Welcome to Health Conversation. Today we're asking Koen Berden, Executive Director for International Affairs at EFPIA, 'Why is a therapeutics waiver extension different to the vaccine waiver?'. Listen to hear their discussion on the challenge and how we're preparing for the future. Hosted on Acast. See acast.com/privacy for more information.
Global News: Canadian Pediatric Society outlines steps to conserve 'vital supply' amid shortages. Critical drug shortages continue across Canada. CPS provides guidelines to help healthcare providers to ensure that children have access to safe and secure supply of necessary medications. Guest: Dr. Charlotte Moore Hepburn. Special advisor for Pediatric Drugs and Therapeutics for the Canadian Pediatric Society and one of the authors of the new guidance document on managing critical drug shortages. Learn more about your ad choices. Visit megaphone.fm/adchoices
Dr. Charlotte Jones-Burton is the Senior Vice President of Product Development and Strategy at Chinook Therapeutics, which is on a mission to change the course of kidney care by discovering and developing precision therapies to maintain kidney function in people who have rare, severe chronic kidney diseases. Charlotte explains, "Our lead clinical program is atrasentan, a highly potent and selective endothelin receptor inhibitor. We believe that it's going to be a best-in-class molecule that's going to target the endothelin pathway. And the condition for which we are developing it is IgA nephropathy. Now, IgA nephropathy is an autoimmune disease that attacks the kidneys, and it affects how our blood is filtered in the small blood vessels of the kidneys that I spoke about. And what happens with IgA nephropathy is that immune complexes can deposit in the kidney and really damage those filtering units inside the kidneys. And when this happens, individuals can have symptoms such as protein spilling into their kidneys. And we know that proteinuria, as we call that, is a strong risk factor for those who will then develop end-stage kidney disease, which means that they may need dialysis or a kidney transplantation to survive." "Now, we know that there are few treatments that are available, and that's why it's really important for patients to also ask the question if there are any clinical trials. And we at Chinook Therapeutics are enrolling patients into clinical trials who have IgA nephropathy. We also are enrolling patients into our AFFINITY clinical trial if they have FSGS, which is also a type of kidney disease, Alport syndrome, or diabetic kidney disease." #ChinookTherapeutics #KidneyDisease #ChronicKidneyDisease #Atrasentan #BIO1301 #PrecisionMedicine #Nephrology #ClinicalTrials #IGAN #RareDisease chinooktx.com Download the transcript here
Dr. Charlotte Jones-Burton is the Senior Vice President of Product Development and Strategy at Chinook Therapeutics, which is on a mission to change the course of kidney care by discovering and developing precision therapies to maintain kidney function in people who have rare, severe chronic kidney diseases. Charlotte explains, "Our lead clinical program is atrasentan, a highly potent and selective endothelin receptor inhibitor. We believe that it's going to be a best-in-class molecule that's going to target the endothelin pathway. And the condition for which we are developing it is IgA nephropathy. Now, IgA nephropathy is an autoimmune disease that attacks the kidneys, and it affects how our blood is filtered in the small blood vessels of the kidneys that I spoke about. And what happens with IgA nephropathy is that immune complexes can deposit in the kidney and really damage those filtering units inside the kidneys. And when this happens, individuals can have symptoms such as protein spilling into their kidneys. And we know that proteinuria, as we call that, is a strong risk factor for those who will then develop end-stage kidney disease, which means that they may need dialysis or a kidney transplantation to survive." "Now, we know that there are few treatments that are available, and that's why it's really important for patients to also ask the question if there are any clinical trials. And we at Chinook Therapeutics are enrolling patients into clinical trials who have IgA nephropathy. We also are enrolling patients into our AFFINITY clinical trial if they have FSGS, which is also a type of kidney disease, Alport syndrome, or diabetic kidney disease." #ChinookTherapeutics #KidneyDisease #ChronicKidneyDisease #Atrasentan #BIO1301 #PrecisionMedicine #Nephrology #ClinicalTrials #IGAN #RareDisease chinooktx.com Listen to the podcast here
This featurette from the 2021 Midyear Clinical Meeting presentation “More than Just a Hill of Beans: Clinical Controversies Related to Acute Kidney Injury in the ICU” summarizes the clinical usefulness of furosemide stress testing in acute kidney injury. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.
Axsome Therapeutics (AXSM) stock price hit a 52-week high recently. Axsome Therapeutics (AXSM) announced that the drug AXS-05 phase 3 trial met endpoints. The drug significantly delayed the relapse of agitation symptoms in Alzheimer's disease patients. 66% of patients had improved agitation at two weeks and 86% at five weeks. George Tsilis compares AXSM to BMY, LLY, BIIB, and SAVA.
Der DAX hat seine Verschnaufpause gestern ausgeweitet. Nach verheißungsvollem Start schloss der Leitindex doch im Minus. Heute könnte es zunächst erneut nach oben gehen. Auch wenn die Vorgaben aus Übersee durchwachsen sind.
Incannex Healthcare Ltd (ASX:IHL | NASDAQ:IXHL) chief medical officer Dr Mark Bleakley tells Proactive they've engaged multinational contract development and manufacturing organisation (CDMO) Eurofins Scientific to manufacture the company's topical ReneCann therapeutic cannabinoid formulation. ReneCann is a proprietary therapeutic developed to treat dermatological conditions caused by disorders of the immune system, including vitiligo, psoriasis and atopic dermatitis, otherwise known as eczema. #InccanexHealthcare #asx #ProactiveInvestors #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews
Kristin Tallent, PharmD, discusses what she has learned in her new business a year in. www.collaborativetherapeutics.com Please support The Business of Pharmacy Podcast™ by checking out our sponsors at www.bizofpharmpod.com/sponsors/
Invex Therapeutics (ASX: IXC) executive director and chief science officer Alex Sinclair joins Small Caps to discuss the company's Evolve phase III trial which is now underway and evaluating its lead drug Presendin in patients with idiopathic intracranial hypertension (IHH). IIH is a rapidly growing disease, with incidences rising 350% over the last 10 year. Around 240 newly diagnosed IIH patients will be recruited to the trial which will be open at 40 sites around the world. Articles:https://smallcaps.com.au/invex-therapeutics-recruiting-iih-patients-nz-clinical-trial-regulatory-approvals/https://smallcaps.com.au/invex-therapeutics-recruits-first-idiopathic-intracranial-hypertension-patient-presendin-trial/ For more information on Invex Therapeutics:https://smallcaps.com.au/stocks/IXC/See omnystudio.com/listener for privacy information.
On this episode of the SPEED CHANGE REPEAT Podcast we are talking with Florian Brand who is CEO and Co-Founder at ATAI Life Sciences. The company is aiming to develop differentiated treatments for patients suffering from mental health orders. Having collected over $500m in capital with noteable backing from investors such as Cathie Wood at ARK Invest, ATAI is at the forefront when it comes to the psychedelics market. Together with Florian we are covering the early founding of the company and dive deep into the company's funding model for compound development as well as the role of digital therapeutics in ATAI's treatment strategy.
Dr. Raj Mehra joins the podcast today to discuss the ongoing clinical trials that Seelos Therapeutics is conducting to investigate Racemic Ketamine as an effective drug candidate for treating patients with Acute Suicidal Ideation and Behavior -The suicide crises in the United States and beyond is an epidemic in itself, and Seelos Therapeutics is working towards delivering the worlds first FDA-approved ketamine treatment for individuals with ASIB. In this episode, Dr. Mehra discusses the clinical data suggesting that R-Ketamine is an effective treatment to help mitigate the suicide crises, as well as the Seelos Therapeutics patenting strategy and and path that a drug must take in order to be adapted into medicalized use. Please consider rating and reviewing the podcast wherever you're listening. Hosted on Acast. See acast.com/privacy for more information.
2:40 Labiotech.eu news4:58 SOTIO Biotech13:43 Eversana19:37 Carl Borrebaeck36:42 Concarlo TherapeuticsThis week, we have four interviews: Franjo Hanzl, vice president commercial development Europe at Eversana; Stacy Blain, founder and CEO of Concarlo Therapeutics; Jens Hennecke, chief business officer at SOTIO Biotech; and Carl Borrebaeck, chairman of the board of directors of Immunovia and professor at the Department of Immunotechnology at the University of Lund in Sweden.Concarlo TherapeuticsConcarlo Therapeutics is a U.S.-based preclinical-stage precision-medicine oncology company. It is developing a novel therapy for drug-resistant metastatic breast cancer as a first indication.Concarlo's patented IpY, a novel therapeutic peptide, will be the first to hit two targets, both CDK4/6- driven cell proliferation and CDK2-driven drug resistance at the same time, and the first to target p27. It is a specific cellular pathway to kill cancer cells rather than just slowing their proliferation.The novel approach relies on the role of p27Kpi, a natural inhibitor, an "on-off" switch that regulates the activities of the major cancer-related proteins, CDK6, CDK4, and CDK2. EversanaEversana is a provider of global services to the life sciences industry. Its integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including start-ups and established pharmaceutical companies, to advance life sciences solutions.Labiotech spoke with Franjo Hanzl, vice president commercial development Europe, at the Medicon Valley Alliance annual summit in Copenhagen, Denmark.Medicon VillageDuring NLS Days, Labiotech visited Medicon Village, in Lund, Sweden. While there, we had the opportunity to chat with Carl Borrebaeck. To say he's involved in biotech would be an understatement. He is chairman of the board of directors of Immunovia and professor at the Department of Immunotechnology at the University of Lund in Sweden, as well as being director of Create Health. Borrebaeck, former vice president of the University of Lund, has been involved in many companies throughout his career, including Alligator Bio, SenzaGen and PainDrainer. He received the AKZONobel Science Award 2009, for contributions to cancer proteomics and antibody-based therapy, a Research! Sweden Award 2012 for his medical research of value for patients and health organizations, and the Royal Academy of Engineering Sciences Gold Medal 2012 for outstanding contributions to biomedical science. He was honored as the Biotech Builder of the Year in 2017.SOTIO BiotechSOTIO Biotech is a clinical stage immuno-oncology company owned by PPF Group based in Prague, Czechia. The company is building a pipeline of oncology programs by pursuing promising early-stage candidates through strategic licensing, M&A and in-house discovery efforts. SOTIO has been active in the clinic in 2022. The company initiated two clinical trials, the first was a phase 2 study for its lead IL-15 superagonist, SOT101. The initiation of the AURELIO-04 trial comes on the heels of positive phase 1/1b data, which showed 15 of 19 patients with advanced/metastatic solid tumors demonstrated clinical benefit with SOT101 in combination with pembrolizumab. The company also plans to enter the CAR-T space with the initiation of its BOXR trial in Q4 2022. SOTIO is well funded into 2023 and plans to use those funds for posting more data across its already promising programs.We spoke with SOTIO Biotech at BIO-Europe.
