Dive into the complete episode list for Life Sciences 360. Each episode is cataloged with detailed descriptions, making it easy to find and explore specific topics. Keep track of all episodes from your favorite podcast and never miss a moment of insightful content.
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Pub. Date
Title
Duration
08 Feb 2023
🚨 EU MDR Challenges & MedTech Trends: Expert Insights from Karandeep Singh Badwal
00:31:01
Navigating EU MDR compliance can be a frustrating and complex process for MedTech companies. In this insightful interview, top MedTech consultant Karandeep Singh Badwal shares his expertise on the latest industry trends, regulatory hurdles, and the key differences between FDA and EU MDR.
🤔 What You’ll Learn in This Video: - The biggest challenges in EU MDR compliance - How notified bodies impact regulatory timelines - FDA vs. EU MDR – Which is better for innovation? - AI and software’s growing role in MedTech - Expert compliance tips for medical device companies
Whether you're a MedTech entrepreneur, regulatory professional, or healthcare innovator, this video provides must-know insights to stay ahead in the industry.
🔔 Subscribe now for more expert interviews and regulatory updates!
⏱️ Timestamps: (0:00) Intro (2:30) From Royal Air Force to MedTech: A Unique Career Shift (7:45) Lessons on Delayed Gratification in Business (12:15) EU MDR Compliance & Challenges (16:30) The Realities of MedTech Consulting (22:00) AI & Software’s Role in the Future of Medical Devices (27:00) Final Thoughts: Building a Legacy in MedTech
🔥 Why GMP Training Is Boring & How to Fix It | QA Audits & Personal Branding Tips w/ Yan Kugel
00:40:25
In this episode, Harsh Thakkar (@harshvthakkar) sits down with Yan Kugel (@yankugel), Managing Director at Qualistery and host of the QualiTalks podcast.
Yan reveals how he’s making GMP learning more engaging, his insights on QA audits, and expert tips for life science professionals to build a strong personal brand on LinkedIn. If you're in quality assurance, GMP training, or life sciences, this is a must-watch!
Topics Covered: 📌 (1:48) - Mastering Quality Assurance 📌 (6:25) - Why GMP Training Is Boring (And How to Fix It) 📌 (14:23) - Lessons from QA Audits 📌 (20:14) - Personal Branding for Life Science Experts 📌 (34:32) - 2023 Qualistery Goals & How You Can Get Involved
From Mining to No-Code: How Vivek Gera is Revolutionizing Pharma
00:34:34
In Episode 003 of LS 360, Harsh Thakkar sits down with Vivek Gera, Co-Founder & CEO of Leucine.io, to discuss how he transitioned from the mining industry to building a no-code platform that’s transforming pharmaceutical manufacturing.
🗣️ Vivek shares: - The inspiration behind Leucine.io - Key challenges in tech-driven pharma solutions - What makes Leucine stand out from competitors - How life science companies can digitize their operations - Advice for entrepreneurs venturing into regulated industries
🎙 Timestamps: (4:25) - How Leucine.io was born (6:49) - Challenges in life sciences tech (10:30) - What sets Leucine apart (19:06) - Compliance vs. Productivity (24:00) - Advice for aspiring entrepreneurs
🔔 Love LS 360? Subscribe for more insights into life sciences, biotech, and innovation!
3 Powerful Writing Tips for Clear Communication & Quality Culture | Lesley Worthington
00:43:53
In Episode 004 of LS 360, Harsh Thakkar sits down with Lesley Worthington, a Writing & Communication Coach for Quality Assurance Professionals.
Lesley shares her journey from QA professional to expert writing coach and reveals 3 powerful tips to improve your writing instantly. She also discusses the impact of clear communication on quality culture, the right way to use acronyms, and whether AI writing tools like ChatGPT will replace creative writers in the future.
⏳ Timestamps: (8:48) – 3 Writing Tips to Improve Your Communication (14:32) – The Right Way to Use Acronyms (23:41) – ChatGPT & AI Writing Tools: Threat or Opportunity? (29:14) – Building Relationships in a Global Workplace (33:47) – Leadership & The Role of Quality Culture
🔹 Mastering SaaS Releases, Hiring the Best Talent & FDA CSA Insights | Rohit Tyagi Interview
00:44:36
In Episode 5 of LS 360, Harsh Thakkar sits down with Rohit Tyagi, President of Sagax Team, to discuss key strategies in SaaS release management, software validation, hiring top talent, and FDA CSA guidance.
Rohit shares his journey from life sciences to building Sagax Team, a quality assurance and lab informatics consulting firm with 50+ experts. Learn about:
- Common pitfalls in software validation & how to avoid them - Best practices for managing SaaS system changes & releases - How leveraging vendor expertise reduces cycle times - Key hiring traits for building a high-performing team - The role of training & upskilling employees for long-term success
🔗 Helpful Resources: 📌 FDA CSA Guidance – Read More 📌 Need IT consulting? – Sagax Team 📌 Love LS 360? Subscribe for more insights!
📍 Timestamps: (2:18) - Top software validation mistakes (9:22) - Rohit's perspective on FDA CSA (17:41) - Hiring people without life sciences experience (24:29) - Managing SaaS releases efficiently (31:10) - Must-have traits for hiring top consultants
Quality Management Evolution: From Inspection to Discovery With Nicole Radziwill
00:39:17
Episode 006: Harsh Thakkar (@harshvthakkar) interviews Nicole Radziwill (@nicoleradziwill), SVP and Chief Data Scientist at Ultranauts Inc, an onshore software & data quality engineering services firm powered by cognitively diverse teams.
In this episode, Nicole discusses the evolution of quality management, the challenges of creating an inclusive work environment, and the intersection between quality management and data management.
Harsh and Nicole also delve into the importance of understanding user needs and the need for a quality 4.0 mindset in digital transformation initiatives.
How to Hire Quality Assurance (QA) Talent and Tips for Job-Seekers Looking For QA Roles With Hemish Ilangaratne
00:41:52
Episode 008: Harsh Thakkar (@harshvthakkar) interviews Hemish Ilangaratne (@hemish-ilangaratne), the founder of Rx-Group.io, a recruitment firm focused on the quality assurance space in the US and Europe.
In this episode, Hemish shares his insights on building a company culture around quality, the importance of references in job applications, and tips for job seekers who have recently been laid off.
Etienne shares his background in engineering, including his experience in the aerospace, steel manufacturing, and aircraft interior industries.
Harsh and Etienne discuss how Quality Management Systems will evolve with technologies like artificial intelligence (AI) in the coming years. Etienne also shares his experience building a community on social media and offers insights to anyone building a community from scratch.
Kathy Walsh shares her experience working with clients to build and design effective quality management systems (QMS) and stresses the importance of integrating QMS into daily operations.
Harsh and Kathy discuss the challenges companies face when transitioning from paper-based to electronic QMS and offer tips for switching. They also touch upon how companies can improve their writing processes and the importance of clear and concise technical documentation.
Mitch shares insights on how to rise above the noise and get noticed by hiring managers, as well as tips for candidates on how to differentiate themselves and add value to their job search.
Harsh and Mitch talk about his unique journey into recruiting and the challenges of finding top talent in today's competitive market. They also discuss the value of taking risks and pushing outside of one's comfort zone for growth, as well as the importance of making and maintaining connections.
The Benefits of Conversation-Based Training in the Medical Industry: Insights from Quality Expert Aaron Snyder
00:43:25
Episode 012: Harsh Thakkar (@harshvthakkar) interviews Aaron Snyder (@aaron-snyder-mscgmp), the Head of Quality at Fresenius Kabi and a lead faculty and trainer for FDA and industry professionals at AAMI.
Aaron touches on the challenges of making regulatory training engaging and interesting, and the importance of understanding the difference between quality and compliance.
Harsh and Aaron discuss Aaron's experience in hiring individuals for quality teams, his role in training FDA and industry professionals, and the motivation behind creating his YouTube channel, "Quality Systems Explained." ----- Links:
Marcus explains how Hoodin's platform helps users gather specific data by monitoring keywords, regulations, and standards from selected sources. He also mentions the importance of AI in the industry and how it can help professionals be more efficient and get more information.
Harsh and Marcus discuss the challenges that life science companies face when trying to monitor content for specific business purposes. ----- Links:
* Hoodin *Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel. ----- Show Notes:
(3:47) Common challenges faced by life science companies in data management.
(8:10) Common needs for monitoring regulatory updates.
(15:37) What do people like about Artificial Intelligence (AI)?
(22:09) What are the pros and cons of AI?
(26:39) How to apply AI to your tasks?
(30:55) Advice for entrepreneurs working in this space.
Investing in Early-Stage Startups: A Personal Perspective with Giovanni Lauricella
00:51:48
Episode 014: Harsh Thakkar (@harshvthakkar) interviews Giovanni Lauricella (@giovannilauricella), the Co-Founder & Managing Partner at Lifeblood Capital and Board Member & Investor at Vivifi Medical.
Giovanni emphasizes the need for entrepreneurs to understand their audience and to have a viable product that solves a problem. He also stresses the importance of being a good storyteller and being able to adapt to the audience
Harsh and Giovanni discuss the importance of networking in building a successful startup and how to overcome the hurdles of fundraising.
----- Links:
* Lifeblood *Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel. ----- Show Notes:
(3:48) Do you have a viable product or not?
(9:32) The value of low-hanging fruit in business.
(15:26) Helping people understand the outcome of a pitch.
(25:32) How to get into the space of Angel Investing
(30:57) Leveraging your network to attract talent.
(36:09) The effect of layoffs on fundraising and talent acquisition.
(40:58) How did the economic pullback freeze up the venture market?
The Promising and Perilous Potential of AI in Life Sciences: A Discussion with Greg Hutchins
00:42:23
Episode 015: Harsh Thakkar (@harshvthakkar) interviews Greg Hutchins (@greghutchins), the Founder of Quality + Engineering and Founder & Director of Certified Enterprise Risk Manager® (CERM) Academy.
Greg Hutchins provides examples of unintended bias in AI systems and the challenge of monitoring and managing AI systems to ensure that they are fair, equitable, and transparent.
Harsh and Greg discuss the NIST AI risk management framework and the AI Bill of Rights, which are being used as deployment and assurance vehicles for federal agencies in the US. They also discuss the challenge of bias in AI systems and the importance of transparency.
Role of AI in Talent Recruitment and Consulting vs. Employment Takeaways with Dharti Pancholi
00:46:58
Episode 016: Harsh Thakkar (@harshvthakkar) interviews Dharti Pancholi (@dhartipancholi), the Founder and Chief Executive Officer at Omni Consulting Services
Dharti discusses her journey in starting her own consulting firm, her experience in both consulting and user-side companies, and her thoughts on recruitment and AI technology.
Harsh and Dharti also discuss the importance of finding the right talent for consulting projects and the role of AI in recruitment. Additionally, they touch on the impact of layoffs in the biotech industry and how it has affected job seekers. ----- Links:
* Omni Consulting *Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel. ----- Show Notes:
(4:32) Consulting vs. user side.
(9:57) How do you recruit for consulting roles?
(14:47) AI’s data analytics.
(19:24) Layoffs in tech companies.
(24:36) Maintaining a balance between time off and work time.
The Promise and Perils of Large Language Models in Healthcare and AI-based Software as a Medical Device with Vivek Thakkar
00:36:30
Episode 017: Harsh Thakkar (@harshvthakkar) interviews Vivek Thakkar (@vivekbthakkar), the Senior Digital Health Consultant at Biologics Consulting
Vivek emphasizes the importance of validating AI-based software in clinical settings to ensure safety and efficacy. He also discusses the challenges of continuous improvement in algorithms and the need for a predetermined change control plan.
Harsh and Vivek also discuss the role of AI in healthcare, the challenges of regulating AI in medical devices, and how companies can go about validating AI-based software as medical devices. They also touch on the potential for AI to generate outlines for regulatory submissions.
The Intersection of Theory and Practice in Quality Management: Perspectives from Amy Wilson and Cliff Berry
00:34:42
Episode 018: Harsh Thakkar (@harshvthakkar) interviews Amy Wilson (@amydwilson) and Cliff Berry (@cliffordberry), co-authors of the book Do Quality Differently, a playbook for creating more success in biopharma (or any) manufacturing.
Amy Wilson and Cliff Berry explore the concepts of the black line and blue line, underscoring the importance of distinguishing between them. They highlight the need to take a comprehensive view of the system, rather than solely focusing on human error.
