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‘World’s Greatest Tuba-Playing Car Salesman’ Bounces Back after Leukemia, Thanks to Wilmot Team – URMC
Posted: July 3, 2022 at 2:32 am
Returning home after a Fathers Day trip to New York City with his daughter in 2016, Scott Kesel thought he had come down with the flu. Bloodwork showed his blood platelets were lower than normal. He followed up with his regular physician and was given the news: he had chronic myelomonocytic leukemia (CMML).
CMML is a rare type of blood cancer that starts in the bone marrow, where blood cells are made. It can involve other areas of the body. There are only about 1,100 cases in the U.S. each year and its more common in people over age 60.
As a Canandaigua resident, Scott started his cancer journey at Wilmot Cancer Institutes Sands Cancer Center at F.F. Thompson. His oncologist laid out all the options: chemo and a stem cell transplant.
Knowing he would need a transplant, his team at Sands had him transfer to Wilmots Hematology team, where he began seeing Jason Mendler, M.D., and his transplant doctor, Omar Aljitawi, M.B.B.S.
He had chemotherapy at Wilmot, where he got to know the infusion nursing staff.
They have put a mindset in place thats so beneficial to the patient, he says.
For a stem cell transplant, his brother was the closest match they could find, although he was only a half-match. That left the option for a haplo-identical transplant available. Historically, it was required to have a closer match in order to do a transplant. With a haploidentical transplant, the donor is only half-matched. Its a newer procedure that is not available at all transplant centers, but the doctors at Wilmot have been performing the surgery since 2015.
He underwent the transplant but, unfortunately, in Scotts case, it didnt work.
For a short period, Scott went to another institution for a clinical trial. Unfortunately, that didnt work either. He developed pancreatitis and had to drop out of the trial. He also experienced cold agglutinin disease, which caused his immune system to attack his red blood cells. Cold temperatures can trigger it and he had to stay at Wilmot for about a month in a temperature-controlled room, set at 80 degrees at all times, to overcome it.
Once that resolved, the team at Wilmot suggested another treatment option to try on Scotts leukemia: a transplant with stem cells from an umbilical cord donation. Umbilical cord blood stem cells came from Australia and Spain to try to save Scotts life. He had only two cord blood units available and he needed both to have a successful transplant, which was his only viable chance to potentially cure his leukemia. Along with the cord blood, he also had radiation therapy with Louis Constine, M.D.
He had nothing but good things to say about the team that took care of him while he was hospitalized on Wilmot Cancer Centers sixth floor, the Blood and Marrow Transplant Unit.
It was exceptional. They were so friendly and accommodating right from the very beginning, he says. It wasnt limited to nurses. Theres medical technicians on the floor that were so friendly and became very good friends.
Scott Kesel (right) with Jason Mendler, M.D., at the 2019 Wilmot Warrior Walk
Thankfully, this time the transplant took. As of June 2022, Scott has been in remission for three-and-a-half years. He credits his team for getting him there.
Its an incredible group of people, he says.
But its not just his team hes grateful for. He appreciates that his life has returned basically back to normal, despite the tumultuous COVID pandemic that happened shortly after his transplant.
Hes gotten back to work and to hobbies he enjoys outside work.
I happen to be the worlds greatest tuba playing car salesman, he jokes.
This summer and fall, he has 28 gigs lined up, with different music groups around the region to keep him busy, and he looks forward to hunting and fishing during his free time.
For it all, he feels fortunate.
You have to be grateful for the outcome, he says. I got a lot of support remotely from people in my community who used the opportunity to promote bone marrow registration and blood drives, which was awful nice.
He adds, Im grateful that I ended up at Wilmot. I really couldnt have been in a better place.
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Hadjiargyrou Is New York Tech’s First Distinguished Professor | Box | New York Tech – New York Institute of Technology
Posted: July 3, 2022 at 2:32 am
Professor Michael Hadjiargyrou, Ph.D., chair of the Department of Biological and Chemical Sciences and director of the D.O./Ph.D. program, has been named New York Institute of Technologys first distinguished professor. This designation is found at most top research universities and recognizes outstanding faculty who have achieved the highest levels of scholarship over the course of their careers, earning national- and international-level distinctions and honors of the highest caliber.
Interim Provost Jerry Balentine, D.O., and I were 100 percent in agreement that Professor Hadjiargyrou should be the first at New York Tech to receive this designation, notes New York Tech President Hank Foley, Ph.D. We have some very impressive faculty researchers, and he is absolutely one of the best. He is instilling his passion for research in our students while conducting important work in our labs in a variety of areas.
Foley pointed to the range of Hadjiargyrous work, which includes studying polymeric electrospun nanofibers for cell/gene/drug delivery systems, gene and miRNA (microRNA) expression, stem cells, and the molecular and cellular basis for bone development and regeneration, and the exciting implications his research has for future applications, such as gene delivery and treatment of difficult fractures.
