Dr. Jorge Estrella is an accomplished scientific physician executive, clinical development strategist, and entrepreneur with more than 25 years of experience leading global pharmaceutical, biotechnology, and medical device programs. As Founding President and Chief Medical Officer of ESTERN Medical CRO Life Sciences International Group, he oversees corporate strategy, scientific leadership, regulatory development, and international business expansion across the US, North America, and Latin America ecosystems.

Throughout his career, Dr. Estrella has successfully directed multidisciplinary clinical development programs spanning Phases I–IV, supporting innovative therapies, diagnostics, medical devices, and imaging technologies. His expertise includes cardiovascular medicine, CNS disorders, infectious diseases, vascular intervention, and advanced radiological imaging.

Prior to founding ESTERN Medical, Dr. Estrella served in senior clinical development leadership roles at EPIX Pharmaceuticals. There, he contributed to the advancement of groundbreaking molecular imaging technologies and played an important role in the development and commercialization of Vasovist® (gadofosveset trisodium), the first FDA-approved MRI blood-pool contrast agent for vascular imaging. He also supported programs focused on molecular imaging applications for thrombosis and cardiovascular disease.

Earlier, Dr. Estrella worked with Guidant ACS Corporation, contributing to the clinical development of innovative interventional cardiology and vascular technologies, including first-generation renal artery and biliary stent Herculink® platform systems. He additionally participated in CNS clinical development initiatives at Janssen Pharmaceuticals involving RISPERDAL® and related neuroscience programs.

Dr. Estrella earned his Medical Degree from the Autonomous University of Guadalajara (UAG) and completed postgraduate residency training in Internal Medicine and Infectious Diseases at the National Institute of Nutrition in Mexico City. He further enhanced his expertise through advanced studies in Clinical Pharmacology and Drug Development Regulation at Tufts University.

Robert Morgan serves as Head of Scientific Regulatory, Legal Affairs & Quality at ESTERN Medical CRO Life Sciences Group and has been a valued member of the Corporate Scientific Advisory Board since 2009. With more than 30 years of international experience spanning regulatory affairs, drug development, quality systems, legal affairs, and clinical research, he brings exceptional leadership and strategic expertise to pharmaceutical, biotechnology, and medical device development programs worldwide.

Mr. Morgan possesses a unique combination of scientific, regulatory, and legal expertise, holding advanced degrees in Biophysics and Law. Throughout his distinguished career, he has successfully guided numerous regulatory submissions, including INDs, CTAs, NDAs, MAAs, 510(k)s, Special Protocol Assessments, Orphan Drug Applications, and Pediatric Development Programs across the United States, Europe, Canada, Latin America, Asia-Pacific, and emerging international markets.

Widely recognized for his contributions to regulatory innovation, Mr. Morgan was instrumental in submitting one of the first FDA-accepted electronic IND applications utilizing the Common Technical Document (CTD) format. His expertise extends from early-stage development strategy and clinical trial design through regulatory approvals and commercialization.

His executive leadership experience includes senior positions with Verastem Oncology, Immunome, Samus Therapeutics, ZIOPHARM Oncology, EPIX Pharmaceuticals, Genzyme, Serono, DuPont Pharmaceuticals, and PAREXEL International. In addition to his industry leadership, Mr. Morgan serves as an educator and mentor in regulatory affairs, quality systems, and drug development. He is an active member of multiple professional organizations and is recognized throughout the global life sciences industry for his contributions to regulatory science and healthcare innovation.

As Senior Director of Clinical Operations at ESTERN Medical CRO Life Sciences Group, Claudia M. Hernandez Castro provides executive leadership for clinical research programs across the United States and Latin America. Since joining the organization in 2008, she has been instrumental in advancing ESTERN Medical’s operational capabilities and supporting sponsors through all phases of clinical development.

Mrs. Hernandez brings more than 25 years of experience across clinical research, medical devices, healthcare operations, and diagnostic imaging. Her professional expertise encompasses cardiology, pulmonary medicine, central nervous system disorders, vascular medicine, and advanced MRI and CT imaging technologies.

