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Curriculum Vitae

261 Pamela Ct, Vallejo CA 94589


E-mail: kahsay@att.net Kahsay Gebretsadik (510) 290-5657

PROFESSIONAL SUMMARY
Over 15 years of experience in the biotechnology and pharmaceutical industry and proficient
in diverse set of analytical, molecular, cellular and microbiological methods for AAV
characterization.

ACCOMPLISHMENTS
Characterized and released hundreds of naturally isolated and engineered purified vectors for
in vivo studies. Developed qPCR and in vitro potency assay methods to determine the vector
genome titer and potency of various vectors. Directed and trained senior research associates
for various assay methods. Prepared dosing solution for various projects for preclinical GLP
and Non-GLP studies. Work with cross functional teams in advancing different projects.

Work History:

Technical Scientist I
BioMarin Pharmaceuticals Inc. August 2017 – Present

Develop qPCR and RT-qPCR for Genomic copy and Gene Expression level analysis of
Liver tissue from AAV GT treated Mice.
Develop transduction assay for PKU vectors to measure the potency of PAH vectors
Optimize various quality control/characterization assays for rAAV (recombinant Adeno
Associated Virus) preps.
Performed routine quality control and characterization assays to ensure the safety and
quality of vectors.
Prepared and titer dosing solutions for IVIS studies in order to facilitate the selection
of best candidates for future studies.
Develop and perform assays for lot release and additional characterization of AAV
vectors, analysis of the capsid proteins and viral DNA, gene expression assays, and
monitoring of residual impurities.

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Sr. Research Associate

BioMarin Pharmaceuticals Inc. June 2015 – August 2017

Optimize various quality control/characterization assays for rAAV (recombinant Adeno


Associated Virus) preps.
Performed routine quality control and characterization assays to ensure the safety and
quality of vectors.
Prepared and titer dosing solutions for IVIS studies in order to facilitate the selection
of best candidates for future studies.
Develop and perform assays for lot release and additional characterization of AAV
vectors, including viral infectivity assays, analysis of the capsid proteins and viral DNA,
gene expression assays, and monitoring of residual impurities.
Contract laboratory oversight for AAV based gene therapy program.
Prepare Master and working cell banks for different cell lines needed for potency and
infectivity assays.
Review data and reports for their GMP compliance and accuracy.

QC Scientist

Avalanche Biotechnologies Inc. November 2014 to June 2015

Develop and qualify TCID50 for determining the infectivity of rAAV based vectors in
HeRC32 cell line.
Develop and qualify Transgene expression assay for determining potency of Avalanche
rAAV products.
Prepare Master and working cell banks for different cell lines needed for potency and
infectivity assays.
Develop and qualify Capsid ELISA assay to determine rAAV Capsid proteins.
Perform qPCR, TCID50, Transgene Expression, Capsid ELISA, Baculo virus plaque assay,
and Endotoxin for in process, release and stability samples.
Write SOPs, protocols and reports for test methods and equipment.
Review data and reports for their GMP compliance and accuracy.

Sr. QC Analyst

BioMarin Pharmaceutical Inc., Novato CA March 2014 – November 2014

Provide testing support for manufacturing for in process samples by various test
methods such as HPLC (HIC, SAX-HPLC and RP-HPLC), Activity (End point and Kinetic),
Protein Content by Bradford, BCA and A280 and Endotoxin.
Testing routine and non-routine samples for TOC, Bioburden and Endotoxin.
Provide testing support for raw material, process development and QC Analytical
groups.
Trending results for in process samples.
Revised SOPs and initiate CRs in TrackWise.
Transfer methods from assay development and perform method validation.

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QC Analyst III

Dynavax Technologies, Berkeley CA October 2010 – January 2013

Manages Dynavax Stability Program

Authored FDA/ICH compliant stability protocols and other stability related SOPs
and initiated stability study as per approved protocols and,
Coordinated/ scheduled stability sample pull and testing, and assisted in
OOS/OOE (Out of Specification/Expectation) and OOT (Out of Trend)
investigations.
Tracked and prepared trend reports to determine appropriate cause of action.
Summarized and authored the stability section of annual report for regulatory
update
Reviewed batch records, release and stability testing data for compliance,
completeness and accuracy
Key person in assay/method transfer from Analytical to QC laboratory
IQ/OQ/PQ of QC equipment’s during relocation and new equipment purchase
Continuously Monitored and trended stability data to ensure assigned retest or
product shelf - life is appropriate. Stability data evaluation using MS Excel
Toolpak, SLIM stat and graph pad prism
Site inspection of CMOs and CROs for cGMP and cGLP compliance.

QC Scientist

Novartis, Vacaville, CA February 2010 – August 2010

Stability Coordinator

Written FDA/ICH compliant stability protocols and other stability related SOPs.
Organized and maintained the stability schedule to ensure timely performance
of all testing.
Monitored and trended stability data to ensure assigned retest or product shelf -
life is appropriate. Stability data evaluation as per ICH Q1E.
Aliqouting, labeling and storing of stability samples into their appropriate
storage condition as per an approved protocol.
Written quarterly, semi-annual and annual trend reports for Aborted and Invalid
assays (AIAs) and OOS with CAPA analysis as per Quality System Requirement
(QSR).

Research Associate (06/2005-11/2008)

Avigen Inc., Alameda, CA June 2001- November 2008

Conducted PK/PD and in vivo efficacy studies screening of small glial attenuator
molecules.
Dosing animals via IV, IP, SC, IM and oral gavage and necropsy of various organ

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for toxicological and drug distribution studies.
Maintained several primary and mammalian cell lines. Prepared working and
master cell banks for QC and development.
Processed and maintained primary rat cortical and hippocampal neuronal cells
and screen several analogs for their kinase inhibition by Fast Activated Cell
Based ELISA and Luminex.
Setting up screening assays for the search of leading candidates for their anti-
apoptotic activity using Cell Death ELISA and LDH cytotoxicity assays
Performed Chronic Constriction Injury (CCI) surgery for Von Frey Test of
mechanical allodynia.

QC Specialist (July 2003 - June 2005)

Performed wide range of routine biological, raw material and analytical assays
for clinical release of recombinant adeno-associated virus (AAV) products
Osmolality, pH test, Appearance, LAL, TOC, Conductivity, HPLC (RP-HPLC
and SEC), SDS-PAGE/Western, AAV Infectivity and AAV Wild Type assays.
Dynamic Light Scattering (DLS) for sub visible particle determination in
AAV final product, qPCR for titer determination and potency of AAV based
vectors.
Prepared and maintained inventory of reference, control and final products
Trending of controls and reference standards.
Trained QC analysts on test methods, laboratory techniques and instrument
usage.
Written and revised numerous analytical and equipment SOPs.
Prepares QC working cell bank and maintained more than 4 cell lines for
different QC assays.
Coordinate calibration and maintenance of QC equipment’s with outside labs.
Maintains stability schedules and conducts stability of Avigen products according
to stability protocols.
QC Analyst II (June 2001-July 2003)

Conducted routine and non-routine analysis of raw materials, in-process


materials, final products and stability samples according to established SOPs.
Written and revised SOPs.
Maintained QC inventory of control, standards and references.

Free University of Brussels, Brussels, Belgium September 1998-September 2000


Graduate student
Principal investigator for testing the anti-fibrogenic effects of naturally occurring and
synthetic compounds in a CCI4 mouse model using a special drug delivery system
(surgically implanted catheter and mini-pumps).

Certificates:

Stability Programs for Product shelf Life- From Development to Approval, August 9 & 10, 2012.

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GLP regulations and rules in the Biotech Industry.
Pharmacy Board Exam for Foreign Pharmacy Graduates

Education:

Master of Science (MSc.) September 2000


Medical and Pharmaceutical Research from Free University of Brussels (VUB)
Bachelor of Pharmacy (Bpharm) November 1993
Addis Ababa University, School of Pharmacy

Publications:

In vivo antifibrogenic effects of histone deacetylase inhibitors


Krista Rombouts, Kahsay Gebretsadik, Marcella Chavez, Albert Geerts
Journal: Journal of Hepatology - J HEPATO, vol. 36, pp. 9-9, 2002

Behavioral changes and development of tolerance to repeated administration of Khat


(Catha edulis Forsk) in Mice. Negussu Mekonnen, Eyassu Makonnen, Kahsay Gebretsadik,
Ethiop. J. Health Dev. 1998; 12(3):253-260

Technical Report:
TR-00561: Comparability Study of ddPCR and qPCR.

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Vincent LEONARD, Ph.D.
Phone: 415 455 7844
vincent.leonard@bmrn.com

Drug Discovery – Cellular and Molecular Virology

SUMMARY
Highly motivated scientist with over 14 years of experience in molecular and cellular virology
with 8 years of drug discovery in the pharmaceutical industry.

• Expertize in the virology and molecular engineering of AAV, influenza virus, human
rhinovirus, measles virus and ebola virus for drug discovery and gene therapy.
• Project leadership experience in the pharmaceutical industry, including in devising discovery
strategies, assay development and validation, screening, hit validation, hit optimization and
pharmacology study design.
• Management of IND-enabling studies, including cellular activity, target identification,
resistance generation, MOA, spectrum of activity, combination, cross-resistance, cytotoxicity.
• Extensive experience establishing, leading and supporting matrix-based R&D groups with
internal and external collaborators.
• Over 9 years of management experience including Ph.D. level scientist, junior/senior
scientists and students.
• Excellent communication skills, experienced in writing research proposals, reports,
manuscripts, presenting at project review meetings and scientific advisory boards.

EMPLOYMENT EXPERIENCE
BioMarin Pharmaceutical, San Rafael, CA 2018 – Present
SENIOR SCIENTIST II (ASSOCIATE DIRECTOR) – NEW AAV CAPSID DISCOVERY FOR GENE THERAPY
• Developed and implemented a bio-informatic approach for identification of new AAV capsids
• Streamlined new capsid selection process and established AAV genome NGS from vector
preparation and natural samples
• Explored capsid engineering and retargeting strategies to control biodistribution
• Designed and coordinated pharmacology studies, including single capsid in-vivo imaging and
vector multiplexing in mice
• Managed 5 research associates from entry level to senior scientist.

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Novartis Institutes for BioMedical Research, Emeryville, CA 2010 – 2018
INVESTIGATOR III – GROUP LEADER RESPIRATORY VIROLOGY 2014 – 2018
• Biology lead for Novartis drug discovery programs on Influenza viruses, Rhinoviruses,
Enteroviruses and one Hepatitis B virus project.
• Coordinated and managed the virology effort for seven research projects at various stages of
development (from target evaluation to IND-enabling studies of lead compound).
• Extensively interacted with representatives of the medicinal chemistry, protein production,
biochemical/biophysical assays, structural biology, bioinformatics, PK and pharmacology line
functions.
• Managed 6 research associates from entry level to senior scientist and 1 Ph.D. level
manager.
• Explored new technologies for target identification and hit finding (including CRISPR screens,
fragment-based screens, DNA-encoded library, covalent chemoproteomics and targeted
protein degradation)
INVESTIGATOR II – INFLUENZA VIRUS LEAD BIOLOGIST 2010 – 2014
• Project Team Leader on phenotypic HTS campaigns and targeted projects (biochemical
screens) for influenza virus drug discovery.
• Responsible for assay developments, hit identification and compound triaging in medium and
high throughput screens.
• Established cell-based assays for quantification of viral entry, replication, egress and
resistance generation for target identification and mode of action studies.
• Established reverse genetic systems (influenza, Ebola replicon) and streamlined whole
genome deep sequencing processes (influenza).
• Managed a team of 3 research associates and visiting students.
• Collaborated with several team members within and outside of Novartis.
• Wrote Python programs to analyze influenza virus genome sequences and predict strain
coverage of current lead series against past and emerging human/animal viral strains.
• Extensively involved in the bioinformatics effort to select a target specific diversity panel of
virus to investigate lead compound strain coverage.

