Category Archives: Genetic medicine

While some people seem to just stay young longer, others age prematurely. Your chronological age of course cant be changed, but research suggests the biological processes that drive aging may in fact be malleable.

Understanding those processes is the goal of the new Potocsnak Longevity Institute at Northwestern Universitys Feinberg School of Medicine.

Dr. Douglas Vaughan, director of the new institute and chair of medicine at Northwestern, discusses aging, the institute and its goals.

Below, a Q&A with Vaughan.

Explain the concept of physiological age versus chronological age. How do you measure physiological age?

Thats a very good question. And its very pertinent to the conversation that were having and the idea that were presenting. It turns out there are a variety of physiological measures that we can perform on any human being that actually change with age. And its the integrated and cumulative measurement of a variety of different parameters that allows us to make a calculation of someones physiological or biological age as opposed to their chronological age.

There are also very specific molecular markers that change with age.

Patients at the new institute will undergo a battery of tests to determine their physiological age. How does that testing differ from what people typically get for an annual physical?

Thatsa really important question. We will actually focus on measures that change with age. So for example we will measure grip strength, we will measure hearing, we will measure heart rate variability, we will measure the capacity of your blood vessels to dilate, we willmeasure how far you walk in five minutes. All these kinds of things arent part of a routine physical exam. Theyre sort of on the edges of it, but theyre not specifically quantified and calculated.

The ultimate aim of your research is to allow people to live well longer. What do you think is feasible when you start looking at how much longer we might be able to extend human lifespans? Are we talking years, decades? Obviously, weve already made significant gains over the last century. How much more do you think we might be able to achieve?

Well, we were making gains until the pandemic hit. I think the average lifespan in the United States has dropped by two years since the pandemic hit. I think we can extend the health span of people, maybe another 10-15 years. I dont think our goal is to have people to make it to 120 or 150. But if we can push back age-related illnesses, whether its cancer or cardiovascular or neurodegenerative disease or lung disease and have people live a fuller, more productive, healthier life, thats the goal of all this. And I think thats within reach.

Youve done research on a community of Amish in Indiana who have a unique genetic variant that seems to allow them to live about 10 years longer than those who dont have the variant. When you look at the science of aging, how much is it about the genetic lottery that we all are dealt? How much is changeable, and how much is not?

Well thats an extremely complicated question. This is conjecture on my part. We certainly dont change the primary components of our genetic makeup, but our genes do change over time.

Our DNA gets modulated or chemically changed and it changes the function of our DNA. One of the processes there that contributes to that is called methylation. And specific patterns of methylation of our DNA predict the development of aging-related illnesses and lifespan. So I think that we actually have the capacity to impact upon that process as well as lifestyle interventions or other therapeutic interventions that could impact upon the aging that we all experience.

In terms of like the specific genetic trait identified in these Amish folks in Indiana, is that something that could be used and applied to people without that genetic variation to help them live longer as well?

So the genes, the genetic variants that this Amish population carries codes for a protein that circulates in our blood. And the carriers of that genetic variant have half the normal level of the protein. And its very easy to measure.

I can measure it in anybody. There are already drugs in clinical trials that lower the level of the protein in human beings. So you can simply take a drug by mouth and lower your level of that specific protein. And there will be other examples that are discovered like that in the next few years. This community is very unique in that it harbors this remarkable genetic variant. Theres no other population quite like it in the world. . Were still investigating the broad impact of that genetic variant. It seems to touch on almost every system in the body.

Theres also a connection between HIV research and aging research. Explain that linkage.

Thats a really important component of our story in regards to the generous individuals that provided the money to create the institute, John Potocsnak and his family, who are very interested in HIV.

HIV was a lethal disease in the 80s. Now its a chronic disease, but were learning that many people with chronic HIV infections look like they age more rapidly than individuals that dont have HIV. I think that biology is really fascinating. It probably provides some insight into the aging process across all human beings, and hopefully well be able to develop some intellectual reciprocity by studying HIV and aging, and aging in human beings that dont have that infection.

What is your ultimate goal for the institute? Where do you hope the research will be in say 10 years?

We really want to contribute to the process of understanding the biology of aging and how it impacts upon the human condition. We hope that we will make a meaningful contribution to extending the healthy lifespan of our species and its as simple and as powerful as that.

And do you think that the benefits of that research and whatever therapies or treatments come out of it are likely to be widely available? Do you think these are the kind of things that could someday be covered on health insurance?

Id be very disappointed if it wasnt. I mean there are there are already drugs out in the marketplace that are suspected to potentially have anti-aging properties. One of the drugs that is commonly mentioned is Metformin thats broadly administered to people with diabetes. But it may have other kinds of interesting properties and its extremely cheap.

So, if a drug like that could be actually beneficial in delaying aging related morbidity that would be broadly applicable to the population. The drug that I talked about thats being developed to block a protein, its not going to necessarily be very expensive. Its not going to be thousands of dollars a month to take a drug like that. Itll be dollars a month.

Interview has been condensed and edited.

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Northwestern's New Longevity Institute Aims to Decode the Mysteries of Aging - WTTW News

Its that time of year again! With 2021 behind us, were going down memory lane to highlight biotech innovations that shaped the yearwith impact that will likely reverberate for many years to come. Covid-19 dominated the news, but science didnt stand still.

Take gene editing. CRISPR spun off variations with breathtaking speed, expanding into a hefty toolbox packed with powerhouse gene editors far more efficient, reliable, and safer than their predecessors. CRISPRoff, for example, hijacks epigenetic processes to reversibly turn genes on and offall without actually snipping or damaging the gene itself. Prime editing, the nip-tuck of DNA editing that only snipsrather than fully cuttingDNA received an upgrade to precisely edit up to 10,000 DNA letters in a variety of cells. Twin prime editing can rework entire genes. These powered-up CRISPR tools now make it possible to tackle previously untouchable genetic disorders.

Yet were still only scratching the surface of gene editing. Peeking into the CRISPR family tree, scientists found a vast universe of alternative CRISPR-like systems to further explore. AI is now helping identify new CRISPR proteinsand their kill switch. Other ideas jumped ship from CRISPR altogether, tapping into another powerful bacterial system to edit millions of DNA sequences without breaking a single DNA strand. Without doubt, the gene editing toolbox will keep expanding.

In other news, quantum mechanics hooked up with neuroscience to speed up AI. AI is now designing its own hardware chips at Google in an efficient full circle. Hopping into our own brains, in a stunning proof-of-concept, AI-powered brain implants were able to fight depression, with ongoing work to treat chronic pain and translate the brains electrical signals from thought to text. In the medical world, a fierce debate on an Alzheimers treatment sparked a new round of alluring ideas to tackle and tame our long-time mind-eating foe.

Theres a ton more. But here are the top three advances thatll keep reshaping biotech far past 2021, with some runners-up.

I know, I know. Were all tired of hearing about Covid-19 and vaccines. Yet their remarkable ability to fight a completely novel infectious virus is nothing short of miraculous. It also showcased the power of the decades-old technology that previously languished in labs, with a platform thats far faster, simpler, and more adaptable than any previous vaccine technology. Because they no longer rely on physical target proteins from a virusrather, just the genetic code for those proteinsdesigning a vaccine just requires a laptop and some ingenuity. The era of the digital vaccine is here, wrote a team from GlaxoSmithKline.

