Why Procurement Can Make or Break a Drug Company

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There's always this challenge, right?
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It's a game of capacity management.
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You can imagine you're buying capacity at the CDMO.
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They could sell it to somebody else.
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What does that look like?
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So, I would say one of the things is just
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how do we start communicating quickly
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and building those relationships?
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In this episode of Executive Edge,
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Greg sits down with Dave Stowe,
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founder and managing partner of Adventus
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and a veteran of PWC, Oliver Wyman,
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Horizon Therapeutics and Purdue Pharma.
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With decades of experience in life sciences and healthcare,
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Dave shares how procurement can influence
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the success of drug development,
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helping organizations manage risk, control costs
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and build the supplier relationships
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that bring innovative therapies to market.
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Hello and welcome to this episode
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of Tenzing's Executive Edge podcast.
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I have a return guest, my first one,
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Dave Stowe is again with us again today
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and he's joined us to continue our discussion
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from a prior episode.
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As a reminder, Dave is the founder
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and managing partner of Adventus,
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a boutique advisory firm that helps emerging biotech
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and pharmaceutical companies scale through periods
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of rapid growth and operational complexity.
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Dave partners with leadership teams
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to build the procurement, finance
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and supply management capabilities needed
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as organizations move from clinical development
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into commercialization and face new demands
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on scale, spend and execution.
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Hi Dave, thanks for returning to continue our discussion.
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Hi Greg, good to be back.
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I appreciate the invitation, thank you.
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Sure, yeah, I think it was such a great discussion
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the last time and we just had to continue this.
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I think it was almost mandatory
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is how I felt when we finished.
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But the last time we talked,
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we really were focused on procurement support
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for the scientific study process
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during the drug development life cycle.
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And that was really focused on the R&D activities
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and how do you support those folks
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and those functional areas in the organization.
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And now we've got a drug that's been approved,
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it's ready to go to production.
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And so today I wanna talk about what's it like
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to support the scale up when you move
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into the production phase of a drug
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and start to produce it and ship it
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and sell it in the market.
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So we're gonna focus on the operation side,
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not so much the commercial side, but let's go.
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What's the first thing, first couple of things
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you think about as you're getting ready to start production?
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How do you kind of frame that up?
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Yeah, well, this really starts early on in the process,
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sometimes at preclinical and early stage clinical
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because you're really talking about
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some very technical aspects about the molecule,
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molecule development and what that means
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in a manufacturing environment.
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So while the testing is still going on,
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like I said, in preclinical or even early stage clinical,
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how you start to think about the manufacturing of it
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is very important.
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And this gets into the fact that sometimes
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you have a very complex molecule,
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the biologics is a very rapidly growing area
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in the pharma space.
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And so you go kind of the size of the molecule
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is the large or it's small, traditional,
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and it can be a situation where just as important
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as it is to think about the actual drug testing,
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you're now thinking about how are you gonna make it
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in a repeatable setup there.
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So now we get into a lot of aspects
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of the physics of making the drug,
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the chemistry of making the drug.
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So it could be something that's gonna be in a vial,
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it could be, you know, what's the delivery mechanism,
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so to speak, is it gonna be in a topical application?
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Is it more of a oral substance,
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you know, a pill that we're gonna take?
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Those things are obviously gonna be
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in the early design stages of the drug,
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but now we're getting into,
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do we have the right partner to manufacture this?
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And typically most companies,
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unless they're extremely large pharmaceutical companies,
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are gonna start looking with a contract development
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manufacturing organization, CDMO,
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and what does that team, that partner,
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that supplier bring to the discussion?
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And so there's some evaluation that goes on there,
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but they may already have partners already,
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but still, this new drug that's being developed
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has a life cycle of its own,
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and an economic aspect to it, too,
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that needs to be brought together,
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both science and procurement,
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so to speak, in the finance area.
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Right, and so these contract manufacturers,
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that seems to be the way most large pharma companies
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anyway are producing, maybe small ones as well,
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you can comment on that,
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but obviously they bring the expertise and the scale
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and the capabilities to do this,
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but how much are they involved, I guess,
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in the procurement of materials and the key ingredients,
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the packaging, anything like that?
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Is it a turnkey, where they offer everything,
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or is it more of a case where you bring us the materials
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and give us the formula and whatever,
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and we'll develop the manufacturing process?
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What's that like?
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Help us understand.
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Yeah, no, it's very complicated global supply chain,
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so I think a few things,
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just to take some very basic steps,
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you have kind of key starting materials, KSMs,
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these are the chemicals that then go into
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an active pharmaceutical ingredient,
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and then there is the making of that
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from there to the dosage form, the type, right?
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So if it's a pill or if it's gonna be an injectable
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or topical application, whatever that might be,
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there are those very big steps in the marketplace.
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Now, there are some CDMOs in certain situations
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that are very specialized and vertically integrated,
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and they may bring a lot of value to that sponsor
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of the drug that's buying this drug.
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So it's important to understand that predominantly
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in a lot of the KSMs, the key starting materials,
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they do start in China, about 37% of the chemicals
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are gonna be globally sourced out of China
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and are gonna come maybe to another CDMO
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that's gonna make the API,
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that could be in Europe, for example,
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or it could be in the US or Japan,
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and then how does it go from there to the next step,
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which is the dosage form,
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and then you're gonna put it in a primary packaging
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and then a secondary packaging,
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and then you're going to ship it to the distribution point,
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however it's been designed to get to the patient there
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and the physician as they administer it.
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So those kind of steps are very important.
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Now, the CDMO marketplace is hundreds of billions
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if you look at that wide range of all those steps
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that I just talked about,
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but even like in a biological situation,
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which is really where a lot of the growth is going on
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with a lot of these drugs,
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that in itself is rapidly growing,
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probably forecasted over the next seven years
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at a compound annual growth rate of 8% to 12%.
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So you're talking about some very rapid growth
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in the manufacturing of these drugs on a global basis.
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There are things that we can maybe,
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as this conversation unfolds,
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we'll talk about a little bit more
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in the global marketplace,
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but the essence of what you're asking there
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is we're gonna start to really work with a CDMO
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early, early in this process,
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and you really need it to be a very strong relationship.
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And maybe this gets into like the concepts of partnerships
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that we wanna have with any supplier,
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but in this situation of a drug manufacturing,
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we will have the technical and the regulatory aspect to it,
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but the start of this should be,
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what's the partnership look like?
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What are those shared goals, business, scientific?
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What are some governance process?
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How are we really gonna work together
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as a partnership, as a supplier to a customer?
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And then what are some definitions of success?
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How do we wanna look at it?
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That kinda, I think, regardless, again,
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whether it's a CMO, CDMO, or it's somebody else
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providing another service to any customer
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is think about that partnership,
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and it really is gonna be,
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it could be a decades-long relationship.
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It could be, it's gonna be a long-term relationship.
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You do not wanna have this type of a supplier situation
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go south because it'll be very dangerous
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and costly for a company.
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Now, that said, that kinda sets up the tone
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of what's the, how do you look at the marketplace,
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and that's a relationship, people-to-people relationship.
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And there are, then, you need to get into
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kinda that technical abilities as you look at it,
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and you need to look at the quality
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and regulatory compliance of the CDMO,
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how good are, how they've been able to comply with FDA
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or other government regulatory bodies.
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What's their operational
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and project management capabilities?
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So once they take this,
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you want them to take a drug into production,
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how are we gonna work together to bring it?
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And then, of course, there's the financial stability
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and business health of these CDMOs
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that are very important to discuss.
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So that's really a big framework, Greg,
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of kinda how to think it through,
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but it goes deep as you go out each leg there.
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Right, it sounds like you start early, though, right?
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As you get a better indicator of that
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this drug's gonna be successful,
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it's gonna pass, and move into production,
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I think you get them engaged very early in the process,
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right?
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Yeah, and they're probably gonna be making those drugs
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that are gonna be in the testing environment, too,
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so that's, now, there's a couple variables in there,
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but basically, that type of relationship starts,
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but it starts, needs to be solidified,
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and so when you get into this kinda technical capabilities,
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you know, you're getting into, like I said early on,
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the molecule type,
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you're getting into kinda the delivery form,
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what does that look like?
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And then maybe the therapeutic areas, right?
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So some CDMOs may be very good
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in certain therapeutic areas of cancer,
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or in cardio, or in diabetes,
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or other, you know, rare diseases,
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whatever it might be,
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but you wanna have that relationship
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so that you know that maybe we're gonna start
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in a small area of small batches,
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and production,
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because we're actually gonna go into
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more of a clinical trials,
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but then over time,
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as you start to get to late-stage clinical,
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which is really where your volume, if you can,
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you're gonna have more and more patients
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trying the drug out,
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and then you're gonna get some indications from the FDA
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that this really has potential for approval.
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They may, FDA may even fast-track that development,
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and that means you're gonna move even faster
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into full-scale production.
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That's kinda how you really kinda think about that
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as you go through it,
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but it takes, you know,
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it's gonna be a years-long type process.
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It's not gonna be something that happens
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in six to 12 months.
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You're talking about something that could be,
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you know, two to five to 10 years
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as you develop it and going through it.
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Yeah, so as we prepared for the call,
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you talked about really three main categories.
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One is the manufacturing, you know, partner, if you will,
266
00:10:46,760 --> 00:10:48,239
the materials, which is,
267
00:10:48,239 --> 00:10:50,520
you've talked about key ingredients,
268
00:10:50,520 --> 00:10:53,119
and, you know, all the different ingredients
269
00:10:53,119 --> 00:10:54,080
that are mixed, I guess,
270
00:10:54,080 --> 00:10:58,159
to create the chemistry and create the product,
271
00:10:58,159 --> 00:11:00,080
and then the logistics was the third one,
272
00:11:00,080 --> 00:11:02,239
and I'm interested, you know,
273
00:11:02,280 --> 00:11:05,039
why you chose the topic of logistics.
