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David B Hayes

Primarily REMOTE |  | 203-512-8873

Physical Address | 23 Washington St., Gorham, NH 03581

Leading Statement

“We often underestimate the importance of deep knowledge of how a drug works in increasing its probability of being properly developed. Kinda apple pie, but often forgotten about.”  (Private communication from James Sabry, Genentech-Roche)


  • Biophysics consultant with a deep understanding of protein thermodynamics and hydrodynamics and biomolecular interactions.

  • An innovator in data visualization and streamlined data analysis. Professional quality software engineering skills are valuable for addressing the impending bottleneck of data analysis that will result from robotics and high throughput instrumentation.

  • Consultant and leading educator in the field of Analytical Ultracentrifugation with extensive experience in AAV capsid characterization, antibody aggregate quantification, reversible self-association, and biomolecular interactions.

  • Consultant and technical writer for regulatory documents, with a focus on the Common Technical Document (CTD) and in applying Quality by Design principles to analytical tests.

  • Deep understanding of protein characterization, stability, and quality control of protein reagents including the small heat shock proteins such as HSP27, TGFβ family members such as GDF11, and antibodies and antibody-like engineered proteins.

  • Experienced Reviewer and editorial board member for the Journal of Pharmaceutical Sciences.

  • Software architect and programmer. Superior ability to interface with and to evaluate information technology projects.

  • Over 10 years experience in the biopharmaceutical industry, 17 years experience teaching in an academic setting, over 5 years experience in commercial quality software engineering.


PhD | 1993 | University of New Hampshire

  • Major: Biophysics

  • Dissertation: “Equilibrium Electrophoresis: Results from the Second Prototype” Tom Laue director

MS | 1991 | University of New Hampshire

  • Major: Biophysics

  • Thesis: “Automated Analysis of Sedimentation Distribution Function” Tom Laue director

Graduate Certificate | 2004 | Northeastern University

  • Major: Bioinformatics

AB | 1984 | Magdalen College, Bedford NH

  • Major: Liberal Studies

  • Thesis: “The Final End of Man is to Love” according to St. Thomas Aquinas.


Founder | IntlSoSci (International Solidarity of Scientists) | June 2019 – Present

  • AUC data analysis and software support for AAV samples in collaboration with BioAnalysis LLC.

  • Founded a single member LLC to perform consulting work in the sciences and to start to build an organization that advocates for scientists and teachers.

Chief Scientific Officer | BioAnalysis LLC | Sept 2020 – June 2021

  • Development of assays and supporting software for a new GMP AUC laboratory.

  • Contract research and biophysical characterization in support of improved processes for biotherapeutic production and purification.

Principal Scientist | Boehringer Ingelheim, Ridgefield, CT | April 2012 – June 2019

  • Responsible for protein characterization queue and various quality investigations. Managed a number of analysts in a matrixed environment and increased the throughput of data analysis for analytical ultracentrifugation work.

  • Discovery department co-lead for the GDF11 project team, and member of other project and biotherapeutic discovery teams. 

  • Managed an external collaboration with Jack Correia and Walter Stafford to develop technology in the field of serum studies and immune complex size.

  • Implemented innovative new instruments in the biophysics group, including fluorescent detection analytical ultracentrifugation, isothermal chemical denaturation, and dynamic light scattering plate reader

  • Represented BI and served as chair of the industrial advisory board of the Biomolecular Interaction Technology Center (BITC).

  • Subject matter expert on protein interactions and characterization of AAV viral preparation.

  • AUC characterization for Biosimilar originator and conformance lots for BI development in Germany.

  • Collaborated on the biophysical characterization of the NIST mab, performing AUC for the HOS book chapter and for the Mock CTD

Scientist II | MedImmune, Gaithersburg, MD | May 2008 – April 2012

  • Designed and executed all analytical ultracentrifugation experiments including training and managing a number of analysts. 

  • Was a subject matter expert and technical lead in characterizing reversible self-association of antibody lead molecules.  Using AUC data for experimental design, developed a high throughput screen using DLS to find buffer conditions.  Used AUC to complete the characterization of half IgG4 molecule from a set of candidates only partly distinguishable by SEC.

  • Participated in protein characterization, particle investigations, and forensic process investigations as part of the biophysics group in analytical biochemistry.

  • Was the CMC representative on an early project team and coordinated assembly and data insertion for CMC section 3.2.S.3 of an IND.

