Phillip Ramsey, Chief Technical Officer at Sangamo Therapeutics, joins BioTalk Unzipped for a candid conversation about one of the central challenges facing advanced therapies: turning extraordinary science into reproducible, scalable medicines.

Thank You to Our Sponsors

Leucentra - https://leucentra.com/

Inspired by Science. Empowered by IT. Leucentra provides specialized IT consulting and services for life sciences and healthcare, helping organizations use technology more effectively to support innovation.

TruTechnologies - https://trutechnologies.ai/

Clinical Trial Execution, Live. TruTechnologies provides live clinical trial execution technology that gives sponsors greater visibility into protocol activities, samples, and study data as they happen.

About This Episode

Recorded onsite at the AAPS National Biotechnology Conference in Boston, Phillip explains why gene therapy manufacturing has not yet reached the maturity of monoclonal antibody production.

As technologies have evolved across retroviral vectors, lentiviral vectors, adenovirus, AAV, lipid nanoparticles, and other advanced modalities, development teams have repeatedly been required to rethink fundamental manufacturing and analytical questions.

Phillip discusses why analytics are critical, why experience across multiple manufacturing lots and products matters, and why there simply is no shortcut to developing the scientific knowledge necessary to manufacture advanced therapies reliably.

He also reflects on the uncertainty of biotechnology.

Early in his career, Phillip was walking down a hallway when his CFO asked if he had cashed his paycheck.

When he said no, she told him not to.

It's a remarkable story that captures something rarely discussed about biotechnology: behind transformative science are people willing to operate through considerable uncertainty while trying to build something that has never existed before.

Gregory and Phillip Discuss

• Viral vector manufacturing and scale-up

• Why analytics are essential to gene therapy development

• AAV manufacturing challenges

• Lentiviral vectors and other evolving delivery technologies

• Lipid nanoparticles and changes in advanced therapy manufacturing

• Why gene therapy cannot simply adopt the established monoclonal antibody manufacturing playbook

• Building process knowledge across lots and products

• Career resilience in biotechnology

• Progress across AAV, CAR-T, and other advanced therapies

• Gene therapy affordability

• The importance of therapeutic durability

• Outcomes-based payment models for advanced therapies

Phillip's message for scientists and industry leaders is straightforward: don't assume the manufacturing problem has already been solved simply because a technology has existed for decades.

The field is still evolving, and some knowledge cannot be shortcut.

About Phillip Ramsey

Phillip Ramsey is Chief Technical Officer at Sangamo Therapeutics and brings more than 35 years of experience across biotechnology and pharmaceutical manufacturing, technical development, operations, quality, and advanced therapies.

Connect with Phillip Ramsey:

https://www.linkedin.com/in/phillip-ramsey-a2074711/

Sangamo Therapeutics:

https://www.sangamo.com/

Connect With BioTalk Unzipped

Gregory Austin on LinkedIn:

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

Dr. Chad Briscoe on LinkedIn:

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

BioTalk Unzipped:

https://www.biotalkunzipped.com/

BioTalk Unzipped unzips, unlocks, and uncovers the stories behind medical progress through conversations with scientists, executives, entrepreneurs, and innovators advancing biotechnology, pharmaceuticals, and medical technology.

Recorded onsite at the AAPS National Biotechnology Conference in Boston.

Special thanks to AAPS and Rebecca Stauffer for supporting the BioTalk Unzipped interview series.

Sponsored by Leucentra, https://leucentra.com/

Inspired by science, empowered by IT. Leucentra helps life science and healthcare organizations evaluate, implement, and get more value from technology that supports innovation.

Tracy Ryan, co-founder of NKore BioTherapeutics and former chief communications officer, joins Gregory Austin and Dr. Chad Briscoe to explain how her daughter Sophie’s pediatric brain tumor transformed her from a parent searching for options into a cancer advocate, research fundraiser, and biotechnology founder.

The conversation examines the scientific reasoning that moved Tracy from medical cannabis advocacy toward NK-cell immunotherapy. She describes an immune-system finding involving Sophie’s natural killer cells, the work of the late UCLA scientist Dr. Anahid Jewett, and the development of an experimental allogeneic NK-cell platform designed to enhance immune activity without genetic engineering.

The episode also explores the practical realities of translating an early scientific hypothesis into a therapeutic program, including donor selection, cell persistence, manufacturing, treatment outside the United States, regulatory requirements, clinical evidence, and the difficulty of raising capital for an emerging cell-therapy company.

At the center of the discussion is a difficult question: how do scientists, founders, regulators, and families preserve urgency when patients need better options, while still requiring the controlled evidence needed to determine whether a therapy is safe and effective?

What you will learn:

• How Sophie’s pediatric brain tumor changed the direction of Tracy Ryan’s life

• Why natural killer cells are important in immune surveillance and cancer biology

• What differentiates allogeneic NK-cell approaches from CAR-T and CAR-NK therapies

• How NKore’s experimental platform was designed to activate donor-derived NK cells

• Why persistence, donor biology, manufacturing, and lymphodepletion matter in cell therapy

• Why early human observations must remain distinct from controlled clinical-trial evidence

• How regulatory pathways and capital constraints shape whether promising science reaches patients

• What parents facing pediatric cancer need from the scientific and medical community

About Tracy Ryan:

Tracy Ryan is a pediatric cancer advocate, entrepreneur, public speaker, and biotechnology co-founder. She formerly served as chief communications officer of NKore BioTherapeutics.

Her daughter Sophie was diagnosed with a brain tumor during infancy, leading Tracy and her family into more than a decade of advocacy, research support, fundraising, and therapeutic exploration. Tracy and her husband also established Saving Sophie to support pediatric cancer research and help families pursue care. Their family’s experience with medical cannabis was featured in the documentary Weed the People.

Connect with Tracy Ryan:

https://www.linkedin.com/in/tracyryan23/

Connect with Gregory Austin:

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

Connect with Dr. Chad Briscoe:

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

Watch more BioTalk Unzipped episodes:

https://www.youtube.com/@BioTalkUnzipped/videos

Visit BioTalk Unzipped:

https://www.biotalkunzipped.com

Learn more about NKore BioTherapeutics:

https://www.nkore.com

Support Saving Sophie:

https://www.savingsophie.org

This episode is brought to you by founding sponsor Lucentra. Lucentra provides information technology consulting for life science and healthcare organizations, helping teams modernize infrastructure, strengthen security, and build scalable technology environments that support scientific innovation.

Subscribe to BioTalk Unzipped for conversations with the scientists, founders, regulators, and business leaders shaping the future of medicine.

Medical and scientific disclaimer:

This conversation is provided for educational and informational purposes only. It does not constitute medical advice, diagnosis, or treatment guidance. The therapies and outcomes discussed may be investigational, preliminary, or based on individual experience. Early observations do not establish safety or efficacy. Patients and caregivers should consult qualified healthcare professionals before making medical decisions.

#CancerImmunotherapy #NKCells #PediatricCancer

Sponsored by Leucentra, https://leucentra.com/

Inspired by science, empowered by IT. Leucentra helps life science and healthcare organizations evaluate, implement, and get more value from technology that supports innovation.

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe speak with Dr. Lakshmi Amaravadi, Head of Oncology Bioanalysis at AstraZeneca, live from AAPS PharmSci 360 in San Antonio.

Dr. Amaravadi unpacks why biomarker validation is not one-size-fits-all, how context of use should guide scientific decision making, and why fit-for-purpose validation matters in modern oncology drug development.

The conversation explores:

00:00 Why oncology bioanalysis is becoming more complex

02:12 FDA biomarker validation guidance and industry response

04:27 What “fit for purpose” means in practice

06:38 PK assay validation vs biomarker assay validation

07:52 What drives Dr. Amaravadi’s work in translational science

10:48 Why validation is not a checkbox exercise

12:19 Advice for young scientists entering bioanalysis

15:12 Why oncology drug development is uniquely complex

18:17 ADCs, bispecifics, T-cell engagers, and conditional T-cell engagers

19:38 Why bioanalysis now requires understanding biology

20:46 Dr. Amaravadi’s path from molecular biology to bioanalysis

24:34 Critical reagent management in complex oncology assays

26:42 Validation, qualification, and context of use

29:03 Final thoughts from AAPS PharmSci 360

This episode is especially relevant for scientists, bioanalytical leaders, translational researchers, clinical pharmacologists, oncology development teams, biomarker scientists, and anyone working at the intersection of drug development, assay validation, and precision medicine.

Dr. Amaravadi discusses how oncology programs now involve ADCs, bispecifics, T-cell engagers, conditional T-cell engagers, complex linkers, multiple measurable species, immunogenicity considerations, and biomarker strategies that require deeper biological understanding. As she explains in the episode, the future of oncology bioanalysis is not simply measuring what is present. It is understanding what the measurement means in the context of the biology and the development decision.

Follow BioTalk Unzipped for conversations with leaders in biotech, pharma, bioanalysis, clinical development, translational science, regulatory strategy, and the future of medicine.

Guest

Dr. Lakshmi Amaravadi

https://www.linkedin.com/in/lakshmi-amaravadi/

Hosts

Gregory Austin

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

Dr. Chad Briscoe

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

Sponsor: Leucentra

Related Links

Celerion

https://www.celerion.com/

In this episode of BioTalk Unzipped, Gregory Austin sits down with Dr. Daniel Reker, Assistant Professor at Duke University, for a wide-ranging conversation on active machine learning, nanomedicine, drug delivery, and the future of AI in biomedical research.

This episode is brought to you by Leucentra.

Inspired by Science Empowered by IT

https://leucentra.com/

Dr. Reker works at the intersection of AI, chemistry, biomedical engineering, pharmacology, and molecular medicine. His lab develops computational and experimental approaches to better understand small molecules, nanoformulations, and drug delivery systems.

The conversation explores how machine learning can support drug discovery and development, especially in areas where datasets are small and the biology is complex. Dr. Reker explains why nanoformulations may be able to improve targeted drug delivery, reduce toxicity, and potentially revive therapeutic agents that previously failed because of safety or tolerability issues.

Gregory and Dr. Reker also discuss explainable AI, the risks of black box thinking, AI bias, predictive modeling, FDA considerations, non-animal models, and the responsible use of AI in education and science.