In this podcast, James Cave (Editor-in-Chief) and David Phizackerley (Deputy Editor) talk about the December 2022 issue of DTB. They discuss cognitive changes that have been reported during the menopause and whether there is a role for MHT (https://dtb.bmj.com/content/60/12/178). They highlight an observational study that found an association between the use of sodium-containing paracetamol and cardiovascular events (https://dtb.bmj.com/content/60/12/181), and talk about the evidence for increasing the dose of vedolizumab in IBD (https://dtb.bmj.com/content/60/12/183). They begin the podcast by talking about their top three highlights from 2022. The contact address for the DTB team is email@example.com. Please subscribe to the DTB podcast to get episodes automatically downloaded to your mobile device and computer. Also, please consider leaving us a review or a comment on the DTB Podcast iTunes podcast page (https://podcasts.apple.com/gb/podcast/dtb-podcast/id307773309). Thank you for listening.
Listen to a blog summary of a trending research paper published by Aging (Aging-US), entitled, "ESR1 dysfunction triggers neuroinflammation as a critical upstream causative factor of the Alzheimer's disease process.” _________________________________________________ The United States government currently has a mind-blowing annual budget of $3.5 billion designated for Alzheimer's disease (AD) and dementia research funding. Therapeutics pushed forward thus far have been largely based on the amyloid-beta (Aβ) cascade hypothesis of AD. Surprisingly, despite decades and billions, these interventions have yielded little to no benefits for AD patients. This lack of efficacy has encouraged some researchers to rethink AD pathology and focus on discovering key triggers and mechanisms of neuroinflammation. “There has been a lengthy and ongoing scientific debate around the causative factors of AD, and the relative importance of both senile Aβ plaques and tau tangles has been largely informed by postmortem investigations of the AD brain. For several decades, the amyloid hypothesis has dominated the field, which has brought forth many high-profile therapeutic attempts that have produced side effects but no real benefits .” Women compose two-thirds of the United States Alzheimer's population. Is this gender-specific risk a result of living longer or is it due to other causes, perhaps related to hormonal differences or gender-associated differential gene expression? Previous studies have found that estrogen may protect neurons from the damaging effects of amyloid-beta plaques and tau tangles. However, in women, estrogen levels tend to decline with age, which could be one reason why aging women are more susceptible to AD. In a new study, researchers Junying Liu, Shouli Yuan, Xinhui Niu, Robbie Kelleher, and Helen Sheridan from Trinity College Dublin, Peking University and Jilin University examined the potential relationship between the estrogen receptor-α gene (ESR1) and neuroinflammation. Their research paper was published on November 1, 2022, in Aging's Volume 14, Issue 21, and entitled, “ESR1 dysfunction triggers neuroinflammation as a critical upstream causative factor of the Alzheimer's disease process.” “AD is characterized by three major questions: Why is age the primary risk factor? Why are women more sensitive to the onset of this form of dementia? And why are neurons in areas of the brain that are essential for memory selectively targeted?” Full blog - https://aging-us.org/2022/11/is-estrogen-dysregulation-behind-alzheimers-pathology/ DOI - https://doi.org/10.18632/aging.204359 Corresponding authors - Junying Liu - firstname.lastname@example.org Video - https://www.youtube.com/watch?v=NPWv39SJOpQ Sign up for free Altmetric alerts about this article - https://aging.altmetric.com/details/email_updates?id=10.18632%2Faging.204359 Keywords - ESR1, Alzheimer's disease, CEBPB/ATF4, APOE, pyroptosis About Aging-US Launched in 2009, Aging-US publishes papers of general interest and biological significance in all fields of aging research and age-related diseases, including cancer—and now, with a special focus on COVID-19 vulnerability as an age-dependent syndrome. Topics in Aging-US go beyond traditional gerontology, including, but not limited to, cellular and molecular biology, human age-related diseases, pathology in model organisms, signal transduction pathways (e.g., p53, sirtuins, and PI-3K/AKT/mTOR, among others), and approaches to modulating these signaling pathways. Please visit our website at https://www.Aging-US.com and connect with us: SoundCloud - https://soundcloud.com/Aging-Us Facebook - https://www.facebook.com/AgingUS/ Twitter - https://twitter.com/AgingJrnl Instagram - https://www.instagram.com/agingjrnl/ YouTube - https://www.youtube.com/agingus LinkedIn - https://www.linkedin.com/company/aging/ Pinterest - https://www.pinterest.com/AgingUS/ Media Contact 18009220957 MEDIA@IMPACTJOURNALS.COM
Using weekly deep out-of-the-money cash-secured puts with Deltas of less than 10 can generate significant annualized returns with greater than 90% probability of success. This podcast uses a real-life example from one of Alan's portfolios with Apple Computer that incorporates both initial structuring and exit strategy implementation. BCI Package, our Best and most Comprehensive Investment package: https://thebluecollarinvestor.com/minimembership/bci-investor-program/ BECOME A BCI MEMBER TODAY: https://www.thebluecollarinvestor.com/membership/ SEE BCI COURSE & PRODUCTS : https://thebluecollarinvestor.com/store/ STOCKS,TRADING,STOCK MARKET,COVERED CALLS,covered call writing,Axsome,Therapeutics,Ellman Calculator,gap-up,cost-to-close,implied volatility,Alpha,Beta,seeking,alpha,cost-basis,time-value,intrinsic- value,put-selling,collar calculator,put calculator,stock option,facebook stock,amazon stock,investing,options,Option,option buyer,strike price,in the money,in the money coverd call,out of the money covered call,covered call writing exit strategies
Nutcracker Therapeutics is a preclinical biopharma company developing multimodal RNA-based therapeutics for HPV-driven tumors, T-cell lymphoma, and Genitourinary tumors. On this episode of the Business of Biotech, Chief Business Officer Geoff Nosrati, Ph.D. offers a comprehensive view of the RNA-based therapeutics landscape and sheds light on what he perceives as an advantageous position at Nutcracker— the capacity to manufacture RNA in-house. If you're curious about the expanding science behind RNA-based therapeutics and their application in biotech, this conversation with a scientist-turned-chief business officer (Nosrati earned his Ph.D. in Biochemistry and Molecular Biology) is a can't-miss episode. Subscribe to the NEW #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!
The Master of Science (MS) in Medical Cannabis Science and Therapeutics program at the University of Maryland School of Pharmacy is in its third class now. The Program provides students with the knowledge they need to support patients and the medical cannabis industry, add to existing research, and develop well-informed medical cannabis policy.The two-year program based at the Universities at Shady Grove in Rockville, Md., blends online instruction with face-to-face experiences to prepare graduates to respond to the increasing demand for medical cannabis with an understanding of the basic science and clinical uses of the cannabis plant.This is also the program all 3 of our hosts met in and graduated from! So in this encore episode from April 2022 Dr. Tiffany Buckley, PharmD, BCPS, BCPP who is an Advanced Practice Psychiatric Pharmacist working with the University program, joins Dr. Hal Altman MD, MS to talk about how it started and who its students are.Be sure to also check out the other episodes in our series with Dr. Tiffany Buckley!
