Let's Combinate - Pharma + Medical Devices with Subhi Saadeh24 Marras 2021

008 - "Follow the Opportunity" with Marta New

On this episode, I had Marta New PhD MBA. Marta and I talk about how business school changed her perspective, depth vs. the value of information when it comes to decision making, mentors in her career and their influence on her development, her experience starting a new company, her time in venture capital and the due diligence process, lessons during the pandemic and some of the influences that inspire her. Happy Thanksgiving! Marta is the CEO of Radyus Research. Before starting Radyus, Marta was the co-founding Partner at Agent Capital, a life sciences-focused venture capital firm based in Cambridge, MA. While at Agent, Marta participated in multiple deals in oncology, immunology and rare disease areas including Orchard Therapeutics (NASDAQ:ORTX), Precision Biosciences (NASDAQ:DITL), Pliant Therapeutics and Verge Genomics, among others. Prior to Agent Capital, Marta was a Principal investor at Baxalta Ventures, the corporate venture capital arm of Baxalta in Cambridge MA, where she was on the investment dilligence team and served as a board observer for Gadeta BV (acquired by Kite/Gilead, 2018), Syntimmune (acq. by Alexion, 2018), and Vitesse Biologics (early stage accelerator funded by Baxalta, Mayo Clinic and Velocity Pharmaceutical Development). Marta started her investment career at Baxter Ventures, the corporate venture capital arm of Baxter in Chicago, IL, transitioning from the Global Renal Marketing franchise, where she was the commercial lead for multiple new products for the Chinese and European markets. She joined Baxter from Northwestern University’s Innovation and New Ventures Office where she was responsible for licensing negotiations, commercial assessment of patents, and industry alliance management. She received her Ph.D. from the University of Illinois at Chicago in microbiology and immunology and completed her post-doctoral training at Northwestern University. She also received an MBA from Northwestern University Kellogg School of Management in Chicago, IL.

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258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

Combination product quality with Ben Locwin: why drug and device quality systems differ, how human factors studies are designed, what to do when a CDMO's clean audit doesn't match its performance, and...

12 Loka 34min

257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

21 CFR Part 4 sets the CGMP requirements for combination products. If your product has a drug and a device in it, you're on the hook for both sets of regulations. In this video, I walk through Part 4 ...

5 Loka 12min

256 - The New FDA Inspection Playbook: Where to Start with QMSR

QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382...

28 Syys 9min

255 - Audit Interview Techniques: How Good Auditors Get Better Evidence

A huge part of the job is knowing how to interview people, understand how work is actually performed, and corroborate what you hear against records, observations, and other objective evidence.In this ...

21 Syys 11min

254 - Saying No Is the Easy Part of Quality

Quality has a reputation for saying no.Sometimes that’s exactly the right call. Other times, “no” is just the easiest answer.In this episode, Subhi breaks down four situations where Quality should abs...

13 Syys 12min

253 - FDA Is Making Big Changes to Its Inspection Approach

FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model.Eric Pittman spent more than 20 years at FDA, conducted approximately 800+ insp...

7 Syys 45min

252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)

Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality.In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually m...

31 Elo 13min

251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy

In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug del...

24 Elo 49min