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1. Professional Profile http://www.gaildonegan.site90.net/
Gail Donegan: Curriculum Vitae
Email: gcdonegan@yahoo.co.uk
Network: http://uk.linkedin.com/in/gaildonegan
Senior Scientist/Team Leader/Research Manager
Outgoing and energetic professional with 10 years experience in academic and clinical research.
Excellent proven track record of bringing projects to successful conclusion using effective
delegation, time management and progress monitoring strategies while networking and identifying
opportunities for future growth.
Wide-ranging hands-on expertise in regenerative medicine, developmental toxicology, drug
development, biomaterials and stem cell biology.
Career to date demonstrates a love of challenge and diversity and I now seek higher level scientific
management opportunities in the global life sciences arena.
Experience
Employment
Education
Selected Publications
References and Recommendations
Additional Information
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Experience
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2. Professional Profile http://www.gaildonegan.site90.net/
Project Management Negotiation Networking Collaboration
ESC isolation & Bioreactor 3D Tissue
Immunohistochemistry
maintenance ; design Culture
Western & Semi- quantitative
MSC isolation & maintenance FACS LSCM & SEM
Dotblot
SDS PAGE PCR ELISA LC/MS (limited)
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Employment
Liverpool School of Tropical Medicine, Molecular and Biochemical Parasitology Group,
Developmental Toxicology: Senior Postdoctoral Associate; 2009 - 2011(Aug) Effectively kick-started
EU project as team leader of workpackage-2 research team with the EU Cordis 'Artemisinins in
Pregnancy' (ARTEMIIP) consortium at LSTM. The research is aimed towards unravelling the
mechanisms behind heart, skeletal and blood cell defects linked to antimalarials used in areas
where, due to parasite resistance, existing therapies are no longer effective. Newer antimalarials
currently in development are also being screened for adverse effects to the fetus Our studies
together with vital work conducted by the Malaria in Pregnancy (MiP) consortium at LSTM to identify
alternative strategies to treat malaria in women of childbearing age will contribute towards WHO
recommendations to alleviate the massive global burden of malaria.
Research Responsibilities
Effectively lead small research team and coordinated multiple optimizations of In vivo, ex vivo &
in vitro models for developmental toxicology
Successfully identified opportunities and new techniques to elucidate mechanisms behind
adverse effects on early populations of hematopoietic stem cells.
Micromass culture to monitor early molecular and cellular events in pre -cartilage condensation
Planning and assay optimization for genomic and proteomic analyses of extraembryonic and
embryonic tissues following drug exposure
Molecular (IHC & RT-PCR) investigation of function and potential targets of drug- associated
oxidative stress and impacts onf hematopoiesis, cardiogenesis and apoptosis
Histology for embryonic chondrogenesis/osteogenesis
Manual & automated haematological screening of fetal blood samples derived from in vivo and
ex vivo models etc.
Research Management Responsibilities
Ensuring timely completion of ARTEMIP Work Package 2 milestones and deliverables
Successful team leadership to four research staff
Key role in planning and implementation of RT-PCR, WB, ELISA, IHC, MS/LCMS, LSCM,
haematology
Assessment of staff resources needed to achieve project deliverables
Coaching and mentoring junior staff, HO licences, organizing external training,
Amending project licences to accommodate ARTEMIP requirements
Ensuring all activities performed by team comply with GCP, GLP and HO requirements,
Production of Standard Operating Procedures (SOPs), Developmental Protocols, Review and
Validation documents
Data analysis using a range of statistical methods
Production of Standard Operating Procedures (SOPs) Development Protocols, Review and
Validation Documents
Promotion of a safe and positive work environement by demonstrating positive cooperative and
friendly attitude towards job responsibilities, line managers, fellow works and visitors while
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3. Professional Profile http://www.gaildonegan.site90.net/
following all safety guidelines and policies
Project Management Responsibilities
Communicating to senior management overviews of research outcomes/outputs and their stage
of development.
Reviewing analyzing and formulation of aspects of research and development proposals e.g.
objectives / purposes of project, potential applications, costs, equipment and HR requirements.