Ratio Therapeutics is a Boston-based pharmaceutical company with the mission to accelerate the development of best-in-class targeted radiotherapeutics for the treatment of cancers. By employing a suite of innovative technologies the company is developing innovative and proprietary Pharmacokinetics (PK) Modulation technology for the construction of improved therapeutic agents and transforming oncology treatment paradigms.Dr. Jack Hoppin is the co-founder, Chairman, and Chief Executive Officer of Ratio Tx. Prior to joining Ratio Tx Jack was the President of Konica-Minolta Precision Medicine and Co-founded InviCRO LLC and Emit Imaging. Jack is a leader in the molecular imaging research and drug development community and brings more than 15 years of experience in the design, development, and commercialization of pre-clinical instrumentation, analytical software, and imaging-based assays.Dr. John Babich is the co-founder, President, and Chief Scientific Officer of Ratio Tx. Prior to Ratio Tx he co-founded Molecular Insight Pharmaceuticals, Inc (NASDAQ: MIPI) where he served as the CEO and chairman of the board, and Noria Therapeutics- a radiotherapy company developing targeted therapeutic and imaging radiopharmaceuticals (alpha-emitting) for use in oncology- acquired by Bayer.In this episode, we discuss the growing field of targeted radiotherapeutics, company founding from the perspective of serial founders, and strategic partnerships in drug development.Hosted by Joe Varriale
On Episode 22 of the Stroke Alert Podcast, host Dr. Negar Asdaghi highlights two articles from the November 2022 issue of Stroke: “Estimating Perfusion Deficits in Acute Stroke Patients Without Perfusion Imaging” and “Five-Year Results of Coronary Artery Bypass Grafting With or Without Carotid Endarterectomy in Patients With Asymptomatic Carotid Artery Stenosis.” She also interviews Dr. George Ntaios about his article “Incidence of Stroke in Randomized Trials of COVID-19 Therapeutics.” Dr. Negar Asdaghi: Let's start with some questions. 1) What is the actual incidence of stroke after COVID-19? 2) In the setting of acute ischemic stroke, can the volume of ischemic penumbra be estimated with just a regular MRI study of the brain without any vascular or perfusion imaging? 3) And finally, can a patient with significant carotid stenosis go through coronary artery bypass graft surgery? We're back here to answer these questions and bring us up to date with the latest in the world of cerebrovascular disorders. You're listening to the Stroke Alert Podcast, and this is the best in Stroke. Stay with us. Welcome back to another issue of the Stroke Alert Podcast. My name is Negar Asdaghi. I'm an Associate Professor of Neurology at the University of Miami Miller School of Medicine and your host for the monthly Stroke Alert Podcast. The November issue of Stroke is packed with a range of really exciting and exceedingly timely articles. As part of our Original Contributions in this issue of the journal, we have a post hoc analysis of the Treat Stroke to Target, or the TST, randomized trial by Dr. Pierre Amarenco and colleagues. We've talked about this trial in our past podcast, and the main study results that were published in New England Journal of Medicine in January of 2020. TST randomized patients with a recent stroke or TIA to either a low target of LDL cholesterol of less than 70 milligram per deciliter or a target LDL of 90 to 110. The main study showed that the low LDL target group had a significantly lower risk of subsequent cardiovascular events without increasing the risk of hemorrhagic stroke. So, from this, we know that achieving a low target LDL is possible and is actually better than the LDL target of 90 to 110 post-stroke. But in the new paper, in this issue of the journal, in a post hoc analysis of the trial, the TST investigators showed that it's not just achieving that magic low target LDL of less than 70 that's important in a reduction of cerebrovascular disorders, but it's also how we achieve it that determines the future of vascular outcomes. So, in this analysis that compared patients on monostatin therapy to those treated with dual cholesterol-lowering agents, that would be a combination of statin and ezetimibe, and showed that in the low LDL target group, only those patients treated with dual therapy had a significant reduction of subsequent vascular events as compared to those in the higher LDL category. But the same was not true for patients on statin monotherapy, even though they had all achieved a low target LDL. Think about this for a moment. Both groups, whether on statin monotherapy or on dual anti-cholesterol treatments, achieved the same low target of LDL, but only those on dual therapy had a lower risk of subsequent vascular events as compared to those that were in the higher LDL target group. Very thought-provoking study. In a separate paper by Dr. Shin and colleagues out of Korea, we learned that survivors of tuberculosis, or TB, are at a significantly higher risk of ischemic stroke than their age- and risk factors–matched non-TB counterparts. The authors used data from the Korean National Health Insurance Services and studied over 200,000 cases diagnosed with TB between 2010 and 2017 and compared them to a pool of over one million non-TB cases for matching. And they found that the risk of ischemic stroke was 1.2 times greater among TB survivors compared to matched non-TB cases after adjusting for the usual confounders, health behavioral factors, and other comorbidities. Now, why would TB increase the risk of stroke? The authors talk about the pro-inflammatory state of this condition, thrombocytosis, that is a known complication of chronic TB amongst other putative and less clear mechanisms. But what is clear is that findings from a large-scale population-based cohort such as the current study support an independent association between TB and ischemic stroke. As always, I encourage you to review these papers in addition to listening to our podcast today. My guest on the podcast today, Dr. George Ntaios, joins me all the way from Greece to talk to us about the much discussed topic of the risk of stroke in the setting of COVID-19. Dr. Ntaios is the President of the Hellenic Stroke Organization and an experienced internist who has been fighting this pandemic in the front lines since the beginning. In an interview, he talks about his recently published paper, his experience, and the lessons learned on balancing scientific rigor against the urgency of COVID-19. But first, with these two articles. In the setting of a target vessel occlusion in patients presenting with an acute ischemic stroke, distinguishing the ischemic core from the ischemic penumbra is of outmost importance. The success of all of our reperfusion therapies heavily lies on our ability to differentiate between the tissue that is already dead, which would be the ischemic core, from the tissue that is not dead yet but is going to die unless revascularization is achieved. That is the ischemic penumbra. Over the past two to three decades, there's been lots of debate over how these entities of dead tissue versus going-to-die tissue are best defined, especially when we're making these distinctions under the pressure of time. We don't even agree on the best imaging modality to define them. Should we rely on CT-based imaging? Do we stop at CT, CT angiogram? Should we do single-phase CTA or multiphase CTA? When do we perform CT perfusion, and what perfusion parameters best define core and penumbra, or should we rely on MRI-based modalities altogether? These questions have all been asked and extensively studied, which is why, as a field, I think, we have at least some agreements today on the basics of core and penumbra definitions. And I also think that overall we are becoming better at doing less imaging to be able to predict tissue outcomes in real time. And there's definitely a growing interest in trying to estimate tissue fate based on a single-imaging modality. So, I think you're going to find an Original Contribution in this issue of the journal, titled "Estimating Perfusion Deficits in Acute Stroke Patients Without Perfusion Imaging," really interesting. In this paper, Dr. Richard Leigh from the National Institute of Neurological Disorders and Stroke, National Institutes of Health, in Bethesda and colleagues evaluated patients with acute ischemic stroke enrolled between 2013 to 2014 in the NINDS Natural History of Stroke study. A little bit about the study: It enrolled stroke patients presenting to three hospitals in Washington, DC, and Maryland with serial MRI scans during the acute and subacute time period after ischemic stroke. For this particular paper, they included patients who received MRI and perfusion-weighted imaging and included only those who were thrombolized. That was their way of ensuring that all patients in their study were in the hyperacute stage of stroke. They then looked at their MR imaging, specifically the fluid-attenuated inversion recovery, or FLAIR, images, for a presence of something called hyperintense vessels in the ischemic territory. Now, this is an audio-only podcast, so unless you're Googling FLAIR hyperintense vessels on MRI, to follow along, I have to take a bit of time explaining this entity. What do we mean by FLAIR hyperintense vessels? We are not just talking about the T2 hyperintense signal that's sometimes noticeable at the site of proximal occlusion. For example, in the setting of an M1 occlusion, we may be able to detect a T2 hyperintense signal at the site of M1 on FLAIR. That's not the point of this paper. The point is to look throughout the area supplied by that said target occlusion, in this case all of the MCA, and see whether there is hyperintense signal in all arteries in that potentially ischemic tissue and how the area delineated by these FLAIR hyperintense vessels could potentially correspond to the area of perfusion deficit on conventional perfusion imaging. It turns out that these hyperintense vessels actually map a pretty large area. So, this is the point of this study. The investigators developed a FLAIR hyperintense vessel scoring system and called it NIH, obviously, because this was a National Institutes of Health study, FHV, which stands for FLAIR hyperintense vessel, scoring system. And the score is based on presence of these hyperintense vessels in three vascular territories: ACA, MCA, or PCA. Now, seeing that MCA is a larger territory, they had to further divide it into four sub-regions: frontal, insular, temporal, and parietal. So, in total, we have six regions now. Each of them would get a score of zero if there were no hyperintense vessels in them, and a score of two if there were three or more FLAIR hyperintense vessels in a single slice, or if there were three or more slices that contained FLAIR hyperintense vessels. And, of course, a score of one would be anything in between. So, we have six regions in total, each maximum getting two points, to give us a composite score of maximum 12 for this scoring system. So, they wanted to see whether there's a correlation between the FLAIR hyperintense vessel score and the volume of perfusion deficits that is detected by conventional perfusion imaging, which is their main study result. But before we go there, it does seem like a lot of work to learn all these regions and count all these hyperintense vessels in these six regions and come up with an actual score. So, they had to do an interrater reliability to see how easy it is to score and how reliable are these scores. So, they had two independent reviewers for their study. On average, the scores of these two independent reviewers differed by one point for a κ of 0.31, which is quite a low interrater reliability. But when they looked at a more liberal way of assessing interrater reliability, where partial credit was given, when the raters were at least close in their scoring, the κ improved to 0.65 for a moderate degree of agreement. So, what that means is that it's not easy to learn the score, and potentially I can give a score and another colleague can give a different score. So, we have to keep that in mind. But I want to emphasize that in the field of stroke neurology, we are kind of used to these poor interrater reliability agreements in general. For example, the interrater reliability of the ASPECTS score, a score that is commonly used in our day-to-day