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The gut microbiome, which consists of trillions of bacteria, viruses, and fungi, plays a crucial role in our health. However, there is still much to learn about this complex ecosystem. On this episode we talk with experts who tell us where the science is—how much we know, and how much we don't. Two companies, Bloom Science and Seres Therapeutics, are leveraging the microbiome to develop new therapeutics. The potential of the microbiome is vast, and further research and technological advancements will continue to unlock its benefits.
The gut microbiome, which consists of trillions of bacteria, viruses, and fungi, plays a crucial role in our health. However, there is still much to learn about this complex ecosystem. On this episode we talk with experts who tell us where the science is—how much we know, and how much we don't. Two companies, Bloom Science and Seres Therapeutics, are leveraging the microbiome to develop new therapeutics. The potential of the microbiome is vast, and further research and technological advancements will continue to unlock its benefits.Follow us on LinkedIn, X, Facebook and Instagram. Visit us at https://www.bio.org/
In this episode of Meeting Mic, we bring you Healio's top headlines from ACG 2023. Paul Feuerstadt, MD, FACG, AGAF, discusses data that link health-related quality of life and microbiome composition among patients with recurrent Clostridioides difficile infection. :38 Edward V. Loftus Jr., MD, FACG, discusses results from the INSPIRE trial for ulcerative colitis. 7:52 Jan Wehkamp, MD, PhD, discusses results from the QUASAR study, in which Tremfya outperformed placebo in clinical response patients with ulcerative colitis. 12:08 Paul Feuerstadt also discusses the evolution of treatment for Clostridioides difficile infection, from antimicrobials to recently FDA-approved live biotherapeutics. 15:32 Thomas F. Imperiale, MD, discusses the results of the BLUE-C study, which evaluated the clinical performance of Cologuard, a next-generation, multitarget stool DNA test. 21:08 Read the full coverage here: https://www.healio.com/news/gastroenterology/20231023/video-rebyota-not-only-shuts-down-recurrence-also-affects-quality-of-life-in-c-diff https://www.healio.com/news/gastroenterology/20231025/video-risankizumab-a-great-option-for-patients-induces-clinical-remission-in-uc https://www.healio.com/news/gastroenterology/20231024/video-more-than-75-of-uc-patients-achieve-clinical-response-at-24-weeks-with-tremfya https://www.healio.com/news/gastroenterology/20231025/video-future-is-now-here-for-recurrent-c-difficile-thanks-to-live-biotherapeutics https://www.healio.com/news/gastroenterology/20231025/sensitivity-of-nextgeneration-cologuard-in-precancer-detection-numerically-exceeded-fit Disclosures: Feuerstadt reports financial relationships with Ferring Pharmaceuticals, Regeneron Pharmaceuticals, Seres Therapeutics and Takeda Pharmaceuticals. Imperiale reports grant and research support from Exact Sciences. Loftus reports financial relationships with AbbVie, Alvotech, Amgen, Arena, Avalo Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Exact Sciences, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iota Biosciences, Iterative Scopes, Janssen, KSL Diagnostics, Lilly, Morphic, Ono Pharma, Pfizer, Protagonist, Receptos, Robarts Clinical Trials, Scipher Medicine, Sun Pharma, Surrozen, Takeda, Theravance and UCB. Wehkamp reports no relevant financial disclosures.
Welcome to our new six-episode series: C. difficile: Preparing the Field for Change. This program will explore how to take a patient-centered approach to treatment and diagnosis, explore emerging treatment options, and discuss best practices for transitions of care. In this episode, Drs. Paul Feuerstadt and Sahil Khanna are joined by guest Dr. Jessica Allegretti to discuss FMT and new microbiome therapies. You can now claim CME for listening – visit agau.gastro.org. This series is supported by educational grants from Aimmune Therapeutics, Inc., Seres Therapeutics, and Ferring Pharmaceuticals, Inc.
Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. AstraZeneca has partnered with genomics biotech company Verge Genomics to gain access to its platform, which uses human tissue data to identify drug targets for nerve system diseases. This collaboration aims to help AstraZeneca's Alexion unit find new drug targets as it expands its pipeline. Advocates are pushing for increased funding for research into antimicrobial resistance, arguing that the proposed $6 billion in funding under the Pasteur Act is insufficient. They believe more needs to be done to combat antibiotic-resistant infections and develop better antibiotics.Roche's under-the-skin version of cancer immunotherapy drug Tecentriq has faced manufacturing delays in the US. The company will not be able to launch the subcutaneous formulation until 2024 as it works with the FDA on manufacturing updates.Otsuka has formed a partnership with Shape Therapeutics to develop gene therapies for eye diseases. Shape Therapeutics will use its machine learning and high throughput screening technologies to identify new adeno-associated virus capsids for gene therapies.Seagen has teamed up with Nurix to develop a new type of cancer drug. This alliance aims to combine Seagen's antibody expertise with Nurix's targeted protein degradation research. This partnership comes as Seagen awaits regulatory approval for its acquisition by Pfizer.CVS has announced a major corporate restructuring, appointing its CFO, Shawn Guertin, as the head of its suite of care delivery businesses. This move comes as CVS experiences declining profits.Medical credit cards are under scrutiny for exploiting loopholes in healthcare debt protection. These cards, often offered in hospitals and physician offices, can be deceptive and lead patients into significant medical debt.A report from the Kaiser Family Foundation (KFF) found that Medicare Advantage (MA) enrollment in rural areas has nearly quadrupled since 2010. However, these plans often have limited provider networks, posing challenges for beneficiaries who already have to travel long distances for care.Sanford Health, a nonprofit health system, has announced a shake-up in its C-suite. CEO Bill Gassen stated that the addition of new voices on the executive team will help the organization remain agile in the future.Walgreens has agreed to pay $44 million to settle claims over fraudulent blood tests conducted by Theranos. If approved by a judge, patients who purchased the tests will receive double the amount they paid plus additional compensation.Nationwide telehealth use remained steady in June, according to a report from Fair Health. Lawmakers have reintroduced legislation to make pandemic-era telehealth flexibilities permanent.The World Antimicrobial Resistance Congress celebrated a milestone in the fight against antibiotic-resistant infections with the FDA approval of Seres Therapeutics' microbiota-based therapy called VOWST for the prevention of recurrent Clostridium difficile. However, efforts to combat other antibiotic-resistant infections and provide sufficient funding through the Pasteur Act face challenges.Lundbeck CEO Dr. Deborah Dunsire shares insights on her recent wins and her favorite rule to break in a 5-minute interview. Gene therapy research is expected to revolutionize biopharma, with over 25 cell and gene therapy products already approved by the FDA.A poll asks whether the pharma industry's reputation is improving, with options for yes, no, and maybe. Last week's poll revealed that 60% of voters believe the drug pricing provisions in the Infrastructure Investment and Jobs Act will harm pharmaceutical R&D investments, while 30% disagreed and 10% were unsure.That's all for today's episode of Pharma and Biotech Daily. Stay tuned for more important news in the world of Pharma and Biotech.
Welcome to our new six-part series: C. difficile: Preparing the Field for Change. This program will explore how to take a patient-centered approach to treatment and diagnosis, explore emerging treatment options, and discuss best practices for transitions of care. In this episode, Drs. Paul Feuerstadt and Sahil Khanna cover risk factors for initial and recurrent C. difficile infection. This episode was originally released as a bonus episode in November 2022. You can now claim CME for listening – visit agau.gastro.org. This series is supported by educational grants from Aimmune Therapeutics, Inc., Seres Therapeutics, and Ferring Pharmaceuticals, Inc.
Welcome to our new six-episode series: C. difficile: Preparing the Field for Change. This program will explore how to take a patient-centered approach to treatment and diagnosis, explore emerging treatment options, and discuss best practices for transitions of care. In this episode, Drs. Paul Feuerstadt and Sahil Khanna describe the shifts in the microbiota with C. difficile infection. This episode was originally released as a bonus episode in November 2022. You can now claim CME for listening – visit agau.gastro.org. This series is supported by educational grants from Aimmune Therapeutics, Inc., Seres Therapeutics, and Ferring Pharmaceuticals, Inc.
Welcome to our new six-episode series: C. difficile: Preparing the Field for Change. This program will explore how to take a patient-centered approach to treatment and diagnosis, explore emerging treatment options, and discuss best practices for transitions of care. In this episode, Drs. Paul Feuerstadt and Sahil Khanna are joined by guest Dr. Colleen Kelly to discuss how to reconcile guideline differences for testing and treatment of C. difficile. You can now claim CME for listening – visit agau.gastro.org. This series is supported by educational grants from Aimmune Therapeutics, Inc., Seres Therapeutics, and Ferring Pharmaceuticals, Inc.
Welcome to our new six-episode series: C. difficile: Preparing the Field for Change. This program will explore how to take a patient-centered approach to treatment and diagnosis, explore emerging treatment options, and discuss best practices for transitions of care. In this episode, Drs. Paul Feuerstadt and Sahil Khanna are joined by guests Rebecca Perez and Cheri Lattimer to discuss case management and transitions of care in C. difficile infection. You can now claim CME for listening – visit agau.gastro.org. This series is supported by educational grants from Aimmune Therapeutics, Inc., Seres Therapeutics, and Ferring Pharmaceuticals, Inc.
