Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

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

May 03, 2023 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 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 for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.
28 min
April 26, 2023 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 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
Niedre Heckman, PhD, MPH, FRAPS is the Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. She's a fellow of Regulatory Affairs Professionals Society (RAPS) (FRAPS), and holds an MPH and PhD in Public Health. Niedre has worked at Takeda, Baxter International Inc., Shire, Baxalta, 3M, and GSK. Niedre has a wide career in Regulatory Affairs, Quality, and Research with focuses in many modalities of medical devices, pharmaceuticals and combination products. Niedre couples her background in RA & QA with her expertise in public health to bring a uniquely patient centric point of view.
44 min
April 19, 2023 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 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, and ISO
- Committee work for industry and advancing the State of the Art
Bob's Book Recommendation: The Immortal Life of Henrietta Lacks (Link)
Bob Nesbitt, is Senior Director, E2E Combination Product, Platform, and Process Development at Abbvie. After “retiring” from Eli Lilly In January 2015, Bob joined Abbvie's Combination Product Development group, where he led the Human Factors group. At Lilly, Bob lead a team that created over a dozen drug delivery devices; taking them from concept to reality. Bob has been involved in the US and International Standards (ISO) Community sInce 1999, working with passionate, knowledgeable Medical Device and Standards personnel from all over the world to create standards which "raise the bar" in Patient Safety in this regulated industry. Currently, he serves as the ISO International Chair for TC84. Prior to becoming chair of TC 84, Bob was an Expert or Convener for various committees, and was the Industry Co-Chair for US TC84 TAG from 2004-2020.
48 min
April 12, 2023 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 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 holding Product & Application Development positions. Currently at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.

26 min
April 05, 2023 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
- 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 team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.
36 min
March 29, 2023078 - Prevention is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei
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 and digital transformation. Ramin has led the creation of new businesses and business units globally across diverse sectors including medical devices, healthcare services, biopharmaceuticals, photonics and high-tech manufacturing. Ramin also serves as a Chairman and Board member for US-based VC & Private Equity backed healthcare and technology companies.

Dr Rafiei is a trusted advisor to Big Tech and Life Sciences companies and serves as a Faculty member at UC San Diego, California. Ramin is the co-founder of Reformulate Health, a global advisory practice focused on strategic commercial, innovation and investment services for leading companies in the biopharmaceutical, biotechnology, digital healthcare, and healthcare investment industries. Ramin holds a Ph.D. in Experimental Nuclear Physics from The Australian National University, with acute understanding of data science, measurement science and machine learning (deep learning) methods.
Links:
https://www.linkedin.com/in/drrafiei/

https://twitter.com/DrRafiei

https://unleash.health/

https://reformulatehealth.com/

https://medium.com/@drrafiei/prevention-as-a-service-a-business-model-that-will-fix-healthcare-166dad254ce5
43 min
March 22, 2023 077 - 8 Databases and How To Use Them 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 "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 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.
23 min
March 15, 2023076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant
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 culture and medical device development and manufacturing environments. Over her career, she has provided regulatory, technical, skill, and management development training support to all operations functions, as well as IT, R&D, Customer Service and senior management. Now, as a training system consultant, she works with clients to design and deliver custom training and build/remediate training systems, including in support of regulatory audit observations and commitments. Joanna has been a GMP TEA member since 2001, and now serves on the Board of Directors as an Advisor. She is one of the founders of the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011. Joanna writes a popular article series for Pharmaceutical Online on the people side of pharma & GMP, provides monthly interactive web courses through LifeScience Training Institute, and through her JGTA, LLC business, authored GMP Training Can Be Fun! along with an ever-expanding line of GMP training games and activities.
29 min
March 08, 2023 075 - Shortages, Pricing, Mastering New Skills, and Building Deep Understanding 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:
- 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 medical devices, pharma and other regulated industries.
34 min
March 01, 2023 074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman
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 within the Medtech and Pharma industry. She worked for both mid size and global manufacturers but one of the largest Notified Body TÜV SÜD, where she was responsible for Combination Products in her last role. Over the years she gained profound expertise in auditing QMS / MDD / MDR, assessing technical documentation incl. biocompatibility of a wide range of class IIa products. She is a certified auditor for ISO 13485 (TÜV SÜD) and QMB (TÜV SÜD). Christiana’s main focus and experience as SME is Article 117 MDR. Within TÜV she was overall responsible for implementing and improving the NBOp assessment process within TÜV SÜD for the DACH & Nordics region. She is a recognized conference speaker for drug device combination products, biocompatibility and EU medical device regulation.
29 min