BioTalk Unzipped

In this episode (EP20) 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. They discuss topics such as the advancements in cancer therapies, the integration of AI and mechanistic modeling in drug development, and the complexities of regulatory submissions. Dr. Shen shares his journey into bioanalysis and his passion for mass spectrometry.  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

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe continue their conversation with Zealic CEO, Chuck Piccirillo. They delve into the unique challenges of the patient journey and the increasing demand for hybrid healthcare solutions that offer more flexibility. The discussion highlights the rise of virtual health, particularly in Europe, and introduces exciting developments in ion channels as a goldmine for new medicines. They also explore the financial intricacies of drug development, the importance of leadership through incremental steps, the value of in-person interactions, and hard-earned lessons in the industry. Finally, Chuck offers invaluable advice for entrepreneurs in the life sciences sector. Chapters 00:17 - Adapting to what is unique in the patient journey. 07:08 - Push for hybrid solutions - more flexibility. 09:20 - Virtual health is emerging, especially in Europe. 14:02 - New News! - Ion Channels are a goldmine for new medicines 19:23 - The Financial Side of Drug Development 21:50 - Leadership - Incremental Steps, the Value of In-Person Interactions, Learning Hard Lessons 30:58 - Advice For Entrepreneurs in Life Science Takeaways Building blocks to build the digital patient experience, then tweak it to the individual drug and form a complex digital and personal adaptive health journey. The healthcare industry needs to find a balance between safety and innovation to ensure patients have access to the best possible care. Remote patient monitoring and decentralized clinical trials are crucial in improving patient engagement and outcomes in the healthcare industry. Virtual visits and technology integration can enhance patient engagement and make healthcare more accessible. While there has been an increase in decentralized trials, the focus is currently on commercial solutions due to the crowded nature of the clinical trial technology space. Virtual health and routine monitoring have the potential to alleviate the burden on healthcare providers and improve patient care. Ion channel research holds promise for developing new medicines and treatments for various conditions. Incremental progress and persistence are key in entrepreneurship and leadership. Sound Bites (regarding adaptability in clinical software) “Imagine if LinkedIn only every 6 months. How engaging would that be?” "And it would actually integrate with like Uber, for example, and help them get a ride if they had to go to the doctor and actually, and all of that is based on these building blocks that we're able to assemble and then press a button." “I think everybody wants whatever aspect of life nowadays to be hybrid anything.” “It’s why we always talk about pragmatic innovation.” “Persistence in the face of opposition of all sorts.” New News Story:  These microscopic tunnels are a goldmine for new medicines https://www.biopharmadive.com/news/ion-channels-drug-research-vertex-biohaven-jazz/719337/  How to reach us: Crohn's & Colitis Foundation https://www.crohnscolitisfoundation.org/  Chuck Piccirillo https://www.linkedin.com/in/cpiccirillo/  Zealic Health - http://www.zealichealth.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 /  Keywords Patient Journey, Hybrid Healthcare Solutions, Drug Development Finance, Leadership in Life Sciences, Entrepreneurship in Life Sciences, Remote Patient Monitoring, Decentralized Clinical Trials, Healthcare Technology Integration, Digital Patient Experience, Clinical Software Adaptability, Pragmatic Innovation, Persistence in Entrepreneurship, Leadership #HealthcareInnovation #VirtualHealth #DrugDevelopment #LifeSciences #Entrepreneurship #DigitalHealth #HybridHealthcare #IonChannels #PatientCare #RemoteMonitoring #ClinicalTrials #Leadership #HealthTech #PragmaticInnovation #Persistence #pharmaceutical #biotech #science #CEO