Mayo Clinic, Rochester, MN 2005 – 2010


RESEARCH FELLOW - SENIOR RESEARCH FELLOW
Laboratory of Dr. Roberto Cattaneo
Main objective: To investigate the role of epithelial cells in measles virus infection of its host and
engineer measles virus “blind” for its natural receptors. This project was part of a larger
objective aiming at de-targeting measles virus from its natural receptors to efficiently retarget it
to tumor specific receptor for oncolytic virotherapy.
• Identification of residues on the attachment glycoprotein of measles virus necessary for
recognition of its epithelial receptor
• Generation by reverse genetic of measles virus “blind” for this receptor, followed by its in vitro
and in vivo characterization.
• Mentored and managed 6 undergraduate students, 3 postgraduate students, 3 laboratory
assistants.
This study demonstrated a role for lung epithelial cells for viral shedding rather than for primary
infection. This work led to the identification of the epithelial receptor for measles virus and to
major publications re-defining measles virus model of infection (referenced hereafter).

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EDUCATION
University of Glasgow, UK 2001 – 2005
PH.D. IN MOLECULAR VIROLOGY
Laboratory of Dr. Richard M. Elliott
Objective: To investigate the role of the viral/viral and viral/host protein interactions involved in
viral replication and assembly of bunyamwera virus. This work led to 4 publications improving
our understanding of the protein-protein interactions involved in Bunyamwera virus replication,
assembly, attenuation and evasion of the host innate immune system.
University of Glasgow, UK 2000 – 2001
MASTER OF RESEARCH IN INFECTIOUS DISEASES
Rotation student in Bacteriology, Immunology and Biochemistry
University of Nancy, France 1999-2000
DEA OF MICROBIOLOGY AND ENZYMOLOGY (equivalent master)
Supervisor: Dr. M. Barrett, University of Glasgow, UK. Title of thesis: Construction and
characterization of a P2 transporter Trypanosoma brucei brucei knockout.

PUBLICATIONS
1. Homotypic interaction of Bunyamwera virus nucleocapsid protein. Leonard VH, Kohl A,
Osborne JC, McLees A, Elliott RM. Journal of Virology, 2005; 79:13166-72.
2. Genetic elements regulating packaging of the Bunyamwera orthobunyavirus genome. Kohl
A, Lowen AC, Leonard VH, Elliott RM. Journal of General Virology, 2006; 87:177-87.
3. Requirement of the N-Terminal region of Orthobunyavirus nonstructural protein NSm for
virus assembly and morphogenesis. Shi X, Kohl A, Leonard VH, Li P, McLees A, Elliott RM.
Journal of Virology, 2006; 80:8089-99.
4. Interaction of Bunyamwera Orthobunyavirus NSs protein with Mediator protein MED8: a
mechanism for inhibiting the interferon response. Leonard VH, Kohl A, Hart TJ, Elliott RM.
Journal of Virology, 2006; 80:9667-75.
5. Measles virus blind to its epithelial cell receptor remains virulent in rhesus monkeys but
cannot cross the airway epithelium and is not shed. Leonard VH, Sinn PL, Hodge G, Miest T,
Devaux P, Oezguen N, Braun W, McCray PB, McChesney MB, Cattaneo R. Journal of Clinical
Investigation, 2008; 118:2448–58. This article was highlighted in the Journal of Clinical
Investigation 2008 118: 2386-2389, Nature News (20 Jun 2008) doi: 10.1038/news.2008.907,
Nature Reviews Microbiology 2008 6: 571, and Molecular Therapy 2008 16: 1353.
6. The measles virus fusion protein transmembrane region modulates availability of an active
glycoprotein complex and fusion efficiency. Mühlebach MD, Leonard VH, Cattaneo R. Journal
of Virology. 2008; 82:11437-45.
7. Measles virus infection of alveolar macrophages and dendritic cells precedes spread to
lymphatic organs in transgenic mice expressing human signaling lymphocytic activation
molecule (SLAM, CD150). Ferreira CS, Frenzke M, Leonard VH, Welstead GG, Richardson
CD, Cattaneo R. Journal of Virology. 2010; 84:3033-42.

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8. Measles virus selectively blind to signaling lymphocytic activation molecule (SLAM; CD150) is
attenuated and induces strong adaptive immune responses in rhesus monkeys. Leonard VH,
Hodge G, Reyes-Del Valle J, McChesney MB, Cattaneo R. Journal of Virology. 2010; 84:3413-
20.
9. The heads of the measles virus attachment protein move to transmit the fusion-triggering
signal. Navaratnarajah CK, Oezguen N, Rupp L, Kay L, Leonard VH, Braun W, Cattaneo R.
Nature Structural and Molecular Biology. 2011; 18:128-34
10. MicroRNA-sensitive oncolytic measles viruses for cancer-specific vector tropism. Leber
MF, Bossow S, Leonard VH, Zaoui K, Großardt C, Frenzke M, Miest T, Sawall S, Cattaneo R,
von Kalle C, Ungerechts G. Molecular Therapy, 2011, 19:1097-106.
11. Adherens junction protein nectin-4 is the epithelial receptor for measles virus. Mühlebach
MD, Mateo M, Sinn PL, Prüfer S, Uhlig KM, Leonard VH, Navaratnarajah CK, Frenzke M,
Wong XX, Sawatsky B, Ramachandran S, McCray PB, Cichutek K, von Messling V, Lopez M,
Cattaneo R. Nature, 2011, 480, 530-533
12. Base of the measles virus fusion trimer head receives the signal that triggers membrane
fusion. Apte-Sengupta S, Negi S, Leonard VH, Oezguen N, Navaratnarajah CK, Braun W,
Cattaneo R. Journal of Biological Chemistry. 2012, 287:33026-35
13. Molecular Basis of mRNA Cap Recognition by Influenza B Polymerase PB2 Subunit. Xie L,
Wartchow C, Shia S, Uehara K, Steffek M, Warne R, Sutton J, Muiru GT, Leonard VH,
Bussiere DE, Ma X. Journal of Biological Chemistry. 2016, 291(1):363-370
14. Structural basis for therapeutic inhibition of influenza A polymerase PB2 subunit. Ma X, Xie
L, Wartchow C, Warne R, Xu Y, Rivkin A, Tully D, Shia S, Uehara K, Baldwin DM, Muiru G,
Zhong W, Zaror I, Bussiere DE, Leonard VH. Scientific Reports. 2017, 7(1):9385. doi:
10.1038/s41598-017-09538-x.
15. The effect of P38 MAP kinase inhibition in a mouse model of influenza. Growcott EJ, Bamba
D, Galarneau JR, Leonard VH, Schul W, Stein D, Osborne CS. Journal of Medical
Microbiology. 2018, 67(3):452. doi: 10.1099/jmm.0.000684.

BOOK CHAPTERS, REVIEW ARTICLES


Measles virus glycoprotein complex assembly, receptor attachment, and cell entry.
Navaratnarajah C, Leonard VH, Cattaneo R. Current Topics in Microbiology and Immunology,
Volume 329, Griffin D.E., and Oldstone M.B.A. (Editors.), Springer-Verlag Berlin Heidelberg
2009.

RESEARCH GRANTS
Wellcome Trust 4 year Ph.D. Program, University of Glasgow, UK. This grant includes a one
year Master of Research followed by a 3 year PhD (total of $160,000) Co-Investigator on NIH
R01 CA 90636 (PI R. Cattaneo), Mayo Clinic, USA.

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PATENT
Patent Number: US2009/036950 Title: “Virus lacking epithelial cell entry” Vincent H. J. Leonard
and Roberto Cattaneo

COMPUTER SKILLS
Computer programming: Completed UC Berkeley Extension “Python Programming” Course
(x442.3). Created a program at Novartis for viral sequence analysis, prediction and monitoring
of viral strains sensitivity/resistance to lead antiviral molecules.
Softwares: VectorNTI, Spotfire, Office

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CURRICULUM VITAE
Addisu Mekonnen Kassie, BSc, MSc, PhD
Contact Centre for Ecological and Evolutionary Synthesis (CEES)
Department of Biosciences, University of Oslo
P.O. Box 1066, Blindern, N-0316
Oslo, Norway
Phone: +4793987362
E-mail: addisumekonnen@gmail.com or
addisu.mekonnen@ibv.uio.no
Website: https://www.mn.uio.no/cees/english/people/phd/addisumk/
ResearchGate: https://www.researchgate.net/profile/Addisu_Mekonnen
ORCID ID: https://orcid.org/0000-0001-8403-1071
ResearcherID: U-6087-2018
Date of birth: 22.03.1976
Gender: Male
Nationality: Ethiopian
Language: Amharic and English
Last Updated: November 2019

RESEARCH INTERESTS
Ecology, behaviour, evolution, genetics, biogeography and conservation biology, including
landscape ecology, foraging ecology, movement ecology, nutritional ecology, gastrointestinal
parasitic ecology, activity budget, locomotion and posture, population genetics, microbiome,
population status, habitat / distribution modelling, forest ecology and management, bamboo,
non-human primates, Africa.

EDUCATIONAL BACKGROUND
2018 PhD in Ecology, Population Genetics and Conservation Biology /Biological
Anthropology - Primatology/, Department of Biosciences, University of Oslo,
Norway.
Thesis title: Effects of habitat fragmentation and degradation on Bale monkeys
(Chlorocebus djamdjamensis) in southern Ethiopia: Integrating ecology, behaviour
and population genetics
(Outcome: Four scientific articles published in BMC Ecology, BMC Evolutionary
Biology and American Journal of Primatology (#2))
2008 M.Sc. in Biology (Ecology and Systematic Zoology), Department of Biology, Addis
Ababa University.
Thesis title: Distribution of the Bale monkey (Chlorocebus djamdjamensis) in the
Bale Mountains and its ecology in the Odobullu Forest, Ethiopia – A study of habitat
preference, population size, feeding behaviour, activity and ranging patterns.
(Outcome: Two articles published in Oryx & International Journal of Primatology)
1998 B.Sc. in Biology, Department of Biology, Addis Ababa University, Ethiopia.

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EXPERIENCES/EMPLOYMENT
2018-present Researcher in CEES, Department of Biosciences, University of Oslo, Norway.
2012-2017 PhD candidate in CEES, University of Oslo, Norway.
2009-2016 Lecturer in Department of Zoological Sciences, Addis Ababa University,
Ethiopia.
2003-2006 Project coordinator in HIV/AIDS Prevention & Control Office Amhara region.
2003 Instructor in Alkan Health Science College.
1998-2003 Biology teacher in government secondary schools.

COURSES TAUGHT
Addis Ababa University Fundamentals of Ecology, Wildlife Ecology and Management,
Environmental Science, and Conservation and Management of
Natural Resources

RESEARCH GRANTS AND AWARDS


Fellowships
2012-2016 Norwegian Quota Scheme PhD scholarship excluding fieldwork grant.

