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A new federal ethics advisory board for fetal tissue research has convened to consider future federally-funded research proposals that involve tissue from aborted babies.
The Human Fetal Tissue Research Ethics Advisory Board of the National Institutes of Health (NIH) met for the first time on July 31, to advise the Health Secretary on the ethics of research proposals involving fetal tissue of aborted babies.
The board was first announced in June of 2019, when the Trump administration decided to halt new research with aborted fetal tissue at NIH facilities, and limited funding of such research conducted outside the NIH.
For the research conducted outside the NIH, or extramural research, the administration announced that an ethics advisory board would be appointed to consider such funding and advise the secretary of Health and Human Services (HHS) on the proposals.
Some researchers have called for the administration to end its moratorium, saying that research with aborted fetal tissue could be vital to developing treatments and a cure for the new coronavirus (SARS-CoV-2).
In February, the HHS announced that it would begin accepting nominations to the board, and during that time period, some researchers at an NIH research laboratory told theWashington Postthat the administrations moratorium on fetal tissue research was hindering possible advances in research on treatments for the coronavirus.
Dr. David Prentice, now a member of the NIH Human Fetal Tissue Research Ethics Advisory Board, told CNA in March that the timing of the comments was peculiar as it could have been related to the consideration of appointments to the board.
Several leading coronavirus vaccine candidates are using cell lines from aborted babies, including some funded by the U.S.; other candidates have been determined to be ethically uncontroversial by the pro-life Charlotte Lozier Institute.
One candidate in particularbeing developed by Moderna and the National Institute of Allergy and Infectious Diseasesis not using fetal cell lines directly in production, but is based on research that involved aborted fetal cell lines. As Moderna was not involved in that research, CLI said that the vaccine candidate is ethically uncontroversial.
The NIH ethics board members are appointed for a duration that lasts as long as the board is convened; the boards charter says that [t]he estimated annual person-years of staff support required is 0.7. Appointments to the board are made by the HHS secretary.
Heading the advisory board is Paige Cunningham, interim president of Taylor University, an evangelical Christian university in Indiana.
Several Catholic bioethicists are on the board, including Fr. Tadeusz Pacholczyk, director of education at the National Catholic Bioethics Center. The co-chair of the Catholic Medical Association (CMA) ethics committee, Greg Burke, is a member, along with CMA member Dr. Ashley Fernandes of the Ohio State University medical school.
The pro-life Charlotte Lozier Institute (CLI) is also represented on the board, with CLI vice president Dr. David Prentice and associate scholars Ingrid Skop and Maureen Condic as members.
Some board members, such as Dr. Lawrence Goldstein of the University of California San Diego, support fetal tissue research; hecalledcell lines from fetal tissue critical in vaccine development, along with stem cell research and the use of humanized mice to develop immune cell-forming tissues.
Two members testified in 2016 before the House select investigative panel of the Energy and Commerce Committee, in a hearing on bioethics and fetal tissue.
Cunningham said at the hearing that [t]he fetus is a human subject entitled to the protections that both traditional and modern codes of medical ethics provide to human subjects.
Kevin Donovan, MD, director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, also testified, noting the current moral ambiguity in the nations discourse on abortion.
We have decided that we can legally abort the same fetus that might otherwise be a candidate for fetal surgery, even using the same indications as justification for acts that are diametrically opposed, he said. We call it the fetus if it is to be aborted and its tissues and organs transferred to a scientific lab. We call it a baby, even at the same stage of gestation, when someone plans to keep it and bring it into their home.
If we cannot act with moral certainty regarding the appropriate respect and dignity of the fetus, we cannot morally justify its destruction, he said.
During the public portion of the July 31 meeting, board members were introduced and then heard from several researchers who were either in support of or in opposition to research using fetal tissue from elective abortions.
The 2008 Vatican documentDignitatis Personaeaddressed the topic of aborted fetal tissue research, saying that there is a duty to refuse to use such biological material even when there is no close connection between the researcher and the actions of those who performed the artificial fertilization or the abortion, or when there was no prior agreement with the centers in which the artificial fertilization took place.
This duty springs from the necessity to remove oneself, within the area of ones own research, from a gravely unjust legal situation and to affirm with clarity the value of human life, the Congregation for the Doctrine of the Faith document stated.
Ruben Mesa, MD, director, Mays Cancer Center at The University of Texas Health San Antonio, MD Anderson Cancer Center San Antonio, TX, reviewed a case of a 68-year-old woman with a myeloproliferative neoplasm, during a virtual Case Based Peer Perspectives event.
Targeted Oncology: What type of testing would you perform on this patient? Are there certain mutations in particular that you are looking for?
MESA: The NGS [next-generation sequencing] panels are helpful. In myelofibrosis, theyre the most necessary in the potential transplant candidate [who is] of intermediate risk [and for whom] youre uncertain of the [prognosis]. In patients who are high risk, its also useful information. If someone hasoverwhelmingly high-risk disease, theyre not going to be at higher risk [based on these results], but I think its helpful information that we continue to learn about in terms of clonal evolution. Or, if they go to transplant, we know what the clones look like at the onset prior to undertaking [the trans- plant]. Our medical therapies have not resolved these muta- tions, but of course that could change. Its helpful information for us to know.