Prior to ESTERN Medical, she held leadership positions with Siemens Medical Solutions, Schering AG Pharmaceuticals, and Medrad, Inc. (Bayer), where she led regional clinical training and physician education initiatives supporting groundbreaking imaging technologies, including MRI, cardiovascular, and multislice CT platforms.

Recognized for her strategic leadership and commitment to operational excellence, Mrs. Hernandez combines extensive clinical knowledge with a practical understanding of healthcare systems and clinical trial execution. She holds a Bachelor of Science degree in Clinical Physical Therapy and advanced graduate training in Diagnostic Imaging Sciences, bringing a comprehensive perspective to clinical research, healthcare innovation, and patient-centered development programs.

Dr. Fabricio Tello serves as Director of Medical Affairs and Pharmacovigilance for ESTERN Medical CRO Life Sciences Group, where he oversees medical strategy, pharmacovigilance operations, drug safety initiatives, and scientific support activities across clinical development programs. With more than 30 years of experience in the pharmaceutical and life sciences industry, he brings a wealth of expertise in clinical research, medical affairs, regulatory compliance, and patient safety.

Throughout his career, Dr. Tello has held senior medical leadership positions with globally recognized organizations, including Bayer Pharmaceuticals and Novo Nordisk. His professional accomplishments include leading regional pharmacovigilance programs, implementing comprehensive risk management strategies, supporting medical monitoring activities, and guiding healthcare professional education programs across multiple international markets.

His therapeutic expertise spans diabetes, obesity, cardiovascular disease, oncology, diagnostic imaging, and specialty pharmaceutical products. Known for his ability to combine clinical insight with strategic leadership, Dr. Tello has contributed significantly to the successful development, approval, and lifecycle management of numerous healthcare innovations.

Dr. Tello received his Medical Doctor degree from the University of Antioquia in Medellín, Colombia, and pursued postgraduate studies in Health Administration at Pontificia Universidad Javeriana. His additional academic training in Molecular Biology, Physiology, Biochemistry, and Molecular Genetics further strengthens his scientific and clinical expertise in supporting global life sciences development programs.

Dr. Hernán Darío Hernández serves as Director of Latin America Operations for ESTERN Medical CRO Life Sciences Group, where he provides strategic leadership, operational oversight, and execution support across the region. Since joining ESTERN Medical in 2006, he has played a central role in strengthening operational capabilities and expanding the organization’s clinical research footprint throughout Latin America.

With a diverse background spanning the healthcare system, governmental institutions, and the life sciences industry, Dr. Hernández brings a strong combination of clinical understanding, operational discipline, and strategic execution. His career has focused on supporting multinational clinical development programs and optimizing regional delivery for pharmaceutical, biotechnology, and medical device sponsors.

Prior to ESTERN Medical, he held clinical and administrative roles within public healthcare institutions in Colombia and Spain, gaining valuable international experience across different regulatory and healthcare environments. This background enables him to effectively navigate complex operational frameworks across both emerging and established markets.

Dr. Hernández is recognized for his expertise in regional operations management, healthcare system coordination, and cross-border clinical execution. His leadership continues to strengthen ESTERN Medical’s mission to deliver high-quality clinical research services across Latin America.

Rodolfo Diaz serves as Director of Healthcare Life Sciences Business Development & Commercialization Strategy at ESTERN Medical CRO Life Sciences Group, where he leads strategic partnerships, commercialization planning, and global market expansion initiatives across the United States and Latin America. He plays a central role in connecting innovation across pharmaceutical, biotechnology, medical device, diagnostics, AI healthcare, and CRO sectors.

He is a Biomedical Engineer with Pre-Medical studies from Universidad Iberoamericana (UIA) and brings more than 25 years of international experience in healthcare commercialization and business development. His career includes senior leadership roles at Siemens Healthineers, Bayer Pharmaceuticals, Schering AG, and Medrad, Inc. (Bayer Radiology).

