203 - Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins

203 - Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins

In this episode of Let’s Combinate, Subhi Saadeh sits down with Jim Collins, a leader in drug delivery with over 30 years of experience at Eli Lilly, Sanofi, and now as an advisor and board member.

Jim shares the history of combination products before the term even existed, from insulin pens in the 1990s to modern platforms and on-body injectors. We cover IP battles that reshaped the industry, supply chain risks that pharma still underestimates, and why platform strategy is one of the most important decisions a company can make today.


Timestamps:

00:00 – Introduction & Guest Welcome

02:00 – Building Lilly’s device organization and launching insulin pens

06:00 – Early “wild west” days of drug delivery vs. today’s structure

07:00 – Intellectual property as a competitive weapon

10:30 – How Lilly, Novo, and Sanofi shaped the IP landscape

13:00 – Device differentiation in the generic space

17:00 – Portfolio vs. molecule decisions in platform strategy

20:00 – Three reasons to develop your own platform

23:00 – Supply chain risk and geopolitical considerations

26:00 – Black Swan risks and lessons for pharma companies

28:00 – Strategic suppliers vs. transactional vendors

33:00 – Drug-device integration inside companies

37:00 – Building organizational capability and governance

38:00 – Future trends: large volume autoinjectors and connected devices

43:00 – Impact of tariffs and supply chain positioning

45:00 – Where to find Jim Collins


Guest Bio:

Jim Collins is a veteran of the drug delivery field with more than 30 years of leadership experience. At Eli Lilly, he built and led the device organization, overseeing the launch of insulin pens, the Forteo Pen, and the Trulicity platform. Later, at Sanofi, he led drug delivery innovation and platform development, including devices for Dupixent. Today, Jim serves as a board member for Enable Injections and advises startups, helping the next generation of innovators navigate IP, supply chain, and platform strategy.


Subhi Bio:

Subhi Saadeh is a Quality Professional and host of Let’s Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large medical device and pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics. Subhi serves as International Committee Chair for the Combination Products Coalition (CPC), as a member of ASTM Committee E55, and previously on AAMI’s Combination Products Committee. For questions, inquiries, or suggestions, visit letscombinate.com or connect on LinkedIn.

Det här avsnittet är hämtat från ett öppet RSS-flöde och publiceras inte av Podme. Det kan innehålla reklam.

Avsnitt(245)

239 - ICH Q11 in 6 Minutes

239 - ICH Q11 in 6 Minutes

In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled.He places Q11 in context with...

20 Maj 6min

238 - 6 Audit Strategies Every Auditor Should Know

238 - 6 Audit Strategies Every Auditor Should Know

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and DiscoveryCourse Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-courseIn this episode,...

13 Maj 10min

237 - ICH Q10: The Pharmaceutical Quality System

237 - ICH Q10: The Pharmaceutical Quality System

his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style...

6 Maj 8min

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood.In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how i...

29 Apr 12min

235 - ICH Q8: How Pharmaceutical Development Actually Works

235 - ICH Q8: How Pharmaceutical Development Actually Works

This episode continues the ICH Quality Series with an overview of ICH Q8 (Pharmaceutical Development), focusing on what it is, how it’s structured, and how to think about it in practice.ICH Q8 defines...

22 Apr 10min

234 - ICH Q7: The GMP Framework for API Manufacturing

234 - ICH Q7: The GMP Framework for API Manufacturing

In this episode of Let’s Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read ...

15 Apr 13min

233 - Most Teams Misunderstand Specifications | ICH Q6

233 - Most Teams Misunderstand Specifications | ICH Q6

ICH Q6 Explained: Specifications, Control Strategy, and What’s Changing in Q6(R1)In this episode of Let’s ComBinate, Subhi continues the ICH Q-series with ICH Q6 and explains why specifications are ce...

8 Apr 6min

232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk

232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk

Subhi Saadeh interviews Lucas Pianegonda, founder of Grad and a plastics expert in medical technology, on how medtech companies actually choose materials—and where it goes wrong. Many teams default to...

1 Apr 34min

Populärt inom Vetenskap

dumma-manniskor
allt-du-velat-veta
p3-dystopia
rss-vetenskapsradion
rss-ufobortom-rimligt-tvivel
medicinvetarna
bildningspodden
paranormalt-med-caroline-giertz
kapitalet-en-podd-om-ekonomi
det-morka-psyket
rss-vetenskapsradion-2
sexet
svd-nyhetsartiklar
vetenskapsradion
pojkmottagningen
ufo-sverige
rss-ronden
rss-personlighetspodden
halsorevolutionen
hacka-livet