Podcasts about inds

In this episode, Ayesha speaks with Ebrahim S. Delpassand, MD, Founder and CEO of RadioMedix, a company developing innovative radiopharmaceuticals for cancer diagnosis, monitoring and treatment. With a focus on both PET imaging and therapeutic radiopharmaceuticals labeled with alpha and beta emitters, RadioMedix is helping to shape the future of precision oncology. Dr. Delpassand brings a wealth of expertise as a board-certified nuclear medicine physician and a seasoned healthcare entrepreneur. He previously served as Deputy Chair and Chief of Clinical Nuclear Medicine at MD Anderson Cancer Center and is the Founder and Chairman of Excel Diagnostics & Nuclear Oncology Center. In addition to leading RadioMedix, he holds adjunct professorships in Radiation Oncology at the University of Texas and in Nuclear Medicine at Baylor College of Medicine. As a principal investigator and sponsor of five active INDs, Dr. Delpassand is a leader in clinical nuclear medicine research and translational drug development. He also co-founded Infinity Care and Infinity Infusion Care, successfully guiding the latter to acquisition by Curative Healthcare in 2002. Tune into the episode to hear Dr. Delpassand discuss the expanding role of radiopharmaceuticals in oncology, the challenges of developing theranostic agents and how his clinical and entrepreneurial background has shaped his vision for advancing nuclear medicine. For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/ Follow Us on Social Media Twitter: https://twitter.com/Xtalks Instagram: https://www.instagram.com/xtalks/ Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

Som ung kontorchef var Thomas Egebo ikke klar over at ledervejen var den rigtige for ham. Det ændrede sig i det øjeblik, han lagde lederansvaret fra sig. Vi har mødt topchefen i Energinet til en snak om, hvorfor han stadig elsker at være leder.  Vært: Anders Hvass Klipper og producer: Kathrine Wismann Musik: Christian Schødts-Sørensen Programmet er produceret af R*******k Productions for Lederstof.dk, som udgives af Lederne. Læs mere på www.lederstof.dk  

FDA's plan to move away from animal toxicity testing could expedite INDs and cut costs for biopharma companies, while helping the U.S. maintain its position as a clinical research hub. On the latest BioCentury This Week podcast, BioCentury's editors discuss the agency's new three-year road map to reduce animal safety studies for mAbs. The editors then discuss the deepening morale crisis at FDA after HHS Secretary Robert F. Kennedy Jr. accused the agency of corruption, encouraged staff to report supervisors over approval decisions they oppose, and endorsed conspiracy theories about the “deep state.” They assess the impact of whipsawing tariff policies and turmoil at FDA on biotech indexes — and why the sky isn't falling just yet for biotech's specialist investors. The editors also highlight recent stories on base editors' efficiency boom and how exosomes are finding new life. This episode of BioCentury This Week podcast was sponsored by RemeGen.View full story: https://www.biocentury.com/article/65562200:01 - Sponsor Message: RemeGen Co.02:38 - Replacing Animal Models09:40 - RFK Jr. & FDA19:36 - NIH30:02 - BioPharma Market Pulse33:23 - Innovation HighlightsTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Today, Niki Gallo, principal consultant of regulatory affairs at Halloran Consulting, joins host Emily Walsh Martin for a deep dive into timeline management pitfalls, the nuances of INDs, and the rapidly evolving FDA landscape. Niki brings to the program her extensive experience shepherding innovative therapeutics through the regulatory process and timely insights into the complexities of transitioning from the bench to the bedside. Whether you’re from industry or academia, today’s conversation will help wrap all our heads around testing novel therapies for the first time in humans. The ASGCT Annual Meeting is almost here! Join us in New Orleans May 13-17 for the premier event in CGT and save $465 by joining ASGCT and using the incredible discounts the Society provides to members. Visit annualmeeting.asgct.org to check out the full program, plan your trip, and register for the ASGCT Annual Meeting. Music by: https://www.steven-obrien.net/--------------------------Bright New Morning - Steven O'Brien (Used for free under a Creative Commons Attribution 4.0 License: https://creativecommons.org/licenses/by/4.0/)Show your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

みそじょw-inds.部第二弾の配信です！みゆき部長、フェイ子さんに続き、おはぎさんも入部されました

Med udgangspunkt i tiltrædelsestalen, som USAs 47. præsident Donald Trump afholdte i går, taler vi i aften om 'taler'. Hvad mener Nattevagtens lyttere om gårsdagens tale, og hvad skal der i det hele taget til for at holde en god tale? Lyt med!See omnystudio.com/listener for privacy information.

