CURRICULUM VITAE
August 28, 2015
Merab Lomia, M.D., Ph.D.
Address: 1, Field House
Close, Ascot, SL5 9LT,
Berkshire, UK
Phone: +44751 6906500
Email: lomiamer@yahoo.com
Website: www.asthma.ge
Citizenship:
1)
United Kingdom
2)
Georgia
Summary: 2 patents in the field of drug development, 29 years of experience in clinical and experimental
medicine and neurology, 17 years of experience in pharmacovigilance, 17 years of experience in clinical
trials
Career and professional experience:
03.05.2011 – till now: Drug Safety Physician, Medical Reviewer, Eli Lilly Erl Wood Centre, Windlesham,
Surrey, UK
Providing medical technical expertise in evaluation of individual adverse events; supporting the case
management staff in ensuring appropriate follow-up; reviewing assessments of listedness based on global and
specific requirements and being accountable for the medical assessment of the information within the case
report; training and mentorship to Global Patient Safety case managers with respect to the medical aspects of
the management, pharmacovigilance expertise through surveillance teams meetings, discussion and training
programs; safety related training programs and presentations. Creation and implementation of Multi-tab
Access Program for proper listedness evaluation of Lilly and non-Lilly products and for fast access to other
frequently used websites, documents and programs.
04.05.2010 – 20.03.2011: Senior Clinical Safety Associate, ICON, Eastleigh, UK
Document and process Serious Adverse Event Reports, spontaneously reported adverse events, and other
medically related information per study specific procedures, provide input and review relevant safety tracking
systems, perform safety review of clinical data (case report forms) and patient labs, completion of quality
control feedbacks forms, attend sponsor and project team meetings and teleconferences. Clinical and postmarketing studies experience.
05.06.2008 – 19.02.2010: Clinical Safety Associate, Novartis Horsham Research Centre, Horsham, UK.
Responsible for the accurate data entry of Serious Adverse Events /Post Marketing Events and the evaluation
on non-expeditable reports within agreed timeframes, in compliance with IMS business rules, standard
operating procedures and regulatory requirements.
23.12. 2004 – 15.10.2007: Senior Medical Advisor, Pharmacovigilance Dept., Georgian Drug Agency,
Tbilisi, Georgia.
Responsible for the risk management and risk minimization plans, monitoring of spontaneous adverse events
registration system, medical and scientific review, analyzing and interpretation of AE reports and aggregate
data reviews. Registration, medical review and analyzing of positive side effects of drugs. Coordination of
SAE activities for assigned projects. See also ‘Pharmacovigilance experience’ on page 3.
10.11.1998 – 13.10.2007 (part-time): Medical Advisor, Chief Neurologist, “Rea” Medical Rehabilitation
Centre for Chronic Disorders, Tbilisi, Georgia. Implementation and monitoring of new methods of
pharmacotherapy of neurological and neurogenic disorders. Pharmacotherapy of bronchial asthma as
neurogenic inflammatory disorder. PI, clinical trials (see ‘Clinical trials’ on page 3). Daily clinical work with
patients, clinical rounds and consultations.
08.01.1997 – 22.12.2004 (till 12 October 1998 – part-time): Pharmacovigilance Specialist, National Drug
Monitoring Center of Pharmacovigilance, Tbilisi, Georgia. Implementation and monitoring of spontaneous
adverse events registration system, medical and scientific review, analyzing and interpretation of AE reports,
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training of physicians and nurses concerning adverse event reporting. See also ‘Pharmacovigilance
experience’ on page 3.
02.10.1993 – 12.10.1998 - Research Scientist Doctor and Lecturer, Neurological Department, Scientific
Research Institute of Pediatrics, Tbilisi, Georgia.
Clinical research studies in child neurology. EEG-computer topography (brain-mapping) and clinical
observational study of antagonists of opiate analgetics for therapy of tics, Tourette syndrome and nocturnal
enuresis. Daily and on-duty clinical work with in- and out-patients. Taught post-graduate courses for
registrars and fellow physicians in neuropharmacology.
01.12.1991 – 01.10.1993 – Senior Medical Investigator, Neurological Department, Scientific Research
Institute of Pediatrics, Tbilisi, Georgia.
EEG-computer topography (brain-mapping), in children with neurological disorders. Daily and on-duty
clinical work with in- and out-patients.
01.11.1988 – 01.12.1991 – Postgraduate Doctoral Study (Doctoral fellowship), jointly in Neurological
Department, Tbilisi State Medical University, and in Department of Metabolic Maintenance of the Brain
Functions, I. Beritashvili Institute of Physiology, Georgian Academy of Sciences, Tbilisi, Georgia. Study
title: Experimental use of fluorochemical “artificial blood” in therapy of various experimental models of
acute cerebral ischemia. Models of brain ischemia in rabbits and rats.
31.08.1986 – 01.11.1988 - Neurologist, Senaki district Mendzhi State Hospital, Georgia.
Medical practice of wide range of out-patients with neurological disorders. Treatment of neurological
patients. Neurological consultations for non-neurological patients. Daily and on-duty clinical work.
01.08.1985 – 31.08.1986 – Specialty training in Neurology, Department of Neurological Diseases, Central
University Hospital, Tbilisi, Georgia.