274
00:11:05,039 --> 00:11:07,520
Everybody always maybe thinks of that after the fact,
275
00:11:07,520 --> 00:11:10,960
but why is logistics an important consideration?
276
00:11:10,960 --> 00:11:13,119
Well, you know, the stability of that molecule
277
00:11:13,119 --> 00:11:15,359
as it's gonna be transported,
278
00:11:15,359 --> 00:11:19,359
and it could be a situation where you could have a,
279
00:11:19,359 --> 00:11:20,640
it needs to be in a cold chain.
280
00:11:20,640 --> 00:11:21,479
Okay.
281
00:11:21,479 --> 00:11:23,159
It could be ambient temperature,
282
00:11:23,159 --> 00:11:25,080
you know, a pill, you know,
283
00:11:25,080 --> 00:11:27,239
just an over-the-counter pill of Tylenol, right?
284
00:11:27,239 --> 00:11:28,479
That's ambient temperature,
285
00:11:28,479 --> 00:11:30,559
but now if there's something that has to be
286
00:11:30,559 --> 00:11:34,400
for a variety of scientific and technical needs
287
00:11:34,400 --> 00:11:38,719
transported in a cold chamber or cold chain,
288
00:11:38,719 --> 00:11:39,599
it's gonna have to do that.
289
00:11:39,599 --> 00:11:41,440
You can have also radioisotopes,
290
00:11:41,440 --> 00:11:43,280
and so you've got half-lives.
291
00:11:43,280 --> 00:11:44,599
You could have something that really,
292
00:11:44,599 --> 00:11:46,760
maybe you might wanna actually make the drug
293
00:11:46,760 --> 00:11:50,119
in the middle of the U.S. in, call it Indiana,
294
00:11:50,119 --> 00:11:52,760
and then you're gonna ship it overnight,
295
00:11:52,760 --> 00:11:54,799
but it has a five-day half-life,
296
00:11:54,799 --> 00:11:56,000
and so you're gonna, you know,
297
00:11:56,000 --> 00:11:58,359
need to have it in the patients
298
00:11:58,400 --> 00:12:00,799
administered in a very short time period.
299
00:12:00,799 --> 00:12:02,000
Again, those are parameters
300
00:12:02,000 --> 00:12:04,159
that are very important to consider,
301
00:12:04,159 --> 00:12:06,359
and that's why, you know, where you,
302
00:12:06,359 --> 00:12:08,760
where the actual CDMO is located
303
00:12:08,760 --> 00:12:11,840
can have also a very big impact on how you get to market,
304
00:12:11,840 --> 00:12:15,960
so those facilities obviously are gonna be fixed.
305
00:12:15,960 --> 00:12:17,000
They're not gonna be moved.
306
00:12:17,000 --> 00:12:18,119
You're not gonna change those
307
00:12:18,119 --> 00:12:21,200
over the life of the cycle of the drug itself,
308
00:12:21,200 --> 00:12:24,359
and you may wanna continue to have other drugs
309
00:12:24,359 --> 00:12:25,919
developed in that same location,
310
00:12:25,919 --> 00:12:27,880
so those are kind of very important things
311
00:12:27,880 --> 00:12:29,159
that have to kind of be thought of
312
00:12:29,159 --> 00:12:31,640
in addition to the technical and regulatory aspects
313
00:12:31,640 --> 00:12:33,000
of your CDMO.
314
00:12:33,000 --> 00:12:33,840
I get it now.
315
00:12:33,840 --> 00:12:36,359
Suffice to say, you're not going out to buy a trucking,
316
00:12:36,359 --> 00:12:38,239
less-than-truckload-on-the-spot market
317
00:12:38,239 --> 00:12:40,280
for these products.
318
00:12:40,280 --> 00:12:42,159
Right, right, right.
319
00:12:42,159 --> 00:12:45,159
Okay, so it has to do with the, you know,
320
00:12:45,159 --> 00:12:47,080
the environment the drug needs to be in,
321
00:12:47,080 --> 00:12:49,599
and also it sounds like there's a real speed issue
322
00:12:49,599 --> 00:12:52,400
sometimes when the half-life is rather short.
323
00:12:53,479 --> 00:12:55,880
Yeah, so you've got the core primary packaging
324
00:12:55,880 --> 00:12:57,039
around the drug itself,
325
00:12:57,039 --> 00:12:58,440
and then you've got the secondary packaging,
326
00:12:58,440 --> 00:13:00,919
which we typically think of folding cartons
327
00:13:00,919 --> 00:13:02,039
in corrugated boxes,
328
00:13:02,039 --> 00:13:04,520
but you can even have the chamber itself
329
00:13:04,520 --> 00:13:06,039
that is gonna be put on a plane
330
00:13:06,039 --> 00:13:07,799
or it's gonna be shipped on a truck,
331
00:13:07,799 --> 00:13:09,080
whatever that might be.
332
00:13:09,080 --> 00:13:11,400
However that is, you've got to think
333
00:13:11,400 --> 00:13:13,159
through that design as well
334
00:13:13,159 --> 00:13:14,880
and talk about what that means
335
00:13:14,880 --> 00:13:17,039
in terms of getting it to the marketplace.
336
00:13:17,039 --> 00:13:20,799
Okay, so in terms of selecting suppliers
337
00:13:20,799 --> 00:13:22,679
and managing those suppliers ultimately
338
00:13:22,679 --> 00:13:24,520
once they've been selected,
339
00:13:24,520 --> 00:13:28,880
what are maybe some of the considerations
340
00:13:28,880 --> 00:13:30,719
people should need to be aware of
341
00:13:30,719 --> 00:13:32,599
and should take into account
342
00:13:32,599 --> 00:13:35,280
as they set up and go out?
343
00:13:35,280 --> 00:13:37,359
What is the sourcing criteria, right?
344
00:13:37,359 --> 00:13:39,520
What kind of regulatory oversight
345
00:13:39,520 --> 00:13:41,159
do we need to be aware of?
346
00:13:41,159 --> 00:13:43,320
Touch on sort of the sourcing process
347
00:13:43,320 --> 00:13:46,320
and the considerations during that, please.
348
00:13:46,320 --> 00:13:48,919
Yeah, so the governance structure
349
00:13:48,919 --> 00:13:51,280
that you want to employ as a sponsor
350
00:13:51,280 --> 00:13:54,359
or as the purchaser of the services
351
00:13:54,359 --> 00:13:55,960
is very important.
352
00:13:55,960 --> 00:13:58,919
So in that kind of governance area,
353
00:13:58,919 --> 00:14:01,159
you're gonna have a team
354
00:14:01,159 --> 00:14:03,200
that's gonna be much more technically focused.
355
00:14:03,200 --> 00:14:04,400
Then you have the team that's quality
356
00:14:04,400 --> 00:14:06,799
and regulatory focused.
357
00:14:06,799 --> 00:14:08,840
And then you've got kind of the overall
358
00:14:08,840 --> 00:14:10,919
kind of supply chain management process
359
00:14:10,919 --> 00:14:12,280
that's going on there.
360
00:14:12,280 --> 00:14:14,400
But in that regulatory area,
361
00:14:14,400 --> 00:14:17,359
which is a lot of the FDA oversight
362
00:14:17,359 --> 00:14:19,880
and other, if you're making it outside of the US,
363
00:14:19,880 --> 00:14:21,159
other government oversights,
364
00:14:21,159 --> 00:14:23,559
but basically that government agency,
365
00:14:23,599 --> 00:14:25,599
you're gonna have that whole quality management system.
366
00:14:25,599 --> 00:14:28,080
And so one of the things that I found important
367
00:14:28,080 --> 00:14:30,960
is that the people that come together
368
00:14:30,960 --> 00:14:32,679
from the sponsor that are the customer
369
00:14:32,679 --> 00:14:33,520
they're gonna be buying it,
370
00:14:33,520 --> 00:14:36,559
the purchasing team needs to have
371
00:14:36,559 --> 00:14:38,080
some good representation folks
372
00:14:38,080 --> 00:14:40,799
that would have a strong experience
373
00:14:40,799 --> 00:14:43,559
and opinion maybe of some of these CDMOs
374
00:14:43,559 --> 00:14:45,760
and what they think about them.
375
00:14:45,760 --> 00:14:47,520
One of the things I started to realize
376
00:14:47,520 --> 00:14:50,119
in some of these sourcing events
377
00:14:50,119 --> 00:14:55,119
is that a director of regulatory of quality,
378
00:14:56,719 --> 00:15:00,960
he or she is going to maybe observe certain aspects
379
00:15:00,960 --> 00:15:05,960
of how good the CDMO is at documenting information
380
00:15:08,400 --> 00:15:10,559
of keeping track of information in their system
381
00:15:10,559 --> 00:15:12,320
or not doing that.
382
00:15:12,320 --> 00:15:15,119
And in that situation, those people
383
00:15:15,119 --> 00:15:17,400
that I found those opinions are very important,
384
00:15:17,400 --> 00:15:20,080
those observations, because no one person
385
00:15:20,080 --> 00:15:22,840
is gonna be able to see the whole picture of those CDMOs.
386
00:15:22,840 --> 00:15:24,960
You're gonna need a team to look at that
387
00:15:24,960 --> 00:15:28,599
and provide that insight and observation.
388
00:15:28,599 --> 00:15:32,039
And so definitely we can have kind of the traditional,
389
00:15:32,039 --> 00:15:33,520
let's look at the supply market,
390
00:15:33,520 --> 00:15:34,719
let's try to understand it,
391
00:15:34,719 --> 00:15:36,440
but then you go deeper into that.
392
00:15:36,440 --> 00:15:39,840
And how do you know that those quality management systems
393
00:15:39,840 --> 00:15:42,599
at the CDMOs are gonna be dependable?