Proactively dealing with changes in the scope of the project as they arose, developing
contingency plans and guidelines to minimize potential risks and crises
Development and implementation of methods and procedures for monitoring projects, such as
audit documents, score sheets, weekly meetings and planners and review documents to inform
management of progress towards milestones and deliverables.
Negotiation of research collaborations with academia, industry and healthcare organizations.
Negotiation of contracts with major equipment suppliers to support research.
Tracking research trends and relevant legislation
Networking and collaborations between academia, NHS and pharma (GSK, HLS, CR, Aintree
University Hospital, Universities of the Algarve, Leiden, Gothenburg, WHO.
Other responsibilities
Lecturing (MRC Centre for Drug Safety Science): Preclinical Screening for Embryotoxicity and
Teratogenicity
Set up of EU FP7 Consortium webpage on LSTM website: Artemisinins in Pregnancy (ARTEMIP)
Dissemination of research output at internal and external meetings worldwide and online:
California, USA: Preclinical Screening Teratogenicity Of Artemisinin Combination Therapies (ACTs)
For Malaria In Pregnancy. Donegan GC, et al. Platform Session III on June 29, 201151st Teratology
Society Annual Meeting in California. USA
Berlin, Germany, Invitation as expert speaker:Advancements in Preclinical Screening Methods for
Artemisinins During Pregnancy. 2010 Donegan GC et al. Informa Life Sciences Inaugural Summit:
Preclinical Safety and Efficacy Testing of Biological Products. Informa. Berlin, Germany. December 2 -
4 2010
Edinburgh, Scotland:Parasite to prevention: Advances in the understanding of malaria 20-22 October
2010
Manchester, UK, Invitation as expert speaker:NC3Rs Roadshow CRACK-IT to identify and unlock
opportunities for scientific progress and reductions in the use of animals while accelerating translation
of research into practice. 6 July 2011.
Online TV: Artemisinins in Pregnancy: The Research, The Future for the BBC (online Autumn 2011)
Birth Defects Research: Preclinical Screening: Teratogenicity of Artemisinin Combination Therapies
(ACTs) for Malaria in Pregnancy Donegan G, et al Birth Defects Research (Part A) 91:327_348 (2011)
Malaria Journal: Screening Methods for Artemisinins During Pregnancy. Donegan G et al. Malaria
Journal 2010, 9 (Suppl 2):
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Covance Drug Development: & NHS Clinical Pathology Laboratories : Clinical Scientist (locum)
Covered sick and maternity leave, responsible to head of Clinical Pathology departments at Covance
and Aintree University Hospitals. 2008 - 2009 - 1 year
Responsibilities
Management of workflows in high throughput clinical laboratories
Effective use of of NHS and CRO laboratory management systems (LIMS) (ClinySYS, (WinPath),
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Clinaxys and FoxPro) to manage and consolidate of large data volumes from multiple,
integrated diagnostic analysers
Reliable and clear reporting to healthcare professionals including theatre staff, consultants,
GPs, clinical research investigators and study directors, sympathetic communication with
patients and their families during high-stress situations.
Haematological analyses (automated/manual) including whole blood count, white blood cell
differential, platelet and reticulocyte analyses, Genotype,molecular analyses,INR and ESR
testing
Using clinical engineering expertise (MSc & PhD) for maintenance and trouble-shooting of
automated clinical diagnostic analysers during analyses of kidney, liver and cardiac function,
pO2 and pCO2 etc. in addition to whole blood count, white blood cell differential, platelet and
reticulocyte analyses, genotype,molecular analyses,INR and ESR testing
Diagnostics for qualitive detection of infectious mononucleosis (glandular fever), sickle cells
anaemia and malaria in whole blood, CSF and serum. Preparation of slides for bone marrow
and blood film analyses
QA & QC weekly & monthly metrology, calibrations for species, sex, pre- existing conditions,
NEQAS & EQAS (Addenbrooks Hospital, Cambridge)to ensure regulatory compliance.