To enthusiasts, mRNA vaccines could transform current treatments for a wealth of diseases, and the field is exploding. Moderna, for example, launched an HIV vaccine humantrial in August to begin assessing its safety, tackling a virus thats escaped classic vaccine tactics for four decades. Along with the National Institutes of Health (NIH), the company also published data on an HIV vaccine candidate that lowered the chance of infection by nearly 80 percent in monkeys, with all subjects developing antibodies against 12 tested strains of HIV. Its no small featthe HIV target, Env, is a formidable target due to its complexity and is coated with a sugar armor to mask vaccine target points. The mRNA vaccine offers new hope.

Viruses aside, mRNA vaccines also represent a new solution to autoimmune or neurodegenerative diseases. BioNTech, the partner of Pfizer for developing Covid-19 vaccines, is applying the technology to tackle multiple sclerosis (MS). In MS, the immune system gradually strips away the insulation on nerve fibers, causing gradual and irreversible damage. Initial results in mice are positive, with the approach highly flexible, fast, and cost efficient, while potentially being personalized to each patient.

Further down the pipeline are mRNA vaccines that tackle cancer or those that deal with antibiotic resistance. Whether the tech can solve some of our toughest diseases remains to be seen, but the field is on a roll.

CRISPRs long been touted as a tool that can radically transform gene therapy. Earlier studies used the gene editing tool to bolster immune T-cells, transforming them into super soldiers that enhance their fight against blood cancers (CAR-T therapy). The tool also scored successes in battling anemia and other symptoms in patients with blood disorders. The down side was that cells needed to be gene-edited outside the body and infused back into the bloodstream. This year elevated CRISPR to the ultimate goal: directly editing genes inside the body, opening the door to curing hundreds of disorders resulting from faulty genetic code.

In a breakthrough, one trial from University College London edited a mutated gene in the liver that eventually leads to heart and nerve damage. Unlike previous attempts, here the CRISPR machinery was delivered into the bloodstream with a single infusion to switch the gene off, sharply decreasing the production of the mutant protein in six patients. Another trial snipped a dysfunctional gene that causes blindness. By directly injecting the treatment into the retina, volunteers were able to better sense light.

Both are edge cases. For the liver trial, CRISPR was delivered using lipid nanoparticleslittle fatty space shipsthat have an affinity for the liver, with more transient gene-editing effects. And unlike the retina, most of our bodys tissues arent immediately accessible to a simple injection. But as proofs of concept, the trials finally bring CRISPR into a vast world of gene-editing possibilities inside the body. Along with advances in delivery, CRISPRand its many upgradesis set to treat the untreatable.

The first few hours and days of a human embryos development are a black boxone we need to crack. Understanding early pregnancy is key to limiting birth defects and pregnancy loss, and improving assistive reproduction technologies.

The problem? Early embryos are hard to come by, and carry significant ethical and legal challenges. This year, several studies circumvented these problems, instead transforming skin cells into blastocysts, a cellular structure that resembles the very first stage of a human embryo.

Torpedoing the usual sperm meets egg narrative, the studies engineered the first complete model of the human embryo using embryonic stem cells and skin cellsno reproductive cells needed. Bathed in a nutritious liquid, the cells developed into blastocysts, containing cell types that eventually lead to all lineages to build our bodies. The artificial embryos are genetically similar to natural ones, stirring up debate on how long they should be allowed to develop. The nightmare scenario? Imagine a mini-brain growing inside an embryo made out of skin cells!

For now thats technically impossible, but the ethical quandary has stirred up concern at the International Society for Stem Cell Research (ISSCR), which governs research related to human stem cells and embryos. Yet surprisingly, this year, they relaxed the 14-day rule for culturing embryos, giving permission to push embryo research past two weeks. With relaxed guidelines, upcoming studies could reveal what happens to a human embryo after implanting into the uterus, and gastrulationwhen genetic cues lay out the bodys overall patterning and set the stage for organ development.

Its a decision mired in controversy, but provides an unprecedented opportunity to revise IVF and, for the first time, examine the first stages of human development. Its also bound to raise ethical quandaries: what if the embryosnatural or artificialbegin developing neurons that fire, or heart cells that pulse? As artificial blastocysts increasingly embody their biological counterparts, one thing is clear: with great power comes great responsibility.

AI predicting proteins: DeepMind and the University of Washington both engineered AI that can solve the structure of a protein based purely on its genetic code. Its a once in a generational advance, a breakthrough of the year, and a tool thatll change structural biology forever. Updates to the original AI can now also predict protein complexesthat is, how one protein unit interacts with anotherand even their function. AI is also beginning to solve RNA structure, the messenger that bridges DNA to proteins. From synthetic biology to drug development, the impact is yet to come.

AI-designed drugs: Its been a long time in the making, but the hype is now real. This year, Alphabet, Googles parent company, launched a new venture called Isomorphic Labs to tackle a new world of drug development using AI. Powerful algorithms are making it increasingly easy to screen drug candidates from millions of chemicals. And the first AI-discovered drug is now going into clinical trials in a safety test for a lung disease that irreversibly degrades the organs function. Its a significant milestone, and the trial may pave the road for the first AI-discovered, human-tested drug that treats diseases.

In another year of living with Covid-19, its clear that the pandemic cant hold science down. I cant wait to share the good, the weird, and (holds breath) more breakthroughs of a generation biotech stories in 2022.

Image Credit: Schferle / 94 images / Pixabay

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These 2021 Biotech Breakthroughs Will Shape the Future of Health and Medicine - Singularity Hub

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If the pandemic had happened ten years ago, what would it have looked like? Doubtless there would have been many differences, but probably the most striking would have been the relative lack of genomic sequencing. This is where the entire genetic code or genome of the coronavirus in a testing sample is quickly read and analysed.

At the beginning of the pandemic, sequencing informed researchers that they were dealing with a virus that hadnt been seen before. The quick deciphering of the viruss genetic code also allowed for vaccines to be developed straight away, and partly explains why they were available in record time.

Since then, scientists have repeatedly sequenced the virus as it circulates. This allows them to monitor changes and detect variants as they emerge.

Sequencing itself is not new whats different today is the amount taking place. Genomes of variants are being tested around the world at an unprecedented rate, making COVID-19 one of the most highly tested outbreaks ever.

With this information we can then track how specific forms of the virus are spreading locally, nationally and internationally. It makes COVID-19 the first outbreak to be tracked in near real-time on a global scale.

This helps with controlling the virus. For example, together with PCR testing, sequencing helped reveal the emergence of the alpha variant in winter 2020. It also showed that alpha was rapidly becoming more prevalent and confirmed why, revealing that it had significant mutations associated with increased transmission. This helped inform decisions to tighten restrictions.

Sequencing has done the same for omicron, identifying its concerning mutations and confirming how quickly its spreading. This underlined the need for the UK to turbocharge its booster programme.

The road to mass sequencing

The importance of genomic sequencing is undeniable. But how does it work and how has it become so common?

Well, just like people, each copy of the coronavirus has its own genome, which is around 30,000 characters long. As the virus reproduces, its genome can mutate slightly due to errors made when copying it. Over time these mutations add up, and they distinguish one variant of the virus from another. The genome of a variant of concern could contain anywhere from five to 30 mutations.

The viruss genome is made from RNA, and each of its 30,000 characters is one of four building blocks, represented by the letters A, G, C and U. Sequencing is the process of identifying their unique order. Various technologies can be used for this, but a particularly important one in getting us to where we are is nanopore sequencing. Ten years ago this technology wasnt available as it is today. Heres how it works.

