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In this episode of TrialTalks, host Naomi Tapia sits down with Dr. Lestter Cruz Serrano, an industry veteran with over 20 years of experience spanning life sciences, pharma, biotech, and clinical research organizations. Dr. Cruz, currently leading medical affairs strategy at Cognizant, shares his journey from being a physician in a clinical setting to pioneering technological innovations in clinical research.
Dr. Cruz discusses the development and success of the Share Investigator Platform, an open SaaS solution transforming clinical trial processes across over 100 countries. He delves into the challenges and triumphs of integrating technology in a traditionally paper-based industry, emphasizing the importance of system interoperability and site engagement.
Listeners will gain insights into how Cognizant's technology is enhancing efficiencies, improving communication between sites and sponsors, and paving the way for future innovations like AI and machine learning in clinical trials. This episode is a must-listen for anyone interested in the intersection of healthcare, technology, and clinical research.
The views expressed in the podcast is solely that of the individual and does not necessarily reflect the views of the individual’s employer.Support the Show.
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In this episode, Naomi welcomes Nathan Nguyen, a seasoned PharmD with a decade of experience in the pharmaceutical industry, specializing in medical information. Nathan is passionate about transforming complex medical knowledge into accessible, actionable insights and guiding others to achieve their professional goals.
Episode Highlights:
Introduction to Nathan Nguyen: Nathan shares his journey from a pharmacist intern to his current role as an Associate Director of Medical Information at Eversana, highlighting key experiences that have shaped his career.Role of Medical Affairs: Nathan explains the critical functions of medical affairs and how it serves as a bridge between clinical practice and research, differentiating it from regulatory affairs and clinical operations.Career Progression: Insights into Nathan’s career progression, starting from an internship in a medical information contact center to taking on project lead roles and eventually becoming an associate director.Technology in Medical Information: Discussion on how emerging technologies, including AI and chatbots, are transforming the medical information landscape and the importance of keeping up with these advancements.Cross-Functional Collaboration: Nathan discusses the collaboration between medical information teams and other departments such as regulatory, pharmacovigilance, and clinical development within CROs.Patient Advocacy: How Nathan ensures patient advocacy is maintained throughout the clinical trial process and post-marketing stages.Challenges in CROs: Nathan shares the biggest challenges he has encountered while managing medical information services across various life sciences organizations within a CRO.Future Trends: Emerging trends in medical information and medical affairs, particularly the role of technology and regulatory considerations.Advice for Aspiring Professionals: Nathan offers valuable advice for individuals aspiring to enter the medical information field, emphasizing the importance of understanding the regulatory landscape and networking.Connect with Nathan Nguyen:
- LinkedIn: https://www.linkedin.com/in/nathannguyen414
- Newsletter: https://medinfoacademy.ck.page/profile
Thank you for tuning in to this insightful episode of TrialTalks. Stay connected with us for more discussions like this. Subscribe to our podcast and leave a review!
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Join us in this powerful episode as we sit down with Katie Ortman Doble, a stage 4 cancer survivor, writer, speaker, and passionate advocate for clinical trials. Katie shares her incredible journey from her diagnosis with a rare form of melanoma to navigating treatment options and ultimately becoming a beacon of hope for others. Discover how her father's medical background and relentless determination played a crucial role in her survival, and learn about the strategic importance of clinical trials in cancer treatment.
Katie's story is not just about battling cancer but also about the importance of patient advocacy, the need for better education on clinical trials, and the strength found in community support. Her experiences offer valuable insights into the world of clinical research and highlight the critical role it plays in saving lives. Tune in to hear Katie’s inspiring tale of resilience, her advocacy work, and the importance of making clinical trials a part of every patient’s treatment plan.
Katie, who currently heads Creative and General Staffing Operations at IQ Clarity, also writes a blog called FutureHappySelf.com, where she shares her journey and offers advice to others. She volunteers for First Descents, a non-profit providing adventure-based healing for young adults with cancer. Katie’s advocacy and writing have earned her numerous accolades, including the Courage Award from the Melanoma Research Foundation and the Out Living It Award from First Descents. She has also shared her experiences in a feature on Huffington Post and was highlighted on NPR's Hidden Brain Podcast in the My Unsung Hero segment.
Don't miss this episode filled with hope, determination, and invaluable advice for anyone facing similar battles.