394
00:15:42,599 --> 00:15:44,760
And then when you look at the quick wave,
395
00:15:44,760 --> 00:15:46,239
obviously you can go to the FDA site
396
00:15:46,239 --> 00:15:47,760
and you can see when the,
397
00:15:47,760 --> 00:15:49,599
what they call the 483 reports are,
398
00:15:49,599 --> 00:15:54,599
if they've been cited for certain issues at the CDMO
399
00:15:55,000 --> 00:15:58,520
that they have to fix before they can go into production.
400
00:15:58,520 --> 00:16:02,239
So there's a lot of important information
401
00:16:02,239 --> 00:16:04,000
to gather in that environment,
402
00:16:04,000 --> 00:16:06,799
but it's also a observation of people
403
00:16:06,799 --> 00:16:08,679
of how they feel they can work with them.
404
00:16:08,679 --> 00:16:10,880
And so the governance structure needs to be written down.
405
00:16:10,880 --> 00:16:12,320
You have a master service agreement,
406
00:16:12,320 --> 00:16:14,400
you have a quality agreement.
407
00:16:14,400 --> 00:16:16,320
All those are part of the legal arrangement
408
00:16:16,320 --> 00:16:18,599
that comes into working with these suppliers,
409
00:16:18,599 --> 00:16:20,919
but it's a people business, right?
410
00:16:20,919 --> 00:16:25,760
And so how do we feel that we can capture that information?
411
00:16:25,760 --> 00:16:28,039
If there are issues and we find them,
412
00:16:28,039 --> 00:16:29,320
how do they wanna talk about them?
413
00:16:29,320 --> 00:16:30,599
What do they wanna say?
414
00:16:30,599 --> 00:16:33,320
Sometimes a lot of this information is very public,
415
00:16:33,320 --> 00:16:34,479
so it's not gonna be hidden.
416
00:16:34,479 --> 00:16:36,520
You're gonna be able to find it very fast.
417
00:16:36,520 --> 00:16:40,919
But if, what would that mean on capacity
418
00:16:40,919 --> 00:16:43,159
and their ability to meet your demands?
419
00:16:43,159 --> 00:16:44,520
And so there's a lot of factors
420
00:16:44,520 --> 00:16:46,159
you wanna kind of work through,
421
00:16:46,159 --> 00:16:48,520
and it's not just a simple RFP
422
00:16:48,520 --> 00:16:51,239
and it's not just a simple solution
423
00:16:51,239 --> 00:16:52,400
that we can just pick somebody
424
00:16:52,400 --> 00:16:54,280
because they fit certain criteria.
425
00:16:54,280 --> 00:16:57,280
You have to have a team looking at that criteria
426
00:16:57,280 --> 00:17:00,039
and talking about it and then making the decision.
427
00:17:00,039 --> 00:17:02,799
And then ultimately that governance team structure
428
00:17:02,799 --> 00:17:04,640
that you're gonna have is gonna mean
429
00:17:04,640 --> 00:17:06,319
each month we're gonna have a review.
430
00:17:06,319 --> 00:17:07,719
What does that review look like?
431
00:17:07,719 --> 00:17:09,680
How are we looking at not just production,
432
00:17:09,680 --> 00:17:11,599
but quality, regulatory compliance?
433
00:17:11,680 --> 00:17:15,160
If they have the FDA coming in for inspections,
434
00:17:15,160 --> 00:17:16,000
what does that mean?
435
00:17:16,000 --> 00:17:17,040
It doesn't mean that it's always bad.
436
00:17:17,040 --> 00:17:19,959
The FDA comes into all these manufacturing sites
437
00:17:19,959 --> 00:17:22,040
at random times or whenever they wanna come in,
438
00:17:22,040 --> 00:17:23,839
and so you just work with people, right?
439
00:17:23,839 --> 00:17:26,000
What does that mean and what are the findings?
440
00:17:26,000 --> 00:17:28,040
What are some of these things coming up?
441
00:17:28,040 --> 00:17:29,760
So it's a communication.
442
00:17:29,760 --> 00:17:32,560
It's a give and take as people build a relationship
443
00:17:32,560 --> 00:17:34,599
that's gonna last a long time.
444
00:17:34,599 --> 00:17:35,439
Right.
445
00:17:35,439 --> 00:17:38,359
Sounds like there's a lot of different
446
00:17:38,359 --> 00:17:40,640
functional stakeholders in this
447
00:17:40,640 --> 00:17:43,880
that you need to manage and seek input from.
448
00:17:43,880 --> 00:17:46,160
I think you used the term opinion a few times there.
449
00:17:46,160 --> 00:17:47,959
Obviously there's opinions, there's data,
450
00:17:47,959 --> 00:17:50,839
there's all sorts of information.
451
00:17:50,839 --> 00:17:52,959
And does that elongate?
452
00:17:52,959 --> 00:17:55,239
To me that just sounds like, ugh,
453
00:17:55,239 --> 00:17:58,599
gonna be a longer process potentially when that's,
454
00:17:58,599 --> 00:18:01,280
but is there a way to speed things up
455
00:18:01,280 --> 00:18:02,640
if you have the right governance
456
00:18:02,640 --> 00:18:04,520
and you can get everybody around the table
457
00:18:04,520 --> 00:18:07,400
to reach a decision more quickly?
458
00:18:07,400 --> 00:18:10,319
Yeah, I mean, yeah, there's always this challenge, right?
459
00:18:10,800 --> 00:18:13,280
It's a game of capacity management.
460
00:18:13,280 --> 00:18:16,079
You can imagine you're buying capacity at the CDMO.
461
00:18:16,079 --> 00:18:18,400
They could sell it to somebody else.
462
00:18:18,400 --> 00:18:19,560
What does that look like?
463
00:18:19,560 --> 00:18:23,839
So I would say one of the things is just
464
00:18:23,839 --> 00:18:26,280
how do we start communicating quickly
465
00:18:26,280 --> 00:18:27,400
and building those relationships?
466
00:18:27,400 --> 00:18:29,439
Now over time you already have a CDMO.
467
00:18:29,439 --> 00:18:32,000
Maybe now they're in the same therapeutic area you're at.
468
00:18:32,000 --> 00:18:33,560
They're expanding their capacities.
469
00:18:33,560 --> 00:18:36,280
That's the partnership and you start to build on that
470
00:18:36,280 --> 00:18:39,040
and continue for the next drug and the next idea.
471
00:18:39,040 --> 00:18:41,359
So nothing is made purely
472
00:18:41,359 --> 00:18:43,359
in a kind of clean sheet way of doing it.
473
00:18:43,359 --> 00:18:47,400
There's a lot of kind of discussions and people know people.
474
00:18:47,400 --> 00:18:51,560
So this is rare that you find something that's really unique
475
00:18:51,560 --> 00:18:55,000
and it's rare that you're gonna get too much caught off guard
476
00:18:55,000 --> 00:18:59,760
but I do find that to speed it up, to answer your question,
477
00:18:59,760 --> 00:19:01,800
I don't know if there's a magic way of doing it
478
00:19:01,800 --> 00:19:04,920
but what it is is it's diligence on the sponsor side.
479
00:19:04,920 --> 00:19:07,959
It's the sponsor team being prepared as a team.
480
00:19:07,959 --> 00:19:10,119
So you're gonna have, like I said, quality people,
481
00:19:10,119 --> 00:19:11,319
technical ops people.
482
00:19:11,319 --> 00:19:13,959
You're gonna have people that are maybe looking
483
00:19:13,959 --> 00:19:15,880
at the clinical trials.
484
00:19:15,880 --> 00:19:17,760
You're getting input from there.
485
00:19:17,760 --> 00:19:21,079
Some of these issues around, I know that in one situation
486
00:19:21,079 --> 00:19:24,560
it was around the viscosity of the molecule, right?
487
00:19:24,560 --> 00:19:29,119
And so this was a situation where you had a parenthal
488
00:19:29,119 --> 00:19:33,560
which is an injectable type, needle type situation
489
00:19:33,560 --> 00:19:38,439
and it was a very small, like under five or 10 milliliters
490
00:19:38,439 --> 00:19:42,079
in the syringe and so there's a certain viscosity
491
00:19:42,079 --> 00:19:44,160
that they were looking at and they really had to get
492
00:19:44,160 --> 00:19:48,119
to that level of technical understanding with the CDMO
493
00:19:48,119 --> 00:19:49,719
which I thought was very important
494
00:19:49,719 --> 00:19:51,560
because if that's done the right way,
495
00:19:51,560 --> 00:19:53,520
then you can make this in mass quantities
496
00:19:53,520 --> 00:19:54,880
the way you need to do that, right?
497
00:19:54,880 --> 00:19:56,959
And so those definitely take some time
498
00:19:56,959 --> 00:19:59,199
but it's the information the sponsor's gathering.
499
00:19:59,400 --> 00:20:03,599
The sponsor is going about with their team
500
00:20:03,599 --> 00:20:07,319
to capture, document and discuss it.
501
00:20:07,319 --> 00:20:10,959
The CDMO is gonna work at the CDMO's pace.
502
00:20:10,959 --> 00:20:12,800
They're gonna try to respond very quickly
503
00:20:12,800 --> 00:20:14,839
but there's also, if you as a sponsor
504
00:20:14,839 --> 00:20:16,520
aren't capturing that information,
505
00:20:16,520 --> 00:20:19,680
the CDMO may or may not know how to respond to you.
506
00:20:19,680 --> 00:20:22,959
So I'd say it's really on the sponsor, the customer's side,
507
00:20:22,959 --> 00:20:25,040
how they go about sourcing this.
508
00:20:25,040 --> 00:20:25,880
Okay.
509
00:20:25,880 --> 00:20:29,079
The reason I ask, I know that this competitive market
510
00:20:29,839 --> 00:20:32,359
the speed to market matters in pharmaceutical.