Harsh, Amy, and Cliff stress the importance of building fluency in the vocabulary and concepts of human and organizational performance in order to enable the adoption of new practices and processes within an organization. The podcast also touches on practical examples from their careers and the challenges of writing their book, Do Quality Differently.
Continuous Validation: The Key to Successful Life Sciences Software with Nagesh Nama
00:38:28
Episode 019: Harsh Thakkar (@harshvthakkar) interviews Nagesh Nama (@nageshnama), the Chief Executive Officer at xLM.
Nagesh shares his perspective on continuous validation and emphasizes the unique capabilities of his platform, which includes the generation of digitally signed PDF reports.
Harsh and Nagesh discuss xLM's platform and its approach to software validation and test automation, as well as challenges related to incorporating AI technology and the importance of data governance
The Thin Line Between Advertising and Misbranding with Darshan Kulkarni
00:41:03
Episode 020: Harsh Thakkar (@harshvthakkar) interviews Darshan Kulkarni (@darshankulkarni), Regulatory and Compliance Attorney at The Kulkarni Law Firm.
Darshan talks about the importance of understanding how to use AI properly. He also discusses his work in advertising compliance, which involves ensuring that companies meet the labeling requirements for their products and that their promotional materials are compliant with FDA and FTC regulations.
Harsh and Darshan discuss various topics such as the use of AI in education and legal work as well as the challenges and risks associated with using AI-generated content in legal documents and journalism.
Personal Branding and Consulting in the Medical Device Industry with Monir El Azzouzi
00:48:14
Episode 021: Harsh Thakkar (@harshvthakkar) interviews Monir El Azzouzi (@melazzouzi), Founder & CEO at Easy Medical Device.
Monir emphasizes the importance of following people in the medical device industry, learning as much as possible, and providing the right vocabulary and language to build self-confidence. Monir also shares his favorite LinkedIn creators, the importance of understanding medical device regulations, and the challenges he faces in consulting.
Harsh and Monir discuss the importance of staying up-to-date with medical device regulations and the challenges that come with consulting in the life sciences industry. Harsh and Monir also discuss the importance of building a personal brand and give tips on leveraging social media to grow a business.
Andy discusses the importance of customer discovery when creating a new product and shares his experience with creating a questionnaire to gain feedback from potential customers. He also talks about the challenges of transitioning from paper to electronic systems in the life sciences industry and the need for intuitive software to facilitate this transition.
Harsh and Andy also discuss the importance of finding an internal champion when pitching a product, highlighting the critical role of building relationships with key stakeholders within an organization.
----- Links:
*Bits In Bio *Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.
----- Show Notes:
(6:31) Paper vs. Electronic QMS implementation.
(11:16) Finding an internal champion.
(19:49) What is a no-code app?
(23:48) How Andy scrapped the idea of building the app.
Balancing Compliance and Innovation in Risk Management: A Discussion with Naveen Agarwal
00:45:05
Episode 023: Harsh Thakkar (@harshvthakkar) interviews Naveen Agarwal (@naveenagarwal), the Principal and Founder of Creative Analytics Solutions, LLC.
Naveen highlights the importance of aligning risk management with innovation and patient well-being, contrasting it with compliance-focused approaches. He also addresses evaluating team risk appetite through diverse perspectives and facilitated discussions to achieve consensus.
Harsh and Naveen delve into the dynamics of risk management within the medical device industry and explore the balance between compliance and courage-driven patient focus. They highlight the importance of streamlined documentation and suggest using diverse perspectives to resolve differences in risk assessment among teams.
Digital Therapeutics Explained with Richard ‘RJ’ Kedziora
00:32:59
Episode 024: Harsh Thakkar (@harshvthakkar) engages in a riveting discussion with RJ Kedziora (@RJKedziora), Co-Founder / Partner and Solutions Architect Estenda Solutions, Inc.
In this episode, RJ uncovers the ins and outs of blending clinical information with imaging data, especially for patients with chronic conditions like diabetes and hypertension. RJ also dives into how data management has evolved and the exciting opportunities AI brings to healthcare.
Harsh and RJ also explore the regulatory landscape surrounding AI in healthcare, discussing the EU and FDA's risk-based approach towards medical devices and AI applications. They emphasize the importance of transparency, data governance, and addressing biases in AI training datasets to ensure the technology serves a diverse population effectively.
Innovation in Healthcare: How to Stay Ahead of the Curve With Kamya Elawadhi
00:27:30
Episode 025: Harsh Thakkar (@harshvthakkar) interviews Kamya Elawadhi (@kamya_elawadhi), SVP of Platform and Corporate Strategy at Doceree.
Kamya shares her wealth of experience in healthcare advertising and innovation, bridging the challenges and opportunities of navigating regulatory environments and leading in the healthcare advertising industry. Throughout the conversation, she offers insights on navigating healthcare regulations, digital nomadism, and innovation in a tightly regulated field based on her personal journey.
Harsh and Kamya discuss the realities and potential of the digital nomad trend in healthcare. They offer a comprehensive view of how remote work impacts business operations, team management, and industry advancements. In this ever-evolving field, they also explore tactics and strategies to remain competitive and relevant. ----- Links:
John emphasizes the critical role of quality plans in ensuring error prevention and maintaining top-notch quality in the life sciences industry. The conversation takes a global perspective as he shares his extensive experience working with regulatory agencies in the US, Europe, and Asia, highlighting the importance of adapting to different regulatory requirements.
Throughout the podcast, Harsh and John share their wisdom on various aspects of the life sciences industry, including communication, technology's evolving role, and intriguing predictions for the future. John also delves into his personal journey, sharing helpful tips on adapting to new work environments, a journey that took him from the East Coast to the West Coast. He encourages listeners to embrace new experiences, maintain an open mind, and focus on continual improvement, emphasizing that these principles are keys to success.
Staying Compliant in a Changing World: Best Practices with Niyati Patel
00:28:14
Episode 027: Harsh Thakkar (@harshvthakkar) interviews Niyati Patel (@niyatipatel), the Director of Quality Engineering at Getinge (Maquet Cardiovascular) and a Sr. Regulatory/ Quality Consultant at Compliance Insight, Inc.
Niyati breaks down the complexities of quality management systems, compliance, and regulations in the industry. She discusses the unique challenges companies face, especially when dealing with drugs, devices, and combination products, and emphasizes the importance of expert consultation and the use of technology in achieving compliance.
Harsh and Niyati debate the differences between a QMS and a BMS and the strengths of each. They elaborate on how a robust QMS acts as the backbone of a company's compliance strategy, integrating various processes and ensuring they are up to par with regulatory standards.
The Surprising Link Between Technology and Mental Health: A Conversation with Dr. Cortney Warren
00:33:15
Episode 028: Harsh Thakkar (@harshvthakkar) interviews Dr. Cortney Warren (@drcortney), a Clinical Psychologist and the Founder and Owner of Choose Honesty LLC.
Dr. Cortney emphasizes the need for mindfulness regarding our technology usage and its effects on our mental health. She also delves into the importance of being truthful about our struggles to better our relationships and mental health.
Throughout the interview, Cortney and Harsh discuss various topics related to mental health, including the role of psychology in therapeutics, the impact of culture on mental health, and the importance of self-awareness. They talk about the importance of listening to others and being open to feedback, even if it's difficult to hear.
The Future of Women’s Health: Insights From Bethany Corbin
00:35:39
Episode 029: Harsh Thakkar (@harshvthakkar) interviews Bethany Corbin (@bethanycorbin), the Co-Founder of FEMInnovation and Managing Partner at Women's Health Innovation Consulting.
Bethany shares her journey, going from law studies to founding FEM Innovation, focusing on improving reproductive health for women. She talks about the challenges women's health companies face, like advertising restrictions and the crucial importance of patient privacy. She explains that many women's health companies struggle to advertise their products and services due to restrictions on certain types of content.
Harsh and Bethany offer invaluable advice for aspiring entrepreneurs and emphasize the significance of small, consistent steps towards achieving goals. They also stress the power of networking and building relationships within the entrepreneurial community.
Unveiling AI’s Impact on Life Sciences Regulation with Ivan Perez Chamorro
00:34:34
Episode 030: Harsh Thakkar (@harshvthakkar) interviews Ivan Perez Chamorro (@ivan-perez-chamorro) the CEO and Founder of MedBoard.
Ivan shares the inspiration behind starting MedBoard. He recognized the need for a platform that provides access to trusted information in the life sciences industry. He describes how AI is integrated into MedBoard to assist users in making decisions and automating tasks, while human expertise and interpretation are still essential. Ivan highlights the benefits of using MedBoard such as staying up to date and being organized, along with time savings and improved transparency. He emphasizes the importance of trust and collaboration in the industry and shares his vision of what is to come.
Harsh and Ivan share their thoughts on the future challenges in the life sciences industry including keeping up with new technologies, regulations, and social movements, as well as improving adoption of digital solutions. They offer tips on building a remote team and how it requires a focus on culture, communication, and hiring people who share the same values.
----- Links:
*MedBoard *Would you rather watch the video episode? Subscribe to full-length videos on our YouTube channel.
----- Show Notes:
(8:21) Data security and adoption in the life sciences industry.
(14:54) Building and hiring for a remote team in the consulting space.
(18:35) Integrating AI in quality and regulatory management.
(24:06) AI in quality and regulatory consulting.
(28:01) Improving patient safety and streamlining clinical trials.
Building a Five Star Career: Tips from Quality Management Pro, Penelope Przekop
00:38:12
Episode 031: Harsh Thakkar (@harshvthakkar) interviews Penelope Przekop (@penelopeprzekop), the CEO at PDC Pharma Strategy and author of the book 'Five Star Career.'
Penelope discusses her background in the pharmaceutical industry and the importance of quality management. She provides practical advice on collaboration, continuous learning, and finding fulfillment in one's career. She introduces her book, 'Five Star Career,' which blends her pharma expertise and personal experience with quality management principles, offering a roadmap to career success.
Harsh and Penelope address the challenges and resistances faced in integrating technology into quality management. They offer a unique perspective on navigating the evolving landscape of the industry. Penelope shares her journey from a corporate job to being an independent consultant, and how transitioning to consulting requires careful planning, networking, and a deep understanding of the industry. She says it's all about self-awareness, personal branding, and overcoming challenges.
Data, Decisions, and AI: The Power of Analytics in Life Sciences with Elizabeth Smalley
00:30:54
Episode 032: Harsh Thakkar (@harshvthakkar) interviews Elizabeth Smalley (@elizabeth-smalley-product-leader), the Director of Product Management, Data and Analytics at Aris Global.
Elizabeth discusses proactive safety signal detection in the context of drug development and the challenges faced in this space. She highlights the importance of utilizing real-world data and changing the methods of detection to overcome these challenges, along with limitations in reporting adverse events and the potential of AI in drug repurposing.
Harsh and Elizabeth touch on ethical considerations in AI and the potential for AI to be used in various emerging sectors of life sciences. They provide tips on staying up-to-date with the latest developments in the field and offer advice for working in life sciences. They emphasize the need for democratizing data and AI to make it accessible to all users.
The Intersection of Science and Art: How Chijindu is Bridging the Gap
00:17:05
Episode 033: Harsh Thakkar (@harshvthakkar) interviews Chijindu E. O. (@chijindu-authorceco), the Founder & Creative Director of Ceco Creations.
Chijindu shares his journey in the field of science and art, starting with creating cartoons and animations to inspire and educate people, noting that visual appeal and creativity can make scientific content more interesting and enjoyable. He emphasizes the impact he hopes to make through his work and encourages others to pursue their passions in art and science He states you must keep pushing forward and never give up on your goals.
Harsh and Chijindu discuss the benefits of combining science and art in medical education and patient communication, as well as the difficulties of balancing the complexity of science with the creativity of art. They discuss the challenges of running a business, and the importance of storytelling in art. They stress the importance of consistency, perseverance, and learning new skills.
Why Quality Assurance is More Than Just Following the Rules with Kimberly Wallbank
00:25:56
Episode 034: Harsh Thakkar (@harshvthakkar) interviews Kimberly Wallbank (@kimberlywallbank), the Principal Consultant at Quality Systems Services, LLC.
Kimberly addresses the evolution of quality and regulatory practices, particularly the increased focus on risk assessment. She discusses the challenges companies face with compliance and the need for a cross-functional approach, as well as the importance of knowledge sharing, metrics, and making quality accessible to everyone.
Harsh and Kimberly review misconceptions about quality management and stress the importance of understanding the role of quality assurance (QA) professionals in ensuring safety and efficacy. They agree that determining the true root cause of issues requires thorough investigation and consideration of various factors.