  • Team member on QbD working group discussing potential critical quality attributes and early risk assessment. Interfaced with a process working group building a design space strategy for downstream processes.

  • Performed biophysical and particle characterization experiments as needed.

  • Served as the MedImmune representative on the BITC industrial advisory board.

Post Doctoral Fellow | Boston Biomedical Research Institute | Jan 2004 – April 2008

  • Became an expert in AUC analysis using SEDANAL and served as an assistant instructor for advanced AUC workshops.  Presented a two day IAP workshop at MIT.

  • Collaborated on AUC projects with various pI’s from BBRI, Tufts, Dana Faber, Biogen Idec, MIT, and Harvard Medical School .

  • Learned various biophysical and scientific techniques including DSC, FRET, and bioinformatics.

  • Earned a graduate certificate, Bioinformatics, 2004 at Northeastern University, Boston, MA

  • Collaborated with crystallographer Roberto Dominguez to provide in-solution biophysical data based on bead modeling and SV-AUC experiments to support various structural projects.

  • Collaborated with YiMing Li from HGSI on the characterization of interferon, albuferon, and pegasys.

  • Performed contract services AUC work for a biotech company with gross fees paid to BBRI of over $100,000.

Tutor and Academic Dean | Magdalen College, Warner, NH | June 2001 – July 2003

  • Led the Curriculum Convocation:  overseeing the design and modification of course,  assigning faculty resources to the Program, upkeep of the Program of Studies documents, review of the academic portion of the college catalog, mentoring junior faculty, faculty recruitment, student advising,  student placement advising, overseeing overall student evaluation and implementation of learning outcomes program.  (Regular meetings weekly, with extra meetings for student evaluation, external interactions, and yearly curriculum review.)

  • Taught across the entire curriculum.

Tutor | Magdalen College, Warner, NH | Sept 1988 – June 2001

  • Under the direction of the Academic Dean (George Stanciu) and with collegial approval by the  Curriculum Convocation redesigned the Biology tutorial, updated The Development of Atomic Theory and Quantum Mechanics tutorial, and designed and introduced the Scripture tutorial for the Magdalen Program of Studies.  It should be noted that in a unified curriculum, tutorials are designed with the whole program in mind, are meant to be taught by every tutor, and need to avoid being dependent on, or influenced by, the personal talents or idiosyncrasies of one tutor, especially the primary designer.

  • Taught across the entire curriculum including Relativity and Quantum Mechanics.

  • Curriculum Convocation member:  included special meeting sequences for studying the nature of education, for studying the impact of Fides et Ratio and Ex Corde Ecclessia, for implementing the new Catechism of the Catholic Church into the Program of Studies, and for a major revision of the Program of Studies implemented in 1991.

  • Courses taught:  Geometry and Reasoning; Astronomy and the Rise of Modern Science; Newtonian Physics; Scripture; Catechetics III Christology-Ecclesiology; Catechetics IV Cannon Law, Marriage and Family, and the Social Teaching of the Catholic Church; Man and Society Ancient; Comparative Cultures; Philosophy of Love; The Biology of Perception and Behavior; Non-Euclidean Geometry and Relativity; The Development of Atomic Theory and Quantum Mechanics; The Human Person and Culture; Man and Society Modern (includes Dante, Machiavelli and Shakespeare); Comparative Cultures, Nature of Man II (Plato’s Republic and Augustine’s City of God)

  • Applied for and received mandatum from the Bishop of Manchester as a teacher of theology in a Catholic College.  Took an oath of fidelity (to the teachings of the church and the local ordinary) yearly.

  • Senior Thesis Advising (over 30 widely varying topics), Senior Thesis Coordinator

  • Contributed to the preparation for and participated in various accreditation self-studies, visits, and meetings including the NEASC, AALE, and state of New Hampshire.

  • Director of the St. Augustine Learning Center and Library, and Senior Thesis Director for the college.

Interim Tutor | Magdalen College, Warner, NH | Oct 1995 – Sept 1998

  • Teaching in a great books program.

  • Teaching Assistant at University of New Hampshire Manchester lab course.

  • Completed Masters and PhD studies while teaching ¾ load.