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University of Bath, Dept of Chemical Engineering / Centre for Regenerative Medicine: Postdoctoral
Research Officer. Successful implementation of new methods to produce co- polymeric and hydrogel
scaffolds for 3D bone tissue models with better surface characteristics, improved sterility and
reproducibility. 2006 - 2007 - 1 year
Research responsibilities
Successful development of bespoke co- polymer and hydrogel scaffolds for 3D musculoskeletal
tissue models.
Enhanced annular flow bioreactor design for osteogenic progenitor cell expansion and
differentiation on PLGA & PLLA scaffolds
Initiated new and simpler methods to produce PLGA micro-tubular tissue culture substrates for
improved surface characteristics, sterility and reproducibility
Optimized non-invasive cell tracking methodologies on non-transparent biomaterial scaffolds
using colloidal staining technologies
Adaptation of cell viability assays to permit non-invasive measurement of tissue model viability
prior to and following perfusion culture
Effective use of IHC & histology SDS PAGE, Western blot, qPCR, cell cycle analyses, ELISA to
elucidate impacts of PLGA degradation under flow on MSC expansion
Effective liaison and networking with collaborating departments, Universities in the UK and US
and hospital personal to facilitate long- and short term project initiatives
Effective reporting, data interpretation and consolidation of information from raw datasets
Presentation at teaching seminars and regular teleconferences outlining results, projections
and future objectives at internal and external meetings
Management of tissue culture laboratories, working to and writing SOPs, keeping records of
cell source, archiving, disposal etc.
Maintenance of databases and spreadsheets to support budget management
Purchase and routine maintenance of key analytical equipment, implementing service contracts
and payment schedules
Other responsibilities
Production and presentation of weekly training seminars focused towards bioreactor
optimization and bioprocessing technologies, selection, expansion and exploitation of
mesenchymal stem cell culture, non-invasive monitoring technologies for continuous tracking
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5. Professional Profile http://www.gaildonegan.site90.net/
of cellular function and viability
Acting as liaison with local schools in Bath and Bristol to promote careers in science
Student training and mentoring of tissue culture techniques, bioreactor setup, stem cell culture
and maintenance
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University of Liverpool, Dept of Clinical Engineering: Postgraduate Researcher/PhD. Doctoral
research into vascular cell response to improve tissue engineered blood vessel integrity in response
to defined physiologically-relevant flow regimes. 2002 - 2005 - 3 years
Research responsibilities
Successful design and build of rotating wall bioreactors for tissue culture under
physiologically -relevant conditions
Generation of functional tissue engineered 3D blood vessel models suitable for
pharmacokinetic/pharmacodynamic analysis
Development of non-invasive integrated monitoring modalities to measure vascular tissue
remodelling response under fluid shear stresses
Efficient and reproducible production of vascular smooth muscle cell sheets from donated
human tissue for seeding biomaterial scaffolds
Innovation of technologies for quantitative uniaxial tensile testing and cell proliferation
analyses of vascular graft models.
Advanced statistical analyses:Correlation analysis, MANOVA combined with ANCOVA to
investigate identifiable correlations between dynamic structural and degradative tissue
remodelling under specific flow regimes.
Successful utilization of hydroxyproline assays, immuncytochemistry, MMP activity assays,
SDS PAGE, Western blot, ELISA, FACS to evaluate impacts of dynamic culture conditions on
vascular cell functionality.
Strategic collaborations with key university departments, allied medical research charities and
biopolymer/pharmaceutical companies.
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Education
DATE COURSE INSTITUTION FOCUS
2010 Prince 2 Foundation
Datrix Project Management
and Practitioner
2010 University of Change Management - Models for shaping
Managing Change
Liverpool and implementing change successfully
2010 University of Developing flexibility of leadership styles to
Managing Your Team
Liverpool get the most from your team
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6. Professional Profile http://www.gaildonegan.site90.net/
2010 Influencing and University of Developing effective communication skills,
Negotiation Liverpool Assessing effectiveness of key messages.