Mr. Diaz was a key contributor to the creation and growth of Medrad’s first Latin American subsidiary, where he supported early-stage market entry, commercial execution, product launches, and long-term regional expansion strategies. He also helped integrate cross-regional commercial operations between Latin America and the United States.

He possesses deep expertise in healthcare commercialization, strategic alliances, product lifecycle strategy, market development, and stakeholder engagement across complex international healthcare ecosystems, with experience spanning cardiovascular, CNS, oncology, imaging, and interventional technologies.

Carmen Serfezi is a seasoned senior executive and global healthcare strategist with more than 35 years of experience leading healthcare sales, marketing, business development, and operational organizations across Europe, Asia, the Middle East, and Latin America. Holding an MBA, she is widely recognized for her entrepreneurial mindset, international leadership capabilities, and proven ability to transform complex business challenges into sustainable growth opportunities.

Throughout her distinguished career, Carmen has successfully recruited, mentored, and led senior executive management and cross-functional teams across the Netherlands, Germany, Italy, France, the United Kingdom, Scandinavia, China, the Russian Federation, the Middle East, Southeast Asia, and Latin America. Her exceptional intercultural communication skills have enabled her to establish and strengthen strategic partnerships throughout Europe, Asia, and emerging global healthcare markets. She is fluent in English, German, and Romanian.

Her executive expertise spans strategic and tactical planning, business entrepreneurship, leadership development, business development, mergers and acquisitions, healthcare commercialization, global market expansion, and international distribution network development.

Among her most significant accomplishments is her 25-year tenure as a member of the Senior Executive Management Team at Medrad Inc., a global leader in MRI/MRA, CT, and angiography medical technologies that later became part of Bayer Radiology & Interventional. Carmen also founded and led S&C Enterprises Ltd. in Cyprus, delivering healthcare product solutions to quality-focused healthcare providers. In addition, she co-founded The Mikan Group LLC in Pittsburgh, supporting emerging medical device companies in bringing innovative technologies to international markets.

As a member of the Executive Advisory Board for Healthcare International Life Science Expansion at ESTERN Medical CRO Life Sciences, Carmen provides strategic guidance supporting global growth, healthcare innovation, and international market development.

John Adams, PhD, is a senior Life Sciences executive recognized for integrating scientific innovation, healthcare technology, business strategy, and global market development. His professional career spans Biotech, Pharmaceutical, Medical Device, and CRO sectors, supporting organizations in advancing clinical research, accelerating R&D pipelines, and achieving sustainable growth.

As Head of Scientific & Senior Business Development Life Sciences at ESTERN Medical CRO Life Sciences, John drives strategic business expansion across the United States, North America, and Latin America. He works with biotechnology companies, pharmaceutical sponsors, medical technology organizations, and CRO partners to develop clinical research opportunities, strategic alliances, and commercialization pathways.

His previous leadership experience at Bayer Pharma included supporting international pharmaceutical development initiatives, operational strategies, and global healthcare partnerships. John’s expertise encompasses clinical trials Phases I–IV, regulatory development, CRO operations, strategic partnerships, market access, and Life Sciences GTM execution.

With a foundation combining engineering, science, and executive management, John completed Biomedical Engineering studies at Stanford University and advanced business education at Harvard Business School. This multidisciplinary education has enabled him to successfully connect emerging healthcare technologies with global business strategies.

As Associate Director, Business Development Life Sciences, Diana Rivera contributes a unique combination of commercial leadership, scientific knowledge, and international market experience to ESTERN Medical CRO Life Sciences. With over two decades of progressive success across healthcare sectors, she specializes in developing strategic partnerships, expanding business opportunities, and supporting organizations navigating complex development and commercialization pathways.

Diana has consistently demonstrated her ability to deliver outstanding results, generating significant revenue growth while building trusted relationships with executives, clinicians, healthcare organizations, distributors, and industry stakeholders. Her career includes leadership positions with respected organizations such as Cencora, Becton Dickinson, Medrad, Inc., Bayer Radiology & Interventional, and GlaxoSmithKline.

