Verbatim Pharma’s Post

Embracing Diversity in Clinical Trials: A Step Towards Inclusive Healthcare Genentech is leading the way in clinical trial diversity, recognizing it as a business imperative. With 20 diversity action plans filed for Phase 3 studies, they’re setting a new standard in the pharma industry. This proactive approach, pushed in part through the Food and Drug Omnibus Reform Act of 2022 (FDORA), ensures that medications are accessible and effective for all, reflecting a commitment that begins in clinical development and extends to commercialization. As advocates for inclusive healthcare, we understand that access to medications is a multifaceted endeavor involving payers, patients, and providers. It’s a journey that starts early in clinical development, ensuring broad access from the outset. Great to see the commitment in oncology and ophthalmology with their Advancing Inclusive Research partner sites. Want to understand how you can better position your assets for commercial success and ensure broad access? Please reach out. #ClinicalTrials #DiversityInHealthcare #InclusiveMedicine #PharmaInnovation #PatientAccess Roche Precision Value & Health PRECISIONadvisors

Today, we are proud to celebrate International Clinical Trials Day, a significant occasion to raise awareness and express our gratitude to healthcare professionals, patients, and participants involved in clinical trials worldwide. At Pro Pharmaceuticals Group, based in Australia, our commitment to accelerating access and transforming lives is at the heart of everything we do. Clinical trials are essential for advancing medical knowledge and developing new treatments. We are deeply thankful for the dedication of everyone involved in these trials, helping to bring innovative therapies to those in need. Are you curious about how clinical trials work and how they contribute to medical advancements? Visit our website to learn more: www.propg.com.au #ProPharmaGroup #ClinicalTrials #InternationalClinicalTrialsDay #AcceleratingAccess #TransformingLives

Check out our latest Q&A published in Contract Pharma, where One2Treat’s CEO, Sébastien Coppe, PhD, shares his expertise on the evolving landscape of clinical research and its pivotal role supporting sponsor's needs.   💡 Patient-centricity in clinical trials is becoming a critical focus, with an emphasis on integrating patient perspectives from trial design to market access. 💡 Innovative statistical methodologies are revolutionizing clinical trials, enhancing patient-centricity and improving trial efficiency. 💡 The increasing complexity of clinical trials and evolving regulatory landscapes open new opportunities for digital innovation, allowing to align multiple important stakeholders (patients, sponsor, regulatory agencies and payers) as early as clinical trial design.   Read the full Q&A to learn how One2Treat is leading the way in transforming clinical trials with a patient-centered approach. 👉 https://lnkd.in/eiPxqDjG #ClinicalTrials #PatientCentricity #Innovation

What were the highlights of the recent clinical trial supply conferences N-SIDE attended?   We haven't finished listing them yet! From reconnecting with familiar industry peers to engaging with new prospects seeking stress-free and sustainable clinical supply planning, our N-SIDE Life Sciences team had a fulfilling experience at conferences across Europe and the US over the past few months!   However, one may particularly stand out: the co-presentation in Barcelona featuring our experts Amaury Jeandrain and Sasha Van Heuverswyn alongside our esteemed partner Sanofi, represented by Arnaud DOURLENS, Head of Clinical Supply Operations. We shared how innovation and data processing combined with a strong culture of performance allowed to double from 35 to 70% the proportion of drug ultimately dispensed to patients and a reduction by up to 50% in the total quantities of drugs required to conduct a trial. This resulted in significant improvements notably in patient service levels, cost savings, and reduced carbon footprint, ultimately enhancing Sanofi's overall performance in clinical trial supply. N-SIDE revolutionizes clinical trials, drastically reducing timelines and enhancing efficiency. Connect with us at our upcoming conferences and discover how we are transforming the industry 👉 https://lnkd.in/e5SgGCFF #LifeSciences #Pharma #Biotech #ClinicalTrials #Conference 

🎉 A Leap Forward in Clinical Trials: FDA’s New Innovation Center 🎉 As I delve deeper into my Master’s studies in Clinical Trials Monitoring, I’m continually amazed by the groundbreaking advancements in drug development. Today, I’m excited to share one such development with you all! The FDA’s Center for Drug Evaluation and Research (CDER) has launched the CDER Center for Clinical Trial Innovation (C3TI) 🚀. This center is set to revolutionize clinical trials, improving their efficiency and effectiveness 📈. C3TI will be a central hub within CDER, supporting innovative approaches to clinical trials, and facilitating the sharing of lessons learned across CDER’s existing clinical trial innovation initiatives. This is a huge step towards accelerating the development of safe and effective new drugs 💊. Let’s celebrate this milestone in drug development and look forward to its positive impact on our industry and, most importantly, on patients’ lives 🎗️. For more details, check out the link below 👇 🔗https://lnkd.in/dWp8Pxr9 #FDA #ClinicalTrials #Innovation #Healthcare

Citeline partnered with Pharma Ignite for a roundtable to discuss the pros and cons of basing clinical trials in today’s European landscape. The free report covers: - The factors making the US a key clinical trial location, despite recent changes to European systems. - A critical element that gives clinical trials in Europe an edge over the United States. - The particular advantages offered by Eastern Europe as a clinical trial destination. - The impacts of new regulatory and process changes in Europe. Varying financial incentives for conducting clinical trials across European countries. https://lnkd.in/eS7a3yMp #clinicaltrials #europe #pharma