Topics include:

• Active machine learning in drug discovery

• AI and nanomedicine

• Cancer therapy and targeted drug delivery

• How nanoformulations may reduce toxicity

• Small datasets in biomedical AI

• Explainable AI and scientific trust

• AI bias and model limitations

• Regulatory implications for predictive models

• The role of AI in education and cognitive development

• The future of integrated data in drug development

Guest bio:

Dr. Daniel Reker is an Assistant Professor at Duke University. His research focuses on computational and experimental approaches to molecular medicine, including active machine learning, drug delivery, nanoformulations, small molecules, and translational pharmacology. He was named to Forbes 30 Under 30 Europe in Science and Healthcare.

Guest contact:

Dr. Daniel Reker

Email: daniel.reker@duke.edu

LinkedIn: https://www.linkedin.com/in/danielreker/

Duke website: https://rekerlab.pratt.duke.edu/

Connect with BioTalk Unzipped:

Gregory Austin

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

Dr. Chad Briscoe

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

BioTalk Unzipped uncovers the stories behind medical progress through conversations with innovators across biotech, pharma, medtech, bioanalysis, clinical research, regulatory science, and drug development.

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Bob Liu, Senior Principal Scientist at Genentech Roche, to unpack one of the most important and misunderstood questions in modern medicine.

This is a rigorous, scientifically grounded conversation on cancer biology, immunotherapy, and the real constraints shaping oncology drug development today.

Dr. Liu brings over a decade of experience across antibody drug conjugates (ADCs), bispecific antibodies, and CAR-T therapies, offering a rare, insider perspective on why a universal cure remains elusive and where meaningful progress is actually being made.

Thanks to our Founding Sponsor:

LEUCENTRA: Helping teams evaluate, implement, and get real value from IT solutions that support innovation, not slow it down. https://leucentra.com/

What You’ll Learn

• Why cancer is not one disease, but more than 200 biologically distinct conditions
• What “curing cancer” actually means in clinical oncology
• How immunotherapies like checkpoint inhibitors and CAR-T are changing outcomes
• The biological limits of eliminating every cancer cell
• How tumors evade immune detection and adapt over time
• Why only about 20% of patients respond to immuno-oncology therapies
• The role of biomarkers, molecular profiling, and precision medicine
• Why early detection remains one of the biggest unsolved challenges
• The economic and regulatory pressures shaping next-generation therapies

Key Insight

Cancer is not simply something to eliminate.

It is a dynamic, adaptive system evolving within the human body. The future of oncology is not just eradication, but control, personalization, and intelligent engagement of the immune system.

Notable Quotes

“Cancer is a collection of more than 200 diseases, each requiring its own specific approach.”

“The cure for some cancers is within reach, but for many others, early detection remains the critical challenge.”

“Our immune system is constantly surveilling. The key is learning how to harness it effectively.”

Timestamps

00:00 – Introduction

02:42 – Bob’s passion - AACR

04:28 – Why we haven’t cured cancer

07:09 – Defining a cancer cure

10:26 – Cancer classification and molecular signatures

14:16 – Methylation profiling in diagnosis

17:22 – Patient resources and navigation

21:14 – FDA shifts toward randomized trials for CAR-T

24:15 – Cost and access challenges

26:33 – Cancer vs cardiovascular disease progress

33:39 – The challenge of early detection

37:48 – Biomarker limitations

39:14 – Immune system dynamics in cancer

45:19 – Bioanalytical challenges in modern therapies

51:08 – Progress and future outlook

About the Guest

Dr. Bob Liu is a Senior Principal Scientist at Genentech Roche specializing in bioanalytical sciences and immunogenicity assessment for advanced oncology therapies, including T-cell bispecifics and CAR-T.

Resources & Links

FDA to tighten approval requirements for CAR-T therapies

https://www.raps.org/news-and-articles/news-articles/2025/12/fda-to-tighten-approval-requirements-for-car-t-cel

American Association for Cancer Research (AACR)

https://www.aacr.org/

National Cancer Institute – Molecular diagnostics and biomarkers

https://www.cancer.gov/about-cancer/diagnosis-staging/diagnosis

Pattern recognition technologies in diagnostics

https://toby.health

Connect

Dr. Bob Liu

https://www.linkedin.com/in/bob-liu-42b8b278/

Dr. Chad Briscoe

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

Gregory Austin

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

Final Thought

The path to curing cancer is not a single breakthrough. It is a long, complex progression of scientific advances, better diagnostics, and deeper biological understanding.

The progress is real.

But the work is far from finished.

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Kate Neville, immunologist turned seasoned biotech patent attorney at Marshall, Gerstein & Borun, to unpack one of the most misunderstood and mission-critical areas of life sciences: intellectual property.

If you are a biotech founder, scientist, executive, or investor, this conversation is essential listening.

We explore what patent prosecution really means, when startups should begin thinking about IP protection, how “freedom to operate” can determine commercial viability, and how emerging AI tools are reshaping the patent landscape.

Dr. Neville brings 25+ years of experience guiding university spin-outs, biotech startups, and global pharmaceutical companies through complex patent strategy. She has helped secure patents for FDA-approved drugs and offers a rare dual perspective as both scientist and attorney.

In This Episode We Discuss:

• The difference between patent prosecution and patent litigation

• Why it is never too early for biotech startups to think about IP

• The U.S. one-year grace period vs. Europe’s stricter disclosure rules

• What “Freedom to Operate” really means for commercialization

• Antibody patents, CDR regions, and the doctrine of equivalents

• How premature disclosure can impact global patent strategy

• The real-world back-and-forth of patent office “office actions”

• AI-assisted prior art search at the USPTO — opportunity or risk?

• How funding cycles influence patent filing decisions

• Women in biotech leadership and venture funding disparities

• The most rewarding part of protecting life-changing therapies

We also break down the USPTO’s new AI pilot programs designed to modernize patent examination and discuss how artificial intelligence may impact biotech patenting over the next several years.

Why This Matters

Intellectual property is often the single most valuable asset in a biotech company.

Strong IP strategy can unlock funding, partnerships, and market exclusivity.

Weak or mistimed IP decisions can permanently limit global opportunity.

For founders and scientists: timing, geography, and disclosure discipline matter more than most people realize.

About Our Guest

Dr. Kate Neville

Partner, Marshall, Gerstein & Borun

PhD in Immunology, JD

LinkedIn: https://www.linkedin.com/in/kate-neville-phd/

Firm Bio: https://www.marshallip.com/katherine-l-neville-ph-d/

Charity Highlight: Girls on the Run Chicago

An organization building confidence and resilience in young girls through mentorship and athletic achievement.

https://www.girlsontherun.org/

Hosts

Dr. Chad Briscoe

Bioanalytical Scientific Leader

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

Gregory Austin

Director, Business Development | Bioanalysis

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

If you enjoyed this episode, subscribe to BioTalk Unzipped on Apple Podcasts, Spotify, or your preferred platform and share with a colleague in biotech, pharma, or life sciences innovation.

With more than 25 years of experience spanning gene augmentation, rare disease biology, CRISPR licensing, and biotech formation, Dr. Hopkins shares how autologous, ex vivo engineered cell therapies may overcome key limitations of current enzyme replacement and viral gene therapies, particularly for Fabry disease.

The conversation dives deep into:

• How lentiviral gene augmentation in patient derived cells enables sustained enzyme production

• Why redosing matters and where one time AAV therapies fall short

• The scientific rationale for early intervention, including potential newborn treatment

• Differences between autologous and emerging allogeneic approaches

• Regulatory pathways for rare disease therapies and recent FDA developments

• The role of non animal models in translational research

• Montana’s early access therapy law and its broader implications

• Building biotech platforms amid a challenging funding environment

Topics include cell based gene therapy, Fabry disease, lentiviral vectors, stem cell engineering, rare disease drug development, regulatory science, and translational medicine.

Subscribe to BioTalk Unzipped for in depth conversations with the scientists and leaders shaping the future of biomedical innovation.

00:00 - Intro

00:53 – Welcome to BioTalk Unzipped, Guest intro: Dr. Chris Hopkins

02:10 – Guest charity: Environmental Defense Fund

03:12 – His journey into rare-disease therapeutics and Glafabra

05:58 – Discovering a new enzyme-deficiency therapy

06:39 – Current standard of care

07:42 – How the new autologous cell therapy works

09:40 – Treating patients earlier (even newborns)

10:33 – Emerging therapies - AAV gene therapy vs. cell-based therapy

12:16 – Long-term results & repeat dosing

14:30 – Future plans: T-cells & allogeneic approaches

18:08 – New News: FDA resubmission for rare disease

20:00 – Navigating FDA pathways

22:06 – Non-animal testing & alternative models

25:50 – Montana’s early-access therapy law & medical tourism

29:03 – Could other states follow?

31:31 – Biotech’s current funding challenges

33:46 – New News: Gene therapy trial saves 4-year-old

37:09 – Long-term vision for expanding therapies

39:53 – Personal segment: outdoor life & skiing

44:43 – Guest question on international trade

Dr. Christopher Hopkins

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

Glafabra - https://www.glafabra.com/

Environmental Defense Fund - https://www.edf.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 Articles:

US FDA asks Stealth BioTherapeutics to resubmit application for rare genetic condition therapy

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-asks-stealth-biotherapeutics-resubmit-application-rare-genetic-condition-2025-05-29/

Gene therapy trial saves boy, 4, from 'death sentence'

https://www.thetimes.com/uk/healthcare/article/gene-therapy-trial-great-ormond-street-70l2sgqw

Montana, revolutionary law passed: unlimited research for longevity

https://en.ilsole24ore.com/art/montana-approved-revolutionary-law-researching-longevity-without-limits-AHmDI7BB?refresh_ce=1

Key Takeaways

1. A new cell therapy could replace lifelong enzyme treatments for Fabry patients.

2. Unlike gene therapy, this treatment can be redosed — no one-and-done limit.

3. Early intervention, even in newborns, may become possible.

4. Montana’s new law could open a fast lane for experimental therapies in the U.S.

5. Despite a tough funding climate, breakthroughs show gene-edited cell therapies are reshaping the future.

#CellTherapy #GeneEditing #RareDisease #BiotechInnovation #GeneticMedicine #HealthcareFuture #MedicalBreakthrough

#CellBasedGeneTherapy #RareDisease #FabryDisease #GeneAugmentation #LentiviralVectors #Biotech #TranslationalScience #GeneticMedicine #BioTalkUnzipped

https://youtu.be/VcPXZmK-XU8

From her early days studying electrochemistry at the University of Kansas to leading cutting-edge bioanalytical programs at Ultragenyx, Dr. DeSilva shares how curiosity and community shaped her four-decade career. She discusses the profound responsibility of working with limited, often irreplaceable patient samples with care.