Summary In this conversation, Dr. Jonathon Hill discusses the unique partnership between his lab and the university, which allows students to become entrepreneurs, develop their own projects, and become the CEO. Dr. Hill discusses the potential for AI to better diagnose disease based on the individual’s genome. He also talks about Lumicell's fluorescent system for highlighting residual breast cancer tissue and the importance of genetic diagnostics in personalized medicine. Dr. Hill shares his advice for students interested in genetics and biotechnology research, emphasizing the value of research experience and taking risks. He also discusses the challenges of regulatory pathways in the biotech industry.  Takeaways The unique partnership between academic institutions and companies can provide students with opportunities to develop their own ideas and become entrepreneurs, fostering innovation and impact in the biotechnology industry.  Lumicell's fluorescent system can help detect residual breast cancer tissue, reducing the need for additional surgeries Genetic diagnostics will play a crucial role in personalized medicine, but there are limitations to relying solely on genetic sequencing Navigating regulatory pathways is a challenge in the biotech industry Sound Bites “We like to say that we are creating CEOs in our labs … CEO at age 23.” “When you go to the doctor, they do a guess and check model.” “Why did you not carefully diagnose the problem and give me the right treatment the first time?” “And medicine needs to go in the direction of AI-aided diagnosis because it's going to lower costs, make things faster and more efficient and better in the long run if we can create if we can create accurate diagnoses.” “Typically about 50% of high school seniors indicate they will go to college. This year it’s down to 37%” Chapters 01:01-The balance between being professor and running a lab 02:00-The unique partnership between university and industry 03:55-More students are looking to pursue entrepreneurship out of college 06:31-How will AI affect genetics research and the industry?  The impact of AI in future diagnoses. 12:58-New News! Lumcell’s breakthrough in residual breast cancer imaging detection. 16:10-Dr Hill’s passions within and outside his professional life. 17:37-Advice for young scientists and budding biotech entrepreneurs. 21:00-Growth of bioinnovations and training scientific students for business success vs. backlash of the cost of education. 28:48-The regulatory hurdles and progress for Wasatch and their DNA research. New News Article The FDA has granted a groundbreaking approval to a fluorescent light system that illuminates leftov...https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer  How to reach us: Dr. Jonathon Hill https://www.linkedin.com/in/jonathon-t-hill/  Wasatch Labs: https://www.wasatchbiolabs.com/  Rainforest Trust - https://www.rainforesttrust.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 /  Image Credits Gattaca https://www.justwatch.com/us/movie/gattaca Lumicell Fluorescent System https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer  https://www.laserfocusworld.com/bio-life-sciences/article/14294960/fluorescence-imaging-system-may-improve-cancer-care  https://vimeo.com/807609920  https://healthandpharma.net/fda-approves-imaging-tumor-detection-breast-cancer-surgeries#google_vignette  Keywords nanopore sequencing, genetic research, epigenetics, rainforest preservation, AI, tobacco addiction, addiction treatment, Alzheimer's disease, DNA methylation #nanopore, #geneticresearch, #epigenetics, #AI, #addiction, #alzheimers, #DNA

Summary In this conversation, Gregory Austin and Chad Briscoe interview Chuck Piccirillo, CEO of Zealic Health, about his experience in the healthcare industry and the focus on patient-centric solutions. Chuck shares his personal journey with colitis and how it ultimately inspired him to start Zealic Health. The company aims to provide highly patient-centric digital platforms to improve care and treatment in the healthcare industry. Chuck also shares the story of how Zealic Health adapted to the war in Ukraine and relocated their employees to Poland. The panel tackles the tough questions around the new LDT as a Medical Device final ruling by the FDA. They then discuss how AI is helping doctors detect cancer and in making better diagnostic decisions. Takeaways Zealic Health focuses on providing patient-centric digital platforms to improve care and treatment in the healthcare industry. The use of AI in healthcare can help accelerate drug development, improve diagnostics, and enhance patient engagement. Zealic Health adapted to the war in Ukraine by relocating their employees to Poland, demonstrating their commitment to their team and their mission. The FDA final ruling is clearly to improve safety but the confusion is in the interpretation of that ruling and  Sound Bites “The biggest challenge is the interpretation of these (LDT) rules.” “Typically I’m not in favor of what Congress is doing.” “Trying to understand how we’re going to navigate the space … it’s just been confusing.” "The FDA is trying to protect us, but they need to navigate these things and engage industry experts." “(regarding AI) Where does marketing end and reality begin?” "AI isn't going to say, 'We don't need the doctor, just use AI.'" “The people who are out of their jobs won't be the ones using AI. The people who are out of their jobs will be the ones who don't.” “The whole promise of AI is taking massive amounts of data and finding those patterns Chapters 01:33 Introduction and Background 04:03 The Crohn’s & Colitis Foundation and Chuck’s struggle with Colitis 07:49 Patient-Centric Solutions in Healthcare and Zealic Health 13:26 Plan B - Moving offices from Ukraine to Poland 20:02 New News!! - The Controversy of LDTs Becoming Medical Devices 27:20 Implications of healthcare and regulations as it applies to AI 30:07 How AI Aids in Diagnosis New News Story: House committee tells FDA to suspend lab developed test rule https://www.healthcaredive.com/news/house-committee-fda-suspend-ldt-rule/721362/  How to reach us: Crohn's & Colitis Foundation https://www.crohnscolitisfoundation.org/  Chuck Piccirillo https://www.linkedin.com/in/cpiccirillo/  Zealic Health - http://www.zealichealth.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: https://www.crohnscolitisfoundation.org/  LDT/FDA, https://x.com/FDADeviceInfo/status/1784965525522493657  Congress, https://worldstrides.com/blog/2013/07/u-s-capitol/  Cost, https://www.freepik.com/photos/increasing-costs  Cancer patient, https://www.freepik.com/free-photo/sick-asian-man-sitting-chair-side-view_33753979.htm  CAD - Computer Aided Detection, https://researchoutreach.org/articles/assessing-performances-computer-aided-diagnosis-breast-cancer/  #BioTalkUnzipped #Podcast #HealthcareInnovation #PatientCare #AIinHealthcare #FDARegulations #Ukraine #LifeSciences #DigitalHealth #AI #pharmaceutical #biotechnology #medicaldevice