According to his Google Scholar profile, Hadjiargyrou has an h-index (a measure research impact based on the total number of his publications and citations) of 37, one of the highest of any New York Tech researcher and considered to be outstanding in the greater research community. Between 1998 and 2022, his published research has been cited 7,711 times. In addition to his scientific research, Hadjiargyrou has also published thought leadership and opinion pieces on topics ranging from scientific integrity to teaching practices.
I am humbled by being named distinguished professor, and I will continue to live up to the title, says Hadjiargyrou. I would like to deeply thank President Foley and Interim Provost Balentine, not only for bestowing this award, but more importantly, for their continual support of my research activities.
Hadjiargyrou, who joined New York Tech in 2012, has been responsible for reinvigorating the Department of Biological and Chemical Sciences, including enriching the curriculum and support for research activities; hiring talented, engaged faculty researchers; and establishing the D.O./Ph.D. program in medical and biological sciences. During his tenure, he has worked to expand the number of undergraduate research opportunities, which has become the hallmark of a New York Tech education.
The creation of a distinguished professorship at New York Tech supports our goals of becoming a [Carnegie-classified] Research 2 university within the next seven years, says Foley, pointing to the universitys other investments in research activities, including adding new instrumentation and resources, new graduate programs, and hiring new research faculty.
Every two to three years, the distinguished professorship role and criteria will be reviewed by the president and provost, and new candidates will be considered for the designation.
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The global tissue engineering market is anticipated to reach US$ 13,236.87 million in 2022 and is project – Benzinga
Posted: July 3, 2022 at 2:32 am
New York, July 01, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Tissue Engineering Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Material Type and Application" - https://www.reportlinker.com/p06289941/?utm_source=GNW However, the market is likely to get impacted by the high cost of treatments related to tissue engineering during the forecast period.
Tissue engineering is a biomedical engineering discipline that uses a combination of cells, engineering, material methods, and appropriate biochemical and physicochemical factors to regenerate, preserve, enhance, or replace various types of biological tissues. Tissue Engineering (TE) is a rapidly evolving discipline that aims to repair, replace, or regenerate tissues or organs by converting fundamental physics, chemistry, and biology knowledge into practical and effective materials or devices and clinical strategies.Tissue engineering has several primary functions in medicine and research: Assisting in tissue or organ repair, including bone repair (calcified tissue), cartilage tissue, heart tissue, pancreatic tissue, and vascular tissue.The field also researches the behavior of stem cells.
Stem cells can develop into many different cell types and help repair areas of the body.The 3D nature of tissue engineering allows the study of tumor architecture in a more detailed environment.
Tissue engineering also provides an environment to test potential new drugs for these diseases.The growth in the number of R&D activities with increasing awareness of tissue engineering in emerging markets is expected to support the global tissue engineering market growth.
Developed nations have adopted technological advances in tissue engineering and regenerative medicine that contribute to expanding the global tissue engineering market.Ever since severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared a public health emergency of international concern in late January 2020, medical professionals and researchers have been urging the need for comprehensive and rapid testing of citizens to plan measures that can contain the spread of the virus.The COVID-19 pandemic has become the most significant challenge across the world.
This challenge was frightening, especially in developing countries worldwide, as it expected to reduce imports due to disruptions in global trade in the coming years.To date, no definitive treatment against the COVID 19 has been established.
Hence, the lack of definitive therapy offers significant opportunities for the tissue engineering market as the US FDA has recently approved the use of plasma therapy for critically ill COVID 19 patients.
Over time, real-time polymerase chain reaction tests and antibody tests have emerged as vital techniques for the global healthcare system in managing the outbreak.The supply chain disruptions and the enormous demand for effective diagnostics and therapeutics for the treatment of COVID 19 put the healthcare research industry in a critical situation in various regions.
Risks were majorly on emerging markets that face healthcare constraints and tighter financial conditions. The COVID-19 pandemic also hampered clinical trials, drug development, and the diagnostics industry's operation in the region.Also, significant disruptions to routine research activities involving tissue engineering and regenerative medicines were observed due to the pandemic.Many industries were affected by the crisis, including tissue engineering research activities, due to the shutdown of research centers, lack of healthcare facilities, and an increasing number of cases.
However, after the emergence of the COVID-19 vaccine, research centers have commenced studies and research on stem cells, regenerative medicine, and other therapies. Hence, the tissue engineering market in Europe is gaining attention after the COVID-19 impact.Based on material type, the global tissue engineering market is segmented into synthetic material, biologically derived materials, and others.In 2022, the biologically derived materials segment is anticipated to account for the highest share of the global tissue engineering market.
A biomaterial plays a significant role in the development of tissue engineering and biomedical devices that naturally increase the regenerative potential of tissues to restore body mechanisms in a state of deterioration.Biologically derived materials are used in creating neo-tissues in vitro that are identical to their fundamental body parts.These materials also help in tissue regeneration by a controlled presentation and on-demand release of specific chemokines at injury sites, tissue-resembling structural, temporary biodegradable support matrices with natural and functional characteristics.