Employee Mental Health is VITAL to Success in ANY Business
00:31:51
Heather talks about the role of art in quality and documentation, challenges with document control methods, and her experience writing an article for Quality Magazine. She shares advice for entering the life sciences industry and the role of mentors in career development.
Harsh and Heather also address the importance of mental health for leaders, the positive outcomes of supporting mental health, and creating programs for employee well-being.
Episode 035: Harsh Thakkar (@harshvthakkar) interviews Heather Wilson (@heatherwilson2), the Associate Director of QMS and Document Control Administration at Xencor.
How SHE is Improving Patient Care with AI Enhanced Medical Devices
00:27:33
Weronika discusses the importance of integrating software with other systems for success and touches on various challenges such as data integration, user needs, and documentation practices. She highlights the evolving role of AI and software in healthcare, emphasizing patient-centered solutions and the importance of continuous learning in the Med-Tech industry.
Harsh and Weronika focus on software as a medical device within the healthcare ecosystem. They cover choosing the right development partner, future trends, and advice for those entering the industry.
Episode 036: Harsh Thakkar (@harshvthakkar) interviews Weronika Michaluk (@weronika-michaluk), the Principal Software as a Medical Device Lead at HTD Health.
His Strategy and Success Story with the MedTech Startup: FastWave
00:26:06
He scaled his business from 0 to 20 million in under 3 years. Get inspired by the story of Scott Nelson's strategic brilliance and entrepreneurial triumph with Joovv and FastWave Medical, a groundbreaking MedTech startup reshaping the industry landscape. Learn about the strategic decisions, challenges overcome, and pivotal moments that defined Scott's path to success.
Harsh and Scott also discuss the challenges and rewards of transitioning from working with large strategic companies to early-stage startups. They emphasize the importance of taking risks, learning from experiences, and being prepared for the ups and downs of entrepreneurship.
You're watching Episode 037: Harsh Thakkar (@harshvthakkar) interviews Scott Nelson (@scottnelsonlive), Co-Founder, President, & CEO of FastWave Medical.
----- Links:
*Fast wave medical *Joovv *If you enjoy this type of content, or would like to watch this episode, subscribe and give us a like on YouTube!
----- Show Notes:
(0:00) Entrepreneurship, Med-Tech, and startup journey.
(2:40) A new medical device for treating complex artery disease.
(6:04) Transitioning from corporate to startup life.
(9:38) Career advice and growth strategies for startups & entrepreneurs.
(13:52) Learning from experience.
(18:48) Decision-making, and consumer health trends.
No Vision, No Problem: How Aaron Golub Redefined Possible
00:19:04
Aaron Golub, a consultant and speaker, shares his story of overcoming adversity as a legally blind athlete and ex-NFL free agent. He discusses his journey from being a third-string high school athlete to becoming the first legally blind Division I athlete.
Aaron also talks about his transition from sports to a career in finance and eventually to consulting with companies. He emphasizes the importance of qualities such as resilience, empathy, and effective communication in leadership.
Aaron shares his perspective on coping with personal adversity and tailoring his advice for different audiences. He aims to be remembered as someone who gave his all to help others succeed.
Democratizing Cell Therapy: A PhD's Quest to Change Medicine Forever
00:32:05
Toon Lambrechts, co-founder of MyCellHub, shares his journey in democratizing access to cell and gene therapy. He discusses the challenges in cell therapy manufacturing, including the high costs and complex logistics.
MyCellHub aims to reduce manufacturing costs and automate processes to make cell therapies more affordable and accessible.
Toon emphasizes the importance of networking and collaboration in building a successful team. He also discusses the future of the industry, including the use of natural language processing and automation.
MyCellHub's ultimate goal is to scale up cell therapies and make them accessible to everyone.
Use This Tech, Transform Science: Flow Meters w/ Bethany Silva
00:20:50
Are you interested in how the latest flow technology is transforming biopharmaceutical manufacturing?
Join us for Episode 40 of the Life Sciences 360 podcast, where Harsh Thakkar (@harshvthakkar), CEO of Qualtivate sits down with Bethany Silva (@bethany-silva), Life Sciences Industry Manager at Endress+Hauser.
They delve deep into the world of flow measurement, focusing on the cutting-edge single-use flow meters based on the Coriolis principle and how this technology is crucial for the development and production of biologics.
👍 Like this video if you find the advancements in biopharmaceutical manufacturing exciting. 💬 Comment below with your thoughts on how technology is shaping the future of medicine production. 🔔 Subscribe to our channel for more insights from industry leaders and experts in life sciences. 📲 Follow us on social media to stay updated with the latest trends and discussions in the biotech and pharmaceutical industry.
The 3 Most Important Pillars of a Next-Generation CDMO, Explained!
00:34:01
Episode 041: J.D. Mowery, President and CEO of KBI Biopharma, discusses his career journey and the role of CDMOs in the biotech and pharma industry. He emphasizes the importance of relationships, risk-taking, and continuous learning in his career success.
J.D. highlights the unique combination of expertise required to work in both biotech and CDMO companies. He explains the challenges faced by biotech and pharma companies that have led to the rise of CDMOs.
Harsh asks J.D. to share the key factors to consider when selecting a CDMO. They introduce the concept of a next-generation CDMO, focusing on regulatory leadership, R&D and innovation, and risk sharing.
📝 Leave us a review! 🔔 Subscribe to our channel, Life Sciences 360, for more expert insights into the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
----- Show Notes:
(0:00) Intro to J.D. Mowery &KBI Biopharma
(3:49) J.D.'s Journey from Biotech to CDMO
(7:17) Biopharma Challenges driving the CDMO trend
(11:47) What to Look for in a CDMO
(14:18) The 3 MOST important pillars of next-gen CDMO
(22:05) Team Leadership & Culture at KBI
(25:28) What J.D. looks for in a New Team Member
(30:32) Most Rewarding Aspect of Working in Life Sciences
Beyond the Pill: When Medicine Meets Mindset with CEO, Will Hind
00:30:39
How can behavioral science optimize pharmaceutical practices?
Episode 042: Will Hind, CEO of Alpharmaxim Healthcare Communications, discusses the challenges and opportunities in integrating behavioral science with pharma strategies.
Find out how this can lead to better patient outcomes and more tailored healthcare solutions.
📝 Leave us a review! 🔔 Subscribe to our channel, Life Sciences 360, for more expert insights into the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
----- Show Notes:
(0:00) Introduction to Behavioral Science in Pharma
(1:33) Why is behavior important in pharma?
(3:09) Data Analysis and Behavioral Science
(6:50) Breaking Down Barriers with Behavioral Science
(9:44) The Biggest Misconception of Behavioral Sciences
(10:52) Research & Clinical Trials
(14:49) The COM-B Model and Pharma Communication
(17:52) Multi-stakeholder Influence on Drug Adoption
(22:33) Role of Behavioral Science in Omni-channel Marketing
How On-Demand Cleanrooms Can Speed Up Drug Development
00:28:24
With the market estimated to reach $11.5 billion by 2028. Clean Rooms on Demand is providing flexible and cost-effective solutions for biotech and pharma companies.
The benefits of using clean rooms on demand include avoiding the high capital outlay and ongoing operational expenses of building and maintaining their own facilities, as well as the flexibility to scale up or down as needed.
Join me in Episode 43 of Life Sciences 360, with Sarah Stevens, the President of Azzur Labs and Azzur Cleanrooms on Demand, part of Azzur Group
The NASA Scientist Who Changed Cancer Diagnostics Forever
00:37:52
Dr. Arnon Chait, CEO of Cleveland Diagnostics, discusses his transition from NASA to the healthcare innovation space and the development of cancer diagnostics.
Dr. Chait emphasizes the importance of using diagnostic advancements to strike a balance between over-screening and under-treating, particularly in the workup of cancer after failed screenings. He discusses the development of their innovative prostate cancer diagnostic test.
In Episode 044 of Life Sciences 360, Harsh and Arnon also emphasize the importance of asking the right questions in scientific research and the need for simple and actionable diagnostic tools in healthcare. They advise individuals to stay curious and interested in order to be productive and successful.
👍 Like this video if you enjoy deep dives into healthcare innovations. 🔔 Subscribe to our channel Life Sciences 360 for more expert insights into the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors and Leave us a Review.
----- Show Notes:
(00:00) Introduction and Background
(06:26) Choosing Cleveland as a Startup Location
(13:13) Balancing Over-Screening and Under-Treating in Cancer Diagnostics
(18:57) Proteins Involved in the Disease Process
(26:41) The Importance of a Solution that Fits the Final Application
(29:05) The Power of Curiosity and Interest in a Career
AI in Life Sciences: Should You Follow This Trend?
00:41:58
Welcome to episode 045 of Life Sciences 360.
On this episode, Nagesh Nama and his team at XLM talk on why Gen.AI is essential in the software test world and share examples of its use in various industries, particularly in life sciences and manufacturing. They address the challenges faced by companies in adopting AI and provide solutions for integrating AI into existing systems.
Harsh and his guests discuss how AI can improve productivity, enhance quality assurance processes, and enable proactive decision-making. The conversation emphasizes the importance of having an AI strategy and encourages SMBs to embrace AI to gain a competitive advantage.
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment any questions you have on Generative AI. Have you implemented this into your operations yet? 🔔 Subscribe to our channel Life Sciences 360for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
----- Show Notes:
(0:00) Human vs. AI Diagnosis
(4:40) Using AI to Automate Clinical Trial Management Systems
(8:18) Challenges of AI adoption & Data Integrity
(13:55) Affordable AI Validation Services for SMBs
(17:55) New Companies Add AI Features, Chat GPT Stays Ahead
(21:58) How To Increase Productivity & Improve Compliance
On this episode, Harsh discuss the intersection of luck and preparation in finding opportunities, particularly in the field of cell therapy. Harsh share insights from his conversation with Dr. Jason Bock, founder and CEO of CTMC, about the advancements and challenges in autologous cell therapies. We delve into topics such as manufacturing, strategy formation, and the impact of cell therapy on oncology.
This episode provides valuable information for anyone interested in the field and invites viewers to explore the possibilities of this groundbreaking technology.
Show notes:
00:00 Introduction 02:40 Autologous Cell Therapies 04:40 Formation of CTMC 08:40 Recognition and Impact 11:48 Challenges in Cell Therapy Manufacturing 15:00 Acquisition of a Facility 17:20 Unexpected Growth 21:49 Houston's Support for Multi-Center Trials 27:52 Conceptualizing Virtual Manufacturing 34:20 Maintaining Focus and Vision
How InVision helps you make drug development decisions? #lifesciences
00:40:12
Welcome to episode 047 of Life Sciences 360.
In this video, We discuss the importance of using AI in decision making in the life sciences industry. Ben highlight the need for evidence-based decision making and the challenges of finding relevant information in a sea of data. Ben introduce InVision, a platform that helps biotech and pharma companies stay informed about clinical trials and changes in the industry.
Watch the video to learn how AI can assist in making informed decisions in the life sciences field.
Chapters : 00:00 - Introduction 00:24 - AI in Decision-Making 00:45 - Welcome and Guest Introduction 01:00 - InThought Research and Infernesis 02:00 - Challenges in Clinical Trials 03:40 - InVision Technology Platform 06:36 - AI Integration in InVision 08:22 - Machine Learning and Natural Language Processing 13:20 - Case Study: Clinical Trial Data Analysis 17:56 - Privacy and Regulation in Healthcare 19:34 - AI and Job Security 24:21 -Practical Applications of AI 26:16 - Spire Bioadvisors 29:40 - Trends in Biotech and Drug Development 32:58 - Future of AI in Healthcare 37:28 - Ben's Personal Insights 39:12 - Closing Thoughts
----- Links:
* Ben Weintraub LinkedIn (https://www.linkedin.com/in/ben-weintraub-0566389/) * inThought Research LinkedIn (https://www.linkedin.com/company/inthought-research/ ) * inThought Research website (https://inthought.com/) *Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ ) *Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have on Generative AI. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
In this episode, Sharmeen discuss the current one-size-fits-all approach in healthcare and the need for precision dosing. Sharmeen explains how DoseMe platform simplifies complex dosing methods at the bedside, benefiting both clinicians and patients. Sharmeen also touch on the integration with electronic health records and the use of real-world data to improve dosing.