At ESTERN Medical, Diana collaborates with pharmaceutical, biotechnology, and medical device sponsors to identify growth opportunities, support regulatory initiatives, and develop customized solutions that strengthen clinical and commercial success across multiple international markets. Her expertise extends across oncology, diagnostics, infusion services, vascular care, specialty therapeutics, healthcare distribution, and business development strategy.

Diana earned her MBA in Marketing from the University of Phoenix and a Bachelor of Science in Biology and Medical Sales from Inter American University of Puerto Rico.

Michael Webb serves as Head of the Corporate Advisory Board for ESTERN Medical CRO Life Sciences Group. He is a seasoned biotechnology executive, board director, and strategic advisor with over 30 years of experience in pharmaceuticals, biotechnology, diagnostics, and healthcare innovation.

Mr. Webb has led multiple life sciences companies through clinical development, regulatory approval, commercialization, and corporate transformation. His expertise includes strategic growth planning, capital markets, M&A, and global business development.

He currently serves as Independent Chairman of Enveric Biosciences (NASDAQ: ENVB) and as President and CEO of Epion Therapeutics, where he leads the advancement of EpiSmart®, a next-generation ophthalmology treatment platform for corneal ectatic disease. Under his leadership, Epion has achieved major clinical and regulatory milestones and advanced toward commercialization.

Previously, he served as CEO of EPIX Pharmaceuticals, where he led global regulatory approvals, IPO execution, and international expansion of molecular imaging technologies. He also held senior leadership roles at CIBA Diagnostics (now Novartis) and served as a consultant with Booz Allen Hamilton.

Mr. Webb holds degrees in Biochemistry and Economics (University of Kansas), an MA in International Relations (University of Sussex), and an MBA from Northwestern University’s Kellogg School of Management.

Daniel Vazquez serves as Head of the Clinical Trials Regulatory Advisory Board for ESTERN Medical CRO Life Sciences Group. He is an internationally recognized regulatory affairs executive with over 30 years of experience in clinical development, regulatory strategy, drug development, and medical device innovation across global markets, including North America, Latin America, Europe, and other international regions.

Mr. Vazquez has led complex regulatory programs spanning pharmaceuticals, biotechnology, medical devices, diagnostics, and emerging healthcare technologies. His expertise includes global regulatory strategy, IND and CTA submissions, NDA filings, market authorization pathways, regulatory intelligence, and multinational clinical trial support across all phases of development.

Prior to ESTERN Medical, he spent over two decades in senior leadership roles at IQVIA and Quintiles, where he contributed to strengthening global regulatory operations and supporting sponsors through clinical development and approval processes worldwide.

He also served as Head of Regulatory Affairs for Latin America and Canada at Philip Morris International, leading regulatory policy, compliance strategy, and product registration initiatives across diverse regulatory environments. In addition, he is President of eHealth Solutions, a consortium focused on advancing healthcare innovation and clinical research development.

Mr. Vazquez is a former President and honorary founder of CAOIC and has served on the CAEME Clinical Trials Board. He holds a Pharmacist degree from the University of Buenos Aires and is widely recognized for his leadership in regulatory science and clinical research strategy.

Dr. Charles Schmidt, M.D. serves as Head of the Scientific Clinical & Medical Affairs Advisory Board for ESTERN Medical CRO Life Sciences Group. An internationally respected physician, clinical research executive, and healthcare strategist, he brings more than 30 years of leadership across the pharmaceutical, biotechnology, medical device, central laboratory, and Contract Research Organization (CRO) industries.

Throughout his career, Dr. Schmidt has held senior executive positions with globally recognized organizations, including Abbott Laboratories, Quintiles, PRA International, Medpace, Eurotrials, and Tigermed. His expertise spans global clinical development, medical affairs, clinical operations, strategic planning, outsourcing, and the successful execution of multinational clinical trials throughout North America, Latin America, Europe, and the Asia-Pacific region.