However, the synthetic material segment is likely to register the highest CAGR in the global tissue engineering market during the forecast period.Based on application, the global tissue engineering market is segmented into orthopedic, musculoskeletal & spine, neurology, cardiology and vascular, skin & integumentary, urology, GI & gynecology, cancer, and others.The orthopedic, musculoskeletal & spine segment is expected to lead the market in 2022.
However, the skin & integumentary segment is anticipated to register the highest CAGR in the global tissue engineering market during the forecast period.The World Health Organization (WHO), the US Food and Drug Administration (FDA), Centers For Disease Control And Prevention, American Heart Association, Biomedical Advanced Research and Development Authority, and Foundation For Innovative New Diagnostics are some of the major primary and secondary sources referred for preparing this report.Read the full report: https://www.reportlinker.com/p06289941/?utm_source=GNW
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The global tissue engineering market is anticipated to reach US$ 13,236.87 million in 2022 and is project - Benzinga
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He Helped Cure the London Patient of H.I.V. Then He Turned to Covid. – The New York Times
Posted: June 13, 2022 at 1:55 am
Visionaries is a limited series that looks at figures who are trying to transform the way we live.
Ravindra Gupta had studied drug-resistant H.I.V. for more than a decade when he first encountered Adam Castillejo, who would become known as the London patient, the second person in the world to be cured of H.I.V. Dr. Gupta, who goes by Ravi, was a professor at University College London straddling the clinical and academic worlds when Mr. Castillejo presented as both H.I.V.-positive and with relapsed lymphoma, after a previous transplant using healthy stem cells from Mr. Castillejos own body had failed.
Building on work by the German hematologist Gero Htter and others that went into curing the first person of H.I.V. Timothy Ray Brown, known as the Berlin patient Dr. Gupta and his colleagues proposed using stem cells from a donor with a rare genetic mutation that prevents certain individuals from being infected with H.I.V. Mr. Castillejo agreed and had his transplant in 2016. Seventeen months later, Dr. Gupta and his team took Mr. Castillejo off the antiretroviral drugs that kept his H.I.V. at bay. In 2019, three years after the transplant, Dr. Gupta published the results in Nature, confirming Mr. Castillejo was cured of H.I.V.
The news shook the scientific world and revitalized the search for a cure. Dr. Gupta was hired as a professor of clinical microbiology at Cambridge and established Gupta Lab on the schools biomedical campus to continue his research.
A few months later, the coronavirus pandemic hit and with nations going into lockdown and medical systems taxed to their breaking point, he found himself drawn into the response.
Respiratory viruses were never anything I would consider getting into. I didnt think we had the skills or expertise to be useful, Dr. Gupta said recently. But, he added, the clinical interface of what I do dragged me into working on SARS. Things got bad here in March, and everything shut down. One of the desperate needs was identified as rapid testing.
Soon his team had completely pivoted and was publishing some of the first research validating rapid and antibody tests for the coronavirus using techniques honed during H.I.V. research. Over the past two and a half years, Gupta Lab has cranked out cutting-edge research, describing how new variants arise and providing some of the first evidence that breakthrough Covid infections were possible in vaccinated individuals.
At his lab at Cambridge, he discussed both the remarkable strides made by scientists over the past three years, as well as the consequences of the publics diminishing trust in scientific knowledge.
This interview has been condensed and edited.
How has earlier research on AIDS/H.I.V. affected the response to the coronavirus?
The response to SARS-CoV-2 has accelerated largely because of H.I.V. advances. There have been huge advances in how we make drugs, target viruses, and a lot of this technology has been honed on H.I.V.
What are the similarities between these two pandemics?
Both have created a huge panic, SARS-CoV-2 more than H.I.V. for good reason, because it is respiratory. Certain people are more vulnerable than others, and socioeconomics certainly matters. Also, in this age of availability of vaccines, the rich versus poor, global north versus global south all of those inequalities have been coming through.
Has this global emergency improved your ability to work with your colleagues across various disciplines?
Its certainly galvanized a load of interactions we otherwise wouldnt have done. We got interested in immunology, we did some very cutting-edge work with colleagues downstairs and in different parts of the building. We started using stem cells to make artificial lungs to do experiments in. All of these things started happening as a result of the emergency. People who we would have never talked to, ideas we would have never had. So its really been exciting scientifically.
Does fatigue account for the publics waning response to Covid?
Yeah, I think so. I think the intensity has caused a burnout of emotional energy. Of course strides have been made in H.I.V. over about 20 years. That happened very quickly for Covid. And in the absence of a vaccine and mRNA technology, we would be in a much darker place.
Across society we are seeing a decline in trust in institutions, but in your field there are rather severe consequences to people refusing to get a vaccine, for example. Has that affected the way you think scientists and the medical establishment must communicate with the public?