practice, and especially in the acute phase, we communicate the extent of early ischemic changes by using the ASPECTS score, has a pretty poor interrater reliability, especially in the first few hours after the ischemic stroke. So, we can make due with a κ of 0.65. Now on to the results of this study. They had a total of 101 patients. Their median age was 73. The median FHV, which is that FLAIR hyperintense vessel score, in their entire cohort was four. And close to 80% of patients enrolled in their study had some perfusion abnormalities on their concurrent perfusion-weighted imaging. Now, briefly, they defined perfusion deficits as areas with delay in the relative time to peak map, or TTP maps, after applying a six-second threshold to these TTP maps. Of note, half of those patients with a perfusion deficit had a significant perfusion deficit, which meant that they had 15 cc or more of perfusion deficit. OK, now on to the main study results. Number one, the score obtained by NIH FLAIR hyperintense score highly correlated with the volume of perfusion deficit. In fact, every one point increase on the NIH-FHV score was approximately equal to 12 cc of perfusion deficit. That's a really useful way of thinking about this score. Each score translated in 12 cc of perfusion deficit. Number two, when they looked at the predictive ability of this score in predicting the presence of significant perfusion deficit, that is 15 cc or more of perfusion delay, the area under the curve was 0.9, which is quite high. This is quite reassuring that the FHV score was sensitive and specific in predicting the presence of significant perfusion deficit. Next finding, how does this score do in predicting a significant mismatch? They calculated mismatch ratio by dividing the perfusion volume to that of ischemic core as measured by diffusion volume as it's done conventionally, and then did the same for the score with the exception that instead of using the perfusion volume, they actually used this score and divided it by diffusion volume. And it turns out that FLAIR hyperintense mismatch ratio had a strong predictive capability in predicting the mismatch ratio of 1.8. So, in summary, if this score is validated in larger studies, it can potentially be used as a quick and dirty way of calculating the amount of perfusion deficit in the setting of target vessel occlusion. And, of course, it can also be used as a predictive way of presence of significant perfusion deficit, which is perfusion deficit of over 15 cc. This is all without the need to do actual perfusion imaging. Now, all we've got to do is to get comfortable with this scoring system and, of course, be able to multiply it by 12 to give us a quick guesstimate of the perfusion volume. And one final word on this is that I think the future of stroke imaging is not in doing more images, but to be able to extract more information from less imaging in the acute setting. Stroke physicians were frequently consulted to see patients that are scheduled to undergo coronary artery bypass graft surgery, or CABG. The stroke consult would be for the optimal perioperative management of an often incidentally found carotid disease. Now, why do I say we were frequently consulted? Because at least anecdotally in my own practice, I feel that over the past decade, the number of these consults has substantially reduced. Why is that? Well, let's dive into this topic and review some of the literature. First off, around 40% of patients who have active coronary artery disease and are scheduled to undergo CABG have concurrent carotid disease, and about 10% of CABG patients have evidence of hemodynamically significant carotid disease. And seeing that the risk factors for coronary artery disease are similar to those causing carotid disease, these high percentages are not surprising at all. But the question to ask is, can we put a patient with significant carotid disease through cardiac surgery? What is the perioperative risk of stroke in this situation? And importantly, should the carotid disease be surgically treated during carotid surgery? This is referred to as synchronous carotid endarterectomy, or CEA plus CABG. Or the carotid disease should be treated either surgically or endovascularly before CABG? We refer to this as staged carotid surgery or post-CABG. This is known as reverse staged carotid surgery. All of these questions are asked from the stroke physicians in that consult, and, like many of you, I have struggled to find the evidence to answer some of them. So, let's briefly review some of the current literature on this topic. The CABACS trial, the acronym stands for the Coronary Artery Bypass Graft Surgery in Patients With Asymptomatic Carotid Stenosis, was a randomized controlled trial that included patients undergoing CABG who are found, exactly like that consult, to have an asymptomatic carotid disease of equal or greater than 70% stenosis. The carotid disease for this trial had to be amenable to carotid endarterectomy, or CEA, and the patients were randomized to either receive synchronous CEA plus CABG or just go through with the CABG alone. The trial started in 2010 and planned to enroll over a thousand patients, but was stopped, unfortunately, prematurely in 2014 due to slow recruitment and withdrawal of funding after only 129 patients were enrolled from 17 centers in Germany and Czech Republic. The original study was published in this journal in 2017. So, what did it find? In their intention-to-treat analysis, the primary outcome of any stroke or death at 30 days was 18% in patients receiving synchronous CEA plus CABG as compared to only 9% in patients receiving isolated CABG. Ouch, a double risk of stroke in those who had concurrent surgical treatment of their carotid disease in addition to CABG. Now, this was an underpowered study, and the results should be understood in that context, but it really didn't appear that synchronous CEA plus CABG would decrease the rate of stroke in the first 30 days. Now, how about the long-term outcomes of these patients? We know that asymptomatic carotid disease carries a cumulative annual risk of stroke, and it's important to see if the risk of subsequent stroke was lower downstream if the carotid was already fixed early on. So, in the current issue of the journal, the CABACS trial investigators, led by Dr. Stephan Knipp from the Department of Thoracic and Cardiovascular Surgery in Essen, Germany, and colleagues are back with the five-year results of this trial. How did synchronous CABG plus CEA do as compared to CABG alone? Well, by five years, the rate of stroke or death was 40% in the combined group and 35% in the CABG-only group. This was not a statistically significant difference. Now, when they broke down the primary outcomes, the rate of death from any cause was similar in the two groups. By five years, the mortality rate was 25% in the combined group and 23% in the CABG-only group. And the same was true for the rate of nonfatal strokes. And also the cumulative rate of nonfatal strokes from year one to year five was similar between the two groups, which meant that the higher stroke risk early on in the CABG plus CEA group was not counterbalanced by decreased rate of stroke later on during the long-term follow-up. And finally, they looked at the rate of disability-producing stroke. First of all, after the first year, no new disabling strokes were observed in either group. That's great news. However, in the early period, unfortunately, close to half of strokes that had happened after the combined CEA and CABG were disability-producing, and about a third of strokes that happened after CABG alone were also disability-producing. So, in summary, even though this study is quite underpowered, it appears that performing synchronous CEA plus CABG increases the preoperative morbidity and mortality in patients with asymptomatic carotid disease without providing any long-term benefits to these patients. Coronaviruses are important human and animal pathogens. By now, I think it's safe to say that most of the population of the world has heard of at least one of the members of the coronavirus's family, which was first identified in late 2019 as the cause of a cluster of cases of pneumonia in Wuhan, China. In the early months of 2020, COVID-19, the disease caused by this novel coronavirus, would rapidly spread to involve much of the world. And on March 11 of the same year, the World Health Organization declared COVID-19 a pandemic. Today, over two and a half years have passed since that day, and an avalanche of scientific papers have since been published about COVID-19, not just in medicine, but in each and every imaginable field of life. Neurology's, of course, no exception. The clinical presentation of COVID-19 largely depends on the severity of the disease and may range from a simple asymptomatic infection to a severe, lethal, multi-organ disease. In the world of neurology, a myriad of neurological symptoms, from loss of sense of taste and smell to headache, all the way to encephalopathy and seizures, have been reported in association with this disease. Early in the pandemic, some studies suggested that COVID-19 is indeed a risk factor for stroke. Like many severe infections, COVID-19 can potentially cause a prothrombotic state and can be associated with thromboembolic events. But most of these earlier studies were smaller observational studies that were completed in an inpatient setting, including those with severe COVID. In fact, to date, we still don't have an accurate and reliable estimate of stroke incidence among patients with COVID-19. On the other hand, stroke is the second leading cause of death globally and the fifth cause of death in the US. In the United States, every 40 seconds, someone has a stroke, and every four minutes, someone dies of a stroke. So, I think the question that everyone should be asking is, has COVID-19 changed this statistic? In this issue of the journal, in the study titled "Incidence of Stroke in Randomized Trials of COVID-19 Therapeutics: A Systematic Review and Meta-Analysis," Dr. Ntaios and colleagues aim to get us a step closer to answering this very important question. Dr. Ntaios is an Associate Professor of Medicine at the University of Thessaly in central Greece, and he's the current President of the Hellenic Stroke Organization. It is my great honor to have Dr. Ntaios today in our podcast to discuss this paper and all things stroke-related COVID-19. Good afternoon, George, and welcome to our podcast. Dr. George Ntaios: Thank you for the invitation, Negar, and for highlighting our work. It's a pleasure to be here with you today. Dr. Negar Asdaghi: Thank you for being here, and congrats on the paper. George, can you start us off by discussing the pathophysiological mechanisms through which COVID can potentially cause a stroke? Dr. George Ntaios: Well, one of the most attractive things about stroke, which makes it fascinating for all of us, is its complexity. So many different pathologies can cause stroke, and, quite frequently, identifying the actual cause of stroke can be really challenging. And in a similar way, the pathophysiological association between COVID and stroke seems to be, again, complex. Different pathways have been proposed. Internal, we talk about two broad mechanisms. One is the vascular inflammation and thrombosis, and the other is cardioembolism. And there are several pathways which are involved in vascular inflammation and thrombosis: activation of the complement, activation of the inflammasome, activation of thrombin, increased production of [inaudible 00:24:47] constriction, state of stress, platelet aggregation, vascular thrombosis. So, collectively, this thromboinflammation could lead to damage of the neurovascular unit and consequently to stroke. And in a similar way, there are several cardiac pathologies which can cause stroke in a COVID patient, like acute left ventricular dysfunction, which can be caused, again, by several mechanisms, like coronary ischemia, stress-induced takotsubo cardiomyopathy, myocarditis inflammation, or also as a result of direct effect of the coronavirus at the myocardial cell. And, of course, we should not forget about atrial fibrillation, which seems to be more frequent in COVID patients. So, we see that the proposed mechanisms behind the association between COVID and stroke, that is, vascular thromboinflammation on one