First the RNA is converted to DNA. Then, like a long thread of cotton being pulled through a pinhole in a sheet of fabric, the DNA is pulled through a pore in a membrane. This nanopore is a million times smaller than a pin head. As each building block of DNA passes through the nanopore, it gives off a unique signal. A sensor detects the signal changes, and a computer program decrypts this to reveal the sequence.

Amazingly, the flagship machine for doing nanopore sequencing the MinION, released by Oxford Nanopore Technologies (ONT) in 2014 is only the size of a stapler; other sequencing techniques (such as those developed by Illumina and Pacific BioSciences) generally require bulky equipment and a well-stocked lab. The MinION is therefore incredibly portable, allowing for sequencing to happen on the ground during a disease outbreak.

This first happened during the 2013-16 Ebola outbreak and then during the Zika epidemic of 2015-16. Pop-up labs were set up in areas lacking scientific infrastructure, enabling scientists to identify where each outbreak originated.

This experience laid the foundation for sequencing the coronavirus today. The methods honed during this time, in particular by a genomics research group called the Artic Network, have proved invaluable.

They were quickly adapted for COVID-19 to become the basis on which millions of coronavirus genomes have been sequenced across the globe since 2020. Nanopore sequencing of Zika and Ebola gave us the methods to do sequencing at a never-before-seen scale today.

That said, without the much larger capacity of the benchtop machines from Illumina, Pacific Biosciences and ONT, we wouldnt be able to capitalise on the knowledge gained through nanopore sequencing. Only with these other technologies is it possible to do sequencing at the current volume.

What next for sequencing?

With COVID-19, researchers were able to monitor the outbreak only once it had started. But the creation of rapid testing and screening programmes for other new diseases, as well as the infrastructure to conduct widespread sequencing, has now begun. These will provide an early warning system to prevent the next pandemic taking us by surprise.

For instance, in the future, surveillance programmes may be put in place to monitor wastewater to identify disease-causing microbes (known as pathogens) present in the population. Sequencing will allow researchers to identify new pathogens, allowing an early start on understanding and tracking the next outbreak before it gets out of hand.

Genome sequencing also has a role to play in the future of healthcare and medicine. It has the potential to diagnose rare genetic disorders, inform personalised medicine, and monitor the ever-increasing threat of drug resistance.

Five to ten years ago, scientists were only just beginning to trial sequencing technology on smaller viral outbreaks. The effects of the past two years have resulted in a huge increase in the use of sequencing to track the spread of disease. This was made possible by technology, skills and infrastructure that have developed over time.

COVID-19 has caused untold damage worldwide and affected the lives of millions, and were yet to see its full impact. But recent advances particularly in the field of sequencing have no doubt improved the situation beyond where wed otherwise be.

Angela Beckett, Specialist Research Technician, Centre for Enzyme Innovation, and PhD Candidate in Genomics and Bioinformatics, University of Portsmouth and Samuel Robson, Reader in Genomics and Bioinformatics, and Bioinformatics Lead, Centre for Enzyme Innovation, University of Portsmouth

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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How COVID-19 transformed genomics and changed the handling of disease outbreaks forever - Down To Earth Magazine

LEXINGTON, Mass., Jan. 4, 2022 /PRNewswire/ -- LogicBio Therapeutics, Inc. (Nasdaq:LOGC), a clinical-stage genetic medicine company, today announced that president and chief executive officer, Fred Chereau, will participate in a fireside chat at the virtual H.C. Wainwright Bioconnect Conference being held January 10-13, 2022. The pre-recorded presentation will be available for on-demand viewing beginning at 7:00 a.m. ET on Monday, January 10, 2022.

A webcast of the presentation will be made available on the Investors section of the Company's website at http://www.logicbio.com/investors. The webcast replay will be available for approximately 30 days.

About LogicBio Therapeutics

LogicBio Therapeutics is a clinical-stage genetic medicine company pioneering genome editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. The company's genome editing platform, GeneRide, is a new approach to precise gene insertion harnessing a cell's natural DNA repair process potentially leading to durable therapeutic protein expression levels. The company's gene delivery platform, sAAVy, is an adeno-associated virus (AAV) capsid engineering platform designed to optimize gene delivery for treatments in a broad range of indications and tissues. The company is based in Lexington, MA. For more information, visit http://www.logicbio.com, which does not form a part of this release.

Investor Contacts: Stephen Jasper Gilmartin Group 858-525-2047 stephen@gilmartinir.com

Media Contacts: Adam Daley Berry & Company Public Relations W:212-253-8881 C: 614-580-2048 adaley@berrypr.com

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LogicBio Therapeutics to Present at the H.C. Wainwright Bioconnect Conference - Stockhouse

SEATTLE--(BUSINESS WIRE)--Curi Bio Inc., a leading developer of human stem cell-based platforms for drug discovery, announced today the second closing of a $10 million oversubscribed Series A financing. New investors include UTC Investment and DS Asset Management, joining current Curi Bio investor and Series A lead Dynamk Capital. The investment will be used to scale Curis existing business and accelerate the development of its innovative engineered tissue analysis platforms, including its Mantarray platform.

Curi Bio is thrilled to partner with the distinguished teams at UTC Investment, DS Asset Management, and Dynamk Capital to fuel our next stage of growth, said Michael Cho, JD, CEO of Curi Bio. To discover new therapies requires human-relevant disease models. Curi is working to close the gap between preclinical results and clinical outcomes, not only in small molecule discovery, but also in frontier areas like next-generation genetic medicines and cell therapies.

With costs to develop a single new medicine now exceeding $2Bn, the need for more human-relevant disease models to improve translational efficiency in the drug development process has never been greater. Curis core platform the Curi Engine integrates human stem cells, tissue specific biosystems, and A.I./M.L.-enabled data analysis to accelerate the discovery and development of new therapeutics. With this three-pronged strategy human cells, systems and data Curi is rapidly becoming a market leader in creating high-fidelity models of human diseases for drug discovery, especially for striated muscle, including cardiac and skeletal muscle, and neuromuscular models.

Curi Bios technology platforms create significant value for pharma and biotech companies by accelerating discovery timelines and increasing the chances of success for new therapies in development, said Dr. Gustavo Mahler, Managing Partner, Dynamk Capital. We look forward to strong growth in Curi Bios customer portfolio.

Curi Bios core technologies and products include NanoSurface Plates for structural maturation, Cytostretcher cell-stretching instruments, and the Mantarray platform for contractility analysis. The Mantarray platform enables researchers to generate and analyze 3D engineered human muscle tissues, providing clinically relevant functional readouts, and reducing reliance on poorly predictive animal models. Curi also offers a suite of customized research services utilizing the Curi Engine, including new assay and model development and phenotypic screening. Curi Bio counts all of the top-ten global pharmaceutical companies among its clients, customers, and partners.

About Curi Bio

Curi Bios preclinical discovery platform combines human stem cells, systems, and data to accelerate the discovery of new medicines. The Curi Engine is a seamless, bioengineered platform that integrates human iPSC-derived cell models, tissue-specific biosystems, and A.I./M.L.-enabled phenotypic screening data. Curis suite of human stem cell-based products and services enable scientists to build more mature and predictive human iPSC-derived tissueswith a focus on cardiac, musculoskeletal, and neuromuscular modelsfor the discovery, safety testing, and efficacy testing of new drugs in development. The companys proprietary technologies are supported by over 100 publications and 19 patents. By offering drug developers an integrated preclinical platform comprising highly predictive human stem cell models to generate clinically-relevant data, Curi is closing the gap between preclinical data and human results, accelerating the discovery and development of safer, more effective medicines.

