Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

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

July 27, 2022 043 - “Half Knowledge Can Hurt” with Shadeed Salam
On this episode of the podcast, I was joined by Shadeed Salem, the Founder and President of Synergy Bioscience. Shadeed and I discuss:
-War Stories in method validation and NCR/OOS's
-What is it that you're going to test and what are you testing for?
-Differences between drug and device methods including Analytical, Physical, Mechanical and Visual methods
-Method Development vs. Method Validation
-How to treat compendia methods (USP, ISO, etc)
-Specificity, Bias, Linearity, Gage R&R
Shadeed Salem MSc MBA CQE CQMOE CQA CSSBB CPGP is an industry matter expert with proven expertise in the establishment and remediation of quality systems based on regulatory requirements such as the FDA 21CFR 210, 211, QSR 820, ISO 9001, ISO 13485, ISO 14971, ISO 14644, and IEC 60601 and guidelines such as ICH, WHO, and PIC/S for pharmaceutical and medical device industries. Thorough knowledge and high level of expertise in writing protocols and implementing numerous validation studies such as Analytical Method Development/Validation, equipment qualification (IQ/OQ/PQ), Cleaning Validation, Cleanroom Qualification, Water System Qualification, as well as manufacturing process validations. Exceptionally skilled in performing Corrective Action / Preventive Action (CAPA) and Root Cause Analysis, Out of Specifications (OOS) Investigations, quality system auditing and compliance gap assessment, as well as providing training based on cGMP requirements.
1 hr 15 min
July 20, 2022 042 - “Reproducible within Limits”
On this episode of the podcast, I walk through some of the takeaways I got from reading "Statistical Method from the Viewpoint of Quality Control" by Walter A. Shewhart.
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Who Was Walter Shewhart? Link
21 min
July 13, 2022 041 - “Health Citizenship” with Jane Sarasohn Kahn
On this episode of the podcast, I was joined by Jane Sarasohn Kahn of Health Populi and THINK-Health. Jane and I discuss:
- US Healthcare System
- Healthcare economics before Healthcare economics
- Her Book: Health Consuming
- Health Consuming vs. Health Citizenship
- US vs. European Healthcare systems
Jane is a health economist, advisor and trend-weaver to organizations at the intersection of health, technology and people. Jane founded THINK-Health after working with health care consultancies in the US and Europe. Jane’s clients span the health/care ecosystem: technology, pharma and life sciences, providers, plans, financial services and consumer goods. She founded the Health Populi blog in 2007. Jane advises on strategy via environmental analysis, scenario and strategic planning. She is on the advisory boards of CanSurround, CAQH’s U.S. Health Efficiency Index, the Health 2.0 Conference, healthBank, HIMSS Connected Health Committee, the Society for Participatory Medicine, Stupid Cancer, and WEGO Health. In her community of Phoenixville, PA, Jane sits on the Board of The Clinic, a free clinic for residents. Jane is a frequent speaker, listed with AHA’s Speakers Express and Executive Speakers Bureau.
1 hr 10 min
July 06, 2022 040 - “Good Science is Good Science” 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:
- Behavioral Neuroscience and the soft skills of Quality
- Quality, Compliance and Risk Management
- Pharmacogenomics and Orwell
- Combination Products
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.
51 min
June 29, 2022 039 - "The Camera Didn't Make the Artist Obsolete" with John Nosta
On this episode of the podcast, I was joined by John Nosta of NostaLab. John and I discuss:
-Pharmaceutical Innovation in the last several decades
-Patient-Centricity in Pharma
-Innovation vs. Implementing Existing Technologies
-Genius Being a Birthright & Mediocrity Being Self imposed
-Telemedicine & Digital Health
-Decentralized Clinical Trials
- Artificial Intelligence, Wonder and Fear
John Nosta is the founder of NOSTALAB—a digital health think tank recognized globally for an inspired vision of transformation. His focus is on guiding companies, NGOs, and governments through the dynamics of exponential change and the diffusion of innovation into complex systems. He is also a member of the Google Health Advisory Board. Further, John is also a frequent and popular contributor to Fortune, Forbes, Psychology Today and Bloomberg. He has also been published in prestigious peer-reviewed journals including The American Journal of Physiology, Circulation, and The American Journal of Hematology. In 2019, he was named to the World Health Organization’s Digital Health Roster of Experts.

