It's fascinating to witness the pharmaceutical industry's shift towards more complex therapies and the crucial role that early integration of medical affairs plays in this transformation. By embedding robust data analytics and regulatory expertise right from the outset, we're not only enhancing compliance but also refining clinical trials for better patient recruitment and real-world applicability. This proactive approach is vital for streamlining drug development and optimizing outcomes, marking a significant evolution in bringing therapies to those needing them.
BioPharma & Entrepreneurial Executive, Advisor & Board Member
In the pharmaceutical development's evolving landscape, medical affairs have never been more critical, especially with complex therapies needing complex clinical trials. By integrating robust data analytics and regulatory expertise, medical affairs professionals are best equipped to address the complexities of clinical trials, ensuring compliance and the integration of valuable patient insights from the outset.
Integrating medical affairs from early development stages is crucial, as it optimizes trial design and patient recruitment while ensuring that trials reflect patient needs and real-world conditions more. Medical affairs' early involvement is essential to reshaping the drug development process, increasing efficiency and patient outcomes. https://lnkd.in/evQscsBi
Done right, with clear expectations for value delivered, Medical Affairs is an important investment for early stage biotechs. For many companies, Phase 3 is too late.
The pharmaceutical industry is undergoing a significant transformation as the demand for complex therapies continues to grow. These therapies require intricately designed clinical trials, with the integration of robust data analytics and regulatory expertise from the early stages of development becoming essential. Early involvement of medical affairs professionals ensures that clinical trials are not only compliant but also optimized for patient recruitment and reflective of real-world conditions.
This shift is reshaping the drug development landscape. By prioritizing early-stage integration, the industry is driving greater efficiency in trial design, enhancing patient recruitment strategies, and ultimately improving patient outcomes. These advancements underscore the importance of adapting to new methodologies and leveraging specialized expertise to navigate the complexities of modern clinical trials.
BioPharma & Entrepreneurial Executive, Advisor & Board Member
In the pharmaceutical development's evolving landscape, medical affairs have never been more critical, especially with complex therapies needing complex clinical trials. By integrating robust data analytics and regulatory expertise, medical affairs professionals are best equipped to address the complexities of clinical trials, ensuring compliance and the integration of valuable patient insights from the outset.
Integrating medical affairs from early development stages is crucial, as it optimizes trial design and patient recruitment while ensuring that trials reflect patient needs and real-world conditions more. Medical affairs' early involvement is essential to reshaping the drug development process, increasing efficiency and patient outcomes. https://lnkd.in/evQscsBi
In the pharmaceutical development's evolving landscape, medical affairs have never been more critical, especially with complex therapies needing complex clinical trials. By integrating robust data analytics and regulatory expertise, medical affairs professionals are best equipped to address the complexities of clinical trials, ensuring compliance and the integration of valuable patient insights from the outset.
Integrating medical affairs from early development stages is crucial, as it optimizes trial design and patient recruitment while ensuring that trials reflect patient needs and real-world conditions more. Medical affairs' early involvement is essential to reshaping the drug development process, increasing efficiency and patient outcomes. https://lnkd.in/evQscsBi
Decentralized clinical trials are taking the healthcare industry by storm, but pharmaceutical companies should bear in mind that this model may not always be the most effective.
How do you determine which strategies are optimal for ensuring research is both insightful and manageable for participants?
Talk to patients!
As Executive Director of Decentralized Clinical Trials at Worldwide Clinical Trials, Scott Palmese says, “Understand when patients will welcome decentralized tactics, and when they will not. If you don’t know the community, perhaps you should not be blanketing tactics that may not make sense and could drive patients away.”
Learn more about the role of decentralized trials below: https://lnkd.in/eZMHXbiK#patientvoices#patientcentric#clinicaltrials
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
The UK is reclaiming its spot as a leader in clinical trials – here’s how NWEH is making it happen.