A special thanks to AAPS (https://www.aaps.org/) for their help and support of this episode.

The conversation dives into:

• Balancing rigor and agility in small-population clinical studies
• Leveraging entrepreneurial mindsets from biotech within big pharma frameworks
• The promise of dried blood spots (DBS) and patient-centric sampling
• Mentorship, curiosity, and the future of scientific leadership
• Her return to Sri Lanka with KU faculty to recruit the next generation of scientists

Throughout the discussion, DeSilva underscores a recurring theme: science thrives when curiosity meets compassion. This episode is a masterclass in both.

Guest Links

Dr. Binodh DeSilva

https://www.linkedin.com/in/binodh-desilva/

Ultragenyx Pharmaceuticals - https://www.ultragenyx.com/

Hosts

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/

Keywords: BioTalk Unzipped, Binodh DeSilva, Ultragenyx, rare disease research, bioanalysis, dynamic drug development, dried blood spots, DBS sampling, biologics, AAPS NBC 2025, Gregory Austin, Chad Briscoe, Celerion, scientific leadership, mentorship in science, biopharma innovation, curiosity in research, Sri Lanka scientists, analytical chemistry, pharma innovation, drug development ethics.

00:00 Preview & Intro

01:58 Deep Viscosity and AI in Antibody Development

04:39 AI Validation and Model Reliability

07:12 International Journey and Collaborative Research

08:42 Future of Formulation Development

10:30 AAPS NBC Experience

11:30 Academic vs. Industry Career Paths

12:31 Collaboration with Pharmaceutical Companies

13:59 Modeling Protein Aggregation Challenges

14:43 Student Engagement and Research Opportunities

15:45 Expanding Applications of Machine Learning

Dr. Pin-Kuang Lai

https://www.linkedin.com/in/pin-kuang-lai/

Stevens Institute of Technology - https://www.stevens.edu/

Dr. Lai’s Publications - https://www.linkedin.com/in/pin-kuang-lai/details/publications/

The DeepViscosity Model - https://devpred.onrender.com/DeepViscosity

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/

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/

Key Takeaways:

• 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.

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.”

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!”

Takeaways

• 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.

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

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

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

Alex helps unpack one of the most important questions in healthcare innovation: when does software become a regulated medical device, and what happens when AI begins influencing clinical decisions?

The conversation moves from classic medical device classifications to 510(k) submissions, De Novo pathways, wearable health technology, clinical decision support software, adaptive AI, liability risk, and the future of “doctor-in-a-box” tools for underserved communities.

This episode is especially relevant for medical device developers, digital health founders, regulatory affairs professionals, biotech leaders, clinicians, investors, and anyone trying to understand how AI will be safely integrated into healthcare. Alex explains why regulatory strategy is not just bureaucracy. It is a public health safeguard designed to protect patients, validate claims, and prevent companies from selling unproven technology into high-stakes clinical environments.

As he puts it in the episode, “You can’t sell snake oil.” In this episode How FDA classifies medical devices by risk Why many Class II devices follow the 510(k) pathway What “substantial equivalence” means When software becomes a medical device Why AI-enabled software raises new regulatory questions How wearable technology may change cardiovascular monitoring Why medical claims create liability risk What makes adaptive AI especially difficult to regulate How FDA may approach predetermined change control plans Why inclusive training data matters for AI in healthcare How AI tools could improve care access in underserved communities

Featured guest Dr. Alex Friedman is a bioengineer and regulatory affairs professional with more than a decade of experience in medical devices, quality systems, FDA submissions, and regulatory strategy. His work includes AI-enabled hospital software, clinical decision support, and Software as a Medical Device.

Connect with Alex Friedman: https://www.linkedin.com/in/alexfriedman/

Charity spotlight Alex selected Americares, a nonprofit organization that delivers emergency medical aid and health programs to people affected by poverty and disaster.

Learn more: https://www.americares.org/

Links and resources All BioTalk Unzipped episodes: https://www.youtube.com/@BioTalkUnzipped/videos

BioTalk Unzipped LinkedIn: https://www.linkedin.com/company/biotalk-unzipped

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

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

Mentioned in the episode Antshrike cardiac health app from Before Health Intelligence: https://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424

Fierce MedTech 2025 forecast on AI, regulators, and government: https://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersect SISU

Sense concussion mouthguard: https://www.sisuguard.com/sisusense/

HITIQ smart mouthguard: https://www.hitiq.com/smart-mouthguard

Prevent Biometrics: https://preventbiometrics.com/

IDX-DR diagnostic software: https://www.healthvisors.com/en/idx-dr/

Nathan brings a clear, practical perspective on one of the most important questions in biopharma: how do we choose the right dose for the right patient, especially in complex areas like oncology and cell therapy?

The conversation explores the changing landscape of pharmaceutical development, including virtual clinical trials, patient engagement, clinical pharmacology, pharmacometrics, oncology dose optimization, and the importance of collaboration across scientific disciplines.

Nathan discusses why dose selection is not just a technical detail. It can shape safety, efficacy, patient experience, regulatory strategy, and ultimately whether a therapy succeeds. The episode also touches on FDA’s Project Optimus, the evolving expectations around oncology dosing, and the challenge of treating immunocompromised patients in areas such as cell therapy.

The discussion also highlights how technology, data, and AI may help improve clinical trial design and patient selection, while still requiring thoughtful ethical judgment and scientific discipline.

Nathan also shares advice for young scientists entering biopharma, including the importance of listening first, learning across disciplines, and approaching scientific collaboration with humility and curiosity.

The episode closes with Nathan’s reflections on success, purpose, and his own Clinical Pharmacology Podcast, which helps educate listeners on clinical pharmacology, pharmacometrics, and drug development topics.

In this episode

Gregory, Chad, and Nathan discuss:

• The changing landscape of pharmaceuticals
• Virtual clinical trials and patient engagement
• How pharmacometrics supports better dose selection
• Why oncology dosing is evolving
• FDA’s Project Optimus and its impact on cancer drug development
• Challenges in cell therapy development
• Treating immunocompromised patients
• The role of collaboration in scientific progress
• Advice for young scientists in biopharma
• Nathan’s Clinical Pharmacology Podcast

Featured guest

Dr. Nathan Teuscher is a clinical pharmacology and pharmacometrics expert, founder of Aplos Analytics, and host of the Clinical Pharmacology Podcast.

Nathan Teuscher:

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

Aplos Analytics:

https://aplosanalytics.com/

Email:

nathan@aplosanalytics.com

Clinical Pharmacology Podcast:

https://teuschersolutions.com/

Spotify:

https://creators.spotify.com/pod/show/clinical-pharmacology

Apple Podcasts:

https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234

Collaboration with BioTalk Unzipped, Ep. 40:

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

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

Connect with BioTalk Unzipped

All BioTalk Unzipped Episodes:

https://www.youtube.com/@BioTalkUnzipped/videos

Dr. Chad Briscoe:

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

Celerion:

https://www.celerion.com/

Gregory Austin:

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

BioTalk Unzipped on LinkedIn:

https://www.linkedin.com/company/biotalk-unzipped

Key themes

Clinical pharmacology and pharmacometrics are central to smarter drug development because they help teams understand exposure, response, variability, safety, and dose optimization.

In oncology, the field is moving beyond the assumption that the highest tolerated dose is automatically the best dose. Better dosing decisions can improve tolerability, patient experience, and development strategy.

Virtual trials and digital tools may help reduce patient burden and increase access, but they must be designed with scientific rigor and ethical responsibility.

Cell therapy presents unique challenges because patient immune status, disease severity, treatment history, and biology can all affect outcomes.

Collaboration is not just a professional virtue. In modern drug development, it is a scientific necessity.

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.”

Keywords

BioTalk Unzipped, Nathan Teuscher, clinical pharmacology, pharmacometrics, drug development, dose optimization, oncology dosing, Project Optimus, virtual clinical trials, patient engagement, clinical research, cell therapy, Mesoblast, FDA approval, immunocompromised patients, biopharma collaboration, pharmaceutical development, clinical trial innovation, AI in pharma, data science in drug development, precision medicine, personalized medicine, Clinical Pharmacology Podcast, Aplos Analytics

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

• Nathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics.
• Light the World charity offers unique giving machines for donations.
• AI can automate repetitive tasks in drug development, freeing up human capital for innovation.
• There are two types of AI: large language models and automated data analysis.
• Large language models can be unreliable in scientific contexts.
• Pharmaceutical companies spend significant resources on report writing, which may not add value.
• Small companies can leverage APIs to access standardized calculations and data analysis.
• The pharmaceutical industry is often insular, limiting the potential of AI.
• AI could potentially eliminate the need for extensive written reports in drug development.
• Collaboration and data sharing are crucial for advancing AI in the pharmaceutical industry. Leveraging data effectively requires combining various data sets and tools.
• The evolution of AI tools is crucial for navigating new technologies.
• Gene editing represents a significant breakthrough in organ transplantation.

New News Story:

• A woman in the US is the third person to receive a gene-edited pig kidney
• https://www.technologyreview.com/2024/12/17/1108905/a-woman-in-the-us-is-the-third-person-to-receive-a-gene-edited-pig-kidney/

Image Credits

• Pig Kidney, https://ny1.com/nyc/all-boroughs/news/2023/08/16/pig-kidney-works-in-a-donated-body-for-over-a-month--a-step-toward-animal-human-transplants

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

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/

Gregory Austin

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

Image Credits

• ​AAPS

Chapters

01:00 How the mathematical models work. Normalization and Scaling in Computational Biology

07:55 Focus on the Immune System and Organ Models

09:05 Collaboration with the Department of Defense

11:03 Drug Discovery and Digital Twins

13:43 NEW NEWS! - AI in Drug Discovery: The MIT Sparrow Algorithm

17:51 Future of Digital Twins in Clinical Trials

18:59 Personalized Medicine and Individualized Treatments

23:33 The Potential of Animal Digital Twins

24:59 Building a Research Infrastructure for Digital Twins

26:03 Privacy and Ownership of Digital Twin Data

30:14 Encouraging Publication and Literature Engagement

How to reach us:

Tomas Helikar

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

X - https://x.com/tomashelikar

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

"Publications are the currency in academia."