Doug Drysdale Chief Executive Officer An experienced Corporate Director and CEO: Doug has chaired the board of directors of a NASDAQ-listed company and, as a CEO for the past 12 years, has built and turned around three pharmaceutical companies. Doug has 30 years of experience in the healthcare sector. During this time, he has formed cohesive management teams, recruited board members, completed 15 corporate acquisitions across three continents, and raised $4 billion in public and private capital. Led the turnaround of Norwich Pharmaceuticals alongside investors and became the Founding CEO of the parent company, Alvogen Group. During his 5.5-year tenure as CEO, Alvogen grew from inception to $450 million in revenues across 35 countries. In early 2014, Doug led the recapitalization of NASDAQ-listed Pernix Therapeutics, raising $65 million. Within the first year of taking the helm as Chairman and CEO, Doug rebuilt the management team and board of directors, combined several operating locations, and grew the company's enterprise value from $80 million to around $800 million. Under Doug's leadership, Pernix raised $465 million of capital. From November 2017 to July 2020, Doug was the Director and CEO of Tedor Pharma, a family-owned contract manufacturing business. Doug's efforts to turn around the industry resulted in 60% revenue growth in 2019, leading to Tedor being recognized as one of America's fastest-growing companies and making it to the 2020 Inc 5000 list. Former Head of M&A at Actavis Group, leading 15 corporate acquisitions across three continents between 2004 and 2008, including a high-profile public hostile takeover attempt in Central Eastern Europe. Over this period, Doug raised approximately $3 billion in capital and managed lending syndicates, including 25+ banks, to fund the company's growth. Actavis was sold to Watson Pharmaceuticals in 2012 for EUR4.25 billion. Doug holds a bachelor's degree in Microbial and Molecular Biology from the University of East Anglia in the U.K. and was recognized as Ernst and Young's Entrepreneur of the Year in 2012. He is an enthusiastic traveler, having visited over 45 countries. He is also an avid reader and enjoys cooking and boating. This video was conducted on behalf of Cybin and was funded by Gold Standard Media LLC and/or affiliates. For our full disclaimer, please visit https://portal.goldstandardir.com/disclaimer/CYBN-183   https://ir.cybin.com/overview/default.aspx NYSE: CYBN I CBOE: CYBN   Addressing Mental Health Challenges Doug and Michael discussed the challenges and frustrations faced by patients and doctors in dealing with mental health issues, particularly clinical depression. With his background in building drug development companies, Doug highlighted the lack of practical tools for addressing these issues. Michael expressed his interest in innovative solutions to mental health problems, given his personal experience with clinical depression. The conversation was set to be more organic and conversational, with Doug sharing more about his company and their approach to mental health. Paradigm Shift in Drug Development Doug expressed his belief that their work has the potential to be a paradigm shift in drug development, moving from daily treatment of symptoms to more interventional therapies that can rapidly fix conditions like depression. He highlighted the promising results from their studies, with patients experiencing benefits lasting at least a year after just a couple of doses. Michael shared his personal experience with depression and burnout, emphasizing the importance of their work in addressing this widespread issue. He also asked Doug about his ability to anticipate future challenges and steps in the approval process for their work. Drug Development Challenges and Success Doug discussed the challenges and complexities of drug development, particularly in the mental health sector. He highlighted the team's experience and success in developing treatments, with 60+ INDs and 37 exits. Doug also emphasized the personal motivation of the team members, many of whom have been affected by mental health issues. He acknowledged the regulatory hurdles and administrative complexities involved in drug development but stressed the importance of these steps in creating effective treatments. Michael added that the success of the treatments could also positively impact the revenue of psychiatrists and their practices. Improving Mental Health Care Efficiency Doug discussed the potential of a new treatment to improve mental health care. He highlighted that depressed patients require a lot of attention, often visiting their physicians multiple times a year for medication adjustments and dealing with side effects. He also pointed out the shortage of psychiatrists and the long wait times for new patients. Doug suggested that their treatment, which only requires dosing once or twice, could keep patients out of the system for at least a year, freeing up resources for new patients. He also mentioned the potential for interventional psychiatry centers to see more patients if the treatment reduces the required visits. Mental Health and Metabolic Connection Michael and Doug discussed the challenges of mental health, particularly financial stress and depression. Michael shared his personal experience of overcoming depression with the help of medication and therapy and expressed his excitement about the potential of innovative work in mental health. Doug emphasized the link between metabolic health and mental health, suggesting that a poor diet can lead to reduced mental function and that mental health issues can affect an individual's metabolic health. Both agreed on the importance of addressing mental health issues to improve overall well-being and happiness. Phase 3 Program Progress and Strategy Doug discussed the progress of their phase 3 program, focusing on the challenges and complexities involved, such as drug scheduling and licensing. He expressed optimism about the potential of their treatments, citing their significant effects and the absence of dosing every day in their studies. Doug also outlined their long-term strategy, which includes leveraging their phase 3 approval in depression to treat other conditions and shift from daily chronic dosing to more interventional treatments. He emphasized the potential to break the cycle of polypharmacy and create a platform for various treatments. Michael supported their work and encouraged more people to learn about their efforts.  

En skelsættende dag, mange har set frem til, Steak House og Martini i 16', og en flugt til New York, Republikanerne kører pre-party for 20.000, Joe Biden sover igennem dagen, kør en præsidentindsættelse indendørs, Trump kører en all-time high på meme-coins, vi er ikke færdige med at Zuckerberg, start noget, stop det igen, og få rosen, Pitch and choice på adressebogen, Burhan G er den danske Mark Wahlberg, Tantholdt og Shamanen, tillykke til Kevin Koshner, “hold på hat og briller for 2025”, Harris manglede de mandlige sportsstjerner, Hollywood er brændt ned, en fredsaftale i Mellemøsten, forbud mod rygning i morgen og hold fri tirsdag og torsdag, Pelle Peter er ikke i chok over hitlisterne, hvad hitter 2025? og de vådeste krøller fra Aarhus V.Få 30 dages gratis prøveperiode (kan kun benyttes af nye Podimo-abonnenter): https://go.podimo.com/dk/hgdg (79 kroner herefter)Eller få 3 mdr. med 50% rabat (kan bruges af tidligere Podimo-abonnenter): https://go.podimo.com/dk/hgdgtilbud (79 kroner herefter) Værter: Esben Bjerre & Peter Falktoft Redigering: PodAmokKlip: PodAmokMusik: Her Går Det GodtInstagram: @hergaardetgodt @Peterfalktoft @Esbenbjerre

Det er ikke hver dag, at man uden at overdrive kan sige, at milliarder af mennesker rundt om på kloden lige sidder og venter på, at en enkelt mand skal åbne munden og sige noget. Men sådan var det, da Donald Trump mandag trådte hen til mikrofonen i rotunden i den amerikanske kongresbygning og i sin tiltrædelsestale lod verden vide, hvad han har tænkt sig at bruge magten til i de næste fire år. I dag spørger 'Du lytter til Politiken' USA-korrespondent Jacob Fuglsang, hvordan Trumps tale så har forandret verden. Og midt under vores snak får han pludselig øje på noget udenfor sit vindue. Noget, man måske – lidt flot – kunne kalde for den gamle verden, der forsvinder.See omnystudio.com/listener for privacy information.