There are bad actors like ASXL1, EZH1/2, [and] the IDH1 muta- tions. The absence of a bunch of these somatic mutations is somewhat reassuring. Its helpful in combination with the clini- cal data. How are they feeling as far as their spleen, cytopenias, etcetera? There are [many] of these models that have been created, and some of which now have genetic data only. Thats probably incomplete. I can put the stained clone in 2 different patients, but if one is 45 years old and healthy and the other is 70 years old with comorbidities, theres no way those patients are doing the same. I think the clone is important, but the clone always has to live in a person.
Which risk-assessment tool do you use most often?
MIPSS [Mutation-Enhanced International Prognostic Score System] is the most popular, and it has a couple of advantages. One is that it has its own website; you can Google it and book- mark it on your computer. I always tell my trainees, dont bother to memorize any prognostic score in terms of how to calculate it because we have [a] calculator. But have a sense of what...the biological [characteristics are] that make a difference in terms of the prognosis for patients that give you some insight into the behavior of the disease. Have a sense of where and when that [is] useful.
There have been multiple models that have been validated. They help to stratify patients in terms of their outcomes in a range of ways. They are largely surrogates [of transformation to acute myeloid leukemia] as well, although its a different issue. The outcome for the patient with myelofibrosis if they pass away from the diseasewhich is still the majority of patientsis [that] they either die of progressive features of myelofibrosis, which can include progressive debilitation, cytopenias, and a range of complications related to that, or they progress to acute leuke- mia and can pass away from those sets of difficulty.
Why are prognostic models referenced in the National Comprehensive Cancer Network (NCCN) guidelines?
I was involved with the original NCCN guidelines for MPNs [myeloproliferative neoplasms].1 Originally, we had the prog- nostic score, or at that point the DIPSS [Dynamic International Prognostic Scoring System] or the DIPSS-Plus...to help stratify whos lower risk or whos higher risk in terms of therapy to get rid of some of the granularity.
Would you consider transplant in this case?
I have had patients who have done well with transplant. Transplant can be curative, but we can also wait too long, partic- ularly in the setting of myelofibrosis. I think when its being used as salvage therapy in myelofibrosis, the outcomes are less [successful] than we would like. In my estimation, the best time to have a transplant is probably before either the patient or physician really feels the patient needs one. Its during their optimal JAK inhibitor response that they probably do the best. Now, on the flip side, thats the time that they have the most to lose in that their quality of life is good and theyre stable. Its a difficult decision.
Which systemic therapies might you consider in this patient?
In terms of medical therapy, we now have 2 approved ther- apies in the front line, both ruxolitinib [Jakafi] and fedratinib [Inrebic], and many others in development that were discussed at the ASCO [American Society of Clinical Oncology] Annual Meeting and at the 25th Annual Congress of EHA [European Hematology Association].
Ruxolitinib has now been approved for a long time with data from the randomized studiesnow almost historical in nature with the COMFORT studies, both COMFORT-I [NCT00952289] and COMFORT-II [NCT00934544]. It showed for the first time in randomized settings a drug that was effective in myelofibrosis. Ruxolitinib was clearly better than placebo [and best alternative therapy] in the COMFORT-I study that Srdan Verstovsek, MD, PhD, and I led, and which was a European study.2
That was relevant because at the time the standard of care was Hydrea [hydroxyurea]. We recognized in retrospect that hydroxyurea is not as great a therapy for myelofibrosis. Its good therapy for ET [essential thrombocytopenia]. It helps to control platelets reasonably well in many, but its not a perfect drug. In polycythemia vera, its a reasonable frontline therapy, although interferon may have advantages. In myelofibrosis, it might help with leukocytosis but doesnt do much for splenomegaly symp- toms, anemia, fibrosis, or progression toward acute leukemia.
Would you send her for transplant, start ruxolitinib or fedratinib, observation, or something else?
Ill remind [you that] this patient is 68 years old, has a big spleen, has a JAK2 mutation, and leukoerythroblastosis...most physicians would start her on ruxolitinib. That would surely be consistent with our NCCN guidelines.1 Some would refer [her] for stem cell transplant. That would not be incorrect. She has some higher- risk features. She has anemia, 2% [peripheral blood] blasts, and mild thrombocytopenia. In all honesty, some of these things we do in parallel.
I dont typically [rely on transplant], but I do send patients who are potentially eligible to visit with a transplant physician so that that process can start. The patient can learn more about the process. We could see what a potential donor solution would be. We could see what sort of initial response to therapy that they have. Patients who go to transplant would likely start JAK inhibi- tion before they would go [for their transplant]. Even if they found a good sibling match, and the patient wants to go through with that, its probably going to take 3 to 4 months and they can be on JAK inhibition before that. They might have a better outcome with the spleen being smaller and going to transplant better. [Its] a bit of an artificial question in that you might choose to do more than one of these things in parallel.
