In this powerful episode (#35) of BioTalk Unzipped, recorded live at the AAPS NBC conference in Boston, Gregory Austin engages in a deep conversation with a leading Neuroscientist, Dr. Robert Thorne, Denali Fellow at Denali Therapeutics, for an intimate and scientific deep dive into the evolving world of brain cancer treatment and CNS drug delivery. Both Gregory and Dr. Thorne share personal stories of losing family members to brain metastases, weaving in the emotional 'why' behind their professional paths.

Dr. Thorne highlights the complexities of the blood-brain barrier, the heterogeneity of brain metastases, and cutting-edge delivery technologies—including focused ultrasound and molecular engineering approaches. The conversation also touches on pediatric brain tumors like diffuse midline glioma (DIPG), emerging research in lysosomal storage diseases, and the collaborative spirit driving innovation in neuroscience today.

This is more than a technical discussion—it’s a human story about grief, hope, and the relentless pursuit of better outcomes for patients with brain diseases.

00:00 Preview & Intro

01:10 Robert Thorne’s Reflections on the AAPS NBC conference

03:14 The Professional Biotech and Pharma League

05:09 A Personal Story Shared: Family Loss to Brain Cancer

07:57 My Reason for Optimism Treating Brain Cancer

08:50 Why Brain Metastases Remain Hard to Treat

11:10 Scientific Advances in Drug Delivery for Brain Cancer

12:30 Seed and Soil Concept in Oncology

15:18 Pediatric Brain Tumors: DNET, DIPG, and Beyond

16:49 Looking Ahead: Hope for Future Therapies

21:32 Closing Gratitude

Dr. Robert Thorne

https://www.linkedin.com/in/robert-g-thorne/

Denali Therapeutics - https://www.denalitherapeutics.com/ 

Dr. Chad Briscoe

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

Celerion - https://www.celerion.com/  

Gregory Austin

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

Celerion - https://www.celerion.com/  

• Personal Connection Fuels Professional Passion: Both Gregory and Dr. Thorne were driven into the life sciences field by family experiences with brain tumors.

• The Blood-Brain Barrier (BBB) Remains a Major Challenge: Brain metastases from cancers like melanoma, lung, and breast cancer still present difficult delivery barriers for therapies.

• Heterogeneity in Brain Mets: Different metastases within the same patient can have vastly different BBB permeability, requiring multifaceted delivery strategies.

• Emerging Drug Delivery Innovations: Focused ultrasound, engineered biologics, and Denali’s own delivery platforms are all promising ways to improve CNS drug penetration.

• Pediatric Brain Cancers Present a Unique Set of Challenges: Diseases like diffuse midline glioma (DIPG) remain largely untreatable, but learnings from lysosomal storage disorders may translate in the future.

• The Power of Community in Science: The conference setting highlights how collaboration and diverse perspectives drive breakthroughs in bioanalysis and drug development.

In this special episode (#34) of BioTalk Unzipped, recorded live at the AAPS NBC conference in Boston, Gregory Austin and Dr. Chad Briscoe sit down with AAPS President Dr. Russ Weiner for an unfiltered look inside AAPS NBC, at the state of rare disease research, the evolution of therapeutic modalities, and the human stories that drive scientific innovation.

From navigating the emotional weight of personal loss to watching his son experience the field firsthand, Russ shares not only his scientific insights but the heart behind his leadership. The conversation spans topics like the rising promise of AI diagnostics, challenges with biomarker sampling logistics, the role of CROs in rare disease trials, and the future of autologous vs. allogeneic therapies.

Dr. Weiner also offers an inspiring vision of industry collaboration, sharing how organizations like AAPS are becoming conduits for progress across low- and middle-income countries, underrepresented diseases, and emerging biotechnologies. Whether you're in the lab, the boardroom, or on the frontlines of clinical trials, this episode will reignite your sense of purpose in this field.

