Podcasts about IRB

O Minuto TCE é um quadro da Rádio TCE com o noticiário diário do Tribunal.Evento em Harvard (EUA) discutiu os desafios que precisam de maior atenção e que impactam diretamente na saúde das crianças e na saúde mental dos jovens.O conselheiro e presidente do Comitê Técnico da Primeira Infância do IRB, Edson Ferrari fala sobre o assunto.Edição de som: Israel Borsatto Reportagem: Lu Zoccoli

Pour cette deuxième émission enregistrée en marge du cinquième congrès mondial consacré à la drépanocytose, qui se tient à Abuja cette semaine, Priorité Santé propose un coup de projecteur sur les initiatives et programmes mis en œuvre en République Démocratique du Congo. La RDC est, après le Nigeria, le deuxième pays le plus touché par la maladie génétique de l'hémoglobine à l'échelle du continent africain. Depuis 2012, la fondation Pierre Fabre s'est engagée auprès des soignants, de la société civile et des autorités locales impliqués dans la lutte, pour améliorer dépistage et prise en charge des patients. Et nous donnons la parole à ces différents acteurs, pour évaluer les progrès et les défis à relever pour améliorer les conditions de vie des personnes drépanocytaires, et en particulier des enfants, en RDC. Cette émission est réalisée avec le soutien de la Fondation Pierre Fabre.  Nancy Madingo, infirmière du programme PAFOVED/CEFA-MONKOLE et au Centre de recherche IRB-one health dédiée à la drépanocytose Pr Léon Tshilolo, pédiatre hématologue, ancien médecin directeur du Centre hospitalier Monkole de Kinshasa, directeur de l'Institut de Recherche Biomédicale 1-Health, associé au CEFA-Monkole, président du REDAC (Réseau d'Étude de la Drépanocytose en Afrique Centrale) et Co-Chair de Sickle In Africa Consortium et Co-Chair du Veme Global SCD Meeting  Dr Patricia Fotto, médecin de santé publique et directrice du Programme national de lutte contre la drépanocytose, en RDC  Christophe Przybylski, directeur scientifique de la Fondation Pierre Fabre. Découvrez le programme de formation gratuit sur la drépanocytose : e-drépanocytose.  Programmation musicale : ► Inoss'B – Bango kaka te► Adekunle Gold – Sinner.

Pour cette deuxième émission enregistrée en marge du cinquième congrès mondial consacré à la drépanocytose, qui se tient à Abuja cette semaine, Priorité Santé propose un coup de projecteur sur les initiatives et programmes mis en œuvre en République Démocratique du Congo. La RDC est, après le Nigeria, le deuxième pays le plus touché par la maladie génétique de l'hémoglobine à l'échelle du continent africain. Depuis 2012, la fondation Pierre Fabre s'est engagée auprès des soignants, de la société civile et des autorités locales impliqués dans la lutte, pour améliorer dépistage et prise en charge des patients. Et nous donnons la parole à ces différents acteurs, pour évaluer les progrès et les défis à relever pour améliorer les conditions de vie des personnes drépanocytaires, et en particulier des enfants, en RDC. Cette émission est réalisée avec le soutien de la Fondation Pierre Fabre.  Nancy Madingo, infirmière du programme PAFOVED/CEFA-MONKOLE et au Centre de recherche IRB-one health dédiée à la drépanocytose Pr Léon Tshilolo, pédiatre hématologue, ancien médecin directeur du Centre hospitalier Monkole de Kinshasa, directeur de l'Institut de Recherche Biomédicale 1-Health, associé au CEFA-Monkole, président du REDAC (Réseau d'Étude de la Drépanocytose en Afrique Centrale) et Co-Chair de Sickle In Africa Consortium et Co-Chair du Veme Global SCD Meeting  Dr Patricia Fotto, médecin de santé publique et directrice du Programme national de lutte contre la drépanocytose, en RDC  Christophe Przybylski, directeur scientifique de la Fondation Pierre Fabre. Découvrez le programme de formation gratuit sur la drépanocytose : e-drépanocytose.  Programmation musicale : ► Inoss'B – Bango kaka te► Adekunle Gold – Sinner.

Você Sabia é um quadro da Rádio TCE sobre ações envolvendo os TCs. Órgãos de controle fiscalizam escolas para verificar abastecimento de água, saneamento e banheiros. O presidente da Atricon, Edilson Silva e o presidente do IRB, Edilberto Pontes comentam a iniciativa conjunta. Edição de som: Israel Borsatto-Radio TCE-GO Reportagem: Isabella Pesce- Rádio Justiça

El envejecimiento es un proceso continuo y gradual que se inicia a nivel celular y molecular a partir de los 20 ó 30 años. Un estudio de del Instituto de Investigación Biomédica y del Centro de Regulación Genómica ha identificado modificaciones en el código genético relacionadas con el envejecimiento sanguíneo, un hallazgo que allana el camino para detectar enfermedades producidas por la vejez y el desarrollo de nuevas terapias para retrasar el envejecimiento en humanos. Hemos entrevistado a Alejo Rodríguez-Fraticelli, investigador ICREA en el IRB y co-autor del estudio.El pasado sábado, 31 de mayo, la Agencia Espacial Europea conmemoró el bicentenario del nacimiento de Johann Strauss II con un gran concierto en directo que fue transmitido a las estrellas mediante la antena de 35 m de espacio profundo de la ESA en Cebreros (Ávila). La celebración tuvo justo un día después del 50 aniversario de la firma de la Convención que dio lugar al nacimiento de la agencia espacial. Alda Olafsson nos ha informado del hallazgo de grandes concentraciones de microplásticos y micropartículas de caucho en poblaciones coralinas de Cladocora caespitosa en las Islas Columbretes, una reserva marina a 60 km de Castellón. Con testimonios de Diego Kersting, líder del trabajo en el Instituto de Acuicultura Torre de la Sal del CSIC. José Luis Trejo nos ha informado de un estudio en el que ha participado sobre los mecanismos neuronales que nos inducen al sedentarismo y las mejores estrategias para fomentar el ejercicio. Jesús Pérez Gil nos ha hablado de otro estudio, del que es coautor, sobre los poros de Kohn, espacios entre los alvéolos que permiten la comunicación y la redistribución del aire, y su papel en distribución del surfactante pulmonar, una sustancia compleja que evitado el colapso pulmonar y facilita el intercambio gaseoso. Adeline Marcos nos ha informado del proyecto europeo TEXTaiL. Empleará por primera vez tecnologías emergentes clave como la Inteligencia Artificial, la digitalización 3D, o los gemelos digitales, entre otros, para capturar y visualizar las características visibles y no visibles de los objetos arqueológicos textiles. Con testimonios de Aggelos Gkiokas, director de la empresa TechnAI y uno de los socios del proyecto.Escuchar audio

El envejecimiento es un proceso continuo y gradual que se inicia a nivel celular y molecular a partir de los 20 ó 30 años. Un estudio de del Instituto de Investigación Biomédica y del Centro de Regulación Genómica ha identificado modificaciones en el código genético relacionadas con el envejecimiento sanguíneo, un hallazgo que allana el camino para detectar enfermedades producidas por la vejez y el desarrollo de nuevas terapias para retrasar el envejecimiento en humanos. Hemos entrevistado a Alejo Rodríguez-Fraticelli, investigador ICREA en el IRB y co-autor del estudio.El pasado sábado, 31 de mayo, la Agencia Espacial Europea conmemoró el bicentenario del nacimiento de Johann Strauss II con un gran concierto en directo que fue transmitido a las estrellas mediante la antena de 35 m de espacio profundo de la ESA en Cebreros (Ávila). La celebración tuvo justo un día después del 50 aniversario de la firma de la Convención que dio lugar al nacimiento de la agencia espacial. Alda Olafsson nos ha informado del hallazgo de grandes concentraciones de microplásticos y micropartículas de caucho en poblaciones coralinas de Cladocora caespitosa en las Islas Columbretes, una reserva marina a 60 km de Castellón. Con testimonios de Diego Kersting, líder del trabajo en el Instituto de Acuicultura Torre de la Sal del CSIC. José Luis Trejo nos ha informado de un estudio en el que ha participado sobre los mecanismos neuronales que nos inducen al sedentarismo y las mejores estrategias para fomentar el ejercicio. Jesús Pérez Gil nos ha hablado de otro estudio, del que es coautor, sobre los poros de Kohn, espacios entre los alvéolos que permiten la comunicación y la redistribución del aire, y su papel en distribución del surfactante pulmonar, una sustancia compleja que evitado el colapso pulmonar y facilita el intercambio gaseoso. Adeline Marcos nos ha informado del proyecto europeo TEXTaiL. Empleará por primera vez tecnologías emergentes clave como la Inteligencia Artificial, la digitalización 3D, o los gemelos digitales, entre otros, para capturar y visualizar las características visibles y no visibles de los objetos arqueológicos textiles. Con testimonios de Aggelos Gkiokas, director de la empresa TechnAI y uno de los socios del proyecto.Escuchar audio

We hear why consumers should use the courts in preference to the IRB settlement mechanism for injury compensation. All to discuss with Sean Guerin SC, Chair of the Council of The Bar of Ireland.

OB/GYNs are entering the IVF space—but what role should they play?This debate is heating up in fertility medicine, and Dr. Stephanie Kuku, a former OB/GYN surgeon in the NHS and now Chief Knowledge Officer at Conceivable Life Sciences, offers her global, tech-forward perspectiveIn this episode, she talks through:What REIs and OB/GYNs really need from each otherWhere the line is on fertility care qualificationsWhat REI oversight could look like in different countriesHow new tech may expand REI roles (not replace them)How Conceivable is building collaborative care models (including their current 100-patient IRB study)The field is changing. How will REIs lead the way forward?

Doctor's Farmacy with Mark Hyman, MD: Read the notes at at podcastnotes.org. Don't forget to subscribe for free to our newsletter, the top 10 ideas of the week, every Monday --------- Cutting-edge medical advances are unlocking new ways to slow aging and enhance health. Plasmapheresis removes harmful inflammatory molecules, toxins, and cellular waste from plasma, helping to reduce biological aging and improve resilience. Muse cells, a powerful form of stem cell therapy, show promise in regenerating tissue and treating complex conditions like ALS and stroke. And peptides—small, naturally occurring signaling molecules—support healing, immune balance, and cellular repair, offering practical tools for longevity and optimized health. In this episode, I talk with Dr. Darshan Shah, Dr. Adeel Khan, and Dr. Edwin Lee about medical advancements that are the ultimate longevity biohacks. Dr. Darshan Shah is a board-certified surgeon, longevity medicine expert, author, and founder of Next Health—the world's largest Health Optimization and Longevity clinic. He has performed over 20,000 surgical procedures and advised thousands on extending healthspan and lifespan. A prodigy in medicine, Dr. Shah earned his MD at 21 and trained at the Mayo Clinic. He has since launched multiple health ventures, authored a book, and patented medical devices. Committed to ongoing learning, he holds alumni status at Harvard Business School and Singularity University. Dr. Shah is a sought-after speaker on health and longevity. Dr. Adeel Khan, M.D. is a cell and gene therapy specialist with a visionary approach that is changing the way we perceive healthcare worldwide. Khan has cemented his reputation as a regenerative medicine expert and a driven entrepreneur. Dr. Edwin Lee is a board-certified endocrinologist, author, and international speaker specializing in hormonal balance, regenerative, and functional medicine. He founded the Institute for Hormonal Balance in Orlando in 2008 and completed fellowships in Critical Care and Endocrinology at the University of Pittsburgh. Dr. Lee is the lead investigator of an IRB-approved senolytic study exploring compounds like Dasatinib, Quercetin, and Fisetin, and recently published the first human trial using BPC157 for knee pain. He is an assistant professor at the University of Central Florida College of Medicine, co-founder of the Clinical Peptide Society, and founder of SavePeptides.org. His latest book is The Fountain of Youth with Peptides. This episode is brought to you by BIOptimizers. Head to bioptimizers.com/hyman and use code HYMAN10 to save 10%. Full-length episodes can be found here: This Breakthrough Blood Therapy Could Add Years To Your LifeStem Cells & Peptides: The Secret to Reversing Chronic Pain and Aging?How Peptides Enhance Healing and Longevity

Cutting-edge medical advances are unlocking new ways to slow aging and enhance health. Plasmapheresis removes harmful inflammatory molecules, toxins, and cellular waste from plasma, helping to reduce biological aging and improve resilience. Muse cells, a powerful form of stem cell therapy, show promise in regenerating tissue and treating complex conditions like ALS and stroke. And peptides—small, naturally occurring signaling molecules—support healing, immune balance, and cellular repair, offering practical tools for longevity and optimized health. In this episode, I talk with Dr. Darshan Shah, Dr. Adeel Khan, and Dr. Edwin Lee about medical advancements that are the ultimate longevity biohacks. Dr. Darshan Shah is a board-certified surgeon, longevity medicine expert, author, and founder of Next Health—the world's largest Health Optimization and Longevity clinic. He has performed over 20,000 surgical procedures and advised thousands on extending healthspan and lifespan. A prodigy in medicine, Dr. Shah earned his MD at 21 and trained at the Mayo Clinic. He has since launched multiple health ventures, authored a book, and patented medical devices. Committed to ongoing learning, he holds alumni status at Harvard Business School and Singularity University. Dr. Shah is a sought-after speaker on health and longevity. Dr. Adeel Khan, M.D. is a cell and gene therapy specialist with a visionary approach that is changing the way we perceive healthcare worldwide. Khan has cemented his reputation as a regenerative medicine expert and a driven entrepreneur. Dr. Edwin Lee is a board-certified endocrinologist, author, and international speaker specializing in hormonal balance, regenerative, and functional medicine. He founded the Institute for Hormonal Balance in Orlando in 2008 and completed fellowships in Critical Care and Endocrinology at the University of Pittsburgh. Dr. Lee is the lead investigator of an IRB-approved senolytic study exploring compounds like Dasatinib, Quercetin, and Fisetin, and recently published the first human trial using BPC157 for knee pain. He is an assistant professor at the University of Central Florida College of Medicine, co-founder of the Clinical Peptide Society, and founder of SavePeptides.org. His latest book is The Fountain of Youth with Peptides. This episode is brought to you by BIOptimizers. Head to bioptimizers.com/hyman and use code HYMAN10 to save 10%. Full-length episodes can be found here: This Breakthrough Blood Therapy Could Add Years To Your LifeStem Cells & Peptides: The Secret to Reversing Chronic Pain and Aging?How Peptides Enhance Healing and Longevity

Atenção (disclaimer): Os dados aqui apresentados representam minha opinião pessoal.Não são de forma alguma indicações de compra ou venda de ativos no mercado financeiro.IPCA-15: Inflação sobe 0,43% em abril e acumula alta de 5,49% em 12 meseshttps://www.moneytimes.com.br/ipca-15-previa-inflacao-abril-2025-visp/CSN avança contra IRB na Justiça e pede mais do que vale a companhiahttps://www1.folha.uol.com.br/colunas/painelsa/2025/04/csn-avanca-contra-irb-na-justica-e-pede-mais-do-que-vale-a-companhia.shtmlNeoenergia (NEOE3) vende 50% da Itabapoana Transmissão de Energiahttps://financenews.com.br/2025/04/neoenergia-neoe3-vende-50-da-itabapoana-transmissao-de-energia/OPA do Carrefour (CRFB3): de ‘virada', acionistas aprovam saída da empresa da bolsa brasileirahttps://www.seudinheiro.com/2025/empresas/opa-do-carrefour-crfb3-de-virada-acionistas-aprovam-saida-da-empresa-da-bolsa-brasileira-mabe/Família Dubrule chama de "chicana" acusação da Toky e mantém OPAhttps://pipelinevalor.globo.com/negocios/noticia/familia-dubrule-rebate-chicana-da-toky-e-mantem-opa.ghtmlA disputa pela Toky escala e chega ao Cade e à Justiçahttps://neofeed.com.br/negocios/a-disputa-pela-toky-escala-e-chega-ao-cade-e-a-justica/EXCLUSIVO: Transformação da Casas Bahia está quase na metade, diz CEOhttps://www.infomoney.com.br/business/exclusivo-transformacao-da-casas-bahia-esta-quase-na-metade-diz-ceo/Azul (AZUL4) levanta R$ 1,66 bilhão em oferta de açõeshttps://www.moneytimes.com.br/azul-azul4-levanta-r-166-bilhao-em-oferta-de-acoes-lmrs/XP comunica vazamento de dados de clientes e faz alerta para contatos suspeitoshttps://www1.folha.uol.com.br/mercado/2025/04/xp-comunica-vazamento-de-dados-de-clientes-e-faz-alerta-para-contatos-suspeitos.shtmlNúmero de passageiros transportados da Azul cresce 9,3% no 1º tri ante 1º tri de 2024https://istoedinheiro.com.br/numero-de-passageiros-transportados-da-azul-cresce-93-no-1o-tri-ante-1o-tri-de-2024-2/Special Coverage from Marketplace: Selling Americahttps://podcasts.apple.com/br/podcast/special-coverage-from-marketplace-selling-america/id201853034?i=1000704227996What the U.S. is offering and demanding in latest Ukraine ceasefire proposalhttps://podcasts.apple.com/br/podcast/what-the-u-s-is-offering-and-demanding-in-latest/id78304589?i=1000704652262What an Iowa Farmer Fears About the Trade Warhttps://podcasts.apple.com/br/podcast/what-an-iowa-farmer-fears-about-the-trade-war/id1200361736?i=1000704713254