For more information, please visit http://www.curibio.com.

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Curi Bio Closes $10M Series A in Oversubscribed Round - Business Wire

A commitment to continuous innovation, scientific leadership, and personalized care provide a firm foundation for this collaborative partnership.

HOUSTON, Jan. 4, 2022 /PRNewswire-PRWeb/ -- US Fertility, the largest physician-led partnership of top-tier fertility practices in the U.S., with more than 60 locations throughout CA, CO, IL, FL, GA, MD, NY, PA, VA, D.C., and Santiago, Chile, and the Center of Reproductive Medicine (CORM), a nationally recognized fertility center serving Houston, the Texas Medical Center, Memorial City, Clear Lake, Beaumont, and surrounding areas in Texas -- announced today that CORM will join the US Fertility partnership. As part of this transaction, CORM will adopt the Shady Grove Fertility (SGF) name and extend the SGF brand into South Texas to become SGF Houston.

SGF, the largest fertility practice partnership in the nation, was founded in 1991 and has 100,000 babies born to its credit. Following this transaction, SGF will have eight practices with 47 locations across the United States.

CORM, the largest private fertility practice in the Greater Houston region, was founded in 1993 by Vicki Schnell, M.D. Having helped more than 20,000 individuals and couples build their families to date, CORM provides high-quality reproductive healthcare that focuses on the patient as a partner. CORM is widely respected for providing advanced, innovative, high-value infertility care in a nurturing environment. The practice stands behind its high success rates with an approach to care that complements well the model followed by SGF.

Vicki Schnell, M.D., FACOG, and Medical Director of CORM said, "We're thrilled to announce this collaboration as it connects practices and providers who share common values and goals. It's evident that the practices in this partnership embrace patient-centric care and show a commitment to continuous innovation and scientific leadership."

John Crochet, Jr., M.D., FACOG, and Administrative Director & Director of Third-Party Reproduction for CORM said, "We are thrilled to be partnering with SGF and US Fertility to further help parents realize their dream of having a family. SGF represents the highest quality clinical standards, and this is one of the key reasons we chose to partner with the company."

Story continues

"While patients of SGF Houston will benefit from interacting with the same physicians and team they've come to know and trust, by adopting the SGF brand, new benefits include access to a range of exclusive financial packages pioneered by SGF," remarks Michael J. Levy, M.D., co-founder of SGF and US Fertility board member. "Among them, SGF's signature Shared Risk 100% Refund Program for IVF and Donor Egg, in which patients take home a baby or a full refund. 82 percent of participants using their own egg take home a baby, and 86 percent of participants using a donor egg take home a baby."

SGF Houston will provide a full range of diagnostic and treatment options to help individuals and couples achieve their family-building goals, including male and female testing, low-tech fertility options, in vitro fertilization (IVF), donor egg, sperm, and embryo, genetic screening and testing, gestational carrier, elective egg freezing, fertility preservation for patients with cancer, and LGBTQ family building.

"We are thrilled to welcome CORM into the US Fertility partnership," shares Mark Segal, CEO, US Fertility. "We recognize the position they have earned among the nation's leaders in reproductive medicine. Their clinical expertise and cutting-edge technology have led to great success for their patients, and we're proud to align ourselves with physicians and team members of their caliber."

Current CORM patients will keep their same physician care team and receive the same quality of care they've come to expect. New and established CORM patients may continue scheduling appointments by calling 281-332-0073. SGF Houston will begin accepting new patients in early summer of 2022.

About US Fertility US Fertility is the largest, physician-led, integrated network of top-tier fertility practices in the United States, offering comprehensive fertility-market-focused non-clinical, administrative, and technical platforms that help domestic and international practices improve patient outcomes and increase patient access. To learn more about partnership- or affiliate-status benefits, call 301-545-1308 or visit http://www.USFertility.com.

About Shady Grove Fertility (SGF) SGF is a leading fertility and IVF center of excellence with more than 100,000 babies born. With 47 locations, including new locations in Colorado and Norfolk, VA, as well as throughout CO, FL, GA, MD, NY, PA, TX, VA, D.C., and Santiago, Chile, SGF offers patients virtual physician consults, delivers individualized care, accepts most insurance plans, and makes treatment affordable through innovative financial options, including 100% refund guarantees. SGF is among the founding partner practices of US Fertility, the largest physician-owned, physician-led partnership of top-tier fertility practices in the U.S. Call 1-888-761-1967 or visit ShadyGroveFertility.com.

About Center of Reproductive Medicine (CORM) The Center of Reproductive Medicine (CORM) is a nationally recognized, all-inclusive fertility center in Southeast Texas with locations in Houston, Beaumont, Clear Lake, and Memorial City. With CORM's Clear Lake-based laboratory and ambulatory surgery center (ASC), this four-physician practice offers a full suite of cutting-edge assisted reproductive technologies. For more information visit InfertilityTexas.com.

Media Contact

Jean Dzierzak, Shady Grove Fertility, 301-545-1375, jean.dzierzak@usfertility.com

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US Fertility Welcomes Center of Reproductive Medicine (CORM), and Extends the Shady Grove Fertility Brand into Houston, Expanding Access to...

The Great Resignation of 2021, which has resulted in millions of Americans quitting their jobs, has unsurprisingly hit the healthcare industry hard.

Many resignations across all industries are spurred by an emotionally jarring and unprecedented pandemic that is now coming upon its third year, prompting many workers to reconsider the trajectory of their lives and careers. The toll has been particularly difficult for healthcare workers on the frontlines of Covid-19 care, many of whom are understandably burned out. According to the Bureau of Labor Statistics, a whopping 534,000 U.S. health care workers left their jobs voluntarily in August alone.

With demand for healthcare workers expected to keep increasing in the coming years, the loss of workers especially among those who decide to leave the industry altogether poses a severe threat for hospitals and other medical facilities already overwhelmed by patients.

There are no easy answers to the healthcare labor crisis. But there are resources medical institutions and their teams can draw on to relieve some of the burden from overworked, stressed-out physicians, nurses and staff and many of them come in the form of technological advancements that may transform how we offer care in the years to come.

Many of these are coming to bear right now. Here are five predictions for healthcare advancements well see gain further traction in 2022.

Prediction: More burnout-busting innovations are on the way.Burnout has long been a serious issue among healthcare workers, but Covid-19 certainly made it worse. In fact, 79% of radiologists, neurologists, cardiologists and critical care physicians who say they feel burned out today actually felt similarly before the pandemic. And a key cause of that stress and fatigue is an abundance of administrative duties and the data deluge required to track and follow-up with patients a longstanding issue exacerbated by the tidal wave of patients suffering from Covid-19.

Fortunately, improvements in technology are reducing that burden. Using new and improved algorithms that quickly and efficiently assess mounds of patient data, while also removing certain repetitive tasks, clinicians are able to unearth the information and insights needed to efficiently treat their patients. Whether its a device, or department or enterprise-wide workflow, we are working to use data, analytics, and AI to first provide insights and then use those insights to automate repetitive tasks and improve workflow efficiencies. We believe it is possible to see a 30% improvement in efficiency through such technologies and software. Patient flow can be managed better by providers, even in overtaxed emergency rooms, and that gives clinicians more time to do the work for which they were trained.

