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.

Tämä jakso on lisätty Podme-palveluun avoimen RSS-syötteen kautta eikä se ole Podmen omaa tuotantoa. Siksi jakso saattaa sisältää mainontaa.

Jaksot(257)

250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualific...

12 Elo 11min

249 - The Best Audit Advice Nobody Told Me

249 - The Best Audit Advice Nobody Told Me

Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may n...

5 Elo 14min

248 - What Is a Quality Unit? QA vs. QC Explained

248 - What Is a Quality Unit? QA vs. QC Explained

What is a Quality Unit and how do Quality Assurance and Quality Control fit within it?In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, m...

29 Heinä 8min

247 - Why Everyone in Pharma and MedTech Should Work in Quality

247 - Why Everyone in Pharma and MedTech Should Work in Quality

Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of ho...

22 Heinä 8min

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

Most discussions about One QMS focus on harmonization.But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organ...

15 Heinä 8min

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and ...

8 Heinä 45min

244 - 5 Critical Quality Differences Between Drugs and Devices

244 - 5 Critical Quality Differences Between Drugs and Devices

Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same an...

1 Heinä 8min

243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work

243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work

Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-sessionFinished medical devices can create a lot of surprises when they are added to combination product kits.A needle, vial a...

24 Kesä 14min

Suosittua kategoriassa Tiede

rss-poliisin-mieli
tiedekulma-podcast
rss-mita-tulisi-tietaa
rss-tiedetta-vai-tarinaa
utelias-mieli
rss-kasvikutsut
filocast-filosofian-perusteet
rss-ranskaa-raakana
rss-ylistys-elaimille
rss-ammamafia
rss-astetta-parempi-elama-podcast
mielipaivakirja
hippokrateen-vastaanotolla
rss-duodecim-lehti
rss-tervetta-skeptisyytta
rss-radplus