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Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL Cell Therapy) to…

Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205

About Regenerative Medicine Advanced Therapy (RMAT) DesignationEstablished under the 21st Century Cures Act, the RMAT designation was established to facilitate development and expedite review of cell therapies and regenerative medicines intended to treat serious or life-threatening diseases or conditions. Advantages include the benefits of the FDA's Fast Track and Breakthrough Therapy Designation programs, such as early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval.

About HDT-AHCT High-dose therapy and autologous hematopoietic cell transplantation (HDT-AHCT) is considered a standard-of-care therapy for patients with aggressive systemic Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).Although efficacious and considered a potential cure, HDT-AHCT is associated with severe regimen-related toxicities (SRRT) that increase patient morbidity and risk for mortality, especially in the aging population. Effective prevention of SRRT may lead to more patients being eligible for a potential cure through HDT and stem cell transplantation.

About SRRT Consequences of Diffuse Injury to the Organ Vascular NichesThe human body is capable of renewing, healing and restoring organs.For example, the human oral-GI tract renews its lining every 3 to 7 days. Both the organ renewal and healing processes are dependent on organ stem cell vascular niches made up of stem cells, endothelial cells (cells that line blood vessels) and supportive cells.When tissues are injured, the vascular niche endothelial cells direct the stem cells, via angiocrine factor expression, to repair and restore the damaged tissue. This restorative capacity is most active during childhood and youth but starts to diminish with increasing age.HDT provided to eradicate cancer cells also cause diffuse, collateral damage to vascular niches of multiple healthy organs. In particular, the organs with the highest cell turnover (ones with most active vascular niches) are severely affected.Specifically, the oral-GI tract, dependent on constant renewal of its mucosal lining, starts to break down upon vascular niche injury.The mucosal breakdown can cause severe nausea, vomiting and diarrhea. In addition, the bacteria in the gut may escape into the circulation, resulting in patients becoming ill with endotoxemia, bacteremia or potentially lethal sepsis.HDT-related vascular niche damage can also occur in other organs resulting in severe or life-threatening complications involving the lung, heart, kidney, or the liver.Collectively, these complications are known as severe regimen-related toxicities or SRRT.SRRT can occur as frequently as 50% in lymphoma HDT-AHCT patients, with increased rate and severity in older patients.

About AB205AB-205 is a first-in-class engineered cell therapy consisting of proprietary 'universal' E-CEL (human engineered cord endothelial) cells.The AB-205 cells are intravenously administered after the completion of HDT on the same day as when the patient's own (autologous) blood stem cells are infused. AB-205 acts promptly to repair injured vascular niches of organs damaged by HDT.By repairing the vascular niches, AB-205 restores the natural process of tissue renewal, vital for organs such as oral-GI tract and the bone marrow. Successful and prompt organ restoration can prevent or reduce SRRT, an outcome that is beneficial to quality of life and cost reductive to the healthcare system.

About CIRMThe California Institute for Regenerative Medicine (CIRM) was established in November, 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure provided $3 billion in funding for California universities and research institutions.With over 300 active stem cell programs in their portfolio, CIRM is the world's largest institution dedicated to stem cell research. For more information, visit http://www.cirm.ca.gov.

About Angiocrine Bioscience Inc.Angiocrine Bioscience is a clinical-stage biotechnology company developing a new and unique approach to treating serious medical conditions associated with the loss of the natural healing and regenerative capacity of the body.Based on its novel and proprietary E-CEL platform, Angiocrine is developing multiple therapies to address unmet medical needs in hematologic, musculoskeletal, gastrointestinal, soft-tissue, and degenerative/aging-related diseases.A Phase 3 registration trial is being planned for the intravenous formulation of AB-205 for the prevention of severe complications in lymphoma patients undergoing curative HDT-AHCT.This AB-205 indication is covered by the Orphan Drug Designation recently granted by the US FDA.In addition, Angiocrine is conducting clinical trials of local AB-205 injections for the treatment of: (1) rotator cuff tear in conjunction with arthroscopic repair; and, (2) non-healing perianal fistulas in post-radiation cancer patients.