Travel Grants
2018 International Network for Bamboo and Rattan (INBAR) to attending the Global
Bamboo and Rattan Congress (BARC2018), Beijing, China.
2016 Margot Marsh Biodiversity Foundation to Conservation International and the
IUCN SSC Primate Specialist Group to attending the International
Primatological Society XXVI Congress, Chicago, USA.
2014 Primate Conservation Inc. to attending the International Primatological Society
XXV Congress in Hanoi, Vietnam.
2014 Conservation International Primate Action Fund – IPS XXV Congress grant in
Hanoi, Vietnam.

Conservation and Research Grants (External)


26. 2018 Prince Bernhard Nature Fund - Bale monkey-bamboo conservation and research
project
25. 2016 Association Francaise des Parcs Zoologiques (AFdPZ) - Boutourlini’s blue
conservation and ecology
24. 2015/16 People’s Trust for Endangered Species – Bale monkey-bamboo conservation
23. 2015 Association Francaise des Parcs Zoologiques (AFdPZ) - Boutourlini’s blue
monkey conservation and ecology
22. 2015 Zoological Society for Conservation of Species and Populations (ZGAP) -
Boutourlini’s blue monkey conservation and ecology
21. 2014 British Ecological Society Ecologists in Africa Grant – Gelada distribution, status
and phylogenetics
20 2014 Mohamed bin Zayed Species Conservation Fund – Colobus monkey status survey
19. 2014 Rufford Small Grants for Nature Conservation – Montane bamboo status survey

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18. 2014 Fresno Chaffee Zoo Conservation Fund – Nutritional ecology of Bale monkey
17. 2014 Conservation International - Primate Action Fund – Nutritional ecology of Bale
monkey
16. 2014 International Primatological Society – Bale monkey sleeping site selection
15. 2012 Rufford Small Grants for Nature Conservation – Bale monkey status & habitat
suitability
14. 2011 Conservation and Research Foundation – Bale monkey behavioural ecology
13. 2011 International Foundation for Sciences – Bale monkey status and ecology
12. 2011 People’s Trust for Endangered Species – Bale monkey behavioural ecology
11. 2011 Conservation des Espèces et des Populations Animals - Bale monkey-human
conflict
10. 2011 Mohamed bin Zayed Species Conservation Fund – Arsi gelada status survey
9. 2010 Columbus Zoo Conservation Fund - Arsi gelada behavioural ecology and
phylogeny
8. 2010 Conservation International Primate Action Fund – Arsi gelada behavioural
ecology
7. 2010 Primate Conservation Inc. – Arsi gelada behavioural ecology
6. 2010 Le Conservatoire pour la Protection des Primates – Bale monkey distribution
5. 2009 Conservation des Espèces et des Populations Animals (CEPA) and Zoological
Society for the Conservation of Species and Populations (ZGAP) – Bale monkey
distribution
4. 2009 Primate Conservation Inc. - Boutourlini’s blue monkey behavioural ecology
3. 2008 Pittsburgh Zoo and PPG Aquarium – Bale monkey behavioural ecology
2. 2007 Primate Conservation Inc. – Bale monkey behavioural ecology
1. 2007 Ethiopian Wolf Conservation Programme – Bale monkey behavioural ecology

PUBLICATIONS
Journal Articles (Peer Reviewed) *denotes corresponding authorship
15. Mekonnen, A. *, Fashing, P.J., Bekele, A. and Stenseth, N.C. (in review). Distribution and
conservation status of Boutourlini’s blue monkey (Cercopithecus mitis boutourlinii), a
Vulnerable subspecies endemic to western Ethiopia. Primates
14. Mekonnen, A. *, Fashing, P.J., Bekele, A. and Stenseth, N.C. (Accepted). Use of cultivated
foods and matrix habitat by Bale monkeys in forest fragments: Assessing local human
attitudes and perceptions. American Journal of Primatology
13. Atickem, A., Stenseth, N.C., Fashing, P.J., Nguyen, N., Chapman, C.A., Bekele, A.,
Mekonnen, A., Omeja, P.A. and Kalbitzer, U. (2019). Build science in Africa. Nature
570: 297-300.
12. Zinner, D., Atickem, A., Beehner, J.C., Bekele, A., Bergman, T.J., Burke, R., Dolotovskaya,
S., Fashing, P.J., Gippoliti, S., Knauf, S., Knauf, Y., Mekonnen, A., Moges, A., Nguyen,
N., Stenseth, N.C. and Roos, C. (2018). Phylogeography, mitochondrial DNA diversity
and demographic history of geladas (Theropithecus gelada). PLoS ONE 13: e0202303.
DOI: https://doi.org/10.1371/journal.pone.0202303
11. Mekonnen, A. *, Rueness, E.K., Stenseth, N.C., Fashing, P.J., Bekele, A., Hernandez-
Aguilar, R.A., Missbach, R., Haus, T., Zinner, D. and Roos, C. (2018). Population genetic
structure and evolutionary history of Bale monkeys (Chlorocebus djamdjamensis) in the

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southern Ethiopian Highlands. BMC Evolutionary Biology 18: 106. DOI:
10.1186/s12862-018-1217-y
10. Mekonnen, A. *, Fashing, P.J., Sargis, E.J., Venkataraman, V.V., Bekele, A., Hernandez-
Aguilar, R.A., Rueness, E.K. and Stenseth, N.C. (2018). Flexibility in positional behavior,
strata use, and substrate utilization among Bale monkeys (Chlorocebus djamdjamensis) in
response to habitat fragmentation and degradation. American Journal of Primatology 80:
e22760. DOI: http://dx.doi.org/10.1002/ajp.22760
9. Mekonnen, A. *, Fashing, P.J., Bekele, A., Hernandez-Aguilar, R.A., Rueness, E.K. and
Stenseth, N.C. (2018). Dietary flexibility of Bale monkeys (Chlorocebus djamdjamensis)
in southern Ethiopia: Effects of habitat degradation and life in fragments. BMC Ecology
18: 4. DOI: 10.1186/s12898-018-0161-4
8. Trosvik, P., de Muinck, E.J., Rueness, E.K., Fashing, P.J., Beierschmitt, E.C., Callingham,
K.R., Kraus, J.B., Trew, T.H., Moges, A., Mekonnen, A., Venkataraman, V.V. and
Nguyen, N. (2018). Multilevel social structure and diet shape the gut microbiota of the
grazing gelada monkey. Microbiome 6: 84. DOI: https://doi.org/10.1186/s40168-018-
0468-6
7. Trosvik, P., Rueness, E.K., de Muinck, E.J., Moges, A. and Mekonnen, A. (2018). Ecological
plasticity in the gastrointestinal microbiomes of Ethiopian Chlorocebus monkeys.
Scientific Reports 8: 20. DOI: 10.1038/s41598-017-18435-2
6. Abu, K., Mekonnen, A. *, Bekele, A. and Fashing, P.J. (2018). Diet and activity patterns of
Arsi geladas in low-elevation disturbed habitat south of the Rift Valley at Indetu,
Ethiopia. Primates 59: 153–161. DOI 10.1007/s10329-017-0640-9
5. Mekonnen, A. *, Fashing, P.J., Bekele, A., Hernandez-Aguilar, R.A., Rueness, E.K., Nguyen,
N. and Stenseth, N.C. (2017). Impacts of habitat loss and fragmentation on the activity
budget, ranging ecology and habitat use of Bale monkeys (Chlorocebus djamdjamensis)
in the southern Ethiopian Highlands. American Journal of Primatology 79: e22644. DOI:
10.1002/ajp.22644
4. Tesfaye, D., Fashing, P.J., Bekele, A., Mekonnen, A., and Atickem, A. (2013). Ecological
flexibility among Boutourlini’s blue monkeys (Cercopithecus mitis boutourlinii) in Jibat
Forest, Ethiopia: A comparison of habitat use, ranging behavior, and diet in intact and
fragmented forest. International Journal of Primatology 34: 615–640. DOI:
10.1007/s10764-013-9684-x
3. Mekonnen, A. *, Bekele, A., Fashing, P.J., Lernould, J., Atickem, A. and Stenseth, N.C.
(2012). Newly discovered Bale monkey populations in forest fragments in southern
Ethiopia: Evidence of crop raiding, hybridization with grivets, and other conservation
threats. American Journal of Primatology 74: 423–432. DOI: 10.1002/ajp.21999
2. Mekonnen, A. *, Bekele, A., Fashing, P.J., Hemson, G. and Atickem A. (2010). Diet, activity
patterns, and ranging ecology of the Bale monkey (Chlorocebus djamdjamensis) in
Odobullu Forest, Ethiopia. International Journal of Primatology 31: 339–362. DOI:
10.1007/s10764-010-9389-3
1. Mekonnen, A. *, Bekele, A., Hemson, G. Teshome, E. and Atickem, A. (2010). Population
size and habitat preference of the Vulnerable Bale monkey (Chlorocebus djamdjamensis)
in Odobullu Forest and its distribution across the Bale Mountains, Ethiopia. Oryx 44:
558–563. DOI: 10.1017/S0030605310000748

Manuscripts in Preparation
20. Moges, A., Bekele, A., Fashing, P.J, and Mekonnen, A. (in prep). Activity budget, ranging
ecology and habitat use of Arsi geladas in Gado-Goro, eastern Arsi, Ethiopia. Ecology
and Evolution

17
19. Moges, A., Mekonnen, A., Fashing, P.J, Bekele, A., and Knauf, S., (in prep). Gastrointestinal
parasitic ecology of Arsi geladas in Gado-Goro, eastern Arsi, Ethiopia. PLoS One.
18. Moges, A., Bekele, A., Fashing, P.J, and Mekonnen, A. (in prep). Effects of habitat
disturbance on the feeding ecology of Arsi geladas in Gado-Goro, eastern Arsi, Ethiopia.
PloS One
17. Mekonnen, A., Fashing, P.J., Chapman, C.A., ….. Stenseth, N.C. and Rothman, J.M. (in
prep.). Effects of forest fragmentation and degradation on the nutritional ecology of Bale
monkeys (Chlorocebus djamdjamensis) in the southern Ethiopian Highlands. BMC
Ecology
16. Yazezew, D., Bekele, A., Fashing, P.J., Ibrahim, H., Mekonnen, A. (in prep). Population
estimate and habitat use of Omo River Guerezas (Colobus guereza guereza) in Wof
Washa Natural State Forest, Ethiopia. PeerJ
15. Yazezew, D., Bekele, A., Fashing, P.J., Ibrahim, H., Mekonnen, A. (in prep). Feeding
ecology and resource availability of Omo River Guerezas (Colobus guereza guereza) in
Wof Washa Natural State Forest, Ethiopia. American Journal of Primatology
14. Yazezew, D., Bekele, A., Fashing, P.J., Ibrahim, H., Mekonnen, A. (in prep). Activity
budget and ranging ecology of Omo River Guerezas in Wof Washa Natural State Forest,
Ethiopia. International Journal of Primatology
13. Ibrahim, H., Bekele, A., Fashing, P.J., Yazezew, D., Mekonnen, A. (in prep). Activity budget
and raging ecology of hamadryas baboon (Papio hamadryas) in north-central Ethiopia.
Movement Ecology
12. Ibrahim, H., Bekele, A., Fashing, P.J., Yazezew, D., Mekonnen, A. (in prep). Feeding
ecology of hamadryas baboon (Papio hamadryas) in north-central Ethiopia. BMC
Ecology
11. Mekonnen, A. (in prep.). Distribution pattern and conservation status of the threatened
Neumann's black-and-white colobus monkey (Colobus guereza gallarum), eastern Rift
Valley of Ethiopia. Oryx
10. Mekonnen, A., Knauf, S., et al., (in prep.). Effects of habitat fragmentation and degradation
on the gastrointestinal parasitic ecology of Bale monkeys in southern Ethiopia. Scientific
Reports
9. Kifle, Z., Bekele, A., Mekonnen, A. and Fashing, P.J. (in prep). Impacts of habitat disturbance
on the activity budget of the Southern geladas (Theropithecus gelada obscurus) in
northcentral Ethiopia. International Journal of Primatology
8. Kifle, Z., Bekele, A., Mekonnen, A. and Fashing, P.J. (in prep). Effects of habitat
encroachment on the population and group size of the southern gelada (Theropithecus
gelada obscurus) in South Wollo, Ethiopia. International Journal of Primatology
7. Kifle, Z., Bekele, A., Mekonnen, A. and Fashing, P.J. (in prep). Effects of habitat disturbance
on the feeding ecology of Southern Geladas (Theropithecus gelada obscurus) in South
Wollo, Ethiopia. American Journal of Primatology
6. Kibaja, M.J., Hernandez-Aguilar, R.A., Mekonnen, A., Nahonyo, C.L. and Stenseth, N.C. (in
prep). Activity budget, ranging ecology and habitat use of Ashy red colobus monkeys
(Piliocobus tephrosceles) in western Tanzania: Comparing groups living in two distinct
habitats. BMC Ecology
5. Kibaja, M.J., Hernandez-Aguilar, R.A., Mekonnen, A., Nahonyo, C.L. and Stenseth, N.C. (in
prep). Diet and feeding patterns of two groups of Ashy red colobus monkeys
(Piliocolobus tephrosceles) living in two distinct habitats in western Tanzania. BMC
Ecology
4. Mekonnen, A., Fashing, P.J., Hernandez-Aguilar, R.A. , …. and Stenseth, N.C. (in prep).
Sleeping site selection of Bale monkeys (Chlorocebus djamdjamensis) at Kokosa forest
fragment in southern Ethiopia. American Journal of Primatology