I går blev Donald Trump indsat som USA's præsident, kort tid efter underskrev han de første dekreter. Trumps kryptovaluta afføder hårde reaktioner. Endnu en gang må Ørsted sluge nedskrivninger for et milliardbeløb.   Vært: Trine Duvander (trdu@borsen.dk)

Finans er på banen med en ny podcast, der giver dig indsigt i en globaliseret verden, der ikke har mere kompleks i årtier. Podcasten tager pulsen på aktuelle emner, der får eller har indflydelse på danske selskabers måde at drive virksomhed på. Hør første afsnit, hvor Finans´ globale korrespondent Thomas Høy kigger ind i fremtiden efter Indsættelsen af USA´nye præsident Donald Trump, og hvad hans første ord som præsident umiddelbart betyder for verdenshandlen og ikke mindst danske virksomheders muligheder for at vokse, vækste, og skabe profit i en verden præget af usikkerhed, spændinger og trusler om toldmure. Gæst: Thomas Høy, global korrespondent, Finans. Vært: Mads Ring Producer: Kasper Søegaard. See omnystudio.com/listener for privacy information.

Indsættelsen af Donald Trump som USA’s præsident nr. 47 tyder på nye tider - men hvilke? Millionærklubben debatterer, hvad fremtiden bringer med tekniske analytiker Lars Persson og investor Steen Jacobsen i studiet. Vært: Bodil Johanne GantzelSee omnystudio.com/listener for privacy information.

Hvem har rettighederne til kunstneres musik, når de dør? Hvilke dilemmaer opstår, når man efter en kunstners død sidder på en musikalsk guldmine? Og hvad gør det ved vores syn på døden, når fx musikere udgiver musik lang tid efter deres død? De spørgsmål stiller K-Live i dag, når vi dykker ned i posthume musikudgivelser i forbindelse med Mac Millers nye album, der er det andet album siden sin død i 2018. Donald Trump bliver officielt udnævnt som USA's præsident mandag aften dansk tid. Vi varmer op med adfærdspsykolog og forfatter Henrik Tingleff, der har skrevet en bog om egodyret - et evolutionært instinkt, der drives vores hunger efter magt og anerkendelse. Donald Trump er - ifølge Tingleff - det tydeligste levende eksempel på et egodyr. Vært: Casper Dyrholm.

We welcome Meredith Brown-Tuttle to AI Uncovered.  Meredith is the Chief Regulatory Strategist at Regulatorium, where she applies her 33 years of experience in the pharmaceutical and biologics industry. She specializes in working with small and medium-sized drug, biologic and combination product companies to navigate global regulatory strategy, intelligence and submission requirements. With a strong focus on innovation, Meredith is dedicated to revolutionizing regulatory science by integrating AI and in silico modeling into every stage of drug development. Most recently, Meredith has focused on advancing global regulatory science through the development of AI tools, aiming to streamline submission processes and improve outcomes for the industry. Her vision includes a future where entirely digital INDs, BLAs and NDAs become standard practice, supported by the widespread use of in silico modeling, digital twins and federated data sharing to enable collaboration without compromising proprietary information.In this episode, Tim  and Meredith explore the evolving landscape of global regulatory strategy and how AI can revolutionize regulatory science. Meredith shares insights from her extensive career, including her experience in crafting INDs and NDAs, her thoughts on transforming data validation standards across the industry and providing strategic guidance to companies navigating complex regulatory requirements. She also delves into the challenges and opportunities presented by AI. In addition to her work at Regulatorium, Meredith serves as a board member at the Alliance for Artificial Intelligence in Healthcare (AAIH), showcasing her commitment to leveraging innovation in regulatory affairs. Meredith is also an accomplished author of over 70 articles and two books, and she has trained thousands of professionals on writing INDs and conducting effective regulatory submissions. Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

In this episode, Ayesha spoke with Judy Chou, PhD, CEO, President and Board member of AltruBio, a company developing first-in-class immunomodulators to target diseases of the immune system. AltruBio's pipeline includes compounds being investigated for indications such as ulcerative colitis, psoriatic arthritis and acute graft vs. host disease. Prior to joining AltruBio, Dr. Chou headed the global Biotech organization at Bayer Pharmaceuticals overseeing the development, manufacturing and distribution of Bayer's biotechnology pipeline, product portfolio & more than 2,000 employees. Before Bayer, Dr. Chou held various leadership roles at biopharmaceutical companies such as Pfizer/Medivation, Tanvex Biopharma, Genentech, Pfizer (Wyeth) and AbbVie (Abbott). Dr. Chou has extensive experience in biologics development with multiple filings of BLAs, NDAs and INDs of novel products. She is well recognized by the biomedical industry for her leadership and received the Most Influential Women in Business Award in 2018 by San Francisco Business Times. Currently, Dr. Chou also serves as the Board of Directors of Akero Therapeutics, the California Institute of Regenerative Medicines (CIRM); and the Advisory Board members of UC Berkeley Engineering School and Silicon Valley Women in Engineering. Before joining the industry, Dr. Chou was a research faculty member at Harvard University Medical School. Dr. Chou obtained her PhD from Yale University and completed her post-doctoral training at Max-Planck Institute in Germany. Tune into the episode to learn about AltruBio's innovative solutions targeting diseases of inflammation. For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/ Follow Us on Social Media Twitter: https://twitter.com/Xtalks Instagram: https://www.instagram.com/xtalks/ Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