00:00 Preview & Intro

01:22 What is conference life like as AAPS President

02:27 Mentoring & Fatherhood at AAPS

03:54 Setting up the Meeting Season for AAPS

05:43 Life back in the Rare Disease Space - a Passion

10:58 The different costs of pharmaceutical & biotech research

12:59 The generosity of Rare Disease Patients

14:41 Dr. Chad Briscoe asks Russ what can we do to help advance Rare Disease efforts

19:57 Rare Disease conversations happening at AAPS and global reach

22:37 Broad use of new technologies, including Olink

24:10 Biggest change expected in Pharma in 10 years

Dr. Russ Weiner

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

AAPS - https://www.aaps.org/home 

Dr. Chad Briscoe

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

Celerion - https://www.celerion.com/  

Gregory Austin

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

Celerion - https://www.celerion.com/  

Takeaways:

• Treating rare diseases early is not only life-saving—it’s economically sound. Gene and cell therapies may carry high price tags, but they dramatically reduce long-term costs.
• The diagnostic delay for rare diseases—often 4 to 7 years—remains one of the biggest barriers to treatment. AI-powered diagnostics and data integration could change that.
• Dr. Russ Weiner shares how personal loss fueled his career in science and how mentoring the next generation, including his son, brings it full circle.
• The shift toward allogeneic cell therapies and in vivo CAR-T treatments will be key to driving down costs and increasing global accessibility.
• CROs must evolve: future-ready organizations will localize biomarker analysis and forge relationships with rare disease investigators to improve site performance.
• Technologies like Olink are revolutionizing biomarker discovery, enabling cost-effective, high-resolution multiplexing that was previously out of reach.
• Spatial imaging, AI pathology, and facial-recognition-based diagnosis are the next wave of precision medicine.

Quotes

“Treating rare disease isn’t just compassionate—it’s a smart investment. Do the math, and curing someone can be far cheaper than managing chronic care for a lifetime.”

“You can’t say it’s not in your backyard when that backyard becomes yours the moment you're on the same plane.”

(on global health and infectious disease risk)

“Some of the most generous people in clinical research are rare disease patients. They fight so no one else has to.”

“It took me six months to even scratch the surface of this portfolio—rare disease isn’t just rare, it’s overwhelmingly complex.”

In this powerful episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Katrina Rogers, a 25-year life sciences veteran, biotech equity advocate, and founder of Evergreen Bioscience Innovation and Katrina Rogers Consulting. Katrina shares her compelling journey from Pfizer to pioneering innovation ecosystems and mentoring underrepresented biotech founders. They unpack the role of board governance, the funding gap for female founders, and how "showing your science" is critical for regulatory success. Katrina also warns of dangerous gaps in understanding between regulators and innovators and why we must protect our basic science infrastructure. If you've ever dreamed of launching a breakthrough therapy, leading a biotech, or making your idea count, this episode is for you.

00:00 Episode Preview & BioTalk Unzipped Introduction

03:09 Katrina’s Charity Highlight: 2nd Harvest (link below)

04:04 Defining Moment in Life Science

05:35 Launching a Consultancy: Overcoming Fears

07:12 Leadership Lessons

09:30 The Importance of Board Composition

13:08 NEW NEWS: The Case for Female Founders

18:04 Knowledge Gaps Between Founders and Regulators

20:23 The Impact of Regulatory Changes

21:32 The Direct Attack on Basic Scientific Infrastructure

25:57 Understanding Market Needs

29:36 The Role of Founders in Leadership and Navigating Leadership Challenges

34:00 The Most Common Mistake by Biotech Founders & What To Do

35:27 Katrina’s Scope & Delivering Unpleasant News

36:51 NEW NEWS: Understanding Tariffs and Drug Pricing

42:23 Empowering Big Ideas

45:26 Overcoming Systemic Barriers

47:24 Advice to My Younger Self

49:38 Proposing Changes to FDA Innovation Pathways

54:54 The Future of Innovation in Biotechnology

Katrina Rogers

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

https://krogersconsulting.com/ 

Katrina’s Favorite Charity: 2nd Harvest (Food Bank) - https://2-harvest.org/ 

Dr. Chad Briscoe

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

Celerion - https://www.celerion.com/  

Gregory Austin

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

Celerion - https://www.celerion.com/  

NEW NEWS

Biotech a Bright Spot for Female Founders Amid DEI Pullback, https://www.biospace.com/business/biotech-a-bright-spot-for-female-founders-amid-dei-pullback?utm_source=chatgpt.com 

Trump signals shift in drug import tariff policy

https://www.techtarget.com/pharmalifesciences/news/366622459/Trump-signals-shift-in-drug-import-tariff-policy 

Quotables

"The world needs your big idea."

"Build trust and that will engender loyalty."

"You need to have a board already established."

"Show them your science."

"Be Specific and people can be incredibly generous with their time."

"Tariffs are incredibly blunt economic instruments."

"You should at least try to get it out there."

