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Dr. Larry Schlesinger Provides Expert Testimony to Texas Senate Health & Human Services Committee

Larry S. Schlesinger
Larry S. Schlesinger, MD, President/CEO of Texas Biomed

Larry S. Schlesinger, MD –

“Good morning and thank you Madam Chairman and your committee. I am the President and CEO of Texas Biomedical Research Institute, and I am here speaking on behalf of the Texas Healthcare & Bioscience Institute (THBI) which is the Texas public policy voice for the healthcare and bioscience industry. THBI’s membership consists of biopharmaceutical companies, research institutions, medical device companies, economic development entities and service companies providing unparalleled networking and synergy to effectively address the public policy needs of Texas’ growing life sciences community.

I am speaking to you today as an infectious diseases physician and an active scientist focused on airborne infections having worked closely with the NIH, BMGF and others for many years and through several infectious disease threats.

Texas Biomed is one of the world’s leading independent biomedical research institutions dedicated to eradicating infection and is a proud partner with THBI. Texas Biomed is the only nonprofit research institute in the nation working exclusively on infectious diseases, delivering both independent and collaborative research that has translated into new discoveries, therapies and vaccines. Our mission is to protect you, your family and our global community from the threat of infectious diseases, which have never been at the forefront of our global consciousness as they are today.

I can’t start today without honoring the lives of those we have lost in this pandemic. We have all heard the numbers…nearly 23,000 people have died in the State of Texas alone. These are the citizens we weren’t able to save, but I would be remiss if I also did not acknowledge all those working on the front lines of this disease saving lives. Research and scientific progress only work with the nurses, doctors and other healthcare workers implementing what we learn.

Today, I want to share with you three key takeaways from this pandemic from the world of science. The first is that science is cumulative, building upon previous discoveries. We are able to make discoveries faster today based on the work years in the making. Two, science is collaborative and needs to remain so in order to attack the challenges of the future and three, infectious disease R&D and education must fundamentally change from Reactive to Proactive going forward with more investment of resources for maximal benefit.

As a community, we have learned that nothing shuts down our economy quite like a pandemic. While we have many health issues to address in our communities, infectious diseases impact us like no other. Every year for the past 30 years, a new disease has emerged. Due to globalization, air travel, animal human intersects, emerging and reemerging viruses will continue to be an issue. A British economist has predicted that by the year 2050, due in large part to drug resistance and increasing epidemics, infectious diseases will overtake heart disease and cancer as the leading cause of death in the world with an immense impact on the world’s economy. Science innovation and technology will help mitigate against this threat.

What took more than a decade to discover the hepatitis virus and months to discover the first SARS virus, took less than 2 weeks to discover the genetic blueprint of SARS-CoV-2. What took months and years with previous diseases, took Texas Biomed scientists just 6 weeks to establish validated large animal models needed to test safety and efficacy of COVID-19 therapies and vaccines. And, the work of scientists over the past several years on developing more powerful vaccine strategies against viruses, enabled scientists to quickly enact new science technology called messenger RNA to jumpstart a vaccine for this pandemic. There has been unprecedented lean in by global investigators, pharmaceutical companies, government entities and a fluid intersection between basic science researchers, animal modelers, clinicians, epidemiologists and clinical trial investigators all getting involved simultaneously. Because of years of prior research, scientists around the world were able to take our collective knowledge and develop therapies and vaccines in record time. This is what is driving innovation and delivering science to the market faster than ever before and we need to sustain this energy, drive and follow through.

It’s important to understand that early preclinical or basic research propels translational research – or research that makes it to our doctor’s offices in the form of medicine – by providing the basic understanding of disease and how our systems interact with the disease, and basic science provides the ability to test therapies and vaccines in various laboratory and animal models for safety and effectiveness.

