MARIANA (BOLOS) HENARY, M.D.
CURRENT TITLE: Consultant Scientist
Clinical Partners Group Global Life Science& Health Care Consulting
EDUCATION: MD Medical Degree in Medicine and General Surgery
Cairo University, Cairo, Egypt March 2003
Postgraduate Studies 2015-2017
Emperor College of Chinese Medicine
Postgraduate Studies. 2020-current
St. Athanasius& St. Cyril Coptic Orthodox Theological Studies
ADDRESS: 7289 Hightop St.
Moorpark, CA 93021
CITIZENSHIP: USA
adu90p@r.postjobfree.com
PROFESSIONAL PROFILE
+15 years Experience in Pharmaceutical Industry and sponsored clinical trials
+10 years Scientist with proven record and publications in Anesthesiology/ Cardiothoracic Surgery /Cardiovascular field.
+7years experience in heart failure, and cardio-metabolic diseases.
Served in several leadership positions at Veterans Affairs Medical Center R& D office and Baylor College of Medicine.
Numerous Publications to merit in peer review international journals (listed below).
Invited speaker to CME Morning Clinical Reports and Grand Rounds.
Assist in the safety management activities for Five Prime Sponsored Clinical Trials
Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
Working knowledge with at least one major safety database system (e.g. Argus, ARIS-g)
Assist with periodic reconciliation of SAEs between the drug safety and clinical trial databases for ongoing clinical studies
Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information
MD US Postdoctoral Fellowship, Cardiology Baylor College of Medicine.
Medical Residency in Anesthesiology Cairo, Egypt.
WORK EXPERIENCE
Consultant Scientist 2019-current
Clinical Partners Group Global Life Science& Health Care Consulting
Leading Medical Communications, Safety and Risk Management, Medical Information for third party vendors.
Assist with periodic reconciliation of SAEs evaluating the drug safety and clinical trial databases for ongoing clinical studies
Served as Senior Manager of Global Medical Affairs for Canadian vendors seeking US market.
Performed scientific literature review for off label drug use (Pain management and Anesthesiology)
Presents to the Medical Affairs team the responsibilities of each team member and the collaboration within and outside of the department.
Maintain thorough and up-to-date knowledge of disease state, clinical information, and product data within relevant therapeutic areas.
Drive strategic development of scientific materials to commercial and colleagues in academic teaching institutes.
Identified opportunities to partner investigators and practitioners on disease state or therapeutic initiatives.
Cardiology Clinical Trials Director July 2013
Michael E DeBakey VAMC R& D
Direct Report to Biymen Bozurt, MD Medicine Chief MEDVAMC Phone 713-***-****
Key Activities:
Played a key role in, regional advisory boards, patient advocacy forums, and medical education programs, and represent at meetings and conferences.
Principal investigator of investigator-initiated protocols, and Co-investigator for sponsored trials; sponsored by Procter& Gamble, GSK, Novartis, Amgen, Baxter, Boston Scientifics.
Execute contracts, develop budgets, provide regulatory oversight.
Monitor trials, run reports of the monitoring findings of investigator-initiated trials conducted at the VA.
Write protocols, review recruitment criteria, lab manuals and standard of operation.
Review and provide input on study protocols, statistical analysis plans, provide safety contents for regulatory filings. Review safety tables, figures, and listings from clinical studies.
Provide clinical/scientific input during the development and execution of clinical trials
Facilitated clinical presentations in a clear and effective manner to various healthcare professional and scientific audiences.
Perform Signal detection, evaluation, and management.
Participate in safety assessments and provide clinical input
Author Safety Assessment Reports and other safety documents and regulatory responses
Participate in interactions with regulatory agencies.
Author MOPs, publications and regulatory submissions
Instructor, 2013-2019
Presented series of lectures titled “Know Yourself Better” target audience, young women.
Lectured classes on neuroscience;
The difference of male and female brain.
Neuroscience of depression Stages of grief / ADD in adult females.
Studied open series of integrative medicine and functional medicine.
Attended Autism One Neuroscience Conferences in 2014 and 2018.