What are the advantages of JAK inhibition with ruxolitinib?
There are patients from the phase 1 study of ruxolitinib at our centers that are still on the therapy. These are individuals that had expected survival [times] of under 3 years. I think that patients that are having a great response to JAK inhibition have their natural history improved. Splenomegaly symptoms were both clinically meaningful [and measurable according to early ruxolitinib activity].
Every time weve looked at it, there is an indication that ruxoli- tinib improves survival for patients. Now, the studies were not survival studies in their design, and that was for a variety of reasons. It would have been largely unethical and unrealistic to expect patients to stay on placebo forever so that they could do worse on a control arm [to prove] survival advantage. Having been involved with caring for patients with myelofibrosis before JAK inhibitors and after, theres no question that these drugs improve survival. Id say that the rate by which patients passed away...has decreased significantly over the past decade as opposed to my first 15 years of treating myelofibrosis. [Ruxolitinib] does not cure the disease, and its not [successful] in every patient. I dont think we yet truly know why we see that difference.
Why is the spleen response with ruxolitinib so important?
I do not believe...that shrinking the spleen because of its mechan- ical effect leads to an improvement in survival. However, the spleen is a good barometer of the quality of JAK inhibitor response, and responding to JAK inhibitors improves survival. I think tracking this thing is important, not just because it shrinks but because it means that whatever benefit were getting from JAK inhibition is present.
What is the optimal dose of ruxolitinib in this patient population?
Weve learned several things over time, including the issue of dosing, as it relates to efficacy and survival. Patients probably need to be on 10 mg twice a day or more to be getting the optimal benefit. Ideally, [we should be] getting them to 15 mg twice a day, or, if reasonable, 20 mg twice a day. There is contro- versy. My colleague...strongly believes we should start everyone at the higher dose. I think its OK to start lower, but you must accelerate the dose. There are likely too many patients out there on a suboptimal dose of ruxolitinib. Starting with those doses is fine, but rapidly increasing the dose where you truly see a signif- icant reduction in the size of the spleen and improvement in the symptoms [is necessary]. If youre not achieving that, then that is when its important to think about second-line therapy, dose adjustments, or a clinical trial.
What adverse effects (AEs) of ruxolitinib are there that treating physicians should be concerned with?
In terms of toxicities, there are issues of cytopenias. In the phase 1 studies, it was thrombocytopenia that was the dose-limiting toxicity. Anemia is the most functional difficulty in that the throm- bocytopenia is present, but it usually is not the driver in terms of limiting your dose.
When would you choose to use fedratinib?
Since last September, we have the approval of fedratinib as well for these patients.3 It was supported by the phase 3 JAKARTA study [NCT01437787], a randomization between fedratinib at 2 different dose levels versus placebo in patients that had intermediate- or high-risk myelofibrosis. The timing of the trial overlapped with the period before ruxolitinib was approved.
There was a nice response in terms of splenomegaly compared with placebo. There was a 500-mg arm that performed reasonably well in terms of efficacy but had more toxicity, so the approved dose is 400 mg.
In terms of toxicity, there are gastrointestinal toxicities. Typically, patients are [given] prophylaxis with antidiarrheals and antinausea drugs. Id have to say most patients dont tend to have a lot of difficulties with that. They can have cytopenias; there [are] no direct head-to-head data between fedratinib and ruxolitinib in terms of rates of cytopenias, but its not clear that there is necessarily a clear advantage between one or the other.
What does the black box warning say for encephalopathy in patients who receive fedratinib?
It was recognized that there were several cases of individuals who had had some degree of CNS [central nervous system] toxicity in 8 cases out of about the 900 patients that were treated. It was suspected that it was Wernicke encephalopathy. The drug was put on a clinical hold. Those cases were subsequently looked at in great detail by neurologists and others, and what was seen was that there was a rare CNS-confusion episode that did occur. It was only clear that 1 of the patients met the criteria of having Wernicke encephalopathy, but they likely had [that] when they were enrolled in the study. In addition, the Wernickes may have been worsened because this patient, at the 500-mg dose, did have a lot of nausea and vomiting.4
With an abundance of caution the drug was approved, but with a black box warning [cautioning physicians to] measure thiamine, replace thiamine if need be, and monitor for Wernicke [enceph- alopathy]. Having prescribed it after its approval, [I have found that] its not a major limiting factor, but just something to be mindful of and exercise every caution.
1. NCCN. Clinical Practice Guidelines in Oncology. Myeloproliferative neoplasms, version 1.2020. Accessed June 29, 2020. https://www.nccn.org/professionals/ physician_gls/pdf/mpn.pdf
2. Mesa RA, Kiladjian JJ, Verstovsek S, et al. Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies. Haematologica. 2014;99(2):292-298. doi:10.3324/haematol.2013.087650
3. FDA approves fedratinib for myelofibrosis. FDA. August 16, 2019. Accessed June 29, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/ fda-approves-fedratinib-myelofibrosis
4. Mullally A, Hood J, Harrison C, Mesa R. Fedratinib in myelofibrosis. Blood Adv. 2020;4(8):1792-1800. doi:10.1182/bloodadvances.2019000954
See original here:
Mesa Discusses Treating Myelofibrosis and Other MPNs - Targeted Oncology
Startup Accelerator is an article series with a focus on new and exciting companies in the 3D printing space, in which 3DPrint.com speaks to startup leadership about their unique technologies and businesses.
