Center for Connected Medicine’s Post

In April 2022, the Food and Drug Administration (FDA) released draft guidance to help medical product creators create a race and ethnicity diversity plan “to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the United States.” The plan seeks to improve racial and ethnic diversity in clinical trial enrollment. In doing so, the FDA wants to support the U.S. government’s Cancer Moonshot plan to make cancer care more equitable. the FDA acknowledges that diversity is a broader question than race or ethnicity. The FDA recommends that clinical trial teams also track other diversity-related data points, including: Sex and gender identity. Age. Socioeconomic status. Disability. Pregnancy or lactation status. Comorbidity. Real world data shows, despite efforts to improve racial and ethnic diversity in clinical trial participation, many trials still run without a representative sample of participants from various racial and ethnic backgrounds. The FDA’s guidance seeks to help clinical researchers improve diversity in clinical trials without imposing additional mandates. #cgt #cellandgenetherapy #genetherapy #celltherapy #cdmo #2024trends #globaldata #asgct #viralvector #biotech

Women’s Health has been historically underfunded which has hindered innovation greatly both in diagnosis and treatment. This critical imbalance persists despite the widespread prevalence of conditions such as #endometriosis, which afflicts an astonishing 10% of females worldwide, and represents a pressing need for more effective diagnostic and treatment options.   A stark disparity becomes evident when comparing Women’s Health to other therapeutic areas within the biopharmaceutical industry. The market is dominated by generics, primarily hormone- targeting drugs, leading to fierce pricing competition. Additionally, regulatory guidance from FDA and EMA on several of these conditions remains conspicuously absent contributing to the already high R&D hurdles for clinical trial sponsors (e.g., lack of clinical trial endpoints, low recruitment rates, inadequate animal models). Furthermore, there is a profound lack of comprehension surrounding the underlying pathophysiology of these diseases, a deficiency in basic research that significantly constrains the development of novel mechanisms of action and/ or bringing innovative treatments from other therapeutic areas into Women’s Health. Nevertheless, there is a growing number of initiatives aimed at supporting early-stage innovative developments. One example of a funding model that encourages transformative research is the BioInnovation Institute (BII). BII provides financial support for innovations that propel the creation of novel solutions, particularly by early-stage life science start-ups operating in diverse areas, including Women’s Health.   Another example is Repro Grants, which is a program that awards grants to scientists or academic institutions dedicated to the advancement of Women’s Health research. While these initiatives undeniably play a pivotal role in propelling early-stage research aimed at unraveling the underlying pathophysiology of diseases, it is imperative to acknowledge that realizing substantial progress in this field will necessitate significantly larger investments. Read the report here: https://lnkd.in/eq3mVaS8 #femtech #female #letsmakelifebetter #womenshealth #1in10 #findingendometriosis #endometriosisawareness Philippa Saunders Mette Nyegaard Krina Zondervan PrecisionLife Endometriosis UK Endometriosis UK Endometriosis Australia Attila Bokor SURGAR Medicon Valley Alliance BioInnovation Institute Hugo Vankelecom Health - Aarhus University World Health Organization Francesco Mureddu Bharati Shivalkar Adrienn Salamon Camilla Fabricius Per Larsen Louise Brown Monika Rubin Kim Edberg Andersen Stinus Lindgreen Rasmus Lund-Nielsen Louise Dreisig Endometriose Faellesskabet Lone Hummelshoj Oriana Kraft FemTechnology Summit Dr. Ana Rita da Costa Pascal Joly Dr. Ilkin Nehls

Despite comprising over half the world's population, women made up only 34% of Phase 1 clinical trial participants for FDA-approved drugs between 2013-2015. In a recent Clinical Leader article, Juan Camilo Arjona Ferreira, Organon's Chief Medical Officer & Head of R&D, highlights the enduring gender biases in drug development and explores opportunities to address current data gaps. The limited involvement of women in clinical trials contributes to expanding knowledge disparities, ultimately affecting health outcomes. The road to health equity is long, but the momentum is building. Join us and others in #womenshealth to make 2024 the year of transformation. 🚀 #WomensHealth #HealthEquity #HereforHerHealth #healthequity https://lnkd.in/enJhv7Us

BREAKING NEWS... Eli Lilly's FDA-approved Kisunla ignites competition in Alzheimer's treatment, vying with Biogen and Eisai's Leqembi. As a life sciences recruitment expert, I see this as a pivotal moment attracting talent passionate about neurodegenerative research. Kisunla's innovative model may shorten treatment periods and lower costs, a significant advantage for patients and healthcare providers. This isn't merely a new drug; it's a symbol of hope for those affected by Alzheimer's. Yet, its price and safety protocols, considering ARIA risks, suggest its impact is just unfolding. What are your thoughts on Kisunla's market entry and its potential effect on Alzheimer's care?