HuffPost article: https://www.huffpost.com/entry/doctor-cancer-clinical-trials-advocacy_n_646515dbe4b0bfd6447f88df
Additional features and blog links: https://www.liinks.co/katiedoble
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In this episode, join Naomi and Rahmeka as they welcome the inspiring Aundria Littlejohn, associate manager at Coach and top Miss New York 2024 contestant. Aundria delves into her unique journey from retail to her current role, driven by her passion for patient advocacy, maternal health, and mentorship. Discover how she champions for underrepresented communities, the pivotal moments that shaped her path, and her innovative initiatives like Copy Genius and Health In Her Hue. Aundria's story is a powerful testament to resilience, community, and the impact of effective mentorship. Don't miss this empowering conversation!
Highlights:
- Aundria's Career Journey: From part-time retail to associate manager at Coach.
- Mentorship Impact: How mentors guided Aundria and how she mentors others.
- Patient Advocacy: Aundria's dedication to improving maternal health and patient care for underrepresented communities.
- Copy Genius: An innovative take on mentorship that accelerates personal and professional growth.
- Health In Her Hue: Connecting Black and Brown women with culturally competent healthcare providers.
- Future Goals: Aundria's ambition to attend law school and advocate for healthcare policy changes on Capitol Hill.
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Join Naomi Tapia and her new co-host Rahmeka Cox Fort for an enlightening episode of TrialTalks Inc.! In this engaging discussion, they dive into the clinical research industry, sharing personal stories and professional insights. Rahmeka recounts her journey from a personal experience with chronic kidney disease in her family to her impactful career in epidemiology and public health. Together, they explore the importance of patient advocacy, cultural competency in clinical trials, and the need for reeducation to enhance patient participation. Tune in to hear about Rahmeka’s inspiring Miss New York experience, the significance of internships, and their plans for future collaborations. This episode is packed with valuable information and heartfelt stories that underscore the human side of clinical research. Don’t miss it!
Highlights:
- Rahmeka Fort's personal and professional journey
- The role of patient advocacy and community engagement
- Insights into clinical research and the importance of cultural competency
- Experiences from the Miss New York pageant and its impact on public health advocacy
- The value of internships in building a career in clinical research
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In this enlightening episode, we sit down with Edye Edens, a seasoned attorney with nearly two decades of experience in healthcare law, ethics, and clinical research. Edie shares her serendipitous journey into the field, starting as an IRB consultant and evolving into a regulatory lead at Weave, an innovative AI-focused company aiming to optimize regulatory processes in clinical trials.
Join us as Edie delves into her unique background, the ethical considerations of using AI in clinical research, and the evolving regulatory landscape. She offers insightful perspectives on the integration of AI in clinical trials, discussing its potential to revolutionize everything from protocol writing to patient recruitment, while maintaining a human-centric approach.
Whether you’re an AI enthusiast, a clinical research professional, or simply curious about the future of technology in healthcare, this episode promises to provide valuable insights and thought-provoking discussions on the intersection of AI, ethics, and clinical research.
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Stay curious, stay inspired, and join us next time on TrialTalks for more behind-the-scenes looks at the cutting edge of clinical research. Don't forget to check out our website at trialtalksinc.com for more resources, and follow us on our social media channels to stay updated on the latest episodes and insights.
👩🔬 Join the conversation and fuel your passion for clinical research with TrialTalks. See you in the next episode!
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Join us on for an enlightening conversation with Bridget Chapital, known as "The Clinical Trials Lady." With over two decades of experience in the medical research industry, Bridget is a seasoned health educator and a purpose-driven science communicator dedicated to raising awareness about all things clinical research.
In this episode, Bridget shares her unique entry into the field, from her early days as a research coordinator to becoming an innovator who shapes the future of clinical trials. She dives into her experiences navigating the challenges and opportunities of the industry, discusses the evolving role of digital technology in clinical research, and highlights her passionate work with Hypothesis Haven Science Club. As the founder of this youth leadership program, Bridget provides early exposure to life science careers, taking young students behind the scenes of the clinical research process.
Discover how Bridget's journey through various roles has equipped her with insights crucial for anyone looking to make a mark in clinical research. Whether you’re a budding professional or a seasoned expert, Bridget’s story offers valuable lessons on growth, adaptation, and the importance of mentorship in this dynamic field.
Tune in to gain a deeper understanding of the paths you can navigate in the world of clinical research and be inspired by Bridget’s commitment to making a lasting impact.