2010 Reproduction Huntingdon Life Industry standard developmental toxicology
Toxicology Sciences drug screening protocols
Faculty of Utilization of Bioreactors
2003 - PhD in Regenerative
Medicine and Semi- Synthetic Biomaterials
2005 Medicine
University of Liverpool in Tissue Engineered Blood Vessels
Faculty of Switching Off Genomic Imprinting
2001 - MSc in
Medicine to Induce Cardiomyogenesis in
2003 Clinical Engineering
University of Liverpool &n bsp; Mesenchymal Stem Cells
1997 - BSc in School of Biological
Sciences University of
Investigation of Transcription Factor
2000 Molecuar Biology
Liverpool Analogues in Yeast and Mammalian Systems
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Selected Publications and Presentations
California, USA: Preclinical Screening Teratogenicity Of Artemisinin Combination Therapies (ACTs) For
Malaria In Pregnancy. Donegan GC, et al. Platform Session III on June 29, 201151st Teratology Society
Annual Meeting in California. USA
Berlin, Germany:Advancements in Preclinical Screening Methods for Artemisinins During Pregnancy. 2010
Donegan GC et al. Informa Life Sciences Inaugural Summit: Preclinical Safety and Efficacy Testing of
Biological Products. Informa. Berlin, Germany. December 2 - 4 2010
Edinburgh, Scotland:Parasite to prevention: Advances in the understanding of malaria 20-22 October
2010
Manchester, UK:NC3Rs Roadshow CRACK-IT to identify and unlock opportunities for scientific progress
and reductions in the use of animals while accelerating translation of research into practice. 6 July 2011.
Online TV: Artemisinins in Pregnancy: The Research, The Future for the BBC (online Autumn 2011)
Birth Defects Research (Part A): Preclinical Screening: Teratogenicity of Artemisinin Combination
Therapies (ACTs) for Malaria in Pregnancy Donegan G, et al Birth Defects Research (Part A) 91:327_348
(2011):
Malaria Journal: Adv ancements in Preclinical Screening Methods for Artemisinins During Pregnancy.
Donegan G et al. Malaria Journal 2010, 9 (Suppl 2):
Journal of Tissue Engineering and Regenerative Medicine: Investigating the Importance of Flow when
Utilizing Hyaluronan Scaffolds for Tissue Engineering. 2009 Donegan GC et al. Journal of Tissue
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7. Professional Profile http://www.gaildonegan.site90.net/
Engineering & Regenerative Medicine. Volume 4, Issue 2, pages 83-95 :
Youtube: Malaria: What Where Why & How? How do you catch malaria? What are the stages of the
disease? What is multi-drug resistance? What impact does parasite resistance have in the fight against
global malaria resurgence? What are antimalarial treatments are available and which should I take them
before traveling to malaria- endemic countries? This is one of a series of Youtube videos designed to answer
some of these questions
A Novel System for Non-Invasive Monitoring of Tissue Remodelling Responses in Vascular
Constructs During Dynamic Culture. Donegan GC, et al. In preparation
Cell-seeding And Proliferation In The Lumina Of PLLA Tubules In A Dynamic Couette-Taylor
Bioreactor, Curran SJ, Donegan GC, et al. 2003 Tissue Engineering, 9(4): 801
The Bioengineered Cardiovascular Construct: Measuring Remodeling Protein Synthesis in Response
to Rotational Stresses. Donegan GC, et al. Oral Presentation Joint Meeting of the Tissue Engineering
Society International and the European Tissue Engineering Society (TESI-ETES now TERMIS)
Lausanne, Switzerland, October 10 - 13 2004
The Effect of Rotational Stresses on Circumferential Remodeling Response in the Tissue Engineered
Vascular Construct Donegan GC, et al. Joint Meeting of the Tissue Engineering Society International
and the European Tissue Engineering Society (TESI-ETES now TERMIS) Lausanne, Switzerland,
October 10 - 13 2004
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Recommendations:
"Gail has been responsible for many changes and improvements to this project, expanding and
enhancing the research profile at LSTM" Dr. Geoff Edwards, Centre for Drug Safety, University of
Liverpool and Liverpool School of Tropical Medicine UK
Gail is a very hard worker and a great team player", Dr Stephen Curran, Scheme Manager and
Technical Specialist, BSI< /span>
"Gail has a friendly, enthusiastic personality, forming good working relationships with her
colleagues. It has been a pleasure to work with her" Dr Patrick Doherty, Course Director at Dept of
Clinical Engineering and Director of Studies in Centre for Lifelong Learning & Professional
Development, University of Liverpool
"Gail is a dedicated and innovative scientist. She is also great to work with, combining common
sense with a broad knowledge base and excellent problem solving skills. I wouldn't hesitate to
recommend her" Dr Muna Whyte, Project Manager, ACM Global
Detailed references upon request
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Additional Information
Preclinical Study Design:Directly responsible for setting up a range of reprotox models including
embryonic (haematopoietic stem cell cultures applicable for developmental toxicology and cancer
research, micromass culture for skeletal development and ADME with postimplantation WEC, a
reprotox-specific 48 or 72 hour experiment which enables monitoring of mammalian fetal
development in the first trimester of pregnancy and bio analysis to characterize adverse drug effects
and potential for lethality, birth defects or dysfunction of multiple organ systems.