Efforts to generate evidence for decision makers is an integrative part of the STREXIT 2 Project from a very early phase. These activities are conducted by Syreon Research Institute with the active contribution of all consortium partners. STREXIT 2 is an observational study sponsored by EORTC - European Organisation for Research and Treatment of Cancer run in parallel to a randomized study testing the efficacy of neoadjuvant chemotherapy in a subset of patients affected by high-risk retroperitoneal sarcoma. “Syreon Research Institute is an independent research-oriented company that has been providing expert services since 2008 in the fields of evidence synthesis, health economics, health policy and public health. Syreon also conducts training for #public health care institutes, the #pharmaceutical #industry and #health services sector. It aims to apply scientific evidence and health economic knowledge in clinical practice to maximise health gain for society. As part of STREXIT 2, Syreon will conduct #economic #evaluations in different countries. It will develop the communication and dissemination strategy, coordinating the related activities. The project results generated, if positive, should inform guideline developers, policymakers, patient advocates and #healthcare payers about the importance of giving access to effective therapeutic alternatives for retroperitoneal sarcoma patients.”     Find out more about STREXIT 2: https://lnkd.in/eQuVVVyA   #STREXIT2_Horizon #HorizonEurope #EUCancerMission #SARCOMA #CancerResearch #ClinicalTrials #Cancer #RetroperitonealSarcoma #SoftTissueSarcoma European Commission #Syreon #SyreonResearchInstitute #HealthEconomics #HTA

Following the FDA's recent approval of the new Alzheimer’s drug Kisunla (donanemab), researchers at Eli Lilly and Company shared key clinical trial takeaways on managing ARIA and the benefits of a limited treatment period. Read about the TRAILBLAZER-ALZ 2 trial and more top news from #AAIC24. #Alzheimers #Health #News

More progress on #clinincaltrial #diversity - updated #FDA guidance; open for public comments through Sept 26th. For too long, clinical trial populations have been far too homogeneous, leading to approval of products that don't work for some of the groups that are most disadvantaged in the health care system. Furthermore, not only do we need to test all drugs and devices in representative populations that have the conditions, we need to ensure #access - of care provision as well as reimbursement. That will also incentivize more companies to develop new therapies for diseases that impact disadvantaged groups uniquely, disproportionately, and/or differently (e.g., endometriosis or lupus for women; sickle cell disease for Black patients; certain cardiometabolic diseases for Latino or indigenous people; and many others). We have a long way to go, but it's good to see progress in this area. #patientsfirst #clinicaltrialdiversity #underrepresentedpatients #biotech #innovation #BiotechCEOSisterhood Biotechnology Innovation Organization Biotech Hangout

We all know the Big Pharma business model. For decades they’ve essentially “borrowed” knowledge from the public domain, deploying extractive and rapacious business practices like patenting existing technologies developed by indigenous groups or co-opting their knowledge of plant medicines without seeking permission or offering compensation. Or acquiring smaller, more innovative companies once a new molecule or application is discovered, rather than innovating themselves. Or getting cozy with the government to manipulate the patent system and the equally dysfunctional healthcare system to push drugs on a distracted populace. Or all of the above. That much is well established. Now that COVID vaccine funds have dried up Big Pharma is desperate for new sources of revenue. After decades of failing to deploy their massive (often pseudo-public) resources to develop better psychiatric drugs to address the growing mental health crisis they have set their sights on psychedelics. We have known that #psychedelics are #medicine for millennia. Big Pharma did not develop these compounds, nature did. The world’s population is suffering because of the impacts of late-stage capitalism and the drug war, in which Big Pharma and their partners in government are complicit. Real change requires reforming these systems.

Breaking the Silence: Unraveling Bias in Drug Discovery for a Healthier Tomorrow! As we enter 2024 we thought this would be a good time to highlight a problem that has existed in our industry for far too long. The lack of inclusivity in drug development is a pressing concern that demands our collective attention! Clinical research, a cornerstone of medical progress, has grappled with persistent biases, leading to unequal access and skewed results. Ethnic minorities are often sidelined in trials, creating disparities in drug efficacy and safety due to diverse genetic responses. Diverse participation in clinical trials is the key to unlocking universally effective and safe drugs. But the bias doesn't stop there. Gender-inclusive research is equally vital. Historical tendencies to predominantly study male subjects have resulted in medications showing different effects in women. It's time to prioritize gender-inclusive protocols for a more comprehensive understanding of drug responses. Addressing these disparities is not just an option; it's a necessity for equitable healthcare outcomes. Let's make a concerted effort to diversify participant pools in clinical trials, ensuring research findings are applicable across diverse populations. Researchers, the power to bring change starts from the initial phases of clinical trials. Develop inclusive protocols through decentralized trial designs, reduce exclusion criteria, and engage patients and the public. Empowering health literacy among patients is crucial, and real-world data adds depth to our understanding, favoring equal access to treatments. Together, let's break down the barriers, fostering a future where everyone benefits equally from medical advancements!  #InclusiveHealthcare #MedicalEquality #DiversityInResearch #InclusiveResearch #HealthEquity #ClinicalTrialsInclusion