Clinical Research and Drug Discovery Podcasts

2024-10-04 Hosts Jane Myles and special guest host Jean Sposaro (BMS) welcomed Joe Unger (Fred Hutch) for a conversation. The COVID-19 pandemic significantly decreased cancer clinical trial enrollment and swift changes were needed from researchers, regulators, and policymakers to ensure research and care could continue. He shares more about a task force created to better understand the impact of the pandemic on the conduct of oncology clinical trials.You can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Ben recently sat down with Dr. Petro Terblanche, the head of Afrigen, Africa’s first mRNA vaccine researcher and manufacturer. From the calamities of COVID-19 vaccine populism, the African public health community & its allies swore that never again would Africa be last in the line when it came to life saving pandemic vaccines, and Petro sets out how this can - and is - being achieved, notwithstanding a wide array of challenges - and opposition. https://www.afrigen.co.za https://medicinespatentpool.org https://www.who.int/initiatives/the-mrna-vaccine-technology-transfer-hub https://www.gavi.org https://cepi.net//home-page #mRNA #vaccines #access #equity #platformtechnology #mRNAhub

Featuring articles on lenacapavir for HIV prevention in cisgender women, tirzepatide for treatment of obstructive sleep apnea, lymphadenectomy for muscle-invasive bladder cancer, secondary T-cell lymphoma after CAR T-cell therapy, and immunity and early colorectal carcinogenesis; a review article on prolonged grief disorder; a Clinical Problem-Solving on avoiding rash decisions; and Perspectives on health care reform and the 2024 U.S. elections, on financial toxicity for patients from the use of AI, on the Supreme Court’s shadowy treatment of public health, and on caring for our communities. Supplement to the New England Journal of Medicine, Vol. 391, No. 13.

Social connection is vital to community well-being. It fosters support, resilience, and a shared sense of belonging that strengthens both individuals and the community as a whole. In this episode of Aging Fast & Slow, we explore the impact of social connection on community resilience. Dr. Thomas Cudjoe from Johns Hopkins School of Medicine shares research on how isolation affects health and community strength and strategies to foster social connection. Tune in to learn how we can build more connected, resilient communities. REFERENCES: Cudjoe TKM, Boyd CM, Wolff JL, Roth DL. Advance care planning: Social isolation matters. J Am Geriatr Soc. 2020 April. Cudjoe TKM, Kotwal AA. Social distancing amid a crisis in social isolation and loneliness. J Am Geri Soc 2020 May 20. Cudjoe TKM, Roth DL, Szanton SL, Wolff JL, Boyd CM, Thorpe Jr., RJ. The epidemiology of social isolation: National Health & Aging Trends Study. J Gerontol B Psychol Sci Soc Sci. 2020 Jan 1. Cudjoe TKM, Selvakumar S, Chung S, Latkin CA, Roth DL, Thorpe Jr., RJ, Boyd CM. (2021). Getting under the Skin: Social isolation and biological markers in the National Health and Aging Trends Study. Journal of the American Geriatrics Society. Golden SH, Cudjoe TKM, Galiatsatos P, Brownlee D, Flanagan E, Crews DC, Maruthur N, Brown M, Ashby A, Hellmann DB, Knox T, Anderson ME. A perspective on the Baltimore Freddie Gray riots: Turning tragedy into civic engagement and culture change in an academic department of medicine. Acad Med. 2018 December.

Featuring articles on systematic vs. targeted biopsy for prostate cancer screening, ziresovir in hospitalized infants with RSV, gene therapy for factor IX deficiency, and a phase 2 trial of tulisokibart for ulcerative colitis; a review article on neuroleptic malignant syndrome; a case report of a woman with kidney lesions and lytic bone disease; and Perspectives on Dobbs revisited, on the role of physicians on ethics committees after Dobbs, on accessible weight scales and exam tables, and on ensuring a safe and sufficient global blood supply. Supplement to the New England Journal of Medicine, Vol. 391, No. 12.

