney@gmail.com; (978) 460-1657 (mobile)
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`EXECUTIVE SUMMARY
`Molecular diagnostics and technology development expert with a track record of success in
`emerging life sciences companies. Built and led teams, strategies, and technology/product
`development to meet corporate objectives. Have demonstrated expertise in genomics,
`biomarker discovery, cancer diagnostics, assay development, process development, clinical trials
`design and oversight, and biomolecule separations.
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`PROFESSIONAL EXPERIENCE
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`Gregor Diagnostics (Madison, WI), Mar 2022 – present
`Chief Scientific Officer
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`• Gregor Dx is developing improved diagnostics for early detection as well as to differentiate
`aggressive from more indolent forms of prostate cancer (PCa).
`The company relies on a multi-modal approach and a novel sample type (seminal fluid) to
`maximize test accuracy.
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`Johnson & Johnson; Lung Cancer Initiative, Oct, 2018-Sep,2021
`VP, Head of Early Detection
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`• Responsible for developing the strategy of the Early Detection pillar within the Lung Cancer
`Initiative (LCI) and establishing collaborations with key external partners to develop and
`validate biomarkers and diagnostics to enable downstream pharmaceutical and medical device
`solutions.
`• Built a small team to execute the strategy and help manage external collaborations and
`coordinate progress with internal stakeholders. The team consists of director-level scientists,
`technical project managers.
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`Curis Inc (Lexington, MA) July 2017-Oct 2018
`VP Diagnostics
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`Curis develops small-molecule compounds in hematological oncology and
`immunotherapy applications.
`• Responsible for development of clinical diagnostics testing strategies, including
`companion diagnostics (as applicable). Led biomarker development for DLBCL drug-
`trials including established IHC tests and development of new gene-expression
`prediction tools.
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`Veracyte Inc (South San Francisco, CA) 2014-2017
`VP Discovery Research
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`Veracyte develops disease-specific classifiers using machine-learning algorithms that are trained
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`to answer specific clinical questions based on high-content genomic data.
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`Transferred technology of the lung cancer test originally developed at Allegro (Percepta™), which
`was acquired by Veracyte in 2014. The following milestones were achieved within the first 12
`months pos-acquisition:
`The lung cancer gene expression test developed at Allegro was successfully translated to
`Veracyte operations, including transfer of all clinical databases, clinical specimen repositories,
`bioinformatics algorithms, and clinical validation data.
`• Results of clinical validation studies were published in New Engl J Med (July, 2015) and BMC
`Medical Genomics (May 2015).
`Percepta™ was launched as a CLIA-certified test at Veracyte’s laboratories in South San
`Francisco, CA (with recent acceptance by NYSDOH).
`Clinical utility studies submitted for publication.
`Led the discovery work for the second-gen multi-gene assay as an aid in diagnosis of
`indeterminate thyroid nodules [Afirma™].
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`Allegro Diagnostics Corp (Maynard, MA) 2009-2014
`SVP and CSO; Research & Development
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`• Responsible for all technical and development milestones of Allegro’s gene-expression profiling
`lung cancer diagnostic test (acquired by Veracyte in 2014). Allegro sponsored parallel
`prospective, multi-center clinical trials enrolling over 2000 subjects to validate the test.
`Responsibilities and achievements include the following:
`Conceived, planned, and gained Board approval of technical direction of company to transition
`from an academic concept to a clinically validated commercial product. ∙ Coordinated clinical
`sample analyses at the company’s registered CLIA laboratory, and all data analysis in
`conjunction with external advisors and consultants.
`Presented strategy, plans and progress regularly at Board of Director meetings and
`Scientific Advisory Board meetings.
`• Recruited/hired key technical and leadership personnel including the Manager of
`Bioinformatics, the CLIA Lab Director. Introduced Regulatory and Business Strategy
`consultants and advisors to the company.
`• Met technical objectives of $2.8M NCI-SBIR grant, and rescued final tranche (>$800k). ∙
`Managed corporate IP and patent portfolio in conjunction with external legal counsel. ∙
`Represented the company and technological developments at scientific and professional
`conferences.
`Presented accepted oral presentations at professional society conferences (ATS and ACCP).
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`• Managed ongoing collaborations and data sharing with Academic partners at Boston University
`School of Medicine. Included on several abstracts and papers presented by BU scientists.