On this week's edition of "Football Never Sleeps" on YouTube, Eric Hansen and Tyler James discussed what's next for the Notre Dame football team following its 49-35 victory at USC, with the final College Football Playoff rankings and seedings less than a week away on the latest edition of "Football Never Sleeps." They also broke down possible CFP matchups, discussed personnel matters, and revealed the latest on the recruiting front, with signing day coming up on Wednesday. And they answered questions live from viewers. Football Never Sleeps is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Next week's "Football Never Sleeps" will be live on Monday at 7 p.m. EST. Want to watch "Football Never Sleeps" on YouTube? Visit here: www.youtube.com/c/InsideNDSports

On this week's edition of "Football Never Sleeps" on YouTube, Eric Hansen and Tyler James discussed the progress Notre Dame has made since its loss to Northern Illinois, College Football Playoff possibilities, the challenges of closing out the regular season Saturday at USC, takeaways from head coach Marcus Freeman's Monday press conference and the latest in recruiting. They answered questions live from viewers on YouTube, too. Football Never Sleeps is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Next week's "Football Never Sleeps" will be live on Monday at 7 p.m. EST. Want to watch "Football Never Sleeps" on YouTube? Visit here: www.youtube.com/c/InsideNDSports

WSBT Sports Director Pete Byrne discusses the points in the season after the Northern Illinois loss that he felt Notre Dame could and would end up in a position to play in the College Football Playoff, the growth of quarterback Riley Leonard and head coach Marcus Freeman, how good running back Jeremiyah Love has been, the improvement on ND's offensive line, the most impressive part of ND's defense, the trajectory of USC's program, his expectations for what a playoff game in Notre Dame Stadium would be like and more. Then Eric Hansen and Tyler James answer questions from X/Twitter and The Insider Lounge (31:31). The Inside ND Sports podcast is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. https://notredame.rivals.com/sign_up?promo_code=NDPOD Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

Jim Lefebvre, author of "Loyal Sons: The Story of The Four Horsemen and Notre Dame Football's 1924 Champions," shares his interest in the history of Notre Dame's football program, how he thinks Knute Rockne would fare as a coach in modern college football, the qualities that Marcus Freeman shares with Rockne, the importance of Notre Dame-Army games a century ago, what made The Four Horsemen special, how this year's game will go, if Army can regain prominence in current era and more. Then Eric Hansen and Tyler James answer questions from X/Twitter and The Insider Lounge (20:28). The Inside ND Sports podcast is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. https://notredame.rivals.com/sign_up?promo_code=NDPOD Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

On this week's edition of "Football Never Sleeps" on YouTube, Eric Hansen and Tyler James discussed the challenge awaiting Notre Dame on Saturday from Army West Point, ND's latest College Football Playoff outlook following a win over Virginia, takeaways from head coach Marcus Freeman's Monday press conference and the latest in recruiting. They answered questions live from viewers on YouTube, too. Football Never Sleeps is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Next week's "Football Never Sleeps" will be live on Monday at 7 p.m. EST. Want to watch "Football Never Sleeps" on YouTube? Visit here: www.youtube.com/c/InsideNDSports

Former Notre Dame offensive lineman Tommy Kraemer (2016-20) discusses Notre Dame's season, the Irish being named semifinalists for the Joe Moore Award, how much a lineman can improve in his first year as a starter, what moving to guard means for a tackle, how quarterback Riley Leonard helps ND's offensive line, what it was like being recruited by and playing for OL coach Harry Hiestand, his relationship with ND's current players, his work with Golden Legacy Partners and more. Then Eric Hansen and Tyler James answer questions from Twitter and The Insider Lounge (23:12). The Inside ND Sports podcast is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. https://notredame.rivals.com/sign_up?promo_code=NDPOD Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

On this week's edition of "Football Never Sleeps" on YouTube, Eric Hansen and Tyler James discussed Notre Dame's latest College Football Playoff outlook following a blowout win over Florida State, what could trip up the Irish in the next three games, takeaways from head coach Marcus Freeman's Monday press conference and the latest in recruiting. They answered questions live from viewers on YouTube, too. Football Never Sleeps is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Next week's "Football Never Sleeps" will be live on Monday at 7 p.m. EST. Want to watch "Football Never Sleeps" on YouTube? Visit here: www.youtube.com/c/InsideNDSports

Dennis Dodd, national college football writer for CBS Sports, discusses Notre Dame's seeding at No. 10 in the first College Football Playoff rankings, how each CFP committee evolves, what we learn with the weekly updates, what has happened to Florida State and USC this season, if steep declines are more likely to happen in the transfer portal era, if Penn State is any good, which team may be a sleeper in the CFP, what major news may be next for college football and more. Then Eric Hansen and Tyler James answer questions from Twitter and The Insider Lounge (29:07). The Inside ND Sports podcast is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. https://notredame.rivals.com/sign_up?promo_code=NDPOD Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

On this week's edition of "Football Never Sleeps" on YouTube, Eric Hansen and Tyler James discussed No. 10 Notre Dame's drop in the AP poll, what the Irish can prove in November as the College Football Playoff rankings start, takeaways from head coach Marcus Freeman's Monday press conference and the latest in recruiting. They answered questions live from viewers, too. Football Never Sleeps is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Next week's "Football Never Sleeps" will be live on Monday at 7 p.m. EDT. Want to watch "Football Never Sleeps" on YouTube? Visit here: www.youtube.com/c/InsideNDSports