"Tas bija garš un ļoti aizraujošs ceļš līdz instrumenta pilnīgai skaņas un arī izskata atgūšanai, ko mēs pašreiz svinam ar pirmo festivālu," teic vokālās grupas "Putni vadītāja un Liepājas Lutera baznīcas "Hammond" ērģeļu atjaunošanas projekta vadītāja Antra Dreģe. "Klasikā" līdz ar Antru uz sarunu aicināta arī komponiste MADARA PĒTERSONE, kura rūpējas par festivāla programmu un koncertiem. Festivāla atklāšanas koncertā otrdien, 29. aprīlī, uzstāsies "Hammond" ērģeļu trio "VAS | BUKOWSKI | SZMAŃDA" no Polijas, kura sastāvā muzicē džeza mākslinieki Ādams Bencs Vāšs (Adam Bence Vas, Hammond ērģeles), Dominiks Bukovskis (Dominik Bukowski, vibrofons) un Kržistofs Šžimanda (Krzysztof Szmańda, bungas). Programmā skanēs Ādama Benca Vāša kompozīcijas. Šis un turpmākie festivāla koncerti klausītājiem atklās ne tikai "Hammond" elektrisko ērģeļu atjaunoto skanējumu, bet arī paplašinās priekšstatu par šī leģendārā instrumenta muzikālajām iespējām un integrāciju dažādos instrumentālajos sastāvos. Tie ļaus ielūkoties arī šī instrumenta vēstures lappusēs. Jā, Liepājas Lutera baznīcas "Hammond" ērģeļu vienreizējo dzīvesstāstu, tāpat kā cilvēka dzīvi, pavada tik daudz niansētu detaļu. Liepājas "Hammond" ir unikāls VEF ražots eksemplārs, ko Liepājas Lutera baznīcai dāvājis Kārlis Ulmanis, to iegādei viņš ziedoja 10 000 latu. Instrumentu uzstādīja 1937., bet iesvētīja 1938. gadā. Instruments, kas vēl šī gadsimta sākumā skanēja dievkalpojumos un koncertos, vairāk nekā 15 gadus nebija darba kārtībā. Tomēr fakts, ka arī mūsu valstī reiz ražots šis kulta instruments, izraisīja lielu rezonansi un interesi Latvijas mūziķu aprindās. 2021. gadā radās ideja šo īpašo instrumentu atjaunot. Restaurācijas projektu vadīt uzņēmās producente Antra Dreģe kopā ar virtuozo džeza pianistu, "Hammond" ērģelnieku un jauno džeza mūziķu skolotāju Ati Andersonu. Ērģeļu restaurācija ilga četrus gadus, procesā piedalījās meistari no Latvijas un Nīderlandes - Vitālijs Aišpurs (Latvija), Ganderts de Bo (Nīderlande), Liepājas Restaurācijas centra speciālisti Ivars Pilips un Didzis Jurkovskis. Hammond svinēšana Ieva Zeidmane: Antra, jūs par Liepājas baznīcā esošajām "Hammond" ērģelēm uzzinājāt pirms dažiem gadiem. Kopš tā laika ērģeles ir ieskandinātas, notikuši koncerti, pievēršot uzmanību šim instrumentam un arī vācot līdzekļus tā atjaunošanai. Visupirms mazliet atgādiniet, kā veicies ar restaurāciju! Antra Dreģe: Tas bija garš un ļoti aizraujošs ceļš līdz instrumenta pilnīgai skaņas un arī izskata atgūšanai, ko mēs pašreiz svinam ar pirmo festivālu. Līdz tam bija neliela ieskriešanās ar koncertiem, lai vienkārši saprastu un testētu instrumentu, kas ir pilnīgi normāla lieta tādam sen klusējošam instrumentam – viss kas var pēkšņi atklāties un izlīst ārā, un tā arī bija: ar restauratoriem tikāmies vairākas reizes, lai sasniegtu ideālo skanējumu, un ceram, ka tas arī tagad kādu laiku labi turēsies, gādīgu roku pieskatīts un gādīgu roku regulāri spēlēts, kas instrumentam ir pats svarīgākais! Bet tas viss sākās diezgan sen, pat senāk nekā pati restaurācija. Vismaz pāris gadu garumā tika vākta informācija un noskaidrots, kas, kā un kāpēc, un 2021. gada nogalē notika pirmie koncerti, kas bija veltīti "Hammond" ērģeļu atjaunošanai, kur mūsu kontā ienāca arī pirmie ziedojumi, par kuriem varējām sākt veikt izpētes darbu. Pēc tam arī pieslēdzās fondi ar atbalstu, un lielu paldies sakām gan Kultūrkapitāla fonda kultūras mantojuma nozarei, gan arī Latviešu fondam un, protams, Liepājas Kultūras pārvaldei, kura mūs ir nemitīgi atbalstījusi šajā ceļā, un man tiešām ir liels prieks un lepnums, ka liepājnieki parūpējušies par savu instrumentu tā, lai tas atkal varētu būt mūsu ikdienā. Instruments baznīcā skanējis vēl divtūkstošo gadu sākumā, dievkalpojumos. Jā, tas apklusa 2006. gadā, un tad jau neatgriezeniski. Domāju, ka liela vaina bija tajā, ka nav pārāk daudz speciālistu, kas varētu strādāt ar senajām lampu tehnikām, ar tādu analogo instrumentu un saprast šos mehānismus – kā tiem jāstrādā. Arī man bija liels izaicinājums, kamēr atradu Vitāliju Aišpuru, kas mums palīdzēja savienot vadus un saprast, ka instruments varētu skanēt un ir vērts tālāk plānot un izvērst restaurācijas darbus. Tā kā tā nav tāda pavisam vienkārša lieta. Bet to, ka šis ir īpašs instruments, liepājnieki paši zināja un nojauta? Trūka vienkārši uzņēmības un līdzekļu atjaunošanai? Bieži vien jau tās lietas, kas ir tieši tev blakus, tu īsti nenovērtē, nepēti un nesaproti… Man bail pat domāt, cik daudz vērtīgu lietu aizgājušas zudībā tāpēc, ka nav pietiekošas informācijas un cilvēki nav iedziļinājušies. No apmēram desmit savulaik VEF ražotajiem Hammond instrumentiem pašreiz zinām par trim. Kas notika ar pārējiem? Visticamāk, tos sagaidīja bēdīgāks liktenis nekā šos trīs, kas pašreiz ir apskatāmi. Cik tālu šobrīd ir instrumenta restaurēšanas process? Vai pilnīgi pabeigts? Bija vēl nedaudz jāpameklē kaut kas instrumenta noformējumam – Ādolfa Irbītes darinātajiem jaukajiem skapīšiem, kuros var ievietot eļļu, ar ko instruments jāeļļo, lai tas skan un lai visi mehānismi ir kārtībā. Arī shēmas tajos glabājas. Atslēgas bija pazudušas, un slēdzenes salauztas. Ilgi un pamatīgi kopā ar Liepājas restaurācijas centra speciālistiem meklējam atslēgas, un burtiski pirms nedēļas izdevās atrast 1936. gadā ražotās atslēgas – turklāt tieši tā paša ražotāja, kas ražojis oriģinālās atslēgas "Hammond" ērģelēm! Pašreiz jau slēdzene ir Liepājā, un ceru, ka uz atklāšanas koncertu jau varēsim skapīšus slēgt ciet un vaļā, likt eļļu un rādīt sanākušajiem, kā tas viss skaisti izskatās. Bet tomēr vēl kādi ziedojumi ir vajadzīgi? Jā, šobrīd esam ceļā uz nākamo posmu. Restaurācija ir noslēgusies, bet nepieciešami ziedojumi, lai uzturētu šo instrumentu, jo ik pa laikam profilaksei kādas lietas jāpadara, un – ja pēkšņi vajadzīgi lielāki remontdarbi, tad atkal jāsauc restaurators no Nīderlandes un jāveic apjomīgāki darbi, kas ir finansiāli ietilpīgāki. Bet pašreiz… Materiālu ir ļoti daudz, esam visu safilmējuši, visu sarakstījuši par to, kas un kā ar instrumentu noticis restaurācijas procesā, taču docents Vitālijs Aišpurs vēl joprojām arhīvos meklē vēsturiskās liecības par ražošanas faktu šeit, VEF. Informācija ir ļoti, ļoti skopa, bet ceram, ka šis milzīgais darbs arhīvos nesīs kaut kādus rezultātus, tādēļ domājam, ka būtu vērts organizēt Baltijā vienīgo "Hammond" ērģeļu muzeju – tādu ekspozīciju ap instrumentu. Festivāla atklāšanā jau varēsim to prezentēt: divās valodās ir nofilmētas videoekskursijas, un cilvēki, kas atbrauks uz Liepāju, sešās minūtēs varēs noklausīties informāciju par "Hammond" vēsturi: instruments nofilmēts gan no ārpuses, gan no iekšpuses ar visiem komentāriem, lai saprastu tā darbības mehānismu un unikalitāti. Unikalitāte ir arī dāvināšanas fakts? Jā, mūsu valsts kādreizējais vadītājs Kārlis Ulmanis bija tiešām devīgs un atsaucīgs pret draudzes vajadzībām un ziedoja 10000 latus, lai šo instrumentu varētu iegādāties, un tas arī, man liekas, ir tāds unikāls fakts – ka valsts amatpersona ir tik ļoti ieinteresēta savas tautas un savas rūpnīcas ražojuma nodošanā draudzes un cilvēku vajadzībām. Tas man liekas ļoti simpātiski un arī simboliski. Plāksne par dāvinājuma faktu piestiprināta pie ērģelēm. Ceru, ka Latvijā nezudīs tie mecenāti, kas vēl joprojām spēj kultūrai un kultūras mantojumam veltīt līdzekļus un palīdzēt tam dzīvot tālāk. Madara, kāda jums kā komponistei šķiet šī instrumenta skaņa? Madara Pētersone: Noteikti autentiska, specifiska. Šis ir tas specifiskais gadījums, ka "Hammond" ērģeles atrodas baznīcā – šajā kontekstā ir interesanti, ka tas atrodas tik ļoti akustiskā telpā, jo džeza kontekstā tam vairāk ir matēts skanējums. Man pašai vēl ir tur ko klausīties un iepazīt! Tas ir autentisks instruments, kura skaņa ir maksimāli atjaunota un cik vien iespējams – atbilstoša instrumentam. Tā visiem ir vienkārši lieliska iespēja dzīvē dzirdēt šo instrumentu, kas neatrodas muzejā aiz slēgtām durtiņām vai aiz lentes, bet to tiešām ir iespējams dzirdēt dzīvajā, un tas ir visunikālākais fakts šī instrumenta sakarā. "Hammond" ērģeļu spēles lietpratējs Atis Andersons atzinis, ka uz šim instrumentam piestāv dažnedažāds repertuārs, sākot ar pavisam akadēmisku klasiku, varbūt pat Bahu, kas baznīcai piestāv, un beidzot ar džezu. Kā jums šķiet? Droši vien, ka piekrītu. Es arī ar komponistes un skaņu pasaules redzējumu redzu, kā to var integrēt netipiskākos, bet pārsteidzoši labi skanošos sastāvos. Tur ir, ko izmantot, mēģināt un atrast – jaunus salikumus. Pat tādus, kuri nav tipiski un nav īstenojušies.  Vairāk – ierakstā.

O Anota Aí é um quadro da Rádio TCE com informações sobre novidades nos TCs. O TCE-GO, em parceria com o IRB e Sercon, promoveu o Ouvidoria Day, evento exclusivo para o público feminino em comemoração ao Mês da Mulher.A conselheira do TCE-GO, Carla Santillo; a desembargadora do TJ-GO, Alice Teles de Oliveira; a procuradora do MPC-GO, Maísa de Casto, e a 3º sargento, Michelly Leite, que atua no Tribunal, foram algumas das que abordaram o tema sobre os desafios que as mulheres enfrentam no ambiente profissional.Edição de som: Israel Borsatto Reportagem: Lu Zoccoli

Dean's Chat hosts, Drs. Jensen and Richey, welcome Dr. Gerit D. Mulder to the podcast!  Dr. Mulder gave Dr. Jensen an opportunity to join his practice at the Wound Healing Institute after residency, providing a tremendous foundation for future research that included the National Institutes of Health, and Department of Defense opportunities.  Dr. Mulder has a storied history in podiatric medical research in the wound care space.  He received his BS at University of Redlands; a masters degree from Cal State - San Bernadino, then received his DPM from the College of Podiatric Medicine. He received his PhD from Chulalongkorn University through University of California San Diego specializing in Biomedical Sciences/Stem Cells.  Gerit speaks 5 languages and has taught wound care, and implemented wound care programs around the world.  Tune in for a fabulous interview! Below is a brief history of Dr. Mulder's activities and qualifications: • Extensive expertise in the development, implementation and management of clinical trials, clinical operations and teams.  Experience as a lead Principal Investigator interacting with and guiding multicenter trials.  Direct interaction with the FDA, Pharmaceutical Industry and Academic Research Centers.  Focus on Inflammatory Diseases, Dermatology and Infectious Disease.  • Responsible for development and oversight than 120 clinical trials. • Supervised, educated, and guided research teams globally. • Developed project budgets, protocols, guidelines, and implementation plans for developing wound clinics. • Provided strategic and tactical input to the medical industry related to clinical trials with emphasis on Phase 1,2 and 3 studies.  • Created tissue and wound repair programs to increase product understanding to assist Emerging Markets. Additional Expertise and Affiliations Include: • Understanding of Regulatory Affairs. • International experience with monitoring and overseeing clinical trials. • Served as a national and international  • Provided input on new product development for novel disease states.  • Conversational skills in English, Spanish, Italian, French, and German • Extensive experience with KOLs and medical advisory boards. Physician at Christus St. Vincent Medical Center, Wound & Hyperbaric Center. December 2021 to current. • Provide advanced clinical care for chronic wounds of all etiologies including diabetic, venous, pressure, trauma and other wounds. • Direct wound and tissue repair and regeneration research Medical Research Consultant – Independent 2019 – current Clinical Tissue Repair and Regeneration Specialist – 2019-current • Consult internationally on Phase 1,2, and 3 clinical trials • Provide input for development and implementation of clinical trials and educational materials for health care providers related to phase 1, 2 and 3 studies as well as approved products. • Provide clinical care to patients with acute and chronic wounds of all etiologies Director, Professor of Surgery and Orthopedics University of California San Diego Medical Center, Wound Treatment and Research Center   April 1998- December 2013 •  Provided clinical and surgical care, conducted medical student, resident and staff education, oversaw clinical research.  Treated more than 3000 patients per year.  Published in peer reviewed medical journals and key presenter at medical conferences globally. • Oversaw research within my division of the Department of Trauma, with focus on tissue regeneration and repair, inflammatory and infectious related diseases and cell regeneration. June 1986-April 1998: President of WCI (Wound Consultants Inc., previously Wound Healing Institute)    WCI offered consulting services to the biotechnology and pharmaceutical industry related to clinical protocols and trials, implementation of related patient care, planning and managing medical education.  Advised on development of new products related to tissue regeneration and repair. Patient Care    Vice President of Marketing and Medical Affairs DermaRx  May 1995- March 1998 Vice President of Clinical and Regulatory Affairs Organogenesis, Inc.   May 1994-May 1995     Wound Clinic Director Veterans Administration Hospital Denver June 1983- Jne 1992 FDA Experience: • Participated as an advisor to the FDA and companies working with the FDA • Completed and submitted 510k for hydrogel, foam, and other wound treatment devices • Completed clinical section of PMA submission on Apligraf for Organogenesis • Consulted as wound care expert on panels for medical and pharmaceutical industry. • Chaired Human Subjects Committee in Denver for two years for a major IRB. • Interacted with FDA on Dermatology and Inflammatory Diesease Dr. Mulder can be reached at (619) 417-9249 or at gerit.mulder@gmail.com;  gerit.mulder@stvin.org  or on LinkedIn at http://www.linkedin.com/pub/gerit-mulder/a/321/6b5

