biomedwoRx: Life Sciences Consulting

When Life’s work gives you joy!

An excellent succinct summary of the White House Clinical Trials Forum held Weds., 26JUN from Moe Alsumidaie in his #ClinicalTrialsVanguard [https://lnkd.in/gUJhSRWb]. Thanks, Moe! The White House Clinical Trials Forum brought together key leaders in science, healthcare, and patient advocacy to address the pressing issues in clinical trials. The event, organized by the White House Office of Science and Technology Policy (OSTP), aimed to highlight innovative approaches to make clinical trials more inclusive and accessible to all Americans. The director of the OSTP emphasized that despite being one of the wealthiest countries, the U.S. faces unacceptable health inequities, with dozens of countries boasting longer life expectancies. The need for inclusive clinical trials that reflect the country’s diverse population to develop effective interventions was highlighted LINK: https://lnkd.in/gK3dzYN9 #Clinicaldevelopment #Diversity #Inclusion Race in STEM The White House biomedwoRx: Life Sciences Consulting

FDA Draft Guidance on Diversity Action Plans: Implications for Pharmaceutical Marketers The FDA has just issued the long-awaited, crucial draft guidance aimed at enhancing diversity in clinical trials through the implementation of Diversity Action Plans (DAPs). This directive is a significant move to ensure clinical trial participants reflect the diverse populations that will benefit from approved clinical products & has been one of the core topics addressed by Race in STEM and our #ClinicalTrialsOBQ 🔥 LinkedIn Audio Group during the past year. LINK: https://lnkd.in/gqFtZX4y “Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step...to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.” > Key Requirements and Changes Mandatory Diversity Action Plans: Sponsors are required to submit DAPs detailing enrollment goals disaggregated by race, ethnicity, sex, & age for Phase III/pivotal studies. This is an opportunity to help define how an innovator's cultural launch messaging will align with the clinical patient segmentation. Regulatory Standard: FDORA (Food and Drug Omnibus Reform Act of 2022) mandates these goals be established before clinical trial initiation, aligning with the existing standard for inclusive clinical development programs. The regulatory standard makes early marketing engagement in the clinical plan a prerequisite. > Why This Matters Clinical Relevance: Diversity in clinical trials is crucial because diverse clinical trial participation ensures that the data reflects the real-world diversity of patients who will benefit from the medical products once approved - a requirement to prove safety & efficacy. Health Impact: Improved diversity in clinical trial data leads to better health outcomes by providing insights that are applicable across different demographic groups, thus enhancing the safety & effectiveness of new therapies. Patient-Centered: The guidance encourages patient advocate engagement & directs innovator companies to champion a JEDI (Justice, Equity, Diversity, Inclusion) approach to therapy development. > Opportunity to Engage Stakeholders are encouraged to provide feedback on the draft guidance via Regulations.gov within 90 days of publication. Comments are welcome & can be submitted electronically at [Regulations.gov](https://lnkd.in/gKA-pzuY]. This is a unique opportunity to contribute to a crucial initiative that aims to make clinical research more inclusive & equitable. #JEDI #DEI #representation #patientrecruitment #clinicaldevelopment biomedwoRx: Life Sciences Consulting

Making human connections at industry and clinical conferences is invaluable. 🤗 Whether you call it networking, meet-ups, or simply connecting - it all comes down to seeing, talking, and laughing together. These interactions become the adhesives for #trust, #collaboration, and #businessopportunities. I am so very grateful for the friends, colleagues, clients, and allies I got to share a little #LeftCoastLivin with at #DIA2024 - the DRUG INFORMATION ASSOCIATION (DIA) meeting in San Diego! Here are just a few of the dozens of photos captured with a #GratitudeAttitude. Thank you, All! 📸 #biotech #clinicaldevelopment #Networking #Opportunities #clinicaloperations #CROs GLSA | Global Life Sciences Alliance biomedwoRx: Life Sciences Consulting

Honored and excited to lead an upcoming session on clinician engagement at GST24. Register now for the HCEA- Healthcare Convention & Exhibitors Association’s 2024 Annual Meeting: #GrowingStrongerTogether24, Wednesday, August 14 – Friday, August 16, 2024, Hotel Flor Tampa Downtown, Tapestry Collection by Hilton, Tampa, Florida Tracy Stuckrath will be our Kick-Off Speaker! https://lnkd.in/gnHjNegs #hceagst24 #contemporaryexhibits Pat Friedlander Sean Feehan Jon Ellms Brendan J. Emerson biomedwoRx: Life Sciences Consulting