"Our culture has expectations that limit us."

"You have to drive that vision."

“Stop playing small - you’re meant for more.”

“Put the Visionaries with the Doers and you’re unstoppable!” 

• Founders should evaluate their board members early in the process.
• Female founders are underrepresented but show higher returns on investment.
• Understanding customer needs is crucial for product development.
• Regulatory changes can create knowledge gaps for founders.
• Basic science is essential for innovation in drug development.
• Leadership challenges often stem from board dynamics.
• Problem-solving tools can help founders navigate challenges. The most common mistake is not doing enough discovery research.
• Building a network is crucial for early-stage entrepreneurs.
• People are generous with their time if you’re super specific about your need!
• Delivering unpleasant news is part of being a problem solver.
• Tariffs can disrupt supply chains and raise drug prices.
• Leadership roles require proactive vision and engagement.
• Cultural expectations can limit innovation and self-worth.
• Anyone can be an innovator with the right support.
• The skilled technical workforce is vital for future innovation.
• Passion drives significant advancements in biotechnology.

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Alfred Botchway, CEO of Attentive Science, to discuss his journey in biomedical science and the groundbreaking work being done at the intersection of AI, non-clinical safety, and drug discovery. Dr. Botchway shares his insights on the role of AI in refining toxicology studies, how stress impacts human health, and his experience founding companies like Xenometrics and Attentive Science.

The conversation dives deep into the complexities of Good Laboratory Practices (GLP), the importance of regulatory standards, and the exciting research happening in anxiety and PTSD treatments. Dr. Botchway also discusses the future of biomedical research, the need for greater collaboration between academia and industry, and how innovations in sample collection are transforming clinical trials.

Whether you’re interested in AI, biomedical innovation, or the future of drug discovery, this episode offers valuable insights from a leader shaping the industry.

Don’t forget to subscribe and let us know your thoughts in the comments below!

Dr. Alfred Botchway

https://www.linkedin.com/in/alfred-botchway-41b01a6/

CEO of Attentive Science: https://www.attentivescience.com/

Dr. Chad Briscoe

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

Celerion - https://www.celerion.com/

Gregory Austin

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

Celerion - https://www.celerion.com/

00:00 Introduction to BioTalk Unzipped

02:32 Dr. Alfred Botchway's Journey in Biomedical Science

03:48 Challenges Founding and Growing Xenometrics

07:30 Starting Attentive Science: A New Venture

09:37 Love of the Work - Variations

10:26 The Role of AI in Non-Clinical Safety Assessments

13:04 The Three Rs: Replace, Reduce, Refine, and AI

15:46 Regulatory Standards and Good Laboratory Practices

20:42 New News! - Research on Anxiety and Drug Discovery

27:07 Cortical Stimulation and Stress Management

27:45 Bridging Academia and Industry

29:26 Engaging the Next Generation in Science

32:42 The Value of Vocational Training in Science

34:47 Community Involvement and Giving Back

37:00 Cultural Influences on Leadership

42:39 Global Expansion and Strategic Goals

48:41 Innovations in Sample Collection for Clinical Trials

Digital Twin Episodes reference with Tomas Helikar:

Transforming Immunology: The Promise of Digital Twins with Dr. Tomáš Helikar

https://youtu.be/jTM_Zlt3wxU

Digital Twins: The Future of Drug Discovery with Dr. Tomáš Helikar

https://youtu.be/NM5X0jTd6UA

In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe reflect on their journey over the past year, discussing key themes and insights gained from their guests. They explore the humanistic approach to healthcare, the impact of AI in drug development, common threads among successful individuals, personal growth through conversations, and the importance of leadership and mentorship in the industry. The episode concludes with exciting plans for future series focused on drug development and global healthcare innovations.

Thanks to CREO Consulting for hosting this episode!

https://creoconsulting.com/ 

Dr. Chad Briscoe

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

Celerion - https://www.celerion.com/  

Gregory Austin

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

Celerion - https://www.celerion.com/  

Takeaways

• Every sample is a person, a patient, a loved one.

• Embrace the fear, take more risks.

• The importance of human connection in drug development.

• AI is becoming integral in drug discovery and development.

• Successful individuals often wish they had taken more risks.

• Leadership in the industry is about raising others up.

• Mentorship plays a crucial role in professional growth.

• Personal growth can come from listening and engaging with others.

• Innovative approaches are essential in addressing industry challenges.