"La evolución no merece un episodio en Noosfera, merece dos. Porque no solo es uno de los procesos más interesantes que puede abordar la ciencia, sino uno de esos que puede abordar desde varias perspectivas complementarias e imprescindibles. Por eso, en este episodio hablaremos de una parte más macroscópica de la evolución, cómo actúa en poblaciones y en las especies y dejaremos la genética para el próximo.Para hablar de ello tenemos con nosotros a Toni Gabaldón, que es doctor en biología, especialmente en el estudio de cómo la evolución de los genomas puede explicar adaptaciones y transiciones en diferentes organismos. Actualmente es presidente de la Sociedad Española de Biología Evolutiva, profesor de investigación ICREA afiliado a dos centros de investigación en Barcelona: El Instituto de Investigaciones Biomédicas (IRB) y en el Centro de Supercomputación de Barcelona (BSC)"

O Minuto TCE é um quadro da Rádio TCE com o noticiário diário do Tribunal. Atricon faz parceria com fundação holandesa para fortalecer políticas públicas para a Primeira Infância no Brasil. Os presidentes da Atricon, Edilson Silva e do IRB, Edilberto Pontes falam sobre o assunto. Edição de som: Israel Borsatto, Radio TCE-GO Reportagem: Isabella Pesce, Rádio Justiça

No 2025. gada 1. janvāra spēkā stājušās izmaiņas transporta un sakaru nozares normatīvajos regulējumus. Izmaiņas skars autovadītāju apliecības iegūšanas noteikumus, transportlīdzekļu tehniskās apskates kārtību. Par izmaiņām, kas skārušas automobiļu īpašniekus un vadītājus, interesējamies raidījumā Kā labāk dzīvot. Skaidro Ceļu satiksmes drošības direkcijas pārstāvis Mārtiņš Mālmeisters un drošas satiksmes eksperts Oskars Irbīts. Kādas izmaiņas nepieciešamas transporta nozares regulējumā, vaicājam arī auto žurnālistam, kā pats par sevi saka - satiksmes kritiķim Paulam Timrotam. Viņš vispirms atzinīgi novērtēja prasību reģistrēt velosipēdus un skrejriteņus. "Elektroskrejriteņu obligāta reģistrācija stājās spēkā 2024. gada vasarā. Velosipēdu ieteicama vai obligāta reģistrācija ir divu apstākļu dēļ," norāda Mārtiņš Mālmeisters. "Pirmais, tās ir īpašumtiesības, jo ir zināms, ka velosipēdiem mēdz "pieaugt kājas" un tie mēdz pazust. Attiecīgi tiesībsargājošām iestādēm, atrodot kādu zagtu velosipēdu, ir daudz vieglāk identificēt tā īpašnieku. Tāpat šogad stājas spēkā transportlīdzekļu evakuācija no ātrgaitas ceļiem vai citiem ceļiem, kuri ir pamesti vai ilgstoši stāv. Tas attiecas ne tikai uz velosipēdiem, elektroskrejriteņiem, bet visiem transporta līdzekļiem." Ja ir evakuēts kāds ilgi ceļa malā stāvējis velosipēds, lai to atgūtu, jāpierāda īpašumtiesības.  Savukārt Irbīts piekrīt Timrotam par to, ka uz ceļiem būtu vairāk japatrulē policistiem. Timrots bilst, ka policijā trūkst cilvēku un līdz ar to kārtība uz ceļiem arvien vairāk jūt ārā. "Mums būtu ļoti jāuzspiež uz to, lai būtu vairāk ceļu policijas ekipāžu, un jāatstāj ar tiem radariem šis robostais mērījums, un tas smalkais mērījums jāatstāj cilvēkam, kurš strādā ar radaru. Tāds ir mans priekšlikums," bilst Pauls Timrots. "Es teikšu, ka jautājumā, kas attiecas par dzīvo policistu satiksmē, absolūti viņam piekrītu," atzīst Oskars Irbīts. "Mans personīgais viedoklis ir tāds, ka mūsu sodu sistēma jau ir pietiekoši efektīva, bet vienkārši vajag piemērot. Bet vajag kādu, kas to piemēro. Viens ir tas, ka mums ir dažādi roboti, kas mūs kontrolē, ir dažādi radari, kameras un kas tik vēl nav, bet es vēl joprojām uzskatu, ka nekas tā neiespaido autovadītāju, kā tāda sirsnīga saruna ar policistu, kādu pāris minūšu, un 10 minūšu pastāvēšanu ceļa malā. Ir šis brīdinājums, kas kaut vai izpaužas kā 10 minūšu noraidījums no satiksmes, vienkārši pastāvēt malā, viņš ir daudz efektīvāks nekā kaut kāds naudas sods, kuru vienkārši cilvēks, varbūt nedomājot, samaksā. Un arī citu valstu pieredze viennozīmīgi liecina to, ka šis preventīvais pasākums daudz labāk uzlabo satiksmi. Satiksmē vienkārši braucoša policijas mašīna sniedz desmitreiz labākus rezultātus nekā kaut kāda sodu palielināšana. Ja mūsu mērķis ir tiešām uzlabot satiksmes situāciju, tad ir satiksmē jāatgriež dzīvais policists, jo šobrīd tiešām viņu iztrūkums ir milzīgs, viņi knapi paspēj noformēt negadījumus. Cik man ikdienā, izbraucot uz smagajiem negadījumiem, iznāk runāt ar šiem policistiem, ka viņi ir pārslogoti. Mums vairs nav šīs policijas specializācijas, ceļu policija kā tāda ir likvidēta. Līdz ar to nevar būt tas policijas pilnīgs universālais kareivis. Mēs redzam, igauņi jau uz šī grābekļa uzkāpa, un viņi atjauno ceļu policiju."  

In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHRP, and the need for greater federal agency involvement. They also cover the impact of new guidance, the Trump administration, and the FDA's relationship with IRBs.We discuss: 1. The FDA's Finalized Guidance on Decentralized Clinical Trials (DCTs): The recent FDA guidance formalizing decentralized elements in clinical trials raises critical questions for Institutional Review Boards (IRBs). While DCTs have existed for years, the official guidance now provides a framework for utilizing healthcare providers (HCPs), remote modalities, and flexible patient engagement. IRBs must consider:Approval Implications: How decentralized elements affect risk-based assessments and informed consent.Data Validity: Whether varying patient experiences impact trial control and data integrity.Protocol Design: Increased complexities in evaluating sponsor protocols that integrate hybrid or decentralized approaches.2. Human Research Protection Programs (HRPPs): IRBs are components of broader HRPPs, which also encompass research compliance, conflict of interest management, and quality auditing. Accreditation bodies like AAHRPP (gold standard for HRPPs) demand higher standards, which could necessitate additional adjustments to align with FDA guidance.3. Regulatory Overlap and Harmonization Challenges: IRBs must navigate overlapping jurisdiction from the FDA and other entities like the Office for Human Research Protections (OHRP). The lack of harmonized regulations between these agencies creates confusion for researchers and inefficiencies in clinical trial oversight.4. FDA Audits and Oversight of IRBs: While the FDA does not directly regulate IRBs, it audits them and issues warning letters or Form 483 observations. IRBs must remain vigilant about FDA compliance, especially with decentralized elements becoming more common.5. Decentralization's Efficiency Debate: There is no blanket conclusion about whether decentralized trials increase efficiency or diversity. IRBs must assess the appropriateness of decentralized approaches on a case-by-case basis, particularly for complex studies like oncology trials or early-phase research requiring hospital stays.6. Calls for Streamlining Oversight: There is growing discussion about reducing redundancy across regulatory bodies to enhance efficiency and lower costs for patients. However, skepticism remains about whether eliminating overlap would ensure adequate protection for trial participants.7. Future Considerations:Adaptation: IRBs must adapt to increased DCT submissions while maintaining rigorous risk-based evaluations.Consistency: Balancing flexibility in decentralized models with the need for consistent oversight practices.Policy Evolution: Ongoing dialogue on whether accrediting bodies like AAHRPP or agencies like OHRP should develop complementary guidance to align with FDA standards.In 2024, IRBs face a critical moment to address these challenges while ensuring that decentralized innovations do not compromise participant safety or trial integrity.Support the show

Patrick Geoghegan chats to Prof Diarmaid Ferriter on how Ireland was transformed over the past 25 years, as told in his new book The Revelation of Ireland, 1995-2020; we also hear the untold story of the women on Wall Street and the misogyny they faced, from Paulina Bren's new book She Wolves: The Untold History of Women on Wall Street; and how the IRB changed the course of Irish history, with John O'Beirne Ranelagh.