Master of Chinese Medicine program (Emperor ’s College of Traditional Chinese Medicine)
POSTGRADUATE TRAINING
Postdoctoral Fellow 07-2006 to 07-2013
Cardiology, Heart Failure Research
Baylor College of Medicine
Houston, TX USA
Mentor: Biykem Bozkurt, MD, Director Winters Center Heart Failure, Assoc. Director CVRI Baylor
Interviewed patients to determine eligibility for the clinical trial, educated the patients about the risk/ benefit ratio of participating, explained the predicted adverse events, consented research subjects, and conducted follow up.
Attended conference call for new cardiac devices and team meetings and investigators meetings.
Reviewed slide for future drug presentations and designed data collection software for genomic bank for heart failure patients.
Triage of incoming cases to prioritize for daily working flow management.
Completion of Case Data Entry
Preparation of SAEs, DREs, and assessing causality and ensuring reporting to the sponsor in timely manner according to GCP guidelines.
Working knowledge with major safety database systems ( e.g. Argus, ARIS-g)
Extensive working knowledge of MedDRA and WHODRUG coding dictionaries.
Ensure all ICON, sponsor and regulatory timeframes are met for the reporting of safety information.
Postdoctoral Fellow 09-2004 to 07-2006
Cardiothoracic Anesthesiology Research
Baylor College of Medicine
Houston, TX USA
Mentor: Salwa Shenaq, MD Chief of Anesthesiology
Involved extensively in the perioperative and intraoperative care on daily basis, attended Coronary Artery Bypass Graft, Valve Repair/ Replacement, observed postoperative flow in SICU.
Intern 07-2003 to 07-2004
University of Texas; Pediatric Anesthesiology, Orthopedic Anesthesiology, Oncology Pain Management
Worked with Janssen Pharmaceutical K.K. on developing new technology (Fentanyl Transdermal Matrix Patch of pain management in cancer patients
Mentor: Samia Khalil, MD
Medical Resident 03-2002 to 11-2003
Cairo University, Cairo, Egypt
Full scope of medical practice
Primary responsibilities include examining patient to determine the type of anesthetic needed, administer and manage according to standard of care, communicating all relevant information to the appropriate medical practitioners, and administering local, intravenous, or spinal anesthetic to the patient. Other duties may include recording the type and amount of anesthesia administered, maintaining the patient’s vital life functions through continual monitoring and assessment during surgery.
Observer 1-2006 to 3-2006
Michael E DeBakey VAMC
CCU (Coronary Care Unit)
Attended morning reports, CME lectures, discussed cases with resident/ fellows and attending physicians.
Observer 11-2008 to 1-2009
Michael E DeBakey VAMC
Internal Medicine/ Cardiology
Attended inpatient rounds/ observed conducting inpatient consults, admissions and discharge.
Observer 5-2003 to 7-2003
University of Texas
Pediatric Anesthesiology, Orthopedic Anesthesiology
Obtained preoperative sheet, conducted patient assessment, and intraoperative procedures related to protocols.
HONORS/ AWARDS
The First Project Award in neurophysiology& Neuroscience sponsored by Cairo University-
Department of physiology, Cairo University
US MEDICAL LICENSE ECFMG CERTIFICATE
USMLE Step CS (Clinical Skills) 11/2009
USMLE Step 2 CK (Clinical Knowledge) 09/2009
USMLE Step 1 06/2008
PUBLICATIONS/ PRESENTATIONS:
In children with obstructive sleep apnea, does caffeine decrease postoperative airway and respiratory complications after general anesthesia for tonsillectomy and adenoidectomy?
Khalil SN, Bolos M, Lingadevaru H, Chuang A.
ANESTHESIOLOGY, September 2004
Does the modality of pain relief affect early postoperative hypoxemia during transport to and recovery in the PACU?
Khalil SN, Bolos M, Lingadevaru H, Maposa D, Chuang A.
ANESTHESIOLOGY, September 2004.
