Increasing More Opportunities for Better Treatment – A conversation with Dr. Charles Schmidt
Jun 01, 2021
As Tigermed is rapidly moving forward to the world stage, Latin America is becoming an essential part of Tigermed’s global branding and strategy. Leveraging our regional expertise in this emerging market is an imperative step to initiating our journey.
Dr. Charles Schmidt, a senior leader with an extensive background in medical research, recently joined Tigermed and was appointed as Head of Latin America to establish capabilities and teams in this region to expand our global collaborations.
For 30+ years of his professional career, Charles has been successful in both the clinical industry and academic sector. He was a physician and professor at Santa Casa Medical School of Sao Paulo (one of the most prestigious medical schools in Brazil), founder of the Brazilian Association of CROs, and VP of the Brazilian Association of Pharmaceutical Physicians. He also served in leadership roles for 20+ years at several global CROs.
As a healthcare professional in Brazil, Charles leads many social and community initiatives, along with many other medical experts, to raise disease prevention awareness and encourage people to face the current pandemic together.
We recently had an engaging conversation with Charles, an experienced leader who speaks four languages and wears many hats from academy to business, to discuss his vision regarding Tigermed’s Latin America strategy and how to bring innovative products to patients.
Charles: So far, our most important advances are that we onboarded experienced senior staff and identified the local CROs that can act as strategic partners. These have already helped us move our current projects forward, especially the regulatory process. We are also working closely with them on local recruitment, e.g., CRAs and CTAs, which are in high demand during the pandemic, to provide the high-quality monitoring we need in the region. Another ongoing effort is the set-up of Tigermed’s legal in principal Latin American countries to comply with local regulations and increase our opportunities for talent acquisition and business development.
Charles: Latin America’s main advantages in clinical development are the outstanding capabilities for patient recruitment, generation of high-quality data, engagement KOLs dedicated to studies, and population diversity. All of which are key to running a successful clinical trial nowadays.
Besides almost 25 years of experience in clinical research following ICH guidelines and GCP, the region is recognized to have important regulatory agencies like ANVISA, ANMAT, COFEPRIS, INVIMA, ISP, and Ethics Committees. Together, these definitely validate the high standards of conducting clinical studies in Latin America.
We expect that more global pharma, biotech, and medical device companies will explore our region, as we have big players in this market segment like Brazil and Mexico. Additionally, we see needs regarding Data Management, Statistics, Medical Writing, Pharmacovigilance, Decentralized Clinical Trials including E-sites, and the provision of specialized and trained coordinators to sites here. Since we intend to support these needs in the future, it is a great opportunity to establish a new team dedicated to providing best-in-class solutions to patients, healthy volunteers, site staff and investigators.
Charles: Well, I’ve accumulated my experience since college. I graduated in medicine and completed a master’s and Ph.D. in infectious disease at a young age. After that, I saw an opportunity in the pharmaceutical industry, opening up my mind to clinical research and medical affairs, which were essential to my career. At that time, the regulatory framework had not yet been very well established, and I had the chance to experience the full development of our local health authorities. I was involved in the adoption of ICH guidelines and the creation and management of educational programs to train new researchers. During that time, many new requests to collaborate came in, not just from Brazil but from overseas as well. Of course, this provided great opportunities for networking locally and globally, increase business, and support our regional teams in their career development. I’m confident all these aspects are valuable to us again now that we are establishing a brand-new team and build solid collaboration between countries.
Dr. Charles Schmidt (Left) together with former President of Brazil Fernando Henrique Cardoso (Right) during a social initiative on COVID-19.
Charles: There are established and well-known companies in Latin America’s pharmaceutical industry, especially in Argentina, Brazil, and Mexico. For the past two decades, they have been developing generics and bringing innovative products to market. Still, they have had difficulties moving forward most of the time due to a lack of experience and high costs. Now, we see the opportunity to integrate resources and partner with global companies, CROs and institutes so that local pharma companies can keep investing in research and producing new treatments and medical devices. This is excellent progress, and I hope Tigermed can be part of this unprecedented development and act as a reference model for these partnerships.
Charles: I think this is a crucial topic in the region, not just for Brazil, but for the total population in Latin America of about 650 million people. With challenges like poor sanitary conditions and healthcare professionals that are in need of the right medical supplies across the region. We hope to increase more opportunities for better treatment and lowering the health cost that is essential for a public and socialized medicine. Also, cultural integration creates better opportunities to learn from each other and leads to better practices in healthcare for all.
Charles: I would say to be a reference CRO for patients, healthy volunteers, investigators, local Health Authorities, and, of course, our sponsors. When I started in the CRO industry, these service providers were like statistical intelligence organizations telling you how to implement protocols. Now, CROs have evolved and drive solutions, provide on-site support, produce meaningful, high-quality data, and engage with their stakeholders throughout a study. A reference CRO means a clinical partner that its stakeholders and sponsors trust, pays attention to their needs, and provides information and solutions proactively, in a transparent, clear, and efficient way.
Click HERE for PDF version of this interview.