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3. Mekonnen, A., Fashing, P.J., Bekele, A., …. and Stenseth, N.C. (in prep.). Geographical
distribution and habitat suitability for Bale monkeys (Chlorocebus djamdjamensis) in the
southern Ethiopian Highlands. Animal Conservation
2. Mekonnen, A., Fashing, P.J., Bekele, … and Stenseth, N.C. (in prep.). Density, abundance and
habitat preference of the Bale monkey (Chlorocebus djamdjamensis) in the Harenna and
Shedem Forests of the Bale Mountains, Ethiopia. International Journal of Primatology
1. Amare, A., Bekele, A., Fashing, P.J., Mekonnen, T., Hayward, M.W. and Mekonnen, A. (in
prep). Diet, activity and ranging patterns of De Brazza’s monkeys (Cercopithecus
neglectus) in the Yayu Biosphere Reserve, Ethiopia. International Journal of Primatology

Book Contributions and IUCN articles


5. Gippoliti, S. Butynski, T.M., Mekonnen, A., Kingdon, J. and De Jong, Y. (in press).
Chlorocebus djamdjamensis. The IUCN Red List of Threatened Species
4. Gippoliti, S., Mekonnen, A., Burke, R.J., Nguyen N. and Fashing, P.J. (in press).
Theropithecus gelada. The IUCN Red List of Threatened Species
3. Fashing, P.J., Nguyen, N., Burke, R.J., Mekonnen, A. and Gippoliti, S. (in press).
Theropithecus gelada ssp. gelada. The IUCN Red List of Threatened Species
2. Fashing, P.J., Nguyen, N., Burke, R.J., Mekonnen, A. and Gippoliti, S. (in press).
Theropithecus gelada ssp. obscurus. The IUCN Red List of Threatened Species
1. Mekonnen, A. and Jafe, K.E. (2016). Bale Mountains Monkey Chlorocebus djamdjamensis.
In: N. Rowe and M. Mayers (eds.). All the World’s Primates. Charlestown, R.I.,
Pogonias Press. pp. 473-474.

PRESENTATIONS AND SCIENCE COMMUNICATIONS


Presentations
6. Mekonnen, A., Fashing, P.J., Bekele, A. and Stenseth, N.C. (2018). Flexibility in use of
cultivated foods and matrix by Bale monkeys in forest fragments: Assessing local
attitudes and perceptions. International Primatological Society XXVII Congress,
Nairobi, Kenya. August 19-25, 2018.
5. Mekonnen, A., Fashing, P.J., Chapman, A.C., Bekele, A. and Stenseth, N.C. (2018). The
threatened Bale monkey as a flagship species for the conservation of highland bamboo
in southern Ethiopia. Global Bamboo and Rattan Congress, Beijing, China. June 25-27,
2018.
4. Rindal, V.D., Trond Reitan, T., Sætre, G-P., Ndimuligo, S. A., Mekonnen, A., and
Hernandez-Aguilar, R.A. (2017). Behavioural flexibility of vervet monkeys
(Chlorocebus pygerythrus) living in a savanna-woodland fragment in Tanzania. 7th
Congress of the European Federation for Primatology. August 21-25, 2017, Strasbourg,
France.
3. Burke, R.J., Atickem, A., Fashing, P.J., Mekonnen, A., Nguyen, N. and Willis, K.J. (2016).
Landscape-level trophic effects of geladas: A herbivore aerial census re-survey approach
in the Ethiopian highlands. International Primatological Society XXVI Congress,
Chicago, USA. August 21-27, 2016.
2. Mekonnen, A., Fashing, P.J., Bekele, A., Hernandez-Aguilar, R.A., Rueness, K.E., Nguyen,
N. and Stenseth, N.C. (2016). Effects of habitat loss and fragmentation on the activity
budget, ranging ecology and habitat use of Bale monkeys (Chlorocebus djamdjamensis)
in the southern Ethiopian Highlands. International Primatological Society XXVI
Congress, Chicago, USA. August 21-27, 2016.

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1. Mekonnen, A., Fashing, P.J., Bekele, A., Rueness, K.E., Atickem, A., Hernandez-Aguilar,
R.A. and Stenseth, N.C. (2014). Dietary plasticity of Bale monkeys (Chlorocebus
djamdjamensis) in continuous and fragmented forests of the southern Ethiopian
Highlands. International Primatological Society XXV Congress, Hanoi, Vietnam.

Invited Seminars
Mekonnen, A. (2014). Behavioural ecology and conservation biology of Bale monkeys in the
Southern Ethiopian Highlands. German Primate Center (DPZ) Kolloquium Series,
Gottingen, Germany.

Media Coverage
1. BioMed Central. Bale monkeys living in different areas have very different DNA.
ScienceDaily. 9 July 2018. www.sciencedaily.com/releases/2018/07/180709202915.htm
2. BioMed Central. Bale monkeys living in different areas have very different DNA. Phys.org,
July 9, 2018. https://phys.org/news/2018-07-bale-monkeys-areas-dna.html
3. Mekonnen, A. Deep genetic divergence among Bale monkeys in continuous forest and
forest fragments. BMC Series blog. July 10, 2018.
http://blogs.biomedcentral.com/bmcseriesblog/2018/07/10/deep-genetic-divergence-among-
bale-monkeys-in-continuous-forest-and-forest-fragments/
4. Røsjø, B. (2018). Bamboo-eating Bale monkeys could still be saved from extinction. Titan
News, University of Oslo, 11 May 2018. https://titan.uio.no/node/2869
5. Anonymous (2018). Bamboo-eating Bale monkeys could still be saved from extinction.
Phys.org, 15 May 2018. https://phys.org/news/2018-05-bamboo-eating-bale-monkeys-
extinction.html
6. Bourton, J. (2010). “Mysterious Bale monkey of Africa loves to eat bamboo”. BBC Earth
News 1 April 2010.
http://news.bbc.co.uk/earth/hi/earth_news/newsid_8587000/8587712.stm
7. Anonymous. (2011). “Ethiopian monkeys survive on bamboo snacks”. Science Illustrated 4:
17. http://www.scienceillustrated.com/nature/2011/08/ethiopian-monkeys-survive-bamboo-
snacks

CURRENT RESEARCH
Principal Investigator & Project Director
2007-present Bale Monkey Research and Conservation Project
Distribution, population estimate and habitat suitability modeling of the Bale
monkey: http://www.rufford.org/rsg/projects/addisu_mekonnen
2014-present Bamboo – Bale monkey research and conservation project:
https://www.pifworld.com/nl/projects/xIa9waD55VI/bamboo-conservation-
and-research/about
Current status of montane bamboo:
http://www.rufford.org/projects/addisu_mekonnen
2010-present Conservation status & ecology Boutourlini’s blue monkey
2016-present Conservation status of colobus monkey in Ethiopia

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RESEARCH AND FIELD EXPERIENCES
2013-present Principal Investigator (PI) and project director – Conservation biology and
behavioural ecology of Bale monkeys in the southern Ethiopian Highlands. CEES,
Department of Biosciences, University of Oslo, Norway.
2010-2011 PI and project director – Bale monkey human-monkey conflict and Arsi gelada
survey, eastern Ethiopia. Department of Zoological Sciences, Addis Ababa
University, Ethiopia.
2010-2011 Co-PI and project director - Behavioural ecology of Arsi geladas at Indetu, eastern
Ethiopia. Department of Zoological Sciences, Addis Ababa University, Ethiopia.
2010-2011 PI and project director - Population status and distribution survey of Bale monkeys
in the southern Ethiopian Highlands. Department of Biology, Addis Ababa
University, Ethiopia.
2009-2010 PI and project director - Population status survey of Boutourlini’s blue monkeys
along the western Rift Valley of Ethiopia.
Co-PI and project director - Behavioral ecology of Boutourlini’s blue monkeys in
the Jibat Forest, western Ethiopia. Department of Biology, AAU, Ethiopia.
2007-2008 PI and project director - Bale monkey conservation and ecology research in
Odobullu Forest and survey in the Bale Mountains, Ethiopia. Department of
Biology, Addis Ababa University, Ethiopia.

