Align, Apply, Adapt: Building Lasting Compliance with Troy Fugate

Send us a textIn this episode of the Life Science Success Podcast my guest is Troy Fugate. The CCO of Compliance Insight, Inc., Troy brings 30+ years of FDA readiness, GMP, and quality leadership—turning complex requirements into practical, culture-shaping solutions and championing the Align–Apply–Adapt framework used across pharma, cell and gene therapy, and medical devices.00:00 Introduction to Life Science Success Podcast00:37 Meet Troy Fugate: CCO of Compliance Insight01:09 Troy's Career Journey and FDA Focus04:10 The Align, Apply, Adapt Framework04:47 Differentiating Compliance Insight08:03 The Importance of Clarity in Compliance17:10 Challenges and Solutions in Compliance25:38 Human Behavior and Continuous Improvement34:39 Troy's Inspirations and Concerns39:07 Final Thoughts and Closing Remarks

Send us a textIn this episode of the Life Science Success Podcast my guest is Byron Purse, co-founder of AlidaBio and professor of chemistry at San Diego State University who is pioneering innovative approaches to studying RNA modifications. Byron brings a wealth of expertise in synthetic and natural nucleic acid modifications, with a passion for advancing biotechnology and human health through his groundbreaking research and entrepreneurial endeavors.00:00 Introduction to Life Science Success Podcast00:29 Meet Byron Purse: Professor and Co-Founder of AlidaBio01:05 Byron's Journey into Life Sciences03:10 From Academia to Entrepreneurship06:49 Founding AlidaBio: Vision and Mission08:59 Innovations in RNA Modifications23:09 Challenges and Successes in Developing the EpiPlex™ Platform28:44 Leadership and Inspiration35:00 Concerns and Future Outlook in Life Sciences43:02 Conclusion and Final Thoughts

Send us a textIn this episode of the Life Science Success Podcast my guest is James Piacentino, CEO of Thrive Genetics, Inc., a pioneering digital health startup focused on transforming addiction risk assessment through genetic and behavioral science. James brings a unique blend of entrepreneurial experience, technical expertise, and personal mission to develop innovative solutions that help healthcare providers manage dependency risk with unprecedented precision.00:00 Introduction to Life Science Success Podcast00:46 Upcoming Podcast Announcement01:08 Introducing James Piacentino01:49 James Piacentino's Background in Digital Health03:29 Corporate Experience and Startup Journey06:53 Founding Thrive Genetics08:35 The Impact of Addiction on Families09:19 Thrive Genetics' Approach to Addiction Risk18:43 Partnerships and Technological Advancements21:29 Combining Genetics, Behavior, and AI25:06 The Conservative Approach to AI in Customer Journeys26:12 Balancing Scientific Rigor with Business Models27:09 Adoption and Value Creation in Technology30:54 The Importance of Customer Feedback40:05 Leadership Lessons and Values-Based Leadership43:18 Inspiration and Overcoming Limiting Beliefs45:29 Concerns and Complexities in Today's World46:47 Excitement for the Future47:35 Conclusion and Farewell

Send us a textIn this episode of the Life Science Success Podcast my guest is Josh Yelen, a CPA, MBA, and the Founder & CEO of Function, a strategic financial leadership and bookkeeping services company that supports businesses across various industries, including life sciences. With over two decades of experience in operations, accounting, finance, and sales, Josh is also a co-founder of Venture Forward Capital, where he supports early-stage entrepreneurs in building disruptive companies.00:00 Introduction to Life Science Success Podcast00:40 Join Our Free School Community01:41 Introducing Our Guest: Josh Yelen02:10 Josh Yelen's Professional Journey04:30 The Birth of Venture Forward Capital and Function09:05 Function's Unique Approach to Financial Services14:55 Challenges in Biotech and Pharma20:40 Trends Shaping the Future of Biotech29:19 Firing the Biggest Client and Growing the Business29:46 Innovative Use of AI in Business30:53 Aligning Company Goals with OKRs32:45 The Importance of Focus and Avoiding Distractions36:46 Leadership Advice and Entrepreneurial Challenges39:31 Motivational Videos and Personal Drive45:37 Concerns About AI and the Future of Work50:48 Excitement for the Future and Final Thoughts

Send us a textIn this episode of the Life Science Success Podcast my guest is Nissan Cohen, a worldwide expert with over 45 years of experience in high purity water systems, pharmaceutical engineering, and water technology innovation. Nissan is the Owner of Biopharmaceutical Water Doc company and has made significant contributions to the field through his extensive publications, technical expertise, and leadership in international professional societies like ISPE.00:00 Introduction to Life Science Success Podcast 00:29 Meet Dr. Nissan Cohen: Water Technology Expert01:24 The Importance of Potable Water01:52 Journey into High Purity Water Systems03:32 Transition to Pharmaceutical Industry06:12 Milestones in Pharmaceutical Water Technology09:54 Current Consultancy and Industry Challenges14:32 Advancements in Pharmaceutical Water Technologies20:51 Sustainability and Zero Liquid Discharge29:22 Agricultural Water Innovations35:43 Leadership and Professional Insights41:23 Concerns and Future Outlook44:42 Conclusion and Final Thoughts