Welcome to our new six-episode series: C. difficile: Preparing the Field for Change. This program will explore how to take a patient-centered approach to treatment and diagnosis, explore emerging treatment options, and discuss best practices for transitions of care. In this episode, Drs. Paul Feuerstadt and Sahil Khanna are joined by guests Drs. Kevin Garey and Melissa Passarello to discuss the impact of recurrent CDI on patients and their lives. This episode does not offer Continuing Medical Education (CME) credits. This series is supported by educational grants from Aimmune Therapeutics, Inc., Seres Therapeutics, and Ferring Pharmaceuticals, Inc.
This is Garrison Hardie with your CrossPolitic Daily News Brief for Tuesday, May 9th, 2023. Samaritan Ministries: Don’t be limited by restrictive networks. There’s another way. A Biblical way. Samaritan Ministries. Say you have a medical need. You don’t have to check and see what hospital is in your network, or be concerned about the doctor being in-network, too. No. You go to the hospital you choose, and don’t give a second thought as to what’s in-network and what’s not, because with Samaritan Ministries, you’re in control of your health care. Afterwards, fellow members pray for you, and send money directly to you to help you pay your medical bills. And when they have a medical need, you’ll do the same for them. That’s what Biblical health care sharing looks like. Check it out today at samaritan ministries dot org slash cross politic First, we start with the news of a coronation for our friends across the pond. https://www.cnn.com/2023/05/06/europe/coronation-king-charles-ckc-gbr-intl/index.html King Charles III is crowned in once-in-a-generation ceremony Britain’s King Charles III has been crowned in a once-in-a-generation royal event witnessed by hundreds of high-profile guests inside Westminster Abbey, as well as tens of thousands of well-wishers who gathered in central London despite the rain. While Charles became King on the death of his mother, Queen Elizabeth II last September, the coronation on Saturday was the formal crowning of the monarch. The service was a profoundly religious affair, reflecting the fact that aside from being head of state of the United Kingdom and 14 other countries, Charles is also the Supreme Governor of the Church of England. In the most significant moment of the day, Archbishop of Canterbury Justin Welby placed the 360-year-old St. Edward’s Crown on Charles’ head. The spiritual leader of the Anglican Church then declared: “God Save the King.” The intricate service lasted just over two hours – about an hour shorter than Elizabeth II’s coronation in 1953 – and followed a traditional template that has stayed much the same for more than 1,000 years. However, it has been modernized in certain key ways. The archbishop acknowledged the multiple faiths observed in the UK during the ceremony, saying the Church of England “will seek to foster an environment in which people of all faiths may live freely.” The King took the Coronation Oath and became the first monarch to pray aloud at his coronation. In his prayer he asked to “be a blessing” to people “of every faith and conviction.” In what is considered the most sacred part of the ceremony, the King was anointed with holy oil by the Archbishop of Canterbury. He was also presented with the coronation regalia, including the royal Robe and Stole, in what is known as the investiture part of the service. Then, for the first time in coronation history, the archbishop invited the British public, as well as those from “other Realms,” to recite a pledge of allegiance to the newly crowned monarch and his “heirs and successors.” Ahead of the event, some parts of the British media and public interpreted the invitation as a command, reporting that people had been “asked” and “called” to swear allegiance to the King. In the face of such criticism, the Church of England revised the text of the liturgy so that members of the public would be given a choice between saying simply “God save King Charles” or reciting the full pledge of allegiance. The ceremony also included a reading from the Bible by UK Prime Minister Rishi Sunak and, in another coronation first, gospel music. Once the King was crowned, his wife, Queen Camilla, was crowned in her own, shorter ceremony with Queen Mary’s Crown – marking the first time in recent history that a new crown wasn’t made specifically for this occasion. After the ceremony, the newly crowned King and Queen rode back to Buckingham Palace in a much larger parade, featuring 4,000 members of the armed forces, 250 horses and 19 military bands. The pomp and pageantry concluded with a royal salute and the customary balcony appearance by the King and family members. They and the crowds below watched a flypast of military aircraft, slimmed down because of the poor weather. Despite the splendor of the occasion, it has not been without controversy. Some have objected to millions of pounds of taxpayers’ money being spent on a lavish ceremony at a time when millions of Britons are suffering a severe cost-of-living crisis. Security is by far the most costly element of large events and the Met said ahead of time that Saturday would be the largest one-day policing operation in decades, with more than 11,500 officers on duty in London. The coronation has also attracted anti-monarchy demonstrations, with a small number of protesters arrested in central London on Saturday morning before the event began. Republic, a campaign group that calls for the abolition of the monarchy, said the idea of the “homage of the people” was “offensive, tone deaf and a gesture that holds the people in contempt.” Some eyebrows were also raised earlier this week when a controversial and widely criticized UK public order bill came into force. Since the death of Queen Elizabeth II last year, there have been a number of instances of anti-monarchists turning up at royal engagements to voice their grievances against the institution. The new rules, signed into law by the King on Tuesday, just days before the coronation, empower the police to take stronger action against peaceful protesters. https://thepostmillennial.com/biden-to-veto-house-remain-in-mexico-bill?utm_campaign=64487 Biden to veto House 'remain in Mexico' bill On Monday, the White House announced that Joe Biden would veto an immigration bill coming out of the House of Representatives that would reinstitute several Trump-era policies including construction of the border wall and the remain in Mexico policy, which stated that anyone seeking asylum had to wait in Mexico as their claim was processed. According to the Associated Press, the White House Office of Management and Budget said in a statement, "While we welcome Congress' engagement on meaningful steps to address immigration and the challenges at the border, this bill would make things worse, not better. Because this bill does very little to actually increase border security while doing a great deal to trample on the nation’s core values and international obligations, it should be rejected." On Thursday, the House is set to vote on the 213-page Secure the Border Act. Thursday also marks the expiration of Title 42, the Trump-era policy instituted under Covid that granted Border Patrol and Department of Homeland Security officials the ability to expel illegal immigrants over health concerns. The Secure the Border Act would also require employers to verify a worker's immigration status for employment and institute the E-Verify system House Majority Leader Steve Scalise said, "Joe Biden sent a message that America’s border is open, and millions of people answered that call and started coming across our border illegally. We’re going to show the president how to solve the problem." The Daily Mail reports, the Secure the Border Act would limit federal funds for NGOs (non-governmental organizations) that aid illegal immigrants crossing the border, would end Biden's expedited entry policy for Nicaraguans, Venezuelans, Haitians, and Cubans, and grant more money for hiring additional border agents. Joe Biden loosened restrictions along the southern border after he took office and HHS Secretary Alejandro Mayorkas made the announcement that migrants seeking asylum would be permitted entry into the US as would unaccompanied minors. US Border Patrol Chief Raul Ortiz said that over the weekend 26,382 apprehensions were made by border patrol and that 11 pounds of fentanyl and 83 pounds of meth were seized. Mexican cartels have exploited Biden's border crisis, with 2,378,944 illegal immigrant encounters reported in the 2022 fiscal year and 1,659,206 reported in FY 2021, by trafficking humans and drugs, especially fentanyl across the border in record numbers. https://www.dailywire.com/news/airlines-may-soon-be-on-the-hook-for-delayed-and-canceled-flights-transportation-dept-says Airlines May Soon Be On The Hook For Delayed And Canceled Flights, Transportation Dept Says Transportation Secretary Pete Boo-tuh-jeg announced on Monday that the agency introduced rules requiring airlines to reimburse customers who incur expenses due to certain delayed and canceled flights, a move which comes as the industry faces elevated demand and a constrained labor force. The proposed rules, which would apply when an airline delays a flight for more than three hours or cancels a flight for a “controllable” reason, would mandate that the firms offer compensation for stranded passengers, as well as a meal or meal voucher, overnight accommodations, and ground transportation between the airport and hotel. “When an airline causes a flight cancellation or delay, passengers should not foot the bill,” Buttigieg said in a statement, noting that the proposed reimbursement rules would be the first in American history. The move comes after Southwest Airlines experienced holiday travel disruptions last year due to extreme winter weather conditions, staff shortages, and an outdated computer system. The carrier canceled thousands of flights days after other carriers had resumed normal operations. Buttigieg told the company, which has since promised to compensate passengers for all expenses incurred during that time, that the disruptions were “unacceptable” and promised that his agency would exercise “the fullest extent of its investigative and enforcement powers” to ensure customers are reimbursed. The new proposals also occur as the sector faces a severely limited pool of available pilots and frontline staff. Carriers previously encouraged commercial pilots to retire as worldwide lockdowns caused demand for air travel to plummet in the spring of 2020, worsening a previous trend toward a lack of available pilots. Elevated prices for airline tickets and a rapid return in travel demand, however, are now prompting lawmakers to consider the problem. Regional Airline Association CEO Faye Malarkey Black told members of the House Transportation and Infrastructure Committee last month that more than 50% of current pilots would be forced to retire within the next 15 years because of federal rules mandating that pilots exit their positions once they reach 65 years of age, even as only 8% of pilots are below 30 years of age due to the high cost of flight education. Buttigieg has opposed legislation that would increase the retirement threshold to 67 years of age, contending that “the answer is to make sure we have as many and as good pilots ready to take their place, to have a stronger pipeline.” https://www.nbcnews.com/health/health-news/fecal-transplant-pill-fda-approval-rcna81779 FDA approves first pill for fecal transplants, made from healthy bacteria in human waste U.S. health officials on Wednesday approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections — an easier way of performing so-called fecal transplants. The new treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some medical specialists have used for more than a decade to help patients. The Food and Drug Administration cleared the capsules for adults 18 and older who face risks from repeat infections with Clostridium difficile, a bacteria that can cause severe nausea, cramping and diarrhea. diff is particularly dangerous when it reoccurs, leading to between 15,000 and 30,000 deaths per year. It can be killed with antibiotics but they also destroy good bacteria that live in the gut, leaving it more susceptible to future infections. The new capsules are approved for patients who have already received antibiotic treatment. More than 10 years ago, some doctors began reporting success with fecal transplants — using stool from a healthy donor — to restore the gut’s healthy balance and prevent reinfections. The FDA approved the first pharmaceutical-grade version of the treatment last year from a rival drugmaker, Ferring Pharmaceuticals. But that company’s product — like most of the original procedures — must be delivered via the rectum. Cambridge, Mass.-based Seres will market its drug as a less invasive option. The treatment will be sold under the brand name Vowst and comes as a regimen of four daily capsules taken for three consecutive days. Both of the recent FDA approvals are the product of years of pharmaceutical industry research into the microbiome, the community of bacteria, viruses and fungi that live in the gut. Currently most fecal transplants are provided by a network of stool banks that have popped up at medical institutions and hospitals across the country. While the availability of new FDA-approved options is expected to decrease demand for donations from stool banks, some plan to stay open. The FDA warned in its approval announcement that the drug “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens,” the agency noted. The FDA approved the treatment based on a 180-patient study in which nearly 88% of patients taking the capsules did not experience reinfection after 8 weeks, compared with 60% of those who received dummy pills.