  
  

Keywords

BioTalk, drug development, AI, mentorship, leadership, podcast, healthcare, innovation, personal growth, industry insights

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Ines Santos and Dr. Julia Sable to discuss their experiences and contributions in the pharmaceutical sciences, particularly focusing on women's roles in the field. The conversation covers their personal journeys into science, the importance of STEAMpark.org in education, exciting projects they've worked on, challenges in CMC for cell and gene therapies, innovations in chiral bioanalysis, and recent industry developments. The panel emphasizes the significance of collaboration and mentorship in advancing medical progress. This conversation delves into the evolving landscape of cancer treatment, particularly the integration of combination therapies like CAR T and oncolytic viruses. It also highlights the importance of empowering women in pharmaceutical sciences through mentorship and community engagement, while emphasizing the role of allyship in fostering an inclusive environment.

01:20 Introduction to BioTalk Unzipped

02:01 Celebrating Women in Pharmaceutical Sciences

03:21 The Importance of STEAM Education

04:09 Personal Journeys into Science

08:02 Exciting Projects and Discoveries

13:52 Challenges in CMC for Cell and Gene Therapies

18:51 Innovations in Chiral Bioanalysis

22:46 NEW NEWS! - New ADC Approved

28:33 Exploring Combination Therapies in Cancer Treatment

32:26 Empowering Women in Pharmaceutical Sciences

37:30 Mentorship and Community Engagement

45:18 The Role of Allyship in Science

47:19 Breaking Barriers and Challenging Stereotypes

54:15 Engaging Diverse Voices in Discussions

56:49 Creating Inclusive Spaces for Feedback & Speaking Up

01:01:15 Avoiding Assumptions in Professional Settings

01:02:04 Setting Boundaries for Work-Life Balance

01:05:24 Measuring Success in Life

01:07:06 Connecting and Networking Effectively

Dr. Ines Santos

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

Dr. Julia Sable

https://www.linkedin.com/in/julia-sable-5b794385/ 

STEAMpark

https://www.steampark.org/ 

WIPS in AAPS

https://community.aaps.org/communities/community-home?CommunityKey=fbfeb62a-884a-46cf-a5ed-24ef7eb43100 

https://www.aaps.org/ 

Dr. Chad Briscoe

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

Celerion - https://www.celerion.com/  

Gregory Austin

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

Celerion - https://www.celerion.com/  

New News Story: 

In Fierce Pharma - Pfizer's blockbuster ADC Adcetris nabs FDA approval to treat large B-cell lymphoma

• https://www.fiercepharma.com/pharma/pfizers-blockbuster-adc-adcetris-nabs-fda-approval-treat-large-b-cell-lymphoma 

Journal Article mentioned:

Emerging applications of quantitative supercritical fluid chromatography-tandem mass spectrometry for chiral bioanalysis

https://www.sciencedirect.com/science/article/abs/pii/S0021967325000767 

Sound Bites

"We want to build our next generation."

"We all want the same result."

"You have to have a level of extrovert."

"If you see something, say something."

"Take action this year."

Image Credits:

AAPS & WIPS logos: https://www.aaps.org/ 

Keywords

BioTalk, pharmaceutical sciences, women in science, CMC challenges, chiral bioanalysis, CAR-T therapies, STEAM education, innovations in medicine, healthcare advancements, biotechnology, cancer treatment, CAR T therapy, women in science, mentorship, allyship, pharmaceutical sciences, community engagement, combination therapies, empowerment, gender equality, engagement, feedback, inclusivity, allyship, professional development, work-life balance, success, networking

#pharmaceutical #women #womenempowerment #science #drugdevelopment #biotech #biopharma #mentor #mentorship  #AAPS #WIPS

In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe welcome Dr. Alex Friedman, a seasoned expert in regulatory affairs for medical devices and AI as Software as a Medical Device.