hand, or cardioembolism on the other hand, are complex, but whether these derangements they have a clinically relevant effect or they are just biochemical derangements without any clinical effect is a debate. For example, the incidence of myocarditis in COVID is about 0.2%. That is, in every 500 COVID patients, you have one patient with myocarditis. But myocarditis has a very wide clinical spectrum ranging from subclinical elevation of myocardial enzymes to full and life-threatening disease. So, obviously, the incidence of severe myocarditis is even lower than 0.2%. And the same is true also for the incidence of myocarditis after COVID vaccination. The CDC estimates that one case of myocarditis occurs every 200,000 vaccinations, with the number being slightly higher in young men after the second dose. And this is extremely rare, and the huge majority of these myocarditis cases, they're mild. So, this is about ischemic stroke. Now, with regard to hemorrhagic stroke and its association with COVID, again, it seems to be, again, very rare. The best estimate that we have comes from the Get With The Guidelines – Stroke Registry and is about 0.2% and involves mainly patients who are already on anticoagulants. So, they had already a risk factor for ICH. So, again, whether all these pathophysiologic derangements in COVID patients, they have a clinical meaningful association with stroke risk or not, I think it's a matter of debate. Dr. Negar Asdaghi: Wow, George, it was a simple question, but it seems like the answer was not that straightforward. Let me just recap some of the things you mentioned. So, first of all, the answer is not straightforward and depends on whether we're talking about ischemic stroke or hemorrhagic stroke. There seems to be a lot of connecting points, at least, so to speak, between COVID and either forms of stroke. But you touched on two major sort of broad mechanisms. One is the idea of vascular thromboinflammation that goes along the lines of many sort of hyperacute, hyperinflammatory processes that can occur, especially in the setting of severe COVID. You touched on activation of thrombin, complement activation, platelet aggregation, sort of an activation of that microvascular or vascular unit in a sense. And then a second mechanism you touched on is the impact of COVID on the myocardium on sort of many different pathways. Again, you talked about acute left ventricular dysfunction, stress-induced myocarditis, and the impact of COVID on perhaps increasing the rate of atrial fibrillation. Again, these are all very complex associations, and some could be already present in a patient who is perhaps of an older age, and COVID is just a modifier of that risk factor that was already present in that particular person. And you also touched on how COVID can potentially increase the risk of hemorrhagic stroke, but the study seems to suggest that those patients already had risk factors for the same. And perhaps, again, COVID is a modifier of that risk factor. All right, so with that information, a number of studies early on, especially, in the pandemic and later, some meta-analyses, have aimed to estimate the incident rate of stroke post-COVID. Can you please briefly tell us what were their findings, and how is your current paper and current meta-analysis different in terms of methodology from those earlier studies? Dr. George Ntaios: Yes. Well, it all started from this letter to the editor at the New England Journal of Medicine. It was published very early in the pandemic during the outbreak in New York. And in this letter, the authors had reported that within a period of two weeks, they had five young patients with COVID and large artery stroke, which they commented that it was much higher than their typical, actually their average, of 0.7 cases during a two-weeks period within the last year. And remember that back then, we knew literally nothing about COVID. So, this letter was really a huge, loud alert that something is going on here and that perhaps our hospitals would be flooded with COVID patients with stroke. So, subsequently, several reports were published aiming to estimate the incidence of stroke in COVID. Rather contradictory with the incidence, estimates are ranging from as low as 0.5% to even 5%. However, these estimates could well be inaccurate. They were observational studies. Most of them were limited to the inpatient setting. Most of them were single-center studies. Most of them, if not all, were retrospective studies. So, there was really a high risk of registration and assessment bias, as well as reporting bias. And also remember that back then during the outbreak, people were really reluctant to visit the hospital, even if they had a serious condition like stroke, an urgent condition, which means that the real incidences could be even higher. So, it was our feeling that these estimates were perhaps inaccurate. And there are also some meta-analyses of these studies which estimate that the incidence of stroke in COVID is about 1.5%. But, of course, any meta-analysis is as good as the studies it includes. So, we tried to find a way to have a more accurate estimate than these estimates. And we followed a different methodology. We studied randomized trials of COVID therapeutics, and we looked for strokes reported as adverse events or as outcome events. And the good thing about randomized trials is the rigorous assessment and reporting of outcomes in adverse events. So, we think, we believe, that this methodology provides a more reliable and a more robust estimate of stroke incidence in COVID patients. Dr. Negar Asdaghi: OK. George, it's very important what you just mentioned, so I wanted to recap for our listeners some of the things you mentioned. It all started with a letter to the editor of New England Journal of Medicine on a report of five young patients that had large vessel occlusion in the setting of COVID. And then, basically, the floodgates opened in terms of all these observational studies that basically reported the same. And subsequent to that, meta-analyses that were completed containing those observational studies predominantly gave us an incident rate of 0.5 to 5%. That's much, much higher than basically the non-COVID–associated incidence rate of stroke in the population-based studies, and basically suggested that COVID-19 is indeed a major risk factor for all types of stroke. So, that's where it all started. And, as you alluded to, these numbers had to be reverified in bigger settings, more controlled setting. And you already answered my next question, which is the difference between those studies and prior meta-analyses to the current meta-analysis is that you basically took the simple question and started looking at it in a controlled setting of randomized trials. And you already answered this question of the methodology, but I want to recap. You took basically patients included in randomized trials of therapeutics for COVID-19, various therapies for COVID-19, and you did a meta-analysis to see what were the incident rate of stroke as an outcome in these trials. So, with that, could you please tell us a little more about the population that you had in this meta-analysis in terms of their age, the types of therapies that these randomized trials had looked at, and the duration of the follow-up, please? Dr. George Ntaios: The follow-up included 77 randomized trials, which corresponds to more than 38,000 COVID patients. The mean age of these patients was about 55 years of age, and they were followed for an average of 23 days after study enrollment. With regard to the set strategy, I think it was not strict at all. I would rather say it was very liberal. We allowed trials of any drug in COVID patients of any age, of any severity, coming from any setting: outpatient, inpatient, either general ward or intensive care unit. And from any country. I don't think that we could achieve a wider inclusion than this strategy did. And the huge majority of patients, more than 95%, they were hospitalized patients. So, by definition, they had severe COVID disease. And the drugs studied in these trials included everything that was actually tried in COVID, including tocilizumab, IL-6R inhibitors, steroids, remdesivir, chloroquine, azithromycin, ritonavir, interferon, ivermectin, and many other drugs. So, I think we tried to include as many trials as possible. Dr. Negar Asdaghi: OK. So, let me see if I got it. You basically included 77 randomized trials. It is a younger population of patients in these trials, median aged 55. You had a total of over 38,000 patients. It's a great sample size for this meta-analysis. And importantly, the duration of follow-up is median of 23 days. And it's just about any treatments we've heard that have been tried for COVID, from dexamethasone to remdesivir and ivermectin. And a rigorous methodology. So, I think we're ready to hear the primary results of this meta-analysis. How many strokes happened in these patients? Dr. George Ntaios: In the overall population, that is both in the hospital and in the outpatient setting, there were totally 65 strokes in these 38,000 COVID patients, which corresponds to one stroke every 600 COVID patients or else an incident of only 0.16%, 0.16%. This is very low, much lower than the previous estimates. And, of note, all strokes occurred in hospitalized patients. There were no strokes at all in the ambulatory COVID patients. So, just to repeat the result, we just found that only one patient will have a stroke every 600 COVID patients who are either hospitalized or are ambulatory. Dr. Negar Asdaghi: OK. So, I need to have these numbers, I think, committed to memory, especially when we speak to family members and patients in the hospital. Ninety-five percent of the patient population of this meta-analysis were inpatient COVID. So, by definition, they must be sicker in terms of the severity of their COVID disease. Out of 38,000 patients, you had 65 events of stroke. So, these are very, very important numbers, a lot basically lower than the incidence rate reported from prior studies. So, I wanted to ask you about the sensitivity analysis that was done in the meta-analysis. Dr. George Ntaios: Yes. When we designed the analysis, we were expecting that we would find numbers was similar to those reported before. So, we thought that perhaps a sensitivity analysis would be able to increase the confidence and the robustness of the results. That's why we did this sensitivity analysis. However, it proved that the number of strokes, the number of outcome events was much lower than what expected. So, the power for those sensitivity analysis to show a meaningful conclusion was low. So, actually, that's why we don't comment at all on those sensitivity analysis because there were so few strokes to support such an analysis. Dr. Negar Asdaghi: OK. So, basically, you had a priori design the meta-analysis based on the assumption that the incidence rate of stroke would be a lot higher, but then later on, when the incidence rates was lower, then the sensitivity analysis didn't really give any meaningful data to us. So, I mean, I think we already talked about this, but I want to ask you, why do you think that the incidence rates were so much lower in your analysis than the prior meta-analysis? Dr. George Ntaios: I believe that our estimate is quite accurate. I think that the reports of stroke incidence published during the pandemic possibly overestimated the association. I think that the early concern that we all had in the beginning, that we would be flooded with strokes during the pandemic, was not confirmed. I think that we can support with decent confidence that stroke is a rare or perhaps very rare complication of COVID. Dr. Negar Asdaghi: Right. That's great news. That really is great news, and we take every bit of good news in these trying times. George, something that was not touched on in the paper, but I want to ask you and basically get your opinion on this matter, is a much talked about concept in the COVID literature of how COVID could potentially modify certain risk factors. There are much talk about how people with pre-existing diabetes or obesity can potentially develop more severe COVID and, hence, have more complications of COVID, including stroke. What is your clinical experience on this matter, and do you think there are certain predictors of development of COVID-associated stroke? Dr. George