Send us a textIn this episode of the Life Science Success Podcast my guest is Victoria Donovan. Victoria is the Founder and CEO of Clinically Media, an award-winning agency that is transforming patient recruitment and retention strategies in clinical research.00:00 Introduction to Life Science Success Podcast00:38 Meet Victoria Donovan: Founder and CEO of Clinically Media01:34 Victoria's Journey into Life Sciences03:12 The Birth and Growth of Clinically Media05:03 Clinically Media's Mission and Vision08:46 Innovative Approaches in Patient Recruitment11:59 Challenges and Future of Patient Recruitment23:45 Leadership and Personal Insights from Victoria Donovan32:34 Conclusion and Final Thoughts

Send us a textIn this episode of the Life Science Success Podcast my guest is Mark Stead, Head of Business Development at Atomic AI, a pioneering biotech company using artificial intelligence and structural biology to develop innovative RNA-targeted therapeutics. Mark brings over 12 years of experience in biotechnology, with a proven track record of negotiating high-value partnerships and driving strategic collaborations in drug discovery.00:00 Introduction to the Life Science Success Podcast00:30 Meet Mark Stead: Journey into Life Sciences03:26 Career Insights: From Amgen to Atomic AI11:20 Innovations at Atomic AI: Leveraging AI and Structural Biology19:37 The Future of AI in Drug Discovery31:03 Leadership and Personal Insights39:38 Conclusion and Farewell

Send us a textIn this episode of the Life Science Success Podcast my guest is Kristien Van Vlasselaer, a Vice President of Operations at Gordian Biotechnology who is a passionate generalist and strategic operations leader dedicated to helping biotech teams execute with excellence. With her unique ability to bridge technical expertise and practical problem-solving, Kristien brings a holistic approach to optimizing organizational performance and driving innovative solutions in the biotech industry.00:00 Introduction to Life Science Success Podcast00:40 Meet Kristien Van Vlasselaer: A Passionate Generalist01:05 Kristien's Journey into Life Sciences02:26 The Generalist Powerhouse in Biotech04:23 Career Evolution and Key Milestones09:03 Challenges and Trends in Biotech11:58 Kristien's Role and Initiatives at Gordian Biotechnology27:43 Innovative Approaches in Osteoarthritis Research28:21 Challenges and Limitations of Animal Models29:23 Complex Problem Solving in Biotech35:12 Leadership Advice and Insights42:31 Inspiration and Concerns in the Industry50:26 The Value of Generalists and Future Outlook52:53 Conclusion and Final Thoughts

Send us a textIn this episode of the Life Science Success Podcast my guest is John Schmitt, a military veteran, entrepreneur, and Co-Founder & CEO of iXpressGenes who is leveraging innovative RNA biomarker technologies to revolutionize trauma screening in healthcare. With over 20 years of leadership experience in the U.S. Army and a Master's degree in Microbiology and Immunology, John is dedicated to developing data-driven solutions for early detection and prevention of trauma-related diseases.00:00 Introduction and Podcast Overview01:02 Welcoming the Guest: John Schmitt02:00 John Schmitt's Journey to Biotechnology05:58 Military Experience and Leadership Insights13:09 Founding  iXpressGenes: The Origin Story17:31 Mission and Objectives of iXpressGenes23:08 Challenges and Innovations in Biomarker Technologies27:42 Personal Leadership and Inspirations35:00 Conclusion and Podcast Wrap-Up

Send us a textIn this episode of the Life Science Success Podcast my guest is Lauri Befus, Vice President of Clinical Operations at M3 Wake Research, a leading integrated site network in the United States. With over 13 years of experience in clinical research and healthcare operations, Lauri brings a unique perspective to clinical trials, focusing on patient-centric strategies and operational excellence.00:00 Introduction to Life Science Success Podcast00:37 Meet Lauri Befus: Vice President of Clinical Operations at M3 Wake Research00:59 Lauri's Journey into Clinical Research01:53 Educational Background and Early Career02:36 Career Progression and Key Milestones04:25 Challenges in the Life Sciences Industry05:18 Diversity and Inclusion in Clinical Trials06:16 Overview of M3 Wake Research07:37 Lauri's Role and Responsibilities13:59 Innovative Projects and Initiatives16:28 Future Goals and Industry Innovations17:31 Leadership Insights and Advice24:19 Conclusion and Final Thoughts