Summary Dr. Andy Vick shares some of the things that surprised him throughout his career and he discusses his passion for reptiles and his experience discussing the pharmaceutical potential of venom with future toxicologists at Ashland University. Next, Andrew Vick discusses his role as an adjunct professor at Ohio State University, his involvement in academia, and how he got into it. We discuss a story about a clinical study that restored hearing in children with gene therapy. The conversation concludes with a discussion about the impact of professional organizations like AAPS on the industry and the importance of networking and fellowship. Takeaways Cancer doesn’t have the same death sentence - fear factor it used to have 30+ years ago. It takes about 10 years for a newly discovered compound to make it on the market. Andrew Vick is passionate about reptiles and has a collection of rare reptiles. He enjoys educating others about reptiles and their pharmaceutical potential, particularly venom. There’s a shift from small molecules to biologics in the past 5 years. Andrew Vick visited Ashland University to discuss the pharmaceutical potential of venom with future toxicologists, combining his passion for reptiles and pharmaceutical science. Andrew Vick is an adjunct professor at Ohio State University, where he teaches in the College of Pharmacy Division of Pharmaceutical Chemistry. His role as an adjunct professor involves giving guest lectures, providing career and professional development for students, and serving on the Dean's Corporate Council. Andrew Vick is also involved in evaluating assets developed in academia and collaborating with industry to develop strategies for bringing products to the clinic. We discuss a study by Regeneron that used gene therapy to restore hearing in children with mutations in the otoferlin gene. Regarding Cell-Gene Therapy we have a lot to learn both from the positive pharmacological potential, but also from a safety and tolerability standpoint. Professional organizations like AAPS play a crucial role in networking and fellowship, providing opportunities for collaboration and learning in the pharmaceutical industry. Sound Bites "I have just a passion for reptiles and have accumulated a small and pretty rare collection of reptiles from around the world." “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.” “AAPS is just kind of part of my DNA.” Chapters 00:21 - Surprises in 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 In The Past 30 Years 10:13 - Educating Future Toxicologists about Reptiles and Pharmaceuticals 15:45 - Andrew Vick's Role as an Adjunct Professor at Ohio State University 21:21 - New News!! - Restoring Hearing in Children with Gene Therapy 27:27 - The Impact of Professional Organizations on the Industry, AAPS New News Story:  The 'little protein factory' that could: Regeneron gene therapy restores hearing in 2 children https://www.fiercebiotech.com/biotech/little-protein-factory-could-regeneron-gene-therapy-restores-hearing-2-kids  How to reach us: Dr. Andy Vick https://www.linkedin.com/in/andy-vick-4467189/   Attralus: https://www.attralus.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: Pharmacognosy - https://pharmacognosy-phytochemistry-natural-products.pharmaceuticalconferences.com/events-list/industrial-pharmacognosy #biotechnology #science #research #toxicology #reptiles  #academia #cellgenetherapy #AAPS