Ntaios: That's a very good point. For the last two years, I was involved in the hospitalization management of COVID patients. So, what we see is what is also described in the literature, that there are certain patient characteristics that predispose them to severe COVID. For example, obesity, for example, older age, pregnancy. Perhaps our analysis was not designed to respond to this question. The data available on the studies that were included, they could not support such an analysis. So, I cannot provide information from our study. But the fact that all strokes in our study, they occurred in hospitalized patients and none of them occurred in ambulatory patients, confirms what is known, that those strokes occurred in patients who, by definition, they have severe COVID disease. So, they confirm this putative association that perhaps severe COVID is associated with stroke rather than just mild COVID. Dr. Negar Asdaghi: All right. Thank you. And I just want to end with this simple question that I get asked often, and I want to see how you respond to patients or their loved ones when you're asked this question: "Doctor, did COVID give me a stroke?" How should we answer that question? Dr. George Ntaios: Yes. As we discussed, I think that stroke is a rather rare or perhaps very rare complication of stroke and certainly less frequent than we initially thought. And in those stroke patients who had already other pathologies which can cause stroke, I would be rather reluctant to attribute it to COVID. I would be perhaps more willing to do so in younger patients, but again, only after exhaustively looking for another cause, like PFO, dissection, etc. I mean, the concern is that if we as the treating stroke physicians assume that the stroke is caused by COVID, then we might discourage patients from doing the necessary diagnostic workup to find the actual cause of stroke. And if it happens, then perhaps an underlying pathology may be missed, which means that the patient will remain vulnerable to stroke recurrence. So, in general, I'm rather very reluctant to say that the stroke is caused by COVID unless a really thorough diagnostic workup shows nothing else at all. Dr. Negar Asdaghi: All right. Very important message now to all practicing clinicians is don't stop at COVID. Don't just say simply, "Oh, this is COVID. COVID gave you a stroke." Keep looking for potential causes of stroke. Still do put that patient in the category of potentially ESUS or cryptogenic stroke if no other causes are found. And keep in mind that stroke is rare or, as George said, a very rare complication of COVID. Dr. George Ntaios, this is an exceedingly timely topic and a very important contribution to the field. Congratulations again on your paper, and thanks for taking the time to chatting with us today. Dr. George Ntaios: Thank you for the wonderful discussion, Negar, and for the focus of our work. Dr. Negar Asdaghi: Thank you. And this concludes our podcast for the November 2022 issue of Stroke. As always, please be sure to check out the table of contents for the full list of publications, as we can only cover a fraction of the incredible science published in this journal each month. And don't forget to check our fantastic Literature Synopsis. In this month's issue, we read a short summary of the ACST-2 trial published in Lancet on the results of a randomized comparison of stenting versus endarterectomy in asymptomatic carotid disease patients with over 60% of carotid stenosis. We also have the results of the CASSISS randomized trial, which was published in JAMA earlier this year, and it studied the effect of stenting plus maximal medical therapy versus maximum medical therapy alone on the risk of subsequent stroke and death in patients with symptomatic intracranial stenosis, either in the anterior or in the posterior circulation. CASSISS did not show that stenting was superior to maximum medical therapy, and sadly, these patients remain at a substantial risk of recurrent stroke despite being on best medical therapy. But I wouldn't be too despondent about the future of interventional therapy for intracranial atherosclerotic disease. After all, we've come a long way since Dr. Charles Thomas Stent, an English dentist, started experimenting with products to advance the field of denture making around 1865. The work that Dr. Stent had started would be continued by his two sons, both dentists, to eventually make its way to products to create surgical tools. But it would be another 100 years before the first percutaneous coronary procedure was completed in 1964. And in honor of Dr. Stent's pioneering work, the device used to keep the coronaries open was named, you guessed it, stents. Today's stroke care cannot be imagined without the use of various stents, and there's no doubt the future is promising for ways in which we will be able to safely treat intracranial atherosclerotic disease amongst all other vascular disorders. And what better way to keep our enthusiasm than staying alert with Stroke Alert. This program is copyright of the American Heart Association, 2022. The opinions expressed by speakers in this podcast are their own and not necessarily those of the editors or of the American Heart Association. For more, visit AHAjournals.org.
Dr. Yaniv Erlich is the co-founder and CEO of Eleven Therapeutics. Prior, he was the CSO of MyHeritage, a consumer genomics company (acquired by Francisco Partners), an Associate Professor of Computer Science at Columbia University and a Principal Investigator at the Whitehead Institute, MIT. We talked with Yaniv about his unique career that led him to leave academia and focus his efforts on building exciting biotech companies. Yaniv shared his insights into academic and non academic career development pathways for scientists, delved into the advantages of building a company in the UK as well as shed some light on how research is done at Eleven Therapeutics. Tune in and join the discussion in our 'mAcademia podcast' group on Facebook. Music Funkorama Kevin MacLeod (incompetech.com) Licensed under Creative Commons: By Attribution 3.0 License http://creativecommons.org/licenses/by/3.0/ --- Send in a voice message: https://anchor.fm/macademia/message
Join Drs Cohen and Gibofsky as they step through a case of refractory psoriatic arthritis, discuss novel therapeutics, review latest clinical trials, and talk about the future in psoriatic arthritis. Relevant disclosures can be found with the episode show notes on Medscape (https://www.medscape.com/viewarticle/970786). The topics and discussions are planned, produced, and reviewed independently of advertiser. This podcast is intended only for US healthcare professionals. Resources Psoriatic Arthritis Workup https://emedicine.medscape.com/article/2196539-workup#c6 GRAPPA Treatment Recommendations: 2021 Update https://www.jrheum.org/content/49/6_Suppl_1/52.long Methotrexate in Psoriasis and Psoriatic Arthritis https://www.jrheum.org/content/96/31 Psoriatic Arthritis Medication https://emedicine.medscape.com/article/2196539-medication#4 Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients https://www.jrheum.org/content/47/6/854 Three JAK Inhibitors Get Boxed Warnings, Modified Indications https://www.medscape.com/viewarticle/958024 Effect of Tofacitinib on Patient-Reported Outcomes in Patients With Active Psoriatic Arthritis and an Inadequate Response to Tumour Necrosis Factor Inhibitors in the Phase III, Randomised Controlled Trial: OPAL Beyond https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6340607/ Upadacitinib in Patients With Psoriatic Arthritis and an Inadequate Response to Non-biological Therapy: 56-Week Data From the Phase 3 SELECT-PsA 1 Study https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8524381/ Multicentre, Randomised, Open-Label, Parallel-Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Naïve to Biological Disease-Modifying Antirheumatic Drug: Final Results by Week 52 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509529/ Improvement in Patient-Reported Outcomes in Patients With Psoriatic Arthritis Treated With Upadacitinib Versus Placebo or Adalimumab: Results From SELECT-PsA 1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8572257/ Bimekizumab in Patients With Active Psoriatic Arthritis: Results From a 48-Week, Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2b Trial https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(19)33161-7 A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment https://clinicaltrials.gov/ct2/show/NCT04908189
SmallCapVoice.com Inc. (“SCV”) announces the availability of a new interview with Dr. Bill Williams, CEO of BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V: BCT), to discuss three key achievements that support the Company's continued growth. The Company recently announced positive initial efficacy data in its 2021-2022 cohort of 12 advanced breast cancer patients. Disease control, tumor shrinkage, and potential survival benefit were observed amongst 12 patients in the Phase I/IIa clinical study of Bria-IMT™ in combination with Incyte's retifanlimab. Bria-IMT™ regimen in combination with Incyte's retifanlimab produced evidence of disease control, tumor shrinkage, and potential survival benefit amongst BriaCell's recent 12 patient cohort in advanced breast cancer. The study, recently awarded U.S. Food and Drug Administration ("FDA") fast track designation, continues with additional clinical data forthcoming. The regimen remains well tolerated as recently reported in Phase I evaluation. 70% of patients showed either disease control or progression-free survival (PFS) benefits compared with their last therapy. Prior to enrollment, the 12 patients in the cohort had already been unsuccessfully heavily pre-treated with at least 2 prior therapy regimens, further underscoring BriaCell's positive patient outcomes.
Meredith Langhorst, a specialist in spinal diagnostics and therapeutics, and her patient Eric Osborn, a veteran of the US Navy, talk about the Reactiv8 therapy and how its restorative neurostimulation approach has helped patients reduce their lower back pain without the need for surgery. Click this link to the show notes, transcript, and resources: outcomesrocket.health
Dr. Will Parsons is an Associate Professor of Pediatrics in the Division of Hematology-Oncology at Baylor College of Medicine. He also serves as the Director of the Baylor Pediatrician-Scientist Training Program, Director of the Center for Personal Cancer Genomics and Therapeutics, and Co Director of the Neuro-oncology and Cancer Genetics and Genomic Programs at Texas Children's. Sr. Parsons earned his MD and PhD from the Ohio State University, did his residency in pediatrics at Johns Hopkins, and a clinical fellowship in hematology-oncology at the national cancer institute followed by a fellowship in neuro-oncology at Johns Hopkins. Today, Dr. Parsons shares his personal and professional journey to becoming a pediatrician-scientist and discusses the role for physician-scientists and PSTPs in pediatric medicine. Credits: Our thanks to Dr. Parsons for being on the podcast. Dr. Parson's Faculty Page: https://www.texaschildrens.org/find-a-doctor/donald-williams-will-parsons-md-phd Host: Bejan Saeedi Executive Producers: - Bejan Saeedi - Joe Behnke - Michael Sayegh - Carey Jansen Faculty Advisors - Dr. Mary Horton - Dr. Brian Robinson Twitter: @behindthescope_ Instagram: @behindthemicroscopepod Facebook: @behindthemicroscope1 Website: behindthemicroscope.com
Ticks are a scourge. They're vectors of multiple serious an debilitating diseases, and evolution has made them perfectly adept at attaching to their hosts—and potentially spreading those diseases virtually undetected— that ability owing to anti-inflammatory and anesthetic proteins in their saliva. But the emerging biotech Akari Therapeutics thinks there's a broad range of medicinal value in those proteins. They've painstakingly developed a recombinant version of one such tick saliva-derived protein, called nomacopan, and put it to work in phase 3 trials to treat rare but deadly severe hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). On this week's episode of the Business of Biotech, Akari President & CEO Rachelle Jacques tells us about the redeeming qualities of tick saliva and how her company is putting it to work. Subscribe to the NEW #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!
