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In this episode of the Life Science Success Podcast my guest is Ian Crone. He is the VP Regulatory strategy and growth at ArisGlobal and a global life sciences leader known for RIM, UDI, IDMP, and data migration expertise, inspiring teams to deliver compliant, client-centric solutions.

00:00 Show Intro
00:30 Meet Ian Crone
01:12 From Lab Bench Up
03:07 Regulatory Deja Vu
05:15 IDMP Explained
07:39 Single Source Truth
10:38 Why Migrations Fail
14:40 Interpretive Drift Risk
15:56 Best of Breed Debate
21:27 Compliance Clock Ticking
23:59 AI Needs Humans
26:00 Why ArisGlobal
27:33 Sportify Overlay Approach
28:49 Data Cortex XDI
31:10 IDMP Data For AI
32:31 AI As Experimentation
33:54 Leading Under Pressure
36:20 Mentorship Lessons
37:05 Personal Motivation Story
39:23 AI Hype Versus Readiness
42:15 Human In The Loop
44:42 Breaking Silos Wins
47:02 Closing And Next Steps

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In this episode of the Life Science Success Podcast my guest is Jennifer Vavala, Founder & Principal at AlignPoint Partners. With more than 27 years in pharma, medical device, and diagnostics leading QA/QC in complex regulated organizations, she focuses on quality systems, inspection readiness, and operational delivery, and developed the Operational Stability Recalibration framework to help leaders rebalance escalating mandates with operating capacity before compliance or delivery risks surface.

00:00 Intro

00:30 Meet Jennifer Vavala

01:39 Microbiology Origins

04:13 Capacity Not Capability

08:43 Across Regulated Sectors

12:25 AlignPoint Partners Mission

13:15 Operational Stability Framework

18:02 Early Warning Signals

19:52 Inspection Readiness Reality

23:55 Executives And Regulators

32:37 Quality Leadership Future

36:15 Inspiration Concerns Excitement

39:39 Wrap Up And Where To Connect

40:19 Outro

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In this episode of the Life Science Success Podcast my guest is Dean Erhardt, President and CEO at D2 Solutions. He brings more than 20 years of experience across pharmaceuticals and consumer products, with expertise in support program development, distribution, and specialty product management, and has worked with over 100 pharmaceutical, biotech, and medical device manufacturers as well as many small and midsized organizations on commercial operations, strategy, and national accounts.

00:00 Intro

00:34 Dean's career: HMO, Cardinal Health, Express Scripts

03:00 Founding D2 Solutions in 2008

04:00 Pricing strategy and middlemen taking 50–70% of revenue

08:00 What separates successful commercialization from failure

10:00 D2's three pillars: distribution, reimbursement, patient services

15:00 Pharmaceutical support programs for specialty medications

16:00 D2's digital patient engagement platform in action

21:00 Resource challenges for small and mid-sized pharma

22:00 Retail deserts and the rise of direct-to-consumer models

24:00 National accounts strategy and long-term payer relationships

26:00 When to engage D2 and cleaning up commercialization missteps

28:00 The prior authorization crisis

31:00 Leadership advice: one vision, said a million times

32:00 AI, remote surgery, and the future of care

34:00 Looming shortage of 3.9 million healthcare workers

36:00 Concerns: aging population, lost patients, NIH funding

37:00 Technology accelerating drug approvals

38:00 Outro

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Jesse Mendelsohn and Michael Grosberg from Model N discuss why U.S. pricing complexity is spreading globally, the collapse of the PBM rebate model, what's really driving the pharmaceutical manufacturing boom, and why direct-to-consumer discount programs won't solve America's drug access problem.

00:00 Introduction to Life Science Success Podcast
00:34 Pressing Issues in Pharmaceutical Manufacturing
00:51 Introducing the Experts from Model N
03:08 Understanding International Reference Pricing
04:14 Impact of US Pricing on Global Drug Launches
09:26 Challenges with Pharmacy Benefit Managers
16:29 Domestic Manufacturing Boom in Pharmaceuticals
23:08 AI in Drug Discovery and Personalized Medicine
29:03 Access and Policy Discussion
30:01 Direct to Consumer Pricing
31:32 TrumpRx Overview
33:11 Compliance Challenges
38:30 Pharmaceutical Revenue Management
41:38 AI in Life Sciences
48:35 Future of Life Sciences
50:45 Concerns and Challenges
53:52 Excitement in Current Work
55:54 Conclusion and Final Thoughts

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In 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 Podcast

00:37 Meet Troy Fugate: CCO of Compliance Insight

01:09 Troy's Career Journey and FDA Focus

04:10 The Align, Apply, Adapt Framework

04:47 Differentiating Compliance Insight

08:03 The Importance of Clarity in Compliance

17:10 Challenges and Solutions in Compliance

25:38 Human Behavior and Continuous Improvement

34:39 Troy's Inspirations and Concerns

39:07 Final Thoughts and Closing Remarks

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In 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 Podcast
00:29 Meet Byron Purse: Professor and Co-Founder of AlidaBio
01:05 Byron's Journey into Life Sciences
03:10 From Academia to Entrepreneurship
06:49 Founding AlidaBio: Vision and Mission
08:59 Innovations in RNA Modifications
23:09 Challenges and Successes in Developing the EpiPlex™ Platform
28:44 Leadership and Inspiration
35:00 Concerns and Future Outlook in Life Sciences
43:02 Conclusion and Final Thoughts

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In 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 Podcast
00:46 Upcoming Podcast Announcement
01:08 Introducing James Piacentino
01:49 James Piacentino's Background in Digital Health
03:29 Corporate Experience and Startup Journey
06:53 Founding Thrive Genetics
08:35 The Impact of Addiction on Families
09:19 Thrive Genetics' Approach to Addiction Risk
18:43 Partnerships and Technological Advancements
21:29 Combining Genetics, Behavior, and AI
25:06 The Conservative Approach to AI in Customer Journeys
26:12 Balancing Scientific Rigor with Business Models
27:09 Adoption and Value Creation in Technology
30:54 The Importance of Customer Feedback
40:05 Leadership Lessons and Values-Based Leadership
43:18 Inspiration and Overcoming Limiting Beliefs
45:29 Concerns and Complexities in Today's World
46:47 Excitement for the Future
47:35 Conclusion and Farewell

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In 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 Podcast
00:40 Join Our Free School Community
01:41 Introducing Our Guest: Josh Yelen
02:10 Josh Yelen's Professional Journey
04:30 The Birth of Venture Forward Capital and Function
09:05 Function's Unique Approach to Financial Services
14:55 Challenges in Biotech and Pharma
20:40 Trends Shaping the Future of Biotech
29:19 Firing the Biggest Client and Growing the Business
29:46 Innovative Use of AI in Business
30:53 Aligning Company Goals with OKRs
32:45 The Importance of Focus and Avoiding Distractions
36:46 Leadership Advice and Entrepreneurial Challenges
39:31 Motivational Videos and Personal Drive
45:37 Concerns About AI and the Future of Work
50:48 Excitement for the Future and Final Thoughts