Dalton Wasserman, a college football analyst for Pro Football Focus, discusses Notre Dame's season to date, what PFF's grades say about quarterback Riley Leonard's pro potential, how good running back Jeremiyah Love has been for ND, how PFF ensures for consistency in grading, what Anthony Treash can provide for Notre Dame's staff, why defensive tackles Rylie Mills and Howard Cross III have lower grades this season, safety Xavier Watts' NFL Draft stock, how to understanding PFF grades better, if Notre Dame is a College Football Playoff team, the biggest misconception about PFF and more. Then Eric Hansen and Tyler James answer questions from Twitter and The Insider Lounge (29:44). The Inside ND Sports podcast is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. https://notredame.rivals.com/sign_up?promo_code=NDPOD Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

On this week's edition of "Football Never Sleeps" on YouTube, Eric Hansen and Tyler James discussed the key players and trends for No. 8 Notre Dame as the Irish (7-1) head into the second bye week of their 2024 season before building their case in November for inclusion in the 12-team College Football Playoff. They also chatted about bye-week priorities and recalibration, the latest on the recruiting trail, and answered viewer questions live. Football Never Sleeps is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Next week's "Football Never Sleeps" will be live on Monday at 7 p.m. EDT. Want to watch "Football Never Sleeps" on YouTube? Visit here: www.youtube.com/c/InsideNDSports

CBS Sports College Football Playoff expert Jerry Palm discusses his observations of Notre Dame this season, if the perception of the programs on ND's schedule are hurting the Irish, how Texas A&M's success is helping ND, why he thinks ND is likely to lose again this season, if bias has been shown in previous playoff committee rankings, how high ND could be ranked if it finishes 11-1 and more. Then Eric Hansen and Tyler James answer questions from Twitter and The Insider Lounge (24:46). The Inside ND Sports podcast is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. https://notredame.rivals.com/sign_up?promo_code=NDPOD Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

On this week's edition of "Football Never Sleeps" on YouTube, Eric Hansen and Tyler James discussed No. 12 Notre Dame's national perception and poll position as it heads into a Saturday showdown with unbeaten and 24th-ranked Navy. They'll also chat about the takeaways from head coach Marcus Freeman's Monday press conference and the latest in recruiting for the Irish. They answered questions from viewers, too. Football Never Sleeps is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Next week's "Football Never Sleeps" will be live on Monday at 7 p.m. EDT. Want to watch "Football Never Sleeps" on YouTube? Visit here: www.youtube.com/c/InsideNDSports

ESPN play-by-play broadcaster Mike Monaco, a Notre Dame graduate, discusses what he learned about Georgia Tech from calling its 31-19 loss to Louisville earlier this season, the importance of quarterback Haynes King to Tech's offense, how he keeps track of ND, his impressions of Louisville and Virginia, how ND guided his journey into broadcasting, the best college football stadium atmosphere he's experienced and more. Then Eric Hansen and Tyler James answer questions from Twitter and The Insider Lounge (33:45). The Inside ND Sports podcast is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. https://notredame.rivals.com/sign_up?promo_code=NDPOD Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

On this week's edition of "Football Never Sleeps" on YouTube, Eric Hansen and Tyler James discussed Notre Dame's offensive progress shown against Stanford, more big injury news from head coach Marcus Freeman's Monday press conference and the latest in recruiting for the Irish. They answered questions from viewers, too. Football Never Sleeps is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Next week's "Football Never Sleeps" will be live on Monday at 7 p.m. EDT. Want to watch "Football Never Sleeps" on YouTube? Visit here: www.youtube.com/c/InsideNDSports

Former Notre Dame offensive lineman Bob Morton (2002-06) discusses his experience watching Notre Dame this season, the priorities for ND's offensive line during the bye week, if offensive tackles Aamil Wagner and Anthonie Knapp's physical limitations are hindering them in pass protection, what should happen when right guard Billy Schrauth returns, if Knapp should stay at left tackle the season, how Pat Coogan has performed at center, what's plaguing ND's run defense, what mattered most about ND's win over Louisville, how confident Morton is in quarterback Riley Leonard's continued improvement, if this team can make the College Football Playoff and more. Then Eric Hansen and Tyler James answer questions from Twitter and The Insider Lounge (30:01). Morton is cohosting "Into the eNDzone" on YouTube for Inside ND Sports after Notre Dame road games this season. https://www.youtube.com/playlist?list=PLcxI5O6h4Kn2uF4WLNNqpjlCw5lLRR4Kt The Inside ND Sports podcast is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. https://notredame.rivals.com/sign_up?promo_code=NDPOD Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

On this week's edition of "Football Never Sleeps" on YouTube, Eric Hansen and Tyler James discussed the latest injury updates from Notre Dame, more takeaways from head coach Marcus Freeman's Monday press conference, what's ahead for the Irish in October and a busy week in recruiting while the Irish were idle. They answered questions from viewers, too. Football Never Sleeps is presented by MyBookie. Sign up with promo code INDS to double your first deposit up to $1,000 (100% deposit bonus). Click here to sign up: https://bit.ly/joinwithINDS Next week's "Football Never Sleeps" will be live on Monday at 7 p.m. EDT. Want to watch "Football Never Sleeps" on YouTube? Visit here: www.youtube.com/c/InsideNDSports

Former Notre Dame quarterback Joe Theismann (1968-70) discusses ND's start to the season, what Riley Leonard's been and what he can become as ND's quarterback, a comparison of Leonard and Jayden Daniels, the difference coaching makes at the position, the pressure of playing QB at ND, how he got the attention of ND's coaching staff as a freshman, playing for assistant coach Wally Moore, what he thinks of Marcus Freeman, his dislike for NIL, what receiving the Knute Rockne Spirit of Sports Living Legend Award means to him and more. Then Eric Hansen and Tyler James answer questions from Twitter and The Insider Lounge (34:37). The Inside ND Sports podcast is presented by MyBookIe: https://www.mybookie.ag/ Inside ND Sports content is now on Autograph. Join the Notre Dame community to find us. Use referral code INDS at the link below. https://link.ag.fan/INDS Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. notredame.rivals.com/sign_up?promo_code=NDPOD Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: www.getdrip.com/forms/284599664/submissions/new