Prediction: Clinicians will decide which AI tools are right for them.Building on the previous point, advancements in data analytics and artificial intelligence are giving clinicians and support staff access to numerous new tools to make their tasks easier to complete. But are they really doing the job?

As with any new advancements, the learning curve can sometimes be steep. In fact, a recent report revealed that slightly less than half of the AI tools being studied by radiologists that could directly contribute to patient care actually led to an increase in the number of exams a radiologist performs in a given amount of time. Most of the rest do not change that number (or therefore the radiologists efficiency) but still could directly contribute to patient care.

Clinicians are eager for tools that seamlessly integrate into their existing workflows, limit screen time and the effort required to input data. My prediction is they will embrace those AI resources that work spectacularly such as deep-learning image reconstruction technology embedded on an MR device that delivers high-quality resolution and shorter scan times and ignore those that dont. The winning AI technologies will emerge in 22, and their effect will be dramatic. When it comes to use of AI to improve off device workflows, either operational or clinical, those AI models that factor in multi-modal datasets (population health information, social determinants of health, genetic information, economic status, multi-modal clinical data etc.) tend to be more accurate and precise as compared to those models which are built on single factor data (single modal information).

Prediction: High-tech solutions will eliminate many healthcare inequities.A longstanding problem in the U.S. is health inequity, as many people from disadvantaged or historically oppressed groups are often at greater risk for poor health outcomes. And the pandemic only worsened the problem.

Since its onset, for example, people of color, American Indians and Alaska Natives have had the highest hospitalization rates for Covid-19. Plus, fears about contracting the virus and the loss of health insurance led to a significant drop in the number of regular screenings for cancer and other diseases. Consequently, it is expected that these delays or missed screening appointments have had negative impacts on early detection and diagnosis, leading to an increase in deaths or severe illness.

But technology is again riding to the rescue, with advancements that hold the promise of enabling health equity for almost everyone by creating new pathways to care. Telehealth exploded in 2020, out of necessity, but is becoming the delivery method of choice for millions. Remote monitoring devices may provide the ability to check on patients in rural areas or who have difficulty finding transportation to get to the doctor. Further, the use of predictive analytics is helping identify at-risk patients before they incur a disease, so that preventive steps can be taken.

Prediction: Precision medicine will drastically improve medical outcomes.The industry has made tremendous advances with technologies that help diagnose and prevent disease. In 2022, genomics the study of a persons genes or DNA will move to center stage, as we will see the availability of tools and techniques to treat diseases and disorders based on each persons genetic fingerprint, environment and lifestyle.

In doing so, we will be replacing the one-size-fits-all approach to medicine with precise treatment solutions that are revamping legacy care delivery models in ways that will significantly improve patient outcomes.

Secondly, use of multi-modal data, including genetic information, imaging, digital pathology and other multi-modal information will enable precise detection of disease state early and the progression, thereby making therapies a lot more effective, while at the same time, lowering the cost. One of the challenges of taking diagnostics upstream, especially in the U.S., is the current reimbursement models. The need and effectiveness of upstream diagnostics and therapies will accelerate the value-based care paradigm in 2022.

While healthcare providers have been facing tremendous burdens, with or without the pandemic, hope and help is on the horizon. As healthcare technology continues to improve, so, too, will the mental, physical and emotional states of the millions of individuals who are devoting their lives to caring for others.

Photo: Nuthawut Somsuk, Getty Images

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5 predictions for how technology will transform healthcare in 2022 and beyond - MedCity News

As we begin a new year, it is a good time to look back at 2021 and contemplate what was an important year for the life sciences industry. From the continuing fight against COVID-19 to new companies emerging in exciting therapeutic areas to the people who mattered most, heres a look at just some of the biggest successes, most dramatic flops and a few that fall somewhere in between.

Closely Watched or Surprising Phase III Successes and Flops

Successes: Biogens Aduhelm: Love it or hate it, agree or disagree with its approval, the first drug for Alzheimers disease approved by the U.S. Food and Drug Administration in 18 years is a big deal. Biogen got the drug through on a surrogate endpoint, that it cleared amyloid plaques, as opposed to proof of clinical efficacy. This could be an indication that the agencys criteria are changing, and the industry is excited. Just two weeks later, the FDA granted Breakthrough Therapy designation to Eli Lillys donanemab based on results from the companys Phase II TRAILBLAZER-ALZ study. This was despite mixed findings in the secondary endpoints. BioMarin scored a first in November when the FDA signed off on Voxzogo, a once-daily injection intended to improve growth in children with achondroplasia, a rare genetic disorder that causes the most common form of dwarfism. The drug has been the focus of some controversy within the dwarfism community who fear its intention is to eradicate dwarfism. And on the COVID-19 front, the FDA gave EUA to AstraZenecas Evusheld, providing a much-needed prophylactic option for adults and adolescents who are moderate to severely immune-compromised.

Flops: A big Phase III failure hit South San Franciscos Theravance Biopharma hard in October. The cardiac candidate for the treatment of symptomatic neurogenic orthostatic hypotension (nOH), failed to hit the primary endpoint, leading to a seismic shift in R&D and the expected loss of approximately 270 jobs. BrainStorm Cell Therapeutics NurOwn was and in many ways, still is a source of much excitement in the amyotrophic lateral sclerosis (ALS) space. In February, the Tel Aviv-based company received feedback from the FDA stating that the Phase III data was not enough to support a Biologics License Application (BLA). The drug did, however, make a meaningful difference for a subset of patients with early-stage disease and advocates and physicians have argued that this should be enough to get NurOwn approved. In October, Idorsias oral substrate reduction therapy for Fabry disease missed the primary endpoint in Phase III, putting the programs future in flux.

COVID-19 Vaccines

Successes: Throughout the year, various COVID-19 vaccines and therapies have received expanded approvals and authorizations around the world. While Pfizer-BioNTechs COVID vaccine is currently the only one with full approval from the U.S. Food and Drug Administration (for people ages 16 and older), Moderna and Johnson & Johnsons vaccines trail closely behind with emergency use authorization for people ages 18 and older. Booster shots have also recently been authorized for some age groups, with the Pfizer-BioNTech and Moderna boosters being recommended over J&Js in many situations by the Centers for Disease Control and Prevention (CDC).

Flops: Although a few COVID-19 vaccines have found success so far, there are also some who have hit some roadblocks along the way. For example, in October CureVac decided to withdraw its EMA application for its COVID-19 vaccine candidate after it showed only 48% efficacy in late-stage trials. Instead, CureVac teamed up with GlaxoSmithKline to target second-generation mRNA vaccines. Earlier in 2021, Merck also decided to discontinue development of its COVID-19 vaccine candidate after seeing mixed Phase I results and already having fallen behind the frontrunners.

Gene Therapy Progress and Setbacks

Successes: Gene therapy and gene editing have the potential to drastically change and even save the lives of people suffering from serious genetic diseases. At the end of June, Intellia Therapeutics and partner Regeneron Pharmaceuticals further proved its potential, announcing the first-ever successful editing of genes inside the human body (in vivo) with a single infusion. The CRISPR/Cas9 therapy, NTLA-2001, is being developed for the treatment of hereditary transthyretin amyloidosis (ATTR) amyloidosis. This led to a cascade of wins in the space as Editas Medicine followed up in September with their own data demonstrating productive in vivo gene editing in a form of inherited blindness called Leber congenital amaurosis type 10 (LCA10). Then in October, LogicBio Therapeutics accomplished a similar feat in small humans, unveiling clinical trial results that showed the first-ever in vivo, nuclease-free genome editing in children.