Chapters

02:26 Introduction to BioTalk Unzipped

03:40 Charity Spotlight: Americares

05:01 Dr. Alex Friedman's Career Journey

11:52 The Regulatory Landscape of Medical Device Classifications

18:52 Regulatory Gameshow!: Classifying Medical Devices

22:28 AI Enabled Software as a Medical Device: An Overview 

25:25 New News!! - Innovative Cardiac Health App: The Case of Antshrike

30:31 The Evolution of Wearable Health Technology

41:17 Liability and Risk in Medical Device Development

43:57 Clinical Decision Support Software - Challenges in Regulating AI in Healthcare

47:13 Self Updating AI Doctors?? - The Future of AI in Public Health

49:00 Navigating FDA Regulations for AI Technologies and Doc in a Box

56:27 New News!! - The Intersection of AI, Regulation, and Innovation

01:07:28 Measuring Success in Life and Work

HOW TO REACH US:

Alex Friedman

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

Alex’s Charity: Americares

https://www.americares.org/ 

Dr. Chad Briscoe

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

Celerion - https://www.celerion.com/  

Gregory Austin

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

Celerion - https://www.celerion.com/  

New News Story - Innovative app from Before Health Intelligence identifies early signs of cardiac issues using wearable device data

New News - 2025 forecast: How will AI, regulators and the government intersect? From Fierce MedTech

Mentioned in the podcast:

Concussion Mouthguard Sensors:

SISU Sense - https://www.sisuguard.com/sisusense/ 

HIT-IQ - https://www.hitiq.com/smart-mouthguard 

Prevent Biometrics - https://preventbiometrics.com/ 

IDX-DR - Diagnosing Software

https://www.healthvisors.com/en/idx-dr/ 

Sound Bites

"The common thread is the science."

"Regulatory has to catch up."

"You can't sell snake oil."

"It's a multidisciplinary effort."

"Software as a medical device is a hot thing."

Image Credits:

Aliens - 

https://www.reddit.com/r/LV426/comments/9i8omb/mildly_disappointing_according_to_the_viewscreens/

https://filmmusiccentral.com/2018/10/16/my-thoughts-on-aliens-1986/

keywords

medical devices, regulatory affairs, FDA, bioengineering, clinical decision support, AI in healthcare, Americares, healthcare innovation, medical technology, software as a medical device, AI in healthcare, regulatory challenges, wearable technology, health apps, FDA regulations, medical device liability, cardiovascular health, quality management system, innovative health solutions, AI, healthcare, clinical decision support, FDA regulations, public health, adaptive software, medical devices, innovation, technology, regulatory affairs

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe continue their conversation with Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. They discuss the challenges and opportunities presented by new technologies, particularly in drug development and patient engagement. The conversation highlights the evolution of pharmaceuticals, and the potential of virtual clinical trials. In this conversation, Nathan Teuscher discusses the importance of optimizing drug dosages in oncology, the challenges faced in cell therapy, and the complexities of treating immunocompromised patients. He emphasizes the need for collaboration in the scientific community and shares his perspective on measuring success in life and career. Additionally, Nathan talks about his podcast, Clinical Pharmacology (https://creators.spotify.com/pod/show/clinical-pharmacology), which aims to educate listeners on clinical pharmacology and related topics.

Chapters

00:51 The Changing Landscape of Pharmaceuticals

03:49 Virtual Clinical Trials and Patient Engagement

08:06 Optimizing Drug Dosage in Oncology

10:55 New News! - FDA Approvals (Mesoblast) and Challenges in Cell Therapy

14:26 The Complexities of Cell Therapy

17:33 Navigating Immunocompromised States in Treatment

20:09 Advice to Young Scientists in Biopharma 

23:04 Defining Success in Life and Career

24:47 The Purpose and Impact of Nathan's Podcast, Clinical Pharmacology

HOW TO REACH US:

Nathan Teuscher

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

Aplos Analytics - https://aplosanalytics.com/ 

Email: [email protected]

Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast

https://teuschersolutions.com/ 

Collaboration with BioTalk Unzipped (Ep. 40)

https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 

Podcast (on Spotify): https://creators.spotify.com/pod/show/clinical-pharmacology

Podcast (on Apple): https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234

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 / 

Takeaways

Nathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics.

Virtual clinical trials can enhance patient engagement and diversity in research.

Finding the right dosage is a critical challenge in drug development.

Project Optimus aims to redefine oncology drug development practices.

AI and data analysis can help identify ideal candidates for clinical trials.

Ethical considerations are paramount in the use of patient data for research. The right dose for each patient varies significantly.

Understanding individual immune system capacities is crucial in treatment.

Collaboration is key to success in the scientific community.

Success is measured by the happiness of loved ones.

Finding joy in helping others is essential for career fulfillment.

Podcasts serve as valuable educational resources.

Engaging with diverse disciplines enhances scientific understanding.

Sound Bites

“If you want to be successful, seek first to understand, then be understood.”

“If you’re looking to help people and in collaboration, you’ll be successful.”

