086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with Fran DeGrazio
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: (0:00) Component Machinability (3:47) Stopper/Plunger Coating ...
24 Mai 202330min
085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote
On this episode I was joined by Jacob Laporte, Co-Founder of the Novartis Biome. Jacob discusses: (1:56)Harvard PhD to Consulting in Innovation Management (11:50)Core & Non-Core Innovation (21:09...
17 Mai 202336min
084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New
On this episode, I was joined by Marta New, the CEO of Radyus Research. Dr. New discusses: (0:00) Intro (1:37) Pre-Clinical Planning (7:15) What's the purpose of an IND? (14:10) Administration...
10 Mai 202350min
083 - Holistic Approach to Container Closure Integrity, Capping/Crimping, RSF, and Annex I/USP 1207 Requirements with Derek Duncan
On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments. Derek walks through: - (2:30) Holistic Approach to CCI - (5:50) Risk Management and C...
3 Mai 202327min
082 - CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R 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: * Common Technical ...
26 Apr 202343min
081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt
On this episode I was joined by Bob Nesbitt, Chair of ISO TC 84 and Director of Combination Products R&D at Abbvie. Bob discusses: - ISO TC 84: Needle Based Injectors, Insulin Syringes, Auto Disable ...
19 Apr 202347min
080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan
On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments. Derek walks through: - CCIT vs. Sterility Testing - Difference between Deterministic a...
12 Apr 202325min
079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: - How FDA Reviews Combination Products - Industry's role in shaping policy - ...
5 Apr 202335min