Flops: The field was not without its share of setbacks, however, as 2021 featured a string of gene therapy clinical trials being paused due to safety concerns. In August, the FDA placed a clinical hold on bluebird bios elivaldogene autotemcel (eli-cel) gene therapy for cerebral adrenoleukodystrophy (CALD). The hold was reportedly due to a Suspected Unexpected Serious Adverse Reaction (SUSAR) of myelodysplastic syndrome in a patient treated with the drug. In September, Astellas Pharma experienced a setback to the development of its gene therapy for X-linked Myotubular Myopathy (XLMTM) after a young patient died following a serious adverse event. It was the fourth death related to treatment with AT132, and came after abnormal liver functions were reported. The previous deaths involved sepsis and gastrointestinal bleed, both consequences of liver failure. While the benefits are huge, so are the challenges. Most gene therapies pass through the liver before arriving at their intended cell target, and high doses can cause liver damage. Other serious health risks include toxicity, inflammation, and cancer.

New and Recalibrating Companies

Launches: Possibly the most unique biopharma launch of the year belongs to Orna Therapeutics. The Cambridge, Massachusetts-based company debuted in February with $100 million in financing and launched a whole new modality along with it. Circular RNA is more compact than linear, and as such, it could be quite effective as a delivery vehicle for small compounds. Fellow Cambridge dweller, Dyno Therapeutics, raked in $100 million in Series A funds in May. Dynos CapsidMap platform leverages AI to improve the design of gene therapies and make them safer, more effective and applicable to more diseases. Operating in another sizzling hot space, GentiBio, Inc. launched in August with $157 million in funding, one of the years largest Series A rounds. GentiBio is using engineered regulatory T cells (Tregs) to restore immune tolerance. And the field of gene editing has spawned an incredibly well-financed new player named Prime Medicine, which uncloaked in July with $315 million in financing. By seeking out genetic mutations at their precise genome location, Prime aims to limit concerns about toxicities or unwanted cellular changes.

Stumbles: Drug development comes with a high risk of failure, however, and many companies were forced to reassess in 2021. In October, Michigan-based Esperion announced it was cutting 40% of its staff and significantly decreasing operational expenses in fiscal years 2021 and 2022 after two recently-launched cholesterol medicines failed to gain traction in the market. Athira Pharma didnt suffer a drug failure in 2021. Instead, the companys integrity and leadership were called into question after former CEO Leen Kawas was placed on a temporary leave of absence in June following reports she altered images that were part of her doctoral thesis.

Oncology

Successes: Excitement around immuno-oncology has been growing for a decade now, since CTLA-4 and PD-1 arrived on the scene in 2011 and 2014/15 respectively. As Mercks PD-1 inhibitor, Keytruda (pembrolizumab), continues to be approved in new indications, a new checkpoint was validated when Bristol Myers Squibb presented the first Phase III data from a trial evaluating an anti-LAG-3 antibody, relatlimab. In combination with Opdivo, relatlimab met the primary endpoint of progression-free survival in first-line metastatic or unresectable melanoma. Another potential checkpoint, TIGIT, continues to be explored by big oncology players like Novartis and BeiGene. Meanwhile, companies like Gilead Sciences, Kite, and Novartis continue to make strong progress against carcinomas with high unmet need such as non-Hodgkin lymphoma and prostate cancer.

Failures: Possible glitches in the oncology clinical development process were highlighted in a study recently published in the Journal of the National Comprehensive Cancer Network (JNCCN). The research, which followed 362 industry-sponsored, randomized Phase III oncology trials conducted from 2008 to 2017, indicated that over 80% of drugs that go into Phase III failed to demonstrate the ability to extend survival. Cancer therapies that failed to hit the mark in 2021 include Novartiss canakinumab, which was being studied in combination with Keytruda and chemotherapy in non-small cell lung cancer (NSCLC); Rafael Pharmaceuticals cancer metabolism drug, devimistat, which failed to improve survival when combined with FOLFIRINOX as a first-line treatment for pancreatic cancer; and ERYTECHs Eryaspase, which did not meet the primary endpoint of overall survival in second-line advanced pancreatic cancer.

People Making Headlines

Successful (or those with the opportunity to be): Mercks Ken Frazier was one of the shining stars making a difference in the biopharma industry this year. Before retiring as CEO in June, Frazier was named CEO of the Year by Chief Executive magazine for his leadership and devotion to social justice and economic inclusion. Another impactful CEO that retired this year was longtime Johnson & Johnson CEO Alex Gorsky, who led the company for nearly a decade. Robert Califf also has the opportunity to make an impact in the industry, should he be named the new commissioner of the U.S. Food and Drug Administration. Califf is familiar with the role, having served in the FDAs top spot for 11 months during President Barack Obamas second term. He was nominated by President Biden in November, and most recently underwent a Senate panel hearing.

Shameful: On the other hand, there are also people that cast a negative shadow on the biopharma industry. A couple names that made infamous headlines this year were Elizabeth Holmes facing trial for her Theranos sham and jailed Pharma Bro Martin Shkreli continuing to find himself in legal trouble years after his guilty verdict for securities fraud and one charge of conspiracy to commit conspiracy fraud. Moncef Slaoui also found himself in hot water in 2021. The former Operation Warp Speed head was fired and stepped down from multiple positions following substantiated sexual harassment allegations against him.

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Biggest Biopharma Successes and Flops of 2021 - BioSpace

In the mid-1300s, fleas hitching rides on rats helped to set off the deadliest pandemic in human history. The rodents, infected with bubonic plague, had climbed aboard merchant ships and caravans heading from Asia to Europe where, historians believe, the fleas abandoned the dying rats and moved in with humans. The infected bugs are cited as a major cause of the Black Death, which killed an estimated 75 million to 200 million people.

Nearly seven centuries later, another fatal illness that appears to have jumped from animals to people spread more quickly on the efficient wheels of modern travel. While the bubonic plague took weeks (at least) to reach neighboring regions from Asia on the sluggish transportation of the Middle Ages, the COVID-19 virus whisked across continents and oceans from China in days, riding with people on planes, trains, and automobiles. It ranks as the sixth most deadly human epidemic or pandemic in history, claiming 5.4 million lives and counting.

COVID-19 is the latest disease to demonstrate an alarming trend in infections: Zoonoses diseases that spill from animals to humans are occurring more frequently and spreading faster than ever. Zika, swine flu, West Nile virus, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome are just some of the major zoonotic epidemics and pandemics from the past several decades. The United Nations Environment Programme (UNEP) estimated in 2016 that up to 75% of emerging infectious diseases in humans are zoonotic.

Its going to happen more often, says David Morens, MD, senior advisor to the directorat the National Institute of Allergy and Infectious Diseases (NIAID), based in Bethesda, Maryland.

Thats not because viruses are getting stronger; rather, infectious disease experts say, human behavior has increased conditions for people to catch diseases from animals and accelerate the spread of infections, largely by bringing people and animals into more frequent contact through development and travel.

The world is getting closer together, says Jay Varma, MD, director of the new Center for Pandemic Prevention and Response at Weill Cornell Medicine Medical College in New York City.