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`U.S. Genomics & Independent Consultant 2009
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`Leveraged my expertise in clinical diagnostics in conjunction with emerging platform
`technologies to meet aggressive development plans and objectives. Brief descriptions of
`selected projects are as follows:
`o U.S. Genomics – collaboration with Becton-Dickinson to develop single-molecule
`mapping platform and methodology for rapid microbiological ID and strain-typing
`applications.
`o Myelogix – founding member of company to commercialize gene-expression
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`microarray diagnostic test for multiple myeloma risk stratification.
`o AlloHealth Diagnostics Inc. – partner in the development of company business plan
`and initial technical due diligence. Business model based on commercialization of a
`licensed gene-expression panel targeting renal-transplant monitoring.
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`Progenika, Inc. (Cambridge, MA) 2007-2008
`Chief Scientific Officer
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`Part of founding team for new US-based subsidiary of Progenika BioPharma (Derio, Spain) in
`the personalized medicine market.
`Established array-based test (LipoChip™) for Hypercholesterolemia testing in newly
`established U.S. labs (transferred from labs in Spain).
`Led technology transfer and helped commercialize a blood group genotyping test (BloodChip™)
`in the U.S., based on developments from the European Bloodgen consortium.
`• Outfitted new clinical diagnostics labs and hired technical team and Medical Director.
`CLIA labs inspected and registered by MA DPH within 3 months of start-up.
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`Investigated new platform technologies for future assays/products, including sequencing and
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`microfluidics platforms.
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`US Genomics (Woburn, MA) 2005-2007
`VP Research & Development
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`Led research and development of a novel single molecule detection platform into genomic and
`protein applications. Transitioned company business model from general platform development
`to biomarker and diagnostics development model. Established collaborations with external
`diagnostics companies, technology development companies, and clinical diagnostics groups.
`Led multidisciplinary team of scientists, engineers, and applications specialists
`Focused on miRNA and protein biomarker applications
`Presented progress to the Board of Directors on a regular basis
`Established miRNA-based gene-expression diagnostics collaboration in lung cancer (Rosetta
`Genomics), and prostate and bladder cancer (Lahey Clinic).
`Led collaboration with Aviir (Palo Alto, CA) in single-molecule detection strategies for protein-
`based cardiovascular disease diagnostics tests. Also established and managed smaller research
`collaborations (including several academic partnerships) in a number of other disease areas.
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`EXACT Sciences Corp. (Marlborough, MA) 2000 - 2005
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`Led the process development leading to the commercialization of the company’s first applied
`genomics assay for colon cancer screening. Developed novel DNA purification platform, formulated
`and led effort to automate and reduce costs, established and managed research collaborations with
`novel platform technology companies in search of ways to reduce assay complexity and improved
`analytical sensitivity and reproducibility.
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`VP Technology Development
`• Defined and led Platform Automation strategy with CTO of Exact.
`Point of contact and technical liason for PreGen-Plus assay at LabCorp. ∙
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`Technical lead for Effipure™, DNA purification technology.
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`Director, Technology Development
`• Developed strategy for high-throughput automation of colorectal cancer screening assay. ∙
`Developed new approach to DNA sample prep based on affinity electrophoresis. Product is FDA
`registered
`Implemented PCR and mutation analysis multiplexing and assay simplification strategies. ∙
`Prepared cost analysis of CRC screening assay as part of a milestone-driven deal for a multi
`million dollar business deal with LabCorp of America (LCA).
`Completed technology transfer of Exact’s first commercial assay (PreGen-26™) to LCA (3Q
`2001).
`• Hired and managed multidisciplinary development team (10 scientists).
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`Molecular Geodesics, Inc. (Boston, MA) 1999 – 2000
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`MGI was founded by Dr. Don Ingber (Harvard Medical School) to capitalize on novel biomimetic
`principles, for the design of innovative biodefense and biomedical materials and devices. I joined to help
`identify and build product development concepts primarily in support of biohazard filtration and
`deactivation strategies.
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`VP R&D
`• Managed all R&D scientific $6.4M DARPA grant (Defense Sciences Organization).
`Secured an additional SBIR contract through DARPA, and early-stage private funding to help
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`finance research.
`• Built and R&D team of 7 professionals (3 Ph.D.’s) with specialization in polymer chemistry,
`tissue engineering, and molecular biology.