Summary Dr. Andy Vick discusses his work at Attralus Therapeutics, a biotech company focused on developing treatments for systemic amyloidosis. He explains the etiology of the disease and how Attralus is attacking it using therapeutic antibodies with a pan amyloid reactive peptide sequence. The company is also developing a diagnostic tool to visualize amyloid burden in patients. Dr. Vick emphasizes the importance of toxicology in drug discovery and development, describing its role in evaluating the adverse side effects of drugs and ensuring safety. He also highlights the challenges of finding animal models for rare diseases like amyloidosis. In this part of the conversation, Andrew Vick discusses his transition from working in a contract research organization (CRO) to a small biotech company. He highlights the similarities and differences between working in biotech, pharma, and CROs, emphasizing the motivation to help others and improve the quality of life. The conversation then shifts to a discussion about a novel mRNA-based cancer vaccine for glioblastoma, which shows promise in early research. The vaccine wraps the RNA specific to a patient's tumor in lipid nanoparticles, stimulating a robust immune response against the cancer.  Takeaways Attralus Therapeutics is focused on developing treatments for systemic amyloidosis using therapeutic antibodies with a panamyloid reactive peptide sequence. The company is also developing a diagnostic tool to visualize amyloid burden in patients. Toxicology plays a crucial role in drug discovery and development, evaluating the adverse side effects of drugs and ensuring safety. Finding animal models for rare diseases like amyloidosis can be challenging. Andrew Vick transitioned from working in a contract research organization (CRO) to a small biotech company, highlighting the similarities and differences between the two. The motivation to help others and improve the quality of life is a common thread in biotech, pharma, and CROs. A novel mRNA-based cancer vaccine for glioblastoma shows promise in early research, stimulating a robust immune response against the cancer. Sound Bites "Attralus Therapeutics is focusing on biologic-based therapeutics and diagnostics related to amyloidosis." "Toxicology is the science of evaluating the adverse side effects of drugs." "Attralus Therapeutics' lead product is a therapeutic antibody with a panamyloid reactive peptide sequence." "This novel mRNA vaccine shows promise against deadly brain cancer."   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 Studying Amyloidosis  22:06 The History of Attralus and Dr. Vick’s Transition There from CRO 32:45 New News! - Promising Results of an mRNA-Based Brain Cancer Vaccine New News Story:  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 https://www.amazon.com/Military-Aircraft-Cockpit-Photograph-Picture/dp/B07Z2KM6KY UF 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 Track: "CLARITY", Mifune Music provided by https://slip.stream  Download / Stream: https://get.slip.stream/KFCilm    Keywords Attralus Therapeutics, systemic amyloidosis, therapeutic antibodies, panamyloid reactive peptide sequence, diagnostic tool, toxicology, drug discovery, drug development, animal models, rare diseases, transition, contract research organization, CRO, biotech, pharma, motivation, quality of life, mRNA-based cancer vaccine, glioblastoma, lipid nanoparticles, immune response #biotechnology #science #research #toxicology #glioblastoma #braincancer #vaccine #amyloidosis

A Diagnostic Breakthrough for Alzheimer’s Summary In this conversation, Dr. Jonathan Hill discusses his work in nanopore sequencing-based technology and its applications in genetic and epigenetic research. He shares his experiences working in Brazil and his passion for preserving the rainforest. The conversation also explores the use of AI in analyzing the genetic underpinnings of tobacco addiction and the potential impact on addiction treatment. Dr. Hill highlights his lab's breakthrough in identifying early biomarkers for Alzheimer's disease using DNA methylation signatures.  Takeaways Nanopore sequencing is a powerful technology that allows for real-time analysis of native DNA and RNA, regardless of length, and provides valuable insights into genetic and epigenetic research. Preserving the rainforest is crucial, and initiatives like the Rainforest Trust play a vital role in protecting the biodiversity and resources found in these ecosystems. AI technologies, when used in conjunction with genetic research, can accelerate the identification of candidate genes associated with complex conditions like tobacco addiction, leading to personalized approaches for smoking cessation and addiction treatment. The integration of AI technologies in genetic research should be approached with caution, as the black box nature of AI can limit our understanding of the underlying biology. It is important to carefully test and explain AI models to build trust among users. The use of nanopore sequencing and DNA methylation signatures shows promise in the early detection of Alzheimer's disease, potentially allowing for personalized approaches to treatment and intervention. Sound Bites "One of my bucket list items, one of my dreams would be to set up a nanopore sequencing lab in the Amazon and just sequence that biodiversity and create that data so we could glean it for everything it's worth and learn so much about how our world works." "Nanopore sequencing is based on protein nanopores that exist in nature, and these particular nanopores can pass DNA through the pore." "AI technologies, when used in conjunction with genetic research, can accelerate the identification of candidate genes associated with complex conditions like tobacco addiction, leading to personalized approaches for smoking cessation and addiction treatment." “Biology is not rocket science, it’s much harder.” "Better diagnosis comes better treatment." Chapters 00:00 Introduction  02:51 Donation to the Rainforest Trust & 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 New News Article Breaking the Genetic Code of Tobacco Addiction https://neurosciencenews.com/genetics-tobacco-addiction-ai-25937/  How to reach us: Dr. Jonathan Hill https://www.linkedin.com/in/jonathon-t-hill/  Wasatch Labs: https://www.wasatchbiolabs.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 Rainforest Trust - https://www.rainforesttrust.org/  https://www.envirobuild.com/blog/rainforest-trust Fire Sponge https://stock.adobe.com/  Amazon Photos: Shutterstock  Medicine Man https://www.rollingstone.com/music/music-lists/stills-from-the-movie-medicine-man-32217/medicine-man-5-159239/  https://www.solarnavigator.net/films_movies_actors/medicine_man.htm Oxford Nanopore Technologies How nanopore sequencing works https://www.youtube.com/watch?v=RcP85JHLmnI  Keywords nanopore sequencing, genetic research, epigenetics, rainforest preservation, AI, tobacco addiction, addiction treatment, Alzheimer's disease, DNA methylation #nanopore, #geneticresearch, #epigenetics, #AI, #addiction, #alzheimers, #DNA

