Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

Let's Combinate - Drugs + Devices with Subhi Saadeh episodes

November 29, 2023 112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer
On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting.
Jeanne and I discuss:
-Steam Sterilization - Moist and Dry Heat
-Biological/Chemical Indicators, Placement and Resistance
-Cycle Development and Validation
-Overkill Cycles vs Product Specific Cycles
-Parametric Release of Steam Sterilized Products
Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.
48 min
November 22, 2023111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh
On this solo episode, I go through a list of 7 books I recommend for med tech, biotech and combination product professionals.
The books are:
Quality is Free by Phillip Crosby

The Combination Products Handbook by Susan Needle

What Country has the Best Healthcare by Ezekiel Emanuel

Switch by Dan and Chip Heath

Managing Oneself by Peter Drucker

Bottle of Lies by Katherine Evan

The Pyramid Principle by Barbara Minto
I find that I read a lot more in December so wanted to give you all some recommendations this Thanksgiving week. Happy Thanksgiving!
20 min
November 15, 2023110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss:
Dealing with CDMO's and CXO's

Supply Chain and Logistics and Pharma and Medical Devices

Reverse Knowledge Transfer

Building Trust with CXO's and Leveraging Surveys

The future of the CDMO Market
Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.
32 min
November 08, 2023 109 - Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste
On this episode, I was joined by Martin Van Trieste, Author of Protecting the Patient at All Costs: The Drug Watch Dogs and is the Former Chief Quality Officer at Amgen and Former CEO at Civica Rx.
Martin and I discuss:
- Protecting the Patient at All Costs
- Quality Leadership and being a Chief Quality Officer in Big Pharma
- Supply Chain Security
- Generic Drugs and Shortages
Martin Van Trieste is an accomplished entrepreneur, board governance expert, executive coach and biopharmaceutical executive. Martin Van Trieste is the Former President and CEO of Civica Rx.
Prior to joining Civica Rx, he worked with Amgen, a leading biotechnology company and also previously served as vice president of worldwide quality for Bayer Healthcare’s Biological Products Division and vice president of quality assurance for the Hospital Products Division for Abbott Laboratories.
Van Trieste has also taken on ventures of his own. He’s the founder of Rx-360, an international nonprofit organization that enhances patient safety by increasing security and quality in the biopharmaceutical supply chain.
He has also served as the chairman of the Parenteral Drug Association (PDA) Board of Directors and was honored with the 2020 Joseph B. Sprowls Lecturer award.
43 min
November 01, 2023108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins
On this episode I was joined by Margaret Jenkins, who's the Founder and Principal at Global Pharma Solutions. Margaret and I discuss:
Clinical Data interpretation and authoring

eCTD Module 2 Overview

Learning drug assays with a device background
Non-Clinical eCTD Module 4

Clinical eCTD Module 5
Margaret Jenkins is the Founder and Principal at Global Pharma Solutions where she works closely with clients to provide strategic solutions, allowing them to follow the most efficient pathway to registration and launch in their chosen markets. Margaret has more than 30 years’ experience in the Pharmaceutical industry both in the UK and Australia, spanning drug discovery, drug development and Regulatory Affairs.
Margaret has hands-on experience in numerous successful global submissions in both the innovator and generic spaces for: US, EU, Asia Pacific and ANZ. Margaret has written all 5 modules of the CTD including writing clinical overviews and summaries, several module 3s (CMC), and summarizing pre-clinical reports.
39 min
October 25, 2023 107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu
On this episode I was joined by Michelle Wu, CEO and Founder of Nyquist. On this episode Michelle and I discuss:
- Pre-Trained Models and Generative AI
- Distilling Decades of MedTech Data/Historical Data Review
- Adopting new technologies in Quality and Regulatory Affairs
- Removing the tribal knowledge barrier
Michelle Wu is the Founder and CEO of NyquistData Inc. Michelle has over seven years of experience in strategic planning, business development, and global strategy. Prior to NyquistData, Michelle was the Founder of Anora.ai, a company that provides artificial intelligence services. Michelle has also worked as a Co-Founder at Waveall Inc., where they helped connect people with common interests through mealtime. Michelle began their career as an Analyst at The Boston Consulting Group. Michelle holds a bachelor's degree in economics from Harvard University.
Michelle Wu pursued a Master of Business Administration (M.B.A.) at Stanford University Graduate School of Business with a focus in healthcare and investment. Prior to that, they completed a Bachelor's degree in Foreign Languages and Literatures, General from Peking University.
33 min
October 24, 2023 106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott
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, 077, 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 with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.

Links: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2024fy2024
https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-statement-fda-continues-take-steps-strengthen-premarket-notification-510k-program

34 min
October 11, 2023 106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman
On this episode, I was joined by Nathan Roman, an expert in temperature mapping and environmental validation. On this episode, Nathan and I discuss:
- Temperature Mapping and Monitoring
- Validation and Commissioning
- Changes in Data Logger Technology
- Cold Chain vs. Ambient
Nathan Roman is a highly accomplished expert in equipment commissioning, qualification, and validation, with over 23 years of hands-on experience in the Health & Life Science industry. In his current role, he successfully manages a team of experts, develops business strategies, and oversees the growth of his practice, all while delivering exceptional services to a diverse portfolio of clients.With expertise in cGMP compliant facilities, R&D labs, and temperature mapping, Nathan ensures regulatory compliance. He excels in placing temperature sensors in control chambers, streamlining processes for faster delivery. Nathan aids professionals in achieving compliance, providing training, collaborating with vendors, and offering temperature mapping guidance. An industry thought leader, he empowers clients with mapping knowledge, sensor placement strategies, and equipment qualification expertise.
33 min
October 04, 2023 105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh
On this episode, I reflect on 8 lessons I learned from recording 100 Episodes of the Combinate Podcast and Ironman Chatanooga.

Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

For feedback on the show or suggestions please contact [email protected]

28 min
September 27, 2023104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
On this episode, I was joined by Sara Waxberg MacNew, Chief Scientific Officer at Design Sciences. On this episode Sara and I discuss:
New FDA Guidance:

Critical Task Definition for Combination Products

Pre-Clinical HF Studies in readiness for IND Submission

URRA

Human Factors Validation vs. Design Validation
Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design leadership at Eli Lilly, Philips Healthcare, and Baxter Healthcare. She is an active member of AAMI where she has contributed to the development and revision of human factors technical information reports and international standards. Learn more about Design Science's impact on Healthcare Technology by following @designscience on all social media platforms.
37 min