Case 1:18-cv-01363-CFC Document 79-11 Filed 03/22/19 Page 1 of 4 PageID #:
`9549
`Holly Prentice, Ph.D.
`
`
`
`
`
` hprenticeconsulting@gmail.com
`
`
`35 Nathan Lane
`Carlisle, MA 01741
`
`(857) 253-8124 (C)
`
`
`
`
`
`Professional Profile
`Consultant with over 20 years of experience in biologics CMC. Participated in the
`development of more than 20 clinical and commercial products.
`
`Experience with CMC teams, tech transfer, oversight of outsourced programs, and
`preparation of regulatory filings. Program types include protein therapeutics, cell therapy
`and gene therapy.
`
`Areas of deep technical expertise include; mammalian expression vectors, recombinant
`CHO cell line development, cell line characterization, batch and fed-batch cell culture
`development, cell culture media and supplements, and the selection and development of
`analytics to support process development.
`Experience
` PRENTICE CONSULTING, LLC - Carlisle, MA
`Principal (Mar 2013 to present)
`
`MOMENTA PHARMACEUTICALS, INC. - Cambridge, MA
`Associate Director (Jan 2011 to Mar 2013)
` Led cell line and cell culture process development for follow-on antibody biologics using
`internally developed proprietary technologies and meeting defined product quality
`targets
` Produced five utility patent applications and contributed a FTO analysis for technologies
`used in process development.
` Oversaw multiple CMOs and CROs for process development, manufacturing, media
`development, cell line generation, GMP cell banking, and testing.
` Recruited and developed a team of seven scientists and engineers for cell line
`generation and cell culture process development.
` Defined $1.5M capital equipment for new development laboratory space and worked
`with architects on lab design modifications.
` Developed resource plans, budgets, and timelines for multiple programs
`
`MILLIPORE CORPORATION - Bedford, MA
`Manager II (Mar 2008 to Dec 2010)
` Led the development and evaluation of novel mammalian expression technologies in the
`areas of cell line screening, vector design, host cell engineering, transfection reagents,
`novel cell culture supplements, and assay design
` Initiated and led collaborations with industrial and academic partners resulting in new
`product concepts and technical publications
` Generated FTO analysis for >10 programs and aided in the defense of an internal IP.
` Led bioreactor process development for production of CHO derived antibody feedstock
`used for multiple programs throughout the bioprocess division
` Led the development of strategic technology roadmaps, a multiyear planning tool
` Co-organized an annual companywide global technology exposition
` Recipient of an innovation award for a novel product design
` Managed budgets and project timelines
` Responsible for 4 direct reports and a group of 9 overall including 3 PhDs
`
`
` H
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 79-11 Filed 03/22/19 Page 2 of 4 PageID #:
`9550
`Holly Prentice, Ph.D. Page 2
`
`
`MOMENTA PHARMACEUTICALS, INC. - Cambridge, MA
`Principal Scientist (Oct 2006 to Mar 2008)
` Managed a CMO for large scale production of a critical reagent enzyme for an API
`manufacturing process and identified replacement GMP CMO
` Oversaw process development and analytics for six E. coli derived enzyme processes
`and their transfer to contract manufacturing
` Identified a CRO and oversaw the outsourced testing as part of a regulatory response
` Managed budgets and project timelines
`
`BIOGEN IDEC, INC. - Cambridge, MA
`Principal Scientist (2004 to Oct 2006)
`Senior Scientist (2000 to 2004)
`Scientist II (Oct 1996 to 2000)
` Responsible for the transition of programs from Research into Development.
` Led or participated in the development of cell lines and processes for over seven clinical
`and commercial programs including antibodies, fusion proteins and other product types.
` Specified and implemented automation for the development of high throughput methods for
`cell line development
` Co-led the development of a commercial cell culture process
` Co-led a Process development team for an early phase clinical candidate including the
`coordination of the CMC section of the IND filing
` Led project teams for multiple programs and represented the department in cross-
`departmental projects
` Participated in the development of a guideline used by the process development group for
`the development of clinical and commercial phase processes
` Led a team to generate strategies for accelerated development of recombinant antibodies
`from cell line generation to IND filing
` Familiar with requirements for Regulatory requirements for recombinant products.
`Experienced in preparing IND and BLA filings.
` Line management responsibility for Scientist and Associate level positions
` Generation of five patent filings as well as FTO analysis to support process development
`activities. Deposition experience.
`
`SERONO LABORATORIES, INC. – Randolph, MA (1994 to Oct 1996)
` Developed a novel expression technology in mammalian cells
` Created a high throughput assay reporter cell line
` Generated recombinant proteins using the baculovirus expression system
` Line management of two associates
`
`Experience prior to 1994 consisted of academic research in a number of laboratories at Harvard
`University (incl. R. Kingston and J. Strominger) and Univ. of Chicago (W. Upholt)
`encompassing subject areas including molecular biology, genetics, and immunology.