Shownotes :
00:00 Introduction 02:58 User Demographics 04:42 Integration with EHR 10:20 Therapeutic Areas 14:00 Bayesian Method 16:20 Real-time Data 20:20 Nerd Out on the Topic 25:00 AUC-guided Dosing 29:00 Implementation Process
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have on Generative AI. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
Understanding Drug Pricing and the Impact of the Inflation Reduction Act with Jesse Mendelsohn
00:39:21
Welcome to episode 049 of Life Sciences 360.
In this episode of Life Sciences 360, host Harsh Thakkar welcomes Jesse Mendelsohn, Senior Vice President at Model N. Jesse delves into the intricacies of revenue optimization and compliance within the pharmaceutical industry. He shares insights on how Model N's platform aids pharmaceutical companies in navigating complex pricing, regulatory challenges, and government negotiations.
Chapters : 0:00 - Introduction 1:30 - Welcoming Jesse Mendelsohn 2:00 - Jesse's Journey with Model N 6:00 - Evolution of Pharma Pricing and Compliance 8:30 - Challenges in Commercial Contracting 12:00 - Regulatory Side of Pharma Pricing 14:30 - Impact of Government as a Major Drug Purchaser 16:00 - Inflation Reduction Act Overview 19:00 - Medicare's Right to Negotiate Drug Prices 21:00 - Aftershocks of the Inflation Reduction Act 23:30 - Key Takeaways for Pharma Executives 26:00 - Impact on Drug Development Strategy 28:00 - Generics and Biosimilars Market Impact 30:30 - Positive Outcomes of the Inflation Reduction Act 32:00 - What's Next for Model N 36:00 - Importance of Accurate Data in Pricing 38:30 - Closing Remarks and Connect with Jesse ----- Links:
Tony Martignetti on Inspired Leadership, Flashpoints, and Divergent Thinking
00:42:25
Welcome to episode 050 of Life Sciences 360.
In this episode, Harsh Thakkar chats with Tony Martignetti, a top leadership development voice on LinkedIn and an advisor to numerous tech and life sciences executives. Tony shares his insights on inspired leadership, the importance of investing in people, and how to unlock potential within teams. They also discuss the concept of flashpoints in both personal and organizational contexts and the value of embracing divergent thinking in the workplace.
Chapters: 00:00 Introduction to Tony Martignetti and Leadership Development 01:04 Advocating for Inspired Leadership 02:23 Influences: Henry Tamir and “No Rules, Rules” Book 04:37 Investing in People: Beyond Pedigree 06:19 Authentic Leadership: Bringing Your Whole Self to Work 09:40 The Core Model: Encouraging Authenticity in Teams 11:33 Identifying and Aligning Personal and Organizational Flashpoints 13:04 Overcoming Barriers: Personal Stories and Career Challenges 16:13 Flashpoints in Organizations: Examples and Insights 19:34 Embracing Divergent Thinking for Innovation 25:30 Convergent Hearts: Building Connection and Understanding 30:46 Practical Tips for Leaders to Foster Innovation and Growth 35:21 Specialist vs. Generalist: Expanding Skills and Knowledge 39:36 Key Takeaways: Expanding Vision and Narrowing Focus
From Genes to Treatments: Howard McLeod on Precision Medicine
00:41:14
Welcome to episode 051 of Life Sciences 360.
We welcome Howard McLeod, a distinguished expert in precision medicine and pharmacogenomics. Howard shares his profound journey into the world of personalized medicine, emphasizing the significant impact of individualized treatments on cancer patients. From groundbreaking gene discoveries to advising cutting-edge biotech companies, Howard's work underscores the value of targeted therapies and their potential to transform patient outcomes.
Howard also discusses his current roles, including his position as the Center Director for Precision Medicine and Functional Genomics at Utah Tech and his advisory role in several companies. He shares insights into exciting projects aimed at improving drug response predictions and mental health treatments for university students through pharmacogenomics.
Chapters
00:00 - Introduction and Guest Welcome 01:00 - The Importance of Experimental Therapies 02:00 - Career Inspiration and Key Moments 04:00 - Mentors and Lessons Learned 06:00 - Practical Applications of Research 08:00 - Staying Grounded in Patient Care 10:00 - Current Roles and Projects 12:00 - Addressing Mental Health in Students 14:00 - Integrating Technology in Medicine 18:00 - Simplifying Complex Medical Information 22:00 - Reflections on Technological Advancements 26:00 - Embracing Change and New Challenges 30:00 - Final Thoughts and Future Outlook 36:00 - Closing Remarks and Contact Information
This episode is a treasure trove of insights for anyone interested in precision medicine, pharmacogenomics, and the future of healthcare. Don't miss Howard McLeod's inspiring journey and the valuable lessons he shares!
👍 Like this video if you enjoy diving deep into the latest leadership trends. 💬 Comment below any questions you have on inspired leadership. 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
#Precision Medicine #Pharmacogenomics #Cancer Treatment #Personalized Medicine #Howard McLeod #Life Sciences 360 #Gene Therapy #Mental Health Treatment #Biotechnology #Healthcare Innovation #Medical Research #Genomic Data #FDA Guidelines #ClinicalPharmacology
Breaking Down Barriers in Psychedelic Drug Development
00:42:22
Welcome to episode 052 of Life Sciences 360.
In this episode, of Life Sciences as we dive into the fascinating world of psychedelic therapeutics with Dr. Sam Clark, the Chief Executive Officer of Terran Biosciences. Dr. Clark shares his journey of founding Terran Biosciences, motivated by the need for better treatment options for psychiatric and neurological disorders. Discover how Terran Biosciences is leveraging a tech company structure to accelerate drug development, utilizing AI in imaging, and pioneering innovative prodrugs.
Learn about the company’s groundbreaking work in developing psychedelics without hallucinations and their mission to make these therapies affordable and accessible to patients.
Subscribe for more insightful conversations with leaders in the biotech and life sciences industries!
Chapters:
00:00 - Introduction 00:12 - Dr. Sam Clark's Motivation and Background 01:00 - Founding Terran Biosciences 01:35 - Challenges in Psychiatric and Neurological Treatment Development 02:55 - Innovating with a Tech Company Structure 03:18 - Use of AI and Drug Development Strategies 04:18 - Slow Translation of Research to Therapies 05:50 - Development of New Prodrugs 07:12 - Explanation of Prodrugs 08:49 - Terran's Lead Assets for Psychotic Disorders 10:16 - Creating Long-Acting Prodrugs 12:16 - Addressing Regulatory Hurdles in Psychedelic Research 14:20 - Pipeline Overview and Future Plans 16:13 - Importance of Collaboration in Psychedelic Research 17:58 - The Rise of Big Pharma Interest in Neuroscience 20:14 - Addressing Stigma Around Psychedelics 23:02 - Overcoming Regulatory Challenges 26:31 - Trends in Psychedelic Funding 31:48 - Making Medications More Accessible 37:00 - Impact of Psychedelic Approvals on the Industry 38:20 - Focus on Patient-Centric Approaches 41:11 - Final Thoughts and Future Announcements
Follow Terran Biosciences on LinkedIn and X, and visit their website for the latest updates and announcements.
-----
Links:
- [Terran Biosciences on LinkedIn](https://www.linkedin.com/company/terran/) - [Terran Biosciences on X](https://x.com/terranbio) - [Dr. Sam Clark on X](https://x.com/neonneurons) - [Terran Biosciences Website](https://terranbio.com) - [Tera XT Website](https://teraxt.com)
Scientist on Epigenetic Tuning and Future Therapies at Tune Therapeutics
00:36:52
Welcome to episode 053 of Life Sciences 360.
In this episode of Life Science 360, our host Harsh Thakkar sits down with Brian Cosgrove, Principal Scientist at Tune Therapeutics. Brian dives deep into the fascinating world of epigenetics and its role in developing therapies for complex diseases. He shares insights on how Tune Therapeutics is leveraging the power of the epigenome to create innovative treatments, particularly focusing on their work with hepatitis B and the promising potential of their tempo platform.
Chapters:
00:00 - Introduction 00:02 - Understanding Cell Differentiation and Gene Regulation 00:37 - Welcome Brian Cosgrove from Tune Therapeutics 01:15 - Brian's Transition from Duke University to Tune Therapeutics 02:03 - The Basics of Epigenetic Tuning 02:38 - How Epigenetics Determines Cell Function 03:55 - The Role of the Epigenome in Gene Expression 05:06 - The Complexity of the Human Body and Scientific Research 06:12 - Deep Dive into Hepatitis B (HBV) 06:57 - Current Treatments for Chronic Hepatitis B 08:32 - The Unmet Need in Hepatitis B Treatment 09:09 - Brian's Career Path and Decision to Join Tune Therapeutics 12:03 - Growth and Evolution of Tune Therapeutics 15:25 - Challenges and Rewards of Joining an Early-Stage Company 17:49 - Introduction to the Tempo Platform 19:04 - How Tempo Platform Works with HBV 20:32 - Epigenetic Regulation of HBV 23:20 - Future Applications of Epigenetic Tuning 24:38 - Timeline for Tune 401 Clinical Trials 26:08 - Anticipated Challenges and Solutions 27:20 - Partnering for Manufacturing and Delivery 28:32 - The Broader Field of Epigenetic Therapies 30:21 - Potential Global Impact of Epigenetic Therapies 32:12 - The Most Rewarding Part of Brian's Work 33:01 - The Personal Side of Working in Life Sciences 35:10 - Final Thoughts and Future Outlook for Tune Therapeutics 36:09 - Closing Remarks and How to Connect with Brian
Stay tuned and don't forget to subscribe for more in-depth conversations with leading scientists and innovators in the life sciences field!
----- Links:
*Brian Cosgrove LinkedIn (https://www.linkedin.com/in/brian-cosgrove-171b926/) *Tune Therapeutics LinkedIn (https://www.linkedin.com/company/tunetx/ ) *Tune Therapeutics website (https://tunetx.com/) *Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ ) *Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have on Generative AI. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
Vector Labs CEO Lisa Sellers on Innovation, Leadership, and Mentorship
00:42:57
Welcome to episode 054 of Life Sciences 360.
In this episode of Life Science 360 ,Today, we are thrilled to have Lisa Sellers, the CEO of Vector Labs, as our special guest. Lisa shares her incredible journey from working at big names like Thermo Fisher and 10x Genomics to leading Vector Labs, a trusted manufacturer of reagents and critical components in the life sciences sector.
In this episode, we dive deep into: - Lisa's transition from being an industry professional to becoming a CEO - The unique challenges and benefits of working in smaller companies - Vector Labs' strategic acquisitions and mergers to expand their product portfolio - The impact of Vector Labs in the pharmaceutical, diagnostic, and academic sectors - Lisa's passion for mentorship and her efforts to inspire the next generation in STEM fields
Chapters :
00:00 - Introduction 00:41 - Welcome Lisa Sellers 01:12 - Lisa’s Career Journey 02:37 - Transition to CEO 05:00 - Comparing Big Companies to Smaller Companies 09:28 - Vector Labs’ Product and Service Overview 14:25 - Recent Acquisitions and Expansions 17:20 - Role of Private Equity in Vector Labs 20:28 - Challenges in Protein and Glycan Detection 23:54 - Vector Labs’ Diverse Customer Base 26:59 - Managing Priorities and Resources 29:00 - Vision for Vector Labs in the Next 5 Years 32:39 - Lisa’s Mentorship and Community Involvement 37:17 - Key Leadership Qualities in STEM 41:28 - Final Thoughts and Closing
Stay tuned and don't forget to subscribe for more in-depth conversations with leading scientists and innovators in the life sciences field!
-----
Links:
*Lisa Sellers: (https://www.linkedin.com/in/lisa-sellers/) *Vector Labs: (https://www.linkedin.com/company/vector-laboratories/) *Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ ) *Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have on Generative AI. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
The Future of mRNA Therapies with Dr. Kate Broderick
00:34:16
Welcome to episode 055 of Life Sciences 360.
In this episode of Life Sciences 360! In this episode, Harsh sits down with Dr. Kate Broderick, Chief Innovation Officer at Maravai Life Sciences. Dr. Broderick shares her journey from academia to leading innovation in the biotech industry, discusses the pivotal role of Clean Cap technology in COVID-19 vaccines, and explores the future applications of mRNA. Learn about the collaborative spirit at Maravai and the exciting developments in genomic medicine, personalized cancer vaccines, and more.
Join Harsh Thakkar in an insightful conversation with Dr. Kate Broderick, the Chief Innovation Officer at Maravai Life Sciences. Discover the future of mRNA, the role of Clean Cap technology in COVID-19 vaccines, and the innovative work happening at Maravai and its subsidiaries.