I think theres a general lack of trust between the public and people who provide information. Thats partly driven by sectors of the public spreading misinformation. I think the actual communication was quite good in the beginning you got clear messages and I think it was quite good. Public health messaging has gotten more complex because no one wants to wear masks.
For example, after vaccination, people thought wed be mask-free. We published a paper in Nature on breakthrough infections and the C.D.C. the next week cited our work as a reason to mask, even with the vaccine. Which sounds normal now, but back then it drove people crazy. But it was the right thing because your responses after a few months could wane, and plenty of people with double-dose vaccinations can end up with re-infections the second time around. So that all contributed to confusion based on lack of education or knowledge of nuance. And one thing we have to deal with now is that communication takes nuance that even scientists cant grasp. So expecting the public to grasp this is pretty much impossible. So were at a crossroads for how we communicate complex messages.
Are there long-term implications if we cant persuade a larger proportion of the population to be vaccinated?
Circulation may take off in places like China, where the population has been relatively nave when it comes to vaccines, and the vaccines arent necessarily the best ones. And if people dont get their boosters on time, we may end up reaching a period when it becomes another major health problem of the magnitude we have already seen. I can foresee in a few years time we may be in trouble again. The worrying thing is that we are winding down a lot of things we developed to deal with this.
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Biden to Pause New Solar Tariffs as White House Aims to Boost Adoption – The New York Times
Posted: June 13, 2022 at 1:55 am
WASHINGTON The Biden administration on Monday announced a two-year pause on imposing any new tariffs on the solar industry, a decision that follows an outcry from importers who have complained the levies are threatening broader adoption of solar energy in the United States.
The move is a victory for domestic solar installers, who said the tariffs would put at risk the Biden administrations goal of significantly cutting carbon emissions by the end of the decade by reducing the flow of products into the United States. But it goes against the wishes of some American solar manufacturers and their defenders, who have been pushing the administration to erect tougher barriers on cheap imports to help revive the domestic industry.
It was the latest example of President Bidens being caught between competing impulses when it comes to trying to steer the United States away from planet-warming fossil fuels, as he has pledged to do. By limiting tariffs, Mr. Biden will ensure a sufficient and cheap supply of solar panels at a time of high inflation and attempt to put stalled solar projects back on track. But the decision will postpone other White House efforts that might have punished Chinese companies for trade violations and lessened Beijings role in global supply chains.
To counteract complaints by the domestic solar industry, the administration said that Mr. Biden would attempt to speed U.S. manufacturing of solar components, including by invoking the authorities of the Defense Production Act, which gives the president expanded powers and funding to direct the activities of private businesses.
The prospect of additional tariffs stemmed from an ongoing investigation by the Commerce Department, which is looking into whether Chinese solar firms which are already subject to tariffs tried to get around those levies by moving their operations out of China and into Southeast Asia.
Auxin Solar, a small manufacturer of solar panels based in California, had requested the inquiry, which is examining imports from Vietnam, Malaysia, Thailand and Cambodia.
In 2020, 89 percent of the solar modules used in the United States were imported, with Southeast Asian countries accounting for the bulk of the shipments.
If the Commerce Department determines that the factories were set up to circumvent U.S. tariffs, the administration could retroactively impose tariffs on shipments to the United States. But under the tariff pause that Mr. Biden ordered on Monday, such levies could not be imposed for the next two years.
The decision is the latest turn in a long game of whack-a-mole the U.S. government has played against low-priced imports in the solar industry.
While U.S. companies were some of the first to introduce solar technology, China came to dominate global solar manufacturing in recent decades by subsidizing production and creating a vibrant domestic market for solar installation. In 2011, the United States imposed duties on Chinese products to counteract subsidies and unfairly low prices. U.S. installers then started buying more products from Taiwan, but in 2015 the United States imposed duties on Taiwan as well.
Trade experts said that pausing the tariffs could undercut trade laws aimed at protecting American workers by allowing companies in China to continue flooding the United States with cheap imports.
On Monday, Auxins chief executive, Mamun Rashid, said President Biden was interfering with the investigation.
By taking this unprecedented and potentially illegal action, he has opened the door wide for Chinese-funded special interests to defeat the fair application of U.S. trade law, Mr. Rashid said in a statement.
To pause the tariffs, a Biden administration official said the administration was invoking a section of the 1930 Tariff Act, which allows the president to suspend certain import duties to address an emergency. Commerce Department officials said their investigation would continue and that any tariffs that resulted from their findings would begin after the 24-month pause expired.
The presidents emergency declaration ensures Americas families have access to reliable and clean electricity while also ensuring we have the ability to hold our trading partners accountable to their commitments, Gina Raimondo, the Commerce secretary, said in a release.
The possibility of tariffs has touched off an ugly battle in recent months over the future of the U.S. solar industry.