The AI Prescription: Revolutionizing Pharma & Patient Care with Jason Burke Summary In Episode 13, Jason Burke discusses the unique approach of the Duke program in providing real-world healthcare data to students. He also highlights the breakthrough in AI-generated drug discovery and its potential impact on investors and startups. The process of assessing technologies for companies and patients is explored, with a focus on evaluating business and technology aspects. The importance of unique intellectual property is emphasized, and the future of AI and software is discussed. The conversation concludes with insights into using AI in everyday life and the role of search engine companies in AI. In this conversation, Chad and Jason discuss the interface between pharma companies and the healthcare industry, highlighting the lack of interplay between the two. They explore the challenges faced by the healthcare industry, including the complexity of the operating environment and the limited infrastructure for research. Jason emphasizes the potential for life sciences firms to become service companies and overcome these challenges. They also delve into Jason's interest in amateur radio and the fascinating world of ham radio, where he has been learning and discovering new things. Takeaways The Duke program provides students with real-world healthcare data, giving them a unique advantage in the job market. AI-generated drug discovery has the potential to revolutionize the pharmaceutical industry and attract more investment to startups. Assessing technologies for companies and patients involves evaluating both the business and technology aspects, including intellectual property. The future of AI and software will see the emergence of new forms of experiences and collaboration between humans and machines. Search engine companies have been late to adopt AI technologies like ChatGPT, but they have already been utilizing AI in their search algorithms.  \There is a need for more interplay between pharma companies and the healthcare industry to ensure better understanding of customer needs and feedback. The healthcare industry faces challenges due to the complexity of the operating environment and limited infrastructure for research. Life sciences firms have the potential to become not just product companies, but service companies and provide valuable solutions to overcome the challenges in the healthcare industry. Doctors want to help patients at the highest level possible but continually grapple with the complexity of the healthcare environment and the sheer volume of patients. Amateur radio, or ham radio, offers a fascinating world of learning and discovery, with a community of innovators constantly finding new and creative ways to use the technology. Chapters 00:29 Unique Approach in Duke Program 05:14 New News! The First AI-Generated Drug Discovery 09:33 Assessing Technologies for Companies and Patients.  11:52 The Importance of Unique Intellectual Property 12:35 The Future of AI and Software 13:36 Data as a Commodity 15:10 Innovation Curves and Technology, AI Compressing it 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 Experiences 22:53 The Future of Healthcare and Pharma - Enough Interfacing? 25:08 The Difficulty of Doctors in Complex Environments and Implementing Precision Medicine 29:03 Jason's Interest in Amateur Radio and Exploring the Ham Radio Community 31:39 Bouncing a Radio Signal Off the Moon & Sending Emails over Radio Waves How to reach us: Jason Burke https://www.linkedin.com/in/jasonburke/ Creo Inc. -  https://www.creoinc.net/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com/  #AI  #pharmaceutical #healthcare #drugdiscovery #futuretech #lifesciences