2024-09-20 Hosts Craig Lipset and Jane Myles hosted a discussion around the long-awaited FDA Final Guidance on DCTs: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties.A host of guests were brought to the stage to share perspectives on what they are excited for about this new guidance, what ambiguity was cleared up, and more!You can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Featuring articles on long-term oxygen therapy in severe hypoxemia, reducing opioid overdose deaths, blocking CSF1R in chronic GVHD, and pomalidomide in hereditary hemorrhagic telangiectasia; a review article on central nervous system vasculitis; a case report of a man with confusion and kidney failure; a Medicine and Society on house staff unionization revisited; and Perspectives on ethical challenges in pragmatic and cluster RCTs, on the sense and sensibility of sensitivity analyses, and on there being no one in charge. Supplement to the New England Journal of Medicine, Vol. 391, No. 11.

2024-09-13 Hosts Craig Lipset and special guest hosts, Ali Holland and Pamela Tenaerts (Medable) hosted a discussion around DCT Adoption in Covid and Beyond with Dr. Pablo Cure and Thomas Radman (NCATS).In 2023, NIH NCATS posted an RFI to understand the role of decentralized methods in trials and DTRA held a listening session and created a response to the RFI with the input of our membership community. This RFI lead to an NIH NCATS 2024 DCT Report released in June 2024. We held a conversation with Dr. Cure and Thomas around catalyzing the use of these innovative methods to drive access for more patients.Blog mentioned in episode --> https://ccos-cc.ctsa.io/news/mikes-blog/you-say-po-tay-toe-and-i-say-po-tah-toeYou can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Featuring articles on treatments in newly diagnosed chronic myeloid leukemia and RNA therapeutics in mixed hyperlipidemia; a review article on clinical approaches to firearm injury prevention; a case report of a woman with edema, arthritis, and proteinuria; and Perspectives on keeping SNAP in line with global evidence, on ingesting risk, on centering the peripheral brain, and on how health care burdens patients. Supplement to the New England Journal of Medicine, Vol. 391, No. 10.

2024-09-06 Hosts Craig Lipset and Dr. Amir Kalali were joined for a conversation about the Trial Innovation Network's Recruitment Innovation Center and their focus on becoming an evidence-based center for recruitment and retention strategies to improve the quality of trials and increase enrollment & health outcomes across America. We'll be joined by Paul Harris, Terri Edwards, Leslie Boone, M.P.H., Mary Stroud, and Brooklyn Henderson (Vanderbilt University) for the discussion.You can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Featuring articles on doxorubicin plus trabectedin in leiomyosarcoma, a monoclonal antibody for migraine prevention, adjunctive argatroban or eptifibatide for ischemic stroke, and a new orthonairovirus associated with febrile illness; a review article on pancreatic cysts; a case report of a man with pain and dyspnea; a Medicine and Society on building a community of medical learning; and Perspectives on supreme power, on shared savings for nursing homes, on moral injury and the global health workforce crisis, and on asking patients if they feel safe at home. Supplement to the New England Journal of Medicine, Vol. 391, No. 9.

2022-12-22 Host Craig Lipset held a conversation around Inspection Readiness for Decentralized Trials. He was joined by special guests Sheila Gwizdak, Doug Shaw and John Sikora for the conversation around inspection readiness for decentralized trials and what to be thinking of, with a focus on patient safety and data integrity.You can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Featuring articles on amino acid infusion and kidney protection, azithromycin to reduce childhood mortality in Niger, belzutifan in renal-cell carcinoma, and a transfusion strategy in traumatic brain injury; a review article on sexual dysfunction in women; a case report of a woman with aphasia, anemia, and a breast mass; and Perspectives on a series of brief cases on efforts toward equity and on controlling global antimicrobial resistance. Supplement to the New England Journal of Medicine, Vol. 391, No. 8.