New News Story:

• MIT’s SPARROW Redefines Drug Discovery With Smart Synthesis
• https://scitechdaily.com/mits-sparrow-redefines-drug-discovery-with-smart-synthesis/

Image Credits

• MIT Molecule, https://news.mit.edu/topic/algorithms?page=2

Chapters

00:00 Introduction to BioTalk Unzipped

01:50 Meet Dr. Tomas Helikar

04:34 The Journey into Systems Biology

10:03 Understanding Digital Twins in Immunology

14:19 The Importance of Personalized Medicine

17:20 Digital Twin Research Funding and Its Impact

18:38 The Role of Digital Twins in Disease Management

21:11 Digital Twin Efforts for Organ Transplants

24:05 Computational Challenges in Modeling

26:36 Mathematical Models in Biological Research

28:11 - NEW NEWS! - Twist Joins Absci in AI Antibody Collaboration

How to reach us:

Tomas Helikar

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

X - https://x.com/tomashelikar

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 /

Charity Mentioned: https://saintpeterlincoln.com/school

FOLLOW ►

LinkedIn: https://www.linkedin.com/company/biotalk-unzipped

Twitter: https://x.com/BiotalkUnzipped

Instagram: https://www.instagram.com/biotalkunzipped/

Takeaways

• Dr. Helikar's research focuses on the immune system's network and disease.
• Systems biology integrates computer science and biology for better understanding.
• Digital twins can provide personalized models for immune system analysis.
• Your digital twin model could tell you how you might respond to a particular disease and if you really need to go to the hospital.
• The immune digital twin reflects an individual's unique immune baseline.
• Research funding is crucial for advancing innovative medical technologies.
• Personalized medicine can improve public health outcomes significantly.
• Computational power is essential for processing complex biological data.
• Mathematical models are vital for simulating biological processes.
• Digital twins can enhance drug discovery and clinical trial efficiency.

Sound Bites

"The immune system is a network of networks."

“Each of our immune system baselines are different.”

"We need to build out this multi-scale model."

New News Story:

• Supplier-Turned-Partner: Twist Joins Absci in AI Antibody Collaboration
• https://www.genengnews.com/topics/drug-discovery/supplier-turned-partner-twist-joins-absci-in-ai-antibody-collaboration/

Image Credits

• Signal Transduction, www.scientificanimations.com - http://www.scientificanimations.com/wiki-images/
• Computational Model, https://computationstructures.org/notes/models/notes.html
• Holland computer center, https://newsroom.unl.edu/announce/cse/16380/90600
• https://news.unl.edu/article/husker-football-game-day-information-announced-for-2023
• https://hcc.unl.edu/office-locations

01:05 - Career Reflections and Contributions to Drug Development

05:28 - Understanding the Integration of Drug Development

09:30 - What Would You Change? Embracing Career Risks in Pharma

11:32 - Navigating Career Paths: Small vs. Large Companies

16:09 - NEW NEWS! - Can Electrical Fields Disrupt Cancer?

23:28 - The Role of AI in Drug Development

31:13 - Encouraging Innovation in a Regulated Industry

Follow Mark, Chad and Gregory:

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 /

BioTalk Unzipped on LinkedIn - https://www.linkedin.com/company/biotalk-unzipped/

New News Story:

• Novocure wins FDA approval for electric field device in lung cancer
• https://www.biopharmadive.com/news/novocure-fda-lung-cancer-approval-optune-lua-tumor-treating-field/729997

Two articles on finding 1000’s of dark matter RNA viruses:

• https://www.fiercebiotech.com/research/deep-learning-ai-model-scans-dark-matter-genomic-data-and-finds-70000-never-seen-rna
• https://www.nature.com/articles/d41586-024-03320-6

Image Credits

• Novocure images courtesy of Novocure: www.novocure.com

Chapters

1:09 - Comparison of the Banking Industry to the Pharma Industry

5:18 - Data Integrity, Same For Decentralized Trials?

8:33 - Biotech Funding Trends

11:18 - NEW NEWS! – Digital Twinning in Clinical Trials

16:15 - What Advice Would You Give to Your Younger Self?

20:57 - Mentorship and Its Impact, How it Shaped Scott

23:45 - Balancing Work and Personal Life

24:32 - The Inflation Reduction Act and Innovation

Takeaways

• The regulatory environment in pharma can slow down innovation.
• Digital twinning in clinical trials could revolutionize drug development.
• Family influences play a significant role in shaping business perspectives.
• The need for a strong company culture to maintain values during growth.
• Biotech funding trends are influenced by macroeconomic factors like interest rates.
• The importance of mentorship in professional development.

Sound Bites

• “The similarities between the banking industry and the pharma industry is eerily similar.”
• “Quality is really what we do.”
• “Being quality is core to software.”
• “It’s really clear people care more about their money than they do their healthcare.”
• “Biotech and large pharma seem to balance each other out.”
• “The career for you is at the intersection of what you are good at and what you like to do.”
• “If you’re good at something and you like to do it, it fuels your energy to keep getting better.”
• “Enjoy the impact in what you’re doing and accomplishing!”

New News Story:

• Digital “Twinning”: Clinical Trials Powered by AI
• https://www.sanofi.com/en/magazine/our-science/digital-twinning-clinical-trials-ai

How to reach us:

Scott Ogle

https://www.linkedin.com/in/scott-ogle/

TruLab - https://trulab.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

Digital Twinning - Credit Getty Images

Simulation - Credit: andrush / Adobe Stock

Tomáš Helikar - https://www.linkedin.com/in/tomashelikar/

Nebraska Swan computer - https://newsroom.unl.edu/announce/cse/16380/90600

Brian Hamilton - https://inmatestoentrepreneurs.org/board/brian-hamilton/

In this 22nd episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Scott Ogle, CEO of TruTechnologies, discussing his journey from finance to the pharmaceutical industry, the impact of personal experiences on innovation, and the importance of technology in clinical trials. They explore how to hire the best employees in this climate, the significance of company culture, and the influence of family on business perspectives.

Chapters

00:00 Introduction to BioTalk Unzipped

03:15 The Impact of Personal Experience on Innovation

08:47 TruLab's Technology and Its Role in Clinical Trials

14:33 The Importance of Sample Management and the Genesis of TruLab

20:33 NEW NEWS! – The Future of Cancer Treatments

23:34 Hiring Patterns and the value of Company Culture

Takeaways

• Scott Ogle's personal experience with his father's illness inspired the creation of TruLab.
• TruLab focuses on eliminating inefficiencies in clinical trial sample management.
• The importance of having fun in one's career for productivity and happiness.
• Hiring for energy and cultural fit is crucial for company success.
• More young people out of college actually prefer working in the office, so it’s a hiring advantage.

Sound Bites

• “Entrepreneurs get excited about their solution but can forget about what problem they’re solving.”
• "We need to iterate on technology in clinical trials."
• “20-25% of biological samples get tossed out.”
• "You can't coach energy in a candidate."
• “Company values. Senior leadership must beat it like a drum.”
• “Interviewing candidates on company values is your North Star.”
• “Go by what people do, not by what they say.”
• “Hallway meetings, that’s where stuff gets done.”

New News Story:

• ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells
• https://www.nature.com/articles/s43018-024-00821-1

How to reach us:

Scott Ogle

https://www.linkedin.com/in/scott-ogle/

TruTechnologies - https://trutechnologies.ai/

Leukemia & Lymphoma Society - https://www.lls.org/

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 /

Keywords: Scott Ogle, TruLab, clinical trial technology, biotech innovation, sample management in clinical trials, hiring for company culture, company values in leadership, finance to pharma journey, revolutionizing clinical trials, impact of personal experience on innovation, biotechnology leadership, clinical trial inefficiencies, cancer treatment news, digital transformation in pharma, family influence in business, company culture in biotech, pharmaceutical funding challenges, ISB 2001 trispecific T cell engager.

Tags: #ScottOgle, #TruLab, #ClinicalTrials, #Biotech, #PharmaInnovation, #Sample Management, #Company Culture, #Hiring Tips, #BiotechLeadership, #PharmaTechnology, #CancerTreatment, #PersonalInnovation, #BiotechFunding, #LeadershipInPharma, #BusinessLeadership, #PharmaceuticalIndustry.

Mentoring in Pharmaceutical Science with Dr. Jim Shen

Summary

In Episode 21 of BioTalk Unzipped, host Gregory Austin and co-host Dr. Chad Briscoe interview Dr. Jim Shen, the executive director and head of regulated bioanalysis operations at BMS. Jim discusses his early career in bioanalysis and the importance of mentorship. He emphasizes the need to recognize and appreciate the success and expertise of others, as well as the importance of building a network of champions, allies, and sponsors. The conversation also touches on the topic of psychedelics as a drug therapy and the recent retraction of scientific papers on MDMA-assisted therapy. Jim shares his passion for photography, particularly infrared photography, and the resurgence of film photography.

Chapters

01:14 - Jim’s Favorite Publication and His Journey into Bioanalysis

04:15 - Finding Joy in Your Work: Pursuing Your Interests and Making a Difference

05:10 - Early Career in Bioanalysis

07:35 - The Importance of Mentorship and Dealing With Adversaries

17:35 - NEW NEWS: Retraction of Scientific Papers on Drug Therapy

24:55 - Personal Interests: Photography and Gaming

Takeaways

• Dr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans.
• Building a supportive and collaborative community is crucial in the field of bioanalysis, where knowledge sharing and networking play a significant role in advancing research and innovation. Recognize and appreciate the success and expertise of others
• Build a network of champions, allies, and sponsors
• Be open to new career opportunities and emerging fields
• Maintain integrity and transparency in scientific research
• Explore different hobbies and interests outside of work

Sound Bites

• “Sponsors are those with the power to change your career. Those people don't come along very often, so you need to really grab them when you see them.”
• “EQ is so important in being successful in your larger pharmaceutical company.”
• “I first tell my staff to divide people into 3 groups, champions, allies, and sponsors.”
• “And it is very hard to be in this field, to be a scientist, but you know, it's the people that make it worthwhile.”