Mythic is merging science and business for groundbreaking drug development. In this episode, Brian Fiske, founder, and CSO at Mythic Therapeutics talks about the work Mythic does, the journey that led him to create the company, and what he has learned along the way. After earning experience in the pharma industry, Brian wanted to start his own company and focus on making drugs for patients rather than on technology. At Mythic, he and his team looked at antibody-drug conjugates focusing on the antibody side to target affected cells. He discusses the importance of connecting with people at the company and work teams and interpreting their feedback. Brian also shares his thoughts on shipping and data management as challenges that, when addressed properly, can make drug development much more efficient. Tune in to this episode to learn from Brian Fiske about the inner workings of Mythic Therapeutics in drug development! Click this link to the show notes, transcript, and resources: outcomesrocket.health
Capstan Therapeutics' CEO, Laura Shawver, Ph.D., talks us through the company's in vivo CAR therapies and what led to the in vivo cell engineering breakthrough that has been decades in the making. Shawver explains the promise of harnessing mRNA and targeted LNP delivery to train a patient's body to make CAR-T cells in vivo. She also details best practices to garner funding and investment partnership.
When psychedelics were first studied more than 50 years ago, researchers noticed that they were useful in helping people explore a greater sense of self. Now, after a half-century hiatus, scientists are studying psychedelics like MDMA, psilocybin, and ketamine as treatment for depression, PTSD, anxiety, and other mental health conditions. So, what promise do they hold as therapeutics? Albert Garcia-Romeu, a researcher at John's Hopkins University, joins Dr. Sanjay Gupta to talk about how psychedelics can alleviate mental suffering and what the path forward might look like.To learn more about how CNN protects listener privacy, visit cnn.com/privacy
Our guest in this episode is Cove Therapeutics CEO, Niren Shah, who discusses the pitfalls of current viral vector based gene therapies and shares how Cove's next generation non-viral gene delivery platform overcomes many of the challenges of viral vectors.
Doug Lindsay has spent the last two decades investigating and tackling rare, complicated medical conditions – first in himself and his family and now through his Personal Medical Consultant service. An innovator, Doug partners with clients and experts to make new things happen. He works to get clients who are stuck in the medical system unstuck. To aid him in his work, he strives to understand healthcare from all levels of organization, from the individual to health systems, public health, and global health. Doug's dogged, indefatigable ability to chase down answers to an individual's complex problems makes him a special asset as a teammate and Personal Medical Consultant. In addition to his Personal Medical Consultant service, Doug Lindsay • Co-chairs PCORI's Congressionally-mandated Rare Disease Advisory Panel (RDAP) • Co-chairs Washington University School of Medicine's Community Advisory Board for the Institute for Clinical and Translational Sciences and the Institute for Public Health (ICTS & IPH). • Is Community Advisory Board member for the National Institutes of Health's ACTIV-1 IM trial. (ACTIV is the US government's public/private/nonprofit collaboration for Accelerating COVID-19 Therapeutics and Vaccines research.) • Is member of the National Institutes of Health's ten-person ACTIV COVID Biospecimen Prioritization Committee. (NIH) • Is member of Academy Health's Global Health Interest Group. • TEDx talk Operation: Adrenal Gland can be found at TED.com • Was speaker in the panel kicking off Academy Health's Datapalooza, 2019 • Has twice been an ePatient Scholar at Stanford Medicine X (2017, 2019) • Appeared on The Dr. OZ Show in fall 2019 as example of The Power of 1 (to make a difference). • Was the first patient invited to give a fireside chat for the Health Management Academy, which hosts C-Suite education conferences for the nation's 100 biggest hospital systems, 2017. • Co-chaired aviation humanitarian nonprofit Wings of Hope's “Taste of Hope” fundraiser • Has been keynote speaker for national organizations like AHIMA, for healthcare conferences like the Society for Participatory Medicine, and at internal corporate events for firms like Pfizer. • Graduated with honors from Rockhurst University's Honors College with a BS in biology in 2016. • CNN online feature “This college dropout was bedridden for 11 years. Then he invented a surgery and cured himself” on his story was the #3 article globally across all media platforms for all of 2019 for time readers spent reading it.
Host Matt Fisher is joined by Bronwyn Spira, CEO and Co-Founder, Force Therapeutics. They discuss the prevalence of musculoskeletal injuries and recovery pathways; opportunity presented by technology to increase access and improve outcomes; meeting patients to improve engagement; collecting, understanding, and building on patient reported outcome measures. To stream our Station live 24/7 visit www.HealthcareNOWRadio.com or ask your Smart Device to “….Play Healthcare NOW Radio”. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen
In this episode of the Ownership Economy, we speak with Molecule Protocol's Co-Founder and Chief Scientific Officer Tyler Golato. Molecule is creating collaborative ecosystems, where stakeholders in drug development can work together to expedite the process of bringing novel therapeutics to patients. The company is connecting leading researchers to funding by turning intellectual property and its development into a liquid and easily investable asset. We talk with Tyler about the model, how the company isapproaching progressive decentralization, and where algorithmic rules of governance intersect with the need for human decision making. We hope you enjoy the episode.
When seeking to generate additional income by writing covered calls on long-term buy-and-hold securities, there is a specific approach we use for covered call writing. Strike selection and position management are specific to our strategy goals. This podcast uses a real-life example with Apple Computer to show strike selection and exit strategy execution if the strike is in-the-money as expiration approaches. BCI Package, our Best and most Comprehensive Investment package: https://thebluecollarinvestor.com/minimembership/bci-investor-program/ BECOME A BCI MEMBER TODAY: https://www.thebluecollarinvestor.com/membership/ SEE BCI COURSE & PRODUCTS : https://thebluecollarinvestor.com/store/ STOCKS,TRADING,STOCK MARKET,COVERED CALLS,covered call writing,Axsome,Therapeutics,Ellman Calculator,gap-up,cost-to-close,implied volatility,Alpha,Beta,seeking,alpha,cost-basis,time-value,intrinsic- value,put-selling,collar calculator,put calculator,stock option,facebook stock,amazon stock,investing,options,Option,option buyer,strike price,in the money,in the money coverd call,out of the money covered call,covered call writing exit strategies
In a series of podcasts to mark the 60th anniversary of DTB, we talk to some of DTB's Editorial Board members and other colleagues about their work and their involvement with DTB. In this podcast, David Phizackerley (DTB's deputy editor) talks to Dr Jo Congleton, who is a consultant in Integrated Respiratory Care in Brighton and Hove. She is also clinical lead for the Kent, Surrey, Sussex Academic Health and Science Network (AHSN) Respiratory Programme. Her interests are in chronic respiratory conditions (particularly COPD) and reducing both variation, and inequalities, in care. This special series of the DTB Podcast is produced by Leticia Amorim. Please subscribe to the DTB podcast to get episodes automatically downloaded to your mobile device and computer. Also, please consider leaving us a review or a comment on the DTB Podcast iTunes podcast page (https://podcasts.apple.com/gb/podcast/dtb-podcast/id307773309). Thank you for listening.
Lab Operations are the foundation for scientific work at Mythic Therapeutics. In this episode, Nimish Gera, Vice President of Biologics at Mythic Therapeutics, talks about the work Mythic Therapeutics does and the role LabOps play in it. Nimish is the scientific co-founder of Mythic, where he oversees the discovery of “antibodies”; These molecules target chemotherapy to a certain area, killing intended cells and minimizing toxicities. With a chemical engineering background, he started working at the lab himself and realized that LabOps personnel are the ones who do critical day-to-day tasks that allow the developments to happen. Finally, he talks about how as a leader he keeps an eye on the use of lab resources and ensures he's including and motivating LabOps employees. Tune in to this episode to listen to what Nimish Gera has learned working at Mythic Therapeutics about LabOps in cancer biologics development! Click this link to the show notes, transcript, and resources: outcomesrocket.health
What You Need To Know About Alzheime'rs Treatments Our host, Lori La Bey talks with Sharon L. Rogers, Ph.D., who is best known as the worldwide leader and development strategist for the highly successful Alzheimer's Disease treatment, Aricept® (donepezil), the standard of care for more than 20 years. After that success, she moved to VC-based start-ups holding a variety of senior executive positions, including CEO, CMO and President. Sharon brings the strength behind 35 years of pharma experience to AMYRIAD Therapeutics as its CEO. We are live today call in & join the conversation (323) 870-4602 Contact Amyriad Therapeutics Website Twitter LinkedIn Contact Lori La Bey Free Educational Resources at www.AlzheimersSpeaks.com Alzheimer's Speaks Radio - Shifting dementia care from crisis to comfort around the world one episode at a time by raising all voices and delivering sounds news, not just sound bites since 2011.
Dr Dennis-Tiwary is in praise of anxiety. She teaches people how to sit with the bad feelings that accompany anxiety by trying to listen to what it is telling us, leverage from the knowledge to understanding to find new solutions and then let go. For example, if you wake in the middle of the night, worried about something that happened during the day. Instead of lying awake and ruminating on these thoughts until they become catastrophic. Take a deep breath, listen to what the thoughts are, sit with the feeling, and then leverage from them. What are they telling you? For example, you may have not finished a task that needs completing or ignored someone that needs your attention. Try, coming back to the present tense and let go of these thoughts and take action on what they are teaching you. Dr Dennis-Tiwary insights offer a new lens about how to think about anxiety. Imagine leveraging anxiety to find a new approach to solve the underlying problems causing the anxious feelings. From Dr. Tracy Dennis-Tiwary website:Tracy A. Dennis-Tiwary, Ph.D. is a professor of psychology and neuroscience, Director of the Emotion Regulation Lab, and Co-Executive Director of the Center for Health Technology at Hunter College, where the mission is to connect researchers, community stakeholders, and technology innovators to bridge the healthcare gap. As Founder and CSO of Wise Therapeutics, she translates neuroscience and cognitive therapy techniques into gamified, clinically validated digital therapeutics for mental health. She has published over 100 scientific articles and delivered over 400 presentations at academic conferences and for corporate clients. She has been featured throughout the media, including the New York Times, Wall Street Journal, ABC, CBS, CNN, NPR, The Today Show, and Bloomberg Television.Future Tense: Why Anxiety is Good For You (Even Though it Feels Bad)Future Tense argues for the radical idea that anxiety is a feature of being human, not a bug. When we tap into our anxiety instead of attack it like an illness, we realize that human anxiety evolved to not only be protective, but to build our creative capacity to be productive. Anxiety achieves this by making us into time travelers, propelling us into future thinking, where we are smarter, more focused, and more hopeful in the face of challenge.This book details how – and why – we should adopt a new mindset about anxiety – a fresh set of beliefs and insights that allow us to use anxiety as information so we can leverage it rather than be overwhelmed by it. I share real-world examples and stories combined with the latest research in psychology, neuroscience, genetics, biology, and sociology. This book celebrates the lives of people who are using anxiety to their advantage and with the goal of making the world a better place. The best solutions in the world won't stick if our view of anxiety unintentionally accelerates it. Support the show
In this feature from the 2021 Midyear Clinical Meeting, our content matter experts share updates from the REDUCE-IT and STRENGTH trials and the role current therapies, as well as new and emerging therapies, play in managing dyslipidemia. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.