Chapters:
00:00 - Introduction 00:03 - Dr. Kate Broderick's Career Background 00:38 - Overview of Maravai Life Sciences 01:22 - Starting in Life Sciences and Career Journey 03:17 - Role of Chief Innovation Officer 04:02 - Turning Ideas into Innovations 05:22 - Blending Research, Development, and Leadership 07:40 - Working at Maravai and Cross-functional Leadership 08:05 - Clean Cap Technology and its Impact 09:15 - Maravai’s Business Units and Synergies 10:25 - Clean Cap in COVID Vaccines 11:48 - Future Applications of mRNA 13:31 - Overcoming Challenges with mRNA 15:09 - Improving Stability and Targeting Specific Cells 17:49 - Importance of Collaboration in Science 19:25 - Maravai's Approach to Partnerships and Collaborations 23:12 - New mRNA Manufacturing Facility 25:22 - Functional Segmentation of Facilities 27:35 - Recognition as a Top Biotech Executive 29:46 - Exciting Areas in Life Sciences for the Future 31:50 - Potential of CRISPR and Base Editing 33:19 - Closing Remarks and Contact Information
Connect with Dr. Kate Broderick: - Kate Broderick (https://www.linkedin.com/in/katebroderick) - Maravai Life Sciences: (https://www.maravai.com) - TriLink Biotechnologies: (https://www.trilinkbiotech.com)
Stay Tuned for More Episodes: Subscribe to Life Sciences 360 for more interviews and insights from leaders in the biotech and life sciences industry.
How Green Elephant Biotech is making labs more sustainable with Joel Eichmann
00:38:36
Welcome to episode 056 of Life Sciences 360.
Welcome to another episode of Life Sciences 360! In this episode, Harsh Thakkar is joined by Joel Eichmann, co-founder and managing director of Green Elephant Biotech. Green Elephant Biotech is a trailblazer in the biotech industry, focusing on sustainability and using plant-based materials to create innovative products. Joel shares the fascinating journey of how Green Elephant Biotech started, the challenges they faced, and the future of sustainable biotech.
Chapters:
00:00 - Introduction 01:23 - Welcoming Joel Eichmann 02:39 - Origins of Green Elephant Biotech 05:15 - From Concept to Commercial Product 07:30 - Early Challenges and Strategies 10:02 - Advice for Aspiring Biotech Entrepreneurs 12:33 - Incorporating Sustainability 15:01 - Hiring and Building the Team 18:37 - Understanding the Life Sciences Industry 21:19 - Balancing Innovation and Sustainability 24:05 - Industry Challenges and Opportunities 27:34 - Generating New Product Ideas 30:13 - Recognition and Awards 31:31 - Long-term Goals and Automation 34:28 - The Future of Automation in Biotech 36:06 - Where to Learn More About Green Elephant Biotech 37:44 - Final Thoughts on Sustainability
Connect with Joel Eichmann -
Green Elephant Biotech: (https://www.greenelephantbiotech.com/) Joel Eichmann: (https://www.linkedin.com/in/joel-eichmann/) Harsh Thakkar: (https://www.linkedin.com/in/harshvthakkar/)
*Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have on Generative AI. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
Bioidentical Hormone Replacement: A Deep Dive with Dr. Greg Brannon
00:38:19
Welcome to episode 057 of Life Sciences 360.
In this special episode of Life Sciences 360, hosted by Harsh Thakkar, we dive into the fascinating world of bioidentical hormone replacement therapy (BHRT) with Dr. Greg Brannon, Medical Director and Founder of Optimalbio. Celebrating National Men's Health Education and Awareness Month, Dr. Brannon shares his expertise on the benefits of BHRT, the science behind hormone therapy, and the insights from his Amazon bestseller book, "Restore."
Chapters: 00:01 - Introduction: Discussing the importance of health education. 00:37 - The significance of hormone health. 01:30 - The journey behind Dr. Brannon's book "Restore." 02:52 - The role of testosterone and hormones in overall health. 03:43 - Dr. Brannon's medical background and shift to hormone therapy. 05:20 - Understanding bioidentical hormone replacement therapy (BHRT). 06:20 - The science behind hormone therapy and its impact on chronic diseases. 08:19 - Broader implications of hormone imbalances in society. 09:41 - Practical advice for optimizing hormone levels. 10:42 - The impact of modern lifestyle on hormone health. 12:09 - Hormone therapy in practice and success stories. 15:11 - The future of Optimalbio and its expansion plans. 16:19 - Closing remarks and contact information for further learning.
Key Takeaways: - Understanding the crucial role of hormones in maintaining overall health. - The benefits of bioidentical hormone replacement therapy (BHRT). - Practical tips for maintaining optimal hormone levels through lifestyle changes. - Success stories from patients who have benefited from hormone therapy.
--- Links:
*Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ ) *Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have on Generative AI. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
Thank you for watching and supporting our channel!
Inside the Lab: How Singota Solutions Leads in Early-Stage Pharma Development
00:32:25
Welcome to episode 058 of Life Sciences 360.
In this insightful episode of Life Sciences 360, hosted by Harsh Thakkar, we explore the dynamic world of Contract Development and Manufacturing Organizations (CDMOs) with Ryan Memmer, Manager of Quality Control and Product Development at Singota Solutions. Ryan shares his journey from working at large pharmaceutical companies to leading a growing team at Singota, a CDMO focused on phase one drug development. He provides a behind-the-scenes look at the challenges and opportunities in this fast-paced environment, and how Singota is uniquely positioned to support early-stage pharmaceutical companies.
Chapters:
00:00 - Introduction: Ryan Memmer’s background and role at Singota. 01:10 - Career Journey: Transition from large pharma to a smaller CDMO. 03:18 - Challenges in CDMO Culture: Overcoming fast-paced industry challenges. 06:59 - Knowledge Sharing and Trust: Building trust in early phase work. 08:03 - Singota's Unique Strengths: What sets Singota apart in the CDMO space. 11:32 - Importance of Diverse Backgrounds: Value of diverse skill sets within the team. 13:04 - Client Collaboration: Singota’s approach to custom client solutions. 17:25 - Broad Client Portfolio: Overview of Singota's diverse client base. 20:03 - Preparing for Commercialization: Adapting to phase three and commercial standards. 24:19 - Singota’s Global Expansion: Expanding operations into international markets. 25:56 - Advice for Aspiring Scientists: Tips for those starting out in QC or product development. 28:22 - Continuous Learning: Emphasizing the importance of cross-functional learning. 31:11 - Closing Thoughts: Final thoughts from Ryan Memmer and how to connect.
- Follow Ryan Memmer: - Singota Solutions Official Website: (https://singota.com/) - Follow Ryan Memmer on LinkedIn: (https://www.linkedin.com/in/memmer-ryan/)
Key Takeaways: - Understanding the unique challenges of working in a CDMO environment. - The importance of knowledge sharing and trust in client relationships. - Singota’s strengths in serving early-stage pharmaceutical companies. - The value of continuous learning and diverse skill sets in the industry.
📅 About Singota Solutions: Singota Solutions is a CDMO specializing in early-phase pharmaceutical development, offering customized solutions to meet the unique needs of small and large clients alike. With a focus on quality, transparency, and adaptability, Singota is committed to delivering high-quality products within accelerated timelines.
--- Links:
*Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ ) *Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
Thank you for watching and supporting our channel!
The Science Behind Tome’s Programmable Genomic Integration Technology with CSO John Finn
00:43:30
Welcome to episode 059 of Life Sciences 360.
In this episode of Life Sciences 360, Harsh Thakkar is joined by John Finn, Chief Scientific Officer at Tome Biosciences. John shares his inspiring journey of overcoming challenges, like his stutter, while making groundbreaking strides in gene therapy. They dive deep into Tome’s unique technology, PGI (Programmable Genomic Integration), which is revolutionizing how large-scale gene insertions are done with pinpoint accuracy. Learn how Tome Biosciences is leading the charge in curing genetic disorders and advancing cell therapy with cutting-edge science.
Chapters: 00:00 - Introduction to the Episode 00:29 - The Vision Behind Gene Therapy 01:13 - John’s Journey and Challenges with Stuttering 03:14 - How Stuttering Shaped John's Career in Science 05:43 - Introduction to Tome Biosciences 07:02 - The Origins of Tome and Founding Vision 09:49 - Why Large-Scale Gene Editing Matters 14:12 - How Tome's PGI Technology Works 20:29 - What Sets Tome Apart in Gene Therapy 24:31 - Future Milestones for Tome Biosciences 30:49 - Overcoming Challenges in Genomic Integration 36:47 - The Power of Team Culture at Tome Biosciences 40:20 - Advice for Aspiring Scientists and Entrepreneurs 42:52 - Where to Connect with John Finn and Learn More About Tome
- Follow John Finn:
*Linkedin - ( https://www.linkedin.com/in/jonathan-john-finn-8b3bb23/ ) *Tome Bio Linkedin - ( https://www.linkedin.com/company/tome-biosciences/ ) * Tome Bio Website- ( https://tome.bio/ )
--- Links:
*Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ ) *Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
Thank you for watching and supporting our channel!
Why the Top 1% are lonely- insights from Dr. Robyn Odegaard
00:36:17
Welcome to episode 060 of Life Sciences 360.
In this episode of Life Sciences 360, host Harsh Thakkar sits down with Dr. Robin Odegaard, a high-performance business psychologist and professional confidant, to discuss the hidden struggles that come with success. They dive deep into topics like imposter syndrome, self-sabotage, complex priorities, and the loneliness that often accompanies high achievement. Dr. Robin shares actionable strategies and insights from her extensive work with lawyers, biotech CEOs, neurosurgeons, and more.
Chapters: 00:00 - Introduction 00:33 - The Voice in Your Head & Head Trash 01:29 - Dr. Robin’s Journey into High-Performance Psychology 02:48 - Understanding Self-Sabotage and How It Manifests 05:10 - The Loneliness of Success: Why It’s “Lonely at the Top” 07:23 - Techniques to Recognize and Combat Self-Sabotage 11:22 - Managing Complex Priorities with the “Foresting Project” 15:48 - Time Audits & Delegation for Effective Time Management 18:41 - The Challenge of Letting Go for High Performers 20:58 - Working with Diverse Clients: From Athletes to CEOs 23:03 - Emotional State Management for Better Communication 27:28 - The Isolation of Success & Who High Achievers Talk To 33:47 - Final Thoughts & Advice for Listeners 35:58 - Conclusion
Don’t forget to like, share, and subscribe for more insightful conversations on achieving success in life sciences and beyond!
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Links:
*Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ ) *Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
Thank you for watching and supporting our channel!
How Samsung Biologics Achieved 16 Top Pharma Partnerships as a CDMO
00:43:15
Welcome to episode 061 of Life Sciences 360.
In this episode of Life Sciences 360, host Harsh Thakkar sits down with Kevin Sharp, Senior Vice President and Head of Global Sales at Samsung Biologics. They dive deep into the evolving CDMO industry, the importance of agility, innovation, and the strategic growth pillars that are driving success at Samsung Biologics. Kevin shares his journey from government roles to life sciences, discusses the rapid advancements in ADCs, and explores how emerging technologies like AI are reshaping the industry.
Chapters:
00:00 - Introduction 00:02 - Overcoming Roadblocks in the Industry 00:10 - Flexibility and Agility in Implementation 00:18 - Innovating Through Challenges 00:24 - The Mission of Life Sciences and Pharma 00:52 - The Speed Factor in Pharma Development 01:26 - Introduction to Kevin Sharp and Samsung Biologics 02:00 - Kevin Sharp's Career Journey to Life Sciences 03:29 - Transition from Pharma to CDMO Space 05:29 - The Rapid Growth of the CDMO Industry 07:14 - Key Challenges in Transitioning to a CDMO Role 09:22 - The Boom of CDMOs and Their Impact 11:32 - Regulatory Challenges and CDMO Expertise 13:48 - Strategic Partnerships with Top Pharma Companies 15:59 - The Importance of Diversification and Capability Growth 18:25 - Building Long-Term Partnerships with CDMOs 22:04 - Adapting to Roadblocks with Agility 23:59 - ADC Market Insights and Samsung Biologics’ Strategy 28:24 - The Future of Life Sciences: New Modalities and Technologies 30:27 - Leveraging Emerging Technologies like AI in CDMOs 34:52 - Leadership and Operational Excellence in Life Sciences 39:20 - Working at Samsung Biologics 41:17 - Final Thoughts and How to Connect with Kevin Sharp
Don’t forget to like, share, and subscribe for more insightful conversations on achieving success in life sciences and beyond!
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Links:
*Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ ) *Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
Thank you for watching and supporting our channel!