American solar companies have said that the prospect of more and retroactive tariffs was already having a chilling effect on imports. Groups such as the Solar Energy Industries Association, whose members include several Chinese manufacturers with U.S. operations, have been lobbying the White House against the tariffs and on Monday welcomed news that the administration would pause any new levies.
Todays actions protect existing solar jobs, will lead to increased employment in the solar industry and foster a robust solar manufacturing base here at home, Abigail Ross Hopper, the president and chief executive of S.E.I.A., said in an emailed statement.
During the two-year tariff suspension window, she said, the U.S. solar industry can return to rapid deployment while the Defense Production Act helps grow American solar manufacturing.
Companies that rely on imported products and U.S. officials who are prioritizing the transition to solar energy have been complaining that the Commerce Department inquiry has injected uncertainty into future pricing for the solar market, slowing the transition away from fossil fuels. NextEra Energy, one of the largest renewable energy companies in the country, had said it expected to delay the installation of between two and three gigawatts worth of solar and storage construction enough to power more than a million homes.
The last couple of months we have had to pause all construction efforts, said Scott Buckley, president of Green Lantern Solar, a solar installer based in Vermont. Mr. Buckley said his company had been forced to put about 10 projects on hold, which would have resulted in the installation of about 50 acres of solar panels.
Mr. Buckley said there was no easy solution to the countrys reliance on imported products in the short term and that the White Houses actions on Monday would allow companies like his to resume installations this year.
This is a get back to work order, he said. Thats the way I think about it. Lets clear the logjams.
But domestic solar producers and U.S. labor unions have said that the recent surge in imports from Chinese companies doing their manufacturing in Southeast Asia clearly violates U.S. trade law, which forbids companies to try to avoid U.S. tariffs by moving production or assembly of a product to another country.
The domestic producers have accused importers who have close commercial ties with China of exaggerating their industrys hardships to try to sway the Biden administration and preserve profit margins that stem from unfairly priced imports.
If you have a supply chain that depends on dumped and subsidized imports, then youve got a problem with your supply chain, said Scott Paul, the president of the Alliance for American Manufacturing.
Were getting dependent on hostile countries without sufficient domestic production to ensure against price hikes and supply shocks, said Michael Stumo, chief executive of Coalition for a Prosperous America, a nonprofit group that promotes domestic manufacturing. Whether its medicine, or PPE, or solar panels, youve got to have domestic production.
Some critics also said the legal rationale for the White Houses moves was specious, arguing that the administration was effectively declaring a state of emergency because of the consequences of its own trade laws.
Scott Lincicome, a trade policy expert at the Cato Institute, a libertarian think tank, said that the administrations actions seemed to be quite the stretch of the statute.
The trade law provision that Mr. Biden invoked allows the president to declare an emergency to exist by reason of a state of war, or otherwise, and during such a state of emergency to import food, clothing, and medical, surgical, and other supplies for use in emergency relief work duty free.
He said critics of U.S. tariffs had long proposed a public interest test that would allow levies to be lifted to mitigate broader economic harm, but Congress had never approved such an action.
In a letter late last month, Senators Sherrod Brown of Ohio and Bob Casey of Pennsylvania, both Democrats, complained that solar importers had spent millions of dollars on advertising and lobbying to urge political interference in the trade enforcement process. Biden administration officials had previously said that the Commerce Departments inquiry was immune to political interference, describing it as quasi-judicial and apolitical.
Solar tariffs have been a source of contention for decades, but they have taken on renewed importance in recent years as the consequences of climate change became more apparent. Chinese companies have expanded internationally, allowing them to continue to ship products to the United States, while American companies have struggled to compete.
The global solar industrys dependence on China has complicated the Biden administrations efforts to ban products linked with forced labor in Xinjiang, the northwest region where U.S. officials say Chinese authorities have detained more than one million Uyghurs and other minorities. Xinjiang is a major producer of polysilicon, the raw material for solar panels.
Solar importers complained that a ban last year on solar raw materials made with forced labor by Hoshine Silicon Industry temporarily halted billions of dollars of American projects, as companies struggled to produce documentation to customs officials to prove that neither they nor their suppliers were obtaining material from Hoshine.
After the Russia invasion of Ukraine in February, high gasoline prices have also impeded a broader desire to push the country away from oil and left Mr. Biden asking oil-producing nations in the Middle East and beyond to ramp up production.
White House officials said Monday that Mr. Biden would sign a suite of directives meant to increase the domestic development of low-emission energy technologies. He is set to make it easier for domestic suppliers to sell solar systems to the federal government. And he will order the Department of Energy to use the Defense Production Act to rapidly expand American manufacturing of solar panel parts, building insulation, heat pumps, power grid infrastructure and fuel cells, the administration said in a fact sheet.
