Let's Combinate - Drugs + Devices

On this episode, I was joined by Peter Birch, CEO and Host of Talking HealthTech. Peter walks through: - Talking HealthTech Podcast with 350+ Episodes - HealthTech Innovation in Australia - Audience building - Peter/TH's Creative Process for Podcasting (2/3/4 episodes per week) Peter Birch is Founder and CEO of Talking HealthTech - a podcast and membership community to learn and connect about...

On this episode, I outline an introduction to one of my favorite APQP tools, Production Part Approval Process(PPAP): - What is PPAP - Inputs, Process, Triggers and Interactions - PPAP Elements and Tools - The difference between first article inspection(FAI) and Capability Studies - Applications and Challenges in use Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a b...

On this I was joined by Ferdous Al-Faruque, Senior Editor at RAPS. Danny discusses: • Landing in Medical Devices and Pharma Regulatory Affairs • Rules of engagement • On the record, Off the record, On Background • Danny's Process in writing, editing and publishing Ferdous Al-Faruque, known as Danny, is Senior Editor at RAPS and specializes in reporting on regulatory affairs, new medical device tec...

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 vs Lamination (13:22) Stopper/Plunger Manufacturing (26:14) USP 381/382 Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Office...

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)Digital Technologies in Pharma (27:39)Democratizing Access and Clinical Trials (32:35)Proteomics Dr. Jacob LaPorte is an ex-Harvard chemist and ex-McKinsey consultant who is passionate about leading d...

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 Route Selection (19:00) Candidate Selection and Animal Models (30:10) Pre-IND Meeting (44:00) IND Submissions and Approval Marta New PhD MBA is the CEO of Radyus Research. She is an experienced drug deve...

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 CCI - (7:30) Lyophilized vs. Liquid CCI - (12:20) Capping/Crimping Parameters and Residual Seal Force(RSF) - (14:30) EU Annex I and USP 1207 Requirements Dr. Duncan began his career at the Dutch Institute...

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 Document * Combination Products Structure for eCTD Submissions * EU vs. US Submission Expectations * Design Controls and Human Factors data placement * Regulatory Roles and Responsibilities in Pharma N...

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 Syringes, On Body Injectors, Sharps Prevention, Cartridge Based Pen Injectors, Inhalers, Single use Drug Delivery devices, Catheters, etc - Crazy Bob's Medical Device - Relationship between AAMI, ANSI,...

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 and Probabilistic Methods - 9 CCI Test Methods in 9 Minutes - CCI vs. Permeation Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry...

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 - Essential Performance Requirements - IMDRF and International Harmonization Opportunities Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a tea...

On this episode, I was joined by Ramin Rafiei PhD, CEO of Unleash Health. Ramin discusses: Experiences in Integrating Combination Products and Digital Health Prevention + Intervention in Health Care Incentives and Outcomes Unleashing consumer brands to improve health Dr Ramin Rafiei is a senior executive and entrepreneur in healthcare and life sciences, specializing in profitable top-line growth a...

On this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them!  If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today. Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies...

On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through: Training programs at companies that had consent decrees The difference between good training and bad GMP training Competence in knowledge work Human Error  Joanna Gallant is an experienced, solutions-driven Quality and training professional who has spent more than 30 years in pharmaceutical, biotechnology, tissue c...

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss:  - FDA Drug Shortages Report  - Drug Shortages and Drug Pricing  - How he approaches Mastering new skill sets and building deep understanding in new areas Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in med...

On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through: - Article 117 requirements for Combination Products in EU - Notified Body Opinions, Timelines, and Interactions\ -Reporting for Combination and when does Eudamed Apply Christiana is a medical device and combination product professional with...

On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses: The Anatomy of a Hazard Hazard Source(HS), Initiating Mechanisms (IM) and Target-Threat Outcome (TTO) Clifton Ericcson How concepts/tools like these fit into the ISO14971 and ISO TR 24971 framworks Naveen Agarwal PhD is an Engineer by t...

On this episode, I was joined by Dan Formosa, legendary designer and founder of ThinkActHuman. On this episode, Dan walks through: - Eliminating the need for instruction through good design - Drug/Device Combination Product Usability - Collaborating with OXO on a Pre-Filled Syringe - Creating the worlds first toothbrush designed for children - Usability and his book on simplifying baseball Dan For...

On this episode, I was joined by Etienne Nichols, who is a Medical Device Guru and Host of the Global Medical Device Podcast. Etienne Discusses:  -Translating lessons from the Steel Industry into MedTech -His experience on combination products  - What is the most important quality system element?  Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning an...

On this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses:  - His experience leading combination product focused organizations at Eli Lilly & Sanofi  - The first autoinjectors and the history surrounding ISO 11608  - Managing a product line, owning P&L and the product development...

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 episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today. Michelle Lott is the founder and principal of leanRAQA, which has supported 100+...

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) · PRRC Role and EU MDR David R Rutledge, Pharm. D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk management, regulatory, and quality. He brings 25 ye...

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 progression • Practical tips for presenting and nerves • Storyboarding and the Minto Principle • How Flu Vaccines are developed globally • mRNA and what it may mean for product development and org str...

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 retiring as Chief Scientific Officer Becoming experienced in Marketing, QA and RA What the C-Suit expects from individual contributors How to recognize opportunities and when to say yes Fran DeGrazio....

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 equal more pain/Quality is free. Prevention is part of performance Environment is as critical as habit Managing constraint changes as the quality journey evolves Quality is conformance to requirements Da...