Supplemental Work

8/19 – 05/20       Highschool Math Teacher for Regina Caeli Academy, Wilton, NH

9/03 – 07/05       Contract Software Researcher, University of NH, Durham, NH

1/00 - 10/03        Software Engineer,, Salem, NH

8/95 – present  Managing Partner, Principle Source Publisher, Warner, NH

6/96 - 12/99        Software Engineer, OMTOOL Inc., Salem, NH

6/94 - 08/94        Research Assistant, University of NH, Durham, NH

6/95 - 08/95        Research Assistant, University of NH, Durham, NH

Homeschool Course Design and Teaching

  • Beauty in Math and Nature

  • Imaginative Literature

  • New Testament

  • American Culture

  • Math is the Language of Nature

  • Thomas Aquinas Commentary on the Nichomachean Ethics

Computer Skills.

Programming in Visual Basic, FORTRAN, C, C++, and JAVA.  Computer Programming and system management with Windows 10, 7, XP, NT, 2000, 98; Linux; Oracle; Java; Java Servlets; HTML; Javascript; Visual Basic; Microsoft Office including VBA macros; Microsoft Excel, Corel Draw; Adobe PageMaker; Adobe InDesign, EndNote 20, Adobe Photoshop.

External Facing Activities

  • Primary Instructor AUC BootCamp, Boston, MA, 2019

  • Participant in the inaugural 2019 Biotherapeutics and Vaccine Development Gordon Research Conference.

  • Scientific Organizer and Instructor, Advanced AUC Workshops, 2016 and 2017 (sponsored by BITC and hosted at Boehringer Ingelheim Ridgefield, CT.

  • Represented biotherapeutics discovery on the QbD implementation workstream and the comparability expert group.

  • Member, Steering Subcommittee for the Bishop and College Theologians representing Magdalen College to the Diocese of Manchester.  Attended the New England Conference on the Implementation of Ex Corde Ecclessia in 2002.

  • Visiting team member representing the AALE in a pre-accreditation visit to New St. Andrews College, Idaho in 2003.

  • Editorial Advisory Board, JPharmSci, 2020 – present.

  • Scientific Advisory Board, JPharmSci 2017-2019.  ( 

  • HOS consortium / CASSS biophysics working group, 2013-present

  • Member, New York Academy of Science, 2013 – 2018.

  • Biomolecular Interactions and Technology Center, Industrial Advisory Board chair, 2012-2018

  • Biomolecular Interactions and Technology Center, Industrial Advisory Board member, 2008-2012

  • Danforth Associates of New England (DANE), a profession association whose members were nominated for excellence in teaching, 1994 – 2000.

  • Co-author of the industry commentary article “Technical Decision-Making with Higher Order Structure Data: Perspectives on HOS Characterization from the Biopharmaceutical Industry” which was selected for the JPharmSci virtual issue because it contained particularly original and significant scientific findings.

  • 2013 and 2019 Top Reviewer” for JPharmSci.


1         Boczkowska, M. et al. X-ray scattering study of activated Arp2/3 complex with bound actin-WCA. Structure 16, 695-704, doi:10.1016/j.str.2008.02.013 (2008).

2         Chereau, D. et al. Leiomodin is an actin filament nucleator in muscle cells. Science 320, 239-243, doi:10.1126/science.1155313 (2008).

3         Eldredge, J. et al. Stoichiometry of LTbetaR binding to LIGHT. Biochemistry 45, 10117-10128, doi:10.1021/bi060210+ (2006).

4         Esfandiary, R. et al. A systematic multitechnique approach for detection and characterization of reversible self-association during formulation development of therapeutic antibodies. J Pharm Sci 102, 62-72, doi:10.1002/jps.23369 (2013).

5         Gokarn, Y. et al. in State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization: The NISTmAb Case Study Vol. 1201 ACS Symposium Series  Ch. 6, 285-327 (American Chemical Society, 2015).

6         Hayes, D. Practical Analytical Ultracentrigugation: vol. 1 What is biophysics. 1 edn, Vol. 1 122 (Indepenedently Published, 2021).

7         Hayes, D., Napoli, V., Mazurkie, A., Stafford, W. F. & Graceffa, P. Phosphorylation dependence of hsp27 multimeric size and molecular chaperone function. J Biol Chem 284, 18801-18807, doi:10.1074/jbc.M109.011353 (2009).

8         Hayes, D. B. & Laue, T. M. in Modern Analytical Ultracentrifugation: Acquisition and Interpretation of Data for Biological and Synthetic Polymer Systems   (eds Todd M. Schuster & Thomas M. Laue)  245-258 (Birkhäuser Boston, 1994).

