Transformation in Trials – Détails, épisodes et analyse

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How do you navigate the complexities of manufacturing cell and gene therapies that are tailored to individual patients? Find out as we sit down with Dr. Bruce Levine from the University of Pennsylvania to unpack the intricacies of clinical research in this groundbreaking field. From the unique emphasis on chemistry, manufacturing, and controls (CMC) to the logistical hurdles of sourcing and modifying patient-derived cells, Dr. Levine offers an expert's perspective on the challenges and advancements that set these therapies apart from traditional drugs. We also shine a light on the vital role of the International Society for Cell and Gene Therapy in driving forward these innovative treatments.

In another riveting segment, we delve into the recent FDA investigation into cases of T-cell malignancies following CAR T-cell therapy. With data gleaned from voluntary reporting databases, we scrutinize causality, immortal time bias, and the need for improved reporting standards. Dr. Levine shares his thoughts on the importance of thorough patient follow-up and effective communication of risks and benefits. We also explore the evolution of cell and gene therapy, tracing Dr. Levine's journey from his early days in immunology research to his pivotal role in shaping the field. This episode is a must-listen for anyone interested in the dynamic and ever-evolving world of cell and gene therapy.

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What if re-engaging with your purpose could revolutionize your job satisfaction and mental health? Join us for our conversation with Jill Donahue, a leader in life sciences whose personal journey through psychology, behavioral science, and a profound personal tragedy has fueled her mission to improve communication and trust within the healthcare community. Jill opens up about how these experiences led her to create initiatives like her book "A Dose of Inspiration" and the Aurora Project, both aimed at fostering a deeper sense of purpose among life sciences professionals.

Step into the world of Johnny, a shuttle bus driver in Phoenix, who discovered how focusing on spreading happiness could significantly transform his work experience and income. This inspiring tale serves as a powerful reminder that a purpose-driven mindset can make a difference in any role, from healthcare to pharma and beyond. Jill and our hosts discuss practical strategies for connecting with your "why" and engaging audiences during presentations through personal motivations and stories, highlighting how genuine connections can enhance both professional and personal experiences.

The conversation shifts to the pharmaceutical industry’s much-needed transformation towards patient partnership. Jill passionately advocates for a shift from product-centric to patient-centric narratives, emphasizing the importance of presenting treatment options and building expertise in specific disease states. This approach, she argues, not only improves patient care but also makes the role of pharma representatives more fulfilling. Tune in to hear Jill's excitement about her book, "A Dose of Inspiration: 100 Purpose Stories from Pharma Leaders," and her dream of igniting a sense of purpose in everyone within the industry.

Notes:
A Dose of Inspiration: 100 Purpose Stories from Pharma Leaders can be found on Amazon or as a free download at www.excellerate.ca/freebook

More information about The Power of Purpose can be found here

Jill can be reached here on LinkedIn

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Ever wondered why the life sciences industry is stuck in redundant vendor qualification processes? Picture an organization where quality is designed rather than inspected. Yes, it's possible and we're about to paint that picture for you in this stimulating conversation with our guests, Dele Babalola and Rani Naik. They've got their fingers on the pulse of the GxP space and are ready to share their insights on the pressing need to evolve from redundant processes. Pay attention as Rani unfolds her unique vision for an agile, phase-appropriate quality organization. 

Imagine a world where vendor qualification is not a daunting task but a streamlined process. We got you thinking, right? Dele and Rani join us to unravel this concept further. It's all about being proactive, focusing on effective oversight, and perhaps venturing into the world of pre-approved vendors. From discussing the role of certification bodies to emphasizing the significance of a proactive approach, we've got this topic well covered. 

Enter the world of vendor management where challenges are like a complex puzzle waiting to be solved. This is where Dele and Rani's expertise shines as they shed light on transparency, collaboration, and the risk-based approach. Here's a plus - they also detail the potential value of remote audits and the importance of having an internal individual who can ensure clear process flow. As we wrap up, we can't help but yearn for a more innovative industry that's ready to take leaps. You won't want to miss this candid conversation.

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Get ready to learn about clinical trials operations from an expert. This episode is an opportunity to learn all about the essential aspects of managing such trials and the core role of contract research organizations (CROs) in the process. We have the privilege of introducing Becky Baggett, Associate Vice President of Project Delivery at Rho, who unravels the complexities of clinical trials for us. She not only lays out the distinct stages and components of a clinical trial but also enlightens us on the crucial collaboration between the sponsor and the CRO, the importance of clinical research sites, data management, and project management. She underscores the absolute necessity of establishing solid relationships, trust, and experience in this highly controlled and regulated field.

As we navigate further, we plunge into the thrilling and demanding world of technology in clinical trials. This part is a trove of information on how technology can streamline trials and why it's crucial to tailor technological applications to the specific needs of therapeutic areas. This episode is not just about information, but also about engaging in a thought-provoking discussion, where we examine the subtleties of conducting trials across different therapeutic areas. We end on a note of aspiration, echoing the collective wish for increased funding in the industry, which could potentially fast track more life-saving medications from lab to market.

Guest
Becky Baggett

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Ever wondered what goes into designing a modern, adaptable, and inclusive lab space? Join us as we uncover the intricacies of laboratory planning with architect and lab planning leader, Marilee Lloyd. Marilee takes us behind the scenes of designing new research labs, divulging the importance of flexibility, adaptability, and the use of modular benching. She sheds light on the unique challenges and considerations of modernizing older labs, while emphasizing the impact of thoughtful lab design on achieving clinical outcomes.

