Expert in Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Expert ID: 733995 Canada
|Year: 1992||Degree: Post-Doctoral Fellow||Subject: Molecular Biology/ Biochemistry||Institution: University of Toronto|
|Year: 1989||Degree: Ph.D.||Subject: Proteomics- Pharmacy and Biochemistry (Summa Cum Laude)||Institution: University of Buenos Aires|
|Year: 1984||Degree: Master in Sciences (Summa Cum Laude)||Subject:||Institution: University CAECE, Buenos Aires, Argentina|
|Year: 1982||Degree: Bachelor of Sciences (Summa Cum Laude)||Subject:||Institution: University CAECE, Buenos Aires, Argentina|
|Years: 2017 to Present||Employer: Undisclosed||Title: Executive Director||Department:||Responsibilities: Founded in alliance with The Clinical Research institute of America to fulfill the needs for quality, unbiased education in the areas of Clinical Research. The company is located in beaming city of Toronto, Canada. Our professional team has in- depth experience in the Clinical Research Industry for the last 25 years. Provides graduates from Science, Health Care and other related professions and disciplines with the highest educational and industry standards in Clinical Research training. We are an independent institution that provides an unbiased approach to Clinical Research Education.
As the Director of Clinical Research I am responsible for developing strategies, plans and management of clinical studies. As a Project Leader I facilitate project team activities and provide backup to other Project Leaders and Clinical Research Staff on project teams. My duties involve the management, design and implementation of clinical development studies (Phases I through IV) ensuring that studies are carried out in accordance with the clinical development plan, regulatory requirements, GCPs/ICH and SOPs.
Study development, cost estimation and resources allocation and recruitment.
Protocol development and implementation; writing and reviewing technical documents, clinical study reports, and clinical sections of IND/NDA/BLA/ANDA, as well as manuscripts, training material, investigators’ brochures, and all other clinical and regulatory documents.
I also handle all Safety Data to be reported to regulatory health authorities and write safety summaries for my clients. Setup Pharmacovigilance program.
Other activities that I personally am responsible is Auditing Clinical Trials (GCP auditing), GxP pre-FDA/HPFBI auditing and CLIA certification/CAP certification auditing and implementation in Canada and the US. ISO 13485/14971
I am directly involved in training for auditors of Clinical Trials (GCP audit), training in GCP, monitoring procedures and training clinical investigators.
Marketing and client liaison, promotion of services and products, planning for future potential products and services. Market research and product development.
Liaison with Health Canada/FDA/ EMA
Some of the Training courses that we offer and I personally teach on site:
o Introduction to Clinical Research
o Good Clinical Practices, a global approach
o GCP audit procedures, How to prepare for a regulatory audit
o Monitoring Clinical Trials
o Clinical SOP writing
o GLP for Clinical Research
|Years: 2010 to 2018||Employer: Clinical Research Institute of America||Title: President and Head of Professional Development||Department:||Responsibilities:|
|Years: 2003 to 2013||Employer: AAPS Inc.||Title: Head of the Clinical Research Program||Department:||Responsibilities: • Responsible on the design and implementation of the Diploma Clinical Research Program at AAPS Canada (see program in aaps.ca)
• Responsible, author and instructor for Professional Development Programs: Clinical Research Audit, Monitoring, Clinical Trials, SOP in Clinical Research, GLP in Clinical Development, Good Clinical Practices a global approach, Introduction to Clinical Research.
|Years: 2000 to Present||Employer: Undisclosed||Title: Director||Department:||Responsibilities: Clinical Development of New Biological and Chemical entitites
Professional Training in Clinical Research
|Years: 1998 to 2000||Employer: Novartis Pharmaceuticals||Title: Senior Scientist- Clinical Research||Department: New Jersey, U.S. Research and Development Department||Responsibilities: Clinical development, Clinical Trials, Safety analysis, New Drug Application, Data analysis and report writing. Complete NDA for NCE in CNS - Epilepsy- Trileptal.