The center is among a slew of recent initiatives designed to address the problem. Last year, NIAID began funding an $82 million grant program to create a global network of Centers for Research in Emerging Infectious Diseases (CREID), with an emphasis on zoonoses. This past May, several international organizations including the UNEP and the World Health Organization created a One Health High-Level Expert Panel to improve understanding of how diseases with the potential to trigger pandemics, emerge and spread, also with a focus on zoonoses. This fall, the School of Veterinary Medicine at the University of Pennsylvania (Penn Vet) in Philadelphia opened the Institute for Infectious and Zoonotic Diseases to foster innovative strategies with health researchers, wildlife management agencies, and others.

Among the strategies for all: Improve surveillance of animals to curtail and maybe even prevent the spread of zoonotic diseases.

Preventing spillover [to humans] is the real way to prevent epidemics, says Jonathan Epstein, DVM, PhD, MPH, vice president for science and outreach at EcoHealth Alliance, a nonprofit that leads a collaboration in the CREID Network to improve the understanding of and response to zoonotic outbreaks in Southeast Asia. But because prevention involves so many complicated strategies, thats the hardest thing to do.

Animals and humans trade bacteria, parasites, and fungi all the time, usually to no harmful effect. As explained by the Centers for Disease Control and Prevention, people commonly contract animal germs through contact with infected creatures (typically with their bodily fluids or through a bite), time spent in areas where those creatures live (such as among chicken coops, caves, and collections of water), or consumption of contaminated food (such as fruit soiled by animals).

Among the challenges to preventing zoonoses is that their routes to humans can be direct or circuitous. The viruses that cause versions of swine flu, for example, jump from pigs to humans mostly at farms, researchers believe. Other zoonoses are delivered by so-called vector insects, which transfer pathogens from host animals to people. These illnesses include Zika (from monkeys via mosquitos) and Lyme disease (from deer and mice via ticks). Some zoonoses use animals as intermediaries: The leading theory behind the outbreak of COVID-19 is that a coronavirus (SARS-CoV-2) jumped from bats to other animals in China before infecting humans through contact with infected animals sold for consumption at wet markets.

The ensuing pandemic has given scientists an opportunity to focus the worlds attention on the zoonotic phenomenon and how to protect against more pandemics. The reasons for the growing risk include the expansion of human development (such as suburban sprawl) and activity (such as deforestation) into the territories of wild animals; climate change, which is forcing animals to migrate into areas populated by people; the globalization of trade, including of animals and animal meat for consumption; urbanization, which is squeezing people and animals into denser living conditions; and more frequent and speedy human travel around the world.

In summary, Morens says, Were stirring the pot.

Some of the worlds most active pots are in Southeast Asia, where scientists frequently venture into animal habitats to track zoonotic outbreaks.

In Thailand, bats are ubiquitous around woodlands, waterways, farms, and homes; theyre even pitched as tourist attractions. Bats are also among the worlds most prolific culprits of zoonoses because they host lots of viruses that dont sicken them but that they spread as they fly from place to place, biting and getting eaten by other creatures and dropping guano, which people harvest as fertilizer.

Thats why scientists spent two decades there (2001-20) collecting blood, urine, and nasal samples from fruit bats, pigs, and hospital patients to see if they carried the Nipah virus (NiV), a rare but deadly zoonotic disease that killed 100 people in neighboring Malaysia and Singapore in 1999 and keeps reemerging among humans in several countries. The pig and human samples in Thailand tested negative, but in 19 of the years the scientists found the virus in bats.

The risk of a NiV outbreak in Thailand is increasingly possible, the researchers warned in a report published last July.

Animal surveillance is a growing strategy to detect the spread of pathogens from one species to the other. The process is routine among livestock used in food production to get an early jump on diseases that might wipe out animals as well as infect people but scattershot among wildlife, due to the effort and cost of getting to habitats and collecting samples. The scientists in Thailand, for example, visited farms to swab mucus from pig noses and forests to draw blood from bat wings and lay tarp under trees to catch bat urine all to track a potential outbreak.

Putting in that effort for an uncertain return is why preventive surveillance is not the norm. Governments and universities typically launch surveillance after a patient is stricken by an illness suspected of coming from an animal because the virus is unknown among humans or has been found in animals before. The detective work includes determining what animals and animal spaces the patient had been in contact with and searching genetic databases kept by universities and governments to see if the pathogen in the patient matches any that have been found in animals.

You want to get an idea of where the problem is most likely to be coming from, then do more close-up surveillance of animals and humans in that area to hone in on the hot spots where transmission is most likely occurring, Morens says.

Once hot spots are found, mitigation actions include continuously testing people and animals to track the contagion; improving human sanitation practices; minimizing human contact with species that host the pathogen (such as by not consuming the host animal and not entering its habitats); and, as a last and controversial resort, killing off thousands of the host animals.

During the project in Thailand, government and academic institutions launched a campaign based on a book, Living Safely with Bats, developed by the U.S. Agency for International Development to teach people how to protect themselves. The strategies included not killing, cooking, or eating bats (which is common in parts of Asia) and not drinking water that might include bat droppings.

Sampling animals also increases knowledge about how a pathogen works. Understanding these viruses gives us the ability to inform the development of drugs and vaccines, to know what other related viruses are out there, and to more rapidly trace outbreaks, says Epstein at EcoHealth, which is based in New York City.

He adds, however, that animal surveillance as its currently carried out has significant limitations.

Early research indicated that Ebola was transmitted to humans by apes maybe. And that SARS was transmitted to humans by civets maybe. Later evidence pointed to bats as the natural reservoir. One limitation of animal surveillance and genetic sequencing of viruses is that they cannot always determine precisely how a pathogen spilled over to people.

Another drawback is the after-the-fact nature of all responses to zoonoses.

Thats the traditional paradigm: Wait until theres a human outbreak, then put intervention into place, Epstein says. Look what happened with COVID. By the time we recognized a handful of cases, it was too late.

He and other veterinary leaders advocate for more surveillance to be regularly carried out in places with high concentrations of animals that harbor viruses that might infect humans and where people come in frequent contact with them. Scientists could see what known and potential zoonoses are spreading among animals and monitor humans more closely, as was done in Thailand.

We need to be thinking about doing that in areas where spillover events are quite possible, like wet markets, notes Daniel Beiting, PhD, associate director of Penn Vets new Institute for Infectious and Zoonotic Diseases.

That approach has limits, too: Its impossible to predict what virus or bacteria from an animal might infect people. I cannot take a sequence of a virus that came out of an animal and tell you that it is definitely going to be a human pathogen, says W. Ian Lipkin, MD, director of the Center for Infection and Immunity at the Columbia University Mailman School of Public Health in New York City.

Thats one reason that surveillance is just one of several strategies against zoonoses. Epstein and others who follow the One Health approach which emphasizes managing the shared environments of people, animals, and plants advocate for larger changes in human behavior, such as curbing development into areas heavily populated by wildlife, reducing deforestation, confronting climate change, and reducing consumption of certain animals.

At Weill Cornell Medicine, Varma sees academic medicine playing a larger role in these efforts, including increasing coordination among veterinary, academic medicine, and public health institutions to share data; providing more interdisciplinary training in medical and veterinary education to increase understanding of contagion; and helping physicians know when to ask ill patients about their contacts with animals that might spread disease.

Says Varma: Doing cross-education about the role of environmental change in the emergence and transmission of disease, understanding how diseases emerge in animals and how human and animal health is integrated building that into the training of clinicians will, over time, help to build the cultural change that leads to better protection for everyone.