511
00:20:32,359 --> 00:20:35,920
Sometimes there's cases such as with the COVID vaccine,
512
00:20:35,920 --> 00:20:37,640
right, that was the warp speed.
513
00:20:37,640 --> 00:20:42,640
I'm sure that had a lot of express lane type decisions
514
00:20:42,640 --> 00:20:45,760
made during that to bring that to market faster,
515
00:20:45,760 --> 00:20:47,319
to get it out faster.
516
00:20:47,319 --> 00:20:49,040
So I'm always just curious about that
517
00:20:49,040 --> 00:20:50,560
because with all these parties,
518
00:20:50,560 --> 00:20:53,280
it sounds like it can get bureaucratic.
519
00:20:53,280 --> 00:20:55,800
So I just wanna understand how you manage that.
520
00:20:55,800 --> 00:20:57,359
So thank you.
521
00:20:57,359 --> 00:20:58,199
Yep.
522
00:20:58,199 --> 00:21:01,000
Yeah, and speed is, just to follow up on that,
523
00:21:01,000 --> 00:21:02,599
is it is very important, right?
524
00:21:02,599 --> 00:21:05,520
Because if you do have a patent on your drug,
525
00:21:05,520 --> 00:21:07,280
that patent has a time period to it
526
00:21:07,280 --> 00:21:10,359
and you're trying to get it to the market
527
00:21:10,359 --> 00:21:13,680
and then you can optimize the economic value of that
528
00:21:13,680 --> 00:21:16,959
to then, again, grow your business and reinvest.
529
00:21:16,959 --> 00:21:20,760
And so if you miss those or you're delayed in production,
530
00:21:20,760 --> 00:21:22,800
so even if the clinical trials are moving along
531
00:21:22,800 --> 00:21:25,280
but there's some problems with the manufacturing of it
532
00:21:25,280 --> 00:21:27,359
or regulatory of the CDMO
533
00:21:27,359 --> 00:21:30,400
where they're failing some FDA issues, which are serious,
534
00:21:30,400 --> 00:21:32,119
then you've got a whole nother delay
535
00:21:32,119 --> 00:21:33,560
that just is extremely costly.
536
00:21:33,560 --> 00:21:35,520
So these relationships are strategic
537
00:21:35,520 --> 00:21:37,560
for these companies' survivals,
538
00:21:37,560 --> 00:21:39,000
whether they're emerging
539
00:21:39,000 --> 00:21:41,199
or they're even established companies.
540
00:21:41,199 --> 00:21:43,239
I mean, when you have a large pharmaceutical company
541
00:21:43,239 --> 00:21:45,040
that may outsource some of this,
542
00:21:45,040 --> 00:21:48,079
they stumble on, if the CDMO stumbles for whatever reason,
543
00:21:48,079 --> 00:21:49,640
that can definitely impact
544
00:21:49,640 --> 00:21:53,400
the large pharma's finances extremely adversely.
545
00:21:53,680 --> 00:21:55,640
Okay, well, about the markets.
546
00:21:55,640 --> 00:21:58,880
So as you look at each one of these areas,
547
00:21:58,880 --> 00:22:01,719
I'll separate it again into the categories we discussed,
548
00:22:01,719 --> 00:22:05,959
which is manufacturing, materials, including packaging,
549
00:22:05,959 --> 00:22:07,800
and logistics.
550
00:22:07,800 --> 00:22:10,119
What are the characteristics of those markets
551
00:22:10,119 --> 00:22:13,239
that people may need to be aware of
552
00:22:13,239 --> 00:22:17,000
and think about as they start looking for suppliers
553
00:22:17,000 --> 00:22:18,680
or evaluating suppliers
554
00:22:18,680 --> 00:22:20,520
that would be part of this value chain?
555
00:22:20,560 --> 00:22:22,199
Sure, so, of course,
556
00:22:24,199 --> 00:22:27,599
if you take a look at the key starting materials,
557
00:22:27,599 --> 00:22:29,199
the chemicals that are going on,
558
00:22:29,199 --> 00:22:31,880
that's really a global marketplace.
559
00:22:31,880 --> 00:22:35,599
So you need to understand what those are.
560
00:22:35,599 --> 00:22:38,239
There is a lot of issues today with tariffs
561
00:22:38,239 --> 00:22:41,800
and discussions about the origination source
562
00:22:41,800 --> 00:22:43,760
of the material and how it goes
563
00:22:43,760 --> 00:22:47,479
through the overall supply chain, global supply chain.
564
00:22:47,479 --> 00:22:50,079
So you could have a situation where things are made in China
565
00:22:50,079 --> 00:22:52,280
and then they ship them to Europe,
566
00:22:52,280 --> 00:22:55,599
like I said, for API manufacturing,
567
00:22:55,599 --> 00:22:57,119
and then they can come over to the U.S.
568
00:22:57,119 --> 00:22:58,680
for the fill and finish, you know,
569
00:22:58,680 --> 00:23:02,400
and putting them in the final primary packaging materials
570
00:23:02,400 --> 00:23:04,280
and then secondary as you ship them out
571
00:23:04,280 --> 00:23:07,000
to wherever they're going, to the hospital or the provider
572
00:23:07,000 --> 00:23:09,599
or they're going to an over-the-counter situation
573
00:23:09,599 --> 00:23:11,560
or a pharmacist, whatever that might be.
574
00:23:11,560 --> 00:23:13,640
So there's all those needs to think about.
575
00:23:13,640 --> 00:23:16,560
But I guess to answer your question is if you're gonna,
576
00:23:16,560 --> 00:23:17,760
they do break that down.
577
00:23:17,760 --> 00:23:19,560
I mean, obviously the packaging market
578
00:23:19,560 --> 00:23:21,959
runs at a different type of, you know, supply and demand
579
00:23:21,959 --> 00:23:24,520
than the raw chemicals are doing it.
580
00:23:24,520 --> 00:23:27,359
And, you know, depending on your relationship
581
00:23:27,359 --> 00:23:29,599
and the decisions you make,
582
00:23:29,599 --> 00:23:31,800
the CDMO may be able to have some of that
583
00:23:31,800 --> 00:23:33,520
already in their operations.
584
00:23:33,520 --> 00:23:35,520
And so they may run a lot of that,
585
00:23:35,520 --> 00:23:39,560
those steps underneath, so to speak, one organization,
586
00:23:39,560 --> 00:23:42,280
but there could still be steps within that organization
587
00:23:42,280 --> 00:23:44,599
that you have to manage and monitor.
588
00:23:44,599 --> 00:23:46,800
A lot of that is just also within there
589
00:23:46,800 --> 00:23:48,920
as there's a lot of that regulatory that I wanna say.
590
00:23:49,040 --> 00:23:52,199
Each one of those steps is gonna have regulatory oversight
591
00:23:52,199 --> 00:23:57,199
that needs to track a master file of the material,
592
00:23:57,839 --> 00:23:59,400
the batch coming through.
593
00:23:59,400 --> 00:24:01,119
And what's the quality management system?
594
00:24:01,119 --> 00:24:03,280
How is it tracking all that information
595
00:24:03,280 --> 00:24:06,280
to make sure that what you're buying
596
00:24:06,280 --> 00:24:08,599
at each step of the way is in compliance?
597
00:24:08,599 --> 00:24:11,239
And if there's an issue, you can address it.
598
00:24:11,239 --> 00:24:13,439
And again, when you go to more of an integrated,
599
00:24:13,439 --> 00:24:17,319
you know, CDMO, it's much more able to manage a lot of that.
600
00:24:17,359 --> 00:24:19,479
You can maybe work with them much easier,
601
00:24:19,479 --> 00:24:21,040
but sometimes you can't do that.
602
00:24:21,040 --> 00:24:24,760
You have to pick along the lines and buy things
603
00:24:24,760 --> 00:24:26,520
or work with the end CDMO,
604
00:24:26,520 --> 00:24:27,599
but you're kind of coordinating
605
00:24:27,599 --> 00:24:29,439
across that whole supply chain.
606
00:24:29,439 --> 00:24:31,479
So that's very important to think about.
607
00:24:31,479 --> 00:24:34,400
So what's driving each one of those markets?
608
00:24:34,400 --> 00:24:38,040
How are things like geopolitical and tariffs impacting
609
00:24:38,040 --> 00:24:39,839
the ability to do that?
610
00:24:39,839 --> 00:24:41,800
You're seeing in the U.S. right now,
611
00:24:41,800 --> 00:24:44,760
a big debate, but a big push for onshoring.
612
00:24:44,760 --> 00:24:46,640
So there is a lot of effort.
613
00:24:46,640 --> 00:24:49,400
Some of the extremely large branded pharmaceutical companies
614
00:24:49,400 --> 00:24:52,599
have made multi-billion dollar commitments
615
00:24:52,599 --> 00:24:54,079
to building in the U.S.
616
00:24:54,079 --> 00:24:56,079
So now they're in a different situation.
617
00:24:56,079 --> 00:24:58,719
Lilly or, you know, Merck and Pfizer,
618
00:24:58,719 --> 00:25:00,319
they have the ability to really kind of
619
00:25:00,319 --> 00:25:02,479
have that capital to do that.
620
00:25:02,479 --> 00:25:06,599
But most drugs are going to be in a situation
621
00:25:06,599 --> 00:25:09,479
where they might be more in an emerging situation
622
00:25:09,479 --> 00:25:11,880
and maybe Lilly or the big pharma
623
00:25:11,880 --> 00:25:13,640
are not yet interested in buying them.
624
00:25:13,640 --> 00:25:14,599
So they're gonna have to think
625
00:25:14,599 --> 00:25:16,079
through their own manufacturing
626
00:25:16,079 --> 00:25:18,800
and really build that out and scale that up.