3 Steps to Avoid Burnout and Thrive in Biopharma, from a Global Expert
00:35:57
Welcome to episode 062 of Life Sciences 360.
In this episode, we dive into an engaging conversation with Tom, a seasoned consultant, on how to recognize the early signs of burnout, foster a healthy and innovative work environment, and implement agility in regulated industries. Tom shares practical strategies for leaders and consultants alike to maintain performance without compromising mental well-being. Whether you're a business leader, consultant, or anyone looking to improve work-life balance, this video is packed with actionable advice!
Chapters:
00:00 – Introduction 00:34 – Life as a Consultant: What It’s Really Like 01:00 – Burnout in Consulting vs. 9-to-5 Jobs 02:06 – Recognizing Early Signs of Burnout 03:56 – Overpromising and Work-Life Balance 04:31 – 3 Key Strategies to Prevent Burnout 05:52 – Managing Priorities and Influencing Decisions 09:55 – The Sandbox Approach to Innovation 12:02 – Innovation in Regulated Industries 14:30 – Encouraging Employee Experimentation 17:39 – Real-World Examples of Innovation Success 18:20 – Leadership Qualities That Promote Innovation 21:50 – Systems for Capturing and Reviewing Ideas 26:03 – Challenges of Implementing Agile in Regulated Industries 29:00 – Countering Opposition to Agile 33:01 – The Best Part of Consulting: Tom’s Take 34:48 – How to Connect with Tom 35:17 – Final Thoughts on Preventing Burnout
Connect with Tom: LinkedIn: https://www.linkedin.com/in/tom-siebeneicher/ Spotify: https://open.spotify.com/episode/0aXLVMPZtFh79TKle9aN9y?si=4Xswz8zGTeKnkkogqB0BTg YouTube: https://www.youtube.com/playlist?list=PL3RKCnY-ES1kNaNP7WnQ37uiweOEbjB7O
Links:
*Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ ) *Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
Thank you for watching and supporting our channel!
How Generative AI Finds Cures for Rare Diseases Faster
00:37:57
Welcome to episode 063 of Life Sciences 360.
We dive deep into the groundbreaking role of AI in healthcare and life sciences with Shweta from Google Cloud. Learn how AI is accelerating drug discovery, enhancing patient care, and revolutionizing rare disease research. If you're passionate about the intersection of technology and health, this is a must-watch conversation!
🔗 Connect with Shweta on LinkedIn: https://www.linkedin.com/in/shwetasingh01/ 📍 Explore more about Google Cloud: (https://cloud.google.com)
Chapters:
00:00 Introduction 00:01 Using Generative AI for Drug Discovery and Molecular Structures 00:11 Synthetic Images from Histological Data for Rare Diseases 00:20 Bayer's AI for Regulatory Dossiers 00:38 Categories of AI Perspectives in Healthcare 01:00 Shweta’s AI Journey & Joining Google Cloud 02:01 Methodical Approach to AI in Healthcare 02:43 AI for Rare Diseases & Accelerating Drug Research 05:01 First Steps for Companies Embracing AI 06:51 Real-World AI Use Cases: Ginkgo Bioworks & Bayer 10:32 Potential Future Frameworks for AI in Regulatory Submissions 13:52 Challenges of Rare Diseases & AI Solutions 16:05 AI's Role in Accelerating Research & Repurposing Drugs 18:10 Broader Applications of AI in Life Sciences Beyond Rare Diseases 19:22 AI for Drafting Clinical Trials & Patents 21:27 Addressing Concerns of AI in Healthcare: Ethics, Safety, and Bias 24:46 Human-in-the-Loop: The Key to Safe AI Use in Medicine 30:39 The Future of AI in Healthcare: Democratizing Access & Proactive Care 37:06 Outro & How to Connect with Shweta
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Links:
*Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ ) *Listen to this episode on the go! 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
👍 Like this video if you enjoy diving deep into the latest healthcare trends. 💬 Comment below any questions you have. Have you implemented this into your operations yet? 🔔 Subscribe to our channel @lifesciences360 for more expert interviews about the rapidly evolving world of life sciences. 📲 Follow us on social media to keep up with the latest news and discussions in the biotech and pharmaceutical sectors.
Thank you for watching and supporting our channel!
How Amprion’s Test is Changing ALS, Dementia, and Parkinson’s Disease Diagnosis
00:37:18
Learn how misfolded proteins trigger cascading effects in the brain, leading to these devastating conditions, and how early detection can change the trajectory of treatment. Whether you’re curious about ALS, Parkinson’s, Dementia, or the role of molecular diagnostics.
In this insightful episode, we dive deep into the world of neurodegenerative diseases, focusing on conditions like ALS, Parkinson's disease, Alzheimer's, and Dementia. Our guest, Russ Lebovitz, co-founder of Amprion, explains their groundbreaking work in detecting misfolded proteins, the primary culprits behind these diseases. From early diagnosis to understanding the role of technology and AI in healthcare, we explore how Amprion’s revolutionary diagnostic tools are shaping the future of brain health.
Chapters: 00:00 - Introduction to the episode 00:13 - Amprion's unique approach to neurodegenerative diseases 00:40 - Misfolded proteins as the root cause 01:25 - Background of the guest, Russ Lebovitz 02:56 - Amprion's elevator pitch and core focus 03:59 - How Amprion detects misfolded proteins 05:57 - Misfolded proteins and their role in diseases 07:45 - The amplification process used by Amprion 09:27 - The causes of protein misfolding 12:29 - How Amprion's test works 14:05 - Early diagnosis through amplification 17:27 - Availability and expansion of Amprion's technology worldwide 21:03 - The role of AI in diagnosing neurodegenerative diseases 23:47 - Challenges in integrating AI into healthcare 27:17 - Predictions for future breakthroughs 32:35 - Collaboration between diagnostic tools, AI, and drug development 36:23 - Conclusion and closing remarks
🔗 Connect with Russ - Amprion website: (https://www.ampriondx.com) - Learn more about misfolded proteins and their role in brain diseases: (https://www.ampriondx.com/science)
- Subscribe to our podcast for more insights on life sciences: 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
Don't forget to like and subscribe for more episodes on brain health, neurodegenerative diseases, and the future of healthcare technology!
Could Worms REALLY Be the Key to Curing Autoimmune Diseases?
00:29:08
In this episode, we dive deep into a fascinating topic worm-derived therapeutics with our special guest Andrea, the founder and CEO of Holoclara. Did you know that autoimmune and allergic diseases were rare before the 1900s? What changed? Andrea shares groundbreaking insights into how worms, which have lived inside humans for millions of years, secrete molecules that could balance our immune system and help us tackle these diseases.
From her early research days at Caltech to founding Holoclara, Andrea walks us through her journey, including:
Chapters:
00:00 - The History of Autoimmune Diseases 01:24 - Why Watch This Video? 02:36 - Andrea’s Research Background 05:49 - The Turning Point: Entrepreneurship and Therapeutics 09:02 - Worms and Human Health: The Therapeutic Connection 11:32 - Worm Communication and Therapeutics 15:24 - The Industrial Revolution and Autoimmune Diseases 19:33 - How Worm-Derived Therapeutics Work 21:33 - Overcoming Challenges in Biotech 24:21 - The Future of Worm-Derived Therapeutics 25:48 - Studying Different Worm Species 26:57 - Life Outside Research 29:29 - Final Takeaway: Embracing Feedback and Opportunity
Andrea also discusses the personal and scientific breakthroughs that led her to create Holoclara, a company dedicated to harnessing worm-derived molecules for modern medical solutions. Learn how roundworms evolved to produce tools that harmonize our immune system, and how these ancient organisms may hold the key to treating modern diseases.
If you're intrigued by this incredible scientific journey and its implications for health, don't miss this episode!
🔗 Learn more about Holoclara: https://www.holoclara.com/ Linkedin: Andrea Choe, Co-Founder and CEO Holoclara https://www.linkedin.com/in/andreachoe/ Company page: https://www.linkedin.com/company/holoclara-inc/
- Subscribe to our podcast for more insights on life sciences: 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
💬 Let us know in the comments: Did you know worms could be this powerful? 👍 Don't forget to hit Like and Subscribe for more fascinating interviews with leaders in life sciences!
Life Sciences Marketing Agency CEO on How to Combine Storytelling and Science for Impact
00:36:46
In this episode, Harsh Thakkar welcomes David Ormesher, CEO of CG Life, a leading marketing agency in the life sciences and pharmaceutical sectors. David shares over 30 years of experience in life science marketing and storytelling. From startups to large enterprises, CG Life helps companies blend complex science with compelling stories to resonate with patients, healthcare professionals, and investors.
David discusses his entrepreneurial journey, how CG Life specializes in biopharmaceutical marketing, and key insights into building an agency that bridges the gap between science and storytelling. He also shares the strategic importance of focusing on the patient journey, how to scale marketing for companies of all sizes, and the role of digital platforms in the ever-evolving landscape of pharma and biotechnology marketing.
Chapters: 00:00 - Introduction 00:09 - The Importance of Storytelling in Life Sciences 01:00 - David’s Journey into Life Science Marketing 02:00 - Starting CG Life and its Evolution 05:00 - Combining Science and Storytelling 08:00 - Challenges and Opportunities in Biopharma Marketing 10:00 - CG Life's Growth Strategy and Key Acquisitions 13:00 - Leveraging Social Media and Digital Platforms in Pharma 17:00 - Storytelling for Different Audiences: Patients, HCPs, and Investors 22:00 - Case Study: Terran Biosciences – Building Market Visibility 24:00 - Case Study: Novo Nordisk – Digital Customer Experience for HCPs 30:00 - Advice for Entrepreneurs Starting a Marketing Agency 34:00 - Lessons Learned from David’s Entrepreneurial Journey 36:00 - Building a Strong Team for Success 37:00 - Final Thoughts and Call to Action
Don’t forget to subscribe and share your thoughts in the comments! Let us know what topics or guests you want to see next.
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Links: Visit CG Life: (https://www.cglife.com) Connect with David Ormesher on LinkedIn: (https://www.linkedin.com/in/davidormesher)
- Subscribe to our podcast for more insights on life sciences: 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
💬 Let us know in the comments: Did you know worms could be this powerful? 👍 Don't forget to hit Like and Subscribe for more fascinating interviews with leaders in life sciences!
The Secret to Better Medications: Standardizing Pharmacogenomics (PGx) Testing
00:29:59
Imagine knowing how your body will respond to a medication before you even take it! In this episode, Harsh Thakkar interviews Sarah Rogers, co-founder and president of the American Society of Pharmacovigilance (ASP) and an Assistant Professor at Texas A&M. Together, they dive deep into the fascinating world of pharmacogenomics—how your genetic makeup affects your response to medications. They discuss the challenges of pharmacogenomic testing, real-world examples of adverse drug reactions, and the future of personalized medicine.
Chapters:
00:00 - Intro 00:16 - Breaking Down Pharmacogenomics 01:39 - Guest Introduction: Sarah Rogers 02:18 - Explaining Pharmacogenomics to a Child 03:24 - Sarah's Start in Pharmacogenomics 04:54 - The Power of Pharmacogenomics 07:00 - Pharmacogenomics Clinic at Texas A&M 09:02 - Challenges of Standardizing PGX Testing 11:14 - The Ideal Pharmacogenomics Workflow 13:39 - Real-World Example of PGX in Action 15:44 - Importance of Integrating PGX into EHR 20:24 - AI and Digital Twins in Pharmacogenomics 21:52 - Lessons Learned in Pharmacogenomics 24:46 - Looking to the Future of Personalized Medicine 28:18 - Final Takeaway 30:22 - Outro
Connect with Sarah Rogers: - LinkedIn: (https://www.linkedin.com/company/american-society-of-pharmacovigilance) - STRIPE Initiative LinkedIn: (https://www.linkedin.com/company/stripe-pharmacogenomics) - Twitter: (https://twitter.com/amsocietypharm) - Newsletter signup for the American Society of Pharmacovigilance: https://www.stopadr.org/
Here are links for some of the information that I mentioned during our meeting: - STRIPE Annual Meeting and Consensus Workshop - (https://www.usp.org/node/289416) - Collaborative Communities: Addressing Health Care Challenges Together (https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/collaborative-communities-addressing-health-care-challenges-together) - Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community - (https://stopadr.org/stripe) - Texas A&M Interprofessional Pharmacogenomics (IPGx) Clinic - (https://ibt.tamu.edu/cores/Texas%20ClinicoGenomics/Texas%20ClinicoGenomics.html) - National Action Plan for Adverse Drug Event Prevention - (https://health.gov/sites/default/files/2019-09/ADE-Action-Plan-508c.pdf) - Figure showing Stakeholders Involved in the Lifecycle of a Pharmacogenomics Test (https://www.nature.com/articles/s41397-024-00345-y/figures/1)
- Subscribe to our podcast for more insights on life sciences: 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
💬 Let us know in the comments: Did you know worms could be this powerful? 👍 Don't forget to hit Like and Subscribe for more fascinating interviews with leaders in life sciences!