We also engage in a lively discussion on sustainable and inclusive lab design with our  guest. Marilee's passion for diversity in the life sciences industry and her dedication to creating environmentally-friendly and welcoming lab spaces is truly inspiring. From reducing air changes and utilizing high-performance fume hoods to fostering inclusivity with elements of nature and thoughtful design, Merilee provides a unique perspective on lab planning.

Guest:
Marilee Lloyd 

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Ever wondered about the science behind a simple cough? What if we told you that a cough is not as simple as it seems and AI technology could revolutionize how we perceive it? Come along as we host Dr. Peter Small, acoustic epidemiologist and Chief Medical Officer of Hyfe, who enlightens us on the complexity of measuring coughs in clinical trials. Hear how traditional cough assessment methods are falling short and the challenges the FDA faces when validating new cough-suppressing medications. Furthermore, we discuss the severe impact of chronic cough on individuals, exacerbated by the COVID-19 pandemic, and how acoustic AI offers a unobtrusive and privacy-preserving solution for cough counting.

Imagine a future where cough monitoring becomes as routine as step counting. In the second half of our chat, Peter shares insights on the potential of acoustic diagnostics in revolutionizing cough treatment. Hear about a promising digital therapeutic for chronic cough, designed to reduce cough frequency, and the scarcity of effective cough treatments in today's medical landscape. From wellness apps to dedicated watches and SDKs for various devices, we discuss different forms of cough recognition technology, setting the stage for a future where technology and healthcare converge in fascinating ways.

Guest:
Dr. Peter Small
Hyfe 

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Join us in a conversation with Nechama Katan, as we investigate the  world of generative AI in life sciences, a realm where technology meets business, and where Nechama, an expert in innovative data in the clinical space of life sciences, will guide us.

We're taking a deep dive into the ever-evolving realm of technology in life sciences. We'll take a look at the shift from standalone to integrated tools, and how generative AI is influencing the distribution of labor in life science companies. We'll also explore the potential uses of generative AI in data summarization, and how it could disrupt the traditional role of programmers in clinical trials. Nehamah will share her experiences with chat GPT, Amazon product reviews, Grammarly, and Databricks AI Assistant, shedding light on how generative AI is being implemented in clinical trials and data analysis.

Finally, we will explore technology's significant role in data analysis. Nechama envisions a future where data is readily accessible to everyone seeking answers. She believes generative AI can help us verify random facts and enhance exploratory data analysis. She'll also share insights on how providing the right context to AI can enhance our understanding of the data in front of us. Tune in for this insightful discussion and be sure to reach out to Nechama for any queries or assistance you may need with a complex problem.

Guest:
Nechama Katan

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What if a pharmaceutical company can be deconstructed and re-assembled in a new configuration? This is already happening in cell and gene therapy manufacturing. Join us for an enlightening conversation with Jason Bock, the founder and CEO of CTMC, who has been at the forefront of this intersection between clinical research and manufacturing. Discover the unique challenges of setting up a manufacturing network for autologous cell therapies and how this relationship between clinical and manufacturing sites differs from traditional methods. Jason shares his journey of moving to MD Anderson Cancer Center, setting up a biotech firm, and transforming the supply chain, thereby expediting product development.

Imagine the thrill of cell therapy advancements and the potential for cures in a single dose! Uncover how the trailblazing minds at CTMC and MD Anderson have submitted six INDs in the span of just 18 months. Half of these are MD Anderson invented therapies, while the rest are biotech invented products. Alongside these exciting developments, we also delve into the implications of such revolutionary treatments on the healthcare system. Understand the challenges that lay ahead in terms of making these potentially curative treatments widely accessible. Tune in for this riveting discussion on the transformation of healthcare, offering a glimpse into the future of medicine.

Guest:
Jason Bock

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How is the pharmaceutical and biotech industry changing in the current financial climate? Our guest today, Ryan Keane, founder and CEO of Korio, shines a bright light on these subjects and more. This discussion is an exploration of our current healthcare landscape, dissecting the challenges companies face as they introduce new technology, the sudden shift in the vendor landscape, and the unexpected destruction of value in biotech due to companies discarding or divesting their assets.

We don't just stop at the surface. Ryan takes us deep into the complexities of customizing Interactive Response Technology (IRT) systems in clinical trials, highlighting the crucial role of education for both buyers and industry employees. We tackle the challenges of communicating complex information to patients and the need for creating reproducible and scalable processes. The conversation veers into the often misunderstood realm of clinical trial supply, the need for a no-code environment, and the importance of having technologically savvy folks who comprehend all the elements.

Guest:
Ryan Keane 

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Ready to lift the lid on the untapped potential of open-source technology in clinical trials? Strap in for a fascinating journey with our guest Lionel van Holle, the founder of Open Source PV. We'll unveil the transformative power of open-source tech in the life sciences industry, including its innate transparency, parallel development capabilities, and cost-effectiveness. Lionel shares insights into the diversity of SAS, R, and Python programmers involved in this field, revealing how the open-source revolution is just around the corner.

The collaboration between code and pharmacovigilance is changing the game, and we're excited to share this revelation with you. Tune in as we navigate the complexities of finding the right code packages and understand the nuances of search engine keywords. We also uncover the tremendous impact of the FDA's move towards open-source data and algorithms, highlighting the future of industry-wide collaborations. Concluding our discussion, we delve into the promise of machine learning and automation in medical writing, demonstrating how tech is poised to interpret data and create automated reports, potentially revolutionizing the way we see medical documentation. Join our enlightening conversation and discover the next frontier in life sciences.

Guest:
Lionel Van Holle

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