627
00:25:18,800 --> 00:25:20,640
And so it's not always an easy thing
628
00:25:20,640 --> 00:25:22,119
that for some of these companies
629
00:25:22,119 --> 00:25:23,319
that are doing drug development
630
00:25:23,319 --> 00:25:24,959
to think that a big company might buy them
631
00:25:24,959 --> 00:25:26,599
and their manufacturing problems
632
00:25:26,599 --> 00:25:28,680
and supply chain problems be solved by somebody else.
633
00:25:28,680 --> 00:25:30,560
It's got to really be thought through.
634
00:25:30,560 --> 00:25:31,839
And I think that's also the value
635
00:25:31,839 --> 00:25:33,520
that any company would bring,
636
00:25:33,520 --> 00:25:35,280
potentially if they want to be acquired,
637
00:25:35,280 --> 00:25:37,959
which is what happens a lot in this industry.
638
00:25:37,959 --> 00:25:39,599
But they have to show that they have
639
00:25:39,599 --> 00:25:42,839
an extremely robust supply chain to make the drug.
640
00:25:42,839 --> 00:25:45,920
And then, you know, big pharma can usually find ways
641
00:25:46,760 --> 00:25:48,079
to expand that market potential
642
00:25:48,079 --> 00:25:50,160
and grow the sales of it once it's there.
643
00:25:50,160 --> 00:25:52,199
But that whole process,
644
00:25:52,199 --> 00:25:54,319
you need to really work with a partner in CDMO
645
00:25:54,319 --> 00:25:57,640
or, you know, understand that marketplace deeply.
646
00:25:57,640 --> 00:25:58,479
Gotcha.
647
00:25:58,479 --> 00:26:00,160
Okay, let's talk about a subject
648
00:26:00,160 --> 00:26:02,599
that it seems like it comes up all the time.
649
00:26:02,599 --> 00:26:04,959
I just had another podcast about risk.
650
00:26:04,959 --> 00:26:07,880
But how do you manage the supply chain risk?
651
00:26:07,880 --> 00:26:10,479
These are, as you mentioned, global raw materials.
652
00:26:10,479 --> 00:26:12,800
I think you said 30 some odd percent
653
00:26:12,800 --> 00:26:14,920
generally is coming out of China, right?
654
00:26:14,920 --> 00:26:18,640
You've got, you know, different supply chains here.
655
00:26:18,640 --> 00:26:21,040
You have packaging coming in a whole different way.
656
00:26:21,040 --> 00:26:24,199
That's a whole different chain than the raw materials are.
657
00:26:24,199 --> 00:26:27,479
And how do you put all that together
658
00:26:27,479 --> 00:26:31,479
in a way that, you know, mitigates any risk
659
00:26:31,479 --> 00:26:34,359
or manages at least the risk to an acceptable level?
660
00:26:34,359 --> 00:26:37,719
Is there alternate sources of supply?
661
00:26:37,719 --> 00:26:38,560
I mean, some of these,
662
00:26:38,560 --> 00:26:41,199
I assume some of these chemicals are pretty specific
663
00:26:41,199 --> 00:26:43,160
and there's not like, you know,
664
00:26:43,160 --> 00:26:46,680
that many suppliers you can provide, especially the actives.
665
00:26:46,680 --> 00:26:48,359
But maybe I'm wrong.
666
00:26:48,359 --> 00:26:50,839
Tell me, how do you manage risk among this,
667
00:26:50,839 --> 00:26:52,560
in this supply chain?
668
00:26:52,560 --> 00:26:55,000
So, yeah, and they're very important.
669
00:26:55,000 --> 00:26:57,400
And I think there's a lot of discussion
670
00:26:57,400 --> 00:27:00,560
about what they call China plus one in the marketplace.
671
00:27:00,560 --> 00:27:03,599
And so, yes, 37% of the key starting materials
672
00:27:03,599 --> 00:27:05,680
are coming roughly from China.
673
00:27:05,680 --> 00:27:08,800
Some of the, you know, a lot of licensing deals
674
00:27:08,800 --> 00:27:11,760
are coming out of China, so the actual molecule.
675
00:27:11,760 --> 00:27:15,040
But there is something about how do you look at things
676
00:27:15,040 --> 00:27:17,560
in terms of alternates?
677
00:27:17,560 --> 00:27:19,400
It's time consuming, it's costly,
678
00:27:19,400 --> 00:27:21,400
but today's day and age, you need to look at it.
679
00:27:21,400 --> 00:27:24,959
And that doesn't mean you always have multiple agreements
680
00:27:24,959 --> 00:27:26,839
for sourcing, but you have to understand
681
00:27:26,839 --> 00:27:28,560
what those options are.
682
00:27:28,560 --> 00:27:32,000
And so looking at the capacity of these CDMOs,
683
00:27:32,000 --> 00:27:35,319
looking at the growth and the capital expenditures
684
00:27:35,319 --> 00:27:38,680
that the large CDMOs are making in the marketplace,
685
00:27:38,680 --> 00:27:39,640
what does that mean?
686
00:27:39,640 --> 00:27:41,599
And so that's one area.
687
00:27:42,439 --> 00:27:43,719
The second area of understanding this
688
00:27:43,719 --> 00:27:46,199
is much more regulatory oriented.
689
00:27:46,199 --> 00:27:49,280
You need to be on top of this issue of any time
690
00:27:49,280 --> 00:27:52,239
the FDA or a potential supplier
691
00:27:52,239 --> 00:27:56,079
is maybe had issues with a 483 finding
692
00:27:56,079 --> 00:27:59,040
or anything out there that seems to indicate
693
00:27:59,040 --> 00:28:02,079
that they might be challenged at meeting
694
00:28:02,079 --> 00:28:04,640
and getting approved to make things
695
00:28:04,640 --> 00:28:07,880
from a regulatory perspective in their own facility.
696
00:28:07,880 --> 00:28:11,400
So those are areas that you wanna monitor.
697
00:28:12,079 --> 00:28:13,800
So I would say you've got the basic kinda,
698
00:28:13,800 --> 00:28:15,479
what's the global market doing?
699
00:28:15,479 --> 00:28:17,079
What's then at the regulatory level?
700
00:28:17,079 --> 00:28:18,280
And that's also global too.
701
00:28:18,280 --> 00:28:20,400
So the FDA, if you're buying something out of China
702
00:28:20,400 --> 00:28:23,199
to come into the US, the FDA is gonna be looking at that.
703
00:28:23,199 --> 00:28:24,719
But you know, you got China, you have India,
704
00:28:24,719 --> 00:28:26,439
you have a global marketplace.
705
00:28:26,439 --> 00:28:28,760
So I think that's a very important thing.
706
00:28:28,760 --> 00:28:31,920
The other aspect about risk is the longer,
707
00:28:31,920 --> 00:28:34,000
we all know there's the longer supply chain is,
708
00:28:34,000 --> 00:28:36,599
the chance of more risk is in there, right?
709
00:28:36,599 --> 00:28:39,760
So if you have a facility in North Carolina
710
00:28:39,760 --> 00:28:42,119
that makes predominantly everything you're looking for,
711
00:28:42,119 --> 00:28:44,959
that's one way to look at a simplified risk.
712
00:28:44,959 --> 00:28:46,520
But if now it's coming across three
713
00:28:46,520 --> 00:28:48,920
or four different countries to get into the US,
714
00:28:49,959 --> 00:28:50,959
that's another area.
715
00:28:50,959 --> 00:28:54,079
So now we've got to start to look at the whole logistics
716
00:28:54,079 --> 00:28:57,959
and the important export issues and transportation costs
717
00:28:57,959 --> 00:28:59,520
and disruptions from that.
718
00:28:59,520 --> 00:29:01,959
And again, what's your mode of transportation?
719
00:29:01,959 --> 00:29:04,199
Once you start getting into more of a finished product,
720
00:29:04,199 --> 00:29:07,040
the transportation is no longer some, you know,
721
00:29:07,040 --> 00:29:10,599
bulk shipments, it's now much more individual shipments.
722
00:29:10,599 --> 00:29:12,520
So that plays a different role
723
00:29:12,520 --> 00:29:14,479
in how people should be looking at risk.
724
00:29:14,479 --> 00:29:17,400
So I think you got to maybe just summarize it.
725
00:29:17,400 --> 00:29:20,560
It's the raw material global market area,
726
00:29:20,560 --> 00:29:22,760
it's the regulatory compliance,
727
00:29:22,760 --> 00:29:24,520
and it's gonna be this kind of how long
728
00:29:24,520 --> 00:29:27,319
is your general supply chain and what does that make sense?
729
00:29:27,319 --> 00:29:29,560
And I feel like we're all coming,
730
00:29:29,560 --> 00:29:31,000
regardless if we're in the pharma industry
731
00:29:31,000 --> 00:29:32,680
or other industries to a realization
732
00:29:32,680 --> 00:29:34,560
that we should be careful that we have,
733
00:29:34,560 --> 00:29:36,839
if we have just a very long supply chain,
734
00:29:36,839 --> 00:29:39,680
because we think the costs are all gonna be lower,
735
00:29:39,680 --> 00:29:41,640
that could be dangerous in terms of the risk.
736
00:29:41,640 --> 00:29:43,359
And I think people are looking at near shoring,
737
00:29:43,359 --> 00:29:47,040
on shoring or shortening that supply chain.
738
00:29:47,040 --> 00:29:48,439
Right.
739
00:29:48,439 --> 00:29:51,880
Yeah, I think there's in Pennsylvania where I live,
740
00:29:51,880 --> 00:29:54,400
there's been a couple manufacturing plants announced
741
00:29:54,400 --> 00:29:57,719
by some of those large branded pharmaceutical giants
742
00:29:57,719 --> 00:29:59,040
that you mentioned.
743
00:29:59,040 --> 00:30:00,599
And I think that's precisely it.
744
00:30:00,599 --> 00:30:02,439
There's a bit of a made in America,
745
00:30:02,439 --> 00:30:04,800
bring back manufacturing here.