The successful conclusion of which enables the Artemisinins in Pregnancy (ARTEMIP) produce
relevant preclinical data to enhance information generated during field trials by the Malaria in
Pregnancy (MiP) for the WHO to make accurate risk: benefit assessments as to the deployment of
newer antimalarial therapies to women of childbearing age.
Protocols and GCP - An acute awareness of the importance of well-designed trials especially when
working to tight deadlines.
Developed multiple protocols in accordance with GCP and Home Office guidelines. The preclinical
studies were meticulously designed to respect rights and dignity at all times and ensure that:-
In vivo studies were replaced with ex-vivo and in vitro studies when appropriate and feasible to
do so, and for initial screening for lead compounds.
Numbers for in vivo experiments kept to a minimum, the maximum information is gained from
each series of experiments, and also by re- examining the findings of pre-existing studies
Experiments were designed to ensure as little stress as possible
Studies were designed so that they did not need to be repeated more than was necessary for
validated results using feasibility studies at the outset.
Experimental work by new staff was conducted under supervision of an experienced HO
licensee until full competency has been ascertained and the worker can be signed off.
Feasibility: No trials should be undertaken before a full program of feasibility, risk/hazard
assessment, bench testing and validation has been conducted therefore relevant feasibility studies
were designed in advance to demonstrate proof of concept, to attempt elucidate unforeseen risks
and to determine whether risks are acceptable during early stages.
Study management: Involvement in the management of key staff in a number of projects involving
multi-disciplinary teams at establishments in the UK, EU and US. Responsible for kick starting the
developmental toxicity research from my joining LSTM in 2009 and have lead the small research team
to success in this highly relevant and worthwhile project to improve human health.
Directly responsible in setting clearly defined long- and short-term project objectives with the
agreement of the whole team including senior management. Anticipated delivery dates were also
agreed with the potential for failure to achieve objectives taken into consideration, contingency
strategies to deal with setbacks as they arise together with initial feasibility studies and risk/hazard
studies
Ensured that there was continuous and thorough tracking of research outputs throughout with
relevant documentation including;
SOPs with fully defined objectives and details of the controls against which the collected
information will be statistically analyzed. The exact methods should be detailed such that all
parties can execute the work in a comparable fashion
Toxicology-specific score sheets to track and quantify QA, QC and robustness (reproducibility)
and validation
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Documented feedback from clients/end users
Review of the relevancy of the experimental data in terms of the overall project objectives
(deliverables)
Possible deviations from the original SOPs and deliverables such as regulatory changes or
changes in legislation
Tracking failure, cause, recommended action, and outcome
Dissemination and Invitation: Invited as an expert speaker in drug development, developmental
toxicology and NC3Rs meetings in the UK (Manchester and Edinburg) and abroad (Beijing, Berlin
& California) during time at the Liverpool School of Tropical Medicine.
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