New News Story:

• Following FDA rejection, a journal retracts papers on MDMA-assisted therapy
• https://www.biopharmadive.com/news/lykos-journal-mdma-retractions-maps-ptsd-unethical-conduct/723945/

How to reach us:

Dr. Jim Shen

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

Bristol Myers Squibb - https://www.bms.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

Travis Kelce:

https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DQY8xlVldVp8&psig=AOvVaw2yCKg3oh923dt0beIIR8w3&ust=1726284386832000&source=images&cd=vfe&opi=89978449&ved=0CBcQjhxqFwoTCICN_OD8vogDFQAAAAAdAAAAABB2

https://www.te-university.com/posts

https://people.com/travis-kelce-says-hes-his-own-worst-critic-on-the-field-8684839

https://www.marca.com/en/nfl/kansas-city-chiefs/2023/07/12/64aec11a268e3e242d8b458e.html

https://www.newheightshow.com/

https://www.aol.com/fans-think-moment-travis-kelce-185629668.html

World of Warcraft Guilds

https://www.dexerto.com/world-of-warcraft/wow-players-critical-of-unrealistic-guild-expectations-for-season-of-discovery-2392361/

Infrared Photography: Jim Shen

Keywords

Pharmaceutical, Mentor, Mentorship, Mentoring, Science, Biotech, Biotechnology, Gaming, Photography, Bioanalysis

Chapters

01:15 - Introduction, Background, and Passion for The American Cancer Society

03:46 - Advancements in Cancer Therapies, Opdualag

08:03 - From Small Molecule to Large to Hybrid

12:52 - NEW NEWS! - Halda Raises $126M for a New Targeted Cancer Therapy

18:30 - Dr. Shen’s Journey from Computers to Chemistry into Bioanalysis

27:00 - The Integration of AI and Mechanistic Modeling in Drug Development

34:30 - Navigating the Complexities of Regulatory Submissions

Takeaways

• Advancements in cancer therapies, such as immunotherapy and antibody drug conjugates, have revolutionized the treatment landscape and improved patient outcomes.
• The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy. More research and collaboration between software and hardware engineers are needed to fully realize its potential.
• Navigating the complexities of regulatory submissions requires adherence to international guidelines and validation of analytical methods to ensure accuracy and precision.
• Dr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans.

Sound Bites

• "Advancements in cancer therapies have revolutionized the treatment landscape."
• "Antibody drug conjugates are one of the most exciting and interesting types of molecules."
• "The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy."

New News Story:

• Startup Halda raises $126M to advance new type of targeted cancer therapy
• https://www.biopharmadive.com/news/halda-series-b-riptac-prostate-cancer/723933/

How to reach us:

American Cancer Society

https://www.cancer.org/

Dr. Jim Shen

• https://www.linkedin.com/in/jimxshen/
• Bristol Myers Squibb - https://www.bms.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 /

Images

ADC Mechanism of Action

https://www.researchgate.net/figure/Antibody-drug-conjugate-ADC-structure-and-mechanistic-schematic-Inset-in-upper-right_fig1_364183953

https://www.researchgate.net/figure/General-structure-of-antibody-drug-conjugate_fig1_355319441

Keywords

Bioanalysis, Cancer, Oncology, Research, Drug Development, Compliance, Regulatory Compliance, AI, ADC, Antibody Drug Conjugates, immunotherapy, Pharmaceutical, Biotechnology, Podcast, Science, Pharmaceutical Science

Chuck Piccirillo returns to BioTalk Unzipped to explore how healthcare organizations can build more adaptive patient journeys without losing the human connection that remains essential to care.

Chuck explains why different patients, therapies, and diseases require different engagement models and why digital health platforms need to be adaptable rather than static.

The conversation examines the growing demand for hybrid healthcare, combining virtual and in-person interactions, and the emergence of virtual-health models in Europe.

In New News, the group explores ion channels and why these microscopic cellular structures continue attracting significant interest as targets for new medicines.

From there, Gregory, Chad, and Chuck move into the economics of drug development and the realities of building a life-sciences company.

Chuck offers lessons on leadership, persistence, incremental progress, and why face-to-face human interaction still matters even in increasingly digital organizations.

The episode concludes with practical advice for entrepreneurs trying to build businesses in life sciences, where scientific ambition has to coexist with capital constraints, regulatory requirements, execution, and patience.

Chapters

00:17 - Adapting to what is unique about each patient journey

07:08 - The push toward hybrid healthcare and greater flexibility

09:20 - The emergence of virtual health, particularly in Europe

14:02 - New News: Why ion channels are a goldmine for new medicines

19:23 - The financial side of drug development

21:50 - Leadership, incremental progress, in-person interaction, and hard lessons

30:58 - Advice for entrepreneurs in life sciences

Key ideas

• Digital patient experiences should adapt to the patient and therapy rather than forcing every patient into the same process.
• Hybrid healthcare can combine the convenience of technology with necessary in-person care.
• Remote monitoring and virtual interactions may reduce some burdens on patients and healthcare providers.
• Ion channels continue to represent an important area of therapeutic research.
• Persistence and incremental progress are fundamental to entrepreneurship.
• Technology does not eliminate the value of real human relationships.

Crohn’s & Colitis Foundation

https://www.crohnscolitisfoundation.org/

Connect with Chuck Piccirillo

Chuck Piccirillo

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

Zealic Health

http://www.zealichealth.com

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

New News

These microscopic tunnels are a goldmine for new medicines:

https://www.biopharmadive.com/news/ion-channels-drug-research-vertex-biohaven-jazz/719337/

Keywords

patient journey, hybrid healthcare, virtual health, ion channels, drug development, life sciences entrepreneurship, remote patient monitoring, decentralized clinical trials, digital health, leadership

#HealthcareInnovation #VirtualHealth #DrugDevelopment #LifeSciences #DigitalHealth #IonChannels #ClinicalTrials #Leadership #Biotechnology

Dr. Jonathon Hill returns to BioTalk Unzipped to discuss the convergence of genetics, AI, diagnostics, entrepreneurship, higher education, and biotechnology.

Jonathon explains an unusual partnership between academia and industry that allows students to build projects with genuine commercial potential, sometimes moving from student researcher to company founder at an exceptionally young age.

The conversation then explores how AI could influence genomic medicine and future diagnosis. Jonathon challenges the traditional trial-and-error model of medicine and considers what could become possible as genetic information and computational tools improve.

In New News, the group discusses Lumicell’s fluorescence-guided technology for identifying residual breast-cancer tissue during surgery and what improved visualization could mean for patients.

Jonathon also offers advice to students interested in genetics and biotechnology, emphasizing laboratory experience, curiosity, and a willingness to take intelligent risks.

The episode closes with a candid look at the regulatory hurdles facing biotechnology companies and a broader question confronting higher education: how can universities give students enough real-world value to justify the growing cost of a degree?

Chapters

01:01 - Balancing life as a professor while running a laboratory

02:00 - The unique partnership between university and industry

03:55 - Why more students are pursuing entrepreneurship after college

06:31 - How AI may affect genetics research, biotechnology, and future diagnosis

12:58 - New News: Lumicell’s breakthrough in residual breast-cancer imaging

16:10 - Dr. Hill’s passions inside and outside his professional life

17:37 - Advice for young scientists and aspiring biotechnology entrepreneurs

21:00 - Bioinnovation, scientific business training, and concerns about the cost of higher education

28:48 - Regulatory hurdles and progress for Wasatch and its DNA research

Connect with Dr. Jonathon Hill

Dr. Jonathon Hill

https://www.linkedin.com/in/jonathon-t-hill/

Wasatch Labs

https://www.wasatchbiolabs.com/

Rainforest Trust

https://www.rainforesttrust.org/

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

New News

FDA approval of Lumicell’s fluorescent system for highlighting residual breast cancer:

https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer

Image credits

Gattaca: https://www.justwatch.com/us/movie/gattaca

Lumicell: https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer

Laser Focus World: https://www.laserfocusworld.com/bio-life-sciences/article/14294960/fluorescence-imaging-system-may-improve-cancer-care

Vimeo: https://vimeo.com/807609920

Keywords

genetics, nanopore sequencing, AI diagnosis, personalized medicine, biotechnology entrepreneurship, precision medicine, fluorescence imaging, breast cancer, genomic medicine

#genetics #AI #personalizedmedicine #biotechnology #breastcancer #diagnostics

Chuck Piccirillo, CEO of Zealic Health, joins BioTalk Unzipped to discuss patient-centered digital health, entrepreneurship, artificial intelligence, regulation, and the personal experience that helped shape his career.

Chuck shares his experience living with colitis and how it influenced his desire to improve healthcare from the patient’s perspective. He explains how Zealic Health approaches digital platforms intended to create more individualized care experiences.

The conversation then turns unexpectedly geopolitical. Chuck describes how the war in Ukraine affected his organization and how the company worked to relocate employees to Poland.

In New News, the discussion tackles the FDA’s final rule involving laboratory-developed tests and the debate surrounding regulation of LDTs as medical devices.

Gregory, Chad, and Chuck examine the difficult balance between protecting patients and creating regulatory uncertainty that may complicate innovation.

The episode closes with AI and diagnostics. Where can artificial intelligence genuinely improve medical decision-making, and where does marketing run ahead of evidence?

The larger question is not whether AI will enter healthcare. It is how healthcare can use it responsibly while keeping clinicians and patients at the center.

Chapters

01:33 - Introduction and background

04:03 - The Crohn’s & Colitis Foundation and Chuck’s experience with colitis

07:49 - Patient-centric healthcare and Zealic Health

13:26 - Plan B: Moving operations from Ukraine to Poland

20:02 - New News: The controversy surrounding LDTs as medical devices

27:20 - Healthcare regulation and its implications for AI

30:07 - How AI can assist medical diagnosis

Crohn’s & Colitis Foundation

https://www.crohnscolitisfoundation.org/

Connect with Chuck Piccirillo

Chuck Piccirillo

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

Zealic Health

http://www.zealichealth.com

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

New News

House committee tells FDA to suspend lab-developed test rule:

https://www.healthcaredive.com/news/house-committee-fda-suspend-ldt-rule/721362/

Image credits

Crohn’s & Colitis Foundation: https://www.crohnscolitisfoundation.org/

FDA/LDT: https://x.com/FDADeviceInfo/status/1784965525522493657

U.S. Capitol: https://worldstrides.com/blog/2013/07/u-s-capitol/

Healthcare costs: https://www.freepik.com/photos/increasing-costs

Cancer patient: https://www.freepik.com/free-photo/sick-asian-man-sitting-chair-side-view_33753979.htm

Computer-aided diagnosis: https://researchoutreach.org/articles/assessing-performances-computer-aided-diagnosis-breast-cancer/

Keywords

digital health, patient engagement, patient-centric healthcare, artificial intelligence, AI diagnostics, laboratory-developed tests, FDA regulation, decentralized clinical trials, healthcare technology

#BioTalkUnzipped #DigitalHealth #AIinHealthcare #FDA #PatientCare #Biotechnology #MedicalDevice

Dr. Andy Vick returns to BioTalk Unzipped for a conversation that moves from drug development and toxicology into reptiles, academia, gene therapy, professional development, and the extraordinary possibilities opening up across modern medicine.