746
00:30:05,319 --> 00:30:07,719
And I also think it is a big mitigation
747
00:30:07,719 --> 00:30:10,119
against a longer supply chain
748
00:30:10,119 --> 00:30:12,839
and the risk that that introduces.
749
00:30:12,839 --> 00:30:15,199
Not to mention, depending on ownership, right,
750
00:30:15,199 --> 00:30:16,959
there's a lot of working capital tied up
751
00:30:16,959 --> 00:30:20,239
in a longer supply chain based on who owns it,
752
00:30:20,239 --> 00:30:23,040
at what point in that supply chain.
753
00:30:23,040 --> 00:30:26,800
So very interesting to see companies sort of position
754
00:30:26,800 --> 00:30:28,800
a bit more manufacturing in the US.
755
00:30:28,800 --> 00:30:30,880
I found that quite interesting.
756
00:30:30,880 --> 00:30:35,880
But, you know, there seems to be damn good reasons for it.
757
00:30:36,520 --> 00:30:38,839
Yeah, and maybe I would like to add a few things here
758
00:30:38,839 --> 00:30:39,839
that's starting to evolve.
759
00:30:39,839 --> 00:30:42,880
This is a bit more future oriented thought
760
00:30:42,880 --> 00:30:45,439
on US manufacturing is that,
761
00:30:45,439 --> 00:30:47,959
not only do we just talk about the supply chain risks
762
00:30:47,959 --> 00:30:49,319
and if you could on-shore things,
763
00:30:49,319 --> 00:30:50,920
but there's another thing that goes on,
764
00:30:50,920 --> 00:30:53,680
which is the green manufacturing, if you will.
765
00:30:53,680 --> 00:30:56,359
The issues of how these chemicals are made
766
00:30:56,359 --> 00:31:00,400
traditionally can be very adverse to the environment.
767
00:31:00,400 --> 00:31:02,319
And there's a lot of good research going on
768
00:31:02,319 --> 00:31:05,479
into the actual, we'll call it green manufacturing areas,
769
00:31:05,479 --> 00:31:07,239
which is good on the chemistry side.
770
00:31:07,239 --> 00:31:09,040
So we got to remember, we start with the molecule.
771
00:31:09,040 --> 00:31:12,479
We don't start with, you know, say steel, like for a car.
772
00:31:12,479 --> 00:31:15,560
But what I'm getting at is that molecule is very important.
773
00:31:15,560 --> 00:31:19,599
The second piece of this is the transition
774
00:31:19,599 --> 00:31:22,520
that's going on over time to more
775
00:31:22,520 --> 00:31:24,400
from a batch production perspective
776
00:31:24,400 --> 00:31:26,760
to continuous flow manufacturing.
777
00:31:26,760 --> 00:31:28,280
And there's been a lot of good research.
778
00:31:28,280 --> 00:31:30,439
There are companies that are specializing
779
00:31:30,439 --> 00:31:33,079
more and more into flow manufacturing.
780
00:31:33,079 --> 00:31:36,000
As we all know, kind of the batch gives the ability
781
00:31:36,000 --> 00:31:38,400
for quality control to be managed.
782
00:31:38,400 --> 00:31:41,400
So if there's an adverse event in the marketplace,
783
00:31:41,400 --> 00:31:43,040
then we can go back to the batch
784
00:31:43,040 --> 00:31:44,640
and we can figure out that we had an issue.
785
00:31:44,640 --> 00:31:47,319
We can pull that batch out of market.
786
00:31:47,319 --> 00:31:48,520
But in the continuous flow,
787
00:31:48,520 --> 00:31:51,400
that means that quality management systems need to evolve.
788
00:31:51,400 --> 00:31:53,920
How we look at, how we sample, how we manage that,
789
00:31:53,920 --> 00:31:55,199
working with FDA compliance
790
00:31:55,199 --> 00:31:56,680
for good manufacturing principles,
791
00:31:56,680 --> 00:31:58,560
all those need to be kind of worked through.
792
00:31:58,560 --> 00:32:02,880
Those are all things that are, in a good way, moving along,
793
00:32:02,880 --> 00:32:05,359
and a lot of support from the FDA too.
794
00:32:05,359 --> 00:32:08,400
So this is like a lot of research going on
795
00:32:08,400 --> 00:32:11,800
and efforts with kind of collaborations with the FDA
796
00:32:11,800 --> 00:32:14,079
to try to figure out how to make it,
797
00:32:14,079 --> 00:32:16,160
let's just call it a lower cost perspective.
798
00:32:16,160 --> 00:32:19,800
And maybe what had happened in the last 25, 35 years,
799
00:32:19,800 --> 00:32:21,719
people started looking at offshoring
800
00:32:21,719 --> 00:32:24,199
because they could think about labor costs,
801
00:32:24,199 --> 00:32:25,959
but environmental costs differently.
802
00:32:25,959 --> 00:32:27,760
Now we bring it back onshore.
803
00:32:27,760 --> 00:32:29,479
We still want to have good wages
804
00:32:29,479 --> 00:32:30,760
and we want to have good environment.
805
00:32:30,760 --> 00:32:32,880
And so those are things that are very important.
806
00:32:32,880 --> 00:32:35,719
And then also responsiveness in a supply chain environment
807
00:32:35,719 --> 00:32:38,599
when you can have more of continuous flow versus batch,
808
00:32:38,599 --> 00:32:39,920
that's always benefits there.
809
00:32:39,920 --> 00:32:42,000
So those are evolutions, I think, Greg,
810
00:32:42,000 --> 00:32:43,000
that are going to take place.
811
00:32:43,000 --> 00:32:45,760
And I'm very optimistic that that can also help
812
00:32:45,760 --> 00:32:49,400
with us calling this still a good economic value
813
00:32:49,400 --> 00:32:50,880
to reshore here in the U.S.,
814
00:32:50,880 --> 00:32:54,359
not just because of tariffs or something like that.
815
00:32:54,359 --> 00:32:59,359
It's interesting about the shift from batch to continuous
816
00:32:59,479 --> 00:33:02,959
and sort of, I think about how do you control that
817
00:33:02,959 --> 00:33:04,599
if there is an issue, right?
818
00:33:04,599 --> 00:33:08,079
I assume everything's still getting time date stamped, right?
819
00:33:08,079 --> 00:33:10,479
So that we know the production window.
820
00:33:10,479 --> 00:33:12,199
Serialization is huge, yeah.
821
00:33:12,199 --> 00:33:14,040
Serialization, right.
822
00:33:14,040 --> 00:33:15,439
So that it can be traced back,
823
00:33:15,439 --> 00:33:17,880
but we see that in, you know,
824
00:33:17,880 --> 00:33:20,880
I have a client who's in the food and beverage business
825
00:33:20,880 --> 00:33:23,680
making beverages and they make batches,
826
00:33:23,680 --> 00:33:26,439
but then those go into tanks and then it runs through,
827
00:33:26,439 --> 00:33:28,119
but everything is stamped,
828
00:33:28,119 --> 00:33:29,920
where it was made, when it was made,
829
00:33:29,920 --> 00:33:33,000
what time it was basically bottled, right?
830
00:33:33,000 --> 00:33:35,880
Very clearly so that they can control any escapes,
831
00:33:35,880 --> 00:33:36,839
if you will.
832
00:33:36,839 --> 00:33:39,160
So I guess the same principles would apply,
833
00:33:39,160 --> 00:33:41,719
but certainly that would be from a,
834
00:33:41,719 --> 00:33:43,319
if I put on my manufacturing hat,
835
00:33:43,319 --> 00:33:46,000
that would be a much efficient operation
836
00:33:46,000 --> 00:33:48,719
to run it in a continuous flow versus batch.
837
00:33:48,719 --> 00:33:50,839
And it would be,
838
00:33:50,839 --> 00:33:54,319
maybe that's one way we bring down drug prices, right?
839
00:33:54,319 --> 00:33:56,760
Right, because you gotta be able to manufacture it
840
00:33:56,760 --> 00:33:58,599
at a reasonable cost.
841
00:33:58,599 --> 00:34:01,560
Right, and I think that is also where you can start
842
00:34:01,560 --> 00:34:03,560
to balance risk and cost, right?
843
00:34:03,560 --> 00:34:06,920
I mean, we maybe went offshore for costs,
844
00:34:06,920 --> 00:34:08,560
but now we see the risks there.
845
00:34:08,560 --> 00:34:09,399
Right.
846
00:34:09,399 --> 00:34:10,639
Bring it back onshore,
847
00:34:10,639 --> 00:34:14,120
people might think inherently there's a higher cost,
848
00:34:14,120 --> 00:34:16,840
but I think the beauty of continuous improvement,
849
00:34:16,840 --> 00:34:20,560
the beauty of innovation and collaboration with people
850
00:34:20,560 --> 00:34:22,320
is we can find ways to take the,
851
00:34:22,320 --> 00:34:25,800
we'll call it the waste out, but do it in the right way.
852
00:34:25,800 --> 00:34:27,760
And those are really some exciting things
853
00:34:27,760 --> 00:34:28,760
that are going on.
854
00:34:29,719 --> 00:34:33,040
Regardless of maybe the geopolitical concerns,
855
00:34:33,040 --> 00:34:35,360
I think the market, the pharma market,
856
00:34:35,360 --> 00:34:37,959
needs to have more of this thought process
857
00:34:37,959 --> 00:34:40,239
on the making of the drug in that kind of,
858
00:34:40,239 --> 00:34:43,280
we'll call it the green continuous flow of manufacturing
859
00:34:43,280 --> 00:34:46,800
and maybe closer to a point of sale to do that.
860
00:34:46,800 --> 00:34:48,840
Now, again, there's a lot of variables
861
00:34:48,840 --> 00:34:50,320
when we go down to specific cases
862
00:34:51,080 --> 00:34:53,159
and specific businesses and specific drugs,
863
00:34:53,159 --> 00:34:55,479
but that's the concepts that are going forward.
