Chief Executive Officer

Julio is the co-founder and CEO of bioaccess.™ Julio believes that Colombia represents an untapped destination for early-feasibility first-in-human clinical research and for companies to first enter the Latin American market and sell their innovations. Since 2010, Julio has supported +100 Medtech to design and operationalize successful clinical trial, regulatory, and market access strategies in Colombia and other countries in Latin America. Julio writes a column at Med Device Online and Clinical Leader, where his articles have been "Featured Editorials" on several occasions. Julio is the host of the LATAM Medtech Leaders podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. He has been interviewed on Colombian TV by Hernán Orjuela —Colombia's most popular TV presenter— about his work helping American Medtechs succeed in Colombia.

In his earlier career, Julio worked at the Johns Hopkins Hospital in Baltimore, MD as a technology consultant assigned to a project to improve the healthcare system in Trinidad & Tobago. Julio's earlier career includes regional roles for Lucent and Nortel, two of the leading global telecom and networking companies in the '90s. Julio has a bachelor's degree in electronics engineering from Saint Thomas University in Bogota, Colombia, and a master's degree in business administration (M.B.A.) from Western New England University in Springfield, MA. Read more.

Founder & Medical Advisor

Dr. Martinez-Clark is a world-renowned physician in Miami, Florida. Having earned his medical degree at Colombia’s acclaimed Universidad del Norte in the city of Barranquilla, Pedro traveled to Ohio’s Case Western Reserve University to begin his post-graduate medical training in Internal Medicine. Having excelled and made a name for himself in the northeast, Dr. Martinez-Clark placed into one of the United States’ most competitive Clinical Fellowships in Cardiovascular Disease (Cardiology), at Beth Israel Deaconess Medical Center, Harvard Medical School. At Harvard, he obtained further fellowship training in Interventional Cardiology, Endovascular Therapies and Vascular Medicine. During his stay at Harvard, Dr. Martinez-Clark participated in many clinical trials, research projects and started his involvement in medical device innovation. It would be no surprise that 8 years later, Dr. Martinez-Clark would become recognized, globally for excellence in medical care, research efforts and medical innovation contributions. In addition to caring for patients, Dr. Martinez-Clark works very closely with several public and private organizations with the common goal of improving the healthcare innovation ecosystem in South Florida. Read more.

Vice President of Operations

Monica leads the company's operations, logistics, accounting, human resources, and general corporate and project-related administrative matters. Monica has worked for global companies such as Alcatel-Lucent and Toshiba. Since 2013, Monica has been involved with a myriad of medical device companies to operationalize regulatory, clinical research, and market access/entry strategies in Latin America. Monica has a B.S. degree in computer sciences and graduate studies in business management from Universidad del Norte; the leading university in Colombia's Caribbean coast. Monica is based in Orlando, FL. Read more.

Director of Regulatory Affairs

Ana is our regulatory affairs expert and leader. She worked in different executive and leadership roles at Colombia’s regulatory agency —INVIMA— for over five years. She is a biomedical engineering university professor at Universidad Javeriana and Universidad de los Andes, two of the top private universities in Colombia. Ana is an external regulatory consultant for the Colombian operations of global companies such as General Electric, Omron Healthcare, Mindray, and others. She has a degree in chemical pharmacology; a master's degree in health economics & pharmacoeconomics; and certificate degrees in clinical epidemiology, good clinical practices & study monitoring, and pharmacovigilance. Ana is also the founder and CEO of Mahu Pharma, a Colombian company with licenses to cultivate cannabis for medicinal and scientific use and the manufacturing of raw materials for cannabis-based products. Ana is based in Bogota, D.C., Colombia.

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.