MONITORING AND COLLABORATION


Monitoring/collaborating with students (MSc and PhD)
2016-2020 Mohamed Kibaja - PhD candidate at the University of Oslo, Norway. Ecology and
conservation of Ashy red colobus monkeys (Piliocobus tephrosceles) in Tanzania.
2016-2019 Ensermu Kibebew - PhD candidate at Addis Ababa University (AAU): Effect of
habitat fragmentation on the ecology of Neumann's colobus monkey.
2015-2020 Meseret Chane, PhD candidate at AAU: Effect of anthropogenic habitat
modification on ecological niche partitioning between DeBrazza’s and
Boutourlini’s blue monkeys
2015-2020 Hussein Ibrahim, PhD candidate at AAU: Behavioral ecology of hamadryas
baboon in and around Borena Sayint National Park, Wollo, Ethiopia
2014-2019 Dr. Amera Moges, PhD from AAU: Arsi gelada behavioural ecology and
conservation, Eastern Arsi, Ethiopia
2014-2019 Dr. Dereje Yazezew, PhD from AAU: Omo River Guereza conservation and
ecology Wof Washa Forest
2014-2018 Dr. Zewdu Kifle, PhD from AAU: Southern gelada ecology and conservation in
and around Borena Sayint National Park, Wollo, Ethiopia
2015-2018 Alemneh Amare: Boutourlini’s blue monkey ecology and conservation biology
2010-2011 Kelil Abu – did his MSc research under my project on Arsi gelada behavioural
ecology – result published in Primates
2009-2010 Dereje Tesfaye – did his MSc research under my project on Boutourlini’s blue
monkey ecology – result published in International Journal of Primatology

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Projects I am collaborating with international researchers/scientists
2014-2019 Prof. Peter J. Fashing and other international collaborators: Determining the
conservation status and phylogeny of geladas in Ethiopia
2015-2018 Dr. Sascha Knauf, German Primate Centre, Germany: Taenia infection ecology

PROFESSIONAL AFFILIATIONS AND MEMBERSHIPS


2016-present African Primatological Society
2014-present British Ecological Society
2014-present Society for Conservation Biology
2014-present International Primatological Society
2013-present IUCN/SSC Primate Specialist Group for the Africa Section and
IUCN Species profile assessor for Bale monkey and geladas
2009-present Biological Society of Ethiopia
2009-present Wildlife Conservation and Environmental Development Association
(WildCODE)

PROFESSIONAL/COMMUNITY SERVICES
Associate Editor
2018-present International Journal of Primatology
Manuscript Peer Reviewer
2013-present American Journal of Primatology, Animal Conservation, Folia
Primatologica, International Journal of Primatology, Oryx, PeerJ, PLoS
ONE, Integrative Zoology
External Grant Reviewer
2018-present Primate Conservation Inc., National Geographic Society

PROFESSIONAL TRAINING
2016 Spatial Ecology, Geospatial Analysis and Remote Sensing for Conservation.
Smithsonian-Mason School of Conservation, George Mason University, Front
Royal, VA, USA.
2015 An Introduction to GIS for Conservation Managers. Durrell Wildlife Conservation
Trust in the Channel Islands, Jersey, UK.
2014 Scientific writing workshop. University of Oslo, Oslo, Norway.
2014 Bibliography and Citation Management Using EndNote Software. University of
Oslo, Oslo, Norway.
2014 DFG full proposal writing workshop on Taenia infection ecology. German Primate
Centre, Gottingen, Germany.

SKILLS – Fieldwork, laboratory, GIS, statistics, and molecular ecology


Fieldwork  Field skills in ecology, behaviour, and conservation biology research and
data collection, including GPS and habitat mapping as well as vegetation
and phenology.
 Field skills in fecal sample collection for genetics, parasite and
microbiome analyses.

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Laboratory  DNA extraction, amplification and sequencing from fecal samples for the
population genetics of Bale monkeys. CEES, Department of Biosciences,
University of Oslo, Norway.
Biostatistics  Well-developed skills in computer applications and statistical packages.
Quantitative skills and data handling including R, SPSS, and PAST.
GIS and Remote  Advanced skills and knowledge of several GIS software packages,
sensing including ArcGIS, QGIS, Geospatial Modeling Environment (GME),
HRT, ERDAS and R.
 Well-developed skills in spatial ecology, geospatial analysis, movement
ecology, remote sensing, land-use cover change, habitat/species
distribution modeling and climate change modeling.
Bioinformatics /  Basic skills in molecular ecology and population genetics, including
Molecular data DNA extraction, sequencing and molecular data analyses using several
analysis software packages: DnaSP, Arlequin, NETWORK, PopArt, JModel test,
BEAST packages, MEGA and others.

PROFESSIONAL REFERENCES
Name: Professor Nils Chr. Stenseth
Mailing address: CEES, Department of Biosciences, University of Oslo, P.O. Box 1066,
Blindern, N-0316 Oslo, Norway
Phone: +4722854584
Fax: +4722854001
Email: n.c.stenseth@mn.uio.no

Name: Professor Peter J. Fashing


Mailing address: Department of Anthropology, California State University Fullerton, 800 N.
State College Blvd., Fullerton, CA 92834, USA
Phone: +657 278 3977
Fax: +657 278 5001
Email: peterfashing@gmail.com or pfashing@fullerton.edu

Name: Professor Colin A. Chapman


Mailing address: Department of Anthropology and McGill School of Environment, McGill
University, Quebec, Montreal H3A 2T7, Canada.
Phone: +514-398-1242
Email: colin.chapman@mcgill.ca or colin.chapman.research@gmail.com

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Peter Colosi
238 Olema Road, Fairfax, CA 94930
Office: 415-506-3486
Home: 415-578-2950
Cell: 415-246-1250
pccolosi@yahoo.com

Summary
Biotechnology professional with extensive experience in research, preclinical
development and business development.

• Established and direct gene therapy group at BioMarin Pharmaceutical. Efforts


have culminated in an AAV therapeutic that has normalized Factor VIII plasma
levels in most subjects. Registrational trial begun in December 2017. Multiple
additional applications in preclinical development.
• Business Development role scouting and evaluating business opportunities and
presenting them to executive management and the Board of Directors.
• Extensive experience with research, preclinical, and early clinical phases of drug
development including regulatory submissions and agency interaction.
• Initiated and managed numerous collaborations.
• Deep knowledge of, and decades of experience in, novel capsid discovery and
development.
• Deep understanding of AAV production systems including transfection- and Sf9-
based systems, and packaging cell lines. Have developed all three.
• Extensive interaction with patent attorneys and familiarity with patent strategy.
• Established Ocular Gene Therapy Unit at the National Eye Institute at the
National Institutes of Health. Resulted in a clinical trial evaluating an AAV vector
for the treatment of X-linked retinoschisis. Preclinical studies successfully
completed for retinitis pigmentosa due to RPGR and RP2 mutation.
• Eleven year tenure at Avigen Inc. Ultimately responsible for Research,
Development, and Manufacturing. Involved in development of business and
intellectual property strategies. Developed production system and vectors used in
clinical trials for hemophilia B and Parkinson’s disease.
• Developed AAV vector-based experimental therapeutics for X-linked
retinoschisis, retinitis pigmentosa due to RPGR and RP2 mutation, diabetic
retinopathy, Parkinson’s disease, hemophilia A and B, chronic heart failure,
glioma and several others.
• Developed numerous improvements in the AAV vector and other viral vector
systems.
• Endocrinology training with emphasis on the somatotropin hormone family.
• 24 years in the biotechnology industry and 7 years in the government sector.
• Authored 65 peer-reviewed articles and inventor on 19 issued patents.

24
Professional Experience

Staff Scientist BioMarin Pharmaceutical Inc.


September 2014 to Present

Group size at 20, including 1 Executive Director, 3 Directors, 2 Senior Scientists, 5


Scientists and 9 SRAs

• Phase 1/2 Hemophilia A trial successful and registrational trial begun in December 2017.
• Business Development role. In collaboration with Business Development, I identify and
screen companies and academic labs for co-development potential, technology licensing or
acquisition. Routinely present and advocate business strategies and opportunities to
executive management and the Board of Directors.
• Initiated PKU project. Designed and optimized PKU vector, and moved it into clinical
development.
• Initiated preclinical development of 3 AAV vector applications.
• Developed new AAV vectors with novel tropisms and improved preexisting immunity.
• Made significant improvement in infectivity efficiency of a non-AAV vector system.
• Received a BioMarin Top Talent Awards in 2017 and 2018.

Principal Scientist 2, Vector Biology Group, BioMarin Pharmaceutical Inc.


June, 2013 to September 2014

Established and directed the gene therapy group at BioMarin. Group size ranged from 1
to 6 scientists including one director, one scientist and 4 SRAs.

• Designed AAV vector and managed preclinical development for current hemophilia A
clinical trial.
• Wrote regulator documents and participated in meetings with the MHRA (Medicines and
Healthcare Products Regulatory Agency, British Health Agency).
• Identified several other potential genetic disease targets. Designed and evaluated AAV
vectors for efficacy in animal models.
• Initiated and managed collaborative effort involving 2 academic labs and a nonprofit to
develop a gene therapeutic for a major genetic disease. Vector is not AAV.
• Developed improved methods for AAV vector production.
• Developed method to improve the performance of AAV vector capsids.
• Received award from CEO and promoted.

25
Senior Scientist, National Eye Institute, NIH March 2006 to May, 2013
Chief, Ocular Gene Therapy Unit

Established and directed the Ocular Gene Therapy Unit of the intramural program of the
National Eye Institute. Group consisted of a Staff Scientist, a Post Doctoral Fellow, an
SRA and a student. The goal of the unit was and still is to develop gene therapeutics for
inherited and acquired retinal diseases and to test them in Phase 1/2 clinical trials at the
NIH.

• Designed vector and did preclinical development for an AAV vector for the treatment of X-
linked retinoschisis in collaboration with Paul Sieving, Director of the NEI. The trial is on-
going.
• Managed the FDA interactions and submissions.
• Developed AAV vectors for the treatment of retinitis pigmentosa due to RPGR and RP2
mutations. Preclinical efficacy studies for both were completed.
• Collaborated with Dr. Carmen Clapp of the National University of Mexico to develop a
novel vector for the treatment of diabetic retinopathy and age-related macular degeneration
based on an anti-angiogenic fragment of prolactin.
• Moved to BioMarin for better opportunity to develop therapeutics.

Senior Director, AAV Group, Avigen Inc. July, 2004 to July, 2005

Responsible for AAV Vector Research, Development and Manufacturing. Directed a staff of 13
including 1 Director, 3 Associate Directors and 3 Scientists. The position was terminated due to
sale of Avigen gene therapy assets to Genzyme, Inc.

• Research: Isolated a murine AAV capsid that was substantially more resistant to human
neutralizing antibodies than standard AAV capsids when used as a gene therapy vector.
• Development: Developed an all-column purification process capable of separating full
AAV2 vector capsids from empty capsids and made it ready for scale-up.
• Assay Development: Developed highly sensitive in vitro antibody neutralization assay for
multiple AAV serotypes. Demonstrated induction of unexpectedly broad humoral response
(against AAV types 1-6) in clinical subjects after treatment with an AAV type 2 vector.
• GMP Manufacturing: Modified the transfection-based AAV vector production process so
that CO2 gassing could be eliminated in order to make the process compatible with the warm
room format of the GMP production suite.
• Management: Presented company technology to potential partners and parties interested in
acquiring the gene therapy assets. Avigen AAV vector technology and intellectual property
were acquired by Genzyme, Inc. in 2005.

26
Director, New Technologies, Avigen Inc. July, 1998 to July, 2004

Hired and supervised a group ranging from 4-12 scientists which ultimately included 2 Associate
Directors and 4 Scientists and 6 SRAs.