Former Notre Dame head coach Charlie Weis Sr. (2005-09) discusses the keys to keeping players locked in for a home opener, evaluating quarterbacks on potential, the value of seeing a transfer quarterback handle a new situation, if he would have enjoyed coaching in the current college football climate, how he watches a game, his connection to defensive coordinator Al Golden, his relationship with head coach Marcus Freeman, how much ND's offensive line can improve, his weight loss journey, his continued ties to South Bend and more. Then Eric Hansen and Tyler James answer questions from Twitter and The Insider Lounge (25:39). Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. notredame.rivals.com/sign_up?promo_code=NDPOD More: Inside ND Sports content is now on Autograph. Join the Notre Dame community to find us. Use referral code INDS at the link below. https://link.ag.fan/INDS Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

Former Notre Dame wide receiver Michael Floyd (2008-11), the program's career leader in receptions, receiving yards and touchdown receptions, discusses playing in the opener as a freshman, why he had success in his first year with the Irish, how to develop chemistry with a quarterback quickly, the loudest college stadium he played in, the differences between the offenses of Charlie Weis and Brian Kelly, how his life has been impacted by his mistakes and the lessons learned from them and more. Then Eric Hansen and Tyler James answer questions from Twitter and The Insider Lounge (16:36). Podcast listeners can sign up for a 30-day free trial of InsideNDSports.com using the code NDPOD at the link below. notredame.rivals.com/sign_up?promo_code=NDPOD More: Inside ND Sports content is now on Autograph. Join the Notre Dame community to find us. Use referral code INDS at the link below. https://link.ag.fan/INDS Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

Carter Karels, who covers Texas A&M for GigEm247, discusses the biggest preseason developments for the Aggies, the fit of quarterback Conner Weigman with offensive coordinator Collin Klein, if A&M has enough running back talent without Rueben Owens, how good A&M's defense is, the biggest question mark on offense for the Aggies, special teams concerns, Kyle Field's atmosphere, how quickly head coach Mike Elko can get things turned around and more. Then Eric Hansen and Tyler James answer questions from Twitter and The Insider Lounge (24:29). Subscribe to InsideNDSports.com through Friday, Aug. 23, with the promo code KICKOFF2024 to receive 60% off the first year of a new annual subscription. Use the link below to take advantage of this deal. https://notredame.rivals.com/sign_up?promo_code=KICKOFF2024 More: Inside ND Sports content is now on Autograph. Join the Notre Dame community to find us. Use referral code INDS at the link below. https://link.ag.fan/INDS Want to receive a daily newsletter from Inside ND Sports? Sign up for free here: https://www.getdrip.com/forms/284599664/submissions/new

Could overcoming addiction be as simple as taking a pill?And what if psychedelics could be our gateway into healing mental health and obesity struggles?Today's conversation is nothing short of fascinating.Join me and special guest Mark Haden and Adi Zuloff-Shani from Clearmind Medicine as we dive deep into the current landscape of psychedelics in the health and wellness space.They share about an incredible new molecule that is currently starting clinical trials and showing promising lasting effects on addiction, depression and obesity.Mark Haden Mark Haden is a trailblazer in the field of psychedelic medicine, currently serving as Director of Clinical Research at Psygen and Adjunct Professor at the University of British Columbia School of Population and Public Health. He was a co-founder and spent 10 years as Executive Director of the renowned Multidisciplinary Association for Psychedelic Studies Canada (MAPS). Haden has dedicated the last 30 years to public education and training on drugs and drug policy, including advising the Health Officers Council of British Columbia on the issues of a regulated market for all currently illegal drugs as well as working with Addiction Services in counselling and supervisory roles. He is a frequent keynote speaker and distinguished author on the issues of drug control policy and psychedelics and was awarded the Queen's Diamond Jubilee Medal for his work on drug policy reform in 2013.Adi Zuloff-Shani, PhD Chief Executive Officer at Clearmind MedicineDr. Adi Zuloff-Shani is a Biomedical Research and Development Executive with a vast experience with over 20 years of strategic and operational leadership in the healthcare industry and a deep understanding of therapeutics development in heavily regulated environments. She has expertise in the Pharmaceutical industry, leading cell and drug development through drug and product development, CMC, non-clinical, all stages of clinical development, as well as clinical development strategies and regulatory (FDA, EMEA, others) interactions, NDAs, leading INDs, as well as parallel EU activities. Dr. Zuloff-Shani holds a Ph.D. in human biology and immunology from Bar-Ilan University, Israel.******************Connect with Clearmind Medicine Team:Facebook: https://www.facebook.com/ClearmindMedicine Twitter: https://twitter.com/ClearmindCMND YouTube: https://www.youtube.com/channel/UCg_JDmUZSqstavsbd3zYmmg Instagram: https://www.instagram.com/clearmindmed/ LinkedIn: https://ca.linkedin.com/company/clearmind-medicine ******************➠ Discover the unique ROOT CAUSE that is keeping you stuck on the sugar rollercoaster every year. Take the QUIZ HERE NOW. ➠ Ready to finally kick your emotional eating habit and build a new healthy relationship with sugar from the inside out? Say goodbye to late night snacking and stress eating for good. Get immediate access to my exclusive and FREE Kick Emotional Eating 3 Part Training here. ➠  Want to stay connected and work with Dani during her year off? Come join us in the Sugar Freedom Collective Monthly Community HERE.   ******************Come hang out with me and keep the conversation going on social media:Instagram: https://www.instagram.com/danielleda