For additional information, please contact:

Angiocrine Bioscience, Inc. John R. Jaskowiak (877) 784-8496 [emailprotected]

SOURCE Angiocrine Bioscience, Inc.

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Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL Cell Therapy) to...

Regenerative Medicine Market with Report In Depth Industry Analysis on Trends, Growth, Opportunities and Forecast till 2026 – Illadel Graff Supply

The latest report on Regenerative Medicine market collated by Market Study Report, LLC, delivers facts and numbers regarding the market size, geographical landscape and profit forecast of the Regenerative Medicine market. In addition, the report focuses on major obstacles and the latest growth plans adopted by leading companies in this business.

Request a sample Report of Regenerative Medicine Market at: https://www.marketstudyreport.com/request-a-sample/1695290?utm_source=illadelink&utm_medium=RV

The Regenerative Medicine Market is anticipated to reach over USD 79.23 billion by 2026 according to a new research. In 2017, the cell therapy dominated the global Regenerative Medicine market, in terms of revenue. North America is expected to be the leading contributor to the global market revenue in 2017.

The regenerative medicine market is primarily driven by the increasing number of individuals suffering from cancer, rising need to monitor and treating these chronic diseases in the limited time. Furthermore, stringent government policies, proper reimbursement policies, and increasing government healthcare expenditure for developing healthcare infrastructure to also boost the market growth in coming years. Also, rising number of organ transplantation, and increasing number of products in pipeline that are waiting for approval create major opportunity for the regenerative medicines in the coming years. However, some of the ethical and religious concerns for the use of stem cells, and lack of proper regulatory for the approval of various drugs would impede the market growth during the forecast period.

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North America generated the highest revenue in the Regenerative Medicine market in 2017, and is expected to be the leading region globally during the forecast period. Increasing number of patients suffering from chronic diseases, improved healthcare infrastructure and health facilities, accessibility of healthcare facilities, are the primary factors driving the market growth in this region. While, Asia Pacific to be the fastest growing region in the coming years. The growth in this region is majorly attributed to the developing healthcare infrastructure of the countries like India, & China, and rising awareness for the use of regenerative medicines as an effective treatment option for chronic diseases.

Regenerative medicine is a branch of medicine that regrows, and repairs the damaged cells in the human body. These medicines include the use of stem cells, tissue engineering, that further helps in developing new organ that function smoothly. These medicines have the caliber of developing an entire organ as these cells are multipotent. The cells are majorly isolated from bone marrow, and umbilical cord blood.

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The key players operating in the Regenerative Medicine market include Organogenesis Inc., Vericel Corporation, Osiris Therapeutics, Inc., Stryker Corporation, and NuVasive, Inc., Medtronic Plc., Acelity, Cook Biotech Inc., Integra LifeSciences, and C.R. Bard. These companies launch new products and collaborate with other market leaders to innovate and launch new products to meet the increasing needs and requirements of consumers.

Regenerative Medicine Market share byMajor regions included:

United States North America Asia Pacific Europe Middle East & Africa

Table of Contents

1. Overview and Scope 1.1. Research goal & scope 1.2. Research assumptions 1.3. Research Methodology 1.3.1. Primary data sources 1.3.2. Secondary data sources 1.4. Key take-away 1.5. Stakeholders 2. Executive Summary 2.1. Market Definition 2.2. Market Segmentation 3. Regenerative Medicine Market Insights 3.1. Regenerative Medicine Industry snapshot 3.2. Regenerative Medicine Ecosystem analysis 3.3. Regenerative Medicine Market Dynamics 3.3.1. Regenerative Medicine Market Forces 3.3.1.1. Regenerative Medicine Market Driver Analysis 3.3.1.2. Regenerative Medicine Market Restraint/Challenges analysis 3.3.1.3. Regenerative Medicine Market Opportunity Analysis 3.4. Industry analysis Porters five force 3.4.1. Bargaining power of supplier 3.4.2. Bargaining power of buyer 3.4.3. Threat of substitute 3.4.4. Threat of new entrant 3.4.5. Degree of competition 3.5. Regenerative Medicine Market PEST Analysis 3.6. Regenerative Medicine Market Value Chain Analysis 3.7. Regenerative Medicine Industry Trends 3.8. Competitive Ranking Analysis 4. Regenerative Medicine Market Size and Forecast by Therapy Type, 2018-2026 4.1. Key Findings 4.2. Tissue engineering 4.3. Cell Therapy 4.4. Immunotherapy 4.5. Gene Therapy 5. Regenerative Medicine Market Size and Forecast by Product Type, 2018-2026 5.1. Key Findings 5.2. Acellular Products 5.3. Cellular Products