This is Garrison Hardie with your CrossPolitic Daily News Brief for Tuesday, May 9th, 2023. Samaritan Ministries: Don’t be limited by restrictive networks. There’s another way. A Biblical way. Samaritan Ministries. Say you have a medical need. You don’t have to check and see what hospital is in your network, or be concerned about the doctor being in-network, too. No. You go to the hospital you choose, and don’t give a second thought as to what’s in-network and what’s not, because with Samaritan Ministries, you’re in control of your health care. Afterwards, fellow members pray for you, and send money directly to you to help you pay your medical bills. And when they have a medical need, you’ll do the same for them. That’s what Biblical health care sharing looks like. Check it out today at samaritan ministries dot org slash cross politic First, we start with the news of a coronation for our friends across the pond. https://www.cnn.com/2023/05/06/europe/coronation-king-charles-ckc-gbr-intl/index.html King Charles III is crowned in once-in-a-generation ceremony Britain’s King Charles III has been crowned in a once-in-a-generation royal event witnessed by hundreds of high-profile guests inside Westminster Abbey, as well as tens of thousands of well-wishers who gathered in central London despite the rain. While Charles became King on the death of his mother, Queen Elizabeth II last September, the coronation on Saturday was the formal crowning of the monarch. The service was a profoundly religious affair, reflecting the fact that aside from being head of state of the United Kingdom and 14 other countries, Charles is also the Supreme Governor of the Church of England. In the most significant moment of the day, Archbishop of Canterbury Justin Welby placed the 360-year-old St. Edward’s Crown on Charles’ head. The spiritual leader of the Anglican Church then declared: “God Save the King.” The intricate service lasted just over two hours – about an hour shorter than Elizabeth II’s coronation in 1953 – and followed a traditional template that has stayed much the same for more than 1,000 years. However, it has been modernized in certain key ways. The archbishop acknowledged the multiple faiths observed in the UK during the ceremony, saying the Church of England “will seek to foster an environment in which people of all faiths may live freely.” The King took the Coronation Oath and became the first monarch to pray aloud at his coronation. In his prayer he asked to “be a blessing” to people “of every faith and conviction.” In what is considered the most sacred part of the ceremony, the King was anointed with holy oil by the Archbishop of Canterbury. He was also presented with the coronation regalia, including the royal Robe and Stole, in what is known as the investiture part of the service. Then, for the first time in coronation history, the archbishop invited the British public, as well as those from “other Realms,” to recite a pledge of allegiance to the newly crowned monarch and his “heirs and successors.” Ahead of the event, some parts of the British media and public interpreted the invitation as a command, reporting that people had been “asked” and “called” to swear allegiance to the King. In the face of such criticism, the Church of England revised the text of the liturgy so that members of the public would be given a choice between saying simply “God save King Charles” or reciting the full pledge of allegiance. The ceremony also included a reading from the Bible by UK Prime Minister Rishi Sunak and, in another coronation first, gospel music. Once the King was crowned, his wife, Queen Camilla, was crowned in her own, shorter ceremony with Queen Mary’s Crown – marking the first time in recent history that a new crown wasn’t made specifically for this occasion. After the ceremony, the newly crowned King and Queen rode back to Buckingham Palace in a much larger parade, featuring 4,000 members of the armed forces, 250 horses and 19 military bands. The pomp and pageantry concluded with a royal salute and the customary balcony appearance by the King and family members. They and the crowds below watched a flypast of military aircraft, slimmed down because of the poor weather. Despite the splendor of the occasion, it has not been without controversy. Some have objected to millions of pounds of taxpayers’ money being spent on a lavish ceremony at a time when millions of Britons are suffering a severe cost-of-living crisis. Security is by far the most costly element of large events and the Met said ahead of time that Saturday would be the largest one-day policing operation in decades, with more than 11,500 officers on duty in London. The coronation has also attracted anti-monarchy demonstrations, with a small number of protesters arrested in central London on Saturday morning before the event began. Republic, a campaign group that calls for the abolition of the monarchy, said the idea of the “homage of the people” was “offensive, tone deaf and a gesture that holds the people in contempt.” Some eyebrows were also raised earlier this week when a controversial and widely criticized UK public order bill came into force. Since the death of Queen Elizabeth II last year, there have been a number of instances of anti-monarchists turning up at royal engagements to voice their grievances against the institution. The new rules, signed into law by the King on Tuesday, just days before the coronation, empower the police to take stronger action against peaceful protesters. https://thepostmillennial.com/biden-to-veto-house-remain-in-mexico-bill?utm_campaign=64487 Biden to veto House 'remain in Mexico' bill On Monday, the White House announced that Joe Biden would veto an immigration bill coming out of the House of Representatives that would reinstitute several Trump-era policies including construction of the border wall and the remain in Mexico policy, which stated that anyone seeking asylum had to wait in Mexico as their claim was processed. According to the Associated Press, the White House Office of Management and Budget said in a statement, "While we welcome Congress' engagement on meaningful steps to address immigration and the challenges at the border, this bill would make things worse, not better. Because this bill does very little to actually increase border security while doing a great deal to trample on the nation’s core values and international obligations, it should be rejected." On Thursday, the House is set to vote on the 213-page Secure the Border Act. Thursday also marks the expiration of Title 42, the Trump-era policy instituted under Covid that granted Border Patrol and Department of Homeland Security officials the ability to expel illegal immigrants over health concerns. The Secure the Border Act would also require employers to verify a worker's immigration status for employment and institute the E-Verify system House Majority Leader Steve Scalise said, "Joe Biden sent a message that America’s border is open, and millions of people answered that call and started coming across our border illegally. We’re going to show the president how to solve the problem." The Daily Mail reports, the Secure the Border Act would limit federal funds for NGOs (non-governmental organizations) that aid illegal immigrants crossing the border, would end Biden's expedited entry policy for Nicaraguans, Venezuelans, Haitians, and Cubans, and grant more money for hiring additional border agents. Joe Biden loosened restrictions along the southern border after he took office and HHS Secretary Alejandro Mayorkas made the announcement that migrants seeking asylum would be permitted entry into the US as would unaccompanied minors. US Border Patrol Chief Raul Ortiz said that over the weekend 26,382 apprehensions were made by border patrol and that 11 pounds of fentanyl and 83 pounds of meth were seized. Mexican cartels have exploited Biden's border crisis, with 2,378,944 illegal immigrant encounters reported in the 2022 fiscal year and 1,659,206 reported in FY 2021, by trafficking humans and drugs, especially fentanyl across the border in record numbers. https://www.dailywire.com/news/airlines-may-soon-be-on-the-hook-for-delayed-and-canceled-flights-transportation-dept-says Airlines May Soon Be On The Hook For Delayed And Canceled Flights, Transportation Dept Says Transportation Secretary Pete Boo-tuh-jeg announced on Monday that the agency introduced rules requiring airlines to reimburse customers who incur expenses due to certain delayed and canceled flights, a move which comes as the industry faces elevated demand and a constrained labor force. The proposed rules, which would apply when an airline delays a flight for more than three hours or cancels a flight for a “controllable” reason, would mandate that the firms offer compensation for stranded passengers, as well as a meal or meal voucher, overnight accommodations, and ground transportation between the airport and hotel. “When an airline causes a flight cancellation or delay, passengers should not foot the bill,” Buttigieg said in a statement, noting that the proposed reimbursement rules would be the first in American history. The move comes after Southwest Airlines experienced holiday travel disruptions last year due to extreme winter weather conditions, staff shortages, and an outdated computer system. The carrier canceled thousands of flights days after other carriers had resumed normal operations. Buttigieg told the company, which has since promised to compensate passengers for all expenses incurred during that time, that the disruptions were “unacceptable” and promised that his agency would exercise “the fullest extent of its investigative and enforcement powers” to ensure customers are reimbursed. The new proposals also occur as the sector faces a severely limited pool of available pilots and frontline staff. Carriers previously encouraged commercial pilots to retire as worldwide lockdowns caused demand for air travel to plummet in the spring of 2020, worsening a previous trend toward a lack of available pilots. Elevated prices for airline tickets and a rapid return in travel demand, however, are now prompting lawmakers to consider the problem. Regional Airline Association CEO Faye Malarkey Black told members of the House Transportation and Infrastructure Committee last month that more than 50% of current pilots would be forced to retire within the next 15 years because of federal rules mandating that pilots exit their positions once they reach 65 years of age, even as only 8% of pilots are below 30 years of age due to the high cost of flight education. Buttigieg has opposed legislation that would increase the retirement threshold to 67 years of age, contending that “the answer is to make sure we have as many and as good pilots ready to take their place, to have a stronger pipeline.” https://www.nbcnews.com/health/health-news/fecal-transplant-pill-fda-approval-rcna81779 FDA approves first pill for fecal transplants, made from healthy bacteria in human waste U.S. health officials on Wednesday approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections — an easier way of performing so-called fecal transplants. The new treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some medical specialists have used for more than a decade to help patients. The Food and Drug Administration cleared the capsules for adults 18 and older who face risks from repeat infections with Clostridium difficile, a bacteria that can cause severe nausea, cramping and diarrhea. diff is particularly dangerous when it reoccurs, leading to between 15,000 and 30,000 deaths per year. It can be killed with antibiotics but they also destroy good bacteria that live in the gut, leaving it more susceptible to future infections. The new capsules are approved for patients who have already received antibiotic treatment. More than 10 years ago, some doctors began reporting success with fecal transplants — using stool from a healthy donor — to restore the gut’s healthy balance and prevent reinfections. The FDA approved the first pharmaceutical-grade version of the treatment last year from a rival drugmaker, Ferring Pharmaceuticals. But that company’s product — like most of the original procedures — must be delivered via the rectum. Cambridge, Mass.