Summary In this episode of BioTalk Unzipped, the hosts discuss the applications and ethical concerns surrounding organoids, which are 3D cell clusters that mimic the features of full-sized organs. They explore the potential of brain organoids in brain-computer interfaces and neuroplasticity. The conversation then shifts to the impact of AI and data sciences in healthcare, with a focus on the challenges and opportunities in implementing AI strategies. The hosts also discuss the future of quantum computing in healthcare and the FDA's IT strategy with 21 CFR Part 11.  Chapters 01:14 - Introduction to BioTalk Unzipped 03:30 - NEW NEWS: Discussion on Organoids and Their Applications  04:45 - Ethical Concerns with Brain Organoids as mini bio-computers 06:31 - Organoid Possibilities in Drug Discovery Research and Brain Interfaces 08:59 - The Potential of Brain Training and Neuroplasticity 10:51 - The Impact of AI and Data Sciences in Healthcare 11:18 - Jason’s Background and Emerging Technologies Transforming Clinical Research 13:43 - The Role of AI in Precision Medicine, Quantum Computing and Business Growth 24:15 - FDA's IT Strategy and the Challenges of Implementing AI 26:32 - The Importance of Strategy and Prioritization in IT, Data Integrity, and 21 CFR Part 11 How to reach us: Jason Burke https://www.linkedin.com/in/jasonburke/ Creo Inc. -  https://www.creoinc.net/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/ Celerion - https://www.celerion.com/  Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ ECI - https://eci-rx.com/  New News Link: The many uses of mini-organs https://www.technologyreview.com/2024/03/08/1089612/the-many-uses-of-mini-organs/  Image Credits Brain - https://www.vecteezy.com/vector-art/658977-kawaii-cute-happy-brain-with-arms-and-legs UFO - https://www.pinterest.com/pin/swampthingy--675891856570360044/ #HealthcareInnovation #Organoids #AI #QuantumComputing #Podcast #BioTalkUnzipped #drugdiscovery

Summary In this episode, Scott Schliebner discusses the unique challenges and complexities of rare disease trials. He highlights the difficulties in recruiting patients, the multidisciplinary nature of care, and the importance of collaboration among various stakeholders. The role of AI in rare disease trials is also explored, with a focus on its potential for patient recruitment and data analysis.  Scott shares success stories in the field and discusses the expanding use of gene therapy to target multiple genes. The conversation concludes with a discussion on the recent FDA approval of Iovance's Amtogvy as the first T-cell therapy for a solid tumor, Melanoma. In this conversation, Scott discusses the potential of cell therapy in targeting solid tumors, particularly melanoma. He highlights the importance of expanding the use of cell therapy to other tumor types and the potential for curative treatments. The conversation also delves into the challenges and questions surrounding pricing and ethics in the gene and cell therapy space. The impact of curative therapies on quality of life and healthcare costs is explored, along with the success of curative therapies in hepatitis C. The high bar of clinical development and regulatory standards is discussed, as well as the potential for cost-effective treatments. The conversation concludes with advice for young professionals and established clinical professionals in the field of drug development. Takeaways Cell therapy shows promise in targeting solid tumors, such as the breakthrough in melanoma treatment, and has the potential to provide curative treatments for various cancer types. The pricing and ethical considerations surrounding gene and cell therapy raise important questions about accessibility and affordability. Curative therapies have the potential to significantly improve quality of life and reduce healthcare costs by eliminating the need for long-term treatments. The success of curative therapies in hepatitis C demonstrates the potential for similar breakthroughs in other disease areas. Young professionals interested in a career in clinical drug development should seek opportunities to gain experience and consider starting in roles such as clinical research coordinators or clinical research associates. Rare Givers is a nonprofit organization that supports caregivers in the rare disease space. Chapters 00:21 - Collaborative Approach in Rare Disease Trials 3:32 - The Role of AI in Rare Disease Trials 6:11 - Success Stories in Rare Disease Trials 11:34 - Expanding Gene Therapy to Target Multiple Genes 16:56 - New News: FDA Approval of Iovance's Amtagvi, The Breakthrough of IOVANCE for Melanoma 19:27 - Targeting Solid Tumors with Cell Therapy, Expanding the Potential of Cell Therapy 20:23 - The Impact of Curative Therapies on Quality of Life and Healthcare Costs 21:11 - Challenges and Questions around Pricing and Ethics 22:37 - Cures for Hepatitis C 23:25 - The High Bar of Clinical Development and Regulatory Standards 24:05 - Pricing Considerations for Different Cancer Types, The Potential for Cost-Effective Treatments 27:45 - Advice for Young Professionals in Clinical Drug Development 31:49 - Advice for Established Clinical Professionals 33:21 - Scott's Hobbies and Interests Learn about and DONATE to Rare Givers: https://www.raregivers.global/  How to reach us: Scott Schliebner https://www.linkedin.com/in/scott-schliebner-1087789/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News Link: https://www.fiercepharma.com/pharma/fda-approves-iovances-amtagvi-first-cell-therapy-solid-tumor  Image Credits Iovance, https://www.iovance.com/  FDA approved, https://www.tipranks.com/news/iovance-nasdaqiova-fda-approves-cell-therapy-stock-gains Amtagvi, https://www.amtagvi.com/ 

