Send us a text

Today we’re diving into the exciting world where genetics meets pharmacology. Dr. Emily Cicali will uncover the mysteries of pharmacogenomics (PGX) and explain how your DNA influences your response to medications. Get ready for insights, real-world applications, and a touch of scientific magic!

Emily J. Cicali, Pharm.D., earned her Doctor of Pharmacy from Philadelphia College of Pharmacy in 2015. She completed a Pharmacy Residency at Tabula Rasa HealthCare in Geriatric Personalized Medicine. Afterward, she joined Tabula Rasa HealthCare as a Research Pharmacist and adjunct faculty, focusing on pharmacokinetics and pharmacogenomics.

In 2017, she transitioned fully into academia, completing a pharmacogenomics fellowship at the University of Florida. Cicali is now a Clinical Associate Professor, runs a virtual pharmacogenetics consultation service called MyRx, and focuses on implementing pharmacogenomics and studying phenoconversion for medication safety.

Highlights of the Episode:

• Pharmacogenomics 101: Discover how this DNA test focuses on liver enzymes to predict your response to medications.
• Why It Matters: Learn how understanding your genetics can reduce trial-and-error in prescribing, especially for depression and anxiety.
• Emily’s Journey: Follow Emily’s path from a student fascinated by genetics to an expert in PGX, highlighting her passion and success.
• Clinical Research Impact: Hear about Emily’s role in clinical trials and how PGX testing is improving patient outcomes in pain and mental health management.

Key Takeaways:

• Personalized Medicine: Understand the importance of personalized medication therapy and how PGX can help tailor treatments to individual patients for better efficacy and fewer side effects.
• Real-Life Applications: Learn about the real-world implications of PGX testing, from reducing opioid use in pain management to improving outcomes for heart attack patients.
• Patient Empowerment: Emily emphasizes the role of PGX in empowering patients by giving them more control over their healthcare and improving communication with providers.

Episode Highlights:
[0:54] Emily explains pharmacogenomics and its significance.
[2:09] The benefits of knowing your genetic makeup before starting medication.
[3:25] Emily’s career journey and her passion for genetics and pharmacy.
[6:34] How PGX testing is integrated into clinical practice at MyRx.
[10:54] Emily’s experience in clinical research and the impact of PGX on patient outcomes.
[17:39] The mechanism of drug metabolizing enzymes and their role in medication efficacy.
[20:23] How to discuss PGX testing with your doctor and insurance considerations.
[26:08] Real-life success stories and patient experiences with PGX.
[30:26] Emily’s hopes for the future of PGX and its broader implementation in healthcare.
[36:43] Resources and advice for listeners interested in PGX testing.

📞 Connect with Dr. Emily Cicali:
Website: https://ufhealth.org/myrx/
Email: MyRx@cop.ufl.edu
Phone: 352-273-6415
LinkedIn: https://www.linkedin.com/in/emily-cicali-pharmd-2164b2a4/

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!

Send us a text

In today’s episode of Heart of the Trial, we’re turning the spotlight on the hilarious and insightful Christine Kanalis, who boasts over 25 years of experience in data management. Get ready for a fun and enlightening dive into the world of clinical trial data!

Highlights of the Episode:

• Meet Christine Kanalis: With a background in statistics and a knack for humor, Christine takes us through her fascinating journey in the clinical trial industry.
• Data Management Magic: Learn what it means to gather, clean, and analyze clinical trial data, and why it’s crucial for the success of any study.
• Unexpected Origins: From dreaming of working in a steel mill to discovering a passion for biostatistics, Christine’s career path is anything but ordinary.
• The Human Side of Data: Discover how Christine’s work impacts the lives of patients, and why she’s so passionate about ensuring the accuracy and integrity of clinical trial data.
• Tech Evolution: Christine shares amusing and eye-opening stories about the evolution of data collection, from floppy disks to cloud storage.