Host Dr. Davide Soldato and guests Dr. Suzanne George and Liz Salmi discuss their JCO article "Overcoming Systemic Barriers to Make Patient-Partnered Research a Reality" TRANSCRIPT TO COME Dr. Davide Soldato: Hello and welcome to JCO's After Hours, the podcast where we sit down with authors from some of the latest articles published in the Journal of Clinical Oncology. I am your host, Dr. Davide Soldato, Medical Oncologist at Ospedale San Martino in Genoa, Italy. Today, we are joined by JCO authors Liz Salmi, Researcher and Patient Advocate, and by Dr. Suzanne George, who works as a Medical Oncologist at the Dana-Farber Cancer Institute where she acts as the Chief of the Division of Sarcoma. She is also Associate Professor of Medicine at Harvard Medical School. Today, we are going to discuss with Suzanne and with Liz the article titled, “Overcoming Systemic Barriers to Make Patient-Partnered Research a Reality.” So thank you for speaking with us, Suzanne, Liz. Liz Salmi: Thanks for having us. Dr. Suzanne George: Yes, thanks. Dr. Davide Soldato: I just want to make a brief introduction because I think that the concept of patient partner research is very wide and I'm not sure that all of the readers of JCO really have a deep understanding because I imagine that there are a lot of ways we can involve patient and patient advocates in the research process. And so I was wondering if you could give us a little bit of an introduction about the concept. Dr. Suzanne George: Sure. I think the point that you raise is really important because there are many terms that are used, patient-partnered research, patient advocacy, but I don't think that there's a single definition as to what that actually means. In the context of our work, we've sort of summarized our experience through something called the PE-CGS or the Participant Engagement and Cancer Genome Sequencing network. And in that project, which is a Moonshot funded network, the intention is to have participants in research be true partners working with traditional academic research teams in order to develop networks specifically focused on cancer genomics. So what we've done, every center is a little bit different in the network, but we're really having research participants not just act, but really work on the research team from the beginning of the project inception all the way through the research project. Liz Salmi: What brings me to the PE-CGS network is my 17 years experience as a person living with a low grade glioma, brain tumor or brain cancer and involving patients in the co-design of research is super critical because patients bring unique lived experiences that can shape research questions, study designs and outcome measures in ways researchers might not anticipate. And we're finding this through our network. So through my work, including my patient experience and brain tumor focused study designs, I've seen firsthand that patient insights can drive more practical implementations that ultimately benefit both patients and the researchers. And so the particular project I work on in the network, we've got like five different arms and different groups of cancer types that are being represented, so I'm basically focusing on the OPTIMUM study around how brain tumor patients can help in this study design. So in this project I serve as not just a participant in the research, but also as a patient co-investigator. Dr. Davide Soldato: That is very interesting. And I think that we really captured the essence of patient-partnered research by having both of you here talking with us about the PE-CGS. And the second question that I wanted to ask is: I really think that the network focuses on something that is quite important right now and currently in medical oncology - so cancer genome sequencing, access to novel therapies - and I think that it's really challenging to imagine a way in which we can really get our patient and get patient advocates to help us designing new trials who are looking into this. And I just wanted to know, do you think that there is something that is particularly challenging when we are speaking specifically about cancer genomics and access to this type of drugs that are targeting specific molecular alteration? Because I think that in general it might be a little bit easier, maybe I'm biased on this, so you can also tell me if I'm wrong, but I think that it's a little bit easier when we are trying to design, for example, behavioral intervention or things that are more commonly found in oncology and a little bit more complicated when we are speaking about genomics. Dr. Suzanne George: So I think that's part of what this network is trying to address, which is really what are the barriers and the opportunities around cancer genomics from the patient perspective and how do we make sure that that perspective is included as we're thinking about study design and inclusion? As Liz mentioned, this network has five different networks within the network, five different centers, and each center is slightly different with the population that it engages with. And so there's diversity there in terms of reaching out to different patient communities and partner communities around potential barriers for genomics research. I think one of the things though that we're finding across the network is that people want to be part of this work. People that have a lived experience of cancer want to help move the field forward. And what we ended up writing about was some of the barriers that get in the way of that. It's awesome to have people like Liz that are like all in and then there's people who are on the other end of the spectrum that want to share their information to help move the field forward around genomics, but then there's all these barriers at the systems level that get in the way of that. So I think that that's one of the challenges we're trying to overcome and learn about across the network. Liz Salmi: Yeah, I think I bring this really interesting, I can't say I'm really interesting, but I think I bring this really niche perspective. Not only am I a person living with a brain tumor and I'm a co-investigator but also like a participant in this study. I also, in my day job, I'm an investigator as part of the director of communications and patient initiatives on the OpenNotes lab at Beth Israel Deaconess Medical Center. And our lab really focuses on how open, transparent communication between doctors and patients improves care. And that's been going on for longer than I've been around on our team. But what I bring to that lab is I focus on engaging both patients and clinicians in spreading the awareness about the power of how easy access and transparent communication, access to information across healthcare settings helps patients feel more involved and informed in their care.   And I work specifically, it's a really niche area. I work on projects that aim to expand access to notes and test results in diverse care settings, really helping tailoring initiatives so that various patient communities can understand how they can be involved in these types of research projects. Ultimately that's what brought me into this space. I might be one of the first generation of patients that actually starts helping co-design studies on things like this. And I think that across a lot of healthcare settings cancer is really what we're focused on. But patients are now increasingly being involved as research collaborators. And there's many different funding institutions such as the NCI but also PCORI they now mandate that funders reflect a shift towards more patient centered research frameworks. So it's like the PE-CGS network isn't the only group that's being funded to do research in this way. And I think other investigators, even outside of the cancer space, but specifically in cancer, need to learn how to do research in this way. Dr. Suzanne George: Yeah, I agree. And I think the other thing that we need to do is if people want to participate and that participation in many of these networks has to do with record sharing and data sharing, the system needs to accommodate that. If people want to share their information in order to allow research to be performed, then we need to make sure that that can happen, and that it's not that the institution systems don't connect with someone else's systems or that you to pay X, Y and Z dollars for the data to go A, B and C, or that some places are on this EHR and some places are on that EHR and so, sure, you can share it, but you have to go through all of these hurdles in order to make it happen. When a patient signs a consent form that says, “I want my data to be used,” we as an investigator community, we owe it to that patient to make sure that their information is being part of the data set that will be used for learnings. And that's part of what we wrote about, is the lots of behind the scenes things that just get in the way and that we need to work towards improving. Liz Salmi: Both Suzanne and I are really passionate about this stuff. And as a person living with a brain tumor for the last 17 years, I'm a chronic research participant. I always, always, am really curious. I'm like, “Yes, let me contribute my data. Whether that's electronic health record data or maybe I'm being interviewed about certain aspects of the cancer care experience.” And the one thing that bummed me out for like the first 10 years of being this chronic research participant is I would enroll in things, I'd be interviewed for things, I'd fill out these surveys and then I never heard anything about what happened with that information and that time I spent. And people would send me like a $10 gift card to Amazon, like, “Thanks for participating,” but really what I wanted to know is like, did you do anything with that? How did that inform things? So that really annoyed me to the point where I was like, I'm just going to be part of the research process and really figure out how we share that information back to everybody who had spent so much time. And so my participation in this space is like, “Let's change it. Let's give people information back.” And now I know it takes a really long time to have a finding that could be published somewhere that we then get it back. But closing the loop on the communications gap is something I'm really passionate about. Dr. Davide Soldato: Do you think that we are changing a little bit this perspective? I feel like we are getting a little bit better in creating patient communities of patients who are included in specific clinical trials. And then we do the effort of creating a community, of keeping people really involved with the research that they are participating in. I think that we are not quite there yet, but I think that we are making some kind of steps in that direction. For example, trying also to inform patients to participate in the study when the publication that is related to that specific study comes out. What is the benefit? What have we discovered? I think that we are not quite there yet. There is a lot of room for improvement, particularly in the way I think we communicate these to patients who participated in research. But I have the impression that we are making some steps forward. So I don't know. Do you share the same thoughts? Liz Salmi: So Dr. George talked about the PE-CGS network and then there's five different cancer types being studied. So the thing I can reflect on is what we've done in the, this is a really long acronym but, Optimizing Molecular Characterization of Low Grade Glioma. Say that 10 times fast. So our particular group is people who donate tissues about their brain tumors. We're really collecting data from people with multiple brain surgeries over time, which is really complicated and to make that process easier. And then once those tissue samples are stored somewhere, studying that information about what changes in the brain tumors over time and then also giving those results back to people so they can take that research level data and bring it back to their neuro oncology team and say, “Hey. Here's what I found out, “and having a conversation. So, this is a long multi touch point study and in order to do that, to even make that possible is the individual patients need to understand what's in it for them. They're donating precious tissue in order to make the research process work. And so in order to do that, it's not just the investigators saying, “Hey. Give us your brain tissue, peace out.” It is we have a whole research advisory council of people living with these particular tumor types who help us co-design how do we do that outreach, how do we explain why this is important, or how do we message the importance of this work so they understand,“Oh, this is what's in it for me and this is what's in it for other people like me.” And from there then with that process, which again I mentioned, all of these multi-step processes, once we're able to understand how patients want to hear that information, what's in it for them, then we bring it back to like those bench scientists, investigators going, “Okay. And here's how this workflow should work for the patients,” and design everything around the patient experience before we even care about what's happening from the scientist researcher perspective. Dr. Suzanne George: I agree. I think to your point, I think the fact that we're all here today talking about this is just like you said, is that we are making progress, right? Like we're even here having this conversation. Just like you said, I think there's opportunities to improve and further refine the communication and the involvement back in the patient community. When I think- if I put on my clinical investigator hat, I'm very involved in PE-CGS, but my primary research interest historically has been clinical trials and drug development. And I think that our approach in communicating results back has just not been consistent. But I do think that there's opportunities, just like you said, to provide summaries of information to loop back. I don't think that we've completely solved: What do we do? How do we provide information back to loved ones of patients that may no longer be alive that participated? How do we provide information to people who maybe we don't have their contact information? What if we lose track of them? How do we also make sure that we give people the choice to know? Do you want to know about this or would you rather just participate and then give space to that research? Because maybe that's how people's best for them. So I think that you're right, we're making progress, but I think that there's also a lot more that we can do. So I'm glad we're talking about it. Dr. Davide Soldato: How much do you think that directly involving patients in this process, like asking them directly and co-designing the trial from the very beginning and understanding the level of information? This might also be another question inside of the question. So first, how much co-designing this type of research helps, and then do we also need to further refine at that level of communication, different communication depending on the level of information that different people want to have? Because I think that that's another level of complexity that we need to work towards at a certain point. We need to work on that first level of giving back the information. But then I think that there is also the other point of providing the information and information that should also be probably adapted to the cultural belief of different patients, to the ethnicity or to whatever cultural background or social background or whatever they may place their most interest in. Dr. Suzanne George: So I think that you're 100% right on all of those points. I think those are all topics that need to be considered. We may be able to get to a certain degree of granularity around those communication points, but on the other hand, we also want to be able to communicate broadly and accessibly as possible. One of the interesting things about PE-CGS, as Liz was mentioning, is each of the five centers has a slightly different focus. For example, one of the centers is focused on American Indians and Tribal Nations, and the communication practices coming out of that center are really unique and really very special and something that's been really, I think for me, very fascinating to hear about. Because to your point, like, just the strategy and what's considered appropriate is just different. I think if we hope to build a research world where our research participants and research data come from a broad swath of the population that really represents the population, the only way that we're going to be able to do that is find ways that bring meaning across the population as well. And that may be different based on where people are coming from and where people are at in their own journeys and in their own lives. But it's on us to be open to that and like to hear that, so we can do the right thing. Dr. Davide Soldato: And I think that this is one of the objectives of the PE-CGS, really trying to bring this type of research participation to really diverse and underrepresented populations, not only in terms of cultural background, but I also think about different types of tumors. Like Liz was referring about brain cancer or low grade glioma, which is a very niche population. And I also think about sarcomas, for example, the degree of variability that we have in that specific type of disease is such that we really need to probably find different ways to communicate also inside of this diversity in terms of single patient and experiences, but also in terms of single diseases. You were speaking a little bit before about the fact that the manuscript is really on the barriers that we would need to identify and then to change to make this system a reality. We were talking a little bit about consenting information and consenting the sharing of information, and I think that you make a very interesting point about the consent process when we are designing research. Could you give a little bit of your impressions about giving informed consent? What we need to change, how can we improve? Dr. Suzanne George: The bottom line is the consent process needs to be simple, clear, and transparent. And sometimes I feel, because the traditional way that we've always gone about consent is frequently consent is as it should be in many ways. These consent forms are developed from a regulatory framework. What are we required to do to consent and how do we meet those requirements? Sometimes that becomes directly at odds with how do we do this simply, clearly and transparently? And I think as a research community, we have to be able to find a common ground there. That has to include regulatory requirements, that has to include IRBs. When we think about consents and work with our patient communities on this, everybody agrees the consents need to be more simple, except the IRB or maybe the IRB agrees, but it's this tension between how do we make it simple, clear and transparent and not get so bogged down in the regulatory that we lose that intent. Liz Salmi: It's complicated. As a person, I mentioned, I'm a chronic research participant living with a brain tumor for 17 years. I remember enrolling in studies and seeing things that are just so complicated. I'm like, “Well, I'm just going to sign off.” I imagine somewhere somebody who knew more than me said, “I should just fill out this thing.” And then as I switched to the research world, I spent more time digging into, “Wow, this is a really complicated consent,” versus, “This is a really streamlined consent and I love this.” And throughout my work with Dr. George and others on the PE-CGS network, an example of a good consent that's easy for people to understand is what the NIH All Of Us research project did, where they're trying to get a million people, more than that, signed up to be in this longitudinal study. And their consent is to go to their website and they have a whole bunch of short YouTube videos. There's a kind of like a quiz involved and they're animated, they have multiple languages involved. And I signed up for that study and I was like, “This is a beautiful consent.” And it's a very plain language. And more consents like that. If you're looking for a good example, go there. I have not been paid by them in any way. I'm a participant in their study. I'm not sure if you guys and your listeners are aware, but there was I think, October 19th of this year or 2024, there was a special communication published in JAMA on an update on the Helsinki Principles for Medical Research involving human participants. And what they're saying is an ethical update is patient engagement in research, which emphasizes the need for continuous, meaningful engagement with research participants and their communities throughout the research life cycle, before, during and after studies. And so this is what we're talking about here. And it's now been embedded in these updated principles. Dr. Suzanne George: That's really great and I agree with you. I think the All Of Us consent process is very accessible. It feels like you can understand it. But the other thing is that, again, I also am not directly involved with All Of Us, but the other thing about it is that they also have a high-touch way to consent where they have navigators and people that will go into communities in a very resource intensive way. So there's all different ways to go about it. We need to find a way that we can balance the complexity around regulatory and the simplicity and transparency that we need in cancer research. Dr. Davide Soldato: Do you think that in terms of patient engagement we are doing better in academic sponsored research compared to sponsored research? A little bit of a provocative question maybe. Dr. Suzanne George: I think that's a really interesting question. I think this idea of participant engagement and involvement is being infused across the research community. And in part, the FDA has prioritized it as well. I think the industry sees the FDA prioritizing this as well. And I think that there are many companies that are involving participant and advocacy communities in different ways in the study design, in the study process early on. So I think it's happening. Liz Salmi: I'll be spicy. I've been a participant, I've been an investigator, co-investigator on studies and I have been reached out to often by pharma of, “Hey Liz, brain tumor patient advocate, would you be kind of like the poster child of our study or be involved in that way?” And I personally want to have no work in that space. I have no interest. However, I am approached, and other people living with cancer have been approached, by industry about lending their likeness or being commercials. And I don't think there's enough education to patient advocates of what that necessarily means, pros and cons. But I also can't speak on behalf of all of the patient advocates who might want to see that's a way that they could lend their voice and advance research. I personally think that there needs to be more involvement from the academic side of creating spaces where patients can be involved in the co-design of research and they also get compensated for their time fairly at the same level or some version of it in a way so they don't just jump to the pharma side of things. But that's an opinion that I have. Opinions. Dr. Suzanne George: I think it's really interesting the point that you make about providing more awareness or information about what it even means to do these things from a patient side. I certainly don't know that side as well, but I do see, often, the term patient advocate used very frequently in many different contexts that mean many different things. And I think that there's an opportunity there for understanding more about what that really means and what it can mean. Liz Salmi: Yeah. We want to involve patients, we want to do patient engagement. The BMJ or the British Medical Journal, have this new policy in place for patients as reviewers of research. And what I find interesting with the BMJ is they also ask patients to declare their conflicts of interest. So this is kind of a new space. If you're involved in patient research or perhaps working with pharma, patients, if you're involved at that level, should also be declaring their conflicts of interest if they're getting paid by a pharma. Or do I have a conflict now that I'm doing this cool ASCO podcast? Maybe. But do we want to overburden patients with tracking all this information? So it's a new world. The more we have access to information, the more we share information, the more we can read studies and we co-design, there's a new space I think over the next 5 to 10 years where how do we define this in a transparent way. Dr. Suzanne George: Yeah, I think you're right. I know that we're getting long, but I just want to say one other thing about that, which is that you're right. If we're bringing patients in to be partners, then we have to treat each other that way. We have to acknowledge- I think this issue that you raise about compensation and about paying people for their time or acknowledging people for their time, I think that's really important and very under-discussed. Liz and I were at the annual meeting for the PE-CGS and someone was there giving a talk about- this was a guest speaker that was giving a talk about a very large high impact grant and that included a patient advocacy kind of module, let's say. And they put in a specific funding and budget for that component that included compensation for the people- from the people in the advocacy community that were spending their time. And the PI of this project, again, not to get into the details of it, but they were sharing that they got a fair bit of pushback on that. But the PI pushed back and said, “Listen, we're compensating other people for their time. These guys, we want them to be partners, we need to treat them as such.” And I think that also again, kind of we're in a new space, but if we're going to do it right, then we have to acknowledge that we're partners. Dr. Davide Soldato: But I think that maybe an experience like the PE-CGS probably can be also a network for expanding awareness for patient advocates and also for creating sort of a new culture about what does that mean and how can we also improve on that part. Because in the end, if we want to engage, we also need to provide patients with the instruments to engage in a way that we think it's both useful for them, that can make research better, but can also make them at the exact same level as everyone who is participating in that research, which I think it's the bottom line of all the concepts that we are discussing right now. Liz Salmi: Yep. Dr. Suzanne George: Yes, I agree. Dr. Davide Soldato: So I think we have covered a lot of things. Just wanted to make one last reference to a point that Suzanne mentioned earlier, which is the interoperability of systems. And I think that when we come to the cancer genome, that is very important, being able to share information, especially for those diverse and less common cancer types that we were discussing earlier. There is a lot of work in gaining all that information and we need to be able to gather all of that information in the same place to advance research. You were mentioning before that the process is actually very complicated and I was wondering if in the network you are already working on some potential ways to address this type of issue. Dr. Suzanne George: I think our first step is really just calling it out, acknowledging how hard this is and what the barriers are. Oftentimes I think in research, we don't talk enough about what our methodologic barriers are. We talk more about what our results are, but not like how hard it is. But like in our projects, the Count Me In project, my network that I'm involved with, we're doing rare tumors. We can only do the United States and Canada because of privacy issues. And we're doing a completely web based platform. So we have the technology. But the privacy laws are impeding our ability to involve other parts of the world. And even within the United States, it's not as easy as we would like to get records. For example, despite the fact that people are saying, “Yes, use my records.” But then it's like, “Okay. Well, that's not that easy. How are we going to get them?” We had to hire a third party vendor in order to get the records, in order to manage all the different consents and releases that were needed across all these different hospital systems. So I think the first question is just calling it out and then from there working together as a community to try to see what the solutions can be, because we need to come up with those solutions. Liz Salmi: Yeah, we're in the same camp as Dr. George and the fact that of the five partners, we're not associated with one particular institution. So we can reach out around the country and get access to those records. And we need them at multiple points in time, over time and it takes a lot of effort and work. And it's not like you could just, say, call hospital A and they have all the information. It's like all of the calls to all of the other sites. And it's not just from one surgery, it's from two or more surgeries. But also the way that people stay involved, and, by people, I mean patients and family members, there's this promise that at some point you're going to get some sort of information in response. Like, it's the “what's in it for me?” aspect of it. We do interviews with those who've been enrolled in the study, those who could be potential enrollees in the future because they've only had one surgery. And what we're learning overall is there's this altruistic nature that people have of- they want to participate in the research because they're like, “Here's my horrible cancer experience. I know other people are going to go through this as well.” There's this guiding light of “I want to do something, and I'm not going to be the person that creates the cure, discovers the genome or whatever for this particular cancer type. But my little bit of participation in this multiplied by 20, 30, 100, 1000 people, is what is going to lead us to the next phase in development and is going to move the needle for this particular tumor type or other cancer types.” And so what I think the impact in this space and participant engagement isn't just something we figure out, like a little research method and a little finding for one small tumor type, it's like the methods to do that is the big impact. The method around participant engagement can impact even beyond the cancer community. Dr. Davide Soldato: Yeah. As Suzanne was saying, we need to be in a system that really helps us and allows us to do that. So I think that you really have a lot of things to work on inside of the network. Dr. Suzanne George: I think one thing that I would say is I think that this issue of interoperability is acknowledged as a challenge. We refer to several different initiatives across the US where this is supposed to ideally change over time. I think people want it to change over time. I think investigators at the ERTC want it to change over time. I think different countries are working on this. And I think, again, the first step is getting us at the table talking about it, and then figuring out ways to move it forward. And I think it's there. I think that there is the will. We just have to figure out the how and continue to work on that together, because there's just a tremendous opportunity. I live in the rare tumor space, and between the FDA and the EMA and the regulatory, the national and the international research groups, the patient communities, people want this to be solved and I do hope that we will be able to get there. Dr. Davide Soldato: So I would like to thank Liz and Suzanne for joining us today. Dr. Suzanne George: Thanks for having us. Liz Salmi: Thank you. Dr. Davide Soldato: Suzanne, Liz, we appreciate you sharing more on your JCO article titled, “Overcoming Systemic Barriers to Make Patient-Partnered Research a Reality.” If you enjoy our show, please leave us a rating and a review and be sure to come back for another episode. You can find all ASCO shows at asco.org/podcasts.   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.     DISCLOSURES Liz Salmi Speaking Honoria: Medscape. Research Funding (Inst): Abridge AI, Inc., Yosemite. Dr. Suzanne George Honoraria CStone Pharmaceuticals Consulting or Advisory Role Blueprint Medicines, deciphera, Bayer,  Lilly, UpToDate, Research to Practice, MORE Health, Daiichi, Kayothera, Immunicum, BioAtla   Research Funding Blueprint Medicines, Deciphera, Daiichi Sankyo RD Novare, Merck, Eisai, SpringWorks Therapeutics, TRACON Pharma, Theseus Pharmaceuticals, BioAtla, IDRx, NewBay Pharma, Acrivon Therapeutics   Patents, Royalties, Other Intellectual Property Company name: UptoDate Stock and Other Ownership Interests Abbott Laboratories and Pfizer Recipient: An Immediate Family Member

Send us a text - your number will not show, so if you want a response include an emailIn episode #138, I chat with Dr. Todd Fiore about how one slight pivot with your research question can lead to many positive outcomes. Todd is the Program Chair for the PhD in Organizational Development and Leadership, University of Arizona Global Campus.Highlights:·  Research framed positively tends to result in more practical, solutions-oriented outcomes.·  Positive research questions make it easier to recruit participants and encourage openness in data collection because participants may be more willing to engage when research focuses on positive practices rather than negative issues.·  A positive approach can reduce challenges with IRB approval, particularly for sensitive topics like trauma.·  Reframing helps novice researchers avoid injecting personal bias into their work - the dissertation is an academic product, not an advocacy project, and should be balanced and unbiased.·  Focusing solely on problems in research can lead to emotional burnout; positive framing keeps the research journey lighter.·  “Once you replace negative thoughts with positive ones, you'll start having positive results” – a guiding philosophy for research success.Other episodes you don't want to miss:The Dissertation Shift with Dr. Todd Fiore  The 4 H's of Doctoral Success with Dr. Todd FioreHow to Get a Job Teaching Online with Dr. Todd Fiore  You might also enjoy: The Best Dissertation is a DONE Dissertation with Dr. Melanie ShawAcademic Writing as if Readers Matter with Dr. Len CassutoYES!! Keep on creating! https://www.expandyourhappy.com/offers/f9BCgMfF/checkoutSupport the showSupport this free content: https://www.buzzsprout.com/1547113/supporters/new Get The Happy Doc Student Handbook: https://www.amazon.com/dp/0578333732Other resources at: http://Expandyourhappy.com Want to make my day? Rate, review, subscribe & share with someone you love.