At one of the largest medical cities in the world, a startup is pushing the limits of bioprinting technology by harnessing the power and precision of light to structure living tissue. Born as a spin-off out of Rice University, Volumetric has come a long way since being founded in 2018, advancing the creation of biomaterials and a biofabrication platform for cancer research, regenerative medicine, and human organ replacement initiatives worldwide.
Efforts to reproduce the vascular architecture in the body have led Jordan Miller, an assistant professor of bioengineering at Rice University, and one of his bioengineering graduate students, Bagrat Grigoryan, to create Volumetric. The duo has been focusing on innovation that allows scientists to create exquisitely entangled vascular networks that mimic the bodys natural passageways for blood, air, lymph, and other vital fluids. Originally dubbed SLATE, which is short for stereolithography apparatus for tissue engineering, the new open-source bioprinting technology uses additive manufacturing to make soft hydrogels and is the basis for the firms commercially available technology.
While most of the attention in tissue engineering typically goes to the progress being done on cells, Volumetric is playing a key role focusing on the extracellular space, that is, what happens outside cells. If we think about solid organs in the body, like the liver, they are very complex biologically, with an intricate blood vessel structure. What is most apparent in that complexity, is the complexity of the architecture, Miller said to 3DPrint.com. There is a fantastic progress on the cell side as researchers are finding newer and better ways to grow cells, differentiate cells, taking stem cells, and making them into organ-specific functions, however, everything outside of the cell is part of our expert research.
With so much research to back up their development, Miller and Grigoryan were confident that commercializing the technology they developed at the lab was the next step. After licensing, it became the basis for the LumenX bioprinters that are manufactured through a partnership between Volumetric and Cellink one of the worlds leading biotechnology companies.
Designed as an entry-level platform to build vasculature, the LumenX achieves complex branching and tapering of vessels. Moreover, the founders claim that the device photographically cures entire layers at once to crosslink structures 50 times faster than other printing methods. This process is performed with incredible resolution, leveraging more than one million simultaneous points of light to bioprint microscopic features down to 200 microns.
As we were creating this technology at the research lab, we immediately began thinking about its potential in society, suggested Miller. We understood that we wanted to take our basic research out of the lab and into the clinical practice where it would have an impact. So, to translate our technology, we knew that it would have to be commercialized, to stand up as part of a business model that could survive. That is when our research became bigger than just an academic paper. Whereas an academic paper can have an impact on peoples mindsets, a commercialized product can have a big impact directly on peoples lives.
The LumenX by Volumetric and Cellink (Image courtesy of Cellink/Volumetric)
So, the company was born out of huge progress that the team made at the lab, plus, dozens of requests from fellow researchers who wanted to use Volumetrics technology to develop their own projects. Miller and Grigoryan licensed their own intellectual property out of the university and into the company Volumetric, and they have been using it to sell bioinks and bioprinters ever since.
This is a very exciting opportunity, because when there is a scientific finding in a research lab, it is not always obvious how it can translate into a direct impact for society, but commercialization is a way to address this issue.
Creating high-quality biomaterials and 3D biofabrication platforms are part of Volumetrics mission. Aside from LumenX, Volumetric founders also developed the only cell-compatible biomaterials on the market for light-based printing, ideal for creating vascular networks within cell-laden hydrogels or lab-on-a-chip devices. The company is pushing the limits in the field of bioprinting by incorporating the unique ability of its technology to print complex, 3D vascularized living tissue, one of the most advanced and hard to mimic tissues in the field.
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Multilayer 3D microfluidic plastic chips can be rapidly printed in minutes with the LumenX (Image courtesy of Volumetric/Cellink)
After witnessing successful university spin-off companies emerge around the world, one thing is clear, a major challenge for many startups is related to funding. However, Miller and Grigoryan were able to tap into the National Science Foundation (NSF) and its Innovation Corps program to get most of the funding for their collaboration, and in just two years, the startup has become a strong seller of specialized printers and hydrogel bioinks for printing tissue constructs.
Another great advantage of the company is its location, right at the heart of the Texas Medical Center (TMC), in Houston, working out of Johnson & Johnson Innovation (also known as JLABS), a global network ecosystem that empowers inventors across a broad healthcare spectrum to accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. It is by far one of the largest medical centers worldwide and a place where clinicians and surgeons are eager to see bioprinting technology, like Volumetrics, translated from bench to bedside.