Follow Bridget on social media:
Facebook/Instagram: @clintrialslady, @hhsciclub
Learn more about Hypothesis Haven Science Club: www.hypothesishaven.com
Explore Bright Ideas Loading Books: www.brightideasloading.com
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Stay curious, stay inspired, and join us next time on TrialTalks for more behind-the-scenes looks at the cutting edge of clinical research. Don't forget to check out our website at trialtalksinc.com for more resources, and follow us on our social media channels to stay updated on the latest episodes and insights.
👩🔬 Join the conversation and fuel your passion for clinical research with TrialTalks. See you in the next episode!
Website: TrialTalksInc.com
Instagram: @trialtalkspodcast / @trialtalksinc
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Join Naomi as she hosts Dr. Jeffrey Huang, a leading scientist from Mammoth Biosciences, in a captivating podcast episode focused on the groundbreaking CRISPR gene editing technology. Jeffrey provides an insightful overview of his journey from neuroscience research to spearheading innovations in gene therapy. He breaks down the complexities of CRISPR, discusses its transformative potential for treating genetic diseases, and addresses the ethical dimensions of this powerful technology. Whether you're deeply embedded in the scientific community or just curious about the future of medicine, this episode is packed with thought-provoking discussions that illustrate the profound impact of CRISPR on healthcare.
Key Topics:
Introduction to CRISPR and its revolutionary role in medicineJeffrey’s transition from academic research to industry leadershipDetailed exploration of CRISPR technology and its applicationsEthical considerations and societal impacts of gene editingChallenges facing CRISPR in clinical settings and its future prospectsCareer insights and advice for emerging scientistsTune in to explore how CRISPR is shaping the future of medical treatments and the ethical landscape of biotechnology. Don’t forget to subscribe for more episodes on the latest clinical research insights and advancements in science and technology!
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In this enlightening episode of Naomi's podcast, we welcome Robert Rachford, a renowned biostatistician and the creator of the educational website Better Biostats. Robert shares his transition from aspiring math teacher to his current role as VP of Biostatistics & Statistical Programming at a global research consulting firm. He discusses the pivotal role of biostatistics in the FDA approval process, illustrating how statistical methods underpin robust clinical trial designs and accurate data analysis, crucial for regulatory compliance and effective drug development.
Robert delves deeper into how his website, Better Biostats, is making biostatistical education more accessible and practical for clinical research professionals. He emphasizes the integration of AI and machine learning in biostatistics, highlighting how these technologies can optimize clinical trials and improve efficiencies in drug development. The conversation also explores the impact of open-source software on enhancing reproducibility and transparency in biostatistical methods, a critical aspect in meeting stringent FDA regulations.The discussion concludes with insights into the continuous need for learning and adaptation in biostatistics to keep pace with technological advancements and regulatory changes. Robert's journey and the resources provided by Better Biostats offer invaluable guidance for anyone interested in the intersection of healthcare, technology, and education, making this episode a must-listen for those eager to understand the critical role of biostatistics in healthcare innovation.
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Stay curious, stay inspired, and join us next time on TrialTalks for more behind-the-scenes looks at the cutting edge of clinical research. Don't forget to check out our website at trialtalksinc.com for more resources, and follow us on our social media channels to stay updated on the latest episodes and insights.
👩🔬 Join the conversation and fuel your passion for clinical research with TrialTalks. See you in the next episode!
Website: TrialTalksInc.com
Instagram: @trialtalkspodcast / @trialtalksinc
Linkedin: TrialTalks Inc. Podcast
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In this enlightening episode of our podcast, we delve into the captivating journey of Ashley, who transitioned from her early days as a medical transcriptionist in the ER to becoming a leader in the field of clinical research. Ashley shares her personal and professional evolution, highlighting the pivotal decisions and adaptive strategies that propelled her into roles as a Clinical Research Associate and beyond. Throughout our discussion, Ashley emphasizes the often-underestimated power of soft skills—such as communication, collaboration, and adaptability—which have played a crucial role in her success and in navigating the complexities of the healthcare industry.
Listeners will gain insight into the challenges and triumphs of shifting career paths within the highly regulated and dynamic environment of clinical research. Ashley also touches on the importance of diversity in clinical studies and the essential nature of effective collaboration between sponsors, CROs, and clinical sites. This episode is a must-listen for anyone interested in the intersections of healthcare, innovation, and personal development, offering valuable lessons on how soft skills can open doors to unexpected and rewarding career opportunities in science and research. Join us to discover how embracing a holistic approach to professional growth can lead to substantial advancements in both personal careers and the field at large.