What drives a seasoned developer from Taiwan to London, and how does one translate a passion for Ruby into groundbreaking projects? Hear from Stan Lo of Shopify's RubyDX team as he shares his captivating journey and his significant impact on the Ruby development landscape. From his essential work on the debug gem and IRB to his current efforts with the Sorbet type checker and Prism parser, Stan delves into the technical intricacies of using C++ for performance and memory management. Gain unique insights into the collaborative decision-making process at Shopify that guided his transition from the Ruby LSP to focusing on Sorbet's integration.We also tackle the hurdles of progressing Ruby's Sorbet parser to Prism and the challenges of maintaining comprehensive Ruby documentation. Discover the importance of community-driven contributions, and how small acts like fixing typos can have a profound impact on the Ruby ecosystem. Experience Stan's personal anecdotes, from climbing adventures to mastering calisthenics, and explore the innovative shift from VS Code to Cursor, amplifying his development experience through AI capabilities. As we gear up for future events like RailsConf and RubyKaigi, there's an air of excitement for community reunions and ongoing projects. Join us for a blend of technical discussion, personal stories, and a call to action for all Ruby enthusiasts.Send us some love.HoneybadgerHoneybadger is an application health monitoring tool built by developers for developers.HoneybadgerHoneybadger is an application health monitoring tool built by developers for developers.Disclaimer: This post contains affiliate links. If you make a purchase, I may receive a commission at no extra cost to you.Support the showReady to start your own podcast?This show is hosted on Buzzsprout and it's awesome, not to mention a Ruby on Rails application. Let Buzzsprout know we sent you and you'll get a $20 Amazon gift card if you sign up for a paid plan, and it helps support our show.

          This show is a special tribute edition to Carole Baggerly. Carole passed October 2024 With, GrassrootsHealth, Carole Baggerly has had the pleasure of helping support a core of 48 initial leading researchers in vitamin D and now, other nutrient researchers. The key implementation innovation in this project is the use of the ‘Field Trial', a formalized methodology, approved by an IRB, used by participating individuals. Currently there are approximately 15,000 participants from all over the world who are helping sponsor the project by testing their vitamin D levels twice a year and answering a health questionnaire to document the outcomes of having vitamin D serum levels in the 40-60 ng/ml (100-150 nmol/L) range. The group has initiated the ‘Nutrient Research Institute' to enable testing and analysis of many nutrients together—to see how they work with each other, which they do. A key focus now is the ability of getting a serum level of children to 40 ng/ml (100 nmol/L) can help prevent major infectious lung diseases and, can help minimize later life diseases as well. A research/field trial publication from GrassrootsHealth showed an 80% reduction in the incidence of breast cancer with a pooled cohort of over 5000 women, from 2 randomized controlled trials and the GrassrootsHealth Field Trial. The group is now working as well on a Type 1 Diabetes Prevention project with the Children with Diabetes Foundation. GrassrootsHealth research with the Medical University of South Carolina showed a 40-60% reduction in the incidence of preterm births by getting the pregnant woman's serum level to at least 40 ng/ml (100 nmol/L).  To find more information: Grassroots Health 

"Dr. Molly Maloof has made it her mission to inspire people to make the right choices and design their unique lifestyle to improve their wellbeing, avoid chronic disease, and radically extend their health span—the length of time in one's life where one is in optimal health free from injury and illness. She believes that lifestyle medicine and personal health technologies will shape the future of health care because they are designed to help individuals achieve the true definition of health: “The ability to adapt and to self-manage, in the face of social, physical and emotional challenges.” The goal is for individuals to move towards physical, mental and social well-being, and not merely the absence of disease and infirmary." Dr. Molly is here today to discuss a range of topics, such as: *relationships and their effect on longevity and healthspan*the relationship between metabolic health and relational health*their latest IRB-approved study to understand the efficacy of our groundbreaking program, the Adamo Method. Order her new book “The Spark Factor” - a breakthrough program for women to revive their lost energy and vitality, developed by a leading biohacker and physician. https://drmolly.co/

Conheça o método SGR através do grupo exclusivo: https://lvnt.app/evowa8 24/10: Bolsa +0,65%, LREN +4%, IRB -7% e Dólar R$ 5,67 Olá, seja bem-vindo a mais um Fechamento de Mercado, comigo Flávio Conde e Ricardo Afonso, e hoje é quinta, dia 24 de outubro, e o programa de hoje é ao Getúlio (Comgás), Aconselvan (Fechado e SGR já deram muitos lucros), RGO, Augusto (SMTO3), Claudinei, Sandro e Franciso Sousa (Luiza Pires ótimo trabalho). O Ibovespa fechou em leve alta de 0,65%, aos 130.067 pontos, com volume ainda fraco de R$ 18 bi, R$ 7 bi abaixo da média de R$ 25 bi das quintas. Por que a Bolsa performou assim? 1º. A bolsa abriu em baixa, como ontem, batendo a mínima às 10h25, aos 128,8 mil pontos, e depois começou a recuperar-se para positivar às 14h e fechar aos 130.067, alta de 0,65%. No Brasil, o Ibovespa abre em queda por conta do 0,54% de IPCA-15 em outubro, acima do 0,50% esperado e o 0,13% de setembro. Entretanto e positivamente, a queda do dólar no mundo e no Brasil, caindo para 5,67 de R$ 5,70, fez os juros futuro recuarem e ações de bancos, varejo e elétricas. E até a Petrobras e Vale subiram mesmo com os preços de petróleo e minério recuando um pouco. 2º. Na B3, 13 ações subiram entre as 15 ações mais negociadas com destaques para: LREN3 4,8% com aumento de capital e bonificação de ações, PRIO3 1,8%, HYPE3 1,5% e B3SA3 1,5%. 3º. Já 2 ações caíram entre as mais negociadas com destaques para: HAPV3 -0,80% em função de uma pequena realização de lucros e SUZB3 -0,30% devido ao recuo do dólar. 4º. O preço do petróleo caiu -0,50%, a US$ 74,7 de US$ 75,2, ontem, dentro do limite da volatilidade diária de -/+2%, e sem novidades. 5º. O minério de ferro alta de 1% para US$ 106,1 de US$ 104,8 por tonelada, como ontem, e sem novidades. 6º. As bolsas americanas apresentaram comportamento misto, 0,70% o Nasdaq e -0,30% o Dow, com investidores comprando muito as ações da Tesla, que subiram 22%, com resultados robustos no 3T24 e, principalmente, com a previsão de Elon Musk de que as vendas de carros podem subir entre 25% e 30% em 2025 versus 15% projetados por analistas. 7º. O dólar à vista caiu 3 centavos, -0,52%, para R$ 5,67 de R$ 5,70, ontem, seguindo o dólar no exterior que recuou -0,39% frente moedas fortes e -0,50% versus moedas emergentes. 8º. O saldo de investimentos estrangeiros no mercado secundário da Bovespa, de ações já em circulação, ficou negativo em R$ 260 milhões na terça-feira, 22 de outubro, conforme dados da B3. No mês de outubro, o saldo acumulado pelos estrangeiros está negativo em R$ 2,8 bilhões. No ano, os estrangeiros tiraram da Bovespa R$ 23,2 bilhões. Os estrangeiros respondem por 58,30% do volume negociado em outubro e por 55,20% do volume no ano. MAIORES ALTAS LREN3 +4.84% R$ 18,83 CVCB3 +4.76% R$ 1,98 COGN3 +4.23% R$ 1,48 MGLU3 +3.61% R$ 9,48 LWSA3 +3.27% R$ 4,42 MAIORES BAIXAS IRBR3 -7.32% R$ 44,22 PCAR3 -2.71% R$ 3,23 BRKM5 -1.69% R$ 17,40 MULT3 -1.30% R$ 25,11 ENEV3 -1.23% R$ 13,66 Conheça a Levante Investimentos: Conheça nossas *Séries de Investimentos*: https://lvnt.app/4q3u3b Acompanhe nosso Instagram:   / levante.investimentos   Fique ligado nas principais notícas do mercado no nosso canal no Telegram: https://lvnt.app/zuntm0

Conheça o método SGR através do grupo exclusivo: https://lvnt.app/evowa8 23/10: Bolsa -0,55%, IRB +12% e SUZANO -4% Olá, seja bem-vindo a mais um Fechamento de Mercado, comigo Flávio Conde e Ricardo Afonso, e hoje é quarta, dia 23 de outubro, e o programa de hoje é ao Carson, Nicoletti, Gilson, Helson, Joao Marcos (Klabin), Rossi, Lucileidi, Liana, Eliseo, Daniel e Sarkis.O Ibovespa fechou em leve queda de -0,55%, aos 129.951 pontos, com volume muito fraco de R$ 18 bi, R$ 7 bi abaixo da média de R$ 25 bi das terças. Por que a Bolsa performou assim? 1º. A bolsa já abriu em caindo bem, como ontem, batendo a mínima às 11h45, aos 128,6 mil pontos, depois começou a recuperar-se para fechar nos 129.233 pontos, -0,31%. No Brasil, a queda do Ibovespa foi puxada pelas ações de commodities, PETR4 -1,2%, VALE3 -1,7% e PRIO3 -1%, com o petróleo recuando -1% e minério -2%. Caíram varejista também com MGLU3 -1,6%, depois que o Citi reduziu preço-alvo de R$ 18 para R$ 11,50 e pares do setor foram juntas. Só subiu Carrefour (CRFB3), com 5%, depois de desempenho de vendas dos supermercados e atacarejos no 3T24 melhor que o esperado e operação de sales-leaseback de R$ 725 milhões. 2º. Na B3, apenas 6 ações subiram entre as 15 ações mais negociadas com destaques para: HAPV3 +3% com investidores aproveitando as quedas das últimas semanas e expectativa de resultados mais positivos no 3T24, WEGE3 0,50% e ITUB4 0,70%. 3º. Já 9 ações caíram entre as mais negociadas com destaques para: VALE3 -1,8% a R$ 59,36 em função da queda de 2% do minério de ferro e PETR4 -1,2% R$ 35,66 seguindo o recuo do petróleo de -1,2%. 4º. O preço do petróleo caiu 1,1%, a US$ 75,2 de US$ 75,6, ontem, dentro do limite da volatilidade diária de -/+2%, com o aumento da estoque de petróleo em 5,5 milhões de barris nos EUA na semana passada. 5º. O minério de ferro recuou -2% para US$ 104,8 de US$ 107 por tonelada, como ontem, em função de incertezas quanto ao impacto dos novos estímulos monetários na economia chinesa. 6º. As bolsas americanas caíam, -1,60% o Nasdaq e -0,96% o Dow, com investidores na defensiva frente a alta dos juros de 10 anos que subiu pela quarto dia consecutivo, de 4,21% versus 4,25%, ontem, mais alguns resultados decepcionantes com Boing, C oca-Cola e preocupação com demanda fraca por iPhone 16 no trimestre. 7º. O dólar à vista ficou estável em R$ 5,70 e sem novidades. 8º. O saldo de investimentos estrangeiros no mercado secundário da Bovespa, de ações já em circulação, ficou positivo em R$ 490 milhões na segunda-feira, 21 de outubro, conforme dados da B3. No mês de outubro, o saldo acumulado pelos estrangeiros está negativo em R$ 2,6 bilhões. No ano, os estrangeiros tiraram da Bovespa R$ 22,9 bilhões. Os estrangeiros respondem por 58,30% do volume negociado em outubro e por 55,20% do volume no ano. MAIORES ALTAS IRBR3 +12.29% R$ 47,71 CRFB3 +5.24% R$ 7,43 COGN3 +4.41% R$ 1,42 YDUQ3 +4.05% R$ 10,79 HAPV3 +3.25% R$ 3,81 MAIORES BAIXAS HYPE3 -3.91% R$ 27,01 LWSA3 -2.95% R$ 4,28 AZUL4 -2.66% R$ 5,48 VIVA3 -2.55% R$ 24,88 RADL3 -2.41% R$ 24,65 Conheça a Levante Investimentos: Conheça nossas *Séries de Investimentos*: https://lvnt.app/4q3u3b Acompanhe nosso Instagram: https://www.instagram.com/levante.investimentos/ Fique ligado nas principais notícas do mercado no nosso canal no Telegram: https://lvnt.app/zuntm0

Megan Mbengue is the revolutionary force behind Trusted Canna Nurse. With over 10 years of nursing experience in diverse fields like oncology, labor delivery, and hospice care, she brings a unique perspective to her practice. She also holds national certifications in three nursing specialties and a Master of Science degree in Medical Cannabis Therapeutics. Codi Peterson is the Chief Science Officer at The Cannigma and a practicing pharmacist with a passion for cannabis-based medicine. Given his diverse pediatric pharmacy experience and knack for educating, he aims to educate as many as possible about the medicinal potential of cannabis Codi and Megan have launched a new IRB-approved survey through the University of California that aims to better understand the signs, symptoms, and challenges of CHS. They want to understand the key indicators of this condition, hear about any remedies that work, and learn more about navigating healthcare as a CHS patient.  If you or someone you know has suffered from CHS (and are over 18), please take a moment to fill out their survey. Not only will you be helping this vital research, but participants will be entered into a drawing to win one of three $100 gift cards. I've put a link in the show description so it's easy to find.  During our conversation, we discuss:  Overview of CHS symptoms   Early Symptoms and the Prodrome Phase  Clinical experiences treating CHS patients  The Potential Causes   Challenges in diagnosing CHS  Treatment and Abstinence from Cannabis  Thanks to This Episode's Sponsor: Trusted Canna Nurse Trusted Canna Nurse was founded by Megan Mbengue and Ariane Williams, two nurses who are dedicated to bridging the gap between traditional medicine and the world of cannabis and psychedelics. They specialize in creating evidence-based treatment plans for all ages that address chronic illnesses, treatment-resistant conditions, mental health, autism, and more.  Learn more at trustedcannanurse.com  Additional Resources Take the CHS Survey! Cannabinoid Hyperemesis Syndrome What You Need to Know [Video] what-is-chs.com Connect with Megan (Instagram, LinkedIn) Connect with Codi (Instagram, LinkedIn) Submit Your Abstract for CannMed 25 Review the Podcast CannMed Archive