“Success in life is the happiness of loved ones around you.”

New News Story: 

After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy

https://www.fiercepharma.com/pharma/fda-nod-gvhd-cell-therapy-gives-australian-biotech-mesoblast

keywords

BioTalk, pharmacology, AI in pharma, drug development, Nathan Teuscher, pharmacometrics, virtual clinical trials, clinical research, pharmaceuticals, virtual trials, healthcare innovation, drug development, patient engagement, medical technology, drug dosage, oncology, FDA approval, cell therapy, immunocompromised, collaboration, success, clinical pharmacology, podcast, healthcare

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. The conversation explores Nathan's career journey, the innovative charity Light the World, and the transformative role of AI in drug development. They discuss the challenges and opportunities presented by AI, particularly in automating data analysis and rethinking traditional reporting methods in the pharmaceutical industry. The episode emphasizes the potential for small companies to leverage cloud-based tools and APIs to enhance efficiency and drive innovation in drug development. In this conversation, the speakers explore the intersection of data analysis, AI tools, and advancements in gene editing with organ transplants.

Chapters

00:00 Episode Preview

00:55 Introduction to BioTalk Unzipped

02:06 Charity Spotlight: Light of the World

04:51 Nathan Teuscher's Career Journey

07:34 Differentiating AI Types in Life Science

12:41 Challenges with Large Language Models

15:39 Rethinking Reporting in Pharma

17:56 The Future of AI and Analytics in Pharma?

18:52 Leveraging APIs (Application Programming Interfaces) for Small Companies

23:05 Leveraging Data, AI, and APIs in 3 Dimensions

26:22 NEW NEWS! - Gene Editing Breakthroughs in Medicine

How to reach us:

Light the World Charity - Church of Jesus Christ Latter Day Saints

https://www.churchofjesuschrist.org/comeuntochrist/light-the-world 

Nathan Teuscher

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

Aplos Analytics - https://aplosanalytics.com/ 

Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast

https://teuschersolutions.com/ 

Collaboration with BioTalk Unzipped (Ep. 40)

https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 

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 / 

Sound Bites

"We don't need to write reports anymore."

Takeaways

New News Story: 

Image Credits

Keywords

BioTalk, pharmacology, AI in pharma, drug development, pharmacometrics, software development, clinical research, Light the World, charity, data analysis, AI tools, gene editing, kidney transplant, pharmaceuticals, virtual trials, healthcare innovation, drug development, patient engagement, medical technology, drug dosage, oncology, FDA approval, cell therapy, immunocompromised, collaboration, success, clinical pharmacology, podcast, healthcare

In this episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Dr. Mark Arnold, a distinguished bioanalytical thought leader. They discuss the impact of recent FDA regulations on drug development, the importance of community support through the Samaritan Purse charity, especially on recent hurricane victims, and the exciting advancements in RNA editing technologies. The conversation highlights the collaborative nature of the pharmaceutical industry and the drive behind bioanalytical work, emphasizing the ultimate goal of delivering effective therapies to patients. 

Chapters

00:00 Introduction to BioTalk Unzipped at AAPS PharmSci 360

03:45 Samaritan's Purse Charity and Community Impact

05:16 Most impactful talk at AAPS?

11:50 Comparative Analysis of FDA and EU Regulations

17:37 The Drive Behind Bioanalytical Work

22:24 NEW NEWS! - Innovations in RNA Editing and Bioanalysis

Takeaways

• ​The FDA's new rules on lab-developed tests could delay biomarker utilization in clinical trials.
• ​Community support through charities like Samaritan's Purse is crucial during crises.
• ​The importance of collaboration in advancing drug development and bioanalytical methods.
• ​Innovations in RNA editing present new bioanalytical challenges.
• ​The drive to help patients is a key motivator for professionals in the field.
• ​

Sound Bites

• ​"I worked on that drug and there's a clear benefit."
• ​"It's getting that new therapy to a patient."
• ​"This is going to change and potentially delay biomarkers."
• ​

New News Story: 

• ​Wave sees RNA editing validation in early trial results

◦https://www.biopharmadive.com/news/wave-rna-editing-aatd-first-trial-data/729981/ 

How to reach us:

Please donate to: Samaritan’s Purse

https://www.samaritanspurse.org/ 

Mark Arnold

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

Blog - https://bioanalysisandbiomarkers.blogspot.com/ 

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 / 

Image Credits

• ​AAPS