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Gamida Cell to Present Corporate Highlights at the Jefferies Healthcare Conference – Business Wire
Posted: June 4, 2022 at 2:25 am
BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, announces that company management will present its corporate highlights at the Jefferies Healthcare Conference, June 8, 2022 with a presentation at 11:00 a.m. ET in New York, NY.
Management will discuss 2022 catalysts and potential milestones including the U.S. market opportunity for omidubicel upon potential U.S. Food and Drug Administration approval, accelerating the development of its first-in-class NAM-enabled natural killer (NK) cell therapy candidate, GDA-201, as a potential new approach for patients with follicular and diffuse large B-cell lymphomas, and expansion of its NAM-enabled cell therapy pipeline with multiple next-generation, genetically engineered NK cells.
A webcast of the event will be available on the Investors & Media section of Gamida Cells website at http://www.gamida-cell.com, and will be available for at least 14 days following the event.
About Omidubicel
Omidubicel is an advanced cell therapy candidate under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. Gamida Cell has completed an international, multi-center, randomized Phase 3 study (NCT0273029) evaluating the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. That study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patients recovery from a stem cell transplant. The Phase 3 study also achieved its secondary endpoints of reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. Gamida Cell initiated a rolling BLA submission for omidubicel in the first quarter of 2022 with full BLA submission on track for the second quarter of 2022. In 2019, approximately 8,000 patients who were 12 years old and up with hematologic malignancies underwent an allogeneic stem cell transplant.1 Unfortunately it is estimated that another 1,200 patients were eligible for transplant but could not find a donor source.2 Omidubicel has the opportunity, upon FDA approval to improve outcomes for patients based on transplanter feedback and increase access for patients to get to transplant. Omidubicel has the potential to treat approximately 2000 2500 patients each year in the U.S. For more information about omidubicel, please visit https://www.gamida-cell.com.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About GDA-201
Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the E.U.5 and U.S. which is the patient population that will be studied in the GDA-201 Phase 1/2 clinical trial.
For more information about GDA-201, please visit https://www.gamida-cell.com. For more information on the Phase 1/2 clinical trial of GDA-201, please visit http://www.clinicaltrials.gov.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About NAM Technology
Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (Nicotinamide), we can expand and metabolically modulate multiple cell types including stem cells and natural killer cells with appropriate growth factors to maintain the cells active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapies with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of, and data reported from, the clinical trials of Gamida Cells product candidates (including GDA-201), anticipated regulatory filings (including the timing of submission of the BLA for omidubicel to the FDA), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cells product candidates (including GDA-201 and omidubicel), and Gamida Cells expectations for the expected clinical development milestones set forth herein. Any statement describing Gamida Cells goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cells clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 24, 2022, as amended, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cells forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
1CIBMTR 2019 allogeneic transplants in patients 12+ years with hematological malignancies.2Gamida Cell market research
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Gamida Cell to Present Corporate Highlights at the Jefferies Healthcare Conference - Business Wire
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ReCode Therapeutics to Present at Jefferies Healthcare Conference – Benzinga – Benzinga
Posted: June 4, 2022 at 2:25 am
ReCode Therapeutics, a biopharmaceutical company powering the next wave of genetic medicines through superior delivery, today announced that David Lockhart, Ph.D., President & Chief Scientific Officer of ReCode Therapeutics will present a corporate overview on Friday, June 10th from 11:00 - 11:25 a.m. ET at the Jefferies Healthcare Conference being held in New York, NY from June 8-10, 2022.
About ReCode Therapeutics
ReCode Therapeutics is a biopharmaceutical company powering the next wave of genetic medicines through superior delivery. ReCode's Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform is a next-generation LNP delivery technology to target organs and tissues beyond the liver. The SORT LNP platform is the foundation for ReCode's pipeline of disease-modifying mRNA and gene-correction based therapeutics for genetically defined diseases for which there are few or no current treatments. ReCode's lead programs are focused on primary ciliary dyskinesia, and cystic fibrosis caused by Class I mutations. ReCode is leveraging its SORT LNP platform and nucleic acid technologies for mRNA-mediated replacement and gene correction in target cells, including stem cells. For more information, visit http://www.recodetx.com and follow us on Twitter @ReCodeTx and LinkedIn.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220603005002/en/
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ReCode Therapeutics to Present at Jefferies Healthcare Conference - Benzinga - Benzinga
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A Medical History of Transplant Surgery Thats Not for the Squeamish – The New York Times
Posted: May 15, 2022 at 2:50 am
SPARE PARTSThe Story of Medicine Through the History of Transplant SurgeryBy Paul Craddock
Paul Craddocks Spare Parts: The Story of Medicine Through the History of Transplant Surgery opens midoperation, as a donor organ (this lifeless gray mass, as Craddock describes it) is sewn into place. Clamps released, the new kidney comes alive, or appears to. Before my eyes, the surgeon removed these devices and in a matter of seconds the kidney turned from gray to pink, then almost red, Craddock writes. It seemed as if life itself had cascaded from one mans body into anothers. The operation is described as state of the art, yet Craddock, a senior research associate in the division of surgery and interventional sciences at the University College of Londons medical school, sets out to show the ancient roots of transplantation. Transplant surgery is far from an exclusively modern phenomenon, he writes, with a surprisingly long and rich history that stretches back as far as the pyramids.
