069 - EU MDR Extension with Michelle Lott
On this episode, Michelle Lott discusses the EU MDR Extension that was formalized by the European Commission and what it means for industry. If you'd like to hear more about Michelle checkout episod...
25 Jan 202317min
068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge
On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses: · His book Mythical Medical · Benefit (As part of Benefit/Risk) · PRR...
18 Jan 202347min
067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True
On this episode I was joined by Jane M. True, VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead at Pfizer. • Following career tracks, "experience", and non-linear career prog...
11 Jan 202347min
066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: Her career at West Pharmaceuticals starting in the lab and ret...
4 Jan 202355min
065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh
This solo episode walks through 8 of the quality lessons I learned by losing 100lbs over the last 10 years. They are: Change takes time Change starts from a small decision More pain does not equ...
28 Dec 202229min
064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling
On this episode, I was joined again by Skip Creveling. During the last episode, Skip walked through Design for Six Sigma(DFSS), and finding/measuring what's important(critical parameters and toleranci...
21 Dec 202254min
063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman
On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. Niedre discusses: - Challenges with glo...
14 Dec 202248min
062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer
I love talking to fellow podcasters and on this episode, I was joined by Dr. Stefan Walzer, the CEO of MArS Market Access & Pricing Strategy. Stefan discusses: Discounts, Rebates, and how Co-Paymen...
7 Dec 202237min