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`PerSeptive Biosystems (Life Technologies) 1990 - 1999
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`Held a number of senior technical management positions, with increasing levels of responsibility over
`nine years. Started as employee 20 (pre-IPO) and helped lead the growth to ~300 people and $100M
`annual sales prior to the merger with Perkin Elmer Corp. in 1998.
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`Sr Director, Chromatography Chemistry R&D (1997-1999)
`• Responsible for new product development, and technical management of all chemistry based
`product lines within the chromatography business unit. Products included proprietary POROS
`chromatography supports (columns and bulk media), Poroszyme (immobilized-enzyme media
`and columns), and ID (immunodetection columns and media).
`Planned portions of annual Roadshows (1997 and 1998), showcasing PerSeptives platform
`technologies in a series of technical and marketing presentations.
`Planned and delivered multiple conference presentations and customer site presentations in
`conjunction with the Sales & Marketing teams to develop large-scale customer accounts. ∙
`Developed annual plans and budget.
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`Senior Director, Materials & Surface Chemistry (1993-1997)
`• Developed chromatography resin products, including design of surface chemistries and
`novel flow-through supports.
`• Managed applications development for chromatography resins. Worked closely with
`marketing and manufacturing departments to launch new products.
`• Built inter-disciplinary team of chemists, engineers, and analytical scientists. Managed
`group of 12 professionals.
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`Coordinated projects for development of novel supports for solid-phase peptide and DNA
`synthesis.
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`Director, Materials Development (1990-1993)
`• Designed and developed macroporous polymer supports for rapid purification of
`recombinant proteins and other biomolecules. Demonstrated benefits of flow-through
`design on protein purification processes.
`Expanded product-line to include multiple particle sizes and pore sizes for high-resolution
`analytical to large-scale purification processes.
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`VOLUNTEER
`Bonnie J Addario Lung Cancer Foundation (San Mateo, CA) 2010-2015
`Scientific Advisory Board
`The BJALCF is a non-profit organization devoted to eradicating Lung Cancer through lung cancer
`awareness, support of medical innovations, and patient advocacy and support. The Foundation launched
`a grant program to support novel means of diagnosing and treating lung cancer early, with a focus on
`personalized approaches. As a member of the SAB I have worked to support the grant program.
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`EDUCATION
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`Ph.D., Chemistry
`Massachusetts Institute of Technology, Cambridge, MA
`Department of Materials Science & Engineering
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`M.S., Chemistry
`Massachusetts Institute of Technology, Cambridge, MA
`Department of Materials Science & Engineering
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`B.S., Chemistry
`Colby College, Waterville, ME
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`Publications:
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`1. Mazzone P, Dotson T, Wahidi MM, Bernstein M, Lee HJ, Feller Kopman D, Yarmus L,
`Whitney D, Stevenson C, Qu J, Johnson M, Walsh PS, Huang J, Lofaro LR, Bhorade SM,
`Kennedy GC, Spira A, Rivera MP; AEGIS Study Team. Clinical validation and utility of
`Percepta GSC for the evaluation of lung cancer. PLoS One (2022).
`
`2. Billatos E, Ash SY, Duan F, Xu K, Romanoff J, Marques H, Moses E, Han MK, Regan EA,
`Bowler RP, Mason SE, Doyle TJ, San José Estépar R, Rosas IO, Ross JC, Xiao X, Liu H, Liu G,
`Sukumar G, Wilkerson M, Dalgard C, Stevenson C, Whitney D, Aberle D, Spira A, San José
`Estépar R, Lenburg ME, Washko GR; DECAMP and COPDGene Investigators. Distinguishing
`Smoking-Related Lung Disease Phenotypes Via Imaging and Molecular Features. Chest.
`2021 Feb;159(2):549-563.
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`3. Patel KN; Angell T; Babiarz J; Barth NM; Blevins TC; Duh QY; Ghossein RA; Harrell RM;
`Huang J; Kennedy GC; Kim SY; Kloos RT; LiVolsi AV; Randolph GW; Sadow MP; Shanik MH;
`Sosa JA; Traweek ST; Walsh PS; Whitney DH; Yeh MW; Ladenson PW. A Genomic
`sequencing classifier for the preoperative diagnosis of cytologically indeterminate thyroid
`nodules. JAMA Surgery. 2018.