Why Antimicrobial Resistance Is the Biggest Challenge in Public Health
00:41:08
In this episode of Life Sciences 360, host Harsh Thakkar sits down with Marc Sheetz, Associate Dean of Research at Midwestern University's College of Pharmacy, to discuss the growing concern of antimicrobial resistance and the field of pharmacometrics.
Marc sheds light on how pharmacometrics is shaping the future of medicine by using predictive models to personalize dosing, making drug treatments more effective while reducing toxicity. This episode dives deep into the intersection of pharmacometrics, AI, and machine learning, revealing how the future of patient care and treatment is rapidly evolving. Marc also shares insights from his current research in the infectious disease space, including his work with pediatric ICU patients.
Chapters:
00:00 Introduction 00:03 Antibiotic Toxicity and Population Models 01:02 The Importance of Antibiotics and Public Health Challenges 01:22 Introduction to Pharmacometric Science 03:12 Using Data in Medicine for Future Predictions 06:01 Tailoring Drug Dosages for Individuals 09:36 The Global Variation in Drug Dosages and Challenges 14:44 The Future of Personalized Medicine and Precision Dosing 21:39 The Intersection of AI, Machine Learning, and Pharmacometrics 26:35 The Role of Technology in Medicine 30:01 How Dosing Software and AI Are Enhancing Patient Care 36:54 Innovation and Research Trends in Medicine
- Connect with Marc Sheetz on Twitter: (https://twitter.com/IDPharmacometrics)
- Learn more about Midwestern University: (https://www.midwestern.edu)
- Follow Life Sciences 360 on LinkedIn (https://www.linkedin.com/company/life-sciences-360)
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Subscribe to our podcast for more insights on life sciences: 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
💬 Let us know in the comments: Did you know worms could be this powerful? 👍 Don't forget to hit Like and Subscribe for more fascinating interviews with leaders in life sciences!
Balancing Leadership Roles in a High-Stakes Industry with Taggart McGurrin
00:30:00
Welcome to another episode of Life Sciences 360! Today, we're diving into the intricate world of life sciences leadership with a special guest who's worn nearly every hat in the industry—Taggart McGurrin. Starting in finance, transitioning to law, and tackling leadership roles across strategy, operations, and regulatory affairs, Taggart McGurrin brings a unique perspective on how to navigate the high-stakes environment of life sciences.
In this episode, we cover:
The Complexities of Life Sciences: Taggart McGurrin explains why this industry has more risk areas than most, from regulatory hurdles to financial pressures.
Triple Threat in Leadership: Discover Taggart's approach to balancing “What you have, what you need, and what you want” for effective decision-making.
Navigating the CFO/COO Role: Taggart shares insights on managing dual executive roles, emphasizing the importance of detail, resilience, and creative pragmatism.
Overcoming Financial Hurdles: Insights on cash flow challenges and how proper planning and investor relations drive success.
Unique Challenges in Life Sciences: The balancing act between meeting regulatory demands and fostering innovation.
Whether you’re a leader in life sciences, considering a C-level role, or just curious about this industry, this episode is packed with practical insights!
Chapters: 00:00 - Intro 01:00 - The Life Sciences Landscape 03:30 - Importance of Patient-Centric Leadership 10:00 - The Role of Detail in Executive Leadership 17:00 - Managing Financial Pressures in Life Sciences 22:00 - Navigating Regulatory Challenges 27:00 - Raising Capital in Life Sciences 29:00 - Final Takeaways
If you’re looking to understand the unique challenges and leadership dynamics within life sciences, this is a must-watch! Don’t forget to subscribe for more content on leadership, innovation, and life sciences trends. 💡
Connect with Tagg McGurrin: https://www.linkedin.com/in/taggartmcgurrin/
- Follow Life Sciences 360 on LinkedIn (https://www.linkedin.com/company/life-sciences-360)
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Subscribe to our podcast for more insights on life sciences: 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
💬 Let us know in the comments: Did you know worms could be this powerful? 👍 Don't forget to hit Like and Subscribe for more fascinating interviews with leaders in life sciences!
ISPE’s Role in Shaping the Future of mRNA and Personalized Medicine
00:34:03
In this episode of Life Sciences 360, we dive into the evolution of pharmaceutical and biotech manufacturing with our guest, Scott, a seasoned expert with nearly 30 years of experience working with industry giants like Novartis, Biogen, Thermo Fisher, and Merck. Scott shares insights on cell culture technology, mRNA vaccines, and the challenges and innovations in scaling biotech facilities. Discover the impact of collaboration and how organizations like the International Society for Pharmaceutical Engineering (ISPE) are transforming the landscape.
Chapters : 00:00 - Introduction to Vaccine Technologies 00:14 - Importance of Collaboration in Pharma Manufacturing 00:22 - The Role of Technology Ecosystems 00:30 - Scott’s Experience with ISPE 00:46 - Motivation Behind Pharma & Biotech Careers 01:09 - Welcoming Scott to Life Sciences 360 01:19 - Scott’s Background & Industry Experience 01:45 - Integrating Technology in Pharmaceutical Facilities 01:59 - Scott’s Current Role & Unique Challenges 02:18 - Interview Kickoff: Scott’s Career Insights 03:11 - The Evolution of Drug Manufacturing 03:39 - Insights for Non-Pharma Audiences 03:59 - Changes in Vaccine Manufacturing Over the Years 04:40 - mRNA Technology and Its Impact 05:05 - Encouraging Viewers to Subscribe 05:59 - Driving Innovation in Manufacturing Facilities 07:01 - Challenges in Scaling New Therapies 08:17 - Overcoming Challenges in New Tech Implementation 09:03 - The Role of Technology Vendors 10:08 - Advancements in Manufacturing Technology 11:02 - Evolution of Biotech Processes 12:09 - Consulting in Cell and Gene Therapy 13:02 - The Infancy of Cell and Gene Therapy 13:23 - Introduction to SoulVentum 14:01 - Separation from 3M and Vision for SoulVentum 15:01 - Scott’s Role at SoulVentum 15:33 - Scott’s Contributions to ISPE 17:18 - Identifying Award-Winning Facilities 18:39 - ISPE Facility of the Year Criteria 20:18 - Global Reach of ISPE Submissions 21:41 - Geographical Insights Post-Pandemic 22:47 - The Role of ISPE in Pharma Collaboration 23:31 - ISPE Communities of Practice 24:47 - Forums & Conferences by ISPE 26:19 - Local ISPE Chapters & Regional Support 26:58 - Scott’s Take on Industry Networking 28:05 - The Importance of Professional Networks 29:05 - Advice on Building a Career in Pharma 30:21 - Scott’s Mission in the Industry 31:42 - Personal Impact of the Work in Pharma 32:26 - Patient Stories and Their Motivational Impact 33:22 - Closing Thoughts & How to Connect with Scott
🔗 Links Mentioned:
Connect with Scott on LinkedIn: https://www.linkedin.com/in/scott-billman-a865093b/ Learn more about ISPE: https://ispe.org/
- Follow Life Sciences 360 on LinkedIn (https://www.linkedin.com/company/life-sciences-360)
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Subscribe to our podcast for more insights on life sciences: 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
💬 Let us know in the comments: Did you know worms could be this powerful? 👍 Don't forget to hit Like and Subscribe for more fascinating interviews with leaders in life sciences!
Astellas Pharma’s Approach to Cell and Gene Therapy
00:36:11
In this episode of LifeSciences 360, we dive into the fascinating world of cell and gene therapy manufacturing with Carlos Yuraszeck. With over 16 years of experience, Carlos shares his deep insights into the unique challenges, opportunities, and innovations in the field, offering a detailed look into what it takes to bring life-saving therapies to patients. We cover everything from the design of manufacturing facilities to the complexities of quality systems, patient-centric innovations, and the future of allogeneic therapies.
If you're interested in the life sciences, cell and gene therapy, or just curious about cutting-edge advancements in medicine, this episode is for you!
Chapters:
00:00 - Intro 00:02 - Understanding Cell and Gene Therapy Facilities 00:09 - Challenges in Cell Therapy Facility Design 00:26 - Automation in Manufacturing 00:42 - Balancing Quality, Cost, and Time 00:53 - Patient-Centric Manufacturing 01:21 - Guest Introduction: Carlos Yuraszeck 02:06 - Carlos’s Journey in Cell and Gene Therapy 03:21 - Unique Factors in Facility Design 04:14 - Making Facilities Operational 05:09 - Subscription Appeal 06:13 - Autologous vs. Allogeneic Cell Therapies Explained 08:13 - Adjusting Processes Based on Patient Variability 09:37 - Stem Cell Derived Therapies 10:39 - Biotech Companies: Autologous or Allogeneic? 12:07 - Strategic Decisions in Facility Design 14:50 - Phase-Appropriate Quality Systems 16:45 - Regulatory Flexibility and Urgency for Patients 18:08 - Change Control in Early vs. Late Phases 19:02 - Batch Records and Operator Judgment 20:27 - Training Focus for Different Phases 22:38 - Balancing Regulatory Requirements and Innovation 24:32 - Risk Assessment Based on Patient Needs 26:18 - The Potential of CAR T Therapies 28:05 - The Allogeneic Space and Future Prospects 31:00 - The Transformative Impact of Cell Therapy 32:22 - Carlos’s Career Lessons and Fear of the Unknown 34:45 - Closing Remarks and Subscription Reminder 36:37 - Outro
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🔗 Links Mentioned:
Connect with Carlos on LinkedIn: https://www.linkedin.com/in/carlos-yuraszeck-5400091/
- Follow Life Sciences 360 on LinkedIn (https://www.linkedin.com/company/life-sciences-360)
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Subscribe to our podcast for more insights on life sciences: 🍎Apple podcast: https://apple.co/3RXPoS1 🟩 Spotify podcast: https://spoti.fi/3EbDZbr
💬 Let us know in the comments: Did you know worms could be this powerful? 👍 Don't forget to hit Like and Subscribe for more fascinating interviews with leaders in life sciences!
Make sure to subscribe for more industry insights, and don't forget to leave a comment or question for our guest, Carlos Yuraszeck!
How to Get Quick Access to GLP-1 Medications without Health Insurance ft. Dr. Jonathan Kaplan
00:41:10
In this episode of Life Sciences 360, we dive deep into the world of GLP-1 medications with Dr. Jonathan Kaplan. We discuss weight management, how these medications work, their impact beyond weight loss, and the ethical considerations surrounding their use. Dr. Kaplan shares his insights on the healthcare industry's evolving landscape, the economic implications, and why these medications are changing everything from cosmetic surgery to chronic disease management.