Featuring articles on osimertinib in stage III EGFR-mutated lung cancer, cognitive motor dissociation in disorders of consciousness, rapid deployment of a brain–computer interface in ALS, and the longevity of a brain–computer interface for ALS; a review article on the genetics of chronic kidney disease; a case report of a boy with autism and decreased vision; and Perspectives on medical expertise, on collecting data on sexual orientation and gender identity, and on the pursuit of polka dots. Supplement to the New England Journal of Medicine, Vol. 391, No. 7.

Featuring articles on crinecerfont in pediatric and adult congenital adrenal hyperplasia, the postacute sequelae of SARS-CoV-2 infection, and nipocalimab in early-onset severe hemolytic disease of the fetus and newborn; a review article on frailty in older adults; a case report of a woman with postpartum anxiety and intrusive thoughts; and Perspectives on refusing to learn the lessons of Covid-19; on preparing for the next pandemic; on collective trauma and commemoration; and on an unknown family history. Supplement to the New England Journal of Medicine, Vol. 391, No. 6.

In this episode of Aging Fast & Slow, we delve into ways to improve the quality of life of older adults needing home- and community-based services. We are joined by Dr. Kali Thomas, Associate Director of Health Services Research in the Center for Equity in Aging at Johns Hopkins School of Nursing. Dr. Thomas' research spans the long-term services and supports continuum, ranging from in-home services to long-term care in assisted living communities. Together we explore these critical issues and discuss innovative approaches and policies to meet the comprehensive medical and non-medical needs of our aging population. References: Home-Delivered Meals Thomas KS, Parikh R, Zullo AR, Dosa D. (2018) Home-Delivered Meals and Risk of Self-Reported Falls: Results From a Randomized Trial. J Appl Gerontol. 2018 Jan;37(1):41-57. PMID: 27798291. Thomas KS, Smego R, Akobundu U, Dosa D. (2017) Characteristics of Older Adults on Waiting Lists for Meals on Wheels: Identifying Areas for Intervention. J Appl Gerontol. 2017 Oct;36(10):1228-1242. PMCID: PMC4877281. Thomas KS, Akobundu U, Dosa D. (2016) More Than A Meal? A Randomized Control Trial Comparing the Effects of Home-Delivered Meals Programs on Participants’ Feelings of Loneliness. J Gerontol B Psychol Sci Soc. Sci. 2016 Nov;71(6):1049-1058. PMID: 26613620 Thomas KS, Mor V. (2013) Providing more home-delivered meals is one way to keep older adults with low care needs out of nursing homes. Health Aff (Millwood). 2013 Oct;32(10):1796-1802. PMCID: PMC4001076. Thomas KS, Gadbois EA, Shield RR, Akobundu U, Morris AM, Dosa DM. (2018) “It’s not just a simple meal. It’s so much more”: Interactions between Meals on Wheels Clients and Drivers. J Appl Gerontol. 2018 Dec 20:733464818820226 [Epub ahead of print]. PMID: 30569811. Title III State Expenditures on In-Home Services Thomas KS. (2014) The relationship between Older Americans Act in-home services and low-care residents in nursing homes. J Aging Health. 2014 Mar;26(2):250-260. PMCID: PMC4112387. Veteran-Directed Care / Self-Directed Care Yuan Y, Thomas KS, Frakt AB, Pizer SD, Garrido MM. (2019) Users Of Veteran-Directed Care And Other Purchased Care Have Similar Hospital Use And Costs Over Time. Health Affairs. 2019. 38(6):1037-104569. Thomas KS, Allen SM. (2016) Interagency partnership to deliver Veteran-Directed Home and Community-Based Services: Interviews with Aging and Disability Network agency personnel regarding their experience with partner Department of Veterans Affairs medical centers. J Rehabil Res Dev. 2016;53(5):611-618. PMID: 27898159. Yuan Y, Thomas KS, Van Houtven CH, Price ME, Pizer SD, Frakt AB, Garrido MM. (2022) Fewer potentially avoidable health care events in rural veterans with self-directed care versus other personal care services. J Am Geriatr Soc. 2022 May;70(5):1418-1428. doi: 10.1111/jgs.17656. Epub 2022 Jan 13. PMID: 35026056; PMCID: PMC9106846 Access to Benefits Thomas KS, Corneau E, Van Houtven C, Aron D, Dosa D, Allen SM. (2021) Inequities in Access to VA’s Aid and Attendance Pension Benefit to Finance Veterans’ Long-Term Care. Health Serv Res. 2021 Jun;56(3):389-399. PMID: 33634467; PMCID: PMC8143693. Kennedy KA, Corneau E, Rickard T, Mills WL, Thomas KS. VA Social Workers Identify Factors Predictive of Enrollment and Variability in Veterans’ Access to Aid and Attendance Benefits. J Gerontol Soc Work. 2023 Jul 24:1-21. PMID: 37483074