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Regenerative Medicine Market with Report In Depth Industry Analysis on Trends, Growth, Opportunities and Forecast till 2026 - Illadel Graff Supply

Leading Human Immunology and Infectious Disease Experts to Join UM School of Medicines Institute of Human Virology – Newswise

Newswise Baltimore, MD, November 12, 2020 Robert C. Gallo, MD, the Homer & Martha Gudelsky Distinguished Professor in Medicine at the University of Maryland School of Medicine (UMSOM) and Co-Founder & Director of the UMSOMs Institute of Human Virology (IHV), announced today that a team of leading scientists in human immunology, virology and stem cell biology, led by Lishan Su, PhD joined IHV on October 1 with academic appointments in the UMSOM Department of Pharmacology. As part of the Maryland E-Nnovation Initiative Fund (MEIF) to recruit top research faculty and a donation to IHV from the Charles Gordon Estate, Dr. Su has been named the Charles Gordon Smith Endowed Professor for HIV Research. Dr. Su will also head IHVs Division of Virology, Pathogenesis and Cancer.

The team will include a 12-person Laboratory of Viral Pathogenesis and Immunotherapy with two faculty appointments as well as major public and private sector research funding.

Dr. Gallo made the announcement in conjunction with University of Maryland School of Medicine Dean E. Albert Reece, MD, PhD, MBA and Margaret M. McCarthy PhD, James & Carolyn Frenkil Deans Professor, Chair of the Department of Pharmacology.

Dr. Su is one of the most successful active basic researchers in America, said Dr. Gallo, who is also Co-Founder and Chairman of the International Scientific Leadership Board of the Global Virus Network. His research is groundbreaking, and we are so pleased to have him join IHV and lead our Division of Infectious Agents and Cancer, which under his sound leadership, will flourish.

Dr. McCarthy added:Dr. Sus continuing ground-breaking work in HIV and Hepatitis B will be a huge asset to the Department of Pharmacology. I look forward to working with him on advances that could open the door to new therapeutics.

Dr. Su was a faculty member in the Lineberger Comprehensive Cancer Center and Professor in the Department of Microbiology & Immunology at University of North Carolina-Chapel Hill since 1996. He received his BS degree in Microbiology from Shandong University, his PhD degree in Virology from Harvard University, and did his post-doctoral training in Stem Cell Biology & Immunology at Stanford University. He worked as a senior research scientist at SyStemix/Sandoz (Novartis), focusing on HIV-1 pathogenesis and stem cell-based gene therapy in humanized mice and in patients.

I am excited to continue and expand my research programs at the Institute of Human Virology (IHV), said Dr. Su. I have long been impressed by the Baltimore-DC area's research centers with great basic and clinical research programs. IHV, co-founded and directed by Dr. Robert Gallo, is one of the first research institutes in the U.S. to integrate basic science, population studies and clinical trials to understanding and treating human virus-induced diseases. The Department of Pharmacology, headed by Dr. Margaret McCarthy, in the University of Maryland School of Medicine, has been outstanding in developing novel therapeutics including breast cancer drugs. I look forward to working with my new colleagues at IHV and the Department of Pharmacology, and across the University of Maryland School of Medicine, to expand and translate my research programs to treating human inflammatory diseases including virus infection and cancer.