Andy shares the discoveries and industry changes that have surprised him over the course of his career, including how dramatically some areas of cancer treatment have changed.

Then science meets one of his personal passions: reptiles. Andy describes his rare reptile collection and his work educating future toxicologists about venom and its potential pharmaceutical applications.

The discussion moves into Andy’s role as an adjunct professor at The Ohio State University and his work connecting academic research, students, and industry.

In New News, Gregory, Chad, and Andy discuss gene therapy used to restore hearing in children with mutations affecting otoferlin. The story opens a broader discussion about the extraordinary therapeutic potential of cell and gene therapy as well as the safety and tolerability questions researchers still need to answer.

Andy closes by discussing the role organizations such as AAPS play in scientific collaboration, networking, mentorship, and professional growth.

Chapters

00:21 - Surprises throughout Dr. Vick’s career

02:24 - The cyclical nature of technology

03:30 - Exploring the pharmaceutical potential of venom

05:35 - Improvements in cancer and other diseases over the past 30 years

10:13 - Educating future toxicologists about reptiles and pharmaceuticals

15:45 - Andrew Vick’s role as an adjunct professor at The Ohio State University

21:21 - New News: Restoring hearing in children through gene therapy

27:27 - The impact of professional organizations such as AAPS

Selected quotes

“It’s probably a good 10 years from the glimmer in a biochemist’s eyes to on the market.”

“There’s a logarithmic difference between great and good.”

“Just use your imagination on a way to tackle a disease and then find a way.”

“Cell and gene therapy opens the door to a whole different category of opportunities.”

Connect with Dr. Andy Vick

Dr. Andy Vick

https://www.linkedin.com/in/andy-vick-4467189/

Attralus Therapeutics

https://www.attralus.com/

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

New News

Regeneron gene therapy restores hearing in two children:

https://www.fiercebiotech.com/biotech/little-protein-factory-could-regeneron-gene-therapy-restores-hearing-2-kids

Image credit

Pharmacognosy:

https://pharmacognosy-phytochemistry-natural-products.pharmaceuticalconferences.com/events-list/industrial-pharmacognosy

Keywords

toxicology, reptiles, venom, drug discovery, drug development, gene therapy, hearing loss, academia, AAPS, cell and gene therapy, biotechnology

#biotechnology #toxicology #genetherapy #hearingloss #AAPS #science

Dr. Andy Vick joins BioTalk Unzipped to discuss systemic amyloidosis, therapeutic antibodies, diagnostics, toxicology, rare disease research, and the transition from CRO life into biotechnology.

Andy explains the biology of systemic amyloidosis and describes Attralus Therapeutics’ approach to developing biologic therapeutics and diagnostics aimed at amyloid disease.

The conversation provides an accessible introduction to toxicology and why safety evaluation is fundamental to drug development. Andy also discusses one of the recurring challenges in rare disease research: finding animal models that adequately represent human disease.

He then reflects on moving from a contract research organization into a smaller biotechnology company and what changes, and what stays remarkably similar, when scientists move between CROs, pharmaceutical companies, and biotech.

New News takes the discussion into cancer immunology with an experimental mRNA-based approach to glioblastoma. The technology packages tumor-specific RNA inside lipid nanoparticles with the goal of generating a strong immune response against the cancer.

It is a conversation that spans fundamental drug safety, rare disease biology, career transitions, and some of the most ambitious approaches being investigated in oncology.

Chapters

02:22 - Dr. Vick’s charity work in Brazil

06:30 - Introduction to Attralus Therapeutics

07:41 - Developing treatments for systemic amyloidosis

10:35 - The role of toxicology in drug discovery and development

16:38 - Using animal models to study amyloidosis

22:06 - The history of Attralus and Dr. Vick’s transition from CRO to biotech

32:45 - New News: Promising results from an mRNA-based brain-cancer vaccine

Connect with Dr. Andy Vick

Dr. Andy Vick

https://www.linkedin.com/in/andy-vick-4467189/

Attralus Therapeutics

https://www.attralus.com/

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

New News

Glioblastoma vaccine turns brain tumors from “cold” to “hot” in humans and dogs:

https://www.fiercebiotech.com/research/glioblastoma-vaccine-turns-brain-tumors-cold-hot-humans-and-dogs

Media credits

Pilot image: https://www.amazon.com/Military-Aircraft-Cockpit-Photograph-Picture/dp/B07Z2KM6KY

University of Florida: https://www.clickorlando.com/news/florida/2024/03/11/university-of-florida-axes-diversity-and-inclusion-office-under-gop-led-law-aimed-at-ridding-similar-programs/

Music: “CLARITY,” Mifune

Music provided by Slip.stream: https://slip.stream

https://get.slip.stream/KFCilm

Keywords

systemic amyloidosis, therapeutic antibodies, toxicology, drug discovery, rare disease, biotechnology, diagnostics, glioblastoma, mRNA vaccine, lipid nanoparticles

#biotechnology #toxicology #glioblastoma #braincancer #amyloidosis #drugdevelopment

Dr. Jonathon Hill joins BioTalk Unzipped to explore nanopore sequencing, genetics, epigenetics, artificial intelligence, addiction research, fertility, and the search for earlier biomarkers of Alzheimer’s disease.

Jonathon explains how nanopore sequencing works and why the ability to analyze native DNA and RNA can provide researchers with information extending beyond the underlying genetic sequence.

His scientific interests also connect with a deeply personal passion for biodiversity. Jonathon describes his time in Brazil and his dream of establishing a nanopore sequencing laboratory in the Amazon to study its extraordinary biological diversity.

The conversation then turns toward AI and genetics, including research into the genetic underpinnings of tobacco addiction. Jonathon discusses both the potential of AI to accelerate biological discovery and the risks of treating opaque models as scientific explanations.

Later, he explains work involving cell-free DNA and fertility before discussing one of the most consequential areas of his research: DNA methylation signatures that may eventually contribute to earlier detection of Alzheimer’s disease.

It is a fascinating look at what becomes possible when genomics, computation, and molecular biology begin converging.

Chapters

00:00 - Introduction

02:51 - Donation to Rainforest Trust and Jonathon’s time in Brazil

06:37 - How nanopore sequencing works

12:45 - New News: AI and the genetic code of tobacco addiction

15:20 - Using AI in nanopore sequencing at Wasatch Labs and Diagnostics

21:14 - Finding cell-free DNA for fertility treatments

22:56 - Breakthrough: Finding early biomarkers for Alzheimer’s disease

Selected quotes

“Biology is not rocket science, it’s much harder.”

“Better diagnosis comes better treatment.”

Connect with Dr. Jonathon Hill

Dr. Jonathon Hill

https://www.linkedin.com/in/jonathon-t-hill/

Wasatch Labs

https://www.wasatchbiolabs.com/

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

New News

Breaking the Genetic Code of Tobacco Addiction:

https://neurosciencenews.com/genetics-tobacco-addiction-ai-25937/

Additional resources and image credits

Rainforest Trust: https://www.rainforesttrust.org/

EnviroBuild / Rainforest Trust: https://www.envirobuild.com/blog/rainforest-trust

Fire Sponge: https://stock.adobe.com/

Oxford Nanopore Technologies, How Nanopore Sequencing Works: https://www.youtube.com/watch?v=RcP85JHLmnI

Keywords

nanopore sequencing, genomics, epigenetics, DNA methylation, Alzheimer’s disease, AI, genetic research, tobacco addiction, biomarkers

#nanopore #genetics #epigenetics #AI #Alzheimers #DNA #biotechnology

Jason Burke returns to BioTalk Unzipped to explore the intersection of artificial intelligence, biotechnology, healthcare, entrepreneurship, and technology strategy.

Jason explains the distinctive approach of the Duke program and the value of exposing students to real-world healthcare datasets rather than purely academic exercises.

The conversation then turns to AI-generated drug discovery and what these technologies could mean for pharmaceutical companies, biotechnology startups, investors, and patients.

Jason also explains how he assesses emerging technologies by looking beyond technical capability to questions of business value, intellectual property, scalability, and practical adoption.

Gregory, Chad, and Jason then tackle a deeper structural problem: pharmaceutical companies develop products for healthcare systems, yet the two sectors do not always interact as closely as they should. They examine the complexity facing physicians and ask whether life-sciences companies may increasingly need to think not merely as product developers, but as providers of services and solutions.

Finally, the science gets wonderfully unconventional as Jason takes us into amateur radio, including bouncing radio signals off the Moon.

Chapters

00:29 - The unique approach of the Duke program

05:14 - New News: AI-generated drug discovery

09:33 - Assessing technologies for companies and patients

11:52 - Why unique intellectual property matters

12:35 - The future of AI and software

13:36 - Data as a commodity

15:10 - Innovation curves, technology, and how AI may compress them

16:41 - Using AI in everyday life

19:04 - Why were search-engine companies late to the generative-AI game?

20:05 - New forms of software and digital experiences

22:53 - The future relationship between healthcare and pharma

25:08 - The difficulty of practicing medicine in complex environments and implementing precision medicine

29:03 - Jason’s interest in amateur radio and the ham-radio community

31:39 - Bouncing a radio signal off the Moon and sending email over radio waves

Connect with Jason Burke

Jason Burke

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

Creo Inc.

https://www.creoinc.net/

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

#AI #pharmaceutical #healthcare #drugdiscovery #futuretech #lifesciences

Science fiction is becoming remarkably close to scientific reality.

