BioTalk Unzipped BioTalk Unzipped

Summary

In this episode of BioTalk Unzipped, the hosts discuss the applications and ethical concerns surrounding organoids, which are 3D cell clusters that mimic the features of full-sized organs. They explore the potential of brain organoids in brain-computer interfaces and neuroplasticity. The conversation then shifts to the impact of AI and data sciences in healthcare, with a focus on the challenges and opportunities in implementing AI strategies. The hosts also discuss the future of quantum computing in healthcare and the FDA's IT strategy with 21 CFR Part 11. 


Chapters

01:14 - Introduction to BioTalk Unzipped

03:30 - NEW NEWS: Discussion on Organoids and Their Applications 

04:45 - Ethical Concerns with Brain Organoids as mini bio-computers

06:31 - Organoid Possibilities in Drug Discovery Research and Brain Interfaces

08:59 - The Potential of Brain Training and Neuroplasticity

10:51 - The Impact of AI and Data Sciences in Healthcare

11:18 - Jason’s Background and Emerging Technologies Transforming Clinical Research

13:43 - The Role of AI in Precision Medicine, Quantum Computing and Business Growth

24:15 - FDA's IT Strategy and the Challenges of Implementing AI

26:32 - The Importance of Strategy and Prioritization in IT, Data Integrity, and 21 CFR Part 11



How to reach us:

Jason Burke

https://www.linkedin.com/in/jasonburke/

Creo Inc. -  https://www.creoinc.net/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/

Celerion - https://www.celerion.com/ 

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

ECI - https://eci-rx.com/ 

New News Link:

The many uses of mini-organs

https://www.technologyreview.com/2024/03/08/1089612/the-many-uses-of-mini-organs/ 

Image Credits

Brain - https://www.vecteezy.com/vector-art/658977-kawaii-cute-happy-brain-with-arms-and-legs

UFO - https://www.pinterest.com/pin/swampthingy--675891856570360044/



#HealthcareInnovation #Organoids #AI #QuantumComputing #Podcast #BioTalkUnzipped #drugdiscovery

Podcast Show Notes:
“How To Prevent And Fix PAINFUL Medical Device Recalls with Debbie Church”


Host: Gregory Austin
Guest: Debbie Church, Regulatory
Senior Manager, Enhanced Compliance Inc. (ECI)

 

In this Bonus Episode (EP11) you get to watch a recording from a previous LinkedIn Live show discussing the methods, strategies, and techniques you can use to prevent and remediate Medical Device
Recalls. 

Introduction


Gregory Austin, Business Development Lead for Enhanced Compliance Inc. (ECI), welcomes listeners to the BioTalk Unzipped podcast’s LinkedIn Live session.
Special guest: Debbie Church, Regulatory Senior Manager at ECI, with over 25 years of experience in the medical device industry.

DISCUSSION HIGHLIGHTS

1. Trends in Medical Device Recalls


Austin highlights the increasing trend
in medical device recalls over recent years.


Data from the FDA website shows a steady rise: 33 recalls in 2020, 62 in 2023, and 23 in Q1 of 2024.
Questions why these recalls continue to increase?

2. Reasons for Recalls


Church elaborates on the reasons behind medical device recalls.
Discusses the consequences of changes leading to unintended outcomes.
Highlights the importance of having robust post-market surveillance programs to handle complaints effectively.


3. Costs Associated with Recalls

Financial Costs: Direct expenses, legal and regulatory costs, and reputation damage.


Operational Costs: Rework, redesign, and supply chain disruptions.
Innovation Impact: Delayed innovation and competitor advantage.
Patient Safety and Trust/Brand: Potential patient harm and loss of trust.
Stock Price Impact: Share price decline after major recall events.

4. Quality Improvement Initiatives


Church shares examples of successful quality improvement initiatives.
Discusses FDA’s updated cybersecurity guidance and improvements in Quality Management Systems (QMS) and Corrective and Preventive Actions (CAPA) procedures.