Clinicians see first hand the need and urgency for replacement tissues to work. Which led us to craft a clinical strategy for a potential organ we could produce, how we would go about producing it, how we would design the clinical trials, and what early studies need to be complete in order to get there, Miller described. Our work goes beyond just theories, its about actually having surgeons work with our tissue scaffolds, to determine whether the material can be implantable. We need to know if they can put a suture through it and pull without the suture coming right out. We know that our work involves thinking about optimizing the material for the cells, but also for the surgeon.
Although Volumetric still has a lot of work ahead, more than 20 years of experience in bioengineering are helping Miller find a balance for both cells and surgeons to strive.
Jordan Miller and Bagrat Grigoryan in 2018 after founding Volumetric (Image courtesy of Volumetric)
Miller has a very particular vision for Volumetrics future, in part because he considers that the technology is highly scalable. He believes that what lies ahead for bioprinting companies like Volumetric is similar to what happened with the Prague-based open-source 3D printing company Prusa, except that in this case, its for biofabrication.
They [Prusa] are using 3D printers to make the parts that they need, relying on a print farm that is running non-stop, and churning out lots of high-value pieces. That is the perfect analogy of what we see for the future of regenerative medicine, where companies, like Volumetric, will develop large bioprinting farms, scaling out living tissue which could eventually become organ and tissue replacements for people.
The researchers at Volumetric have been working flat-out to provide a blood vessel structure for engineered tissue constructs. This is one of the most difficult feats in the filed, as researchers working towards the biofabrication of artificial vasculature have encountered several challenges to create the functional vessel-like structures that can supply oxygen and nutrients to cells of 3D bioengineered tissues. However, Millers advances at his laboratory at Rice and Volumetric led him to create the first bioprinting technology that addresses the challenges of multivascularization:
Right now, the field of regenerative medicine has the most potential its ever had, we know much more about how cells interact with materials than before, and our technology platform is allowing people to go deeper into biology and develop new materials to move the field forward.
A different combination of chemotherapy drugs together with umbilical cord blood may result in a safer, more universal treatment for a variety of genetic disorders. emarys / iStock / Getty Images Plus
Researchers at the University of Pittsburgh Medical Centre may have developed an innovative method of transplanting stem cells, resulting in a safer, universal treatment for a variety of genetic disorders. Through combining this approach with umbilical cord blood, treatment is also more accessible to ethnic minorities, a demographic that historically has had difficulties accessing bone marrow transplants.
The study, published in Blood Advances and the largest of its kind to date, used umbilical cord blood to treat 44 children with varying non-cancerous diseases. Umbilical cord blood is a potent source of hematopoietic stem cells cells that are able to form red and white blood cells in the patients. Due to their ability to develop into different types of cells, this treatment can be used to address many different types of disorders.
We wanted to offer a uniform concept to a wide array of diseases, said Dr. Paul Szabolcs, the Chief of Bone Marrow Transplantation and Cellular Therapies at UPMC Childrens Hospital and principal author of the study. We successfully reduced the intensity of chemotherapy and nevertheless, we were still able to engraft all our patients.
Typically, before receiving a stem cell graft (either umbilical cord blood or bone marrow) patients undergo an intense round of chemotherapy to kill off the patients own immune system and allow the new cells to grow. This method is effective but damaging to the body. For patients who do not have cancer and are pursing this treatment to improve the quality of their life (versus saving their life), the risks may simply be too high.
The approach developed by the team at the Pittsburgh Medical Centre uses a different combination of chemotherapy drugs, which are not as potent to the body. The goal of this approach is not to kill every cell in the patients bone marrow, but to make enough room for the new cells to flourish.
We successfully reduced the intensity of chemotherapy and we were still able to engraft all our patients, says Szabolcs. Using maximum intensity, you might be inadvertently killing patients and causing irreversible organ disease. [We used] use reduced intensity and have excellent survival.
This more moderate procedure is promising for conditions where the standard intensity regime poses a barrier to bone marrow or cord blood transfusions. More than half of the patients in the study had a form of leukodystrophy a genetic disorder that leads to the destruction of the protective coating of the nerves in the brain and spinal cord, according to the National Organization for Rare Disorders.
Three year survival rate after the standard chemotherapy preparation for umbilical cord blood transfusions for individuals with leukodystrophies ranges from 49 per cent to 77 per cent depending on their health at the time of the transfusion. The reduced-intensity approach reported a three year survival rate of 94 per cent.
The stem cells in umbilical cord blood provide a promising treatment as recipients do not have to have a perfect HLA (immune profile) match with the donor.
About 70 per cent of patients who need stem cells or bone marrow transplants have to rely on an unrelated donor to find a match, according to the University of British Columbia Medical Journal. This can create accessibility concerns for ethnic minorities. A 2012 study calculated that match rates for unrelated donors ranges from two per cent for POC to 46 per cent for Caucasians.
Since 2012, Canadian Blood Services has extended campaigns to communities with low match rates to increase the presence of donors. The concern still remains, however. Cord blood offers a hopeful alternative.
Its really applicable for ethnic minorities where the perfect HLA match might be elusive in the living donor population, says Szabolcs. And cord blood is readily available.