-based Seres will market its drug as a less invasive option. The treatment will be sold under the brand name Vowst and comes as a regimen of four daily capsules taken for three consecutive days. Both of the recent FDA approvals are the product of years of pharmaceutical industry research into the microbiome, the community of bacteria, viruses and fungi that live in the gut. Currently most fecal transplants are provided by a network of stool banks that have popped up at medical institutions and hospitals across the country. While the availability of new FDA-approved options is expected to decrease demand for donations from stool banks, some plan to stay open. The FDA warned in its approval announcement that the drug “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens,” the agency noted. The FDA approved the treatment based on a 180-patient study in which nearly 88% of patients taking the capsules did not experience reinfection after 8 weeks, compared with 60% of those who received dummy pills.
This is Garrison Hardie with your CrossPolitic Daily News Brief for Tuesday, May 9th, 2023. Samaritan Ministries: Don’t be limited by restrictive networks. There’s another way. A Biblical way. Samaritan Ministries. Say you have a medical need. You don’t have to check and see what hospital is in your network, or be concerned about the doctor being in-network, too. No. You go to the hospital you choose, and don’t give a second thought as to what’s in-network and what’s not, because with Samaritan Ministries, you’re in control of your health care. Afterwards, fellow members pray for you, and send money directly to you to help you pay your medical bills. And when they have a medical need, you’ll do the same for them. That’s what Biblical health care sharing looks like. Check it out today at samaritan ministries dot org slash cross politic First, we start with the news of a coronation for our friends across the pond. https://www.cnn.com/2023/05/06/europe/coronation-king-charles-ckc-gbr-intl/index.html King Charles III is crowned in once-in-a-generation ceremony Britain’s King Charles III has been crowned in a once-in-a-generation royal event witnessed by hundreds of high-profile guests inside Westminster Abbey, as well as tens of thousands of well-wishers who gathered in central London despite the rain. While Charles became King on the death of his mother, Queen Elizabeth II last September, the coronation on Saturday was the formal crowning of the monarch. The service was a profoundly religious affair, reflecting the fact that aside from being head of state of the United Kingdom and 14 other countries, Charles is also the Supreme Governor of the Church of England. In the most significant moment of the day, Archbishop of Canterbury Justin Welby placed the 360-year-old St. Edward’s Crown on Charles’ head. The spiritual leader of the Anglican Church then declared: “God Save the King.” The intricate service lasted just over two hours – about an hour shorter than Elizabeth II’s coronation in 1953 – and followed a traditional template that has stayed much the same for more than 1,000 years. However, it has been modernized in certain key ways. The archbishop acknowledged the multiple faiths observed in the UK during the ceremony, saying the Church of England “will seek to foster an environment in which people of all faiths may live freely.” The King took the Coronation Oath and became the first monarch to pray aloud at his coronation. In his prayer he asked to “be a blessing” to people “of every faith and conviction.” In what is considered the most sacred part of the ceremony, the King was anointed with holy oil by the Archbishop of Canterbury. He was also presented with the coronation regalia, including the royal Robe and Stole, in what is known as the investiture part of the service. Then, for the first time in coronation history, the archbishop invited the British public, as well as those from “other Realms,” to recite a pledge of allegiance to the newly crowned monarch and his “heirs and successors.” Ahead of the event, some parts of the British media and public interpreted the invitation as a command, reporting that people had been “asked” and “called” to swear allegiance to the King. In the face of such criticism, the Church of England revised the text of the liturgy so that members of the public would be given a choice between saying simply “God save King Charles” or reciting the full pledge of allegiance. The ceremony also included a reading from the Bible by UK Prime Minister Rishi Sunak and, in another coronation first, gospel music. Once the King was crowned, his wife, Queen Camilla, was crowned in her own, shorter ceremony with Queen Mary’s Crown – marking the first time in recent history that a new crown wasn’t made specifically for this occasion. After the ceremony, the newly crowned King and Queen rode back to Buckingham Palace in a much larger parade, featuring 4,000 members of the armed forces, 250 horses and 19 military bands. The pomp and pageantry concluded with a royal salute and the customary balcony appearance by the King and family members. They and the crowds below watched a flypast of military aircraft, slimmed down because of the poor weather. Despite the splendor of the occasion, it has not been without controversy. Some have objected to millions of pounds of taxpayers’ money being spent on a lavish ceremony at a time when millions of Britons are suffering a severe cost-of-living crisis. Security is by far the most costly element of large events and the Met said ahead of time that Saturday would be the largest one-day policing operation in decades, with more than 11,500 officers on duty in London. The coronation has also attracted anti-monarchy demonstrations, with a small number of protesters arrested in central London on Saturday morning before the event began. Republic, a campaign group that calls for the abolition of the monarchy, said the idea of the “homage of the people” was “offensive, tone deaf and a gesture that holds the people in contempt.” Some eyebrows were also raised earlier this week when a controversial and widely criticized UK public order bill came into force. Since the death of Queen Elizabeth II last year, there have been a number of instances of anti-monarchists turning up at royal engagements to voice their grievances against the institution. The new rules, signed into law by the King on Tuesday, just days before the coronation, empower the police to take stronger action against peaceful protesters. https://thepostmillennial.com/biden-to-veto-house-remain-in-mexico-bill?utm_campaign=64487 Biden to veto House 'remain in Mexico' bill On Monday, the White House announced that Joe Biden would veto an immigration bill coming out of the House of Representatives that would reinstitute several Trump-era policies including construction of the border wall and the remain in Mexico policy, which stated that anyone seeking asylum had to wait in Mexico as their claim was processed. According to the Associated Press, the White House Office of Management and Budget said in a statement, "While we welcome Congress' engagement on meaningful steps to address immigration and the challenges at the border, this bill would make things worse, not better. Because this bill does very little to actually increase border security while doing a great deal to trample on the nation’s core values and international obligations, it should be rejected." On Thursday, the House is set to vote on the 213-page Secure the Border Act. Thursday also marks the expiration of Title 42, the Trump-era policy instituted under Covid that granted Border Patrol and Department of Homeland Security officials the ability to expel illegal immigrants over health concerns. The Secure the Border Act would also require employers to verify a worker's immigration status for employment and institute the E-Verify system House Majority Leader Steve Scalise said, "Joe Biden sent a message that America’s border is open, and millions of people answered that call and started coming across our border illegally. We’re going to show the president how to solve the problem." The Daily Mail reports, the Secure the Border Act would limit federal funds for NGOs (non-governmental organizations) that aid illegal immigrants crossing the border, would end Biden's expedited entry policy for Nicaraguans, Venezuelans, Haitians, and Cubans, and grant more money for hiring additional border agents. Joe Biden loosened restrictions along the southern border after he took office and HHS Secretary Alejandro Mayorkas made the announcement that migrants seeking asylum would be permitted entry into the US as would unaccompanied minors. US Border Patrol Chief Raul Ortiz said that over the weekend 26,382 apprehensions were made by border patrol and that 11 pounds of fentanyl and 83 pounds of meth were seized. Mexican cartels have exploited Biden's border crisis, with 2,378,944 illegal immigrant encounters reported in the 2022 fiscal year and 1,659,206 reported in FY 2021, by trafficking humans and drugs, especially fentanyl across the border in record numbers. https://www.dailywire.com/news/airlines-may-soon-be-on-the-hook-for-delayed-and-canceled-flights-transportation-dept-says Airlines May Soon Be On The Hook For Delayed And Canceled Flights, Transportation Dept Says Transportation Secretary Pete Boo-tuh-jeg announced on Monday that the agency introduced rules requiring airlines to reimburse customers who incur expenses due to certain delayed and canceled flights, a move which comes as the industry faces elevated demand and a constrained labor force. The proposed rules, which would apply when an airline delays a flight for more than three hours or cancels a flight for a “controllable” reason, would mandate that the firms offer compensation for stranded passengers, as well as a meal or meal voucher, overnight accommodations, and ground transportation between the airport and hotel. “When an airline causes a flight cancellation or delay, passengers should not foot the