Dr. Su has extensive research experience in human immunology, virology and stem cell biology. Dr. Su made important contributions to several areas of human immunology and infectious diseases, particularly in studying human immuno-pathology of chronic virus infections. His lab at UNC-Chapel Hill published important findings in identifying novel virological and immunological mechanisms of HIV-1 pathogenesis. Furthermore, his lab established humanized mouse models with both human immune and human liver cells that support HCV or HBV infection, human immune responses and human liver fibrosis. In recent years, Dr. Sus group discovered, and focused on, the pDC-interferon axis in the immuno-pathogenesis and therapy of chronic HIV & HBV infections. The group also started investigation of the pDC-IFN axis in tumor microenvironments and in cancer immune therapy.

Im so pleased to welcome Dr. Su to our faculty. His work advances the mission of the School of Medicine, which is to provide important new knowledge in the area of immunology and chronic disease to discover new approaches for treatments, said Dean Reece, who is also University Executive Vice President for Medical Affairs and the John Z. and Akiko K. Bowers Distinguished Professor. Dr. Sus stellar research capabilities will provide vital opportunities for collaboration across our Institutes and Departments.

About the Institute of Human Virology

Formed in 1996 as a partnership between the State of Maryland, the City of Baltimore, the University System of Maryland and the University of Maryland Medical System, IHV is an institute of the University of Maryland School of Medicine and is home to some of the most globally-recognized and world-renowned experts in all of virology. The IHV combines the disciplines of basic research, epidemiology and clinical research in a concerted effort to speed the discovery of diagnostics and therapeutics for a wide variety of chronic and deadly viral and immune disorders - most notably, HIV the virus that causes AIDS. For more information,www.ihv.organd follow us on Twitter @IHVmaryland.

About the University of Maryland School of Medicine

The University of Maryland School of Medicine was chartered in 1807 and is the first public medical school in the United States and continues today as an innovative leader in accelerating innovation and discovery in medicine. The School of Medicine is the founding school of the University of Maryland and is an integral part of the 11-campus University System of Maryland. Located on the University of Marylands Baltimore campus, the School of Medicine works closely with the University of Maryland Medical Center to provide a research-intensive, academic and clinically based education. With 43 academic departments, centers and institutes and a faculty of more than 3,000 physicians and research scientists plus more than $400 million in extramural funding, the School is regarded as one of the leading biomedical research institutions in the U.S. with top-tier faculty and programs in cancer, brain science, surgery and transplantation, trauma and emergency medicine, vaccine development and human genomics, among other centers of excellence. The School is not only concerned with the health of the citizens of Maryland and the nation, but also has a global vision, with research and treatment facilities in more than 30 countries around the world. For more information, visitwww.medschool.umaryland.edu.

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Leading Human Immunology and Infectious Disease Experts to Join UM School of Medicines Institute of Human Virology - Newswise

UB researcher narrows time window for administering specific treatment to infants with Krabbe disease – UB Now: News and views for UB faculty and…

A team of UB researchers has published a paper in Nature Communications that is helping to define the best time to give a specific treatment to infants born with Krabbe disease (KD). This treatment has been found to prolong life for these infants for as long as a few years.

The paper was published online in Nature Communication Oct. 23.

Daesung Shin, assistant professor in the Department of Biotechnical and Clinical Laboratory Sciences and the Neuroscience Program, both in the Jacobs School of Medicine and Biomedical Sciences at UB, is the lead investigator. He also conducts research at UBs Hunter James Kelly Research Institute.

KD is an inherited disorder that destroys myelin, the protective coating of nerve cells in the brain and throughout the nervous system. In most cases, signs and symptoms of Krabbe disease develop in babies before 6 months of age, and the disease usually results in death by age 2. When it develops in older children and adults, the course of the disease can vary greatly.

The progressive neurologic disorder is caused by a deficiency of galactosylceramidase (GALC). GALC is an enzyme that breaks down galactosylceramide, an important component of myelin, which ensures the rapid transmission of nerve impulses.

Although there is no cure for KD, hematopoietic stem cell therapy (HSCT), a therapy that makes blood cells, reduces neurologic deterioration and improves developmental advances. These benefits are dependent on the severity of the disease at the time the stem cells are transplanted, and are only beneficial if delivered at a clinically defined pre-symptomatic time point before symptoms appear.

