Jorge L Estrella M D

As the President and Chief Medical Officer at ESTERN Medical CRO Life Sciences, I am responsible for leading the operations of a prominent international Contract Research Organization (CRO) specializing in full life science clinical trials across the US-North America and Latin America/South America emerging markets. With local offices spanning two continents and operations in over twenty-two countries, we are experts in clinical trial development, including IND, NDAs, PMAs, and 510Ks, while managing trial phases I through IV for a diverse range of clients, including pharmaceutical, biotech, medical device, and medtech companies, as well as academia in various therapeutic areas such as cardiology, CNS, rare diseases, oncology, MRI/MRA diagnostic imaging, ophthalmology, interventional cardiology, and others. In my role, I am responsible for identifying and evaluating new and emerging scientific and clinical R&D platforms for biotech, pharmaceutical, and medical device companies, including those utilizing novel technologies. Additionally, I lead efforts in developing potential business collaboration alliances and partnership strategies that align with our company's strategic priorities, influencing the overall business R&D clinical strategy across all of our business units within the clinical research organization (CRO). My leadership and expertise are vital in guiding the organization towards continued success and growth, while maintaining our commitment to delivering exceptional clinical trial development services to our sponsors.

As a member of the Clinical Scientific Officer Advisory team at Julius Clinical ARO, I played a critical role in supporting the unique combination of scientific academia and research as part of the Clinical Research Organization. I provided invaluable expertise on diverse Phase III Cardiovascular IND & NDA projects, leveraging my extensive track record of clinical and regulatory strategic R&D experience to meet the needs of our Pharmaceutical sponsors and corporate clients. My contributions included drawing upon my extensive International network of scientific KOLs to provide comprehensive insights and recommendations, helping to drive the success of our clients' clinical trial programs. Through my efforts, I played an integral role in guiding our clients through the complex clinical and evolving regulatory landscape, ensuring that they remained compliant while maximizing their clinical trial results. Overall, my role as part of the Clinical Scientific Officer Advisory team at Julius Clinical ARO allowed me to leverage my expertise and experience to provide unparalleled support to our Pharmaceutical sponsors, helping to drive the success of their clinical trial programs and contribute to the broader advancement of cardiovascular research.

As the Senior Director of Clinical Development at the global clinical research department of EPIX Pharmaceuticals Inc. in Cambridge, Massachusetts, I was fortunate to lead two crucial drug development projects MS325, including Vasovist® on a global scale. Working alongside my management team, we successfully penetrated international & emerging markets & established the first clinical commercial agent in its class, gadofosveset trisodium. My responsibilities included overseeing the clinical & case studies of Vasovist®, which demonstrated the drug's effectiveness in enhancing the visibility of Cardiovascular blood vessels through Magnetic Resonance (MRI/MRA) imaging. Moreover, I led efforts to obtain clinical & regulatory approval for global marketing of Vasovist® in the United States & 34 other countries, paving the way for the product's launch & commercialization. Reporting directly to the CEO & President at EPIX Pharma, I also collaborated with senior executives at Schering Pharmaceuticals AG & Berlex Laboratories Inc. (now Bayer Pharmaceuticals AG) on the development of EP-2104R. This imaging pharmaceutical aimed to enable the detection of blood clots using MRI. Through my experience at EPIX Pharmaceuticals Inc., I gained insights into the complexities of drug development in the life science industry. My track record of success in this role attests to my ability to leverage my expertise & extensive network to drive results that align with organizational priorities. Moreover, my contributions in this position demonstrate my proficiency in navigating the clinical & regulatory landscape & successfully launching products on a global scale. Overall, my work at EPIX Pharmaceuticals Inc. enabled me to play a significant role in developing novel drug therapies that can improve patient outcomes. As a life science executive, I remain committed to leveraging my expertise to drive results that align with industry priorities & drive innovation in the life sciences sector.

As the Senior Physician Director Clinical Trials Coordinator at Guidant Corporation Inc.'s Advanced Cardiovascular Systems (ACS) in Santa Clara, California, I was responsible for overseeing the clinical R&D implementation, support, and development of implantable Class III Medical Devices Stent trials in interventional clinical development for cardiovascular, renal, and peripheral arteries. My international clinical responsibilities included leading trials for the RX HERCULINK® Stent platforms, which culminated in the development of the first global Renal & Peripheral Stent system platforms. Throughout my tenure at Guidant, now known as Boston Scientific Inc & Abbott Vascular, I worked closely with a team of KOLs physicians, clinical research associates, and key stakeholders to ensure the successful execution of these trials. As the Senior Physician Director Clinical Trials Coordinator, I was responsible for developing and implementing clinical R&D protocols, managing study timelines and budgets, and ensuring compliance with regulatory agency requirements. Additionally, I oversaw the clinical development of training materials and provided training to clinical site staff and internal teams. My role also involved managing relationships with key opinion leaders (KOLs) and physicians, as well as collaborating with cross-functional teams including marketing, regulatory affairs, and R&D to ensure alignment on clinical trial objectives and study designs. Overall, my experience at Guidant Corporation Inc.'s ACS division equipped me with the expertise and skills necessary to effectively manage and oversee complex clinical trials in the medical device industry, specifically in the life science interventional cardiology space.

As the Senior Director of Clinical Research at Janssen Pharmaceuticals, Inc, I was responsible for overseeing all aspects of clinical research and R&D operations and business management in the fields of cardiovascular, CNS, and oncology for phases II, III, and IV clinical studies. One of my key achievements during my tenure at Janssen was working on the international clinical CNS development of RISPERDAL® (risperidone) and antipsychotic drugs used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder. I played a key role in the medical clinical research development department, which led to the successful approval of this novel global Phase III compound by the US-FDA, EU, and other global regulatory agencies. My responsibilities included managing clinical trials, developing and implementing protocols, ensuring regulatory compliance, overseeing data analysis, and providing medical oversight for clinical studies. I also collaborated with cross-functional teams, including biostatistics, regulatory affairs, and clinical operations, to ensure timely and efficient execution of clinical trials. Through my leadership and strategic planning, we successfully completed multiple clinical studies that led to the approval of RISPERDAL® and other novel compounds. I also provided scientific and medical expertise to support business development opportunities and partnerships, contributing to the growth of Janssen's clinical research portfolio. Overall, my experience as a Senior Director of Clinical Research has given me a strong foundation in clinical research and development, as well as expertise in the regulatory landscape of pharmaceuticals.