And so we are off, on a thrilling and often terrifying ride through transplantation and the theories and techniques that made it possible. It begins in Renaissance Italy, where the push for rhinoplasty came not from kings but from the general populace, who had perfected skin grafts long before the European medical profession such as it was. (The Sushruta Samhita, a 500 B.C. Sanskrit text that Craddock cites, described skin grafts, among hundreds of other surgeries.) Craddocks tantalizing opening assertion is that late-16th-century specialists were merely catching up with farmers, who had long ago learned a way to graft skin from an arm to a nose, masking nasal bridge collapses caused by syphilis or mutilation from duels, both common. In Italy, skin grafting had evolved as a peasants operation, linked culturally and technically to the farmers procedure of plant grafting.
The book is arranged chronologically by procedure: from that 16th-century skin grafting to 17th-century blood transfusions to 18th-century tooth transplants. It skips lightly over the 1800s (and the development of germ theory, anesthesia and nursing) and winds up with 20th-century kidney and heart transplants. Craddock explains the scientific theories underlying each new technique and then he highlights a star, or several. In addition to nose repair, Leonardo Fioravanti claimed to have cured leprosy and discovered the antiseptic attributes of aquavit and urine; in 16th-century Bologna, he urinated on patients (literally) while metaphorically urinating on a medical establishment he saw as devoted to moribund classical texts. As Craddock puts it, Fioravanti preferred to base his own medical system on the collective, intuitive wisdom of centuries a live tradition with no written component as opposed to a raft of dead, book-learned knowledge.
The reigning such text was by Galen of Pergamon, the first-century Greek philosopher, who was silent on skin grafts (Aristotle related the bodys largest organ to the crust on a polenta) but famously described health in terms of the four humors blood, yellow bile, phlegm and black bile, the flow of which was thought to be affected by mood, personality and the stars. Medicine was a matter of humoral balance, often regulated by bleeding. Galens anatomical descriptions, though still gospel in the 16th century, were hampered by a Roman rule against dissection of humans. When Andreas Vesalius, a Flemish anatomist, published On the Fabric of the Human Body in 1543, based on his own dissection of corpses, it helped to highlight the importance of scientific observation and to reconceive the heart as pumplike. It also stressed the idea that blood was better inside the body than out inspiring a slew of experiments that made life in Paris and London horrible for dogs. The heart was now perceived as a ruler or king, the seat and organ of all passions, prompting questions about dogs (whether a fierce Dog by being often new stocked with the blood of a cowardly Dog, may not be more tame) and then humans. In 1667, French doctors infused a man with calfs blood in part to improve his character. Sheep, docile in the Bible, were a go-to for human transfusion, though a butcher, infused by members of an English scientific society, irritated doctors when he slaughtered and then ate his donor. By 1700, a faint professional decorum, fortified by public ridicule, shut the experiments down.
The generally unsuccessful attempts to transplant teeth, Craddock argues, coincided with a view of the body as a machine, complete with transferable parts complicating the work of philosophers, and enriching that of salespeople. Enter the dentist, offering advice (gargle with urine!) and private tooth transplants to fancy customers put off by public tooth-yankers. The new teeth were eventually supplied by young and poor mouths: As Craddock points out, the dystopian reality of body shopping has a dark precedent in teeth. The search for what animated the human machine also led to theories on nerves and the associated disorders observed to particularly affect the more developed upper classes. The soul was body-bound, a material thing that pulsed through it.
Cut to 1901. Immunology is a new discipline, and the previous blood types dog, cat, sheep, human have evolved into our modern iteration, named by the Viennese researcher Karl Landsteiner. In the same year, Alexis Carrel, a young French surgeon whose mother owned textile factories, studied with Marie-Anne Leroudier, one of Lyons finest embroiderers (and one of very few women featured in Spare Parts). Leroudiers dexterity in handling unfathomable intricate decaying fabrics taught the young surgeon how to stitch together blood vessels, making kidney and heart transplants as well as bypass surgery possible, though her contributions were minimized by Carrel and the bulk of Western scientific history. After being drummed out of Europe, Carrel, whose experiments make Dr. Frankenstein look like a genial Marcus Welby, landed in 1930s New York, where his passion for eugenics earned him the friendship of Charles Lindberg. Together, they would invent a perfusion device to keep an organ viable outside the body all in the pursuit of weeding the weak from society. Carrels book, Man, the Unknown, was a U.S. best seller in 1936; the German edition praised the Nazis eugenics work.