At NWEH, we are proud to lead the way with innovative technologies and meaningful collaborations, such as our pilot with the Clinical Practice Research Datalink (CPRD). Discover how this initiative aims to test a new model combining NWEH’s secure, tried and tested FARSITE platform, with the scale and depth of CPRD’s 18-million anonymised patient records to speed up the process for safely and securely finding participants for UK clinical trials.
Dive into the vision of our CEO Jonathan Wogel and our CMO Professor Martin Gibson in their latest interview with Pharmaphorum.
#ClinicalTrials#Innovation#CPRD#ClinicalResearch#Pharma#Pharmaceutical#DiscoverMore#DeliverBetterhttps://lnkd.in/ej4UxHq9
Nelson Advisors Partner Lloyd Price shares his thoughts on Clinical Trial diversity with PMLiVe - Pharmaceutical Market Europe
It will take a modern alchemy to ensure the recent huge advances in science are translated into better prospects for patients around the globe as, despite life-changing potential, clinical trials struggle to escape their tainted past.
Influential voices are now clamouring for cultural, conceptual and mechanical components to be blended in a furnace of intent to create a precious alloy that can deliver new therapies to broader and more relevant audiences.
New clinical intelligence and understanding are propelling a marked increase in clinical trials this year – passing the 500,000 mark in April globally – yet many will fall short because they target a narrow band of patients selected, or more critically, available for their clinical trials.
A lack of diversity is not just an economic misfire, it has become societally unacceptable and is now laden with the jeopardy of brand alienation that stretches way beyond niche condition areas and minorities.
> Price sees a range of digital approaches that could energise trial enrolment among under-represented communities and boost retention.
> But he cautions: “It’s important to remember that technology is a tool, and its success hinges on its implementation alongside culturally sensitive practices and a genuine commitment to diversity within the research community.
> By making trials more accessible, culturally sensitive and transparent, technology can pave the way for more inclusive research and ultimately, better healthcare outcomes for everyone.
‘Results from a poll of 2,000 people reveal respondents have significant trust in vaccines and prescription drugs but less trust in pharma companies’
“Overall, technology has the potential to revolutionise clinical trial design and recruitment, leading to more diverse participation and ultimately, fairer and more generalisable medical research.”
https://lnkd.in/eSgBcGHG
Nelson Advisors Partner Lloyd Price shares his thoughts on Clinical Trial diversity with PMLiVe - Pharmaceutical Market Europe
It will take a modern alchemy to ensure the recent huge advances in science are translated into better prospects for patients around the globe as, despite life-changing potential, clinical trials struggle to escape their tainted past.
Influential voices are now clamouring for cultural, conceptual and mechanical components to be blended in a furnace of intent to create a precious alloy that can deliver new therapies to broader and more relevant audiences.
New clinical intelligence and understanding are propelling a marked increase in clinical trials this year – passing the 500,000 mark in April globally – yet many will fall short because they target a narrow band of patients selected, or more critically, available for their clinical trials.
A lack of diversity is not just an economic misfire, it has become societally unacceptable and is now laden with the jeopardy of brand alienation that stretches way beyond niche condition areas and minorities.
> Price sees a range of digital approaches that could energise trial enrolment among under-represented communities and boost retention.
> But he cautions: “It’s important to remember that technology is a tool, and its success hinges on its implementation alongside culturally sensitive practices and a genuine commitment to diversity within the research community.
> By making trials more accessible, culturally sensitive and transparent, technology can pave the way for more inclusive research and ultimately, better healthcare outcomes for everyone.
‘Results from a poll of 2,000 people reveal respondents have significant trust in vaccines and prescription drugs but less trust in pharma companies’
“Overall, technology has the potential to revolutionise clinical trial design and recruitment, leading to more diverse participation and ultimately, fairer and more generalisable medical research.”
https://lnkd.in/e_bUfuhN
Future mapping for emerging biotech CxOs and their teams - manage controllable risks | allocate resources | unify teams
9moDone right, with clear expectations for value delivered, Medical Affairs is an important investment for early stage biotechs. For many companies, Phase 3 is too late.