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Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the Covid-19 pandemic, Stephen Hahn, FDA commissioner, and Anand Shah, FDA deputy commissioner for medical and scientific affairs, wrote in a blog post on the FDA website.
The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures, Hahn and Shahwrote. The FDA has established a strong regulatory foundation to support the uptake of advanced manufacturing, and COVID-19 provides the unique impetus to spur further advancement of medical manufacturing.
They highlighted key regulations the agency has promulgated in recent years to support advanced manufacturing, specifically:
Additional efforts have been undertaken during the current public health emergency, Hahn and Shah pointed out. A multiyear effort between CDER and the US Biomedical Advanced Research and Development Authority (BARDA) is looking at how continuous manufacturing processes can support the production of medical countermeasures. Further, the FDA Office of the Chief Scientist (OCS) and the Center for Devices and Radiological Health (CDRH) are working with the National Institutes of Health and the Departments of Veterans Affairs to share information on 3D printing standards to increase the stock of essential medical supplies including personal protective equipment and certain medical device parts.
FDA also is working within the International Council for Harmonization to make sure that continuous manufacturing guidances are aligned internationally to support innovators, Hahn and Shah wrote.
Because pandemics by nature are unpredictable, our approach to manufacturing must be adaptable. Advanced manufacturing provides an approach for protecting our supply chain and improving our response capacity during crisis situations, they concluded. By establishing the regulatory foundation, the FDA has created a pathway for industry to continue adopting the needed improvements in manufacturing technology for the benefit of public health.
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FDA touts advanced manufacturing to address Covid-19 shortfalls - Endpoints News
Newswise NEW YORK, August 5, 2020The Cancer Research Institute (CRI), a U.S. nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all cancers, awarded more than $30.2 million in research grants and fellowships in the 2020 fiscal year ending June 30, 2020. In total, CRI gave 94 awards that will advance cancer immunology research at 56 institutions in 8 countries. This also includes an unprecedented six-month extension of funding support for 23 postdoctoral fellows in response to the global COVID-19 pandemic.
While the novel coronavirus has upended all aspects of life across the globe, CRI and our scientists remain committed to fulfilling the promise of cancer immunotherapy, said Jill ODonnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute. Were proud to support these brilliant scientists and clinicians, especially our young researchers and future leaders, at a critical time in order to bring the benefits of immunotherapy to more cancer patients.
The awards, which are funded entirely by individual, foundation, and corporate donors, include:
The 2020 Cancer Research Institute Lloyd J. Old STARs, or Scientists Taking Risks include:
To help advance immunotherapy for two types of ultra-rare cancer, chordoma and fibrolamellar cancer, which affect the bones of the spine and the liver, respectively, the Cancer Research Institute has partnered with two nonprofits focused on these diseases to fund promising research aimed at improving outcomes for patients with these cancers. These include:
Among this years Technology Impact Award recipients is Neville Sanjana, Ph.D., of the New York Genome Center, who is using massively-parallel genome engineering to comprehensively map all genes that can boost immune responses against pancreatic cancer, which will hopefully enable the development of next-generation T cell therapies for difficult-to-treat cancers.
Finally, included in the Impact Grants is funding for a glioma study carried out by Robert Michael Angelo, M.D., Ph.D., and Sean Bendall, Ph.D., of Stanford University in collaboration with investigators at City of Hope, Stanford, the University of California, Los Angeles, and the University of California, San Francisco, who will use Multiplexed Ion Beam Imaging (MIBI) to image intact, well-annotated glial tumor tissue from pediatric and adult patients in response to vaccine, checkpoint inhibitor, and cellular therapies. This dataset will inform therapeutic strategies based on the presence of tumor targets, expression of immune inhibitory proteins, and the types and functional statuses of T cells and myeloid cells within the context of an intact tumor microenvironment.
To view our full roster of 2020 grant and fellowship award recipients, visit cancerresearch.org/funding. More information about CRIs grants, fellowships, and other programs is available at cancerresearch.org/grants.
About the Cancer Research InstituteThe Cancer Research Institute (CRI), established in 1953, is a highly-rated U.S. nonprofit organization dedicated exclusively to saving more lives by fueling the discovery and development of powerful immunotherapies for all cancers. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 26 members of the National Academy of Sciences, CRI has invested $445 million in support of research conducted by immunologists and tumor immunologists at the worlds leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to cancerresearch.org.
August 04, 2020 08:30 ET | Source: RenovaCare, Inc.
Dr. Lydia M. Evans, Director, RenovaCare, Inc.
ROSELAND, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR;www.renovacareinc.com), developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, today announced the appointment of Lydia M. Evans, M.D. to its Board of Directors. A noted dermatologist, oncologist, and doctor of internal medicine, Dr. Evans has held numerous academic, private, and commercial appointments, and brings extensive insights into the science, technology, and market positioning of wound and skin regeneration therapies.