`Education
`
`Harvard University, Cambridge, MA
`Ph.D. in Molecular Biology with Robert Kingston, Ph.D.
`Cold Spring Harbor, NY Yeast Genetics Course
`
`University of Chicago, Chicago, IL
`
`
`
`M.S. in Geophysical Sciences with Thomas Schopf, Ph.D.
`Rensselaer Polytechnic Institute, Troy, NY
`
`
`B.S. in Biology
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 79-11 Filed 03/22/19 Page 3 of 4 PageID #:
`9551
`Holly Prentice, Ph.D. Page 3
`
`
`Patents and Patent Applications
`1. Methods of Cell Culture. US20140271622, H. Prentice, published Sep 18, 2014.
`2. Methods of Cell Culture. US20140273057, H. Prentice, R. Tijani & B. Belongia, published
`Sep 18, 2014.
`3. Methods of Cell Culture. US20140274911, B. Collins, H. Prentice, B. Belongia & R. Tijani,
`published Sep 18, 2014.
`4. Methods of Cell Culture. US20140274912, H. Prentice, published Sep 18, 2014.
`5. Cell culture process. US Patent 8,852,889, H. Prentice.
`6. Methods for producing mammalian cells. US Patent 8,809,049, H. Prentice & B.
`Ehrenfels,
`FLP-Mediated recombination. WO 2005/038020, H. Prentice & L. Caamano, published
`April 28, 2005.
`8. Methods and constructs for expressing polypeptide multimers in eukaryotic cells
`using alternative splicing. US Patent 7,569,362, H. Prentice.
`9. An expression cassette and vector for transient or stable expression of exogenous
`molecules. US Patent 7,494,805, W. Sisk & H. Prentice.
`10. High expression locus vector based on ferritin heavy chain gene locus. WO 2004/037982,
`H. Prentice, published May 5, 2004.
`11. Method of expressing and secreting soluble extracellular domains of human
`gonadotropin hormone receptors. U.S. Patent 6,033,903, Sisk, W.P., Cheng,
`S.V.Y., Buckler, D.R. & H.L. Prentice.
`
`7.
`
`
`Publications
`1. Kwon T, Prentice H, Oliveira J, Madziva N, Warkiani ME, Hamel JP, Han 2017
`Microfluidic Cell Retention Device for Perfusion of Mammalian Suspension Culture
`J. Sci Rep. Jul 27;7(1):6703.
`2. Potty AS, Xenopoulos A, Patel S, Prentice H & DiLeo A 2014. The Effect of Anti-
`apoptosis Genes on Clarification Performance. Biotechnology Prog. 30(1):100-7.
`3. Doneanu CE, Xenopoulos A, Fadgen K, Murphy J, Skilton SJ, Prentice H, Stapels
`M, Chen W. 2012. Analysis of host-cell proteins in biotherapeutic proteins by
`comprehensive online two-dimensional liquid chromatography/mass spectrometry.
`MAbs. 4(1):24-44.
`4. Prentice, H, Ehrenfels, B, & W. Sisk 2007. Improving performance of mammalian
`cells in fed-batch processes through "bioreactor evolution". Biotechnol Prog.
`23(2):458-64.
`5. Prentice, H, Tonkin, C, Caamano, L & W.P. Sisk 2006. High-level expression of
`proteins using sequences from the ferritin heavy chain gene locus. J Biotechnol.
`128(1):50-60.
`6. Lukashev M, LePage D, Wilson C, Bailly V, Garber E, Lukashin A, Ngam-ek A,
`Zeng W, Allaire N, Perrin S, Xu X, Szeliga K, Wortham K, Kelly R, Bottiglio C, Ding
`J, Griffith L, Heaney G, Silverio E, Yang W, Jarpe M, Fawell S, Reff M, Carmillo A,
`Miatkowski K, Amatucci J, Crowell T, Prentice H, Meier W, Violette SM, Mackay F,
`Yang D, Hoffman R, Browning JL. 2006. Targeting the lymphotoxin-beta receptor
`with agonist antibodies as a potential cancer therapy.Cancer Res. 66(19):9617-24.
`7. Taylor, F.R., H. Prentice, E.A Garber, H.A. Fajardo, E. Vasilyeva & R.B. Pepinsky
`2006. Suppression of sodium dodecyl-polyacrylamide gel electrophoresis sample
`preparation artifacts for analysis of IgG4 half-antibody. Anal. Biochem. 353(2):204-
`8.