A double-blind comparison of intravenous ondansetron and placebo for preventing postoperative emesis in 1- to 24-month-old pediatric patients after surgery under general anesthesia
Khalil SN, Roth AG, Cohen IT, Simhi E, Ansermino JM, Bolos ME, Cote CJ, Hannallah RS, Davis PJ, Brooks PB, Russo MW, Anschuetz GC, Blackburn LM.
Anesthesia & Analgesia 2005 Aug;101(2):356-61
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16037143&query_hl=1&itool=pubmed_docsum
Caudal Regional Anesthesia, Ropivacaine Concentration, Postoperative Analgesia, and Infants
Samia Khalil, MD, Hemanth Lingadevaru, MD, Mariana Bolos, MD, Mary Rabb, MD, Maria Matuszczak, MD, Douglas Maposa, MD, and Alice Chuang, PhD.
Anesthesia & Analgesia 2006 Feb;102(2):395-9.
http://www.anesthesia-analgesia.org/cgi/content/abstract/102/2/395
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16428531&query_hl=1&itool=pubmed_docsum
Impact of Alpha 1-Adrenergic Antagonist Use for Benign Prostatic Hypertrophy on outcomes in Patients With Heart Failure.
DhaliwalA,Habib G, DeswalA, Verduzco M, Souchek J,, Ramasubbu K, MDab, Aguilar D, Ma T,, Jneid H, Bolos M, Bozkurt B,. The American Journal of Cardiology. 2009 Jul; 104(2): 270-275.
New insights into mechanisms of action of carvedilol treatment in chronic heart failure patients--a matter of time for contractility.
Bozkurt B, Bolos M, Deswal A, Ather S, Chan W, Mann DL, Carabello B.
J Card Fail. 2012 Mar;18(3):183-93. doi: 10.1016/j.cardfail.2011.11.004. Epub 2011 Dec 22
Recurrent low-level Troponin I elevation is a worse prognostic indicator than occasional injury pattern in patients hospitalized with heart failure.
Ather S, Hira RS, Shenoy M, Fatemi O, Deswal A, Aguilar D, Ramasubbu K, Bolos M, Chan W, Bozkurt B.
Int J Cardiol. 2013 Jun 20;166(2):394-8. doi: 10.1016/j.ijcard.2011.10.113. Epub 2011 Nov 25.
PMID: 22119115 [PubMed - in process]
Does Intraoperative TEE Measurement of the Aortic Annulus Correlate with the Size of the Implanted Aortic Prosthesis?
Prasad Atluri, M.D., Sheela S. Pai, M.D., Mariana Bolos, M.D., Joseph Huh, M.D. Faisal Bakaeen, M.D., Salwa A. Shenaq, M.D., MBA, CPE
Department of Anesthesiology & Department of Cardiothoracic Surgery, Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine, Houston, Texas
Jordan Conference of Anesthesiology
In Children with Obstructive Sleep Apnea, Does Caffeine Decrease Postoperative Airway and Respiratory Complications after General Anesthesia for Tonsillectomy and Adenoidectomy?
S.N. Khalil, M. Bolos, H. Lingadevaru, A. Chuang
SPA Pediatric Anesthesiology 2005
http://www.pedsanesthesia.org/meetings/2005winter/man/2005%20P6_Khalil.pdf
Does the Modality of Pain Relief Affect Early Postoperative Hypoxemia during Transport to and Recovery in the PACU?
S.N. Khalil, M. Bolos, H. Lingadevaru, D. Maposa, A. Chuang
Society for Pediatric Anesthesia March 4-7, 2004
http://www.pedsanesthesia.org/meetings/2004winter/pdfs/2004_P25.pdf
In Children with Obstructive Sleep Apnea, Does Caffeine Decrease Postoperative Airway and Respiratory Complications after General Anesthesia for Tonsillectomy and Adenoidectomy?
Samia Khalil, M.D., Mariana Bolos, M.D., Hemanth Lingadevaru, M.B.B.S., Alice Chuang, Ph.D.
ASA Annual Meeting Abstracts 2004
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm;jsessionid=84DBFE57B6BAA39BFA9420CAF8287CA6?year=2004&index=16&absnum=1447