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Stay curious, stay inspired, and join us next time on TrialTalks for more behind-the-scenes looks at the cutting edge of clinical research. Don't forget to check out our website at trialtalksinc.com for more resources, and follow us on our social media channels to stay updated on the latest episodes and insights.
👩🔬 Join the conversation and fuel your passion for clinical research with TrialTalks. See you in the next episode!
Website: TrialTalksInc.com
Instagram: @trialtalkspodcast / @trialtalksinc
Linkedin: TrialTalks Inc. Podcast
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In this enlightening episode, we dive deep into the heart of innovation within clinical trials with Scott, a pioneering force behind MedVector. This groundbreaking conversation sheds light on how MedVector is redefining the landscape of patient recruitment and accessibility to cutting-edge medical treatments through an ingenious model that bridges the gap between local healthcare providers and clinical research. By enabling treating physicians to host clinical trial appointments without the necessity to become investigators, MedVector is not only expanding access to advanced medical options but also maintaining the crucial continuum of patient care.
The discussion navigates through the challenges of traditional clinical trial recruitment processes and the innovative solutions MedVector introduces to overcome these hurdles. Scott elucidates how MedVector's approach is streamlining the integration of healthcare providers into clinical trials, thereby facilitating a seamless fusion of care delivery and medical research. This episode is a beacon for anyone interested in the future of healthcare, clinical research, and the pivotal role of technology in enhancing patient outcomes and advancing medical science.
Stay curious, stay inspired, and join us next time on TrialTalks for more behind-the-scenes looks at the cutting edge of clinical research. Don't forget to check out our website at trialtalksinc.com for more resources, and follow us on our social media channels to stay updated on the latest episodes and insights.
👩🔬 Join the conversation and fuel your passion for clinical research with TrialTalks. See you in the next episode!
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Dive deep into the lifecycle of drugs and medical devices with your host, Naomi Tapia, on this enlightening episode of TrialTalks. Whether you're navigating a career in clinical research or just fascinated by the journey from innovation to market, this episode has something for everyone.
Join us as we embark on a voyage from the spark of initial innovation in laboratories around the globe to the rigorous phases of clinical trials that lead to groundbreaking treatments and devices. Discover the intricate steps of discovery, target identification, and the pivotal phases of clinical testing that each potential new therapy must pass through before it can make its way into the hands of patients and healthcare professionals.
We peel back the layers of the clinical trial process, shedding light on the essential roles and the dynamic career paths within the field of clinical research. From the biostatisticians who design the trials to the clinical research coordinators who keep everything on track, this episode celebrates the unsung heroes of medical science.
For a closer look at how drugs and devices are brought to life and how you can be a part of this exciting field, tune in to this episode of TrialTalks. Immerse yourself in a world where innovation meets rigor, and where every failure paves the way for future success.
🔗 References & Further Reading:
- FDA's Drug Development Process: An official guide by the U.S. Food and Drug Administration outlining the steps from research and discovery to drug approval. (https://www.fda.gov/patients/drug-development-process/step-3-clinical-research)
- ClinicalTrials.gov: A database of privately and publicly funded clinical studies conducted around the world, offering insights into the scope and scale of ongoing research. (https://clinicaltrials.gov/)
- "The Drug Development Process" by the Pharmaceutical Research and Manufacturers of America (PhRMA):** A detailed overview of the phases of drug development, including preclinical research and clinical trials. (https://www.phrma.org/science/drug-discovery-and-development)
- "Medical Device Development: A Regulatory Overview" by the Food and Drug Law Institute: This publication provides a comprehensive look at the regulatory pathways for medical device approval in the U.S. (https://www.fdli.org/resources/medical-device-development-a-regulatory-overview/)
- "Why 90% of clinical drug development fails and how to improve it?" Acta Pharmaceutica Sinica B, 12(7), 3049–3062. Published in the National Center for Biotechnology Information (NCBI): An insightful article discussing the evolution and future direction of clinical trials.(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9293739/)
Episode Transcript: https://drive.google.com/file/d/134JuNapn87yX0H2Ix27c_8vcD60u0kFZ/view?usp=drive_link
Stay curious, stay inspired, and join us next time on TrialTalks for more behind-the-scenes looks at the cutting edge of clinical research. Don't forget to check out our website at trialtalksinc.com for more resources, and follow us on our social media channels to stay updated on the latest episodes and insights.
👩🔬 Join the conversation and fuel your passion for clinical research with TrialTalks. See you in the next episode!
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Join us as we dive into Naomi's journey of starting this podcast series and discover the engaging topics she's excited to explore with you!
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