`8. Makrides, S.C. & H. Prentice 2002. Why choose mammalian cells for protein
`production? In “Gene Transfer and Expression in Mammalian Cells” (S.C. Makrides
`Ed.), Elsevier Pub., Amsterdam, New York, Oxford.
`
`

`

`Case 1:18-cv-01363-CFC Document 79-11 Filed 03/22/19 Page 4 of 4 PageID #:
`9552
`Holly Prentice, Ph.D. Page 4
`
`9. Saltsman, K, H. Prentice & R. Kingston 1999. Mutations in the
`Schizosaccharomyces heat shock factor that differentially affect responses to heat
`and cadmium stress. Mol. Gen. Genet. 261:161-169.
`10. Saltsman, K, H. Prentice & R. Kingston 1998. The C-terminal hydrophobic repeat
`of Schizosaccharomyces heat shock factor is not required for heat-induced DNA-
`binding. Yeast. 14:733-746.
`11. Gallo, G., H. Prentice & R. Kingston 1993. Heat Shock Factor is required for
`growth at normal temperatures in the fission yeast Schizosaccharomyces pombe.
`Mol. Cell. Biol. 13:749-761.
`12. Prentice, H. & R. Kingston 1992. Mammalian promoter element function in the
`fission yeast Schizosaccharomyces pombe. Nuc. Acids Res. 20:3383-3390.
`13. Prentice, H. 1992. High efficiency transformation of Schizosaccharomyces pombe
`by electroporation. Nuc. Acids Res. 20:621
`14. Greene, J., Z. Larin, I. Taylor, H. Prentice, K. Gwinn & R. Kingston 1987. Multiple
`basal elements of a human hsp70 promoter function differently in human and
`rodent cell lines. Mol. Cell. Biol. 7:3646-3655
`15. Miura, N., H. Prentice, P. Schneider and D. Perlmutter 1987. Synthesis and
`regulation of the human complement C4 genes in stable transfected mouse
`fibroblasts. J. Biol. Chem. 262:7298-7305
`16. Prentice, H., P. Schneider & J. Strominger 1986. C4B gene polymorphism
`detected in a human cosmid clone. Immunogenetics 23:274-276
`17. Sorrentino R, Auffray C, Boss J, Grossberger D, Kappes D, Levy D, Lillie J,
`Mengler R, Okada K, Prentice H, et al. Major histocompatibility complex class II
`antigens: genes and proteins. Mt Sinai J Med. 1986 3:202-9.
`18. Okada, K., J. Boss, H. Prentice, T. Spies, R. Mengler, C. Auffray, J. Lillie, D.
`Grossberger & J. Strominger 1985. Gene organization of the DC and DX
`subregions of the human major histocompatibility complex. Proc. Natl. Acad. Sci.
`USA 82:3410-3414
`19. Okada, K., H. Prentice, J. Boss, D. Kappes, T. Spies, R. Raghupathy, R. Mengler,
`C. Auffray & J. Strominger 1985. SB subregion of the human major
`histocompatibility complex: gene organization, allelic polymorphism and expression
`in transformed cells. EMBO J. 4:739-748
`20. Sandell, L., H. Prentice, D. Kravis & W. Upholt 1984. Structure and sequence of
`the chicken type II procollagen gene: Characterization of the region encoding the
`carboxy-terminal telopeptide and propeptide. J. Biol. Chem. 259:7826-7834
`
`
`Selected Abstracts and Presentations
`1. Strategies for Rapid Cell Line Development. Accelerated Bioprocess Development,
`October 2013, Seoul, Korea
`2. An analytical and cell culture platform for the development of a biogeneric. IBC -
`Cell Line Development and Engineering, June 2012, San Francisco,CA
`3. Invited workshop panelist for “Challenges of Integrating New Technologies”. IBC –
`Cell Line Development and Engineering, June 2009, San Diego, CA
`4. Invited workshop panelist for “Advances in Media Development”. IBC – Antibody
`Development and Production, March 2009, Carlsbad, CA
`5. Enriching transfected populations of cells for higher productivity using paramagnetic
`beads. 5th International congress on recombinant antibodies, 2006, Zurich,
`Switzerland.
`6. Schizosaccharomyces pombe as a genetic system for the study of transcriptional
`phenomenon common to higher eukaryotes. Cold Spring Harbor Meeting:
`Regulation of Eukaryotic mRNA transcription, 1991, Cold Spring Harbor, New York.
`7. Schizosaccharomyces pombe as a genetic system for the analysis of a mammalian
`promoter: Characterization of the human hsp70 promoter and a heat inducible
`factor which binds the heat shock element. 15th International Conference on Yeast
`Genetics and Molecular Biology, 1990, The Hague, The Netherlands.
`
`