Jason Burke joins BioTalk Unzipped for a wide-ranging discussion of emerging technologies and how they could change drug discovery, clinical research, precision medicine, and healthcare.

The conversation begins with organoids, three-dimensional cell structures designed to reproduce important characteristics of human organs. Gregory, Chad, and Jason discuss their applications in research as well as the ethical questions that become particularly interesting when brain organoids enter the conversation.

Jason then explains his background and discusses the technologies he believes could materially transform clinical research.

The discussion moves into AI, data science, precision medicine, and quantum computing before addressing a challenge every organization eventually confronts: implementing powerful new technologies without sacrificing data integrity, regulatory compliance, or sound strategy.

The episode concludes with discussion of FDA expectations, 21 CFR Part 11, and why successful digital transformation requires more than simply adopting the newest technology.

Chapters

01:14 - Introduction to BioTalk Unzipped

03:30 - New News: Organoids and their applications

04:45 - Ethical questions surrounding brain organoids and biological computing

06:31 - Organoids in drug-discovery research and brain interfaces

08:59 - Brain training and neuroplasticity

10:51 - The impact of AI and data science in healthcare

11:18 - Jason’s background and emerging technologies transforming clinical research

13:43 - AI in precision medicine, quantum computing, and business growth

24:15 - FDA IT strategy and the challenges of implementing AI

26:32 - Technology strategy, prioritization, data integrity, and 21 CFR Part 11

Connect with Jason Burke

Jason Burke

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

Creo Inc.

https://www.creoinc.net/

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

New News

The many uses of mini-organs:

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

Image credits

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

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

#Organoids #AI #QuantumComputing #HealthcareInnovation #DrugDiscovery #ClinicalResearch

Scott Schliebner returns to BioTalk Unzipped for a deeper discussion of rare disease clinical trials, gene therapy, cell therapy, cancer treatment, and one of the most difficult questions in modern medicine: how should potentially curative therapies be valued and made accessible?

Scott first expands on the operational complexity of rare disease studies, including patient recruitment, multidisciplinary care, and the importance of collaboration among stakeholders.

The conversation then examines how AI might help identify patients and analyze increasingly complex clinical datasets.

A major focus is the FDA approval of Iovance’s Amtagvi, discussed in the episode as the first T-cell therapy approved for a solid tumor. Scott, Gregory, and Chad examine what progress in melanoma might mean for the broader effort to bring cell therapies into solid tumors.

That leads to a larger discussion about gene and cell therapy economics. If a therapy can eliminate years of ongoing medical treatment, what should it cost? How should healthcare systems weigh upfront expense against long-term health and economic benefit?

The episode concludes with practical career advice for both early-career and experienced clinical-development professionals.

Chapters

00:21 - A collaborative approach to rare disease trials

03:32 - The role of AI in rare disease trials

06:11 - Success stories in rare disease development

11:34 - Expanding gene therapy to target multiple genes

16:56 - New News: FDA approval of Iovance's Amtagvi and the melanoma breakthrough

19:27 - Targeting solid tumors with cell therapy and expanding its potential

20:23 - How curative therapies could affect quality of life and healthcare costs

21:11 - Pricing and ethical challenges surrounding advanced therapies

22:37 - Lessons from curative treatments for hepatitis C

23:25 - The high bar for clinical development and regulatory standards

24:05 - Pricing considerations across cancer types and the possibility of cost-effective treatments

27:45 - Advice for young professionals entering clinical drug development

31:49 - Advice for established clinical professionals

33:21 - Scott’s hobbies and interests

Rare Givers

Learn more or donate:

https://www.raregivers.global/

Connect with Scott Schliebner

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

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

New News

FDA approves first T-cell therapy for a solid tumor:

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

Image credits

Iovance: https://www.iovance.com/

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

Amtagvi: https://www.amtagvi.com/

#melanoma #raredisease #celltherapy #genetherapy #clinicaltrials #science

Scott Schliebner joins BioTalk Unzipped to explore rare disease development, clinical research, artificial intelligence, and the operational realities of building organizations across international boundaries.

The episode begins with a discussion of Rare Givers, an organization supporting caregivers in the rare disease community.

Scott then explains what led him into clinical research before the conversation turns to the Epitomee weight-loss capsule and the changing landscape of obesity treatment.

From there, Scott shares lessons from building North American infrastructure for a European MedTech-focused CRO, including the cultural differences that can influence how global teams work together.

The discussion then moves into AI and machine learning. Rather than treating AI as a buzzword, Scott, Gregory, and Chad examine practical applications across clinical trials, patient recruitment, data analysis, quality, and regulatory compliance.

Finally, Scott breaks down why rare disease trials are so challenging and why successful development often requires collaboration among patients, caregivers, investigators, sponsors, and other stakeholders.

Chapters

00:53 - Introduction and charity donation to Rare Givers

02:30 - The mission of Rare Givers

04:08 - What inspired Scott to enter clinical research

06:12 - New News: The Epitomee weight-loss capsule

11:25 - Epitomee, targeted weight-loss approaches, and competition with Wegovy

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

16:35 - Cultural differences when doing business across countries

23:53 - AI, machine learning, and generative AI in clinical trials, drug development, FDA compliance, and quality

30:13 - Understanding rare disease trials and overcoming their unique challenges

33:12 - Is it a zebra or a horse?

Key takeaways

• Rare disease trials often require unusually sophisticated patient-identification and recruitment strategies.
• Caregivers are an essential part of the rare disease ecosystem.
• AI may improve patient recruitment, data analysis, and other areas of clinical research, but implementation must be thoughtful.
• Building international clinical-development organizations requires understanding cultural as well as operational differences.

Rare Givers

Learn more or donate:

https://www.raregivers.global/

Connect with Scott Schliebner

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

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

New News

Epitomee announces 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 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 credit

Rare Disease Day:

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

#clinicaltrials #raredisease #AI #drugdevelopment #biotechnology

Dr. Russell Grant returns to BioTalk Unzipped for a conversation about scientific skepticism, leadership, mentorship, emerging technology, and the discipline required to separate compelling science from compelling headlines.

Russ explains what happens in his mind when he encounters an extraordinary scientific claim and why experimental execution matters as much as the conclusion of a publication.

The conversation then turns to brain-computer interfaces and Neuralink, raising larger questions about neuroscience, brain biochemistry, and how far technology may eventually take us.

Russ also shares lessons from his leadership within the Triangle Area Mass Spectrometry Discussion Group, including how strong professional communities help bridge academia and industry. He discusses mentoring scientists, developing people, and keeping teams focused on scientific fundamentals while still pursuing ambitious work.

And, as always on BioTalk Unzipped, we get outside the laboratory and learn more about the person behind the science.

Chapters

01:22 - What does Russ Grant’s brain do when he sees a groundbreaking publication?

07:47 - New News!

13:10 - Dr. Grant’s leadership with TAMS and why the organization has been successful

24:05 - Have the challenges facing graduate students changed over the past two decades?

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

30:56 - Leadership, career development, and developing the people you lead

35:51 - Memorable quotes and lessons

37:30 - What Russ does for fun

Connect with Dr. Russell Grant

Dr. Russell Grant

grantr@labcorp.com

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

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

Organizations 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

Neuralink implants brain-computer interface in first human trial participant:

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

Image credits

Clint Eastwood clip: https://www.youtube.com/watch?v=eJJXIcig2h8

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

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

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

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

Dr. Russell Grant joins BioTalk Unzipped to discuss a career that has taken him from the United Kingdom to the United States, from large pharmaceutical organizations into diagnostics, and across the evolving worlds of mass spectrometry and laboratory medicine.

Russ explains important differences between bioanalysis supporting clinical trials and laboratory testing used directly in patient care. He also shares his experience working through the extraordinary demands created by COVID-19 and why seemingly small improvements in laboratory efficiency can have meaningful consequences when multiplied across thousands of patients.

The conversation also examines a remarkable gene therapy story involving the restoration of hearing in a child with genetic hearing loss.

Beyond the technology, Russ discusses why diagnostics became such an important part of his career, the role scientific integrity plays in trustworthy research, and what concerns him about problems within scientific literature.

It is a conversation about science, healthcare, professional reinvention, and the responsibility researchers have to get the science right.

Topics explored

• Moving from the UK to the United States and from pharma to diagnostics
• Clinical-trial bioanalysis versus diagnostic laboratory medicine
• The evolving role of mass spectrometry
• Improving healthcare through better laboratory processes
• Working through the COVID-19 pandemic
• Gene therapy and genetic hearing loss
• Scientific integrity and academic fraud
• Why diagnostics can directly affect patient outcomes

Connect with Dr. Russell Grant

Dr. Russell Grant

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

Connect with the hosts

Dr. Chad Briscoe

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

Gregory Austin

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

New News

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

https://www.fiercebiotech.com/biotech/lilly-makes-waves-says-gene-therapy-restored-hearing-child-genetic-hearing-loss

Image credits

David Gilmour, Getty Images

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

#biotechnology #diagnostics #science #innovation #patientcare

Explore the regulatory challenges amidst the technology and the AI explosion, with insights into the FDA's evolving role and its mission for public safety. Learn how ChatGPT transcends boundaries, from revolutionizing travel planning to enhancing workplace productivity. 💼

Delve into the nuances of ChatGPT's capabilities and limitations, navigating the fine line between its potential and pitfalls. Uncover concerns surrounding AI detectors in academia and the intricate realm of Deep Fakes. 🤖

Step into the conversational realm of ChatGPT, contrasting its prowess with conventional assistants like Alexa.

Follow Dr. Stephanie Pasas Farmer's impactful journey, from combating malaria in South Africa to her unique career trajectory. 🌍

Tune in as she shares the most surprising moments of her career and imparts invaluable advice for aspiring scientists and entrepreneurs. Don't miss out on this riveting exploration of innovation, integrity, and entrepreneurship in the scientific realm! 🚀

#Science #ChatGPT #Innovation #Entrepreneurship #LifeScience #SoftwareTools #FDA #AI #CareerAdvice

01:00 - Data integrity concerns and new software tools.

05:43 - How are Regulators dealing with this technology and AI explosion? Regulatory Challenges and FDA’s Role. FDA agents speaking about AI at conferences.

10:00 - Using ChatGPT in your non-work life for things like Travel Planning.

13:15 - Using ChatGPT for Work.

14:40 - Limitations of ChatGPT.