864
00:34:55,479 --> 00:34:59,600
And so there's a really strong industry look
865
00:34:59,600 --> 00:35:01,760
at trying to do that type of solution there.
866
00:35:01,760 --> 00:35:04,840
Sure, makes a lot of sense.
867
00:35:04,840 --> 00:35:07,560
So what else is coming in the future?
868
00:35:07,560 --> 00:35:10,840
Any other sort of predictions or projections
869
00:35:10,840 --> 00:35:12,679
based on trends you're seeing out there?
870
00:35:12,679 --> 00:35:17,679
Well, so as we go, the biologics marketplace is growing.
871
00:35:18,679 --> 00:35:22,320
There is in the therapeutic thought process
872
00:35:22,320 --> 00:35:24,600
of how they look at cancer treatments
873
00:35:24,600 --> 00:35:28,360
or other areas of these applications,
874
00:35:28,360 --> 00:35:33,360
weight loss, diabetes, those are huge growth areas,
875
00:35:33,560 --> 00:35:36,439
potential and existing growth volume.
876
00:35:36,439 --> 00:35:40,040
And also you see some of these aspects of growth,
877
00:35:40,040 --> 00:35:42,800
not just in the U.S. market, but globally.
878
00:35:42,800 --> 00:35:46,439
And I feel that we all know that diseases
879
00:35:46,959 --> 00:35:49,040
don't just stop at the border, they go globally.
880
00:35:49,040 --> 00:35:50,879
And so how do you service that?
881
00:35:50,879 --> 00:35:55,719
And so maybe a commentary like on treatment of diseases
882
00:35:55,719 --> 00:35:57,879
in Sub-Saharan Africa or something like that.
883
00:35:57,879 --> 00:35:59,639
And we talk about logistics.
884
00:35:59,639 --> 00:36:00,479
You know, there's companies
885
00:36:00,479 --> 00:36:03,959
that make certain packaging materials
886
00:36:03,959 --> 00:36:05,360
where if the temperature,
887
00:36:05,360 --> 00:36:07,639
they're shipping a vaccine in cold chain
888
00:36:07,639 --> 00:36:10,760
in a certain defined temperature parameter.
889
00:36:10,760 --> 00:36:13,120
If it goes out of that, they get a visual warning
890
00:36:13,120 --> 00:36:15,639
and then they can pull that batch off.
891
00:36:15,679 --> 00:36:17,399
So you see like innovations like that,
892
00:36:17,399 --> 00:36:20,120
again, trying to ship it to long distances,
893
00:36:20,120 --> 00:36:21,560
get it to those point of care.
894
00:36:21,560 --> 00:36:23,199
So on a global basis,
895
00:36:23,199 --> 00:36:24,399
we're not just thinking about the U.S.,
896
00:36:24,399 --> 00:36:27,439
but we're thinking about how we service human health
897
00:36:27,439 --> 00:36:28,919
across the globes.
898
00:36:28,919 --> 00:36:30,879
I think those are very nice, innovative.
899
00:36:30,879 --> 00:36:33,040
I mean, some of that's been around the market a long time,
900
00:36:33,040 --> 00:36:35,679
but it's also how it continues to evolve.
901
00:36:35,679 --> 00:36:38,439
And then more with thinking of the point of care,
902
00:36:38,439 --> 00:36:41,320
what does that point of care look like
903
00:36:41,320 --> 00:36:44,320
to helping people with their health, wherever they might be?
904
00:36:44,320 --> 00:36:47,000
So many things are kind of evolving
905
00:36:47,000 --> 00:36:48,800
and that's the exciting part of this whole industry
906
00:36:48,800 --> 00:36:50,639
is that we're not just talking about,
907
00:36:50,639 --> 00:36:52,360
I have cancer and I want to treat that,
908
00:36:52,360 --> 00:36:54,239
or I have diabetes and I want to treat that.
909
00:36:54,239 --> 00:36:56,840
We're talking about how do we help people flourish?
910
00:36:56,840 --> 00:36:58,520
Kind of back to some of our conversations
911
00:36:58,520 --> 00:36:59,639
from the first podcast,
912
00:36:59,639 --> 00:37:02,840
we were talking about the innovation of drug development.
913
00:37:02,840 --> 00:37:05,159
Now, maybe a good way to summarize this
914
00:37:05,159 --> 00:37:07,080
is how do we think about a supply chain
915
00:37:07,080 --> 00:37:09,159
to the point of care, right?
916
00:37:09,159 --> 00:37:11,080
And that's where the physician and the patient
917
00:37:11,080 --> 00:37:13,199
and the hospital and the clinician,
918
00:37:13,199 --> 00:37:15,639
those people are at in Africa, like I said,
919
00:37:15,639 --> 00:37:17,080
Latin America, Asia,
920
00:37:17,080 --> 00:37:19,000
wherever it might be to servicing them.
921
00:37:19,000 --> 00:37:20,639
So I think those are some exciting things
922
00:37:20,639 --> 00:37:22,719
that are going on, which then gives us opportunity
923
00:37:22,719 --> 00:37:25,439
why you see the growth in the CDMO marketplace
924
00:37:25,439 --> 00:37:28,959
going at an eight to 12% compound annual growth rate
925
00:37:28,959 --> 00:37:31,080
is that there is opportunity to continue to grow.
926
00:37:31,080 --> 00:37:31,919
Okay.
927
00:37:31,919 --> 00:37:35,239
In one sense, and call me an idiot if I'm being one,
928
00:37:36,199 --> 00:37:40,879
I see it's almost as though this manufacturing process
929
00:37:41,679 --> 00:37:44,719
and everything is moving more toward a consumer product,
930
00:37:44,719 --> 00:37:45,560
right?
931
00:37:45,560 --> 00:37:47,120
Maybe taking on some of the best practices
932
00:37:47,120 --> 00:37:48,479
that consumer products go through,
933
00:37:48,479 --> 00:37:51,679
continuous manufacturing being an example,
934
00:37:51,679 --> 00:37:54,840
but putting it closer to the point of use, right?
935
00:37:54,840 --> 00:37:57,560
So that the logistics costs are less
936
00:37:57,560 --> 00:38:00,000
and you just have a less expensive way
937
00:38:00,000 --> 00:38:02,840
to get product to the customer.
938
00:38:02,840 --> 00:38:05,040
I look at the patient as the customer here
939
00:38:05,040 --> 00:38:08,320
and it seems like some of the trends you're talking about,
940
00:38:08,800 --> 00:38:11,760
it's still heavily regulated.
941
00:38:11,760 --> 00:38:16,120
We're not gonna dismiss risk completely here,
942
00:38:16,120 --> 00:38:20,239
but manage that risk and make it look a bit more
943
00:38:20,239 --> 00:38:23,120
like a consumer products company.
944
00:38:23,120 --> 00:38:25,320
The lines maybe would blur a little bit
945
00:38:25,320 --> 00:38:26,679
maybe between a pharma company
946
00:38:26,679 --> 00:38:28,560
and a consumer products company.
947
00:38:28,560 --> 00:38:30,040
I know that's a big leap,
948
00:38:30,040 --> 00:38:33,040
but at least it sounds like some areas
949
00:38:33,040 --> 00:38:36,280
can be looked at that way and improve that way.
950
00:38:36,280 --> 00:38:38,879
Yeah, well, you get to some things like generics, right?
951
00:38:38,879 --> 00:38:40,919
So generics are low cost, right?
952
00:38:40,919 --> 00:38:42,719
Because there's no more patent protection on it,
953
00:38:42,719 --> 00:38:43,919
it's not a branded.
954
00:38:43,919 --> 00:38:46,879
And the other thing too is I think roughly 90%
955
00:38:46,879 --> 00:38:50,320
of at least the US market consumption of some drugs
956
00:38:50,320 --> 00:38:51,679
is generic drugs, right?
957
00:38:51,679 --> 00:38:53,479
So the cost needs to be lower.
958
00:38:53,479 --> 00:38:57,080
And the other aspect about this maybe is to say
959
00:38:57,080 --> 00:38:58,639
that the economics sometimes,
960
00:38:58,639 --> 00:39:00,479
if you don't take the core cost lower,
961
00:39:00,479 --> 00:39:03,560
like we just talked about with continuous flow manufacturing
962
00:39:03,719 --> 00:39:06,399
and certain collaborations with the FDA
963
00:39:06,399 --> 00:39:07,879
on your quality management systems
964
00:39:07,879 --> 00:39:11,040
for managing and tracking the drug itself
965
00:39:11,040 --> 00:39:13,719
when it's in the market to track all that stuff,
966
00:39:13,719 --> 00:39:15,879
concern could be that the costs are still high.
967
00:39:15,879 --> 00:39:17,639
If the costs are still high and you have a generic
968
00:39:17,639 --> 00:39:18,800
where the prices are low,
969
00:39:18,800 --> 00:39:21,479
you're gonna see manufacturers exit the market.
970
00:39:21,479 --> 00:39:24,280
That's also another thing where most people are trying,
971
00:39:24,280 --> 00:39:27,080
especially as they age, they're starting to take statins
972
00:39:27,080 --> 00:39:29,159
or whatever it might be for their health.
973
00:39:29,159 --> 00:39:32,280
And those are typically a little bit more generic oriented.
974
00:39:32,280 --> 00:39:34,280
And so that could be a big concern.
975
00:39:34,280 --> 00:39:36,800
So we need to keep the costs coming down,
976
00:39:36,800 --> 00:39:38,399
but in a smart way of doing that.