bill,” Buttigieg said in a statement, noting that the proposed reimbursement rules would be the first in American history. The move comes after Southwest Airlines experienced holiday travel disruptions last year due to extreme winter weather conditions, staff shortages, and an outdated computer system. The carrier canceled thousands of flights days after other carriers had resumed normal operations. Buttigieg told the company, which has since promised to compensate passengers for all expenses incurred during that time, that the disruptions were “unacceptable” and promised that his agency would exercise “the fullest extent of its investigative and enforcement powers” to ensure customers are reimbursed. The new proposals also occur as the sector faces a severely limited pool of available pilots and frontline staff. Carriers previously encouraged commercial pilots to retire as worldwide lockdowns caused demand for air travel to plummet in the spring of 2020, worsening a previous trend toward a lack of available pilots. Elevated prices for airline tickets and a rapid return in travel demand, however, are now prompting lawmakers to consider the problem. Regional Airline Association CEO Faye Malarkey Black told members of the House Transportation and Infrastructure Committee last month that more than 50% of current pilots would be forced to retire within the next 15 years because of federal rules mandating that pilots exit their positions once they reach 65 years of age, even as only 8% of pilots are below 30 years of age due to the high cost of flight education. Buttigieg has opposed legislation that would increase the retirement threshold to 67 years of age, contending that “the answer is to make sure we have as many and as good pilots ready to take their place, to have a stronger pipeline.” https://www.nbcnews.com/health/health-news/fecal-transplant-pill-fda-approval-rcna81779 FDA approves first pill for fecal transplants, made from healthy bacteria in human waste U.S. health officials on Wednesday approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections — an easier way of performing so-called fecal transplants. The new treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some medical specialists have used for more than a decade to help patients. The Food and Drug Administration cleared the capsules for adults 18 and older who face risks from repeat infections with Clostridium difficile, a bacteria that can cause severe nausea, cramping and diarrhea. diff is particularly dangerous when it reoccurs, leading to between 15,000 and 30,000 deaths per year. It can be killed with antibiotics but they also destroy good bacteria that live in the gut, leaving it more susceptible to future infections. The new capsules are approved for patients who have already received antibiotic treatment. More than 10 years ago, some doctors began reporting success with fecal transplants — using stool from a healthy donor — to restore the gut’s healthy balance and prevent reinfections. The FDA approved the first pharmaceutical-grade version of the treatment last year from a rival drugmaker, Ferring Pharmaceuticals. But that company’s product — like most of the original procedures — must be delivered via the rectum. Cambridge, Mass.-based Seres will market its drug as a less invasive option. The treatment will be sold under the brand name Vowst and comes as a regimen of four daily capsules taken for three consecutive days. Both of the recent FDA approvals are the product of years of pharmaceutical industry research into the microbiome, the community of bacteria, viruses and fungi that live in the gut. Currently most fecal transplants are provided by a network of stool banks that have popped up at medical institutions and hospitals across the country. While the availability of new FDA-approved options is expected to decrease demand for donations from stool banks, some plan to stay open. The FDA warned in its approval announcement that the drug “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens,” the agency noted. The FDA approved the treatment based on a 180-patient study in which nearly 88% of patients taking the capsules did not experience reinfection after 8 weeks, compared with 60% of those who received dummy pills.
Flagship Pioneering is fertile ground for a bevy of blossoming biotechs, and one of its most prolific sowers is General Partner Avak Kahvejian, Ph.D. Dr. Kahvejian counts Seres Therapeutics, Rubius Therapeutics, Codiak BioSciences, Cygnal Therapeutics, Ring Therapeutics, Cellarity, Laronde, and Generate Biomedicines among the companies he's played a leading hand in launching. On this episode of the Business of Biotech, Kahvejian takes us under the hood of one of the most burgeoning businesses in biotech, sharing details on the people, processes, and technologies fueling its rapid growth.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!
Eric Shaff is the President and CEO of Seres Therapeutics, which is focused on the gut microbiome in order to develop bacteria as an oral treatment for bloodstream infections, cancer, and immune system diseases. The first therapy is SER-109 for recurrent C. diff infection an orphan disease with inadequate solutions for patients. The starting point for Seres is that the health of the microbiome is the starting point for preventing infections from occurring. Eric explains, "The real susceptibility of someone getting C. diff is not just the bad actor bacteria. But really the susceptibility of the microbiome and an injury to the microbiome, and susceptibility to infection. Typically what happens is if people get antibiotic therapy, which can be very effective in knocking back or killing all bacteria, it creates a significant niche in the microbiome, or an injury. There is what we call a race to repair, so either a patient will naturally repair and restore their microbiome, or C. diff may infiltrate, which can lead to an infection and a recurrence." "Typically, if a patient is going to have a recurrence, it happens quickly. If they get C. diff, they take antibiotics, and the hope is that C. diff will not infiltrate to cause an occurrence. If it does, then people typically recur quickly. What happens following antibiotic therapy, is we treat patients with an oral regimen of SER-109, which is a consortium of bacteria in spore form you put in the capsule. That was the approach we took to our phase 3 study, where we had an 88% reduction in recurrence, which is a significant impact for patients suffering from this terrible disease." @SeresTX #SeresTherapeutics #Microbiome #OralMicrobiomeTherapy #Cdiff #RecurrentCdiff #AMR #AntimicrobialResistance #InfectionProtection serestherapeutics.com Download the transcript here
Eric Shaff is the President and CEO of Seres Therapeutics, which is focused on the gut microbiome in order to develop bacteria as an oral treatment for bloodstream infections, cancer, and immune system diseases. The first therapy is SER-109 for recurrent C. diff infection an orphan disease with inadequate solutions for patients. The starting point for Seres is that the health of the microbiome is the starting point for preventing infections from occurring. Eric explains, "The real susceptibility of someone getting C. diff is not just the bad actor bacteria. But really the susceptibility of the microbiome and an injury to the microbiome, and susceptibility to infection. Typically what happens is if people get antibiotic therapy, which can be very effective in knocking back or killing all bacteria, it creates a significant niche in the microbiome, or an injury. There is what we call a race to repair, so either a patient will naturally repair and restore their microbiome, or C. diff may infiltrate, which can lead to an infection and a recurrence." "Typically, if a patient is going to have a recurrence, it happens quickly. If they get C. diff, they take antibiotics, and the hope is that C. diff will not infiltrate to cause an occurrence. If it does, then people typically recur quickly. What happens following antibiotic therapy, is we treat patients with an oral regimen of SER-109, which is a consortium of bacteria in spore form you put in the capsule. That was the approach we took to our phase 3 study, where we had an 88% reduction in recurrence, which is a significant impact for patients suffering from this terrible disease." @SeresTX #SeresTherapeutics #Microbiome #OralMicrobiomeTherapy #Cdiff #RecurrentCdiff #AMR #AntimicrobialResistance #InfectionProtection serestherapeutics.com Listen to the podcast here
How can GI health significantly determine the general health of the rest of the body? Since so many bodily systems utilize products produced along the gastrointestinal tract, minor issues can be increased throughout the body. Listen up to learn: How the gut microbiome has the potential to make or break the body's health How the Western diet may be threatening your gut's health How "bacterial economics" governs GI systems Executive vice president and chief medical officer at Seres Therapeutics, Dr. Lisa von Moltke, discusses her work developing therapeutic techniques to treat gastrointestinal conditions and microbiomes. Through the study of how the gut microbiome and gastrointestinal health affect the operation of the rest of the body, new therapies have been developed to combat GI-targeted infections. New therapies are also being produced to prevent infection with patients undergoing transplants and grafts. Immunosuppressants are also a weak point regarding gut health since they open windows of vulnerability for infections to target your gut. Therefore, developing techniques to treat various diseases without affecting GI health and the gut microbiome may be the next most valuable step in developing pharmaceutical therapeutics. For more information, visit https://www.serestherapeutics.com. Episode also available on Apple Podcasts: apple.co/30PvU9C
Join our resident Business Ninja Kelsey together with Jason Goldsmith, Senior Director of Donor Medical and Analytical Science at Seres Therapeutics as they talk about how living bacteria from our own body can fight diseases. This is the main focus of Seres Therapeutics as they discover and develop Ecobiotic™ therapeutic products - novel drugs to treat important diseases by targeting the underlying biology of the human microbiome. Founded by Flagship VentureLabs, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome. Current candidates span infectious, metabolic, and inflammatory diseases. For more information, please visit http://www.serestherapeutics.com/ -----Do you want to be interviewed for your business? Schedule time with us, and we'll create a podcast like this for your business: https://www.WriteForMe.io/-----https://www.facebook.com/writeforme.iohttps://www.instagram.com/writeforme.io/https://twitter.com/writeformeiohttps://www.linkedin.com/company/writeforme/https://www.pinterest.com/andysteuer/Want to be interviewed on our Business Ninjas podcast? Schedule time with us now, and we'll make it happen right away! Check out WriteForMe, more than just a Content Agency! See the Faces Behind The Voices on our YouTube Channel!