Impact of AI in Rare Disease Trials with Scott Schliebner Summary In this episode, the hosts welcome Scott Schliebner as their guest and kick off with a charitable act, donating to Rare Givers. They delve into the Epitomee weight loss capsule's potential impact, then shift to discussing the challenges of establishing a North American infrastructure for a MedTech CRO, navigating cross-cultural dynamics. Later, they investigate the transformative potential of AI and machine learning in clinical trials. Scott Schliebner weighs in on the intricacies of rare disease trials, emphasizing patient recruitment hurdles, interdisciplinary care, and stakeholder collaboration. The conversation also delves into AI's role in addressing these challenges, particularly in patient recruitment and data analysis. #clinicaltrials #science #ai #raredisease #drugdevelopment Takeaways Rare Givers (https://www.raregivers.global/) is a nonprofit organization that supports caregivers in the rare disease space. The Epitome weight loss capsule is an innovative medical device that tricks the body into feeling full, aiding in weight loss. Building a North American infrastructure for a MedTech CRO requires navigating cultural differences and finding key leaders who can adapt to a startup environment. AI and machine learning have the potential to transform clinical trials by improving drug discovery, analyzing large datasets, and enhancing patient retention.  Chapters 00:00 - Introduction and Charity Donation - Rare Givers 02:30 - Discussion on Rare Givers 04:08 - What inspired Scott to the Clinical space 06:12 - New News: Epitomee Weight Loss Capsule 11:25 - Epitomee target drug delivery application weight loss competition with Wegovy 14:05 - Building a North American infrastructure for EU-based MedTech focused CRO 16:35 - Cultural idiosyncrasies to be aware of doing business with different countries 23:53 - The Impact of AI and Machine Learning, and generative AI in Clinical Trials, drug development, FDA compliance, and quality control 30:13 - Understanding Rare Disease Trials, and overcoming challenges  33:12 - Is it a Zebra or a Horse? DONATE to Rare Givers: https://www.raregivers.global/  How to reach us: Scott Schliebner https://www.linkedin.com/in/scott-schliebner-1087789/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ New News Link: Epitomee® announces the filing of a novel Weight Loss Capsule for FDA clearance https://www.prnewswire.com/news-releases/epitomee-announces-the-filing-of-a-novel-weight-loss-capsule-for-fda-clearance-302081225.html NIH Study publication: Safety, tolerability and efficacy of a novel self‐use biodegradable device for management of obesity https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6700511/  Image Credits Zebra - https://www.rarediseaseday.org/event/6th-annual-rare-disease-day-virtual-race/ 