16:19 - Concerns about False Positives for AI detectors in academics and Deep Fakes, which are so difficult to detect.

17:13 - The Conversational Nature of ChatGPT.

19:57 - Stephanie’s Work in South Africa. She helps a non-profit for malaria and unmet medical needs globally. Building out the laboratory capabilities there. .

22:22 - The most surprising thing in her career. Advice for Aspiring Scientists and Entrepreneurs.

Dr. Stephanie Pasas Farmer: https://www.linkedin.com/in/stephanie-pasas-farmer/

spfarmer@bdatasolutions.com

Ariadne Software: https://www.ariadnesolutions.com/

BioData Solutions: https://www.bdatasolutions.com/

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

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

Image Credits

KU basketball, stubhub, https://www.stubhub.com/kansas-jayhawks-basketball-tickets/performer/6849

BTS, https://www.teenvogue.com/story/bts-billboard-music-awards-2018

Cardi B, https://www.xxlmag.com/cardi-b-reacts-criticism-not-dropping-album-tour/

Taylor Swift, https://www.tiktok.com/discover/You-broke-my-hand-and-you-didnt-even-seems-sorry-taylor-swift

Costa Rica, https://www.pixelstalk.net/

Deep fake, https://www.trymaverick.com/blog-posts/are-deep-fakes-all-evil-when-can-they-be-used-for-good

Korean food, https://spoonuniversity.com/lifestyle/i-learned-the-secret-to-mastering-korean-bbq-by-growing-up-in-my-familys-restaurant

Africa, https://en.wikipedia.org/wiki/Africa

WRIB, https://www.wrib.org/

AAPS, https://www.aaps.org/home

APA, https://www.bostonsociety.org/APA/

🧠 Dive into the practical side of Stephanie's software and the ever-evolving landscape of machine learning regulations. Get a glimpse into Stephanie's perspective on machine learning vs. expert systems and the challenges of navigating this dynamic field.

🌐 Discover what lies ahead for AI in Stephanie's software and the integration of her companies. The conversation extends to QPCR Analysis, exploring the monitoring of DNA and RNA for safety and efficacy. Uncover the resurgence of PCR technology with new applications.

🔍 Join us for a casual chat packed with insights, anecdotes, and a peek into the future of bioanalysis. Tune in now and enjoy the exploration of BioTech innovation with BioTalk Unzipped! 🧬🎧 #biotechnology #AIInnovation #Podcast #pharmaceutical #science

Segment list:

3:22 - Journey into Bioanalysis

7:56 - Stephanie starting her own company - Ariadne Software - the problem that inspired a company

12:44 - RedThread: An AI-Enabled Auditing Tool - human augmented intelligence

15:54 - What is the learning aspect of the software? Vigilante Computer Scientist? Regulations for machine learning.

19:04 - Machine Learning vs. Expert Systems. Machine learning analysis

20:52 - What is next for AI in Stephanie’s software and combining her companies.

22:23 - Expanding into QPCR Analysis. Monitoring DNA and RNA, safety and efficacy.

25:05 - PCR - what’s old is new again based on new applications.

Dr. Stephanie Pasas Farmer: https://www.linkedin.com/in/stephanie-pasas-farmer/

Ariadne Software: https://www.ariadnesolutions.com/

BioData Solutions: https://www.bdatasolutions.com/

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

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

Image Credits

KU logo, https://www.amazon.com/Open-Road-Brands-Jayhawk-Framed/dp/B07QJ4CK32

KU banner, https://www.amazon.com/Kansas-Jayhawks-Chalk-University-College/dp/B005RON6UA

Shifting focus, we delve into a groundbreaking Sickle Cell Therapy breakthrough, discussing its triumphs, challenges, and the crucial aspect of affordability. Despite the hurdles faced by payers and insurance companies, we find inspiration in the thrill of witnessing healing.

Discover the role of AAPS in shaping the biotech future and efforts to engage students. Episode 4 also highlights Russ’ passions, including a heartfelt case study and insights into his AAPS Presidential platform. Explore surprising career moments, the transformative power of AI, and personal aspects of Russ’ life, from scuba diving to family.

The episode concludes with valuable advice on mentoring, self-worth, and navigating the intricacies of career development.

Join us on BioTalk Unzipped for a captivating journey where science meets stories, leaving you enlightened and inspired.

#biotechnology #AI

#careerdevelopment #cellgenetherapy #science #career

SEGMENTS

1:15 - Be Brutal to the Cell and Gene Therapy Industry - Where is CGT really going? Will it bankrupt insurance companies?

3:50 - Sickle Cell Therapy breakthrough, side effects, and affordability

4:22 - Difficulty for payers, insurance companies, but the thrill of people getting healed

8:20 - Role in AAPS. Bringing in students to AAPS.

10:16 - Russ’ #1 Passion and a Heartbreaking case study of a young woman.

11:06 - Russ’ #2 Passion and his AAPS Presidential platform and amazing science done outside the US

15:07 - What we need to do to help the world and realities we don’t often see

17:51 - What’s the most surprising thing in Russ’ career?

19:31 - AI changed everything

23:43 - Russ’ other passions: scuba diving and family

27:37 - Funny stories and knowing your worth

29:24 - Always mentoring and always find a mentor

31:09 - Who’s in charge of your career?

33:51 - The difference between career development and promotion

How to find our guest, Dr. Russ Weiner, Head Oncology and Cell Therapy Clinical Biomarker Sciences and Operations at Takeda:

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

Your BioTalk Unzipped Cohosts:

Gregory Austin, Business Development Manager at ProPharma Group

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

Dr. Chad Briscoe, Executive Vice President of Global Bioanalytical Services at Celerion

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

Image credits: Image by Tumisu from Pixabay Giphy: The Chemical Brothers; PBS Digital Studios; http://www.gizmodo.com.au/2015/07/did-an-australian-university-just-say-wi-fi-gives-you-and-your-kids-cancer/; http://dynamicoceans.tumblr.com/post/99418047836/manta-ray-glittering-in-the-sunlight-despite Photo by Andres Siimon on Unsplash Tenor AAPS Cardiac cell beating courtesy of IGI Deputy Director Bruce Conklin Liquid Diving Adventures, https://www.liquiddivingadventures.com/blog/post/2020/11/27/socorro-islands-mexico-only-by-liveaboard

In Episode 2 of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe examine some of the fundamental challenges facing drug discovery and development, including the enormous scientific uncertainty involved in turning an idea into a medicine.

The conversation moves into artificial intelligence and its growing role in biopharmaceutical research. Gregory and Chad explore where AI could accelerate discovery and development, but also what increased reliance on AI may mean for education, critical thinking, and the way future scientists learn.

They also look beyond technology to something even more fundamental: the motivation of the scientists doing this work. What keeps people pursuing difficult scientific problems when experiments fail, companies change direction, and years of work may never become an approved therapy?

Gregory concludes the episode by sharing the unconventional path that brought him into biotechnology and pharmaceuticals.

This episode is designed for anyone curious about how medicines are developed, whether you work inside the industry or simply want to better understand the science shaping healthcare.

Chapters

00:56 - Chad Briscoe’s take on one of the greatest challenges in drug discovery and development

05:41 - A declaration about science

10:02 - The use of AI in biopharmaceutical science

15:17 - How AI may affect education and learning

16:57 - Swifties and science

17:42 - What drives scientists working toward medical progress

20:18 - Gregory’s journey into biotech and pharma

Connect with the hosts

Gregory Austin

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

Dr. Chad Briscoe

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

Resources mentioned

The Boston Society / Applied Pharmaceutical Analysis:

https://www.bostonsociety.org

Tom Shull:

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

#biotechnology #pharmaceutical #science #drugdevelopment #drugdiscovery #research

Hosted by Gregory Austin and Dr. Chad Briscoe, the podcast brings biotechnology, pharmaceutical development, drug discovery, clinical research, and emerging medical technologies to life through candid conversations with the scientists, executives, entrepreneurs, and innovators helping move medicine forward.

The idea behind BioTalk Unzipped started simply: some of the best conversations about science happen when people put down the presentations, pull up a chair, and talk openly.

Think intelligent biotech conversation with the accessibility and personality of a great conversation over a drink.

We explore questions such as:

• How does a promising scientific idea become a medicine?

• Why do drug-development programs succeed or fail?

• What breakthroughs are genuinely changing healthcare?

• How are AI, cell and gene therapy, precision medicine, bioanalysis, clinical research, and new technologies reshaping drug development?

• What can we learn from the people behind the science?

BioTalk Unzipped is scientifically credible without being inaccessible and serious about medical progress without taking itself too seriously.

Watch all BioTalk Unzipped episodes:

https://www.youtube.com/@BioTalkUnzipped

Connect with the hosts:

Dr. Chad Briscoe

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

Gregory Austin

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

#Biotechnology #DrugDevelopment #DrugDiscovery #ClinicalResearch #Pharmaceutical #Science #BioTalkUnzipped

Welcome to the premiere of BioTalk Unzipped, where Gregory Austin and Dr. Chad Briscoe explore the science, people, decisions, failures, and unexpected moments behind medical progress.

In this inaugural episode, Gregory and Chad introduce themselves, explain what drew them into biotechnology and pharmaceutical development, and discuss why they created a podcast designed for scientists and non-scientists alike.

The conversation explores an uncomfortable reality of biotech: even companies built around talented scientists and promising ideas can fail. Gregory and Chad examine what happens when science, capital, execution, and business realities collide, and why setbacks remain an important part of innovation.

Chad also shares some of the biggest surprises from his career in bioanalysis and drug development, while the conversation turns toward what young scientists and industry professionals can do to build successful careers.

BioTalk Unzipped was created to make biotechnology more understandable without stripping away the complexity that makes the field so fascinating.

In this episode

• Meet BioTalk Unzipped hosts Gregory Austin and Dr. Chad Briscoe
• Why biotechnology companies fail, even when the science looks promising
• Unexpected lessons from a career in drug development
• What aspiring scientists need to understand about building a career
• Why the human stories behind science matter

Connect with the hosts

Gregory Austin

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

Dr. Chad Briscoe

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

Gregory Austin’s book, Stellar Resume Writing: Secrets From a Corporate Recruiter:

https://www.amazon.com/dp/B07NTK6RG2

#biotechnology #pharmaceutical #science #drugdevelopment #drugdiscovery