1) Clinical Development
• Contributed to regulatory documents in support of a hemophilia B clinical trial using a
liver-directed approach.
• Designed vector and contributed regulatory documents for Parkinson’s disease clinical
trial using and aromatic amino acid decarboxylase vector.
2) AAV vector assay development and production research
• Optimized and scaled a suspension culture-based method for producing AAV vectors in
Sf9 insect cells. The method reproducibly out-produced the standard roller bottle-based
method while dramatically reducing the staff and cost.
• In 2002 the group assumed the responsibility for the Avigen Research Vector Core.
Achieved a 4-fold increase in productivity after a staff reduction from 14 to 3 through staff
selection, training and refinement of production methods. Reduced cost by 50%. At peak
demand, the group produced 1.5e16 vector genomes per year comprising over 50 different
AAV vector preparations.
• Developed a rapid, general (any AAV serotype), and high yield research vector production
method. The Research Vector Core’s high productivity and low unit cost of vector was
due in large part to this method.
3) Preexisting humoral immunity to currently used AAV vector serotypes and development
of vectors that were much more resistant to neutralization by human sera.
• Demonstrated substantial and previously under-appreciated human serum neutralization of
commonly used AAV vector serotypes.
• Developed new AAV vector capsids that were substantially more resistant to human
preexisting humoral immunity from several non-primate sources. Produced novel vectors
from caprine and bovine capsids that are substantially more resistant to human
neutralizing sera.
• Used a comprehensive ala-scan of the surface of AAV2 to design mutant AAV2 capsids
that were 10-fold more resistant than wild type capsids to neutralization by pooled human
plasma. The mutagenesis effort also identified a novel region on the surface of the AAV2
capsid that is required for transduction. Turns out that the “dead zone” we identified is the
AAVR binding site.
4) Preclinical support for a Chronic Heart Failure application using AAV6 SERCA2a.
• Collaborated with Roger Hajjar of Massachusetts General Hospital to do preclinical
studies to validate the use of an AAV6 SERCA2a vector for the treatment of Chronic
Heart Failure. Designed and produced vectors to optimize cardiac transduction in pigs and
sheep. Demonstrated that AAV6 SERCA2a vector increased cardiac contractility when
delivered to sheep via catheter under optimized conditions.

27
Senior Scientist, Avigen Inc. January, 1997 to July, 1998
Research Scientist, Avigen Inc. March, 1994 to January, 1997

Hired and supervised a staff of 0-3 that included one Post Doctoral Fellow.

• Designed vector and contributed to regulatory documents for hemophilia B clinical trial
using a muscle-directed approach.
• Developed the Avigen helper virus-free, AAV vector production method, which was the
basis of Avigen’s GMP production procedure.
• Production method approximately 1000-fold more productive than most other methods at
the time and licensed to Stratagene Inc. for research use.
• Defined the helper functions of adenovirus for AAV vector production and used this
information for production plasmids.
• Worked closely with legal to patent production method.
• Managed collaborations with 2 Japanese academic labs to develop glioma application and to
investigate improvements in the production process.
• Produced research vector for internal use and for corporate and academic collaborators.
Over 75 vector preparations were produced. Experimental therapies for glioma, beta-
thalassemia, and hemophilia B were developed.

Postdoctoral Fellow, Univ. of California, San Francisco October, 1992 to Sept., 1993

• Developed HIV reporter vectors for expression cloning.

Postdoctoral Fellow, Genentech, Inc. Jan., 1988 to September, 1992

• Identified proline-rich domain essential for signaling in the cytoplasmic region of the human
growth hormone and prolactin receptors using a mutagenesis approach. This was later
determined to be the Janus kinase binding site.
• Cloned and expressed ovine placental lactogen, one of the few functional homologues of
human growth hormone, for use in structural studies of human prolactin and growth
hormone receptor binding. Demonstrated that human growth hormone receptor binding of
ovine placental lactogen and human growth hormone are mediated by nonhomologous sets
of amino acids.

Postdoctoral Fellow, Northwestern University Nov., 1986 to Dec., 1987

• Cloned novel, second lactogenic hormone from mouse placenta, mouse placental lactogen I.
Produced recombinant protein for physiological studies.
• Characterized the carbohydrate structures of proliferin-related protein, a novel
antiangiogenic protein made by the placenta.

28
Education
B.A. with Honors 1980 Biology University of California, Santa Cruz

Ph.D. 1986 Biology University of California, Santa Cruz

• Devised protein purification protocols for growth hormones, prolactins, and placental
lactogens from a variety of species including mouse, hamster, peromyscus mouse,
California Ground Squirrel, elephant seal, and sheep. The purified proteins were used for
physiological studies and structural analysis.
• Demonstrated the presence of multiple placental lactogen species in the mouse.
• Discovered, purified, and characterized a novel glycosylated mouse placental lactogen.

Patents
Issued

Methods and compositions for treating genetically linked diseases of the eye
United States Patent # 9,873,893
Paul Albert Sieving, Ronald Avery Bush, Peter C. Colosi, Yong Zeng
January 23, 2018

Adeno-associated virus factor VIII vectors


United States Patent # 9,504,762
Peter Cameron Colosi, Amit Nathwani, Jenny Mcintosh, Edward Tuddenham
November 29, 2016

AAV Virions with decreased immunoreactivity and uses thereof


United States Patent # 7,259,151
Surosky, R.T., Lochrie, M.A., Colosi, P.C., Arbetman, A.E.
August 21, 2007

Polynucleotides for use in recombinant adeno-associated virus virion production


United States Patent # 7,125,705
Colosi, P.
October 24, 2006

High-efficiency wild-type-free AAV helper functions


United States Patent # 7,037,713
Colosi, P.
May 2, 2006

29
Accessory functions for use in recombinant AAV virion production
United States Patent # 6,897,063
Colosi, P. C.
May 24, 2005

Gene therapy for the treatment of solid tumors using recombinant adeno-associated
virus vectors
United States Patent # 6,531,456
Kurtzman, G. J., Colosi, P. C.
March 11, 2003

Accessory functions for use in recombinant AAV virion production


United States Patent # 6,482,633
Colosi, P. C.
November 19, 2002

High-efficiency wild-type-free AAV helper functions.


United States Patent # 6,376,237
Colosi, P.
April 23, 2002

High-efficiency AAV helper functions


United States Patent # 6,365,403
Natsoulis G., Kurtzman G., Colosi P.
April 2, 2002

Adeno-associated vectors for expression of factor VIII by target cells


United States Patent # 6,221,349
Couto, L. B., Colosi P. C., Quan X.
April 24, 2001

Gene therapy for the treatment of solid tumors using recombinant adeno-associated
virus vectors
United States Patent # 6,218,180
Kurtzman, G. J., Colosi, P. C., Yoshida, J., Mizuno, M., Okada, H.
April 17, 2001

Adeno-associated virus vectors for expression of Factor VIII by target cells


United States Patent # 6,200,560
Couto, L. B., Colosi P. C., Quan X.
March 13, 2001

High-efficiency AAV helper functions


United States Patent # 6,027,931
Natsoulis G. , Kurtzman G. , Colosi P.
February 22, 2000

30
Adenovirus helper-free recombinant AAV virion production
United States Patent # 6,004,797
Colosi, P. C.
December 21, 1999

High-efficiency wild-type-free AAV helper functions


United States Patent # 6,001,650
Colosi, P.
December 14, 1999

Adeno-associated virus vectors comprising a first and second nucleic acid sequence
United States Patent # 5,952,221
Kurtzman, G. J., Colosi P. C., Yoshida J. , Mizuno, M., Okada, H.
September 14, 1999

Adenovirus helper-free system for producing recombinant AAV virions lacking


oncogenic sequences
United States Patent # 5,945,335
Colosi, P.
August 31, 1999

Compositions and methods for the synthesis of growth hormone receptor and
growth hormone binding protein
United States Patent # 5,688,763
Hammonds, G. R., Leung, D. W., Spencer, S. A., Wood, W. I., Colosi, P. C.
November 18, 1997

Applications

Adeno-Associated Virus Factor VIII Vectors, Associated Viral Particles and


Therapeutic Formulations Comprising the Same
Publication number: 20170087219
Stuart Bunting, Peter Cameron Colosi, Erno Pungor
Filed: September 23, 2016

31
Publications
Manuscripts

1. Mookherjee, S., Chen, H. Y., Isgrig, K., Yu, W., Hiriyanna, S., Levron, R., Li, T.,
Colosi, P., Chien, W., Swaroop, A., and Wu, Z. 2018. A CEP290 C-Terminal
Domain Complements the Mutant CEP290 of Rd16 Mice In Trans and Rescues
Retinal Degeneration. Cell Rep.16;25(3):611-623.

2. Cukras, C., Wiley, H. E., Jeffrey, B.G., Sen, H. N., Turriff, A., Zeng, Y.,
Vijayasarathy, C., Marangoni, D., Ziccardi, L., Kjellstrom, S., Park, T. K.,
Hiriyanna, S., Wright, J.F., Colosi, P., Wu, Z., Bush, R. A., Wei, L. L., and
Sieving, P. A. 2018. Retinal AAV8-RS1 Gene Therapy for X-Linked
Retinoschisis: Initial Findings from a Phase I/IIa Trial by Intravitreal Delivery.
Mol Ther. Sep 5;26(9):2282-2294.

3. Bunting, S., Zhang, L., Xie, L., Bullens, S., Mahimkar, R., Fong, S., Sandza, K.,
Harmon, D., Yates, B., Handyside, B., Sihn, C.R., Galicia, N., Tsuruda, L.,
O'Neill, C.A., Bagri, A., Colosi, P., Long, S., Vehar, G., and Carter, B. 2018.
Gene Therapy with BMN 270 Results in Therapeutic Levels of FVIII in Mice and
Primates and Normalization of Bleeding in Hemophilic Mice. Mol Ther.
7;26(2):496-509

4. Zhu, W., Shen, F., Mao, L., Zhan, L., Kang, S., Sun, Z., Nelson, J., Zhang, R.,
Zou, D., McDougall, C.M., Lawton, M.T., Vu, T.H., Wu, Z., Scaria, A., Colosi,
P., Forsayeth, J., Su, H. 2017. Soluble FLT1 Gene Therapy Alleviates Brain
Arteriovenous Malformation Severity. Stroke 48(5):1420-1423.

5. Marangoni, D., Bush, R.A., Zeng, Y., Wei, L.L., Ziccardi, L., Vijayasarathy, C.,
Bartoe, J.T., Palyada, K., Santos, M., Hiriyanna, S., Wu, Z., Colosi, P., and
Sieving, P.A. 2016. Ocular and systemic safety of a recombinant AAV8 vector for
X-linked retinoschisis gene therapy: GLP studies in rabbits and Rs1-KO mice.
Mol Ther Methods Clin Dev. 16;5:16011.

32
6. Bush, R.A., Zeng, Y., Colosi, P., Kjellstrom, S., Hiriyanna, S., Vijayasarathy, C.,
Santos, M., Li, J., Wu, Z., and Sieving, P.A. 2016. Preclinical Dose-Escalation
Study of Intravitreal AAV-RS1 Gene Therapy in a Mouse Model of X-linked
Retinoschisis: Dose-Dependent Expression and Improved Retinal Structure and
Function. Hum Gene Ther. 27(5):376-89.

7. Díaz-Lezama, N., Wu, Z., Adán-Castro, E., Arnold, E., Vázquez-Membrillo, M.,
Arredondo-Zamarripa, D., Ledesma-Colunga, M.G., Moreno-Carranza, B.,
Martinez de la Escalera, G., Colosi, P., and Clapp, C. 2016. Diabetes enhances
the efficacy of AAV2 vectors in the retina: therapeutic effect of AAV2 encoding
vasoinhibin and soluble VEGF receptor 1. Lab Invest. 96(3):283-95.

33
8. Mookherjee, S., Hiriyanna, S., Kaneshiro, K., Li, L., Li, Y., Li, W., Qian, H., Li,
T., Khanna, H., Colosi, P., and Swaroop, A., Wu, Z. 2015. Long-term rescue of
cone photoreceptor degeneration in retinitis pigmentosa 2 (RP2)-knockout mice
by gene replacement therapy. Hum Mol Genet. 15;24(22):6446-58.

9. Shen, F., Mao, L., Zhu, W., Lawton, M. T., Pechan, P., Colosi, P., Wu, Z., Scaria,
A., and Su, H. 2015. Focal and Systemic Delivery of AAV Vector Expressing
Soluble FLT1 Inhibits and Reverses Brain Angiogenesis. Gene Ther. 22(11):893-
900.