A Symposium specifically developed for Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers. Distinguished members and keynote speakers provide insight as to what impacts the patient and families on both quality and economic topics, what role leadership plays in creating the right culture for patient-centered care, and how to identify, evaluate, and prioritize innovations that can quickly touch the lives of patients battling C. diff. infections. Courtney Jones ” Microbiome, Microbiota, and Gut Health.” Denise Cardo, MD “Everyone Has a Role in Antibiotic Awareness.” Larry Kociolek, MD “C. diff. Infections in Pediatrics.” This event was sponsored by Seres Therapeutics. Seres Therapeutics mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics Enjoy the program!
A Symposium specifically developed for Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers. Distinguished members and keynote speakers provide insight as to what impacts the patient and families on both quality and economic topics, what role leadership plays in creating the right culture for patient-centered care, and how to identify, evaluate, and prioritize innovations that can quickly touch the lives of patients battling C. diff. infections. Courtney Jones ” Microbiome, Microbiota, and Gut Health.” Denise Cardo, MD “Everyone Has a Role in Antibiotic Awareness.” Larry Kociolek, MD “C. diff. Infections in Pediatrics.” This event was sponsored by Seres Therapeutics. Seres Therapeutics mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics Enjoy the program!
Welcome to the second episode of a special four (4) part series: A Symposium Created For Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers. Welcome to a Symposium specifically developed for patients, families, and caregivers. The Patient & Family C. diff. Symposium: where a gathering of healthcare professionals, keynote speakers, health advocates, practitioners, educators, are transforming the patient experience, and changing the way people experience C. diff. infections worldwide. Simon Cutting, Ph. D. “Bacillus, and C. diff. Spore Overview. “ Teena Chopra, MD ” Introduction to Infection Prevention.” Doe Kley, RN, MPH “C. diff. Transitioning from Hospital to Home. This event was sponsored by Seres Therapeutics, Seres Therapeutic's mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics Enjoy the presentations by the topic leaders joining us!
Welcome to the second episode of a special four (4) part series: A Symposium Created For Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers. Welcome to a Symposium specifically developed for patients, families, and caregivers. The Patient & Family C. diff. Symposium: where a gathering of healthcare professionals, keynote speakers, health advocates, practitioners, educators, are transforming the patient experience, and changing the way people experience C. diff. infections worldwide. Simon Cutting, Ph. D. “Bacillus, and C. diff. Spore Overview. “ Teena Chopra, MD ” Introduction to Infection Prevention.” Doe Kley, RN, MPH “C. diff. Transitioning from Hospital to Home. This event was sponsored by Seres Therapeutics, Seres Therapeutic's mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics Enjoy the presentations by the topic leaders joining us!
Join us with our guests from GoodNature, a Seres Therapeutics program; April Garcia, Site Manager of GoodNature Irvine California, and two GoodNature donors who will share their experiences. They will discuss the who, what, and how in donating poop to potentially support C. diff patients. With microbiome therapeutics on the forefront, it will be an educational discussion.
Join us with our guests from GoodNature, a Seres Therapeutics program; April Garcia, Site Manager of GoodNature Irvine California, and two GoodNature donors who will share their experiences. They will discuss the who, what, and how in donating poop to potentially support C. diff patients. With microbiome therapeutics on the forefront, it will be an educational discussion.
Our guests from Seres Therapeutics shared the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study's efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to a placebo. Listen in and learn more from the leading topic experts.
Our guests from Seres Therapeutics shared the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study's efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to a placebo. Listen in and learn more from the leading topic experts.
Alex Murray with Seres Therapeutics GoodNature, a stool donation program from Seres Therapeutics, collects poop from healthy people and then studies the poop in hopes of advancing medical treatment options or potentially providing commercial therapies for gastrointestinal infections and disorders. Seres Therapeutics' mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics. […] The post Alex Murray with Seres Therapeutics appeared first on Business RadioX ®.
Our host Anna Mohl speaks to Dr. Matt Henn, Ph.D, Chief Scientific Officer & Executive Vice President at Seres Therapeutics about understanding the microbiome. They'll help us better understand how trillions of living organisms in our guts can affect everything from our digestion, to our mood, to how we fight off infections. Dr. Henn also talks about Seres' work to develop what could potentially be the first approved pharmaceutical treatment based on the microbiome, and he gives us a glimpse of what's on the horizon for innovations in the field.This podcast is hosted by Nestle Health Science. This podcast represents the opinions of host Anna and her guests on the show and do not reflect the opinion of Nestle Health Science. The content is for informational purposes only and should not be taken as medical advice, please consult your healthcare professional for any medical questions.
Paul Biondi, Executive Partner, Flagship Pioneering and President, Pioneering Medicines Paul joined Flagship Pioneering in 2019 as Executive Partner, Flagship Pioneering and President, Pioneering Medicines. In his role at Flagship, Paul works with growth company CEOs and their teams to achieve the best attainable value for each company and serves on the boards of selected Flagship companies including Seres Therapeutics, Valo Health. As a member of Flagship's senior leadership team, Paul is involved in strategic and operational aspects of Flagship, including leading Pioneering Medicines. Pioneering Medicines is an initiative of Flagship dedicated to conceiving and developing an innovative pipeline of life-changing treatments for patients. By harnessing the power of Flagship's scientific platforms, Pioneering Medicines will create novel medicines that deliver benefits to more patients, sooner. Pioneering Medicines also enters into strategic partnerships to jointly conceive new products by combining partners' R&D priorities with Flagship's unique platform capabilities, providing partners access to the full spectrum of innovation across Flagship as well as the R&D expertise that Pioneering Medicines offers. Paul joined Flagship Pioneering following a seventeen-year tenure at Bristol-Myers Squibb (BMS). Most recently, Paul served as the Senior Vice President of Strategy and Business Development where he had enterprise-wide responsibility for establishing and evolving BMS's strategy, and for pursuing strategic transactions to access external innovation, enhance BMS's capabilities and strengthen the company's portfolio. Prior to this role, Paul held a series of leadership roles within BMS' R&D organization overseeing strategy, portfolio and project management, and clinical and business operations. Prior to BMS, Paul spent nine years at Mercer Management Consulting. He received his M.B.A. from the J.L. Kellogg School of Management at Northwestern University and his B.A. from Dartmouth College.
Join us with our guests from GoodNature, a Seres Therapeutics program; April Garcia, Site Manager of GoodNature Irvine California, and two GoodNature donors who will share their experiences. They will discuss the who, what, and how in donating poop to potentially support C. diff patients. With microbiome therapeutics on the forefront, it will be an educational discussion.
Join us with our guests from GoodNature, a Seres Therapeutics program; April Garcia, Site Manager of GoodNature Irvine California, and two GoodNature donors who will share their experiences. They will discuss the who, what, and how in donating poop to potentially support C. diff patients. With microbiome therapeutics on the forefront, it will be an educational discussion.
Join us with our guests from GoodNature, a Seres Therapeutics program; April Garcia, Site Manager of GoodNature Irvine California, and two GoodNature donors who will share their experiences. They will discuss the who, what, and how in donating poop to potentially support C. diff patients. With microbiome therapeutics on the forefront, it will be an educational discussion.