PART 2! THIS WEEK, join our clinical diversity webinar! Make sure to secure your spot. Our very own Steven Fuller will once again lead an engaging conversation with this "back by popular demand" expert panel. You don't want to miss this! Our panelists include: Tiffany Ashton, MAS, CCRA, Director of Operations at ClinEssentials. Barry Holmes Jr., VP of Strategy and Development at Genesis Medical Research Group Téa Romero, MPsy, MBA, Director of Alliance Management at Scout Michael W. Young, Principal & Founder at biomedwoRx: Life Sciences Consulting Join us as we explore the intricacies of representation in trials, delve into the needs of scientific research and real-world application and examine the importance of trial design, and assess current approaches to diverse cultural groups with an emphasis on possible enhancements. This session is not to be missed! REGISTER HERE: https://lnkd.in/d2h5gEBt #Clinicaldevelopment #Medical #Barriers #STEM #Diveristy #Webinar #ClinicalTrials #PatientRecruitment Race in STEM BioTalent

June is an innovation packed month in Life Science! Overlapping a fantastic American Society of Clinical Oncology (ASCO) 2024 was the Biotechnology Innovation Organization Annual Conference (#BIO2024) in San Diego: ~ 20,000 attendees, 2000 exhibitors! biomedwoRx: Life Sciences Consulting (Yuko Terasawa / Michael W. Young) was energized to support our emerging pharma and technology clients, joyfully meet up with colleagues and collaborators, and, importantly, engage new professionals at this critical path conference! #BIO2024 #LifeSciences #drugdevelopment Keliomics Promedigen EDETEK Inc. Notable Open Biopharma Research and Training Institute #FoundationforBiomedicalResearchandInnovationatKobe #LeftCoastLivin #GratitudeAttitude

Keliomics CEO, Frank Lau, MD, FACS engaging interested partners at the #OregonPavillion at the Biotechnology Innovation Organization annual conference. Accompanied by Ben Williams CMO, they have been making impressive strides in recent months to advance their innovative cancer ex-vivo tumor platform. #exvivotumors #drugdevelopment biomedwoRx: Life Sciences Consulting

An exhilarating week in Chicago at the American Society of Clinical Oncology (ASCO) ends with satisfied client companies sharing promising data, oral presentations, compelling posters, study steering committee meetings, and well-attended exhibit booths! Grateful to have the opportunity to advance their corporate objectives at #ASCO2024 with 40,000+ attendees, 577 exhibits, and over 5,000 abstracts! Thank you to each of our valued client companies! #AML #MDS #HeadandNeck #PIT #PredictiveMedicine #GratitudeAttitude biomedwoRx: Life Sciences Consulting

Elevating Your Expertise and Assuring Your Value: The Imperative of Continuing Education for Strategic Consultants in Life Sciences In the fast-evolving landscape of life sciences, strategic consultants play a pivotal role in guiding businesses and development platforms toward clinical success and corporate valuation. However, to remain at the forefront of innovation and best practices, continual education is not just beneficial but imperative. One of the more effective actions for staying abreast of the latest advancements is through attending state-of-the-art presentations at major conferences and medical congresses, networking with innovative professionals, and remaining in a state of constant reconnaissance. Scientific meetings serve as invaluable platforms where consultants can augment their knowledge, expand their subject matter expert (SME) networks, and gain insights into cutting-edge data and technology. While it may seem like an additional burden to compensate consultants for attending national and international meetings, the return on investment far outweighs the costs incurred. In the fields of oncology and hematology, where groundbreaking discoveries occur with stunning frequency, staying informed is particularly crucial. Major meetings such as the American Association for Cancer Research (22,000 attendees in San Diego this April at #AACR2024), the anticipated 40,000 attendees at the American Society of Clinical Oncology (ASCO) (#ASCO2024 in June in Chicago), and the 25,000 expected at the American Society of Hematology (#ASH2024 in San Diego) are indispensable for strategic consultants aiming to remain at the vanguard of these dynamic disciplines. These conferences offer unparalleled opportunities to delve into the complexities of #smallmolecules, #biologics, and #cellandgene therapies, which are revolutionizing treatment paradigms and reshaping the future of medicine. By participating in these events, consultants not only enhance their understanding of emerging trends but also gain firsthand exposure to the pulse of the industry. This deepened knowledge equips them to provide informed guidance to clients, make better strategic decisions, and ultimately elevate the value they bring to their respective organizations. In summary, while the commitment to continuous education may require resources, the benefits it yields in terms of knowledge enrichment, network expansion, and industry foresight far surpass the investment. For strategic consultants in the life sciences industry, embracing a culture of lifelong learning is not just advantageous—it's indispensable for driving innovation, supporting our clients, and maintaining a competitive edge in a rapidly evolving landscape. If you’re a consultant, what’s your view? And if you’re client-side, how do you support your consultant’s expertise?   #LifeSciencesConsulting #ClinicalDevelopment #SolvingProblems #lifelonglearning #continuousimprovement biomedwoRx: Life Sciences Consulting