Even though it is widely accepted that early treatment is essential for the most positive outcome, the precise therapeutic window for treatment and what happens during this early time have never been elucidated, Shin says.

To address that issue, his team used mutations to create a novel mouse model of KD.

We engineered an inducible knockout mouse for the GALC gene deletion in specific cells at specific times, which provided us with the opportunity to directly ask when and where GALC enzyme is required for brain development, Shin explains.

We were particularly interested in the role of early developmental GALC function, he says. Our study not only revealed a key developmental process that requires GALC in the perinatal period, but also demonstrated that temporal GALC expression is likely a major contributor to brainstem development.

The researchers found that by increasing GALC levels at or before this newly defined perinatal period they could improve the effectiveness of therapeutic interventions for KD.

For the first time, our work showed the mechanistic evidence to explain why treatment must occur so early, with the defined critical postnatal period at days 4-6 in mice, and demonstrated that temporal GALC expression during this time is a major contributor to brainstem development, Shin says. Augmenting GALC levels at or prior to this newly defined period would likely improve the efficacy of therapeutic interventions for Krabbe patients.

While the time scale between mice and humans is considerably different, the sequence of key events in brain maturation between the two is consistent, he notes. It was estimated that the mouse nervous system at postnatal days 4-6 corresponds to a gestational age of 32 weeks in humans. Therefore, we anticipate that if our result is correct, then in utero treatments at, or prior to, 32 weeks should have better outcomes than conventional postnatal treatment for Krabbe babies.

Shin says his team will further identify which cell type needs to be targeted with therapy.

This work will directly impact the design of novel treatment options for KD patients, he says, noting that KD studies are at the basis of research on other, more common neurodegenerative diseases, such as multiple sclerosis and Parkinsons disease. Therefore, the teams work will have implications beyond KD.

Co-authors on the research were Nadav I. Weinstock, MD-PhD student, and Conlan Kreher, former masters student, both of the HJKRI and the Department of Biochemistry in the Jacobs School; Jacob Favret, research technician in the Department of Biotechnical and Clinical Laboratory Sciences; Lawrence Wrabetz and M. Laura Feltri, both co-directors of the HJKRI and members of the departments of Biochemistry and Neurology, as well as the Neuroscience Program.

Duc Nguyen and Ernesto R. Bongarzone of the Department of Anatomy and Cell Biology in the College of Medicine at the University of Illinois at Chicago also participated in the research.

The project was initiated with the support from Empire State development fund for HJKRI, and further developed and finalized by the R01, R56 and R03 grants from National Institutes for Health-National Institute for Neurological Disorders and Stroke awarded to Shin.

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UB researcher narrows time window for administering specific treatment to infants with Krabbe disease - UB Now: News and views for UB faculty and...

FibroGenesis Announces the Filing of its 250th Patent for Fibroblast Cell Therapy Platform – PRNewswire

World Leader in Fibroblast Technology Advances Intellectual Property Position with their 250th Patent Filed Today.

"Our scientific team is creating new opportunities for this "super cell," commented Tom Ichim, Ph.D., Chief Scientific Officer of FibroGenesis. "Internal data and emerging third party validation, shows our proprietary universal donor fibroblast-based product outperforms existing approaches. Our broad intellectual property establishes FibroGenesis as the gatekeeper for anyone entering this space."

"As we continue to organically expand our intellectual property portfolio, we are humbled by the equally expanding clinical capabilities of this unique cell source," said Pete O'Heeron, Chief Executive Officer, FibroGenesis. "Our new clinical programs are providing evidence of a cell source superior to stem cells and our proprietary position gives us the protection to continue our growth."

About FibroGenesis

Based in Houston, Texas, FibroGenesis, is a regenerative medicine company developing an innovative solution for chronic disease treatment using human dermal fibroblasts. Currently, FibroGenesis holds 250 U.S. and international issued patents/patents pending across a variety of clinical pathways, including Disc Degeneration, Multiple Sclerosis, Parkinson's, Chronic Traumatic Encephalopathy, Cancer, Diabetes, Liver Failure and Heart Failure. Funded entirely by angel investors, FibroGenesis represents the next generation of medical advancement in cell therapy.