About My Guest: Cory Rice, DO, graduated from Baylor University with a bachelor's degree in forensic science and then completed medical school at the Arizona College of Osteopathic Medicine in Glendale, Arizona. He attended Methodist Medical Center of Dallas for his internship, residency, and chief resident year in internal medicine. He spent two years in outpatient traditional internal medicine (including inpatient work in critical care and hospitalist medicine) before starting Modern Medicine, a network of outpatient practices that provide progressive yet personalized patient care using the most comprehensive lab work and therapies available today. Dr. Rice's professional interests include nutrition-based chronic disease management, thyroid optimization, and bioidentical hormone replacement therapy, or BHRT, for men and women. His clinical expertise is in most areas of chronic disease and, ultimately, the treatment and reversal of some of the more commonly encountered conditions in clinical practice today. He is passionate about helping patients reach their health goals while, in many cases, helping them get off prescription medication. His practice locations are a blend of both functional medicine and lifestyle medicine. Dr. Rice is an expert in the area of advanced bioidentical hormone replacement therapy, including pellet therapy as a Biote Certified Provider having performed over 20,000 procedures himself.  Additionally, he has completed coursework and certifications through the Institute for Functional Medicine (IFM) and the American Academy of Anti-Aging Medicine (A4M). Dr. Rice has served on medical advisory boards and speakers bureaus and has appeared on local and national media discussing healthcare topics like obesity, healthy eating, hormones, thyroid, and autoimmune illness. He is actively involved in educating healthcare providers and trainees on functional medicine, lifestyle medicine, and hormone optimization. Additionally, Dr. Rice has been the Principal Investigator on several IRB-approved case studies involving his clinics and patients. Social Handles: Website Facebook Instagram LinkedIn Summary: In this episode of the Back to the Basics podcast, Dr. Cassie Smith sits down with Dr. Cory Rice to discuss the profound impact of hormone health and functional medicine on overall well-being. Dr. Rice shares his journey from traditional medicine to focusing on preventative care, emphasizing the importance of personalized hormone therapy and how balancing hormones like estrogen, testosterone, and thyroid can dramatically improve energy levels, cognitive function, and quality of life. During the conversation, they explore the role of nutrition, gut health, and detoxification in restoring and maintaining health. Dr. Rice also addresses common misconceptions about hormone therapy, such as fears around cancer and heart disease, and highlights the life-changing benefits patients can experience when hormone levels are optimized. Timestamps: 00:21 Special Guest: Dr. Corey Rice01:25 Dr. Rice's Journey into Medicine04:48 From Law Enforcement to Functional Medicine06:33 What Is Functional Medicine?07:58 Nutrition and Sick Soil Syndrome10:04 Regenerating Health in 30 Days12:46 Impact of Antibiotics on Gut Health14:08 Hormones and Their Role in Health18:22 Customized Hormone Therapy22:05 Factors Affecting Hormone Therapy25:31 Adjusting Hormone Doses29:55 Early Signs of Hormonal Imbalance34:20 Benefits of Hormone Therapy42:00 Debunking Hormone Therapy Myths51:00 Hormone Delivery Methods58:12 Oral Estrogen and Liver Health1:06:00 Growing Need for Hormone Therapy1:10:15 Benefits of Regular Sauna Use1:16:00 Final Thoughts on Hormone Therapy Connect with Modern Endocrine: Check out the ⁠website⁠ Follow Cassie on ⁠Instagram⁠ Follow Cassie on ⁠Facebook⁠ Follow Cassie on ⁠YouTube⁠ Follow Cassie on ⁠TikTok⁠ Sign up for Modern Endocrine's ⁠newsletter⁠ ⁠Disclaimer

In this episode, Istvan Fekete joins us to discuss the intricacies of Congruency Reviews. We will explore the common mistakes individuals may encounter during these reviews and examine effective strategies for handling these errors. Additionally, we will delve into the processes that can be implemented to mitigate risks associated with congruency reviews. The discussion will also cover the potential benefits of involving third-party to ensure the accuracy and integrity of the review process.Points Discussed:•What are the biggest mistakes made in Congruency Reviews?  •What would a CAPA consist of? •Do institutions want to allocate funds for additional quality checks? •Do contracts need IRB congruency checks?•Who should do a Congruency Review?•What errors occur in congruency reviews besides human error?  Support the show

In this episode of WCG Talks Trials, we are joined by host Joanne Thomas, Clinical Reviewer and Patient Advicate at WCG, along with our guest Currien MacDonald, WCG's Medical Chair Director. This episode covers the roles of IRB in ethical clinical research, frequently asked questions, and a general overview of the IRB's role in clinical trials. 

Quer melhorar a performance da sua carteira e minimizar os riscos? Preencha o formulário para participar da pré consultoria com o meu time de especialistas e conhecer a estratégia de maior sucesso da Levante: https://app.pipefy.com/public/form/Jy... 05/09 - Bolsa +0,29%, IRB +6%, ASAI -4% e R$ 5,57 O Ibovespa subiu um pouco, 0,29%, para 136.502 pontos, com volume fraco de R$ 19 bilhões, R$ 6 bilhões abaixo da média de R$ 25 bilhões das quintas. Por que a Bolsa performou assim? 1º. A bolsa ficou o dia inteiro rabiscando para cima e para baixo entre 136 mil e 136,6 mil pontos em dia de volume fraco. A boa notícia do dia foi, finalmente, a queda do dólar em -1,2% influenciado pelo segundo dia de desvalorização da moeda norte-americana versus moedas fortes e emergentes devido a queda das taxas de juros de longo prazo dos EUA. 2º. Na B3, das 15 ações mais negociadas apenas 6 ações caíram: Petrobras ON e PN, PRIO, Equatorial, 3R e Eletrobras. 3º. Nove ações subiram entre as 15 mais negociadas: VALE, Itaú, Bradesco, Embraer, B3, BB, Hapvida, Rumo e JBS. 4º. O preço do petróleo subiu, 0,20%, fechando a US$ 72,7 de US$ 72,2, ontem, dentro do limite da volatilidade diária de -/+2%, e sem novidades. 5º. O preço do minério de ferro caiu -1,6% para US$ 95,6 de US$ 97 por tonelada, ontem, dentro da volatilidade diária de -/+2%, devido a fraqueza do setor imobiliário chinês e nenhuma medida forte para ajudar o setor. 6º. As bolsas americanas foram mistas hoje, 0,25% o Nasdaq e -0,50% Dow Jones. Investidores venderam ações de cias. mais dependentes da economia americana depois da divulgação de que foram criados “apenas” 99 mil empregos no setor privado em agosto quando eram esperado 111 mil empregos. 7º. O dólar à vista finalmente caiu e fechou a R$ 5,57, cinco centavos abaixo dos R$ 5,63, de ontem, em função do segundo dia de desvalorização da moeda norte-americana versus moedas fortes e emergentes. 8º. Nos EUA, os títulos de 10-anos caíram pelo terceiro dia e foram de 3,77% para 3,72% a.a. com os dados mais fracos da geração de empregos no setor privado em agosto. No Brasil, as taxas de juros dos títulos do Tesouro do Brasil recuaram, de novo, seguindo as taxas americanas, com o Prefixado 2031 indo 12,08% para 12,02% a.a., mas ainda estão em nível muito alto. 9º. O saldo de investimentos estrangeiros ficou negativo em R$ 265 milhões na terça-feira, 3 de setembro, conforme dados da B3. Com isso, o saldo acumulado em setembro está negativo em R$ 334 milhões. No ano pelos estrangeiros está negativo em R$ 21,5 bilhões. MAIORES ALTAS IRBR3 +6.14% R$ 51,69 MRVE3 +5.99% R$ 7,79 NTCO3 +3.55% R$ 13,99 CMIN3 +3.31% R$ 5,93 LREN3 +3.15% R$ 18,03 MAIORES BAIXAS ASAI3 -3.91% R$ 9,59 AZUL4 -3.66% R$ 4,74 BEEF3 -2.83% R$ 7,20 BRKM5 -2.29% R$ 18,35 STBP3 -2.22% R$ 13,64 Conheça a Levante Investimentos: Conheça nossas *Séries de Investimentos*: https://lvnt.app/4q3u3b Acompanhe nosso Instagram:   / levante.investimentos   Fique ligado nas principais notícas do mercado no nosso canal no Telegram: https://lvnt.app/zuntm0

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Viral vector manufacturers are facing challenges such as high production expenses, low titers, empty capsids, and limited scalability when producing cell and gene therapies. To overcome these challenges, they are turning to next generation production processes to create a cost-effective and robust AAV manufacturing process. This new approach aims to produce higher titers and full capsids, increase efficiencies resulting from high yields, and drive down the cost per dose. By implementing these strategies, manufacturers can improve the productivity of AAV production and bring promising treatments to the market more effectively.Embecta received FDA approval for its insulin patch pump, featuring a larger insulin reservoir based on feedback from people with type 2 diabetes. Meanwhile, Illumina avoided a fine for its acquisition of Grail in a European court victory. The ARPA-H program will focus on AI degradation in medical tools, while a pathology group is suing to block an FDA lab test rule. Additionally, Medtronic's chief medical officer of acute care and monitoring has departed for a new role.The text discusses various updates in the biopharma industry as of September 3, 2024. It covers topics such as the next challenger to Prevner, advancements in AI drug discovery, concerns over suicide risk of obesity drugs, Recursion's lead drug safety, Vaxcyte's positive data for a pneumococcal vaccine, Sanofi's mixed results in MS drug trials, and the value of digital insights in pharma success.A new study predicts a healthcare labor shortage by 2028, with certain states and specialties facing acute shortages. The study also reveals disparities in fighting medical bills, as uninsured and less educated patients are less likely to question their bills. The ARPA-H program will focus on addressing AI degradation in medical tools. Other updates include tracking healthcare worker strikes and data breaches. The use of technology is transforming healthcare to combat challenges such as workforce shortages and shifting care utilization patterns.FDA Commissioner Dr. Robert Califf is considering reforms to advisory committees, including potentially scrapping expert voting in some circumstances. Califf believes that the discussions within these committees may be more valuable to the FDA than the final vote outcomes. Eliminating voting could help clarify the role of advisory committees. Other potential reforms being discussed include addressing conflicts of interest.The text discusses the importance of getting the Institutional Review Board (IRB) review right the first time and introduces a checklist of critical questions to ask potential IRB partners to ensure a smoother review process. By asking the right questions and choosing the right IRB, the review process can be more efficient and effective.Novo Nordisk's drug Ozempic will continue to face shortages into the fourth quarter due to supply issues, even as the company tries to expand its indication. Astellas Gene Therapies is closing its biomanufacturing facility in San Francisco, affecting about 100 employees and shifting manufacturing to North Carolina.In a landscape where consumers are willing to switch brands to save money, it is crucial for brands to establish and maintain loyalty among shoppers. By leading with value, moving consumers from awareness to loyalty to advocacy, and creating connection and community, brands can build brand love even in the face of economic pressures.The text discusses how emerging oncology innovations have led to more effective therapies for cancer patients. The increased investment in cancer research has introduced new treatments such as cell and gene therapies, antibody drug conjugates, and checkpoint inhibitors. Despite these advancements, the industry still faces challenges in expanding access and improving outcomes.

We speak with Jim Greiner, PhD about his work in researching the outcomes of the justice system, focusing on implementing evidence-based decision making rather than applying precedent. We also explore his ideas on how to make IRB rulings more transparent to help build trust in science. 

In this episode, we hear the remarkable story of Wenora Johnson, a three-time cancer survivor who faced the challenges of job loss, single motherhood, and pursuing an education, all while navigating her diagnoses. Wenora shares her experiences with warmth, humor, and wisdom, offering valuable insights for anyone facing adversity. We delve into the cultural taboos surrounding cancer in her community, the critical role genetics played in her health journey, and why involving loved ones in our health decisions is so essential. Wenora's story goes beyond survival; it's about how she turned her experience into a passion for patient advocacy, making a lasting impact in the cancer community. Key Highlights: 1. Given the significant role genetics play as a risk factor for cancer, it is important to keep your family and loved ones informed.  2. Give yourself grace; you don't have to become a patient advocate fighting for systemic change. It's perfectly okay if your focus is simply on getting through today. 3. Having a supportive healthcare team that genuinely wants to see you succeed is crucial—not only for the effort they'll put forth but also for inspiring you to stay healthy and proactive in your treatment.  Feeling lost in your cancer experience? We've created interactive, disease-specific maps to help you see all the paths you might face. Launching this Fall! Sign up for access here. About our guest: Wenora Johnson is a three-time cancer survivor (Colorectal, Endometrial and Basel Cell Carcinoma), Volunteer Research/Patient Advocate and Navy Veteran. As a volunteer with various organizations, she shares her understanding of policy; research; genetic testing; hereditary cancer; patient engagement and clinical trials with patients and the healthcare community. Being a Lynch Syndrome patient, Wenora advocates for genetic testing and awareness. She serves on various panels and review boards to provide extensive feedback on her role as a patient and research advocate with organizations such as CAP (College of American Pathologist); Clinical Trials Curator for Fight CRC; FORCE (Facing Our Risk of Cancer Empowered) Research Advocate, Peer Navigator and Board Member; a Consumer Reviewer for the DoD Peer Reviewed Cancer Research Program; a PCORI Ambassador and Clinical Trials Panel Member; IRB for local community hospital; NRG Oncology Patient Advocate Committee Member and the AACR Scientist~Survivor Program - presenting a poster on financial toxicities and disparities among minority patients; Center for Genomic Interpretation (CGI) Acceptable Thresholds Committee Board Chair and an External Advisory Board Member for WCG Clinical Services.  She has written various patient advocate blogs and participated as a guest speaker/panelist and serves as the Community Patient Advocate for the University of Chicago Comprehensive Cancer Center and the University of Chicago Cancer Center. Wenora works in administration in the greater Chicagoland area and enjoys reading and traveling with her family. Visit the Manta Cares website  Disclaimer: All content and information provided in connection with Manta Cares is solely intended for informational and educational purposes only.  This content and information is not intended to be a substitute for medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

In this episode, Justin Osborne, Associate Vice President at HRP Consulting Group, shares his 17-year journey in clinical research, focusing on his roles in Institutional Review Boards (IRBs) and HRP's consulting services for universities. Justin also highlights the value of networking and resources for universities. The episode concludes with insights into Justin's experience as a podcast host and his goals for expanding the "On Research" podcast.Justin Osborne is the Associate Vice President of the HRP Consulting Group. He has over 15 years of experience in the human subject research field. He began his research career on the commercial IRB side before shifting to the local IRB world. Justin served as a non-scientific board member at the University of Cincinnati's IRB for several years before returning to the commercial IRB arena. Additional resources: HRP Consulting Group  https://thehrpconsultinggroup.com/  CITI Program's Series – Institutional Review Board (IRB) Administration  https://about.citiprogram.org/series/irb-administration/  CITI Program's Series – Human Subjects Research  https://about.citiprogram.org/series/human-subjects-research-hsr/  

Paul is in Arizona. What's going on? Mayor Keller has big plans to turn downtown Albuquerque around. There are worse ideas than the Baby bond idea being discussed for next year's legislative session.  Paul was in National Review recently with a piece outlining the potential harm Kamala Harris would do to NM's economy. EBON says they'll begin construction on the new solar plant at Mesa del Sol in Q4. Lots still not determined including IRB's. Did Kamala really propose price controls? What would be the impact if implemented? $25,000 for first time home buyers, what could go wrong?  RGF is hosting an event on October on the 3rd with Trent England of Save our States.

In this episode, we discuss review boards for research with human subjects. Are they necessary? Are they efficient? Are scientists well equipped to make judgements about ethics? And are economists more ethical than psychologists?    Shownotes Whitney, S. N. (2015). Balanced ethics review: A guide for institutional review board members. Springer. Schrag, Z. M. (2010). Ethical imperialism: Institutional review boards and the social sciences, 1965–2009. JHU Press. Kinsey ReportsMasters & Johnson How Institutional Review Boards can be (and are) Weaponized Against Academic Freedom Weaponizing the IRB 2.0 Psychologists' Involvement in Torture and the APA. Psychology Today.  

Dr. Deb Kimless has been in the medical cannabis field since 2013 where her diverse involvement spans many areas including cannabis cultivation, processing, formulation, testing, patient care, and conducting research. She consults within the industry as an advisor for companies who are interested in novel formulations specific to medical conditions, develops protocols, obtains IRB approval, conducts clinical trials, and helps to publish the results. At CannMed 24, Deb presented a poster that shared data from an open-label clinical trial investigating using a cannabinoid-enhanced topical cream for alleviating Restless Leg Syndrome. RLS is condition that affects up to 10% of the US population, including Deb. She found relief using a CBDA-based topical cream and is working with the product manufacturer to conduct clinical trials that demonstrate its effectiveness.  During our conversation, we discuss:  The symptoms of RLS and possible causes  Deb's own struggles with RLS  Why many conventional and pharmaceutical treatments of RLS fall short  Why CBDA appears to be effective at alleviating RLS symptoms  Why a transdermal approach is better than ingesting or inhaling cannabinoids  Results from the open label clinical trial including some remarkable success stories  Thanks to This Episode's Sponsor: Trusted Canna Nurse Trusted Canna Nurse was founded by Megan Mbengue and Ariane Williams, two nurses who are dedicated to bridging the gap between traditional medicine and the world of cannabis and psychedelics. They specialize in creating evidence-based treatment plans for all ages that address chronic illnesses, treatment-resistant conditions, mental health, autism, and more.  Learn more at trustedcannanurse.com  Additional Resources chylorelief.com - USE CODE "CANNMED20" for 20% OFF! Email Deb - dkimless@gmail.com Review the Podcast CannMed Archive

The 1916 Easter Rising was organised by a tiny group of conspirators. They were the Military Council of the Irish Republican Brotherhood - a small, oath bound organisation dedicated to achieving an Irish Republic by any means necessary, including violent insurrection. Despite the impact of the Rising, the IRB was eclipsed in history by the IRA and faded away in less than 10 years. Ciarán Dunbar is joined by John O'Beirne Ranelagh, author of ‘The Irish Republican Brotherhood, 1914-1924'. Hosted on Acast. See acast.com/privacy for more information.