10. Wu, Z., Hiriyanna, S., Qian, H., Mookherjee, S., Campos, M. M., Gao, C., Fariss,
R., Sieving, P.A., Li, T., Colosi, P., and Swaroop, A. 2015. A long-term efficacy
study of gene replacement therapy for RPGR-associated retinal degeneration.
Hum Mol Genet. 15;24(14):3956-70.

11. Marangoni, D., Wu, Z., Wiley, H. E., Zeiss, C. J., Vijayasarathy, C., Zeng, Y.,
Hiriyanna, S., Bush, R. A., Wei, L. L., Colosi, P., and Sieving, P. A. 2014.
Preclinical safety evaluation of a recombinant AAV8 vector for X-linked
retinoschisis after intravitreal administration in rabbits. Hum Gene Ther Clin Dev.
2014 Oct 16.

12. Lee, S. H., Colosi, P., Lee, H., Ohn, Y. H., Kim, S. W., Kwak, H. W., and Park
TK. 2014. Laser photocoagulation enhances adeno-associated viral vector
transduction of mouse retina. Hum Gene Ther Methods. 25(1):83-91.

13. Thompson, D. A., Khan, N. W., Othman, M. I., Chang, B., Jia, L., Grahek, G.,
Wu, Z., Hiriyanna, S., Nellissery, J., Li, T., Khanna, H., Colosi, P., Swaroop, A.,
and Heckenlively, J. R. 2012. Rd9 is a naturally occurring mouse model of a
common form of retinitis pigmentosa caused by mutations in RPGR-ORF15.
PLoS One. 7(5):e35865.

14. Ramirez, M., Wu, Z., Moreno-Carranza, B., Jeziorski, M.C., Arnold, E., Díaz-
Lezama, N., Martínez de la Escalera, G., Colosi, P., and Clapp, C. 2011.
Vasoinhibin gene transfer by adeno-associated virus type 2 protects against
VEGF- and diabetes-induced retinal vasopereability. Invest Ophthalmol Vis Sci.
52(12):8944-50.

15. Hou, X., Kumar, A., Lee, C., Wang, B., Arjunan, P., Dong, L., Maminishkis, A.,
Tang, Z., Li, Y., Zhang, F., Zhang, S.Z., Wardega, P., Chakrabarty, S., Liu, B.,
Wu, Z., Colosi, P., Fariss, R.N., Lennartsson , J., Nussenblatt, R., Gutkind, J.S.,
Cao, Y., and Li, X. 2010. PDGF-CC blockade inhibits pathological angiogenesis
by acting on multiple cellular and molecular targets. Proc Natl Acad Sci U S A.
107(27):12216-21.

34
16. Kumar, A., Hou, X., Lee, C., Li, Y., Maminishkis, A., Tang, Z., Zhang, F.,
Langer, H. F., Arjunan, P., Dong, L., Wu, Z., Zhu, L. Y., Wang, L., Min, W.,
Colosi, P., Chavakis, T., and Li, X. 2010. Platelet-derived growth factor-DD
targeting arrests pathological angiogenesis by modulating glycogen synthase
kinase-3beta phosphorylation. J Biol Chem. 285(20):15500-10.

17. Wu, Z., Yang, H., and Colosi, P. 2009. Effect of genome size on AAV vector
packaging. Mol Ther. 18(1):80-6.

18. Park, T. K., Wu, Z., Kjellstrom, S., Zeng, Y., Bush, R. A., Sieving, P. A., and
Colosi, P. 2009. Intravitreal delivery of AAV8 retinoschisin results in cell type-
specific gene expression and retinal rescue in the Rs1-KO mouse. Gene Ther.
16(7):916-26.

19. Palomeque, J., Chemaly, E. R., Colosi, P., Wellman, J. A., Zhou, S., Del Monte,
F., and Hajjar, R. J. 2007. Efficiency of eight different AAV serotypes in
transducing rat myocardium in vivo. Gene Ther. 14(13):989-997.

20. Qu, G., Bahr-Davidson, J., Prado, J., Tai, A., Cataniag, F., McDonnell, J., Zhou,
J., Hauck, B., Luna, J., Sommer, J. M., Smith, P., Zhou, S., Colosi, P., High, K.
A., Pierce, G. F., and Wright, J. F. 2007. Separation of adeno-associated virus
type 2 empty particles from genome containing vectors by anion-exchange
column chromatography. J Virol. Methods. 2007 140(1-2):183-92.

21. Lochrie, M. A., Tatsuno, G. P., Arbetman, A., Jones, K., Pater, C., Smith, P.,
McDonnell, J., Zhou S., Kachi, S., Kachi, M., Campochiaro, P., Pierce, G., and
Colosi, P. 2006. Adeno-associated virus (AAV) capsid genes isolated from rat
and mouse liver genomic DNA define two new AAV species distantly related to
AAV-5. Virology 353(1): 68-82.

22. Lochrie, M. A., Tatsuno, G. P., Christie, B., Wellman, J. A., Zhou, S., Surosky,
R., Pierce, G. F., and Colosi, P. 2006. Mutations on the external surface of adeno-
associated virus type-2 capsids that affect transduction and neutralization. J.
Virol. 80(2):821-834.

23. Arbetman, A. E., Lochrie, M., Zhou, S., Wellman, J., Scallan, C., Doroudchi, M.
M., Randlev, B., Patarroyo-White, S., Liu, T., Smith, P., Lehmkuhl, H., Hobbs, L.
A., Pierce, G. F., and Colosi, P. 2005. Novel caprine adeno-associated virus
(AAV) capsid (AAV-Go.1) is closely related to the primate AAV-5 and has
unique tropism and neutralization properties. J. Virol. 79(24):15238-45.

24. Sabatino, D. E., Mingozzi, F., Hui, D. J., Chen, H., Colosi, P., Ertl, H. C., and
High, K. A. 2005. Identification of mouse AAV capsid-specific CD8+ T cell
epitopes. Mol. Ther. 12(6):1023-1033.

35
25. Matsushita, T., Okada, T., Inaba, T., Mizukami, H., Ozawa, K., and Colosi, P.
2004. The adenovirus E1A and E1B19K genes provide a helper function for
transfection-based adeno-associated virus vector production. J. Gen. Virol.
85(8):2209-2214.

26. Grimm, D., Zhou, S., Nakai, H., Thomas, C.E., Storm T.A., Fuess, S., Matsushita,
T., Allen, J., Surosky, R., Lochrie, M., Meuse, L., McClelland, A., Colosi, P., and
Kay. M.A. 2003. Preclinical in vivo evaluation of pseudotyped adeno-associated
virus vectors for liver gene therapy. Blood 102(7):2412-2419.

27. Yoshida, J., Mizuno, M., Nakahara, N., and Colosi, P. 2002. Antitumor effect of
an adeno-associated virus vector containing the human interferon-beta gene on
experimental intracranial human glioma. Jpn. J. Cancer Res. 93(2): 223-228.

28. Cunningham, J., Oiwa, Y., Nagy, D., Podsakoff, G., Colosi, P., and Bankiewicz,
K.S. 2000. Distribution of AAV-TK following intracranial convection-enhanced
delivery into rats. Cell Transplant. 9(5): 585-594.

29. Burton, M., Nakai, H., Colosi, P., Cunningham, J., Mitchell, R., and Couto, L.
1999. Coexpression of factor VIII heavy and light chain adeno-associated viral
vectors produces biologically active protein. Proc. Natl. Acad. Sci. USA. 96(22):
12725-12730.

30. Ogasawara, Y., Urabe, M., Kogure, K., Kume, A., Colosi, P., Kurtzman, G. J.,
and Ozawa, K. 1999. Efficient production of adeno-associated virus vectors using
split-type helper plasmids. Jpn. J. Cancer Res. 90(4): 476-483.

31. Maeda, Y., Ikeda, U., Shimpo, M., Ueno, S., Ogasawara, Y., Urabe, M., Kume,
A., Takizawa, T., Saito, T., Colosi, P., Kurtzman G., Shimada, K., and Ozawa, K.
1998. Efficient gene transfer into cardiac myocytes using adeno-associated virus
(AAV) vectors. Journal of Molecular and Cellular Cardiology 30(7): 1341-1348.

32. Yang, J., Hirokawa, Y., Dougherty, C., Colosi, P., Yang, J.H., and Nandi, S.
1998. Adeno-associated virus vector mediated transduction of primary normal
human breast epithelial cells. Oncology Reports 5:793-797.

33. Nakai, H., Herzog, R.W., Hagstrom, J.N., Walter, J., Kung, S.H., Yang, E.Y., Tai,
S.J., Iwaki, Y., Kurtzman, G.J., Fisher, K.J., Colosi, P., Couto, L.B., and High,
K.A. 1998. Adeno-associated viral vector-mediated gene transfer of human blood
coagulation factor IX into mouse liver. Blood 91(12): 4600-4607.

36
34. Mizuno, M., Yoshita, J., Colosi, P., and Kurtzman, G. 1998. Adeno-associated
virus vector containing the herpes simplex virus thymidine kinase gene causes
complete regression of intracerebrally implanted human gliomas in mice, in
conjunction with ganciclovir administration. Japanese Journal of Cancer Research
89(1):76-80.

35. Matsushita, T., Elliger. S., Elliger, C., Podsakoff, G., Villarreal, L., Kurtzman, G.
J., Yuichi, I., and Colosi, P. 1998. Adeno-associated virus vectors can be
efficiently produced without helper virus. Gene Therapy 5(7): 938-945.

36. Gardner, J.P., Zhu, H., Colosi, P., Kurtzman, G.J., and Scadden, D.T. 1997.
Robust, but transient expression of adeno-associated virus-transduced genes
during human T lymphopoiesis. Blood 90(12): 4854-4864.

37. Urabe, M., Hasumi, Y., Ogasawara, Y., Matsushita, T., Kamoshita, N., Nomoto,
A., Colosi, P., Kurtzman, G.J., Tobita, K., and Ozawa, K. 1997. A novel
dicistronic AAV vector using a short IRES segment derived from hepatitis C virus
genome. Gene 200: 157-162.

38. Maeda, Y., Ikeda, U., Ogasawara, Y., Urabe, M., Takizawa, T., Saito, T., Colosi,
P., Kurtzman, G., Shimada, K., and Ozawa, K. 1997. Gene transfer into vascular
cells using adeno-associated virus (AAV) vectors. Cardiovascular Research 35:
514-521.

39. Kessler, P.D., Podsakoff, G.M., Chen, X.-J., McQuiston, S.A., Colosi, P.C.,
Matelis, L.A., Kurtzman, G.J., and Byrne, B.J. 1996. Gene delivery to skeletal
muscle results in systemic delivery of a therapeutic protein. Proc. Natl. Sci. USA
93:14,082-14,087.

40. Okada, H., Miyamura, K., Itoh, T., Hagiwara, M., Wakabayashi, T., Mizuno, M.,
Colosi, P., Kurtzman, G., and Yoshida, J. 1996. Gene therapy against an
experimental glioma using adeno-associated virus vectors. Gene Therapy 3(11):
957-964.

41. Colosi, P., Wong, K., Leong, S. R., and Wood, W. I. 1993. Mutational analysis of
the intracellular domain of the human growth hormone receptor. J. Biol. Chem.
268:12617-12623.