As Senior Clinical Research Scientist in the CNS department, I was responsible for all activities related to the clinical section of a NDA as well as management of a group of professionals. Some of the main tasks were as follows:
Preparation of the NDA (New Drug Application) documentation for submission to the FDA (Food and Drug Administration) and the EU
Protocol, case report forms, investigation brochures writing
Summary report writing (ISS),
Safety reports and safety analysis,
Efficacy analysis (ISE),
Safety Data analysis and conciliation of databases,
Final Clinical Trial Report writing. Responsible for writing and follow up of Named Patient Program.(special access program)
Responsible of Emergency Drug Release Program for a specific anti-epilepsy drug.
Participated in the submissions to regulatory authorities (HPB).
Recruitment & Direct Supervision of monitors
Conciliation of all documentation
Interaction with the FDA to respond to queries related to the specific submission.
Preparation of Clinical Expert reports to the EU for Global drug approval
Interaction with biostatistics and regulatory departments in the resolution, format and delivery of the NDA
Other activities included preparation of the electronic submission of the NDA, as well as design and development of internal database for the Clinical Trials Reports, and Summary reports as well as the entire part of the clinical NDA
Management and supervision of associates
|Years: 1996 to 1998||Employer: Consulting||Title: Pharmaceutical Consultant||Department:||Responsibilities: Consulted on a regular basis pharmaceutical clients on issues regarding clinical trials and drug development.|
|Years: 1992 to 1994||Employer: Ciba Geigy Canada Ltd.||Title: Clinical Project Manager||Department:||Responsibilities: Responsible for the overall management of Clinical Trials in adherence to GCP SOPs. Phases II and III
Project organization and management,
Planning and scheduling,
Planning and allocation,
Study cost estimation.
Protocol design and writing.
Selection of investigators and centers,
Initiations, co-ordination and close supervision of Monitoring Activities.
Training of Monitors, Investigators and coordinators, in GCP’s and trial management
Data management and resolution,
Data analysis and report writing.
Handling of Serious Adverse Experiences SAE’s.
Interacted with Basel head office and Canada and participated in international project teams.
CNS area diseases: Stroke, Head Trauma, Epilepsy, and Depression.
Design and writing SOP’s (Standard Operational Procedures)
|Years: 1989 to 1992||Employer: Scientific Laboratory Research||Title: Post-Doctoral Research Fellow||Department: Banting and Best Department of Medical Research||Responsibilities: Work was focused on the bio-analytical study of biological compounds to determine function and activity under specific circumstances. Basically, study of hormonal regulation of Adenylyl Cyclase by cDNA cloning, cell culture and DNA recombination, PCR amplification DNA sequencing and analysis. Design and development of new biochemical/molecular techniques.|
|Years: 1985 to 1989||Employer: Faculty of Pharmacy and Biochemistry, University of Buenos Aires||Title: Research Associate - Proteomics||Department:||Responsibilities: Work was focused in the analysis, determination and quantization of biomolecules by the state of the art technology. Protein Biochemistry (proteomics), Analytical method design, Chromatography (protein and organic compound purification, characterization and quantization by HPLC ) Amino acid analysis, Chemical Modification & quality control (HPLC, Spectral Analysis). Spectrophotometry (molecular spectral analysis, derivative analysis). Scale-up. Specific studies on Human Growth Hormone included secondary and tertiary structure analysis. Also responsible for running entire laboratory operations (teaching and research) under GLP’s, and performed all grant applications.|
|Academic Teaching Experience:
• Teaching Assistant, Faculty of Pharmacy & Biochemistry, University of Buenos Aires: Biological Chemistry II Biochemistry II, Physiology and Immunology. (1985-1989)
• Associate Professor: Metabolic Regulation, Faculty of Medicine, University of Buenos Aires (1988)
|Medical / Professional|
The following post-graduate studies were done in the period 1985-1988 at the University of Buenos Aires: Metabolic Regulation, Genetic Engineering, Non-Linear Equations analysis and regression, Molecular Immunology.
|Publications and Patents Summary|
Original papers: 5
|Other Relevant Experience|
|Computer Literacy: Extensive knowledge of the following programs/environments: Windows, Microsoft Office (PowerPoint, Microsoft Publisher, Microsoft Project, Outlook), MS Word, Adobe Professional, among others
|Spanish||Full working knowledge|