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`4. Pavel AB, Campbell JD, Liu G, Elashoff D, Dubinett S, Smith K, Whitney D, Lenburg ME,
`Spira A. Alterations in bronchial airway microRNA expression for lung cancer detection.
`Cancer Prev. Res.2016; 10(11)
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`5. Perez-Rogers JF, Gerrein J, Anderlind C, Liu G, Zhang S, Alekseyev Y, Smith KP, Whitney D,
`Evan Johnson W, Elashoff DA, Dubinett SM. Shared gene expression alterations in nasal
`and bronchial epithelium for lung cancer detection. JNCI: Journal of the National Cancer
`Institute. 2017; 109(7).
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`6. Hu Z, Whitney D, Anderson JR, Cao M, Ho C, Choi Y, Huang J, Frink R, Smith KP, Monroe R,
`Kennedy GC. Analytical performance of a bronchial genomic classifier. BMC cancer. 2016;
`16(1):1.
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`7. Vachani A, Whitney DH, Parsons EC, Lenburg M, Ferguson JS, Silvestri GA, Spira A. Clinical
`utility of a bronchial genomic classifier in patients with suspected lung cancer. Chest. 2016
`Feb 16.
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`8. Silvestri GA, Vachani A, Whitney DH, Elashoff M, Porta Smith K, Ferguson JS, Parsons E,
`Mitra N, Brody J, Lenburg ME, Spira A. A Bronchial Genomic Classifier for the Diagnostic
`Evaluation of Lung Cancer. New Engl J Med, 2015. 373(3):243-51.
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`9. Whitney DH, Elashoff MR, Porta-Smith K, Gower AC, Vachani A, Ferguson JS, Silvestri GA,
`Brody JS, Lenburg ME, Spira A. Derivation of a bronchial genomic classifier for lung cancer
`in a prospective study of patients undergoing diagnostic bronchoscopy. BMC Med
`Genomics. 2015; 8:18.
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`10. Neely LA, Rieger-Christ KM, Neto BS, Eroshkin A, Garver J, Patel S, Phung NA, McLaughlin
`S, Libertino JA, Whitney DH, Summerhayes IC. A MicroRNA Expression Ratio Defining the
`Invasive Phenotype in Bladder Tumors. Urologic Oncology: Seminars and Original
`Investigations. 2010, 28: 1, 39-48.
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`11. Moore JK, Smith JA, Whitney DH, Durkee KH, Shuber AP. An electrophoretic capture
`method for efficient recovery of rare sequences from heterogeneous DNA. Biotechniques
`(2008), 44(3):363-74.
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`12. Eisenberg I, Eran A, Nishino I, Moggio M, Lamperti C, Amato AA, Lidov HG, Kang PB, North
`KN, Mitrani-Rosenbaum S, Flanigan KM, Neely LA, Whitney D, Beggs AH, Kohane IS, Kunkel
`LM. Distinctive patterns of microRNA expression in primary muscular disorders. Proc Natl
`Acad Sci U S A. (2007) 23;104(43):17016-21
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`13. Qui H, Ferrell EP, Nolan N, Phelps BH, Tabibiazar R, Whitney DH, Naelfski EA. Fluorescence
`single-molecule counting assays for high-sensitivity detection of cytokines and
`chemokines. Clin Chem. (2007) 53(11):2010-2.
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`14. Nalefski EA, D'Antoni CM, Ferrell EP, Lloyd JA, Qiu H, Harris JL, Whitney DH. Single-
`molecule detection for femtomolar quantification of proteins in heterogeneous
`immunoassays. Clin Chem. (2006) 52(11):2172-5.
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`15. Kann L, Han J, Ahlquist D, Levin T, Rex D, Whitney D, Markowitz S, Shuber A. Improved
`marker combination for detection of de novo genetic variation and aberrant DNA in
`colorectal neoplasia. Clin Chem. (2006) 52(12):2299-302
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`16. Olson J, Whitney DH, Durkee K, Shuber A. DNA Stabilization is Critical for Maximizing
`Performance of Fecal DNA Based Colorectal Cancer Tests. Diagn Mol Pathol. (2005)
`14(3):183-91
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`17. Whitney D, Skoletsky J, Moore JK, Boynton K, Kann L, Brand R, Syngal S, Lawson M, Shuber
`A. Enhanced retrieval of DNA from human fecal samples results in improved performance
`of colorectal cancer screening test. J. Mol Diagn. (2004), 6 (4); 386-395.