977
00:39:38,399 --> 00:39:40,560
And you use the kind of consumer model,
978
00:39:40,560 --> 00:39:42,719
the consumer package goods, so to speak,
979
00:39:42,719 --> 00:39:43,879
whether it be a soft drink
980
00:39:43,879 --> 00:39:46,760
or whatever it might be, bottled water,
981
00:39:46,760 --> 00:39:48,800
those are still consumed by the human person,
982
00:39:48,800 --> 00:39:50,639
but they're consumed differently.
983
00:39:50,639 --> 00:39:53,159
And a drug obviously has a very specific application.
984
00:39:53,159 --> 00:39:55,199
You want, in many situations,
985
00:39:55,199 --> 00:39:56,399
they're not always over the counter.
986
00:39:56,399 --> 00:39:58,159
They're done by prescription for a reason
987
00:39:58,159 --> 00:39:59,800
so that the physician, the clinician,
988
00:39:59,800 --> 00:40:01,439
he or she can work with the patient
989
00:40:01,439 --> 00:40:03,439
to get the right prescription.
990
00:40:03,439 --> 00:40:06,280
So all those play into the point of care
991
00:40:06,280 --> 00:40:08,199
and where's that point of care and what does that look like?
992
00:40:08,199 --> 00:40:10,479
But if you can think about,
993
00:40:10,479 --> 00:40:14,000
how do we start to really look at cost structures
994
00:40:14,000 --> 00:40:17,199
and look at more partnerships with manufacturers,
995
00:40:17,199 --> 00:40:20,639
contract manufacturers, how do we then take that cost
996
00:40:20,639 --> 00:40:23,479
so that it is competitive and it can be for generics
997
00:40:23,479 --> 00:40:25,560
as well as branded pharmaceuticals?
998
00:40:25,560 --> 00:40:27,120
And that's, I think, where some of the debate
999
00:40:27,120 --> 00:40:29,080
is kind of going on there is how can we do that?
1000
00:40:29,120 --> 00:40:31,639
Otherwise, we end up in an importation situation
1001
00:40:31,639 --> 00:40:34,199
and then we have other challenges that are out there,
1002
00:40:34,199 --> 00:40:35,879
which aren't bad in themselves,
1003
00:40:35,879 --> 00:40:37,360
but they're also the quality,
1004
00:40:37,360 --> 00:40:39,080
you get into the regulatory, there are concerns
1005
00:40:39,080 --> 00:40:40,959
that sometimes some things that are imported
1006
00:40:40,959 --> 00:40:43,879
are not the same raw material rigor
1007
00:40:43,879 --> 00:40:46,719
that goes into validating those raw materials.
1008
00:40:46,719 --> 00:40:47,919
And sometimes people say,
1009
00:40:47,919 --> 00:40:50,199
I have to stay on more of the branded pharmaceutical
1010
00:40:50,199 --> 00:40:53,320
than the generic because of some of those inherent
1011
00:40:54,479 --> 00:40:58,639
molecular level type drugs or components that are in there.
1012
00:40:59,199 --> 00:41:01,959
And doing that, not to say that all generics
1013
00:41:01,959 --> 00:41:03,600
have those issues, it's just that sometimes
1014
00:41:03,600 --> 00:41:05,679
those things can impact your body
1015
00:41:05,679 --> 00:41:06,639
differently than my body.
1016
00:41:06,639 --> 00:41:08,719
And sometimes you see physicians and clinicians
1017
00:41:08,719 --> 00:41:12,239
kind of do that type of changing in prescriptions to do that.
1018
00:41:12,239 --> 00:41:14,080
Again, all to the goal of human health
1019
00:41:14,080 --> 00:41:16,439
and improving that in an efficient way.
1020
00:41:16,439 --> 00:41:17,600
Right, right.
1021
00:41:17,600 --> 00:41:18,439
Yeah.
1022
00:41:18,439 --> 00:41:19,560
That's awesome.
1023
00:41:19,560 --> 00:41:23,320
Well, Dave, I really appreciate you coming back
1024
00:41:23,320 --> 00:41:26,600
to discuss this part of the life cycle of a drug
1025
00:41:26,639 --> 00:41:29,800
and very operationally focused here.
1026
00:41:29,800 --> 00:41:32,479
Obviously, there's a lot of considerations.
1027
00:41:32,479 --> 00:41:34,959
It's a very complicated supply chain,
1028
00:41:34,959 --> 00:41:37,840
very complicated manufacturing operation.
1029
00:41:37,840 --> 00:41:39,919
And I think some of that complexity
1030
00:41:39,919 --> 00:41:41,639
comes from the regulatory nature,
1031
00:41:41,639 --> 00:41:44,600
which needs to be there to protect
1032
00:41:44,600 --> 00:41:46,280
the public health and the people.
1033
00:41:46,280 --> 00:41:49,040
But it seems like you've got a good grasp,
1034
00:41:49,040 --> 00:41:52,479
if not a great grasp on how it works today
1035
00:41:52,479 --> 00:41:54,560
and where it could be going.
1036
00:41:54,560 --> 00:41:57,840
So I appreciate you sharing that with the audience today.
1037
00:41:57,840 --> 00:42:02,600
Any closing thoughts you have about this part of
1038
00:42:02,600 --> 00:42:06,080
the drug life cycle that maybe we missed
1039
00:42:06,080 --> 00:42:07,439
or I failed to ask you about
1040
00:42:07,439 --> 00:42:10,239
that you wanted to bring to the party today?
1041
00:42:10,239 --> 00:42:12,439
Well, I appreciate the discussion here.
1042
00:42:12,439 --> 00:42:14,760
One of the things that maybe just the thought process
1043
00:42:14,760 --> 00:42:17,679
is that so often people,
1044
00:42:17,679 --> 00:42:20,199
this is more of a public perception of drugs,
1045
00:42:20,199 --> 00:42:23,040
is they look at companies that make them
1046
00:42:23,080 --> 00:42:24,879
that are publicly traded.
1047
00:42:24,879 --> 00:42:25,959
So they see the financials
1048
00:42:25,959 --> 00:42:28,000
and they see the cost of goods sold,
1049
00:42:28,000 --> 00:42:29,280
making of the drug,
1050
00:42:29,280 --> 00:42:33,840
can be maybe that the cost is 10 to 15 to 20%
1051
00:42:33,840 --> 00:42:36,959
of the total cost structure of a pharma company.
1052
00:42:36,959 --> 00:42:38,040
And they look at those margins
1053
00:42:38,040 --> 00:42:40,760
and they say those gross margins are very high.
1054
00:42:40,760 --> 00:42:44,239
And what I say is definitely the math is there.
1055
00:42:44,239 --> 00:42:46,840
So you see that the margins are high, very high.
1056
00:42:46,840 --> 00:42:48,520
However, the idea is that you take that money
1057
00:42:48,520 --> 00:42:51,560
and you plow it back into more drug development
1058
00:42:51,560 --> 00:42:54,159
or acquisition of emerging pharmaceutical companies
1059
00:42:54,159 --> 00:42:55,959
for the next elevation of human health
1060
00:42:55,959 --> 00:42:56,879
and development there.
1061
00:42:56,879 --> 00:42:59,760
So maybe just a perspective that people might miss there
1062
00:42:59,760 --> 00:43:01,679
as they look at this and the debate
1063
00:43:01,679 --> 00:43:03,479
and a lot of pharmaceutical companies
1064
00:43:03,479 --> 00:43:06,719
sometimes might take a little bit of a public,
1065
00:43:06,719 --> 00:43:08,679
you know, negative perception
1066
00:43:08,679 --> 00:43:10,600
because of those financial numbers,
1067
00:43:10,600 --> 00:43:13,280
but it's very costly to make it
1068
00:43:13,280 --> 00:43:15,719
and keep it being made at the cost it is
1069
00:43:15,719 --> 00:43:18,439
because if it's not done right in the team,
1070
00:43:18,439 --> 00:43:20,360
something happens with those supply base,
1071
00:43:20,360 --> 00:43:23,199
it can be very costly, not just in financial,
1072
00:43:23,199 --> 00:43:24,600
but human health issues too.
1073
00:43:24,600 --> 00:43:26,399
So glad to talk about this.
1074
00:43:26,399 --> 00:43:28,159
I really appreciate the opportunity
1075
00:43:28,159 --> 00:43:30,560
to talk with you and Tenzing about, you know,
1076
00:43:30,560 --> 00:43:33,239
the pharmaceutical marketplace, which is extremely big
1077
00:43:33,239 --> 00:43:35,360
and there's a lot of angles on purchasing
1078
00:43:35,360 --> 00:43:36,639
and supply chain management
1079
00:43:36,639 --> 00:43:38,439
that different parts of these companies
1080
00:43:38,439 --> 00:43:41,360
have to excel at and work together
1081
00:43:41,360 --> 00:43:44,560
to have the products that you and I need
1082
00:43:44,560 --> 00:43:46,679
when we talk with our own physician about our health.
1083
00:43:46,679 --> 00:43:47,919
So thanks, Greg.
1084
00:43:47,919 --> 00:43:48,959
Yeah, no, you're welcome.
1085
00:43:48,959 --> 00:43:51,879
And appreciate you joining us, as I mentioned before.
1086
00:43:51,879 --> 00:43:54,879
It's always great to talk to you and thanks.
1087
00:43:54,879 --> 00:43:57,600
Maybe we'll come back one more time in the future,
1088
00:43:57,600 --> 00:44:00,399
but, you know, congratulations on being
1089
00:44:00,399 --> 00:44:04,120
the first repeat guest on the Executive Edge podcast.
1090
00:44:04,120 --> 00:44:04,959
All right.
1091
00:44:04,959 --> 00:44:05,800
Thank you.
1092
00:44:05,800 --> 00:44:08,080
All right, Dave, until next time, you take care.
1093
00:44:08,080 --> 00:44:09,320
Thank you.
1094
00:44:09,320 --> 00:44:10,159
Thanks, Greg.
1095
00:44:10,159 --> 00:44:11,000
Take care, bye.