The 𝗖𝗲𝗹𝗹 & 𝗚𝗲𝗻𝗲 𝗧𝗵𝗲𝗿𝗮𝗽𝘆 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝗦𝘂𝗺𝗺𝗶𝘁 is your gateway to mastering the complexities of the field, from 𝗜𝗡𝗗 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀 to 𝗕𝗟𝗔 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹𝘀, and beyond!   𝗘𝘅𝗽𝗹𝗼𝗿𝗲 𝘁𝗵𝗲 𝗡𝗲𝘄𝗹𝘆-𝗥𝗲𝗹𝗲𝗮𝘀𝗲𝗱 𝗔𝗴𝗲𝗻𝗱𝗮 𝗛𝗲𝗿𝗲 - https://ter.li/ggrnnp   𝗗𝗼𝗻'𝘁 𝗠𝗶𝘀𝘀 𝘁𝗵𝗶𝘀 𝗢𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝘆 𝘁𝗼:   💡Learn from industry giants like Bristol Myers Squibb, bluebird bio, and Orchard Therapeutics - U.S. on 𝗼𝘃𝗲𝗿𝗰𝗼𝗺𝗶𝗻𝗴 𝗹𝗮𝘂𝗻𝗰𝗵 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀.   💡Discover the 𝗽𝗼𝘄𝗲𝗿 𝗼𝗳 𝗲𝗮𝗿𝗹𝘆 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗮𝗳𝗳𝗮𝗶𝗿𝘀 𝗶𝗻𝘃𝗼𝗹𝘃𝗲𝗺𝗲𝗻𝘁 in product development with insights from Editas Medicine, ImmPACT Bio, and Vor Bio.   💡Embed a 𝗽𝗮𝘁𝗶𝗲𝗻𝘁-𝗳𝗶𝗿𝘀𝘁 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵 throughout the drug development lifecycle, guided by leaders like Adaptimmune and Alexion Pharmaceuticals, Inc..   𝗙𝗶𝗻𝗱 𝗢𝘂𝘁 𝗠𝗼𝗿𝗲 𝗛𝗲𝗿𝗲 - https://ter.li/ggrnnp   We hope you'll join fellow 𝗖𝗵𝗶𝗲𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗢𝗳𝗳𝗶𝗰𝗲𝗿𝘀 and 𝘀𝗲𝗻𝗶𝗼𝗿 𝗹𝗲𝗮𝗱𝗲𝗿𝘀 in medical affairs, medical communications, field medical, and medical science liaisons this December for unparalleled networking and learning!   #CellAndGeneTherapyMedicalAffairsSummit

Are you ready to innovate your company? The FDA is leading the way by establishing the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI aims to enhance the efficiency, effectiveness, data quality, and coordination of clinical trials through innovative approaches. Currently under development, C3TI will provide various stakeholders, including sponsors, contract research organisations, and other service providers in the research industry, with access to resources and information on clinical trial design and innovation. The Center will enable internal and external parties to: - Engage in collaborations, - Access information on clinical trial innovation efforts more easily, - Identify resources that support the use of innovative modalities, and - Discover development programs where clinical trial innovations can have a significant impact. The goals of these efforts are to: - Improve the efficiency and effectiveness of clinical trials, - Accelerate the development of safe and effective new drugs, - Increase the participation of diverse populations in clinical trials, and - Keep those involved in clinical research up-to-date with the latest clinical trial innovations, Where do you stand in your journey towards innovation? #clinicalresearch #clinicaldevelopment #regulations

James Lind is not a name most of us recognise and yet we all owe him a huge debt of gratitude. His comparison of potential remedies for scurvy back in 1747 is widely considered the first ever randomised clinical trial and a turning point in the history of medical research.   International Clinical Trials Day continues to shine a light on his groundbreaking legacy and rightly so. To this day, the relentless pursuit of evidence-based medicine and robust clinical trial design underpins our industry’s efforts to develop life-changing medicines for the people who need them most. That is why, as a member of the board of the European Federation of Pharmaceutical Industries and Associations (EFPIA), I am so passionate about the importance of reversing downward trends in Europe’s R&D and clinical trial investment. To restore Europe’s reputation as an innovation powerhouse, we must fast-track smarter, more patient-centric trials and increase the global share of clinical trials in Europe.   While the pace of medical advancement has completely transformed the healthcare landscape since the 18th century, I see Lind’s curiosity, thirst for knowledge and quest for scientific rigor in my own Astellas colleagues as we seek to advance innovations with the greatest potential to transform lives.   #ClinicalTrialsDay #CTD2024

Now live on our website! Don't miss your chance to learn more about and register for our upcoming webinar: Accelerating Market Access of New Medicines. By the end of this free, digital event, participants will 📌 Understand the role of compassionate use programs in providing access to new medicines with limited clinical data. 📌 Explore strategies to expedite the national evaluation process for new medicines in low and middle-income countries. Participants will also receive a digital certificate of attendance following completion of the webinar. Follow the link below to learn more and register! #gmdpacademy #medicalaffairs #gmdpacademy #medicinesdevelopment #NDA #newdrugapplication #pharma #pharmaceuticaldevelopment #marketaccess #webinar #continuingeducation #continuouslearning