Mike Nally is the Chief Executive Officer of Generate Biomedicines and a CEO-Partner at Flagship Pioneering. Mike brings significant experience leading global organizations and is passionate about working with teams and partners to bring innovations to patients. Mike previously served as Chief Marketing Officer at Merck & Co. In this role, Mike was responsible for Global Marketing and Brand Strategy across a vast portfolio, exceeding $40B in revenue, of innovative medicines and vaccines. Prior to this role, Mike served as President of Global Vaccines at Merck, providing a broad portfolio of pediatric, adolescent, and adult vaccines to the world. In this position, Mike and his team worked to drive a dramatic increase in the reach and public health impact of vaccines, while delivering significant business growth. Additionally, Mike has led the company's business in Sweden and the UK, focusing on the development and implementation of innovative, customer-centered approaches that delivered improved business results and accelerated patient access to our medicines. He has also held a variety of positions in Commercial Operations, Business Development and Investor Relations. Geoffrey von Maltzahn is an inventor, entrepreneur, CEO, and the co-founder of multiple groundbreaking companies in therapeutics and agriculture. Geoffrey is a General Partner at Flagship Pioneering and has co-founded companies that represent, in aggregate, over $10 billion in public and private market capitalization. Through his role in Flagship Labs, Geoffrey has created companies that include Generate Biomedicines, Tessera Therapeutics, Indigo Agriculture, Sana Biotechnology (NASDAQ: SANA), Kaleido Biosciences (NASDAQ: KLDO), Seres Therapeutics (NASDAQ: MCRB), and Axcella Health (NASDAQ: AXLA). These are pioneering, respectively, generative biology, gene writing, plant microbiome products for crop improvement, engineered cells and cell-specific gene therapies, novel chemistries to drive the human microbiome, the first microbiome therapeutics, and amino acid-based drugs. Geoffrey recently served as founding CEO for Generate Biomedicines and currently serves as a Board Director. Additionally, he is Chief Executive Officer and Director of Tessera Therapeutics, Chief Innovation Officer and Director of Indigo, and Director of Kaleido Biosciences and Sana Biotechnology. He recently served as Chief Executive Officer of Cobalt Biomedicine, which he led from inception to merger with Sana Biotechnology, and as Kaleido's Chief Executive Officer, where he led the company from inception to the launch of multiple clinical studies. Geoffrey also served as Chief Executive Officer of Indigo, where he led the development of the company's plant microbiome platform and the discovery of the company's first commercial products: Indigo Cotton, Indigo Wheat, Indigo Corn, and Indigo Soy, which are now used on over a million acres. Previously, Geoffrey was the Chief Technology Officer of Seres Therapeutics, where he led the discovery of SER-109, the first microbiome therapeutic to report positive phase 3 data, and built out the company's discovery platform. Geoffrey has deep expertise in genome engineering, the microbiome, bioengineering, and nanotechnology. He is listed as an inventor on over 200 patent applications and patents, and he has co-authored more than 20 peer-reviewed articles. Geoffrey has received a number of awards and honors, including Bloomberg 50's Ones to Watch; Business Insider's 30 Biotech Leaders Under 40; Endpoints News' 20 Biopharma Leaders Under 40; Boston Chamber of Commerce's Ten Outstanding Young Leaders; the prestigious Lemelson-MIT Student Prize, awarded to the most innovative students at MIT; the National Inventors Hall of Fame Graduate Student Prize; the Biomedical Engineering Society Graduate Research Award; and the Harvard-MIT Martha Gray Prize.
How can GI health significantly determine the general health of the rest of the body? Since so many bodily systems utilize products produced along the gastrointestinal tract, minor issues can be increased throughout the body. Listen up to learn: How the gut microbiome has the potential to make or break the body's health How the Western diet may be threatening your gut's health How "bacterial economics" governs GI systems Executive vice president and chief medical officer at Seres Therapeutics, Dr. Lisa von Moltke, discusses her work developing therapeutic techniques to treat gastrointestinal conditions and microbiomes. Through the study of how the gut microbiome and gastrointestinal health affect the operation of the rest of the body, new therapies have been developed to combat GI-targeted infections. New therapies are also being produced to prevent infection with patients undergoing transplants and grafts. Immunosuppressants are also a weak point regarding gut health since they open windows of vulnerability for infections to target your gut. Therefore, developing techniques to treat various diseases without affecting GI health and the gut microbiome may be the next most valuable step in developing pharmaceutical therapeutics. For more information, visit serestherapeutics.com. Episode also available on Apple Podcasts: apple.co/30PvU9C
In this episode, Ayesha talks about Nestlé's marketing of Seres Therapeutics' oral microbiome drug for recurrent C. Difficile infection (CDI). CDIs are the leading cause of hospital-acquired infections in the US, with recurrence being a common problem. It typically develops after the use of antibiotics which can wipe out the gut's healthy bacteria. Seres' microbiome drug SER-109 aims to restore the healthy bacteria via an oral capsule that contains a protective species of gut bacteria. Nestlé has been a big player in the gastrointestinal space and first partnered with Seres in 2016. The latest venture of the partnership will have the food and beverage giant utilize its global pharmaceutical business Aimmune Therapeutics to take on the role of lead commercialization party for the oral microbiome drug.The team also discussed the World Health Organization's (WHO) adding IL-6 receptor blockers to its treatment guidelines for severely and critically ill COVID-19 patients. This includes IL-6 blockers from Roche (Actemra) and Sanofi (Kevzara). While IL-6 receptor antagonists initially met with mixed results in COVID-19 trials, recent data suggests it can cut improve survival outcomes in critically ill patients. The WHO also called on manufacturers to reduce the cost of the IL-6 receptor monoclonal antibodies to help increase access to the drugs in low- and middle-income countries.Read the full articles here: Nestlé to Market Seres' Oral Microbiome Drug for C. Difficilev WHO Calls on Roche and Sanofi to Lower Costs for Life-Saving COVID-19 Treatment For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured
Our guests from Seres Therapeutics shared the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study's efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to a placebo. Listen in and learn more from the leading topic experts.
Our guests from Seres Therapeutics shared the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study's efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to a placebo. Listen in and learn more from the leading topic experts.
Star Bulk Carriers president Hamish Norton (SBLK) on global shipping and supply chain headwinds and where to find the best talent for the shipping industry. Seres Therapeutics (MCRB) sees big health benefits where the sun doesn't shine. Lydall (LDL) watches its filter technology grow in popularity. Raven Industries (RAVN) prepares for a future of autonomously driving tractors. The Drill Down with Cory Johnson offers a daily look at the business stories behind stocks on the move. Learn more about your ad choices. Visit megaphone.fm/adchoices
Dr. Brenda Raud is a postdoctoral researcher at the Netherlands Cancer Institute and Dr. Jason Goldsmith is the Director of Donor Medical Sciences at Seres Therapeutics. In addition to their work as immunology researchers, Brenda and Jason are also hosts of the new Immunology Podcast, a sister podcast to the Stem Cell Podcast.
A Symposium specifically developed for Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers. Distinguished members and keynote speakers provide insight as to what impacts the patient and families on both quality and economic topics, what role leadership plays in creating the right culture for patient-centered care, and how to identify, evaluate, and prioritize innovations that can quickly touch the lives of patients battling C. diff. infections. Courtney Jones ” Microbiome, Microbiota, and Gut Health.” Denise Cardo, MD “Everyone Has a Role in Antibiotic Awareness.” Larry Kociolek, MD “C. diff. Infections in Pediatrics.” This event was sponsored by Seres Therapeutics. Seres Therapeutics mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics Enjoy the program!
A Symposium specifically developed for Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers. Distinguished members and keynote speakers provide insight as to what impacts the patient and families on both quality and economic topics, what role leadership plays in creating the right culture for patient-centered care, and how to identify, evaluate, and prioritize innovations that can quickly touch the lives of patients battling C. diff. infections. Courtney Jones ” Microbiome, Microbiota, and Gut Health.” Denise Cardo, MD “Everyone Has a Role in Antibiotic Awareness.” Larry Kociolek, MD “C. diff. Infections in Pediatrics.” This event was sponsored by Seres Therapeutics. Seres Therapeutics mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics Enjoy the program!
A Symposium specifically developed for Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers. Distinguished members and keynote speakers provide insight as to what impacts the patient and families on both quality and economic topics, what role leadership plays in creating the right culture for patient-centered care, and how to identify, evaluate, and prioritize innovations that can quickly touch the lives of patients battling C. diff. infections. Courtney Jones ” Microbiome, Microbiota, and Gut Health.” Denise Cardo, MD “Everyone Has a Role in Antibiotic Awareness.” Larry Kociolek, MD “C. diff. Infections in Pediatrics.” This event was sponsored by Seres Therapeutics. Seres Therapeutics mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics Enjoy the program!
Welcome to the second episode of a special four (4) part series: A Symposium Created For Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers. Welcome to a Symposium specifically developed for patients, families, and caregivers. The Patient & Family C. diff. Symposium: where a gathering of healthcare professionals, keynote speakers, health advocates, practitioners, educators, are transforming the patient experience, and changing the way people experience C. diff. infections worldwide. Simon Cutting, Ph. D. “Bacillus, and C. diff. Spore Overview. “ Teena Chopra, MD ” Introduction to Infection Prevention.” Doe Kley, RN, MPH “C. diff. Transitioning from Hospital to Home. This event was sponsored by Seres Therapeutics, Seres Therapeutic's mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics Enjoy the presentations by the topic leaders joining us!
Welcome to the second episode of a special four (4) part series: A Symposium Created For Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers. Welcome to a Symposium specifically developed for patients, families, and caregivers. The Patient & Family C. diff. Symposium: where a gathering of healthcare professionals, keynote speakers, health advocates, practitioners, educators, are transforming the patient experience, and changing the way people experience C. diff. infections worldwide. Simon Cutting, Ph. D. “Bacillus, and C. diff. Spore Overview. “ Teena Chopra, MD ” Introduction to Infection Prevention.” Doe Kley, RN, MPH “C. diff. Transitioning from Hospital to Home. This event was sponsored by Seres Therapeutics, Seres Therapeutic's mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics Enjoy the presentations by the topic leaders joining us!