5. Reporting Process and Regulatory Collaboration


Walks through the process of reporting a medical device recall to regulatory authorities.
Explores how regulators collaborate with industry stakeholders to improve the effectiveness of recalls and prevent future issues. 

Conclusion


Austin summarizes the discussion, emphasizing the multifaceted costs of medical device recalls.
Highlights the importance of robust post-surveillance programs, quality control, and proactive prevention measures.
Invites listeners to reach out for further assistance or questions.

 

Contact Information:

Gregory Austin: gregory.austin@eci-rx.com

https://www.linkedin.com/in/gregoryaustin1/

Debbie Church, Sr. Manager of Regulatory Compliance, ECI

https://www.linkedin.com/in/debbie-kidder-church-b921a169/ 

Enhanced Compliance Inc.

https://eci-rx.com




#MedicalDevices #Recalls #QualityAssurance #RegulatoryCompliance

Summary

In this episode, Scott Schliebner discusses the unique challenges and complexities of rare disease trials. He highlights the difficulties in recruiting patients, the multidisciplinary nature of care, and the importance of collaboration among various stakeholders. The role of AI in rare disease trials is also explored, with a focus on its potential for patient recruitment and data analysis. 

Scott shares success stories in the field and discusses the expanding use of gene therapy to target multiple genes. The conversation concludes with a discussion on the recent FDA approval of Iovance's Amtogvy as the first T-cell therapy for a solid tumor, Melanoma. In this conversation, Scott discusses the potential of cell therapy in targeting solid tumors, particularly melanoma. He highlights the importance of expanding the use of cell therapy to other tumor types and the potential for curative treatments. The conversation also delves into the challenges and questions surrounding pricing and ethics in the gene and cell therapy space. The impact of curative therapies on quality of life and healthcare costs is explored, along with the success of curative therapies in hepatitis C. The high bar of clinical development and regulatory standards is discussed, as well as the potential for cost-effective treatments. The conversation concludes with advice for young professionals and established clinical professionals in the field of drug development.

Takeaways


Cell therapy shows promise in targeting solid tumors, such as the breakthrough in melanoma treatment, and has the potential to provide curative treatments for various cancer types.


The pricing and ethical considerations surrounding gene and cell therapy raise important questions about accessibility and affordability.


Curative therapies have the potential to significantly improve quality of life and reduce healthcare costs by eliminating the need for long-term treatments.


The success of curative therapies in hepatitis C demonstrates the potential for similar breakthroughs in other disease areas.


Young professionals interested in a career in clinical drug development should seek opportunities to gain experience and consider starting in roles such as clinical research coordinators or clinical research associates.


Rare Givers is a nonprofit organization that supports caregivers in the rare disease space.



Chapters

00:21 - Collaborative Approach in Rare Disease Trials

3:32 - The Role of AI in Rare Disease Trials

6:11 - Success Stories in Rare Disease Trials

11:34 - Expanding Gene Therapy to Target Multiple Genes

16:56 - New News: FDA Approval of Iovance's Amtagvi, The Breakthrough of IOVANCE for Melanoma

19:27 - Targeting Solid Tumors with Cell Therapy, Expanding the Potential of Cell Therapy

20:23 - The Impact of Curative Therapies on Quality of Life and Healthcare Costs

21:11 - Challenges and Questions around Pricing and Ethics

22:37 - Cures for Hepatitis C

23:25 - The High Bar of Clinical Development and Regulatory Standards

24:05 - Pricing Considerations for Different Cancer Types, The Potential for Cost-Effective Treatments

27:45 - Advice for Young Professionals in Clinical Drug Development

31:49 - Advice for Established Clinical Professionals

33:21 - Scott's Hobbies and Interests

Learn about and DONATE to Rare Givers:

https://www.raregivers.global/ 

How to reach us:

Scott Schliebner

https://www.linkedin.com/in/scott-schliebner-1087789/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