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`18. Traverso G, Diehl F, Hurst R, Shuber A, Whitney DH, Johnson C, Levin B, Kinzler KW,
`Vogelstein B. Multicolor in vitro translation. Nat Biotechnol. (2003), 21 (9); 1093-7.
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`19. Gordon NF, Whitney DH, Londo TR, Nadler TK. Affinity perfusion chromatography.
`Methods Mol Biol. 2000; 147, 175-93.
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`20. Fahrner RL, Whitney DH, Vanderlaan M, Blank GS, Performance comparison of protein A
`affinity-chromatography sorbents for purifying recombinant monoclonal antibodies.
`Biotechnol. Appl. Biochem. (1999), 30, 121-128.
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`21. Lynch M, Lynch P, Gordon N, Whitney DH, Meys M, McCoy M, Nadler T. Strategies for
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`rapid purification of fusion proteins: targets for drug discovery, Am. Biotechn. Labs, June
`1998, p.8
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`22. Whitney DH, McCoy M, Gordon N, Afeyan N. Characterization of Large-pore Polymeric
`Supports for Perfusion Chromatography, J. Chromatogr., A, 807 (1998), 165-184.
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`23. Gordon N, McCoy M, Mu N, Nadler T, Londo T, Whitney DH, Perfusion Chromatography: A
`New Tool for Rapid, High Resolution Chromatography of Biopolymers. Chromatography,
`Journal of Separation and Detection Sciences, 18(4), 236 (1997)
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`24. Mhatre R, Nashabeh W, Schmalzing D, Yao X, Fuchs M, Whitney DH, Regnier F, Purification
`of antibody Fab fragments by cation-exchange chromatography and pH gradient elution. J.
`Chromatogr. A, 707 (1995), 225.
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`25. McGuinness B, Britt SD, Mu N, Whitney DH, Afeyan N, Continuous flow solid phase peptide
`synthesis on POROS chromatography supports. Peptides 1994, Proceedings of the Twenty
`third European Peptide Symposium.
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`Patents & Applications:
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`1. Sato T, Yang R, Whitney D. Protein Predictors for Lung Cancer. WO 2023/242206 A1
`(Dec, 2023).
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`2. Kennedy G, Chudova D, Wang E, Wilde J, Whitney D, Elashoff M. Algorithms for
`Disease Diagnostics. US 2021/0262040 A1. (Aug, 2021)
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`3. Whitney DH, Luo J. Methods for Evaluating COPD Status. US Patent application
`2016/0024583 A1 (Pub date, Jan, 2016).
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`4. Whitney DH, Elashoff M. Methods for Evaluating Lung Cancer Status. WO
`2016/011068 (Jan 2016).
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`5. Whitney, DH, Luo J. Methods and Compositions for Detecting Cancer Based on miRNA
`Expression Profiles. US Patent application 2015/0080243 A1, (Mar 2015).
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`6. Shuber A, Kann L, Whitney DH. Methods for Analysis of Molecular Events. US Patent
`8,409,829 (granted Apr 2013)
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`7. Shuber A., Kann L, Whitney D. Methods for Analysis of Molecular Events. U.S. Patent
`7,776,524 (granted Aug, 2010)
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`8. Shuber A, Whitney D. Repetitive Affinity Separation and Uses Therefor. U.S. patent
`7,767,468 (granted Aug, 2010)
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`9. Shuber AP, Whitney DH. Method for Stabilizing Biological Samples for Nucleic Acid
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`Analysis. US Patent 2008/0124714 A1, (filed May, 2005)
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`10. Whitney DH, Shuber AP, Moore JK. Automated sample preparation methods and
`devices. US Patent application 20030204331, Filed Nov., 2002
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`11. Ingwall, R, Troll M, Whitney D. Volume Phase Hologram with Liquid Crystal in
`Microvoids Between Fringes. U.S. 5,198,912 (Mar, 1993).
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`12. Wnek G, Whitney D. Substituted Acetylenic Polymers and Conductive Materials
`formed Therefrom. U.S. 4,672,093 (June, 1987).
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