Description: In Episode 8 of BioTalk Unzipped, we dive deep into the scientific mind of Dr. Russell Grant, exploring how he navigates groundbreaking publications with a healthy dose of skepticism. From microsampling blood spots to dissecting experimental execution gaps, Dr. Grant reveals his strategies for separating scientific sizzle from substance. In our latest segment of "New News," we discuss Elon Musk's Neurolink gaining FDA approval for clinical trials, sparking debates about neuroscience's role in the 21st century. With insights into the risks and rewards of understanding brain biochemistry, this episode challenges conventional thinking. Discover the secrets behind Dr. Grant’s legendary leadership with the Triangle Area Mass Spec (TAMS) group, where mentorship, empowerment, and strong networks bridge academia and industry. Uncover how Dr. Grant encourages scientists to stay focused on foundational processes while striving for brilliance in their work. From unexpected breakthroughs in sensitive testosterone measurements to fostering career development in his team, Dr. Grant shares invaluable lessons in leadership and personal growth. Tune in for memorable quotes, career insights, and a glimpse into Dr. Grant's life beyond the lab. Join us as we unzip the world of science with Dr. Russell Grant on BioTalk Unzipped! #biotechnology #diagnostics #science #innovation #leadership #pharmaceutical SEGMENTS: 1:22 - What does Russ Grant’s brain do when he sees a groundbreaking publication?  7:47 - New News! 13:10 - Dr. Grant’s leadership with the TAMS (Triangle Area Mass Spec) group and why it’s so successful.  24:05 - Has the challenges for grad students changed in the past 2 decades? 26:49 - When Russ’ work led to something truly unexpected,  30:56 - Leadership in career development and the people they lead 35:51 - More memorable quotes 37:30 - What Russ does for fun. How to reach us: Dr. Russell Grant grantr@labcorp.com https://www.linkedin.com/in/russell-grant-5144a26/  Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Gregory Austin https://www.linkedin.com/in/gregoryaustin1/ Conferences mentioned: ASMS - https://www.asms.org/  MSACL - https://www.msacl.org/  ADLM - https://www.myadlm.org/  TAMS, Triangle Area Mass Spectrometry Discussion Group - https://tamsgroup.org/  New News Link: https://www.fiercebiotech.com/medtech/neuralink-implants-brain-computer-interface-first-human-trial-participant  Image Credits Client Eastwood, Firefox - https://www.youtube.com/watch?v=eJJXIcig2h8  Neuralink - https://dig.watch/updates/neuralinks-first-human-implant-shows-promising-results  Tricorder Tech: That Star Trek Medical Scanner Is Getting Much Closer https://astrobiology.com/2023/11/tricorder-tech-that-star-trek-medical-scanner-is-getting-much-closer.html  Neuralizer - https://meninblack.fandom.com/wiki/Neuralyzer 

Join us for Episode 7 of our podcast as we delve into the fascinating journey of Dr. Russell Grant, from the UK to America, navigating through large pharma to the field of diagnostics. Discover the nuances between bioanalytical approaches in clinical trials versus clinical healthcare, and Russ's insights on GLP environments. Learn how Russ tackled the challenges of COVID, and hear the incredible New News breakthrough in restoring hearing in an 11-year-old using gene therapy. Russ shares his American dream, his passion for diagnostics, and his thoughts on scientific integrity. Tune in for a captivating discussion on the critical role of diagnostics in saving lives and the pursuit of scientific excellence. #biotechnology #diagnostics #science #innovation #patientcare SEGMENTS: 1. Transitioning Across Continents: A Tale of Professional Evolution - From the UK to America, Exploring Pharma to Diagnostics. 2. Navigating Bioanalytics: Unraveling the Contrast Between Clinical Trials and Healthcare Applications, with a Focus on Mass Spec. 3. Efficiency in Action: Revolutionizing Patient Care by Shaving Seconds Off Injections, One Assay at a Time. 4. COVID Chronicles: Dr. Russel Grant's Vital Role Amidst the Pandemic's Chaos. 5. New News!: A Landmark Achievement in Gene Therapy Unveiled. 6. Crossing Borders: Dr. Russel Grant's Journey to America - Dreams, Challenges, and Triumphs. 7. Fueling Passion: Understanding Russ' Zeal for the Field of Diagnostics. 8. The Power of Diagnosis: Unveiling How Diagnostics Serve as Lifelines in Healthcare. 9. Navigating Integrity: A Candid Discussion on Scientific Literature, Academic Fraud, and the Path Forward for Scientists. Connect with: Dr. Russell Grant: https://www.linkedin.com/in/russell-grant-5144a26/  Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/  Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/  New News link: Lilly makes waves, says gene therapy restores hearing for child with genetic hearing loss Image Credits: David Gilmour (Getty Images) Sir Isaac Newton, https://en.wikipedia.org/wiki/Isaac_Newton

Welcome to Episode 6 of our podcast featuring Dr. Stephanie Pasas Farmer! 🎙️ Join us as we delve into the intricate world of data integrity, unveiling new software tools and the transformative impact they bring. Discover how virtual audits post-COVID, coupled with cloud security measures, are reshaping the landscape. 🔍 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/   

🎙️ Episode 5 of BioTalk Unzipped is here! Join hosts Gregory Austin and Dr. Chad Briscoe as they chat with Dr. Stephanie Pasas Farmer, founder of Ariadne Software and BioData Solutions. Explore the origins of Stephanie's companies, and the creation of RedThread, an AI-Enabled Auditing Tool that blends human intelligence with AI. 🧠 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