みそじょw-inds.部初の公開収録。（ただ三人で推しの話をしているのを垂れ流してるだけです

I denne uges episode af Det Kommer An På tager jeg hul på makrofordeling og udregning af kalorier. Vi kan bruge denne udregning til både at tabe os og tage på - og selvom det lyder meget komplekst, så er det faktisk relativt simpelt. Udregninger: Eksemplet er ved en mand på 80 kg - Brug din egen vægt for at udregne dit eget ligevægtstal. Find dit hvilestofskifte: 80*22 = 1760 (Indsæt din vægt i stedet for 80) Find dit ligevægtsindtag: 1760*1,5 = 2640 (Gang med 1,3-2,2 alt efter hvor aktiv du er) Protein: 1,6-2,2 gram protein pr. kg. kropsvægt Fedt: 25-35% af dit daglige kalorieindtag Kulhydrat: Resten af dine kalorier Musik: Fabian Thorgersen Instagram: @tyrenferdinand

Ultra Deep Picasso v. Dynamic Inds.

TWO Gene therapy INDs approved in the past week! JAG201 for SHANK3 https://pmsf.org/breaking-news-from-jaguar-gene-therapy/ ETX101 for SCN1A https://encoded.com/press-releases/encoded-therapeutics-announces-us-ind-clearance-and-australian-cta-approval-for-dravet-syndrome-gene-therapy-candidate-etx101/    Mike's Gene Therapy Cheat Sheet https://docs.google.com/spreadsheets/d/1jwH5piRH9gOmylz-pCNd_DFnpEHJ6EkFyoaMjidBk6c/edit?usp=sharing    TAKE THE ROCHESTER SURVEY https://redcap.link/NDDCaregiverSurvey    SPRINT FOR SYNGAP24 is on! https://Syngap.Fund/Sprint24   APARITO ANNOUNCEMENT LI - https://www.linkedin.com/feed/update/urn:li:share:7157828674245783552/ X - https://x.com/cureSYNGAP1/status/1751969751621046667 FB - https://www.facebook.com/cureSYNGAP1/posts/pfbid07mabzGJhcZZZkm3vUy9EkZutAtTL16y4gytED52Xyzjayp3ew62zEXiDA8aEsuYWl   This is the program: https://www.aparito.com/patient-group-programme/   RAVICTI GROUP https://www.facebook.com/groups/butyrate/   Give all three of our podcasts 5 stars everywhere.   https://podcasts.apple.com/us/channel/syngap1-podcasts-by-srf/id6464522917    This is a podcast subscribe! https://podcasts.apple.com/us/podcast/syngap10-weekly-10-minute-updates-on-syngap1/id1560389818 Episode 132 of #Syngap10 - February 6, 2024 #epilepsy #autism #intellectualdisability #id #anxiety #raredisease #epilepsyawareness #autismawareness #rarediseaseresearch #SynGAPResearchFund #CareAboutRare #PatientAdvocacy #GCchat #Neurology #GeneChat

Regulatory affairs teams have an outsized impact on business revenue, bringing new products to market quickly, managing registrations and licenses to keep products on the market, and staying updated on changing standards and regulations that might impact market clearance. Yet most regulatory affairs teams are treated primarily as operational cost-centers, resulting in poor productivity measurement, unclear objectives, and limited investments in people and technology.       During this podcast episode, we'll discuss why medtech companies should invest in their regulatory teams  Who is James Gianoutsos?  James Gianoutsos is the Founder & CEO of Rimsys Regulatory Management Software, a cloud-based solution to digitize, automate, and create regulatory order for MedTech companies. James is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. His professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. James also has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, MDR, MDSAP, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link James Gianoutsos LinkedIn:  https://www.linkedin.com/in/jwgianoutsos/  Rimsys website: https://www.rimsys.io/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Bruce Thompson, CEO of Kincell Bio. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Bruce, covering: The daunting and exciting prospect of launching a CDMO spin-out focused on early-phase companies The challenges and opportunities of pivoting a facility from innovator-owned to CDMO-owned Navigating from technical leader to a first CEO role... and the importance of covering your blind spots Why Bruce is seeing an upturn in the market and the emergence of more diverse opportunities.   Bruce is the CEO of Kincell Bio, bringing over 28 years of experience to his position. Before this, he was Vice President and Technical Lead for the Cell Therapy Franchise at Resilience, Inc., where he helped build the development and GMP manufacturing capabilities and served as a technical advisor internally and externally. He has over 18 years of CMC strategy, product development, and cell therapy manufacturing experience. In his first startup role, he was Vice President of Process Sciences at Lyell Immunopharma, where he was responsible for Process and Analytical Development and tech transfer of processes and methods to a newly built state-of-the-art cGMP facility. Prior to Lyell, Bruce served as the Sr. Director of the Therapeutic Products Program at Fred Hutchinson Cancer Research Center (FHCRC), where he led GMP manufacturing of cell and gene therapy products. He was responsible for supporting >15 active clinical programs and contributed to the filing of 6 INDs for various cell therapy programs. Bruce also spent nearly ten years at Pfizer in the Pharmaceutical Sciences division, and he received his B.A. in Biology, an M.S. in Biochemistry from The Ohio State University, and a Ph.D. in Microbiology and Immunology from the University of Louisville. Please subscribe, tell your industry colleagues, and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital, and content agency helping companies differentiate, get noticed, and grow in life sciences.  