42. Fuh, G., Colosi, P., Wood, W. I., and Wells, J. A. 1993. Mechanism-based design
of prolactin receptor antagonists. J. Biol. Chem. 268:5376-5381.

43. Ogren, L., Southard, J.N., Colosi, P., Linzer, D.I.H., and Talamantes, F. 1989.
Mouse placental lactogen-I: RIA and gestational profile in maternal serum.
Endocrinology 125:2253-2257.

37
44. Colosi, P., Thordarson, G., Hellmiss, R., Singh, K., Forsyth, I.A., Gluckman, P.,
and Wood W.I. 1989. Cloning and expression of ovine placental lactogen. Mol.
Endocrinol. 3:1462- 1469.

45. Colosi, P., Ogren, L., Southard, J.N., Thordarson, G., Linzer, D.I.H., and
Talamantes, F. 1988. Biological, immunological, and binding properties of
recombinant mouse placental lactogen-I. Endocrinology 123:2662-2667.

46. Colosi, P., Swiergiel, J., Wilder, E., Olviedo, A., and Linzer, D.I.H. 1988.
Characterization of proliferin-related protein. Mol. Endocrinol. 2:579-586.

47. Smith, W.C., Colosi, P., and Talamantes, F. 1988. Isolation of two molecular
weight variants of the mouse growth hormone receptor. Mol. Endocrinol. 2:108-
116.

48. Campbell, G.T., Wagoner, J., Colosi, P., Soares, M.J., and Talamantes. 1988.
Development of and retention of phenotypically-specialized cells in pituitary
allografts in the hamster. Cell Tissue Research 251:215-220.

49. Colosi, P., Talamantes, F. and Linzer, D.I.H. 1987. Molecular cloning,
characterization, and expression of mPL-I cDNA. Mol. Endocrinol. 1: 767-776.

50. Colosi, P., Ogren, L., Thordarson, G., and Talamantes, F. 1987. Purification and
partial characterization of two prolactin-like glycoprotein hormones from the
midpregnant mouse conceptus. Endocrinology 120: 2500-2511.

51. Colosi, P., Holekamp, K.E., Thordarson, G., Southard, J., and Talamantes, F.
1986. Purification and partial characterization of prolactin from the California
ground squirrel (Spermophilus beecheyi). Biol. Reprod. 3: 1017-1023.

52. Jackson, LL., Colosi, P., Talamantes, F., and Linzer D.I.H. 1986. Molecular
cloning of mouse placental lactogen cDNA. 1986. Proc. Natl. Acad. Sci. USA 83:
8469-8500.

53. Thordarson, G., Villalobos, R., Colosi, P., Southard, J., Ogren, L. and
Talamantes, F. 1986. The lactogenic response of cultured mouse mammary
epithelial cells to mouse placental lactogen. Journal of Endocrinology 109: 263-
274.

54. Soares, M.J., Bartke, A., Colosi, P., and Talamantes, F. 1984. Identification of a
placental lactogen in pregnant Snell and Ames dwarf mice. Proc. Soc. Exper.
Biol. Med. 175: 106-108.

55. Marr, G.A., Colosi, P., Desjardins, C., and Talamantes, F. 1983. Development
and characterization of a homologous radioimmunoassay for deer mouse
(Peromyscus maniculatus bairdii) prolactin. Life Sciences 33: 463-466.

38
56. Bewley, T.A., Colosi, P., and Talamantes, F. 1983. Conformational comparisons
of stored and secreted ovine pituitary prolactin. Arch. Biochem. Biophys. 225:
436-445.

57. Colosi, P., Bewley, T.A., and Talamantes, F. 1983. Isolation, purification, and
characterization of deer mouse (Peromyscus maniculatus bairdii) prolactin. Life
Sciences 33: 463-466.

58. Soares, M.J., Colosi, P., Ogren, L., and Talamantes, F. 1983. Identification and
partial characterization of a lactogen from the midpregnant mouse conceptus.
Endocrinology 112: 1313-1317.

59. Soares, M.J., Colosi, P., and Talamantes, F. 1983. The development and
characterization of a homologous radioimmunoassay for hamster pituitary
prolactin. Proc. Soc. Exp. Med. Biol. 172: 379-381.

60. Bewley, T.A., Colosi, P., and Talamantes, F. 1982. Conformational studies of
secreted mouse pituitary prolactin. Biochemistry 21: 4238-4243.

61. Colosi, P., Marr, G.A., Lopez, J., Haro, L., Ogren, L., and Talamantes, F. 1982.
Isolation, purification, and characterization of mouse placental lactogen. Proc.
Natl. Acad. Sci. 79: 771-775.

62. Soares, M.J., Colosi, P., and Talamantes, F. 1982. Development and
characterization of a homologous radioimmunoassay for mouse placental
lactogen. Endocrinology 110:668-670.

63. Colosi, P. and Talamantes, F. 1981. The amino acid compositions of secreted
mouse prolactin, growth hormone, and hamster prolactin: the presence of one
tryptophan in mouse prolactin. Arch. Biochem. Biophys. 212: 759-761.

64. Colosi, P., Markoff, E., Levy, A., Ogren, L., Shine, N., and Talamantes, F. 1981.
Isolation and partial characterization of secreted hamster pituitary prolactin.
Endocrinology 108: 850-854.

65. Markoff, E., Colosi, P., and Talamantes, F. 1981. Homologous


radioimmunoassay for secreted mouse prolactin. Life Sciences 28: 203-211.

39
Book Chapters

Talamantes, F., Colosi, P., Soares, M.J., Markoff, E., Haro, L. Lopez, J., Marr, G.A., and
Ogren, L. 1985. Studies on the biochemistry and physiology of mouse prolactin, growth
hormone, and placental lactogen. In Proceedings of the Ninth International Symposium
on Comparative Endocrinology. B. Lofts and W.N. Holmes, eds. Hong Kong University
Press, pp. 569-571.

Talamantes, F., Soares, M.J., Colosi, P., Haro, L., and Ogren, L. 1984. The biochemistry
and physiology of mouse placental lactogen. In Frontiers and Prospectives of Prolactin
Secretion: A Multidisciplinary Approach. F. Mena and C. Valverde R., eds. Academic
Press, pp. 569-571.

40
GABOR VERES Ph.D.
112 Garner Dr., Novato, CA 94947
650-269-3670
gbrvrs@gmail.com

PROFESSIONAL OBJECTIVES: To identify breakthrough cell and gene therapy indications and lead the development
from pre-clinical research to regulatory approval. Discover and apply novel technologies to deliver improve therapeutic
efficacy.

• Lead multiple projects from pre-clinical research to clinical development in Phase I/II-III and MAA/BLA filing
• Initiated and led multiple research programs to correct genetic and acquired diseases with gene and cell therapy,
gene editing in -Thalassemia, SCD, adrenoleukodystrophy (ALD), hemophilia, DMD, WAS, LCA, α1-AAT
deficiency and cancer (CAR-T, cancer vaccine, oncolytic virus)
• Lead the identification of new therapeutic indications as part of corporate strategy
• Developed multiple gene delivery systems for gene therapy applications (AAV and LVV)
• Progressive managerial experience; supervised up to 40 scientists and research associates
• Planned and maintained R&D department budgets up to $ 20 million $
• Experienced in regulatory issues and policy to support IND filing (>10 IND filings)
• Invented several patents, built strong intellectual property portfolio

PROFESSIONAL EXPERIENCE:

Vice President, head of Gene Therapy 2019 – present


Biomarin Pharmaceuticals, Novato, CA

• Leads gene therapy and platform research programs, identifies new therapeutic indications
• Provides research support for leading therapeutic programs in Phase I/II-III

Vice President, Pre-clinical Research 2010 - 2019


Bluebirdbio Inc. Cambridge, MA

• Lead research and development programs in -thalassemia, sickle cell disease,


adrenoleukodystrophy, monogenic diseases and oncology (CAR-T)
• Reorganized and expanded preclinical research; hired key scientists and research associates
• Designed and directed efficacy and safety studies to support IND filings
• Provided research and preclinical support for FDA and EMA interactions
• Provided pre-clinical research support for gene editing and CAR-T cell programs
• Established and managed academic and industrial collaborations and joint projects with corporate partners

Vice President of Research and Development 2006 - 2009


APPLIED GENETICS TECHNOLOGY CORPORATION, FL

• Identified new therapeutic applications, directed proof of concept studies


• Designed and directed toxicology, pharmacology and bio-distribution studies
• Developed and supervised monitoring studies for clinical trials
• Established Scientific Advisory Board, organized meetings with key opinion leaders
• Maintained R&D support for clinical programs
• Provided R&D support for fund raising and business development

41
Director of Development
SANGAMO Biosciences, Richmond, CA 2005 - 2006

• Reorganized and led the gene delivery, analytical and development groups to support preclinical and clinical
projects
• Coordinated large-scale production, purification, and assay development for product release and characterization
for GMP grade plasmids, viral vectors and cell lines

Director of Research & Development 2004 – 2005


GENETHON, Evry, France

• Directed the operation of the R & D department with 30 scientists and research associates
• Led the planning and organization of the strategic preclinical research and development programs
• Directed assay development activities to support IND filing and coordinates external and in house GMP vector
manufacturing
• Led project team to file IND submission for muscle disease program, generated preclinical and CMC section of
IND documents
• Coordinated external academic collaborations with an annual budget of over $ 2 million

Sr. Director of Research


CELL GENESYS INC, Foster City, CA 2000 - 2004

• Led expansion of the research department from 20 to about 40 by recruiting talented scientist and research
associates; reorganized the department to reflect project priorities
• Initiated and implemented new research projects for cancer applications (glioblastoma and anti-angiogenesis),
metabolic diseases and hemophilia to broaden the product pipeline
• Initiated preclinical efficacy, pharmacology and toxicology studies for cancer, hemophilia and metabolic disease
programs to support IND filing
• Led project team to file IND and RAC submission for metabolic disease program, generated preclinical and CMC
section of pre-IND and RAC documents

Director
NOVARTIS/SYSTEMIX; Palo Alto, CA 1993 - 2000

• Established and implemented short and long-term strategy for viral platform development, infectious
disease/HIV, cardiovascular, CNS and cancer gene therapy research programs
• Initiated and led the development of multiple RNA based inhibitory strategies against HIV-1 (RNA-decoys,
antisense-RNA, ribozymes)
• Allocated resources for research programs through matrix management oversaw and coordinated research projects
between international research sites
• Initiated and managed more than 10 external collaborations with academic laboratories and biotechnology
companies. Evaluated novel technologies and made recommendations on licensing of novel viral systems and
anti-HIV genes

Senior Scientist /Group leader


SANDOZ RESEARCH INSTITUTE. Vienna, Austria 1992 - 1993

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Gabor Veres Page 3

ACADEMIC RESEARCH EXPERIENCE:

Assistant Professor
University of Zurich Zurich, Switzerland

Postdoctoral Fellow
Institute of Molecular Pathology Vienna, Austria

Staff Scientist
Biological Research Center Szeged, Hungary

Postdoctoral Fellow
Baylor College of Medicine Houston, Texas

EDUCATION:

Ph.D. in Genetics and Biochemistry


Attila Jozsef University Szeged, Hungary

M.S. in Genetics and Biochemistry


Attila Jozsef University Szeged, Hungary

PROFESSIONAL DEVELOPMENT:

Biotechnology Executive Course UC Berkeley

Project/Portfolio Management Courses Novartis

Management Training Novartis/Cell Genesys

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