Dr. Schmidt also serves as Professor and Coordinator of the Postgraduate Clinical Research Program at the Faculdade de Ciências Médicas da Santa Casa de São Paulo, where he mentors future clinical research professionals.

As Founder and Former President of the Brazilian Association of CROs (ABRACRO), he has helped shape Brazil’s clinical research industry. He also serves as Director of the Brazilian Society of Pharmaceutical Physicians (SBMF) and is an active member of the DIA Latin America Steering Committee.

He earned his Medical Degree from the Faculdade de Ciências Médicas da Santa Casa de São Paulo, completed Master’s and Doctoral degrees at the Federal University of São Paulo (UNIFESP), and pursued postgraduate studies in Healthcare Management at the University of São Paulo (USP). His scientific, operational, and academic leadership provides exceptional value to ESTERN Medical and its global sponsors.

Dr. Juan E. Gutierrez serves as Senior Corporate Diagnostic Radiological Imaging Scientific Advisory Board Member for ESTERN Medical CRO Life Sciences Group. He is an internationally recognized neuroradiologist, physician-scientist, and clinical development executive with over 30 years of experience across diagnostic imaging, radiopharmaceuticals, oncology, cardiovascular medicine, CNS disorders, and global pharmaceutical development.

Dr. Gutierrez has played a key role in the development and commercialization of advanced imaging agents and radiopharmaceutical technologies, contributing to early- and late-phase clinical trials, imaging biomarker validation, regulatory strategy, and multinational study execution across global markets. His expertise spans clinical operations, medical affairs, investigator engagement, and translational imaging science.

He currently serves as Director of Medical and Scientific Affairs at RADMD, providing strategic leadership in imaging services and clinical research programs. Previously, he was Medical Director at Neurelis, Inc. and earlier served as Vice-Chair of Clinical Operations and Associate Professor of Neuroradiology at The University of Texas Health Science Center at San Antonio, where he contributed to academic research, clinical training, and imaging innovation.

Dr. Gutierrez also held senior leadership roles at Bayer HealthCare and Schering AG, where he directed global diagnostic imaging development programs involving major contrast agents, including Vasovist®, Magnevist®, Gadovist®, Ultravist®, Iopamiron®, and Dotarem®. He earned his MD from CES University in Colombia and completed advanced fellowships in Interventional Radiology at Jackson Memorial Hospital and Neuroradiology at Thomas Jefferson University.

Dr. John Amedio is an internationally recognized pharmaceutical development executive, CMC expert, and scientific advisor with over 30 years of leadership experience across biotechnology, pharmaceutical, and life sciences organizations. His expertise spans Chemistry, Manufacturing and Controls (CMC), process development, analytical sciences, manufacturing operations, regulatory strategy, and global commercialization.

As Head of Amedio CMC, he advises biotechnology and pharmaceutical companies on product development strategy, regulatory readiness, manufacturing scale-up, and commercialization planning. His guidance has supported the successful advancement of multiple development-stage and commercial therapies across global markets.

Prior to joining ESTERN Medical CRO Life Sciences Group’s Corporate Scientific Advisory Board, Dr. Amedio held senior leadership positions, including Acting Chief Manufacturing Officer at Samus Therapeutics, Vice President of CMC & Commercial Manufacturing at Corbus Pharmaceuticals, Senior Vice President of Technical Operations at ArQule (now Merck), and Vice President of Manufacturing & Process Development at Ziopharm Oncology. He also held scientific leadership roles at EPIX Pharmaceuticals and Sandoz Research Institute (now Novartis).

His technical expertise includes small molecules, peptides, oncology therapeutics, sterile and non-sterile manufacturing, formulation development, technology transfer, and global cGMP operations. He is widely recognized for bridging scientific innovation with operational execution and regulatory compliance in complex global development environments.

As a member of ESTERN Medical’s Scientific Advisory Board, Dr. Amedio provides strategic leadership in pharmaceutical development, manufacturing sciences, quality systems, and global regulatory strategy.