1 hr 5 min
June 22, 2022038 - "Clinical Trials" with Dan Sfera
On this episode, I was joined by Dan Sfera, aka "The Clinical Trials Guru". Dan and I discuss:
Clinical Trials from the View of the Patient and the link to Primary Care

Institutional Review Boards

Informed Consent

Patient Accrual, Inclusion/Exclusion and Screen Failure

Role of the Sponsor

Sponsor/CRO/Study Site Dynamics

Roadblocks in Clinical Research

Decentralized Clinical Trials
Dan Sfera is the Founder and Site Director of Yuma Clinical Trials, Founder of the CRA and CRC Academies, Co-Founder of DSCS Sweat Equity and Investments, and one of the Author's of the Comprehensive Guide to Clinical Research. He is also the Host of The Random Musings from The Clinical Trials Guru Podcast.
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Links:
Book: Comprehensive Guide to Clinical Research
Podcast: Link
1 hr 14 min
June 15, 2022 037 - Reflections #1 - (Episodes 001-25)
On this episode I go through the lessons I've learned through the podcasting process, and reflect on the first 25 episodes of the Combinate Podcast.
Constructive Feedback or Guest Suggestions can be made at letscombinate.com
35 min
June 08, 2022036 - "Those Moments Keep You Grounded" with Yousef Arman
On this episode of the podcast, I was joined by Yousef Arman, Founder of The Vial Store. Yousef and I discuss:
His background growing up around Pharmacists and Pharmacies

What starting a Pharmacy Requires and Day to Day Operations

Pharmacy Pricing/Costs and how they make money

Demand Planning, Formularies and how pharmacies always seem to have medications

The role of Specialty Pharmacies in developing areas

The Vial Store and where the idea came from
Yousef's Articles:
The Evolution of Pharmacy – A Short History Part 1 – The Ancients: Link

The Evolution of Pharmacy – A Short History Part 2 – The Middle Ages to 1900: Link

The Evolution of Pharmacy – A Short History Part 3 – The Last 150 Years: Link
Yousef Arman, is the Founder of The Vial Store. Established in August 2015, The Vial Store provides reliable, cost effective and quality products that exceed its customers’ expectations. It demonstrates relentless commitment to quality, integrity and continuous improvements.
Headquartered in Chicago, Illinois, the company sells vials, ointment bottles, pharmacy jars, prescription bags and other pharmacy supplies across the United States and Canada.
43 min
June 01, 2022 035 - “Safety is Safety” with Khaudeja Bano
On this episode, I was joined by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss:
- Safety function (Drug vs. Device)
- 21 CFR Part 4 Subpart B
- Specific Post-Market Safety Reporting Expectations
- Industry Challenges with implementing PMSR Requirements
- Working in Quality with a background in Safety
- Self Marketing, Toastmasters and Professional Development
Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.
48 min
May 25, 2022 034 - "Agent" with Mitch Robbins
On this episode, I was joined by Mitch Robbins, founder of the Anthony Michael Group based in Denver, Co. Mitch and I discuss:
- How he got into recruiting
- The business model for recruiting (contract, retained, engaged)
- Interview Matrix - interview strategies for objective unbiased candidate selection
- The overall recruiting/hiring process and some of the tools AMG uses to find the best candidates (Market Mapping, Intake Calls, and More)
- How to select the best candidate by using a case study or test drive
- When a recruiter should be engaged?
- His Podcast The MedTech Talent Lab
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Mitch Robbins is the founder and Managing Director of The Anthony Michael Group. Mitch has an extensive background in the recruitment and staffing industry. Prior to founding The Anthony Michael Group, Mitch worked for two of the most prestigious, nationally recognized search firms Spherion and Management Recruiters International (MRI). Mitch achieved a ranking as high as #12 out of over 3,500 recruiters within MRI.
He was the recipient of multiple achievement awards for excellence in recruiting. These included the Southwest Region Rookie of the Year, and MRI’s Pacesetter distinction. Mitch has been the choice of the experts to deliver training to both rookie and seasoned recruiters across multiple disciplines on numerous occasions.
The Anthony Michael Group, or AMG, is a boutique executive search firm. Headquartered in a suburb of Denver, CO we assist Food, Beverage, Pharmaceutical, Biotech, Medical Device, and Diagnostics organizations across the United States to hire the top 15% of Regulatory & Quality leadership talent at the CXO, VP, Director, and Manager levels. When you work with The Anthony Michael Group, you can count on our team’s tenacity, authenticity, and accountability while we deliver results for you.
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Links
AMG About - Link
AMG Blog - Link
MedTech Talent Lab - Recorded Shows Link
MedTech Talent Lab - Live Weekly on Linkedin at 2PM EST Wednesdays at Link

55 min