Visit http://www.Fibro-Genesis.com.

SOURCE FibroGenesis

http://www.Fibro-Genesis.com

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FibroGenesis Announces the Filing of its 250th Patent for Fibroblast Cell Therapy Platform - PRNewswire

FROM THE LABS: Hispanic Heritage Spotlight: Interview with Dr. Nino Rainusso – Baylor College of Medicine News

From the Labs sat down with Dr. Nino Rainusso, assistant professor of pediatrics hematology/oncology and a member of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine. Dr. Rainusso shared what inspired him to become a pediatric oncologist, his experience finding a research position in a Baylor lab and something few know about him.

I was born and raised in Per where I attended medical school at Universidad Peruana Cayetano Heredia. Early in my training I realized that if I wanted to better understand the medical conditions of my patients, I had to be involved in biomedical research. I wanted to become a physician-scientist in the field of pediatric neurology. This changed when I met my wife. Her brother had neuroblastoma, a common pediatric cancer that frequently develops in nerves associated with the adrenal glands located on top of the kidneys. When he died of the cancer, my career took a different path. Instead of spending my life as a pediatric neurologist, I became a pediatric oncologist.

During my rotations in medical school, I saw that doctors were exceptionally good at providing medical care for their patients but didnt have time to do research. That motivated me to come to the U.S. where I would have opportunities to continue my career as a physician-scientist.

After I completed my residency in general pediatrics at the University of Illinois at Chicago, I was accepted at Baylor for my fellowship in pediatric oncology. I dove into research in the second and third years. Having many patients with different types of tumors for which the treatment outcome has not significantly changed for the last 30 years meant that there was a wealth of research opportunities. One day, I attended a talk about cancer stem cells that inspired me to apply that approach to pediatric solid tumors.

I joined Dr. Jeff Rosens lab at Baylor. I liked his lab for its open-minded environment and collaborative atmosphere that many Baylor labs have.

I was not sure about what his response would be when I proposed to work in his group.

He has spent his entire life doing research in breast cancer and I, with little lab experience under my belt, was proposing to do research in osteosarcoma stem cells. Osteosarcoma is the most common bone cancer in children and young adults. I was expecting that he would try to change my mind, but instead he said, OK, welcome! I loved it! I am very grateful that I ended up working in Jeffs lab. He has been a wonderful mentor, and I learned a lot working in his group.

When it was time for me to have my own lab, I joined Dr. Jason Yusteins group at Texas Childrens Cancer & Hematology Centers. We took a new approach to study osteosarcoma. One limitation of studying this condition is working with cell lines, which do not seem to recapitulate most of the characteristics of tumors in patients.

We decided to generate patient-derived tumor xenografts models of pediatric sarcomas where the tissue from a patients tumor is implanted into immunosuppressed mice. These tumors closely resemble the characteristics of the original tumor allowing to have better understanding of cancer biology and to evaluate novel therapies.

We collaborate with other investigators to test new treatments such us immunotherapy in these xenograft models, which may put us a step closer to bringing more effective therapies to patients. I believe that our research would not be possible without the participation of multiple colleagues at Texas Childrens Hospital and the nurturing scientific environment provided by Baylor College of Medicine.

My close friends Alicia and Miguel are superb science teachers in a high school that serves economically disadvantaged communities.

Their schools have many dropouts and one of the reasons seems to be lack of opportunities for students to know what they could become.

Most students, not only Hispanics, are not aware of what scientists do or what a research lab looks like.

One idea could be to sponsor science fairs in these schools and award prizes that also include student tours of Baylor or Texas Childrens lab facilities. Students also need to be aware of scholarships they could apply for to pursue a higher education.

Finally, academic institutions and researchers may also participate in school talks to promote a better understanding of science and its direct repercussions in our daily life and to reduce the mistrust in science, which is a growing topic of significant concern.

I am a Star Wars fan so my office has many items from a galaxy far, far away.

By Ana Mara Rodrguez, Ph.D.

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FROM THE LABS: Hispanic Heritage Spotlight: Interview with Dr. Nino Rainusso - Baylor College of Medicine News