In this episode my guest is Jason Bock PhD.  Jason is the CEO of CTMC / A joint venture between Resilience and MD Anderson Cancer Center. Jason Bock has been in biotech and biopharma for over 20 years, mostly in Biologics development. He founded Ctmc, a technology platform to industrialize cell therapies and bring them into the MD Anderson Clinic. Ctmc is a joint venture between MD Anderson and National Resilience. Ctmc partners with preclinical biotech, MD Anderson faculty, and Factus to provide a capital-efficient model to bring impactful single dose curative treatments to patients. Ctmc has filed three INDs in the first six months since it spun off on novel cell therapies brought into the clinic. Ctmc has progressed on the seven clinical studies that it supports. Ctmc recently announced that it was the recipient of a $9.1 million grant to help develop cell therapy platforms and improved ways of making these cell therapies. Jason is inspired by the patients and patient-centricity. He is concerned about the challenges, logistical and manufacturing challenges with autologous cell therapy. What excites him is the potential to transform healthcare and be single-dose curative treatments.

Endometriosis is a disease which affects more than 11% of American women between the ages of 15 and 44, and yet people haven't been looking at the root cause of endometriosis and how to effectively treat it. On today's episode, Somer Baburek, the CEO and Co-Founder of Hera Biotech talks to us about women's healthcare and how her company is leading the way to find a solution to treat endometriosis and why women's healthcare needs more attention and funding.Key takeaways to listen forCombined physician specialties and its impact on research explorationThe drastic gap in funding for women's healthcareHow to use biopsy analysis in narrowing treatment discovery What's next for endometriosis diagnosis?Today's healthcare system and what makes it an innovation eraThe latest technological way of navigating disease treatment for womxn Resources mentioned in this episodeBruce J. Nicholson, Ph.D.Nameer B. Kirma, Ph.D.About Somer BaburekSomer Baburek is the CEO and Co-Founder of Hera Biotech. Before founding Hera Somer spent seven years with the most significant life science VC Fund in San Antonio, assisting with diligence activities. Somer also served in 2 of the fund's sister companies as the Director of Clinical Operations. During her time with the companies, the clinical program went from a single investigator-initiated IND to 4 open INDs, saw the successful license of a 5  product line to the most prominent industry participant, and successfully managed an End of Phase 2 Meeting with the FDA before the companies acquired for USD 250M. Somer took a short break following the exit, looking for available technology in her field of passion, women's health. After completing diligence on the underlying technology, Somer founded Hera Biotech and began developing the world's first non-surgical, tissue-based test capable of diagnosing and staging endometriosis.Connect with SomerWebsite: Hera BiotechLinkedIn: Hera BiotechInstagram: @HeraBiotechTwitter: @HeraBiotechFacebook: Hera BiotechSupport the show!Want to learn more about us? Visit our website at www.periodtopause.com or send an email to amanda@periodtopause.com.Follow us on Instagram: @periodtopauseFollow our Facebook Page: Period to Pause

De ville lave et statskup i Tyskland. Og de havde detaljerede planer for det nye land, de ville skabe. For eksempel ville de indsætte deres egen regent. Nemlig Heinrich XIII, også kendt som Prins Reuss, en radikaliseret 71-årig mand fra en tysk adelsslægt. Men så langt kom det aldrig. I det her afsnit fortæller journalist på Politikens udlandsredaktion – og tidligere tysklandskorrespondent – Jesper Thobo-Carlsen om ugens tyske drama.

2023 is just around the corner, and it's shaping up to be a big year for Umoja Biopharma. The company is on the leading edge of the effort to break the solid tumor barrier with in vivo CAR T-cell therapies, with one such effort currently enrolling patients for a phase 1 trial. It's planning two more INDs in the coming year.  This episode of the Business of Biotech finds us getting the inside story from Umoja Chief Operating Officer David Fontana, whose storied career includes leadership positions at heavyweights including Sanofi, SeaGen, Pfizer, Juno, and BMS. Fontana shares on how he applies his experience playing a lead role in the success of Breyanzi, Adcetris, Bavencio, and  Relatlimab in his new role at Umoja, the outsourcing battle scars that motivated the company to build its own 146,000 square foot development and manufacturing facility, and much more. 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!

In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA's jurisdiction over IRB's in medical device clinical trials, sponsor obligations for investigator-initiated studies, and compliance for expanded access INDs and for GMPs in the case of hospital manufacturing of cell culture products and 3D printing.

Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

Regulatory landscape is growing increasingly complex with new European Union Medical Device Regulations and In Vitro Diagnostic Regulations. In fact, research from MedTech Europe predicts that as many as 76% of products will be withdrawn from the market as a result and the complexity isn't limited to just our friends in Europe. The US, Australia, Canada, China, and many more countries are adapting their regulatory approach. The only thing that doesn't change is change itself - applies both in life and regulatory.  Today we're going deeper into how to modernize regulatory affairs, specifically for medtech. James Gianoutsos is the Founder & President of RimSys - a regulatory information management platform that centralizes regulatory activities in the cloud. From product documentation to streamlined submissions to monitoring market status, RimSys can save RA teams hours and hours. Any life sciences founder listening in can learn from James's experience jumping into entrepreneurship from his career in Quality/Regulatory and how to get to market faster utilizing digital technologies.  Enjoy!About James GiantoutsosJames Gianoutsos is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James' professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants. James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.About RimsysRimsys was founded in 2017 by regulatory affairs professionals who asked the simple question: “Isn't there a better way to do this?” Like all RA teams, they spent hours looking for information, manually managed global product registrations, and struggled to keep up with changing regulations and standards. The Rimsys Platform is designed specifically to help medtech companies address these challenges, and confidently establish global regulatory compliance.Show noteshttps://www.rimsys.io/Rimsys Series A postJames Giantoutsos LinkedInQualio WebsitePrevious episodes: https://www.qualio.com/from-lab-to-launch-podcastApply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8Music by keldez