Key Takeaways:

• The Importance of Data Integrity: Understand why accurate and complete data is essential for the approval of new drugs and treatments.
• Behind the Scenes: Get a peek into the challenges and triumphs of data management, including the sometimes-frantic efforts to keep technology running smoothly.
• Inspiring Journeys: Christine’s story is a testament to the power of passion and adaptability in building a rewarding career.

Episode Highlights:

• [0:01] Suzanne welcomes listeners and introduces Christine Kanalis.
• [0:25] Christine’s hilarious introduction and her role in data management.
• [1:57] Christine’s journey from a budding mathematician to a director in data management.
• [6:24] The pivotal moment in Christine’s career that made her fall in love with biostatistics.
• [10:50] The evolution of data collection methods over the past 25 years.
• [17:03] The critical role of statisticians and data managers in clinical trials.
• [26:47] Christine’s “why” and what keeps her motivated in the industry.
• [30:19] A heartwarming story of a successful study and its impact on patients.
• [35:11] Christine’s advice for those interested in a career in data management.
• [44:18] Christine’s podcast, The Mental Funny Bone, and where to connect with her.

📞 Connect with Christine:

• Email: christinekanalis@gmail.com
• LinkedIn: https://www.linkedin.com/in/christine-kanalis-5151832/
• Podcast: The Mental Funny Bone https://thementalfunnybone.buzzsprout.com/

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!

Send us a text

Today we're diving into the fascinating world of clinical trial data management with none other than software expert Sam Rolfe. This episode is a rollercoaster ride through the complexities and innovations in managing the documents and data of clinical trials. Buckle up for an insightful and fun discussion!

In this episode, Sam shares his journey from a sports science degree to becoming a key player in the world of clinical trial data archiving. Discover how the evolution of technology has transformed the way we store and manage critical clinical data, ensuring it remains accessible and usable for decades. Sam and Suzanne discuss the importance of regulatory compliance, the risks of outdated storage methods, and the future of decentralized trials.

Having spent the last 12 years working with SaaS Solutions built for Biotech, Pharma and CROs – Sam has experience in software delivery (project management and implementation), pre-sales and full end-to-end sales of both individual applications and platform solutions. He is passionate about how 'true cloud' SaaS solutions help drive Life Sciences companies to bring drugs and devices to patients faster; with greater efficiency, safety and compliance, while reducing the overall cost of development.

Highlights include:

• Sam’s accidental entry into the industry and his passion for making a difference.
• The challenges and importance of archiving clinical trial data for the long term.
• Real-life stories about outdated storage methods, including CDs and DVDs, and the risks they pose.
• The impact of COVID-19 on clinical trials and the rise of decentralized trials.
• Why proper data management and system validation are crucial for the safety and efficacy of new drugs.

Sam also reveals some hilarious and eye-opening anecdotes, like the tale of a clinical trial participant using their dog to cheat step count data. This episode is packed with valuable insights, humor, and a genuine passion for improving patient outcomes through better data management.

So, grab your headphones and join us for a deep dive into the techy side of clinical trials. Whether you're an industry insider or just curious about the behind-the-scenes magic that brings new treatments to market, this episode has something for everyone.

✨ Episode Highlights:

• [0:01] Suzanne's intro and welcoming Sam Rolfe.
• [0:30] Sam's background and the importance of archiving clinical trial data.
• [4:00] The risks of outdated storage methods and the transition to electronic systems.
• [10:00] The impact of COVID-19 on clinical trials and the rise of decentralized trials.
• [14:00] Validation of systems and why it's critical for regulatory compliance.
• [20:00] Fun and unexpected stories from the world of clinical trials.
• [30:00] Sam’s advice for new biotech companies entering the clinical trial arena.
• [40:00] Suzanne and Sam wrap up with a discussion on the importance of communication in the industry.

📞 Connect with Sam:

• LinkedIn: https://www.linkedin.com/in/sam-rolfe
• Email: sam.rolfe@arkivum.com

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!