The first heart transplant surgeons were less health- than prize-oriented. As one doctor put it: Virtually all the patients subject to the procedure died, having satisfied the macho aspirations of their surgeons. Meanwhile, any technical successes had more to do with medicines deeper communal understanding of immunology how to address organ rejection than with surgical breakthroughs.
Craddocks conclusion is meant to feel hopeful: According to colleagues at U.C.L. in London, printing an entire replacement body part might only be a decade away. But it doesnt reassure so much as concern a reader, especially given the case of Paolo Macchiarini, the U.C.L.-affiliated celebrity surgeon (unmentioned by Craddock) widely lauded for performing the worlds first synthetic trachea transplants using stem cells but currently on trial in Sweden for aggravated assault against his patients. In fact, what inspires most hope is what ends up seeming like the accidental subtext of Spare Parts. It relates to the way Renaissance Italian farmers saw themselves in trees: distinctly individual trees that, as Craddock notes, science has only recently become aware are in communication with one another, not to mention us. If we look more carefully at the forest, the past indicates, we just might repair ourselves through the trees.
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Mesenchymal Stem Cells Market to Witness Growth Acceleration | Celprogen Inc., Thermo Fisher Scientific, Inc. Queen Anne and Mangolia News – Queen…
Posted: May 15, 2022 at 2:50 am
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CORRECTING and REPLACING Paracrine Announces Appointment of Biotech Veteran David H. Crean, Ph.D. to the Board of Directors – Business Wire
Posted: May 15, 2022 at 2:50 am
SAN DIEGO--(BUSINESS WIRE)--Please replace the release with the following corrected version due to multiple revisions.
The updated release reads:
PARACRINE ANNOUNCES APPOINTMENT OF BIOTECH VETERAN DAVID H. CREAN, PH.D. TO THE BOARD OF DIRECTORS
Paracrine, Inc., a privately-held company developing its novel cell therapy platform in late-stage clinical trials in advanced wound care, announced today the appointment of David H. Crean, Ph.D. as an independent Director of the company.
We are delighted to welcome Dr. Crean to the Paracrine Board, said Christopher J. Calhoun, Chairman and CEO of Paracrine. Davids board and advisory experiences in the healthcare and biotechnology fields will provide immense value to Paracrine as we continue to execute our strategy of developing safe, cost-effective cell therapies in the $21 billion wound care market.
I am happy to join Paracrines Board of Directors at this exciting time in the companys development, added David H. Crean, Ph.D. Together with the team, I am looking forward to contributing to Paracrines clinical and commercialization strategy, achieving the companys financing goals and successfully implementing our vision of providing urgently needed innovative therapeutic options in chronic wound care. I am particularly excited with our lead program in treating diabetic foot ulcers, where prior studies have demonstrated Paracrines cell therapy resulted in twice the wound closure rate of non-healing ulcers in half the time.
David is Founder and Managing Partner of Cardiff Advisory LLC, an investment banking firm focused on providing strategic and financial advisory for M&A, partnering and capital financing transactions within the life sciences and healthcare sectors. David is also a Co-Founder and Managing General Partner of Equitos Venture Partners, a life sciences-focused investment firm with a goal to start deploying capital in 2022. In addition, David is an investment partner with Suncoast Venture Partners and Mesa Verde Venture Partners, two micro life science seed stage & incubator venture funds.
Dr. Crean currently serves as Chairman of the Board of Directors for Phoenix Molecular Designs, Lead Independent Director of Histogen, Inc. (Nasdaq: HSTO) and serves on the Board of Directors of California Life Sciences (Executive Committee), and BIOCOM (Chairman of Capital Development).
David is a contributing writer for PharmaBoardroom.com and Forbes.com. As a result of his trusted and outstanding advisory work, he has been awarded numerous recognitions including San Diegos 500 Most Influential people in 2019 - 2021, 2020 Top Thought Leaders by Axial, M&A Advisor of the Year in 2019, and the 2018 Healthcare Hero Award.
David holds FINRA Series 79 and Series 63 licenses and is a Registered Investment Banking Representative of BA Securities LLC, Member FINRA SIPC. He holds a Doctorate of Philosophy (Ph.D.) Degree in Biophysics and a Masters of Science (MS) Degree in Oncology from the State University of New York at Buffalo. He earned a Bachelor of Science (BS) Degree in Biology/ Pre-Med from Canisius College. Additionally, he holds a Masters of Business Administration (MBA) Degree with a finance concentration from Pepperdine University Graziadio School of Management.
About Paracrine
Paracrine, Inc. is a biotechnology company committed to unlocking the potential of autologous stem cells for patients suffering from serious chronic illnesses by discovering, developing, and delivering innovative and effective human therapeutics. The company is advancing multiple late-stage clinical trials, initially targeting the $21 billion advanced wound care market segment. Paracrines device-enabled cell therapy platform bears the promise of cost-effectively addressing common underlying pathology of debilitating chronic diseases due to its multi-modal mechanisms of action.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Paracrine assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.
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