9         Hayes, D. B. & Stafford, W. F. SEDVIEW, real-time sedimentation analysis. Macromol Biosci 10, 731-735, doi:10.1002/mabi.201000075 (2010).

10       Khalil, A. M. et al. Differential Binding Activity of TGF-beta Family Proteins to Select TGF-beta Receptors. J Pharmacol Exp Ther 358, 423-430, doi:10.1124/jpet.116.232322 (2016).

11       Lee, S. H., Hayes, D. B., Rebowski, G., Tardieux, I. & Dominguez, R. Toxofilin from Toxoplasma gondii forms a ternary complex with an antiparallel actin dimer. Proc Natl Acad Sci U S A 104, 16122-16127, doi:10.1073/pnas.0705794104 (2007).

12       Lee, S. H., Weins, A., Hayes, D. B., Pollak, M. R. & Dominguez, R. Crystal structure of the actin-binding domain of alpha-actinin-4 Lys255Glu mutant implicated in focal segmental glomerulosclerosis. J Mol Biol 376, 317-324, doi:10.1016/j.jmb.2007.11.084 (2008).

13       Li, Y. et al. Characterization of the self-association of human interferon-alpha2b, albinterferon-alpha2b, and pegasys. J Pharm Sci 101, 68-80, doi:10.1002/jps.22751 (2012).

14       Myzithras, M. et al. Development of an ultra-sensitive Simoa assay to enable GDF11 detection: a comparison across bioanalytical platforms. Bioanalysis 8, 511-518, doi:10.4155/bio.16.17 (2016).

15       Padyana, A. K. et al. Crystal structure of human GDF11. Acta Crystallogr F Struct Biol Commun 72, 160-164, doi:10.1107/S2053230X16001588 (2016).

16       Rebowski, G. et al. X-ray scattering study of actin polymerization nuclei assembled by tandem W domains. Proc Natl Acad Sci U S A 105, 10785-10790, doi:10.1073/pnas.0801650105 (2008).

17       Ridgeway, T. M. et al. An apparatus for membrane-confined analytical electrophoresis. Electrophoresis 19, 1611-1619, doi:10.1002/elps.1150191016 (1998).

18       Smith, S. C. et al. GDF11 does not rescue aging-related pathological hypertrophy. Circ Res 117, 926-932, doi:10.1161/CIRCRESAHA.115.307527 (2015).

19       Wei, Y., Lee, J., Dziegelewski, M., Marlow, M. S. & Hayes, D. B. Determination of the SLAMF1 self-association affinity constant with sedimentation velocity ultracentrifugation. Anal Biochem 633, 114410, doi:10.1016/j.ab.2021.114410 (2021).

20       Weiss, W. F. t. et al. Technical Decision Making With Higher Order Structure Data: Perspectives on Higher Order Structure Characterization From the Biopharmaceutical Industry. J Pharm Sci 105, 3465-3470, doi:10.1016/j.xphs.2016.09.003 (2016).

21       Wilkinson, I. C. et al. Monovalent IgG4 molecules: immunoglobulin Fc mutations that result in a monomeric structure. MAbs 5, 406-417, doi:10.4161/mabs.23941 (2013).

22       Wright, R. T., Hayes, D., Sherwood, P. J., Stafford, W. F. & Correia, J. J. AUC measurements of diffusion coefficients of monoclonal antibodies in the presence of human serum proteins. Eur Biophys J 47, 709-722, doi:10.1007/s00249-018-1319-x (2018).

23       Wright, R. T., Hayes, D. B., Stafford, W. F., Sherwood, P. J. & Correia, J. J. Characterization of therapeutic antibodies in the presence of human serum proteins by AU-FDS analytical ultracentrifugation. Anal Biochem 550, 72-83, doi:10.1016/j.ab.2018.04.002 (2018).

24       Yang, D. et al. Weak IgG self- and hetero-association characterized by fluorescence analytical ultracentrifugation. Protein Sci 27, 1334-1348, doi:10.1002/pro.3422 (2018).

25       Yphantis, D. A. et al. in Modern Analytical Ultracentrifugation: Acquisition and Interpretation of Data for Biological and Synthetic Polymer Systems   (eds Todd M. Schuster & Thomas M. Laue)  209-226 (Birkhäuser Boston, 1994).

26       Zhou, Y. et al. GDF11 Treatment Attenuates the Recovery of Skeletal Muscle Function After Injury in Older Rats. AAPS J 19, 431-437, doi:10.1208/s12248-016-0024-x (2017).

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