Triumvera is a clinical-stage immuno-oncology company, anchored in a deep understanding of T cell biology. Triumvira is developing unique, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat a broad range of patients with cancer.Our company is backed by a strong intellectual property portfolio and a management team with deep experience in cell therapy, oncology drug development and manufacturing. By accessing the latest industry technologies, we are pursuing highly innovative autologous and allogeneic approaches for our TAC-based programs.Get interviewed on the Matt Brown Show: www.mattbrownshow.comAfter Hours Entrepreneur: Your Guide to Profitable, 6-Figure YearsQuit your job. Make more money.Listen on: Apple Podcasts Spotify
This podcast will detail the 3 legs of a collar trade and how to determine the best option strike prices to use. The calculations will be shown using the BCI Collar Calculator which will show maximum gain and loss. A real-life example with SLV will be used to bring home the essential information. BCI Package, our Best and most Comprehensive Investment package: https://thebluecollarinvestor.com/minimembership/bci-investor-program/ BECOME A BCI MEMBER TODAY: https://www.thebluecollarinvestor.com/membership/ SEE BCI COURSE & PRODUCTS : https://thebluecollarinvestor.com/store/ STOCKS,TRADING,STOCK MARKET,COVERED CALLS,covered call writing,Axsome,Therapeutics,Ellman Calculator,gap-up,cost-to-close,implied volatility,Alpha,Beta,seeking,alpha,cost-basis,time-value,intrinsic- value,put-selling,collar calculator,put calculator,stock option,facebook stock,amazon stock,investing,options,Option,option buyer,strike price,in the money,in the money coverd call,out of the money covered call,covered call writing exit strategies
Our bodies contain an inner clock that helps to regulate hormones and biochemistry. This clock is referred to as the circadian rhythm. The fine timing of this biological rhythm requires signaling from light. With the change in seasons, many of us feel the systemic effects of less daylight in various ways, one of which is altered mood. Seasonal Affective Disorder (SAD) is a type of depression that correlates with seasonal patterns. In today's episode, we discuss the biochemistry of how light regulates the circadian rhythm, the etiologies of seasonal affective disorder, and various treatment strategies which have been used to improve symptoms. Today on The Lab Report: 2:15 The circadian rhythm and chronobiology – defining terms 5:00 Light signals and hormonal regulation of the biological clock 7:25 Health implications of seasonal change 9:30 Seasonal Affective Disorder 13:45 Vitamin D – What does it do? 18:10 Therapeutics and interventions 21:00 Question of the Day: Can seasonal affective disorder happen in the summer? Subscribe, Rate, & Review The Lab Report Thanks for tuning in to this week's episode of The Lab Report, presented by Genova Diagnostics, with your hosts Michael Chapman and Patti Devers. If you enjoyed this episode, please hit the subscribe button and give us a rating or leave a review. Don't forget to visit our website, like us on Facebook, follow us on Twitter, Instagram, and LinkedIn. Email Patti and Michael with your most interesting and pressing questions on functional medicine: email@example.com. And, be sure to share your favorite Lab Report episodes with your friends and colleagues on social media to help others learn more about Genova and all things related to functional medicine and specialty lab testing. To find a qualified healthcare provider to connect you with Genova testing, or to access select products directly, visit Genova Connect. Disclaimer: The content and information shared in The Lab Report is for educational purposes only and should not be taken as medical advice. The views and opinions expressed in The Lab Report represent the opinions and views of Michael Chapman and Patti Devers and their guests.See omnystudio.com/listener for privacy information.
Welcome back again to Entrepreneur Rx! This week on the podcast, John has a very awe-inspiring conversation with Stacy Blain, co-founder and Chief Scientific Officer at Concarlo Therapeutics. The team of scientists at Concarlo is developing new medications that use p27, a natural inhibitor, to stop cancer cells from multiplying in drug-resistant patients. A discovery made in a university setting led Stacy Blain to pursue a further investigation and drug development on her own, for which she had to navigate an extensive process of entrepreneurship, assembling her own team, and finding funds to change the way cancer is treated. She shares the journey it took her to get Concarlo to where it currently is and explains the work they are doing with p27, in addition to targeted therapy, to bring cancer patients a treatment that is less toxic and seeks to avoid remission, mutations, or ultimately, drug resistance. Tune in to this episode and learn from Stacy's experience venturing into business with her discovery!
Ankit Mahadevia, Co-Founder and CEO for Spero Therapeutics. Ankit focused on novel treatments for Gram Negative infections. He built team responsible for 11 approved antibacterial drugs and raised $97M in private capital across Seed through Series C crossover round to enable construction of multi program late stage infectious disease pipeline and he leads program that achieved positive Phase III outcome in single pivotal trial required for US approval. Here are some key moments from our conversation: Brief introduction of yourself and your company. (00:43) What inspired you to write a book? (01:38) Introverts can be great leaders. (05:48) Being transparent and believing in something bigger than you are. (08:43) What's your take on introvert leadership? (09:09) How do you help yourself to get the space you need to recharge after being drained through the interactions with others? (17:06) How do you define your true north as a leader and how did that feed into the book that you've written? (19:02) Finding, attracting and retaining the right people. (30:22) Any advice you have for people who are might introverted? (32:30) Challenges you faced along the way and some challenges as an introvert leader? (38:25) My transparency is a strength. (41:11) What's the one most important thing you'd want to leave the audience with? (42:36) Final and closing thoughts for the audience. (43:27)
In a particularly candid conversation, 4BIO Managing Partner Dmitry ‘Dima' Kuzmin and Ray Therapeutics Co-Founder & CEO Paul Bresge share the recipe for a successful relationship between biotech VC firm and startup. Bresge offers insight into VC engagement strategy and pitch, Kuzmin dishes on what investors look for in terms of "fundability" and what throws red flags, such as— perhaps ironically— a CEO like Bresge who has a deep and incredibly personal connection to the indication he's pursuing. The pair also discuss, in real and tangible terms, what constitutes a material, cultural match.
Neuroene Therapeutics Co-Founder and CEO Sherine Chan, Ph.D., joins Rich Bendis on BioTalk to discuss winning the 7th Annual BioHealth Capital Region Crab Trap, their drug discovery platform and being located at JLABS @ Washington, DC.
An updated Covid-19 booster shot came out last month, but as of last week, only 1 in 10 people have gotten one. Maybe we're all a little booster fatigued. Dr. Shireesha Dhanireddy is the director of the Infectious Diseases Clinic at Harborview, and the Clinical Lead at UW Medicine's COVID-19 Vaccines and Therapeutics program. She's here to tell us why people have been slow to get their next booster, and what might happen if more people don't get theirs soon.
Dr. Linda O'neill, VP of External Innovation at Horizon Therapeutics describes how strategic partnerships can assist biotech startups in moving new therapies through development to deployment. She discusses her company's collaborative approach, and how working together can assist in efforts to navigate the challenging business and regulatory environment.
In this episode, we review Paxlovid (nirmatrelvir/ritonavir) from the perspective of its pharmacology, efficacy, safety, pharmacists' authority to prescribe, drug interactions, and rebound symptoms after Paxlovid therapy. Key Concepts Paxlovid is the preferred outpatient therapy for COVID-19 in patients at high risk for progressing to severe COVID-19. It likely has similar efficacy to IV monoclonal antibodies and IV outpatient remdesivir but differences in vaccination rates and patient populations makes a direct comparison difficult. The 5-day course of Paxlovid is generally well tolerated. “Paxlovid mouth” (dysgeusia) is relatively common and is characterized by a terrible metallic or garbage-like taste in the mouth during therapy. As of July 2022, licensed pharmacists have the authority to assess patients for Paxlovid and prescribe the therapy; however, Medicare/Medicaid reimbursement has not clearly established how reimbursement of clinical services can occur. “Rebound” COVID-19 symptoms may or may not be due to Paxlovid (versus the natural course of the disease). If rebound symptoms occur, they are almost always mild or asymptomatic in nature and do not require additional treatment. References DailyMed - PAXLOVID- nirmatrelvir and ritonavir kit (nih.gov). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7bdddfba-bd31-44cb-ba9e-23a4e17a4691 Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals. CDC. June 15, 2022. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html EPIC-HR Study: Hammond J, Leister-Tebbe H, Gardner A, et al. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022;386(15):1397-1408. doi:10.1056/NEJMoa2118542. https://www.nejm.org/doi/full/10.1056/NEJMoa2118542 COVID-19 Rebound After Paxlovid Treatment. CDC Health Alert Network. May 24, 2022. https://emergency.cdc.gov/han/2022/han00467.asp FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations. Administration for Strategic Preparedness & Response (ASPR). July 6, 2022. https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Pages/important-update-06July2022.aspx PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers. https://www.fda.gov/media/158165/download