As RenovaCare continues to advance our portfolio of regenerative technologies, strategic leadership from our Board is increasingly critical as we look to regulatory approval and commercialization. Dr. Evans knowledge and experience will be a strong addition to our Board at such an important time as the Company continues to pursue bringing first-in-class regenerative therapies to market, stated Alan L. Rubino, RenovaCare CEO & President.
"Im pleased to join the RenovaCare Board of Directors at a time of growing demand for modern therapies that promise natural regeneration for burns, wounds, skin disorders and cosmetic imperfections. The RenovaCare CellMist and SkinGun represent an impressive therapeutic approach that replaces painful and complex skin grafting procedures with a gentle mist of the patients own cells. I look forward to assisting the Company in its development, concluded Dr. Evans.
A Columbia Presbyterian and Memorial Sloan Kettering-educated dermatologist, oncologist and doctor of internal medicine, Dr. Evans specializes in state-of-the-art treatments for aesthetic and medical dermatologic procedures. She is currently an Associate Clinical Attending Physician in the Department of Dermatology at New York Presbyterian Medical Center in New York City, a position which includes significant teaching responsibilities. She is also a Fellow of the American Academy of Dermatology, a Diplomate of the National Board of Medical Examiners, the American Board of Internal Medicine, and the American Board of Dermatology. She is a member of the Leadership Society of the Dermatology Research Foundation and has served as the New York State Chairperson for the Psoriasis Research Foundation. Dr. Evans was Consulting Dermatologist to LOral Paris from 2000 to 2012, spurring new product development in dermatologist-inspired skincare directly to consumers. About RenovaCare RenovaCare, Inc. is developing first-of-its-kind autologous (self-donated) stem cell therapies for the regeneration of human organs. Its initial product under development targets the bodys largest organ, the skin. The companys flagship technology, the CellMist System, uses its patented SkinGun to spray a liquid suspension of a patients stem cells the CellMist Solution onto wounds.
RenovaCare is developing its CellMist System as a promising new alternative for patients suffering from burns, chronic and acute wounds, and scars. In the US alone, this $45 billion market is greater than the spending on high-blood pressure management, cholesterol treatments, and back pain therapeutics.
RenovaCare products are currently in development. They are not available for sale in the United States. There is no assurance that the Companys planned or filed submissions to the U.S. Food and Drug Administration will be accepted or cleared by the FDA.
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LEXINGTON, Ky., Aug. 3, 2020 /PRNewswire-PRWeb/ -- Introducing Ardent Animal Health MediVet Biologics rebrands company and positions its platform of innovative products for transformative growth
MediVet Biologics is announcing a new name and a new look for its corporate brand as it relaunches itself as Ardent Animal Health.
In the years since its inception in 2016, the new Ardent Animal Health has developed into a global leader in the areas of veterinary regenerative medicine and oncology solutions for animals. The company's core mission is to develop affordable, innovative treatments for animal cancer and disease while supporting its veterinary partners in their efforts to make a positive impact on pet health.
"The name 'Ardent' captures the spirit of our organization as a company with fiery passion for innovation guided by compassion for the well-being of animals. The new brand translates the enormous and unique impact our veterinarian customers make each day in the lives of their patients. Our aim is to leverage our brand to accelerate connecting pet owners seeking advanced care to our expanding network of progressive veterinarian partners around the world," says Thomas Masterson, President of Ardent Animal Health.
Under its former brand of MediVet Biologics, Ardent Animal Health developed the first in-clinic adipose regenerative stem cell therapy kit, ActiStem Therapy. A major scientific advancement in animal regenerative medicine, the product offers an economic solution for owners of pets suffering from osteoarthritis, hip dysplasia, and ligament and cartilage injuries, as well as numerous mobility ailments. In addition to regenerative cells from fat, Ardent-certified hospitals offer other biologic treatments such as Platelet Rich Plasma, or PRP, a blood-derived treatment gaining popularity in human sports medicine.
Ardent Animal Health is unique for a company of its size, as it has surrounded its current and pipeline products with strong intellectual property and multiple collaborative university studies. This has allowed the company to grow, cementing its current technology, and look toward the future for its stem cell-based product pipeline candidates. Ardent Animal Health will launch with an extensive following of pet owners and veterinarians positively impacted by its products and services. The studies, passionate customers, and patient outcomes continue to provide momentum for the company's technology and products. Over 20,000 veterinary patients have received treatment of an Ardent Animal Health regenerative product or service.
Ardent Animal Health has also introduced cutting edge science to fight against canine cancer with its cancer vaccine service, K9- ACV, an immunotherapy vaccine generated from a canine patient's own cancerous tumor. K9-ACV is designed to stimulate the canine patient's immune response to attack the cancer. "We are looking to meet an unmet need in pet cancer, at the family veterinarian office when needed. 50% of dogs over the age of ten will develop some type of cancer, so there is a need for a broadly applicable approach that can improve lifespan at a reasonable cost. Our preliminary studies and extensive market research indicate this approach will provide access to pets that need it," Masterson said.