Welcome to the second episode of a special four (4) part series: A Symposium Created For Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers. Welcome to a Symposium specifically developed for patients, families, and caregivers. The Patient & Family C. diff. Symposium: where a gathering of healthcare professionals, keynote speakers, health advocates, practitioners, educators, are transforming the patient experience, and changing the way people experience C. diff. infections worldwide. Simon Cutting, Ph. D. “Bacillus, and C. diff. Spore Overview. “ Teena Chopra, MD ” Introduction to Infection Prevention.” Doe Kley, RN, MPH “C. diff. Transitioning from Hospital to Home. This event was sponsored by Seres Therapeutics, Seres Therapeutic's mission is to transform the lives of patients worldwide with revolutionary microbiome therapeutics Enjoy the presentations by the topic leaders joining us!
Join us with our guests from Seres Therapeutics as they discuss the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study's efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to placebo. Listen in and learn more from the leading topic experts.
Join us with our guests from Seres Therapeutics as they discuss the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study’s efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to placebo. Listen in and learn more from the leading topic experts.
Join us with our guests from Seres Therapeutics as they discuss the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study's efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to placebo. Listen in and learn more from the leading topic experts.
Join us with our guests from Seres Therapeutics as they discuss the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study’s efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to placebo. Listen in and learn more from the leading topic experts.
Join us with our guests from Seres Therapeutics as they discuss the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study's efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to placebo. Listen in and learn more from the leading topic experts.
Join us with our guests from Seres Therapeutics as they discuss the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study’s efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to placebo. Listen in and learn more from the leading topic experts.
Join us with our guests from Seres Therapeutics as they discuss the latest news on SER-109 and positive topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. The study’s efficacy results exceeded the statistical threshold previously provided in consultation with the U.S. Food and Drug Administration (FDA) that could allow this single clinical study to fulfill efficacy requirements for a Biologics License Application (BLA). The SER-109 safety results were favorable, with an adverse event profile comparable to placebo. Listen in and learn more from the leading topic experts.
Challenge Discussed : Microbiome technologies have been increasingly leading several industry transformations and 2019 will witness many new developments in this space. Frost & Sullivan believes that the growing research across microbiome science will deeply impact several industry sectors in the coming years.Speaker : Vandana IyerKey Takeaways :What is the direct impact on the pharmaceutical sector?1. OTC probiotics - gut health –for while2. Novel microbiome-based therapies for gastrointestinal disorders are likely to emerge this year3. There’s a close competition between Seres Therapeutics and Rebiotix, as both advance their phase III orphan drug candidates for the prevention of clostridium difficile infection (CDI). Industry experts are sure to watch this space closely for any upcoming regulatory approvals.4. Interestingly, genetic engineering platforms have caught up with skin microbiomics. Azitra is one of the niche players that is not only looking at leveraging skin microbes and active microbial derivatives to enhance skin health, but also looking to engineer commensal bacteria to express therapeutic proteins.Moving on to the skin care industry…1. Whoever said that beauty was skin deep was not completely wrong, because science reveals that skin health can be altered by the composition of tiny micro-organisms that are present on the surface on the skin. There are several emerging personal care companies that are leveraging microbiome science to make groundbreaking new personal care formulations - defy aging, while also improving skin moisture control. Emerging European start-ups, such as Gallinée, are sure to be growing competitors for the long established luxury cosmetic brands.2. You’ll be pleasantly surprised to know that the use of oral microbiome-supplements can also enhance skin health. The microbes are surely going to help redefine skincare by shifting the spotlight towards overall skin health.What about Microbes in the F&B space?1. Consumers are also increasingly aware about the rising importance of microbiome in human health and wellness, so, it is not surprising that there is a growing demand for healthy F&B products.2. Ganeden’s BC30 strain has been used in a wide range of sweet and savoury packaged food products, as well as in several hot and cold beverages.3. Recent research has revealed that the microbiome story also impacts mental health. Interestingly, there’s data that shows that non-live, probiotic-derived ingredients can also provide health benefits.4. Thus, microbiome-derived ingredients are poised to completely transform human wellness, much beyond the traditional digestive health space. Finally, How will microbes influence indoor air environment?1. The most recent sector to get impacted by the microbiome wave has been the indoor air environment industry.2. Emerging industry participants such as BetterAir are looking to infuse indoor air environment with a healthy population of microbes to reduce the risk of asthma and allergic diseases.3. This trend is likely to have a greater penetration in the next few years as larger industry participants look to transform the traditional heating, ventilation and air conditioning settings.It is quite evident from the above facts that the microbes are here to stay. Frost & Sullivan’s research will provide detailed technological insights on how these tiny micro-organisms can potentially lead industry level disruptions across the world.On that note, I hope you enjoyed this session.Please join us for future podcasts and become a member of our Leadership Council by emailing us at digital@frost.com.Thank you for your time. Have a nice day!Website: www.frost.com See acast.com/privacy for privacy and opt-out information.
Join us with our guest Barbara McGovern, MD. Since 2012 Dr. McGovern has been working within the pharmaceutical arena and currently is head of Medical Affairs at Seres Therapeutics, which is developing microbiome-based therapies. Their lead microbiome therapeutic drug is SER-109, which is being evaluated in a phase 3 clinical trial for recurrent Clostridium difficile infection. We will be discussing the role of the Microbiome in reducing the risk of C. diff. infection recurrence.
Join us with our guest Barbara McGovern, MD. Since 2012 Dr. McGovern has been working within the pharmaceutical arena and currently is head of Medical Affairs at Seres Therapeutics, which is developing microbiome-based therapies. Their lead microbiome therapeutic drug is SER-109, which is being evaluated in a phase 3 clinical trial for recurrent Clostridium difficile infection. We will be discussing the role of the Microbiome in reducing the risk of C. diff. infection recurrence.
This episode will provide foundational educational information about the microbiome by answering the fundamental questions of what is it, why is it important, how does it impact patients with C. difficile infections, and what are the possibilities of the microbiome as a therapeutic target for future drugs. This interview will be with Dr. Matthew Henn, Senior Vice President and Head of Drug Discovery & Bioinformatics at Seres Therapeutics, Inc,. Seres Therapeutics is a leading microbiome therapeutics company dedicated to creating a new class of medicines to treat diseases resulting from imbalances in the microbiome. These first-in-class drugs, called Ecobiotics®, are ecological compositions of beneficial organisms that are designed to restore a healthy human microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases.
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This episode will provide foundational educational information about the microbiome by answering the fundamental questions of what is it, why is it important, how does it impact patients with C. difficile infections, and what are the possibilities of the microbiome as a therapeutic target for future drugs. This interview will be with Dr. Matthew Henn, Senior Vice President and Head of Drug Discovery & Bioinformatics at Seres Therapeutics, Inc,. Seres Therapeutics is a leading microbiome therapeutics company dedicated to creating a new class of medicines to treat diseases resulting from imbalances in the microbiome. These first-in-class drugs, called Ecobiotics®, are ecological compositions of beneficial organisms that are designed to restore a healthy human microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases.
This episode introduces Seres Therapeutics, a leading microbiome therapeutics company, which recently published in the Journal of Infectious Diseases positive results from an open-label Phase 1b/2 study of SER-109 for the treatment of patients with recurrent C. difficile infections (CDI). Seres Therapeutics is creating a new class of medicines to treat diseases resulting from functional deficiencies in the microbiome, a condition known as dysbiosis. New insights into the human microbiome are fundamentally reshaping how we understand and treat a wide range of diseases, creating new possibilities for patients not served by current therapeutic approaches. Ecobiotics are ecological compositions of beneficial organisms that are designed to reestablish a healthy microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases. This interview will include forward-looking statements on Seres Therapeutics current expectations and projections about future events. These statements are based upon current beliefs, expectations and assumptions, and are subject to a number of important risks and uncertainties, including those set forth in Seres Therapeutics filings with the SEC, many of which are difficult to predict. Actual results may differ materially from such statements. The information included in this interview is provided only as of the date of this interview, and Seres Therapeutics undertakes no obligation to update any forward-looking statements stated in this interview on account of new information, future events, or otherwise, except as required by law. Seres Therapeutics has provided financial support to the C Diff Foundation.
This episode introduces Seres Therapeutics, a leading microbiome therapeutics company, which recently published in the Journal of Infectious Diseases positive results from an open-label Phase 1b/2 study of SER-109 for the treatment of patients with recurrent C. difficile infections (CDI). Seres Therapeutics is creating a new class of medicines to treat diseases resulting from functional deficiencies in the microbiome, a condition known as dysbiosis. New insights into the human microbiome are fundamentally reshaping how we understand and treat a wide range of diseases, creating new possibilities for patients not served by current therapeutic approaches. Ecobiotics are ecological compositions of beneficial organisms that are designed to reestablish a healthy microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases.brbr This interview will include forward-looking statements on Seres Therapeutics current expectations and projections about future events. These statements are based upon current beliefs, expectations and assumptions, and are subject to a number of important risks and uncertainties, including those set forth in Seres Therapeutics filings with the SEC, many of which are difficult to predict. Actual results may differ materially from such statements. The information included in this interview is provided only as of the date of this interview, and Seres Therapeutics undertakes no obligation to update any forward-looking statements stated in this interview on account of new information, future events, or otherwise, except as required by law. Seres Therapeutics has provided financial support to the C Diff Foundation.
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