New News Link:

https://www.fiercepharma.com/pharma/fda-approves-iovances-amtagvi-first-cell-therapy-solid-tumor 

Image Credits

Iovance, https://www.iovance.com/ 

FDA approved, https://www.tipranks.com/news/iovance-nasdaqiova-fda-approves-cell-therapy-stock-gains

Amtagvi, https://www.amtagvi.com/ 

Impact of AI in Rare Disease Trials with Scott Schliebner

Summary

In this episode, the hosts welcome Scott Schliebner as their guest and kick off with a charitable act, donating to Rare Givers. They delve into the Epitomee weight loss capsule's potential impact, then shift to discussing the challenges of establishing a North American infrastructure for a MedTech CRO, navigating cross-cultural dynamics. Later, they investigate the transformative potential of AI and machine learning in clinical trials. Scott Schliebner weighs in on the intricacies of rare disease trials, emphasizing patient recruitment hurdles, interdisciplinary care, and stakeholder collaboration. The conversation also delves into AI's role in addressing these challenges, particularly in patient recruitment and data analysis.


#clinicaltrials #science #ai #raredisease #drugdevelopment Takeaways


Rare Givers (https://www.raregivers.global/) is a nonprofit organization that supports caregivers in the rare disease space.


The Epitome weight loss capsule is an innovative medical device that tricks the body into feeling full, aiding in weight loss.


Building a North American infrastructure for a MedTech CRO requires navigating cultural differences and finding key leaders who can adapt to a startup environment.


AI and machine learning have the potential to transform clinical trials by improving drug discovery, analyzing large datasets, and enhancing patient retention. 



Chapters

00:00 - Introduction and Charity Donation - Rare Givers

02:30 - Discussion on Rare Givers

04:08 - What inspired Scott to the Clinical space

06:12 - New News: Epitomee Weight Loss Capsule

11:25 - Epitomee target drug delivery application weight loss competition with Wegovy

14:05 - Building a North American infrastructure for EU-based MedTech focused CRO

16:35 - Cultural idiosyncrasies to be aware of doing business with different countries

23:53 - The Impact of AI and Machine Learning, and generative AI in Clinical Trials, drug development, FDA compliance, and quality control

30:13 - Understanding Rare Disease Trials, and overcoming challenges 

33:12 - Is it a Zebra or a Horse?

DONATE to Rare Givers:

https://www.raregivers.global/ 

How to reach us:

Scott Schliebner

https://www.linkedin.com/in/scott-schliebner-1087789/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

New News Link:


Epitomee® announces the filing of a novel Weight Loss Capsule for FDA clearance



https://www.prnewswire.com/news-releases/epitomee-announces-the-filing-of-a-novel-weight-loss-capsule-for-fda-clearance-302081225.html



NIH Study publication: Safety, tolerability and efficacy of a novel self‐use biodegradable device for management of obesity



https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6700511/ 




Image Credits

Zebra - https://www.rarediseaseday.org/event/6th-annual-rare-disease-day-virtual-race/ 

Description:

In Episode 8 of BioTalk Unzipped, we dive deep into the scientific mind of Dr. Russell Grant, exploring how he navigates groundbreaking publications with a healthy dose of skepticism. From microsampling blood spots to dissecting experimental execution gaps, Dr. Grant reveals his strategies for separating scientific sizzle from substance.

In our latest segment of "New News," we discuss Elon Musk's Neurolink gaining FDA approval for clinical trials, sparking debates about neuroscience's role in the 21st century. With insights into the risks and rewards of understanding brain biochemistry, this episode challenges conventional thinking.

Discover the secrets behind Dr. Grant’s legendary leadership with the Triangle Area Mass Spec (TAMS) group, where mentorship, empowerment, and strong networks bridge academia and industry. Uncover how Dr. Grant encourages scientists to stay focused on foundational processes while striving for brilliance in their work.