According to Mr. Masterson, the company's strength in these core innovative therapeutic areas will allow the organization to accelerate growth following its recent transition in both leadership and ownership. As a portfolio company of STUCK Fund 1, based in Milwaukee, WI, Ardent Animal Health will continue to develop novel approaches for early disease detection and treatments, with a focus on precision medicine for pets in need.
"We will continue to focus much of our strategy in creating novel products and services utilized in veterinary hospitals. We believe that this approach is key to the future of animal health. It is important not only for value creation but to ensure veterinarians have the ability to diagnose and treat their patients with the same leading-edge strategies underway in human health. Our animal family members deserve it."
Disclaimer Experimental Cancer Vaccines created by Ardent Animal Health are provided under 9 CFR 103.3 via USDA Center for Veterinary Biologics oversight for use under supervision/prescription of a licensed veterinarian. Safety & efficacy have not been yet established.
About Ardent Animal Health
Since 2016 Ardent Animal Health based near Lexington, KY, has provided advanced medical strategies to veterinary hospitals around the world. Ardent provides regenerative medicine treatments such as ActiStem Therapy and PureVet PRP to veterinarians for pain and disease in companion and equine patients. Additionally, Ardent Animal Health is pursuing advanced strategies for detection and treatment of canine cancer. Through creation of its own intellectual property and strategic licensing partners, the company's portfolio includes current and future offerings aimed to raise the standard for animal healthcare.
About STUCK Fund 1
Ardent Animal Health represents an innovation-focused element of the STUCK Fund 1 portfolio, as Ardent competes in the fast-growing and recession-resistant pet health sector. STUCK Fund 1, based in Milwaukee, WI, was founded in 2014 to live out the lessons the investment firm's founders learned from growing its business into an international, $100 million organization. STUCK founders were honored with numerous accolades in their prior ventures, including the Muskego Manufacturing Business of the Year award and the Waukesha Business Alliance Manufacturing Business of the Year honor, among several others. Currently, the investment firm supports like-minded entrepreneurs to accelerate and sustain the growth of their businesses.
Media Contact: Matt Yeich (859)885-7111 email@example.com
SOURCE Ardent Animal Health
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MediVet Biologics Rebrands as Ardent Animal Health - Benzinga
A Church Point Police Department captain has died from serious medical complications after contracting COVID-19.
Church Point Police Chief Dale Thibodeaux shared news of Capt. Kevin Trahans death in a post from the departments Facebook page Saturday morning. Thibodeaux wrote that Trahan returned to the job in April after a period of absence to receive a bone marrow or stem cell transplant at MD Anderson Cancer Center in Houston to ward off an unspecified cancer.
He later contracted the virus while on the job, the chief said.
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In a July 22 post on his personal Facebook, Thibodeaux said that the department and Trahans family were asking for prayers while Trahan was hospitalized in the intensive care unit. After being diagnosed with COVID-19, Trahan also suffered from pneumonia, clots in both legs and suffered strokes while sedated on a ventilator, the chief relayed from Trahans son.
Trahan died around 10:30 p.m. Friday at a Monroe hospital and Church Point police officers will be escorting his body back to Acadia Parish Saturday, Thibodeaux said.
Trahan, 59, leaves behind his wife, Brenda, who also works for the Church Point Police Department, three adult children, two stepdaughters, two grandchildren and a step-granddaughter, Thibodeaux said.
He tried to help everyone and would give you the shirt off his back if he could. Capt. Trahan was also a dedicated officer and always gave a hundred percent all the timeWith all Capt. Trahan fought through and continued to do his job on a professional level, he was and always will be a true hero, Thibodeaux wrote.
Go and protect the heavens, my dearest friend, family and my brother. The Lord needs you right now more than we do, I guess. You will be missed dearly.
Trahan served in law enforcement for roughly 30 years as a deputy with the Acadia Parish Sheriffs Office and an officer with the Church Point Police Department, the chief said. When Thibodeaux assumed the chief position, Trahan became his right hand man.
While close from their time in law enforcement, the two men were more than brothers in blue they were also family. Trahan was married to Thibodeauxs sister-in-law, he said.
Trahan was generous, kind, determined, hardworking and had a way of talking to people that reached them, Thibodeaux said. He was passionate about helping people and serving the community; even after his treatment at MD Anderson, it was impossible to keep him assigned to desk duty because he was determined to give his best effort on patrol, the chief said.
Everyone who knew him liked him.
His personality was something else. Theres no way he didnt walk into a room and liven it up in some kind of way, Thibodeaux said.
Other law enforcement officers shared condolences online and remembered Trahans commitment to serving the community and mentoring other officers.
It was an honor to know and learn from such a great man. Captain Kevin Trahan was genuinely a good guy who was beyond willing to teach and show beginning officers the way to become a good officer. In the two years I've been with the police department I have gotten to ride and sit with him many times and just simply listen to his stories and learn many things. He will definitely be missed, Church Point Police Officer Holden Hare shared on Facebook.
I received some of the best advice from you when I started this career and I will forever hold on to that advice and guidance youve given me. May you finally Rest In Peace as your legacy will never be forgotten, Hunter Hare wrote.