Regulatory Affairs Expert

Harvey has over ten years of experience in the pharmaceutical industry in Latin America, including five years in managerial positions for top global Pharma companies. Harvey has a deep knowledge of the regional biopharmaceutical sector and has ample experience obtaining marketing authorizations for new drugs and medical devices in several countries in the region. Harvey has had several Latin America regulatory affairs leadership positions at global Pharma companies including Bausch Health, Sanofi Aventis, Sanofi Genzyme, and Sanofi Pasteur. Harvey has been accountable for more than 105 new marketing authorizations including 86 drugs and 19 medical devices of all risk levels in 10 countries. Harvey's regulatory drug experience includes new chemical entities that include biologics and chemical synthesis products such as monoclonal antibodies, proteins, hormone analogous, vaccines, and other products with bioavailability and bioequivalence requirements. Harvey has been instrumental in the regulatory registration of Dupixent, Praluent, Somatuline, Dengvaxia, Lantus, Botox, Cerdelga, Cerezyme, and Synvisc, among others. Read more.

Regulatory Affairs Expert

Katherine is a medical device and in vitro diagnostic regulatory expert and has advised many foreign manufacturers on obtaining market clearance for their innovations in Colombia. Before bioaccess™, Katherine worked at Colombia's regulatory agency, INVIMA, where she import licenses for diagnostic reagents, medical devices, and investigational products for clinical studies. Katherine is an industrial microbiologist from Universidad Javeriana, one of Colombia's top three best universities. She also has a Master's degree in Quality Management and Integrated Systems from Universidad Santo Tomás in Bogotá, Colombia.

Financial Accountant

Daisy believes that corporate finance is an unexplored possibility that companies with good sales and poor allocation of resources need for their growth and long-term sustainability. Daisy works with bioaccess™ vendors, clients, and team members to develop and streamline processes for invoicing, accounts payables and receivables, payment management, general ledger, financial statements, budgets, forecasting, and financial reporting. Daisy has worked in the accounting and financial area since 2019 and has gained experience in real estate accounting, consulting, and clinical research companies. Besides advising companies in their accounting and finances, Daisy also provides consulting services to individuals who want to normalize their finances or file annual tax returns. During college, Daisy was recognized and awarded for having one of the top grades in Colombia's equivalent to the SAT Subject Tests. Daisy holds two bachelor’s degrees, one in business management and another in accounting, from Universidad del Atlántico, Barranquilla, Colombia. She speaks Spanish English and Portuguese.

Clinical Trial Manager

Sergio strongly believes that innovation and medical research are the best ways to impact the medical field significantly. He also recognizes the potential of innovative medical solutions in Latin America, where access to the most recent medical discoveries is an unprecedented opportunity to improve the population’s quality of life.

Early in his career, Sergio became involved in medical research and technology solutions to medical problems. His main area of interest became artificial intelligence, a tool to diagnose medical conditions. Before bioaccess™, Sergio worked in the medical affairs department at Novartis and as a general practitioner for Colsubsudio, one of the top healthcare companies in Colombia. Sergio is constantly broadening his skill set. He has taken courses in epidemiology and public health from the Imperial College London and various soft skills courses as he understands the importance of good communication skills. Sergio speaks fluent English, Spanish and German and is working on six projects, including degenerative disc disease, venous and artery diseases, and vascular access technologies. Sergio has an M.D. degree from Universidad de Los Andes, one of the top universities in Latin America.

Clinical Trial Associate

Jose has been interested in research since the beginning of his career and has worked right from his early stages with some of the best vascular surgeons in Latin America doing clinical research. He believes that research is a fundamental part of medicine and patient care. He thinks the impact of clinical research projects is to improve the physicians scope of work in almost all health fields and is also a way to achieve timely and effective treatments. Jose has supported the development of various research papers, the most important ones being: 1. Pulmonary embolism after hybrid therapy with endovascular laser ablation combined with polidocanol foam sclerotherapy: case report, Colombia, 2020. Awaiting for publication. 2. GOLDEN RATIO in diameters of veins common femoral, femoral and popliteal veins. Bogotá-Colombia, 2020. In data collection. 3. Post-sclerotherapy foam fibrosis rate: polidocanol vs lapirium hydrochloride. Bogotá-Colombia, 2020. In data collection. 4. Historia del síndrome postrombótico. Review, Colombia, 2022, In process. 5. Peritoneal tuberculosis: case report, Medellin-Colombia, 2022, in process.

Jose has been trained and certified in multiple courses including a wide variety of important skills such as neuropathic pain in primary care, blood transfusions, Basic Life Support (BLS) and inflammatory bowel disease. He is constantly learning and is able to adapt and learn from challenging situations, such as coordinating clinical trials and assisting in the management of complex projects for bioaccess.

Clinical Trial Manager

Laura is convinced that the development of new medical technologies allows physicians to offer the best care to patients with limited options when facing different pathologies. Laura is a Clinical Trial Manager at bioaccess™ –a contract research organization (CRO) that allows medical device companies to work hand in hand with investigators and sites in Latin America, to carry out clinical trials that seek to validate the safety and efficacy of medical innovations. Before bioaccess™, Laura worked in the inpatient ward for over two years, where she strengthened her knowledge and skills in patient care. Laura has an M.D. and epidemiology degree from Universidad del Rosario, one of the first medical schools in Colombia. She had a full scholarship during medical school, with an emphasis in medical an surgical specialties, and training in Radiology and Diagnostic Imaging during her internship.

Clinical Trial Associate

Juan has experience in regulatory affairs, new product launches, and cost-effectiveness analyses for new drugs in Latin America. His expertise includes systematic literature search, data collection and processing, and development of protocols and scientific articles in different research areas such as epidemiology, neurosciences, anesthesia, and public health. Juan worked as a consultant for different Colombian governmental entities such as the Colombian Ministry of Health, the Institute for Health Technology Assessment (IETS), and international organizations such as PAHO and UNICEF. Juan is a professor at Universidad de Los Andes, teaching young medicine students about creating research projects, the healthcare system, and neglected infectious diseases. At bioaccessTM, Juan's role is to support regulatory submissions for new medical device clinical trials. Juan has a strong interest in research, evidence-based medicine, and the use of new health technologies. Juan holds an M.D. degree from Universidad de Los Andes, one of the top universities in Latin America, and also holds a master's degree in HIV from Universidad Rey Juan Carlos in Spain. Juan is a candidate for a master's degree in epidemiology and public health at Universidad de Los Andes.