Education:
01.08.1979 – 01.08.1985: Medical Doctor’s Degree, Tbilisi State Medical University, Faculty of Internal
Medicine
01.08.1985 – 31.08.1986: Specialty training in Neurology, Department of Neurological Diseases, Central
University Hospital, Tbilisi, Georgia
01.11.1988 – 01.11.1991: Postgraduate Doctoral Study, jointly in Tbilisi State Medical University and
Beritashvili Institute of Physiology
24.09.1993 – PhD Degree. Thesis: “Experimental use of perfluorochemical gas-carrying blood substitute
during acute brain ischemia” (in Georgian, Eng. abstr). Tbilisi, 1993, 254p. See # 25 in:
http://www.nplg.gov.ge/ec/en/dis/catalog.html?pft=biblio&from=21&rnum=10&udc=616.8
Patents:
In the field of drug development:
1) EU, USA: WO 0066096, New Indication for Use of Antiepileptic Agents and Medicines.
http://www.wipo.int/pctdb/en/wo.jsp?wo=2000066096
2) Georgia:
P 2487, New indication for 5-carbamoyl-5H-dibenz(b,f)azepine, its derivatives and analogues
P 2612, New indication for use of antiepileptic agents and medicines
Language skills: English, Russian, Georgian, Mingrelian.
Computer skills: SPSS for Windows, MS Word, Excel, PowerPoint, Adobe Photoshop, web-design
Pharmacovigilance experience:
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risk assessment risk management, risk minimization plans, medical input into PSURs and
other periodic reports, ICRs and aggregate data review
medical and scientific expertise for regulatory documents
coordination of AE and SAE activities for assigned projects
adhering to current regulations and FDA, EMEA and ICH guidelines relating to ADR monitoring
AE and ADR reporting plans for National Drug Monitoring Center of Pharmacovigilance and
Georgian Drug Agency
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-
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management of case-handling process, medical and scientific analysis and review of AE reports
AE forms in hospitals and out-patients stations: instructions for the completion (CIOMS Form, etc.)
medical review of AE and SAE information received from research sites
preparing and submitting of expedited safety reports to pharmaceutical companies, ethic committees
and national regulatory authority (till 2004 - Pharmacological Committee of Georgia, Ministry of
Health)
SUSAR and annual reporting review for clinical trials
consulting of healthcare system authorities in pharmacovigilance
training of physicians and nurses concerning adverse event reporting
management of data entry into safety database, ARGUS, ARIS Global
generation of queries to sites for follow-up information for Georgian Drug Agency
presentations of AE reporting at hospital and pharmaceutical company meetings
Standard Operational Procedures (SOP) for Georgian Drug Agency
review of pharmacovigilance publications and information sources to keep updated on current
regulations
Therapeutic Area/Lab Experience:
Oncology - Phase III, IV, multi country
Diabetes - Phase III, IV, multi country
Bronchial Asthma, COPD - Phase III, IV, multi
country
Endocrinology - Phase III, IV, multi country
Neurology - Phase III, IV, multi country
Cardiology - Phase III, IV, multi country
Psychiatry - Phase III, IV, multi country
Transplantology - Phase III, IV, multi country
Urology - Phase III, IV, multi country
Infections - Phase III, IV, multi country
Viral Hepatitis - Phase III, IV, multi country
Clinical trials:
Links to registered clinical trials: http://www.clinicaltrials.gov/ct/search?term=Lomia&submit=Search
Reviewer of medical journals:
Respiratory Medicine, http://www.sciencedirect.com/science/journal/09546111
The Journal of Neurology, Neurosurgery, and Psychiatry, http://jnnp.bmj.com
Publications:
Dissertation: “Experimental use of perfluorochemical gas-carrying blood substitute during acute brain
ischemia” (in Georgian, Eng. abstr). Tbilisi, 1993, 254p. See # 25 in:
http://www.nplg.gov.ge/ec/en/dis/catalog.html?pft=biblio&from=21&rnum=10&udc=616.8
Articles in peer-review and international journals:
Lomia M. Bronchial asthma as neurogenic paroxysmal inflammatory disease: Do some antiepileptic drugs
have antiasthmatic properties? Medical Hypotheses, 2007, vol. 69, no. 4, pp. 858 – 859. http://www.medicalhypotheses.com/article/PIIS0306987707001454/abstract , or doi:10.1016/j.mehy.2007.02.004
Lomia M, Tchelidze T, Pruidze M. Bronchial asthma as neurogenic paroxysmal inflammatory disease: a
randomized trial with carbamazepine. Respir Med, 2006, vol.100, no.11, pp. 1988-1996.
http://www.resmedjournal.com/article/PIIS095461110600103X/abstract , or
doi:10.1016/j.rmed.2006.02.018
Lomia M, Chapichadze Z, Pruidze M, Platonov P. Efficacy of monotherapy with carbamazepine
and valproic acid in patients with bronchial asthma: Is asthma a neurological disease? The Internet
Journal of Neurology. 2005. vol. 4, no 1. http://ispub.com/IJN/4/1/6172
Books: 1 book, with co-authors (in Georgian), Articles in Georgian and Russian journals: 15 articles.
Abstracts of international conferences: 19 publications, Abstracts of Georgian conferences: 13
publications.
You can find more detailed version of my CV on web-page www.asthma.ge/author/index.html , and links to
my published papers and Internet scientific publications on my website www.asthma.ge .
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