Nav muļķīgu jautājumu, ir muļķīgas atbildes - vai šo teicienu var pielietot arī zinātnē? Vai zinātnieki atļaujas būt drosmīgi un uzdot neērtus, dažkārt arī visai muļķīgus jautājumus un pie kā var novest atbilžu meklējumi? Par izgudrojumiem, atklājumiem un pētnieka ikdienu, ļaujoties jautājumiem, kuri nav ikdienas pētījumu plānā,  saruna ar zinātniekiem, kuri raidījumos Zināmais nezināmajā, runājot par sev tuvajām jomām, ne reizi vien runājuši līdzībās ar citām dzīves jomām, izmantojuši radošus piemērus, aicinājuši paraudzīties plašāk. Tāpēc esam pārliecināti - viņi noteikti nebaidās uzdot drosmīgus, varbūt pat muļķīgus jautājumus, un nebaidās arī kļūdīties. Raidījuma viesi - fiziķis, Latvijas Universitātes profesors, Latvijas Universitātes Padomes priekšsēdētājs Mārcis Auziņš un Latvijas Universitātes Mikrobioloģijas un biotehnoloģiju institūta vadošais pētnieks Jānis Liepiņš. "Ir miljoniem piemēru, kuri parāda to, ka, ja mums nebūs šo naivo, dumjo, ja gribat, vārda vislabākajā un pozitīvajā nozīmē, jautājumu, kas ir noveduši pie zinātnes kaut kādu robežu pārkāpšanas, kaut kādu jaunu ideju rašanās, šīs praktiski modernās lietas nevarēs attīstīties," vērtē Mācis Auziņš. "Manā mīļajā kvantu fizikām ja mēs tagad ļoti pamatoti un pragmātiski runājam par kvantu tehnoloģijām, tad, ja nebūtu tie kvantu fizikas pamatu radītāji, kas uzdeva vistrakākos jautājumus un atrada vistrakākās, neiespējamās atbildes, ja tas nebūtu noticis, tad šobrīd šīs tehnoloģijas nebūtu. Ne velti par šiem pirmsākumiem ir man ļoti mīļa grāmata, kas ataino cilvēkus un notikumus, kurus dažus es personīgi pazīstu, kura saucās "Kā hipiji izglāba fiziku". Tieši par to, ka bija cilvēki, kuri uzdeva absolūti neparastus, neordinārus jautājumus, kas iziet no tā veida, kā "zolīds zinātnieks par lietām domā". Izgāja ārpus šiem rāmjiem, uzdeva absolūti neiespējamus jautājumus, ieguva atbildes, kuras joprojām rada mums pārdomas, vai tiešām tā var būt? Un tagad tas ir novedis pie tehnoloģijām." "Ir daži piemēri no bioloģijas un radniecīgām zinātnēm, kur tieši filozofiski vai varbūt, kā Mārcis teica, mazliet hipotētiski jautājumi, kas būtu vai kā varēja būt tā, ir novedusi pie ļoti nopietniem pētījumiem," skaidro Jānis Liepiņš. "Piemēram, ja 19. gadsimtā Darvins teica, ka izskatās, ka sugas savā starpā ir radniecīgas un viņas vēl aizvien evolucionē atbilstoši vides apstākļiem. Tas ir ļoti jauki un interesanti, un tad mēs varētu aizdomāties, ka kādam ir kādreiz bijis kopīgs sencis vai vairāki senči, kuri tad te dzīvoja, un tad sāksies šī diferenciācija. Bet tad ir domu eksperiments: bet klau, kā tad šis sencis ir radies? Un tas ilgu laiku bija ļoti hipotētisks jautājums, bet, sākot no pagājušā gadsimta 20. - 30. gadiem un mazliet vēlāk šis hipotētiskais jautājums kļuva par ļoti nopietnu praktisku jautājumu. Vai mēs varam kaut nedaudz ielūkoties jau praktiskā veidā šajā teritorijā, kur beidzās neorganiskā ķīmija un sākās organiskā ķīmija, precīzāk, bioorganiskā ķīmija un varbūt jau kaut kādi šūnu elementi? Un izrādās, jā, jūs varat laboratorijā atveidot vidi, kas, iespējams, ir bijusi uz Zemes, testēt, kā laika gaitā zibeņu un elektro izlaižu laikā, karstuma laikā rodas dažādas organiskās vielas. Un daudzas no tām patiešām ir tādas pašas, ko mēs sastopam mūsdienu bioloģiskajos organismos. Tas liek domāt, ka patiešām šis lēciens no neorganiskās vides uz dzīvību ir iespējams. Mēs tikai nezinām, kā tas notiek. Bet šis jautājums no tādas hipotēzes - kā tas varēja būt, jau kļūst par ļoti praktisku jautājumu - mēģināsim noskaidrot, kā. Arī bioloģijā šie "what if" jautājumi ir ļoti noderīgi, un patiešām viņi palīdz virzīties un atrast jau fundamentālas lietas." Starp citu, Amerikā 28. septembris pat tiek atzīmēts kā diena, kad uzdot muļķīgos jautājumus. Šo varat paturēt prātā arī Latvijā, kad datums tuvosies, bet mēs jau tagad jūlijā kopā ar fiziķi Mārci Auziņu un biologu Jāni Liepiņu pakavēsimies pārdomās, kas tad vispār ir muļķīgi jautājumi un kāpēc tos svarīgi uzdot. Pārāk maz cilvēku savus jaunos produktus vēlas aizsargāt ar patentu „Vidēji gadā mums iesniedz ap 100 - 120 pieteikumus patentam, un ar nožēlu jāatzīst, ka ir pārāk maz to, kuri vēlas savus jaunradītos produktus aizsargāt ar patentiem, jo patents nodrošina monopoltiesības tirgū,”  saka Patentu valdes vadošā eksperte Eiropas patentu jautājumos Māra Rozenblate. Sarunā ar viņu skaidrojam, par kādiem izgudrojumiem piešķir patentu, cik ilgā laikā tas notiek un kas Latvijas patentu valdes darbības sākumā pagājušā gadsimta 20. gados iesniedza pieteikumus patentu valdē. Pirmās preču zīmju un izgudrojumu aizsardzības apliecības Patentu valde izsniedza 1922. gada sākumā. Tās saņēma Rīgas tabakas fabrika “A/S Maikapar” un Andrejs Golvers savam pieteiktajam izgudrojumam “Pārlabojumi par bungusitdzirnavām”, jeb vienam no trieciendzirnavu veidiem. Pirmie Latvijas patenti piešķirti zemniekam Jānim Prātam par linu galviņu nosukāšanas un nokulšanas mašīnu un Jānim Minussam par izgudroto pārvietojamo istabas krāsni, kurai varēja regulēt gaisa plūsmu. Tādu  informāciju par patentu vēsturi Latvijā var lasīt Latvijas patentu valdes interneta mājaslapā, bet turpmāk nedaudz ielūkosimies patentu  piešķiršanas aizkulisēs un atsauksim atmiņā, kādi ievērojami latviešu izcelsmes izgudrotāji savulaik ir saņēmuši patentu. Zināmākie latvieši, kas saņēmuši patentu ir aviokostruktors  Kārlis Irbītis, kurš patentēja vairākus izcilus izgudrojumus un projektēja vertikālās pacelšanās lidmašīnu, kas iezīmēja pavērsienu šādu lidaparātu būvniecībā. Jāmin arīaudējs un steļļu konstruktors Pēteris Viļumsons, kurš pagājušā gadsimta 20. gados ieguva patentu par pusautomātisko steļļu izveidošanu, vācbaltu izcelsmes konstruktors Valters Caps un viņa miniatūrā fotokamera „Minox”. Turpinot runāt par šodienas izgudrojumiem, vaicāju Mārai  Rozenblatei, cik lielā mērā patentu piešķiršana attiecas uz informācijas tehnoloģijām?