Featuring articles on belantamab mafodotin for multiple myeloma, autoantibodies targeting nephrin in podocytopathies, neutralizing anti–interleukin-10 autoantibodies in IBD; a review article on Parkinson’s disease; a Clinical Problem-Solving on going down the rabbit hole; a Medicine and Society article on race-based screening under the ethics microscope; and a Perspective on a legacy of cruelty to sexual and gender minority groups. Supplement to the New England Journal of Medicine, Vol. 391, No. 5.

2024-07-26 Hosts Craig Lipset and Jane Myles were joined by Sarah Dunsmore (NIH/NCATS), Paul Harris (Vanderbilt University), and Daniel Hanley (Johns Hopkins University) for a discussion around the use of decentralized elements and methods in the Trial Innovation Network. Read more about the trials conducted that included decentralized elements in their paper here --> https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10465321/Learn more about the Trial Innovation Network on their website --> https://trialinnovationnetwork.org/You can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Jeff Sturchio catches up with friend of the pod, Dr. Meg Doherty, WHO’s Director of HIV, Hepatitis and Sexually Transmitted Diseases. It has been a busy week at the Munich AIDS Conference for the World Health Organization, and Jeff gets Meg to unpack their conference program, particularly the release global data on HIV, viral hepatitis and STIs. 

With the #PUTPEOPLEFIRST being the call to action here at the International Aids Society Conference 2024, youth advocate Sinentlantla Gogela catches up with Y-isha Raphael about the work she has been doing at the conference, her views on the current state of youth activism and advocacy.  Sinentlantla Gogela is one of the current APHA CHAMPIONS based in South Africa, passionate about uplifting her community, keeping young girls period positive and taking all the haters to task be it in meeting rooms or on social media. She is a student at UWC pursuing her BA in physiotherapy and psychology and hoping to use that education to further her community work and advocacy. Together they delve into the complexities of young African people taking on these big issues, keeping up with their mental health and standing up for their peers.

Ben talks with Hatice Beton and Alan Donnelly about why the G20 established a new partnership on Health & Development in 2018, just prior to the COVID-19 pandemic, and how the era of pandemics is radically transforming high-level political fora like this. Guests: Alan Donnelly - Executive Chairman Sovereign Sustainability And Development & Convenor of The G20 Health And Development Partnership Hatice Beton - Executive Director, G20 Health And Development Partnership Links: https://g20healthpartnership.com

Jeff and Ben sit down with Heidi Larson from the Global Listening Project, reflecting on how the HIV movement influenced pandemic preparedness.

Yvette and Ben meet Gilead’s Dr. Moupali Das to discuss the latest clinical trial results for a new prevention technology that reduces HIV transmission by 100 percent in women. How did the research go and what plans does the company have to provide for the 100s of thousands of girls and women in need across Africa?

Featuring articles on treatments for metabolic dysfunction–associated steatohepatitis, blinatumomab in adults with ALL, and sotorasib for KRAS G12C–driven vascular malformations; a review article on HIV-associated tuberculosis; a case report of a woman with rapidly progressive dementia; and Perspectives on the abandonment of people subjected to sexual and intimate partner violence, on multicancer early detection tests, and on coping in the setting of serious illness.