From unexpected breakthroughs in sensitive testosterone measurements to fostering career development in his team, Dr. Grant shares invaluable lessons in leadership and personal growth. Tune in for memorable quotes, career insights, and a glimpse into Dr. Grant's life beyond the lab.

Join us as we unzip the world of science with Dr. Russell Grant on BioTalk Unzipped!

#biotechnology #diagnostics #science #innovation #leadership #pharmaceutical



SEGMENTS:


1:22 - What does Russ Grant’s brain do when he sees a groundbreaking publication?  7:47 - New News!


13:10 - Dr. Grant’s leadership with the TAMS (Triangle Area Mass Spec) group and why it’s so successful. 


24:05 - Has the challenges for grad students changed in the past 2 decades?


26:49 - When Russ’ work led to something truly unexpected, 


30:56 - Leadership in career development and the people they lead


35:51 - More memorable quotes


37:30 - What Russ does for fun.



How to reach us:

Dr. Russell Grant

grantr@labcorp.com

https://www.linkedin.com/in/russell-grant-5144a26/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

Conferences mentioned:

ASMS - https://www.asms.org/ 

MSACL - https://www.msacl.org/ 

ADLM - https://www.myadlm.org/ 

TAMS, Triangle Area Mass Spectrometry Discussion Group - https://tamsgroup.org/ 

New News Link:

https://www.fiercebiotech.com/medtech/neuralink-implants-brain-computer-interface-first-human-trial-participant 

Image Credits

Client Eastwood, Firefox - https://www.youtube.com/watch?v=eJJXIcig2h8 

Neuralink - https://dig.watch/updates/neuralinks-first-human-implant-shows-promising-results 

Tricorder Tech: That Star Trek Medical Scanner Is Getting Much Closer

https://astrobiology.com/2023/11/tricorder-tech-that-star-trek-medical-scanner-is-getting-much-closer.html 

Neuralizer - https://meninblack.fandom.com/wiki/Neuralyzer 

Join us for Episode 7 of our podcast as we delve into the fascinating journey of Dr. Russell Grant, from the UK to America, navigating through large pharma to the field of diagnostics. Discover the nuances between bioanalytical approaches in clinical trials versus clinical healthcare, and Russ's insights on GLP environments. Learn how Russ tackled the challenges of COVID, and hear the incredible New News breakthrough in restoring hearing in an 11-year-old using gene therapy. Russ shares his American dream, his passion for diagnostics, and his thoughts on scientific integrity. Tune in for a captivating discussion on the critical role of diagnostics in saving lives and the pursuit of scientific excellence.


#biotechnology #diagnostics #science #innovation #patientcare

SEGMENTS:

1. Transitioning Across Continents: A Tale of Professional Evolution - From the UK to America, Exploring Pharma to Diagnostics.

2. Navigating Bioanalytics: Unraveling the Contrast Between Clinical Trials and Healthcare Applications, with a Focus on Mass Spec.

3. Efficiency in Action: Revolutionizing Patient Care by Shaving Seconds Off Injections, One Assay at a Time.

4. COVID Chronicles: Dr. Russel Grant's Vital Role Amidst the Pandemic's Chaos.

5. New News!: A Landmark Achievement in Gene Therapy Unveiled.

6. Crossing Borders: Dr. Russel Grant's Journey to America - Dreams, Challenges, and Triumphs.

7. Fueling Passion: Understanding Russ' Zeal for the Field of Diagnostics.

8. The Power of Diagnosis: Unveiling How Diagnostics Serve as Lifelines in Healthcare.

9. Navigating Integrity: A Candid Discussion on Scientific Literature, Academic Fraud, and the Path Forward for Scientists.



Connect with:

Dr. Russell Grant: https://www.linkedin.com/in/russell-grant-5144a26/ 

Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/ 

Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ 



New News link:

Lilly makes waves, says gene therapy restores hearing for child with genetic hearing loss



Image Credits:

David Gilmour (Getty Images)

Sir Isaac Newton, https://en.wikipedia.org/wiki/Isaac_Newton