Dr. Christina Prevett // #ICEPelvic // www.ptonice.com  In today's episode of the PT on ICE Daily Show, #ICEPelvic division leader Christina Prevett discusses Take a listen to learn how to better serve this population of patients & athletes or check out the full show notes on our blog at www.ptonice.com/blog. If you're looking to learn more about our live pregnancy and postpartum physical therapy courses or our online physical therapy courses, check our entire list of continuing education courses for physical therapy including our physical therapy certifications by checking out our website. Don't forget about all of our FREE eBooks, prebuilt workshops, free CEUs, and other physical therapy continuing education on our Resources tab. Are you looking for more information on how to keep lifting weights while pregnant? Check out the ICE Pelvic bi-weekly newsletter! EPISODE TRANSCRIPTION INTRODUCTIONHey everybody, Alan here. Currently I have the pleasure of serving as their Chief Operating Officer here at ICE. Before we jump into today's episode of the PT on ICE Daily Show, let's give a shout out to our sponsor Jane, a clinic management software and EMR. Whether you're just starting to do your research or you've been contemplating switching your software for a while now, the Jane team understands that this process can feel intimidating. That's why their goal is to provide you with the onboarding resources you need to make your switch as smooth as possible. Jane offers personalized calls to set up your account, a free date import, and a variety of online resources to get you up and running quickly once you switch. And if you need a helping hand along the way, you'll have access to unlimited phone, email, and chat support included in your Jane subscription. If you're interested in learning more, you want to book a one-on-one demo, you can head on over to jane.app.com. And if you decide to make the switch, don't forget to use the code icePT1MO at signup to receive a one-month free grace period on your new Jane account. CHRISTINA PREVETT Hello everybody and welcome to the PT on ICE Daily Show. My name is Christina Prevett. I am one of our lead faculty within our pelvic health division. Sorry for coming on here a little bit early. We are in the throes of young kids finishing school and trying to work around new schedules. So apologies for being a little bit early. But today what I wanted to talk to you all about was what do we really know about resistance training in pregnancy. And as many of you who have kind of followed the podcast in the past know, I'm a postdoctoral research fellow at the University of Alberta looking specifically at resistance training in pregnancy, which means that a big part of my job in my postdoctoral fellowship is to be very aware of the state of the literature and then where my role is as a person trying to build a program of research to be able to add to the existing body of literature. And I'm going to start this episode talking a little bit about my story getting into this because I think that it's relevant. So my PhD research was in high load resistance training in a geriatric population. I love my older adults. You know that I'm part of the older adult division. And I had two children while I was going through my doctoral studies. I was going part time. And then I was also a national level weightlifter before I got pregnant with my daughter. So I was doing a lot of heavy resistance training during my pregnancy. And I had a committee meeting during my pregnancy talking about, you know, obviously that I was going to go off on that leave, et cetera. And one of my committee members, whose name is Stu Phillips, many of you know him from the protein metabolism and resistance training literature. He said, you know, Christina, if you think that there isn't any research in loading the older adult appropriately, wolf when it comes to what we know in pregnancy. And I thought that was super fascinating and of course being the nerdy researcher that I am, I looked into the research and I recognized that he was right. And So I kind of want to talk today about what we truly do know, what the state of the literature is, a little bit about me trying to change that, I'm going to talk a little bit about some of my research studies, and then where we can go going forward. So we know in a general population that resistance training is one of the best things that we can do for our overall health. I don't tend to try and put people into specific buckets that you have to exercise in a specific way because the best exercise is the one that you do. But in terms of longevity and maintaining independence into older age, supporting whatever exercise you like to do with resistance training is definitely a recommendation that I'm gonna make with a lot of passion. Whether you choose to prescribe to that exercise program or not, Resistance training is one of these exercise modalities that is going to allow us to have independence. It's going to stave off a lot of chronic disease and musculoskeletal injury. And we know that, you know, the best exercise program is the one that we start as early in our life as possible and go into older adulthood. I'm going to try and put on as much muscle mass as I can before the age of 40 and then hold onto it for dear life into hopefully 100. And so we have a lot of really positive evidence for resistance training in a general, like reproductive age population, but then also into older adulthood. We've talked a lot about it in the Jerry segment. But when we don't have evidence, right, around exercise, or we don't have any evidence in any type of intervention in pregnancy, we freeze, right? And I say this all the time. If we don't know, the answer is no. and when we aren't sure we freeze, which is where bed rest and pelvic rest recommendations have come in when complications can creep up in pregnancy because we don't really know what we can do, right? We're not really sure what we can do. So we want to give a recommendation that we're doing something. And so we pull people back from activities of daily living, sport, exercise and we say like, let's not do anything because you know, there's this complication happening. And where evidence is starting to show now is that many of our complications have pro-inflammatory cascades and therefore exercise might be a really important mitigating factor or modifiable influence on a person's experience of complications during pregnancy. But the baseline is that if we don't know that the answer is no. And so that knee jerk reaction has trickled into a lot of our recommendations around exercise in pregnancy and specifically around resistance training. So when we look at public perception of resistance training or exercise in pregnancy in general, it's really interesting because aerobic training is generally seen as more positive as something that you're doing to benefit the health of mom and baby. But there's a lot of fear-focused messages that are put into the resistance training space. And gosh, we've seen this all the time, right? Like we see when a person lifts a heavy deadlift and they're pregnant, like go into the comment sections and you just are gonna heave because you see everybody telling you that your baby's gonna die and that you're being reckless and all this type of thing. And so if we're going to combat these messages, and we know that the perception is generally more negative because of a lot of fear and thoughts of danger around resistance training and pregnancy, we have to one, know where the state of the research is. And then two, we have to build levels of evidence that are going to gradually gain us more confidence and being able to remove some of those fears around resistance training. I've done podcast episodes before where I talk about risk tolerance of providers to allow individuals to flex their own decision making during pregnancy and how in low to moderate intensity exercise, we tend to feel very good in that risk tolerance zone, but where we get a little squeamish is in these higher intensity zones. Part of the reason for that is the state of the literature currently. So right now I can't speak specifically to my results because I haven't published this yet, but I am working on a systematic review on resistance training during pregnancy. And we have pulled about 50 studies on resistance training during pregnancy, which sounds like a lot, which it is. And it's been a lot of work to get the systematic review under control. But what we have noticed and what I have seen over and over and over again is a couple of things about the resistance training literature. Number one is that we have very few studies that look at resistance training in isolation. And you may not think that's necessarily a bad thing, because a lot of people are exercising in multiple modalities. Think about functional fitness, they're doing aerobic training and resistance training. But when we know that there's a lot of incurred benefit of aerobic training, especially when it's dosed appropriately, there's an interference effect that we see in the literature. So what I mean by that is that we know that there is benefits of aerobic training on rates of gestational hypertension and preeclampsia. We know that individuals who respond and continue to do aerobic training have less rates of gestational diabetes. We know all of these things already. So when we put in a known benefit and then kind of add in resistance training, we can't say with confidence that resistance training reduces our risk of gestational diabetes because we know that aerobic training does and aerobic training is in that multi-component program. So it's a big issue right now that we don't have a ton of research that's on resistance training in isolation, because then we can't isolate and say resistance training benefits X, Y, Z outcome, and aerobic training, there may be overlap, and they also do X, Y, and A, B, C, but without studies done in isolation, interventional studies done in isolation, we can't really say that this is incurring some sort of benefit. The second thing about our current state of the literature is that the resistance training research is unbelievably underdosed. So I'm gonna make a comparison for you. So the evidence that we have right now around resistance training in those with congestive heart failure in their 70s and 80s is higher dosed than a lot of the resistance training literature in pregnancy. Let me say that again. A lot of our dosing for resistance training is higher in our older adults with frailty, multi-morbidity, and complexity than it is for our uncomplicated pregnancies. When I am looking at that research, that makes me sad, and it just shows how much we need to do. When there is a randomized control trial that comes out in 2024, and the aerobic dosing is 70 to 80% of heart rate reserve, which is a great intensity for the aerobic training, and the resistance training part of the exercise program is using a yellow Theraband, I see red and I start to rage. And so the dosing here is unbelievably poor, especially for somebody, right, who we are not thinking has low musculoskeletal reserve going into their pregnancy, right? In general, individuals are not having trouble with activities of daily living as soon as they find out they're pregnant. And so we are going in almost with this assumption that individuals who are pregnant cannot have higher loading on their skeleton. And we're worried about strain, but a strain is not happening on the body with a yellow TheraBand for a person who's of reproductive age who is pregnant. Like that is not an appropriate dose. And so it's concerning that there is not an appropriate dosage for our resistance training interventions, especially when it is dosed appropriately. the aerobic side. So this brings me to our next problem. is if resistance training isn't dosed appropriately, if I am getting an individual who is pregnant with no complications to do a 16-week exercise program where the max amount that they are allowed to lift is two kilos or 4.4 pounds, and I wish I was lying about that prescription, can I realistically, as a provider and as a researcher in that space, say resistance training was the part of that exercise program that incurred the positive benefit? Right, going back to my first point about how when we have multi-component programs and there's a known benefit for aerobic training, it's hard to see the additive effect of resistance training. In combination with the fact that the resistance training prescription is not sufficient, what I would deem sufficient, to drive musculoskeletal adaptation or maintenance to prevent deconditioning in a pregnant individual. That creates a problem. It creates a problem and it creates all the downstream issues that we're seeing where pregnant individuals are restricted, right? Like when our max is a yellow fare ban on a 2024 randomized control trial, that don't lift more than 20, don't lift more than 30 pounds. that's gonna hold, you know, that's not gonna get better because we don't have any evidence to back us up, right? And so this is like a call to action around how we need to change some of our thought processes around the way that we are prescribing exercise for pregnant individuals, but we also need to push back on academia and be like, hey, like, this is not okay for this to be the state of our literature because I hate that I have to say this and my postdoctoral supervisor and I were having this conversation. Do we even have enough evidence in resistance training in pregnancy to truly be able to include it in our guidelines? And the answer is we don't. Not really. We're extrapolating from our general population literature and we're saying, well, based on some of the preliminary literature we have right now, light toning exercises seem to be okay. Literally the term in a big conglomerate of our RCTs was saying that they did aerobic training and light toning for our resistance training interventions. That drives me. It drives me with just unbelievable amounts of passion about why it is so important for this clinician science bridge to happen. It is why I will not step away from literature and doing research because we just need to demand so much better. And so what does that mean going forward? we need more research in this area. And so that is where my postdoctoral work has really taken off. So when we are thinking about our literature base, when the state of the literature is a two pound dumbbell, and I'm saying, I want to do an RCT where women are deadlifting over a hundred pounds, you can imagine that that amount of gap can create issues with an IRB board or an ethics board saying, whoa, whoa, whoa, whoa, whoa. We don't want to put mom and baby at risk. here's what we need to do. And so because of that, we need to build layers of evidence. So if you guys remember from your schooling, right, we have our levels of evidence from level five, which kind of our clinical commentaries, our professionals who are doing this in practice, that when the evidence isn't there to back us up, and then we go retrospective, prospective, RCT, and then systematic reviews and meta-analyses are kind of at the top of this evidence pyramid. And so when we are trying to build an area that does not have a ton of research to back us up, we need to start building levels of evidence. And that's what I'm trying to do. And so this started with our cross-sectional survey. You've heard us talk about this on our podcast, this podcast in the past, where the first thing that we have to do is show that there are individuals who are heavy lifting during their pregnancy. And so the cross-sectional survey that was published last year was the first step in that process. say, hey, look, we put out a survey for a couple of weeks online. We got almost 700 women who had lifted heavy during their pregnancies to tell us about their experiences. Great. Look, there's this need. They are very confused about what they're allowed to do and what they're not allowed to do. Like they're getting advice, like don't lift more than 20 pounds. Two, if you were doing it before, you can continue doing it now. Just don't strain your body. And even the strain on the body is a little bit question marks because, you know, there's so much that goes into it, et cetera. Right? It creates a situation where we recognize that there is a need because there is an absence of literature and there are people who need the answers to that. The next part is that we're going to start doing retrospective data taking and so right now I have two research studies that are open for enrollment and I am going to beg all the clinicians who are listening to this if you have a person who fits these bills if you could please please please send them our studies because I hope that the first part of this podcast tells you that there is just so much we need to do. There is so much that we need to do in this area, and I need your help in order to do it. So our retrospective study is taking individuals who have given birth within the last year and tracked their exercise through a training app. So if that was Wattify, if that was an Excel spreadsheet, if that was, you know, pen and paper, whatever it may be. If you tracked your exercise during pregnancy, specifically your resistance training, and you gave birth in the last year, we want you in our research study. So what we're going to do is we're going to ask you a whole bunch of questions about your pregnancy, your labor and delivery, how you felt about it, all those types of things, and then we're going to ask you to upload your training logs. And so what we're gonna try and do is descriptively see how did people modify? Are there any issues with resistance training that are popping up as patterns that clinicians or providers or obstetricians need to be aware of? And then how can we use that information to start help counseling individuals on strength training during pregnancy? And so that's a retrospective study. We also have a prospective study that is open for analysis. This is gonna take me about three and a half years to get out, but that is okay. So we are taking individuals who are less than 20 weeks pregnant, so in that first trimester, first half of their pregnancy, and we are following them forward over time. So every trimester, we are asking individuals questions about exercise during pregnancy, and we are asking you to upload your training logs. And so what that's going to do is it's going to build on our level of evidence, right? So now we have cross-sectional snapshots in time. There are recall biases that happen with that. We have our retrospective study that because we were using the training log, that recall bias is worked around because we have evidence of what they did over time. And then the prospective study, we are getting their thoughts in real time going forward. And so now we've gone from a level five of evidence and we're going to be pushing up to level With that evidence, my next goal is something interventional. Right now, we're going to have this building of evidence that we're seeing that is going to allow me to apply for funding for a randomized control trial that looks at different dosing schemas for individuals who are deciding that they want a resistance train during their pregnancy. SUMMARY And so if you have any individuals or if you are listening and you are in one of these two camps, I would love for you to join our army to try and build the level of evidence on resistance training in pregnancy. It is so necessary. It is so needed. And we are going to be leading the way in our pelvic division. We are very actively involved in research. Obviously, I'm a postdoctoral research fellow, so I'm there in the weeds of it, but also our other faculty are involved in the trenches as well. And it's just so, so, so important that we do this the right way and that we gradually build a level of evidence. And I am not okay with where we are right now. We need to do better. I will be part of the trying to make this better. And I'm recruiting you all to my cause to try and help me out. So I will post these research links in the captions, or you can head over to my Instagram at drchristina underscore private, and you can hopefully sign up for some of our studies. All right, if you are wanting to hear me get all fired up about other stuff or you wanna hear some of our faculty on the road, we have two courses in July that are still open for participation if individuals wanna sign up. I am in Cincinnati, Ohio. That is a smaller course. So if you are interested, July 2021, I'm in Cincinnati, Ohio. If you are interested and you are closer to Wyoming, we have a course July 27th, 28th in Wyoming. If you cannot get on the road because of kiddos like me who is coming early because kiddos are home for the summer, we have our next online cohort starting July 6th. So we are past 90% sold out for that course. So if you are looking to get in, please don't wait because there may not be the opportunity and then you'll have to wait until the fall. All right, that's all I got. 19 minutes. I'm sorry, I just get so passionate talking about resistance training in pregnancy. I hope you all have a wonderful week, and we'll talk to you all soon. OUTRO Hey, thanks for tuning in to the PT on Ice daily show. If you enjoyed this content, head on over to iTunes and leave us a review, and be sure to check us out on Facebook and Instagram at the Institute of Clinical Excellence. If you're interested in getting plugged into more ice content on a weekly basis while earning CEUs from home, check out our virtual ice online mentorship program at ptonice.com. While you're there, sign up for our Hump Day Hustling newsletter for a free email every Wednesday morning with our top five research articles and social media posts that we think are worth reading. 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Join our Chief Analytics Officer Silvio Galea, along with Dr. Donna Snyder & Dr. Barbara Bierer to discuss opportunities on the ethical and regulatory challenges regarding artificial intelligence in clinical trials. The discussion is focused through the lens of the IRB review, and how a multi-stakeholder task force led by the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women's Hospital and WCG will address the growing need for guidance in this rapidly evolving area of research.

https://brandeismd.com/ Youtube Facebook Instagram mensmedicalstore.com I know you guys are gonna like this episode of the MHS PODCAST with the legendary Dr. Judson Brandeis More on Dr. Brandeis Below Dr. Judson Brandeis is honored to have been voted Top Urologist in the SF Bay Area by SF Magazine from 2014 to 2020. In February 2019, he opened his comfortable office in San Ramon, where he focuses his practice entirely on Men's Sexual Health and Rejuvenation. BrandeisMD is a national leader in technology and innovations in sexual medicine. Dr. Brandeis is the National Director of Clinical Excellence for GAINSWave and created and runs the SWEET Study, the largest study of Shockwave Therapy for ED ever performed. BrandeisMD was one of the first offices in California for offer PT-141, Oxytocin, and Apomorhine for erectile dysfunction. Dr. Brandeis created and directed 5 IRB-approved clinical research protocols in sexual medicine, two of which are still active. These include the SWEET Study, the largest study of shockwave therapy use in treating erectile dysfunction (active), SWAP study for Peyronie's Disease (completed), P-LONG for penile elongation (active), LuBE for improving the intensity of orgasms (completed), and the SURGE study (completed), which tests a transdermal serum to improve penile blood flow in prostate cancer patients. Support the Show Click a Link BelowBelow

The Human Subjects Protection Program (HSPP) Office at the University of Louisville supports researchers and provides educational resources and compliance reviews to ensure research meets federal and university policies. Unlike the IRB, which approves research to ensure ethical standards, the office assists with the research proposal preparation and submission process. They also clarify whether projects qualify as research and help with submissions involving human subjects. They encourage faculty to reach out early in their planning stages and utilize available templates and tools. Regular updates and resources are provided through their website and listserv to facilitate research processes and maintain compliance. Do you have comments or questions about Faculty Feed? Contact us at FacFeed@louisville.edu. We look forward to hearing from you. --- Send in a voice message: https://podcasters.spotify.com/pod/show/hscfacdev/message

Trial of the Week: Ketamine for EM Agitation Special Guest: Justin Lin, PharmD, BCPS, BCCCP @jjlinpharmd   Justin Lin joins to review the May Trial of the Week “Efficacy of ketamine for initial control of acute agitation in the emergency department: a randomized study” published in the American Journal of Emergency Medicine in 2021. We set the scene by discussing how this research idea started, review the classic agitation presentation at his institution, and highlight evidence comparing pharmacotherapy treatment options prior to this study. Then we dive into the Trial of the Week, discussing the study design and results. What was the biggest pushback from providers or the IRB? Any unique education strategies? Would results stay the same with increased IV push administration? What would the comparator arm be if this study was replicated today? Plus, the most challenging part of this project, Justin's favorite agent, and so much more.   Reference list: https://pharmacytodose.com/wp-content/uploads/2024/05/ketamine-for-em-agitation-trial-of-the-week-references.pdf   PharmacyToDose.Com @PharmacyToDose PharmacyToDose@Gmail.com Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk devices, and share invaluable advice on mitigating risks associated with clinical trials. Whether you're a newcomer or a seasoned professional in the MedTech industry, this episode offers essential insights to ensure your clinical studies are compliant and efficient.Key Timestamps:00:01:20 – Introduction to Dr. Mike Drues and his accolades.00:05:30 – Explanation of IRBs and their role in clinical trials.00:15:10 – Differences between traditional and commercial IRBs.00:22:40 – Discussion on significant vs. non-significant risk devices.00:32:00 – Importance of pre-submission meetings with the FDA.00:44:15 – Steps to take when an IRB disapproves your clinical trial.01:00:30 – Practical tips for choosing the right IRB for your study.Quotes:"Most 510 devices do not need clinical data. But if you do, even for a non-significant risk device, vetting that with the FDA in advance is wise." – Dr. Mike Drues"You don't want to create a problem where none exists, but avoiding FDA consultation can lead to costly surprises later." – Dr. Mike Drues"The primary mission of an IRB is to ensure the safety of the patients at that institution." – Dr. Mike DruesTakeaways:Key Insights:Understanding IRBs: IRBs are local entities responsible for the ethical oversight of clinical trials, ensuring patient safety and compliance.Risk Classification: The classification of your device as significant or non-significant risk dictates whether FDA approval is needed for your clinical trial.Strategic Pre-Submission: Engaging in a pre-submission meeting with the FDA can prevent costly delays and ensure your clinical trial meets all necessary endpoints.Practical Tips:IRB Shopping: If faced with an IRB denial, consider alternative institutions or commercial IRBs to avoid delays.Comprehensive Submissions: Prepare thorough submissions for IRBs, including device descriptions, clinical trial protocols, and informed consent forms.Physician Champions: Having a physician advocate at the institution can streamline the approval process and facilitate patient enrollment.Future Questions:How will the evolving landscape of MedTech regulations impact the approval process for new devices?What role will real-world evidence play in future clinical trials for medical devices?How can smaller companies navigate the complexities of FDA and IRB requirements effectively?References:Etienne Nichols on LinkedInMike Drues on LinkedInFDA Guidance on Artificial Intelligence and Medical DevicesFDA Guidance on Avoiding Potential Issues with Your 510(k) SubmissionGood Clinical Practices (GCP) regulations for IRBsMedTech 101:What is an IRB?An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The primary purpose of an IRB is to ensure the ethical and safe treatment of participants in clinical trials.What is an IDE?An Investigational Device Exemption (IDE) allows a medical device to be used in a clinical study to collect safety and effectiveness data. An IDE must be approved by the FDA for significant risk devices before a clinical study can begin.Questions for the...

We discuss six critical errors in the informed consent process:1. Exclusion of Principal Investigator: PI was not allowed to engage in the informed consent process.2. Lack of Detailed Discussion: Staff members did not take the time to thoroughly discuss the study's potential benefits and risks with prospective subjects.3. Inadequate Training: Coordinators lacked knowledge about the study and lacked a research background, leading to insufficient information provided to participants.4. Unauthorized Handling of Paperwork: Unqualified individuals would sign required forms without proper understanding or expertise.5. Lack of oversight: Subjects were allegedly denied meetings with sponsors, FDA, or IRB, citing privacy laws as a barrier.6. Signature Verification Issues: Signatures were not compared with subjects' identification, posing challenges in ensuring the authenticity of informed consent.For assistance with clinical trial compliance, contact Darshan at 302-252-6959

Learn the business and management skills you need by enrolling in the University of Tennessee Physician Executive MBA program at nonclinicalphysicians.com/physicianmba. Get the FREE GUIDE to 10 Nonclinical Careers at nonclinicalphysicians.com/freeguide. Get a list of 70 nontraditional jobs at nonclinicalphysicians.com/70jobs. =============== Dr. Maria Abunto is the Senior Manager of Medical Science Liaisons at Exact Sciences, a molecular diagnostics company specializing in the detection of early-stage cancers. Before that, she was a Global Medical Science Liaison for Stryker. She previously worked as an epidemiologist and investigator for the NIH and as a medical scientific expert on the IRB at a large children's hospital. She holds a master's degree in public health from the University of Pittsburg and completed her medical degree at the University of the East in Manila, Philippines. Maria has been an active member of the Medical Science Liaison Society, and mentors other physicians interested in pursuing jobs as an MSL. She frequently lectures on the topic. Because of her expertise, she was asked to present at the 2023 Nonclinical Career Summit on this topic. Today's podcast episode is an excerpt from that lecture. In it, she describes the duties of an MSL, the pros and cons of the job, the salary to be expected, and tips for pursuing your first position as an MSL. You will find all of the links mentioned in the episode at https://nonclinicalphysicians.com/first-nonclinical-msl-job/

☕️ No Morning Call de hoje, Henrique Esteter fala o ambiente neutro na abertura novamente dos Estados Unidos, mas com China impulsionada por perspectivas de estímulos.O petróleo recua, mas o minério de ferro se recupera com intensidade.*Dentre os principais destaques: *(i) IRB reverte prejuízo e tem lucro de R$ 24 milhões em novembro de 2023;(ii) Acionistas do GPA aprovam limite de aumento de capital autorizado para até 800 mi ações;(iii) Latam amplia liderança no mercado aéreo brasileiro em 2023, diz Anac.