Chapters:
00:00 Introduction 00:02 Dr. Jonathan Kaplan’s Background 00:16 Overview of GLP-1 Medications 00:25 The Significance of GLP-1s 00:35 Future FDA Approvals 00:51 Welcome to the Episode 01:12 Meet Dr. Jonathan Kaplan 01:19 Dr. Kaplan’s Journey into Weight Management 02:09 Early Days Before the GLP-1 Hype 02:30 Compounding Pharmacy and Medication Shortages 03:17 Success of the Weight Management Program 03:23 YouTube Subscriber Request 04:17 GLP-1 Mechanisms Explained 05:00 How GLP-1s Work in the Body 05:51 Historical Timeline of GLP-1 Medications 06:48 Semaglutide’s Evolution 07:23 The Rise of Ozempic and Wegovy 07:43 New Developments in Weight Management 08:54 Accidental Discoveries and Hormones 09:35 Significance of GLP-1 Discoveries 10:02 Medication Approval and Insurance Hurdles 10:43 Patient Expectations vs. Reality 12:09 Misconceptions About Weight Loss 12:51 Other Health Benefits Beyond Weight Loss 14:10 The Complex Psychology of Weight Loss 15:16 Importance of Diet and Exercise 16:10 How to Get Access to These Medications 18:02 Transparent Pricing Model 20:19 Maintenance and Subscription Options 22:04 Challenges with Insurance 23:21 Insurance Pitfalls and Complications 24:42 Speed of Access and Medication Availability 25:41 Ethical Considerations in Prescribing GLP-1s 27:28 Balancing Ethics and Accessibility 29:35 Broader Impact on Public Health and Economics 30:35 Transforming Healthcare Through Weight Management 32:12 Future of GLP-1 Medications 33:58 Changing Consumer Preferences and Food Labels 35:51 Reflections on Dr. Kaplan’s Career 37:06 Closing Remarks 39:11 Key Takeaway on Safe Access 41:03 Conclusion and Gratitude
🔗 Links Mentioned:
Dr. Jonathan Kaplan, Founder and CEO at Build My Health
Linkedin - (https://www.linkedin.com/in/buildmybod/) - Visit Dr. Jonathan Kaplan’s website: (https://www.drwell.com) - Website : (https://www.buildmybod.com/author/kaplan/)
- Follow Dr. Well on TikTok and Instagram: (https://www.tiktok.com/@drwellrx)
- Contact Dr. Jonathan Kaplan: jkaplan@drwell.com
- Follow Life Sciences 360 on LinkedIn (https://www.linkedin.com/company/life-sciences-360)
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Why 55% of Clinical Trials Fail – The Truth About Drug Development
00:43:51
Have you ever wondered why so many clinical trials fail before reaching the market? In this episode, we dive deep into the hidden challenges of clinical trials with Rob Freishtat, President and Co-Founder of Uncommon Cures and a professor at George Washington University School of Medicine and Health Sciences.
Rob shares insider knowledge on why over 55% of clinical trials fail, the high costs of drug development, and how misaligned priorities between researchers, regulators, and sponsors can derail promising treatments. He also reveals how streamlining clinical trials, improving patient recruitment, and leveraging AI and real-world data can help bring life-saving drugs to market faster.
If you're curious about the future of medicine, drug approvals, or how rare disease treatments are developed, this is an episode you don’t want to miss!
Chapters:
00:00 Introduction – Why Clinical Trials Matter 02:59 The Real Reason Many Clinical Trials Fail 08:18 Where the Industry Wastes the Most Money 15:28 How Misalignment in Drug Development Happens 27:00 The Future of AI in Clinical Trials 34:19 How to Fix Broken Clinical Trials 41:03 Final Thoughts & Key Takeaways
Why Most New Drugs Don't Launch: The Hidden Challenges in Pharma
00:37:44
Have you ever wondered why so many new drugs fail even after years of research and billions in investment? In this episode, we dive deep into the challenges of drug commercialization, the role of AI in pharma, and the biggest mistakes companies make before going to market.
Our guest, Dan Cummings, is a leading expert in go-to-market strategy, having worked with top health tech, medtech, and biotech startups. He shares insider insights on why even successful clinical trials don’t guarantee a product’s success and how companies can improve their chances.
We also explore: - The shocking statistics behind drug approvals - Why less than a third of new drugs in 2025 will meet expectations - The #1 mistake pharma companies make before launch - How AI is transforming drug development & commercialization - What makes some drugs cost millions of dollars, while others are much cheaper
This episode is packed with industry insights, expert opinions, and bold predictions about the future of pharmaceuticals.
Chapters:
00:00 Introduction
03:54 The Challenges of Drug Commercialization
05:35 Market Access & Value-Based Pricing
12:00 Predictions for 2025 Drug Approvals
13:23 The Role of AI in Pharma
16:59 Why Most Drug Launches Miss Expectations
18:25 Lessons from Biotech Success Stories
23:46 The Future of Pharma & Go-to-Market Strategies
29:31 How Companies Can Improve Their Launch Success
Why Science Marketing Will Make Your Company EXPLODE in 2025?
00:44:05
Have you ever wondered why marketing in the life sciences industry is so different from traditional marketing? In this episode, we dive deep into the power of science marketing, the impact of brand storytelling, and how companies can successfully position their products in a competitive market.
From publishing content to collaboration with industry, we'll show you how to harness the power of science marketing for success. Why do some breakthrough innovations never reach their full potential, while others become industry leaders?
Our guest, Elizabeth Chabe, is the CEO of High Touch Group and a leading expert in scientific marketing. She shares invaluable insights on how companies can build credibility, shorten sales cycles, and effectively communicate complex innovations to investors, researchers, and the public.
We also explore: ✅ Why scientific breakthroughs fail without proper marketing ✅ The biggest mistakes life sciences companies make ✅ How to pitch complex ideas to experts & decision-makers ✅ The secret behind pharma ads & storytelling in healthcare ✅ How conferences & live demonstrations can transform your brand
This episode is packed with expert strategies, real-world examples, and game-changing marketing insights for biotech, medtech, and pharma professionals.
⏱️ Chapters: 00:00 Introduction 02:24 Why Science Marketing is Crucial 05:38 How to Tailor Your Message for Experts 14:29 The ROI of Marketing – Why It’s a Game Changer 22:24 The Secret Behind Pharma Ads & Storytelling 27:31 A Genius Conference Marketing Strategy 32:25 The Future of Science Marketing & Live Engagement 35:04 Why Elizabeth Runs a Global Business 38:50 A Sneak Peek Into Her Book – The Giants Ladder 42:31 Final Thoughts & Takeaways
🔗 Links Mentioned: 📌 Connect with Elizabeth Chabe on LinkedIn: https://www.linkedin.com/in/eviselli/ 📌 Learn more about the work she does at High Touch Group 📌 Grab a copy of Elizabeth's book, The Giants Ladder
Have you ever wondered if AI could help doctors find cancer faster and more accurately? In this episode, we explore OmniScreen, an AI-powered biomarker tool that is revolutionizing cancer diagnostics.
Joe Oakley, a pathologist and expert in digital pathology, explains how OmniScreen was trained on 3 million digital slides to detect cancer biomarkers with higher precision and speed. He shares how AI is reducing testing time, preserving tissue samples, and improving early cancer detection.
We also tackle the big question: Will AI replace pathologists? Joe breaks down the role of AI in pathology and why it should be seen as a tool to assist rather than replace doctors. Plus, learn how AI is helping hospitals, pharmaceutical companies, and researchers in drug development and clinical trials.
🔹 Key Topics Covered: ✔️ How OmniScreen is transforming cancer diagnostics ✔️ AI vs. traditional cancer detection methods ✔️ The role of AI in hospitals, pharma, and research ✔️ Will AI replace pathologists? The expert’s take ✔️ The future of AI-driven cancer research
🎙️ Guest: Joe Oakley, Lead Consultant/ Founder at Oakley Pathology Consultants, LLC 🔗 Connect with Joe Oakley: LinkedIn
📌 Chapters: 00:00 Introduction 00:49 The problem: Can AI find cancer faster? 01:19 How OmniScreen speeds up cancer detection 01:58 The AI behind OmniScreen: Trained on 3 million slides 02:28 How cancer diagnosis worked before AI 04:31 The evolution of pathology and diagnostic tools 06:10 Why AI can detect cancer better than traditional tests 07:24 How OmniScreen works step by step 08:34 The real impact: Saving time, tissue, and costs 10:04 Who are the early adopters of OmniScreen? 11:59 The role of hospitals, pharma, and researchers 14:12 The cost of AI-driven cancer detection 15:52 The big debate: Will AI replace pathologists? 17:10 Why AI is a tool, not a replacement 19:35 Future impact on drug development and clinical trials 22:09 AI’s role in personalized medicine 24:42 The future of AI in cancer research 27:10 How AI is changing clinical trials 30:05 Key takeaways from the episode 32:40 Where to find Joe Oakley & final thoughts 36:00 Closing remarks
Why Equitable Healthcare is the KEY to Better Health
00:22:03
Equitable healthcare is the key to bridging health gaps and creating better patient outcomes. In this episode, Amy West, Principal, Advisory Services at HitLab, share her insights on how technology, digital health, and data can reshape access to care—especially for underserved communities.
Learn how addressing social determinants, using remote patient monitoring, and integrating wearables can empower patients and reduce disparities.
From real-world examples to actionable insights, Amy shares a vision for a more inclusive and effective healthcare system. Whether you’re a clinician, policymaker, or simply curious about the future of medicine, discover how innovative tools and a patient-centric approach can pave the way for true health equity.
🎙️ Guest: Amy West | Principal, Advisory Services & Chair for the Women’s Health Tech Initiative at HITLAB 🔗 Connect with Amy West: LinkedIn
Tired of Supply Chain Errors? Here’s the Fix: Drug Serialization for DSCSA Compliance
00:39:50
Drug serialization is at the heart of modern pharmaceutical supply chain security. In this episode Michael Rowe, Senior Director of DSCSA and Serialization Services at TwoLabs, talks about the critical role of drug serialization and DSCSA compliance in safeguarding the pharmaceutical supply chain.
Michael explains how unique serial numbers, standardized data, and digital traceability are revolutionizing how drugs are tracked from manufacturer to pharmacy.
Discover real-world challenges and innovative solutions that ensure product integrity, reduce counterfeiting, and enhance operational efficiency in the pharma industry.
Whether you're involved in manufacturing, distribution, or regulatory affairs, learn how embracing drug serialization and DSCSA compliance can transform your operations.
🎙️ Guest: Michael Rowe | Senior Director of DSCSA and Serialization Services at TwoLabs 🔗 Connect with Michael Rowe: LinkedIn 📲 Learn more about TwoLabs More information on FDA and DSCSA
📌 Chapters: 00:00 Introduction to DSCSA and Its Importance 03:07 Understanding the Drug Supply Chain Security Act 05:54 The Role of Serialization in Drug Traceability 09:04 Impact of DSCSA on Different Stakeholders 11:54 Challenges in Compliance and Operational Changes 15:01 The Role of Technology in DSCSA Compliance 20:21 Blockchain Challenges and Opportunities 22:47 AI in Exception Handling 27:38 Client Approaches: From Strategy to Implementation 32:12 Real-World Compliance Success Stories 35:53 Consequences of Non-Compliance 38:29 Resources for DSCSA Compliance
Digital Health Expert: THIS is the No.1 Roadblock to Healthcare AI Adoption
00:35:12
Healthcare AI adoption is transforming the way we address risk, confidentiality, and patient care. In this episode, RJ Kedziora, co-founder of Estenda Solutions talks about the practical steps to safely integrate AI in clinical workflows.
Learn how to manage data privacy, mitigate algorithmic bias, and keep a human in the loop to prevent misdiagnoses. Discover real-world strategies for using AI ethically, from ambient listening to second-opinion checks, and why it’s irresponsible not to harness AI’s potential.
The discussion also highlights how AI can enhance the roles of healthcare professionals, ultimately improving patient outcomes.
🎙️ Guest: Richard Kedziora | co-founder/COO of Estenda Solutions 🔗 Connect with Richard Kedziora: LinkedIn
📌 Chapters: 00:00 Introduction to AI in Healthcare 03:01 Understanding Risks in AI Implementation 06:02 Confidentiality and Data Protection 09:03 Ethics and Explainability in AI 11:52 Bias in AI and Its Implications 15:09 Mitigating Risks in AI Usage 17:51 The Role of Humans in AI Decision Making 21:04 AI Enhancing Healthcare Professionals' Roles 24:10 Future of AI in Healthcare 26:57 Final Thoughts and Resources
A CCO’s Brutally Honest Advice if You Want to Succeed in Pharma Commercialization
00:31:45
Early Commercialization Strategies That Actually Work (Especially for Startups!) In this episode, John Harlow, Chief Commercial Officer at Melinta Therapeutics, shares real-world strategies for how lean pharma startups can win the commercialization game—without Big Pharma budgets.
Discover how small companies can pivot fast, creatively optimize distribution, and make strategic decisions without endless red tape. John breaks down the critical mindset shift from R&D to commercial readiness, how to build high-performing teams in resource-constrained environments, and why smaller organizations often out-execute the giants.
We also discuss how to prioritize spend, what leaders should know before leaving Big Pharma, and the overlooked advantages of smaller teams.
📌 Chapters: 00:00 The Challenges of Small Pharma 02:31 Understanding Melinta Therapeutics 04:44 Resource Constraints in Small Companies 08:30 The Speed of Decision-Making in Startups 10:15 Building a Cross-Functional Team 11:34 The Benefits of Small Team Dynamics 16:51 Case Study: Distribution Strategy Pivot 19:52 Creative Problem Solving in Resource Constraints 23:40 Staying Updated in the Pharma Space 27:34 Trends in Biotech and Pharma Startups 29:49 Building vs. Buying in Pharma
Subscribe for more insights on Biotech and Pharma Startups!
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