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Into the wild: Scientists strive to stop animal diseases from igniting the next pandemic - AAMC

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Tessera Therapeutics, a biotechnology company pioneering a new approach in genetic medicine known as Gene Writing technology, today announced the expansion of its executive leadership team with appointments of Michael Holmes, Ph.D., Chief Scientific Officer, Iain McFadyen, Ph.D., Chief Data Officer, and Becky Lillie, Chief Human Resources Officer. Jacob Rubens, Ph.D., Co-Founder of Tessera and Senior Principal, Flagship Pioneering, has transitioned from Tesseras Chief Scientific Officer to Chief Innovation Officer. In addition to the three executive appointments, Rebecca Wais, Ph.D., JD, Vice President, Intellectual Property and Legal Affairs, and Ian OReilly, Vice President, Head of GMP Quality, recently joined the Tessera team to bolster the companys internal legal and manufacturing capabilities.

Michael, Iain, and Bec are invaluable additions to our Tessera team and our mission to cure disease by writing in the code of life, said Dr. Geoffrey von Maltzahn, CEO and Co-Founder of Tessera and General Partner, Flagship Pioneering. Their leadership, experiences, and mindsets will be critical in helping to realize our aspirations in genetic medicine, attract and maintain the best talent, and develop our pipeline of Gene Writer candidates to cure and prevent severe diseases.

We set out to revolutionize the field of genetic medicine by pioneering Gene Writing technology that can unlock the therapeutic potential of engineering DNA and address the short-comings of todays gene therapy and gene editing approaches, said Dr. Jacob Rubens. To realize this goal, were building the fields top team across all levels and functions of our organization. Were thrilled that our research will be led by Mike Holmes, whose previous roles included spearheading development of the industrys first gene editing platform and therapeutic candidates.

Michael Holmes, Ph.D., Chief Scientific Officer Dr. Michael Holmes has joined Tessera Therapeutics as its Chief Scientific Officer to lead the development of novel technologies and transformative therapies. Dr. Holmes has more than 20 years of experience working on the development and clinical translation of genome editing- and gene therapy-based approaches. He has an accomplished track record of translating genome engineering technologies to product candidates as evidenced by leading ten therapeutic programs across ex vivo and in vivo therapies. Prior to joining Tessera, Dr. Holmes was the Chief Scientific Officer of Ambys Medicines, and he also held various leadership positions at Sangamo Therapeutics, Inc., including Senior Vice President and Chief Technology Officer.

Dr. Holmes led the efforts that resulted in the first ever clinical candidate of a genome editing-based therapy and has extensive experience in the genome editing of T-cells, hematopoietic stem cells, and hepatocytes. He was also responsible for the research efforts to develop the SB-525 human factor 8 protein (hFVIII) cDNA program, which achieved the highest ever reported level of hFVIII in animal studies and is currently being evaluated in a Phase III study for hemophilia A.

Dr. Holmes holds a Ph.D. in Molecular and Cell Biology from the University of California, Berkeley. He also has a B.S. in Molecular Biology from the University of California, San Diego. To date, Dr. Holmes has authored more than 60 publications in the field of genome editing and gene regulation and he is listed as an inventor on more than 40 issued and pending U.S. patents.

After working in the field of genetic medicine for more than 20 years, I was inspired by the capabilities and performance of Tesseras Gene Writer candidates and their potential to fundamentally reshape the field of genetic medicine, said Dr. Holmes. Our Gene Writer tools can make single base pair changes, insertions and deletions, and write entire genes, each with meaningful advantages over current tools, and without reliance upon viral vectors. I look forward to working with the incredible team to advance our Gene Writing platform and to develop win-state medicines that can transform the lives of patients.

Iain McFadyen, Ph.D., Chief Data Officer Dr. Iain McFadyen serves as Chief Data Officer to help advance Tesseras goal of developing potentially curative medicines across multiple therapeutic areas. Previously, Dr. McFadyen held executive and senior leadership positions at LifeMine Therapeutics and Moderna, Inc., respectively. As Chief Data Officer at LifeMine, Dr. McFadyen oversaw the development of the genomic search-based drug discovery platform, led the growth of the Data Sciences department as well as built a fully integrated informatics platform, and led target identification validation efforts. At Moderna, he founded, built, and led the Computational Sciences department, which included people working in data science, and helped develop the platform that delivered mRNA and lipid nanoparticles to patients in the form of the coronavirus vaccine. Throughout his career, Dr. McFadyen has worked in computational biology, computational chemistry, data science, and machine learning/artificial intelligence. He has experience working across various modalities (including mRNA, proteins, and vaccines) and scientific areas that he will apply to his work at Tessera.

"I was drawn to Tessera because I believe Gene Writing technology is the future of medicine, said Dr. McFadyen. Ive previously developed industrial computational platforms for engineering RNA and for discovering genes with unique functions, and I am thrilled to leverage this experience towards creating and optimizing our Gene Writing platform at Tessera.

Dr. McFadyen earned his Ph.D. in Pharmacology from Loughborough University (UK) and the University of Michigan in the Traynor Lab, later serving as a Postdoctoral Research Associate at the University of Minnesota. He received his B.S. in Medicinal and Pharmaceutical Chemistry from Loughborough University. Dr. McFadyen is the author of 21 publications and the inventor on eight patents and patent families with 16 patent applications pending.

Becky Lillie, Chief Human Resources Officer Becky Lillie joins Tessera as the Chief Human Resources Officer to lead the HR function and oversee talent management strategies and incentives to enable the business strategy. Previously, Ms. Lillie served as the Chief Human Experience Officer at Alexion Pharmaceuticals, Inc., where she modernized HR, IT, and Patient Advocacy departments. As a seasoned human capital strategist with over 25 years of experience in the pharmaceutical industry, Ms. Lillie has deep expertise in designing and executing human-centered organizations, operating models, and corporate governance structures.

In todays quickly evolving and highly competitive biotech industry, its more important than ever to demonstrate strong leadership and to build an employee environment that fosters innovative growth and development, said Ms. Lillie. I look forward to working with Tessera to continue building a robust team of scientists motivated by the challenge of developing a new category of genetic medicines to change how we approach disease.

During her career, Ms. Lille progressed through the ranks at Alexion from Executive Director through to Chief Human Experience Officer over several years, modernizing its HR operation and revamping the R&D operating model in the process. She also held leadership positions in R&D at AstraZeneca and Pfizer Inc. Ms. Lillie earned her B.A. in Communications with an emphasis in Public Relations from the University of North Dakota in Grand Forks.

About Tesseras Gene Writer Tools Tesseras Gene Writer tools are based on natures genome architects, Mobile Genetic Elements (MGEs)the most abundant class of genes across the tree of life, representing approximately half of the human genome. Tessera has evaluated tens of thousands of natural and synthetic MGEs to create Gene Writer candidates with the ability to write therapeutic messages into the human genome. Tesseras research engine further optimizes the discovered Gene Writer candidates for efficiency, specificity, and fidelityessentially compressing eons of evolution into a few months.

About Tessera Therapeutics Tessera Therapeutics is pioneering Gene Writing technology, which consists of multiple technology platforms designed to offer scientists and clinicians the ability to write therapeutic messages into the human genome, thereby curing diseases at their source. The Gene Writing platform allows the correction of single nucleotides, the deletion or insertion of short sequences of DNA, and the writing of entire genes into the genome, offering the potential for a new category of genetic medicines with broad applications both in vivo and ex vivo. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability. For more information about Tessera, please visit http://www.tesseratherapeutics.com.

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Tessera Therapeutics Adds New Executives to its Leadership Team as the Company Continues to Pioneer Gene Writing Technology as New Category in Genetic...