Texas Biomed, in particular, quickly developed and validated the leading nonhuman primate animal model being used to test the safety and efficacy of current therapy and vaccine candidates this past Spring and also validated a small animal model for the virus to help screen for new therapies quickly, in partnership with the Bill & Melinda Gates Foundation. We were able to do this based on our longstanding expertise in developing animal models predictive of human responses. We also have an outstanding track record of working with industry partners and the FDA in helping bring therapies and vaccines to market. Because of this, the Institute currently has robust partnerships with several Operation Warp Speed companies such as Regeneron, Novavax, as well as partnerships with Pfizer, the National Institutes of Health, BARDA, Department of Defense and others (over 30 in total) and has amassed over $42M in contracts this year alone.

Perhaps you did not know that it was the data created in Texas Biomed’s animal models that propelled the clinical trials for the monoclonal antibody cocktail therapy created by Regeneron and given to the President and the Pfizer vaccine currently being reviewed by the FDA. Our science goes deeper than simply testing new therapies and vaccines but also creating innovative new approaches to vaccine and therapy development. I want you to know that I am confident in the science being created and the scientific process. I am confident that the FDA is fully examining the data it is receiving in a comprehensive and independent fashion to ensure that whatever interventions are approved (currently the 2 vaccines) have the rigor to back them up. I trust my colleagues at the NIH, CDC, and FDA who all want what we want, the tools we need to end this pandemic.

While the therapies we have to combat COVID-19, including the antibodies by Eli Lilly and Regeneron, are progress, they are still only helpful to small numbers of people. There are 570 new therapies in the pipeline from early discovery to clinical trials. The current therapy discovery pipeline is robust, and we need better therapies as a bridge to vaccination to help prevent deaths in those infected. With regard to vaccines, I am excited about their reported effectiveness to date and that distribution to those who need it most will begin soon. Having said this, there are still many unknowns. How long will they last? What will be their impact over time in different populations of the world? What about people who don’t respond to the vaccine or have a partial response? And most importantly, how effective will we be at educating the public to take the vaccine to achieve herd immunity? Research needs to continue. We need to move this science forward, and we must also prepare for unanticipated challenges in manufacturing and distribution over 2021. Despite these unknowns and challenges, I am hopeful that we will get past this pandemic and heartened by the magnitude of attention we are giving this issue.

This brings me to my last point. I do not believe that we have handled prior infectious disease threats properly and we have not learned from them enough. We can do better. We have not been adequately prepared. Reacting to a current threat will always put us behind and force us to play catch up. When previous threats have subsided so has public attention to the problem and resources. We need transformational change to a Proactive, sustainable approach. We need a new, more cohesive model going forward. This was articulated by our own President Bush in a presentation to the NIH in 2005 but never enacted. We need to get ahead of the next pandemic, because there will be a next time. And we need to be more aware and informed about the epidemics of the 20th century that are still with us. There is no cure for HIV yet. We have no vaccine for tuberculosis which kills 1.5 M people a year or for Malaria which is highly drug resistant and kills nearly ½ M people each year. These diseases have not gone away. They have only gotten worse with the singular attention on COVID-19. Closer to home, sepsis remains the #1 infectious disease killer in our hospitals.

Education of the public becomes the essential element for this pandemic. I understand HHS reported the first educational roll out late last week, and this is what is necessary in 2021 if we are going to see real progress. This need to occur at the national, state and local levels.

In closing, I was asked to share some best practices given all we know about COVID-19 to this point. I moved to Texas three years ago from Ohio for several reasons. As a state, Texas has tremendous resources, expertise and opportunity to lead in averting infectious disease threats.  Perhaps the state’s most effective weapon, however, is its spirit to band together and do what is right by our neighbors…wash your hands, wear your mask and stay physically distanced from others. These best practices are also steeped in science.

I do believe there is cause for hope and celebration at this critical juncture in the pandemic. As I said before, scientific, pharmaceutical, private and public partners have come together to take years of learning and produce ground-breaking innovations in record time. If we continue to invest in infectious diseases R&D in a Proactive manner, we can get ahead of the curve next time and if we ban together to educate our community about the benefits of scientific success, we will see an end to this and future pandemics.

Science is the true hero in all this. We just need to be prepared to support our hero moving forward. I thank you for the opportunity to share a bit about what we are learning in the scientific community and welcome any questions or comments.”