Weekly REDEW: The Drug Development Process – From Discovery to Commercialization

Another week, another webinar…that’s what I always say. I was never sure why I said it though, until last week’s B-MOW on EDA’s webinar was followed by this week’s email from GlobalCompliancePanel inviting me to a live webinar. Maybe I got this webinar email because I posted last week about webinars. Or maybe I’m just prescient. Regardless, I’m dedicating this week’s Random Economic Development Email of the Week to ” Live Webinar – The Drug Development Process – From Discovery to Commercialization”.

How familiar are you with the complex and cross-functional activities that make up the drug development path? If you are involved in any step of drug development from discovery research through process development, pre-clinical and toxicological testing, GMP manufacturing, clinical trials and regulatory affairs, an understanding of how your role fits in with the other activities is key to achieving effective and efficient development and commercialization.

Areas Covered in the Session:

* The transition from discovery to development
* The purpose of Pre-clinical studies; The four major clinical phases (1-4) in the drug development process and the rationale for each with key deliverables
* Discovery and development milestones
* Where do IND and NDA fit into the process
* Overview of the key government regulations that impact the development process (Code of Federal Regulations and ICH)
* Designing the drug with the patient and regulations in mind
* The criticality of effective project management for cross-functional teams during the development process with special focus on managing activities performed by contract manufactures, labs and suppliers.

So, clearly, I don’t fit the bill for their target audience member. But you know who does care about the commercialization of new drugs? The global health community! And what’s an important way for them to do that successfully? Public-private partnerships like the ones that Global Health Nexus is trying to establish. Which has actually been in the news quite a bit.

One of the recent mentions that just caught my eye was the Seattle Times article talking about Coca-Cola’s investment in health education and prevention in Africa. It’s actually for a pretty gruesome reason (“Less than 10 years ago, Coca-Cola was hiring two workers for every one job opening it had in Africa…because they knew that one would get sick and die.”), but also a business reason, which is the point. As Global Health Nexus has been thinking about how to craft the ask to nontraditional global health investors – for example, large corporations like Coca-Cola – we’ve been focusing on the “business case.” For some companies, that’s the leveraging of a global supply chain or opening up of a new market. But there needs to be a bottom line reason for a large corporation to invest in commercialization of global health technologies that otherwise might not pencil out.

Interestingly, while they might not pencil out in the short term, it seems that some companies are taking the long view. In an interview about why they joined BioVentures for Global Health, the SVP of Genzyme talked about how they’re seeing a return on investments that once seemed unfeasible:

Genzyme was focused on orphan diseases, which were orphaned in the sense that the pharmaceutical industry hadn’t seen a financial rationale for investing, and as a result no one was trying to develop drugs for them. Now, 20 years later, orphan diseases are a very robust area of drug development because companies like Genzyme have shown that you can build sustainable business models around them. Neglected diseases are very much in that same vein and I’m attracted to them for the same reason. I think our industry can make a great contribution, and playing a role in helping to identify the ways biotech can get involved in global health and then helping the industry actually do so seems to me to be a very important and rewarding thing to contribute.

It’s actually a great interview, with a lot of talk about how emerging markets are a big incentive for biotech to get involved with global health:

Genzyme has always seen global health as what I would call a ‘strategic responsibility,’ which combines our strategic interests and our social responsibilities…As a global company, emerging markets are very important to us and are a key part of our future.  As a company and an industry, we have unique capabilities that allow us to develop novel therapies for the diseases that affect the people in these markets.  We feel we have a responsibility to contribute those capabilities.  From a shareholder perspective, those contributions are justified by our corporate interest in being a part of the emerging market community.

But perhaps the most important reason to work hard to leverage these public-private partnerships is that we can’t rely on the Gates Foundation to do everything for us forever. As fantastic as it has been – and will continue to be – to benefit (regionally and internationally) from the world’s largest philanthropy, there are limits even to what one multi-billion dollar giver can do. And it’s not just because you should never put all your eggs in one basket (“The Gates Foundation has really raised the profile of global health all over the world,” one researcher said. “But what happens if Bill Gates comes out tomorrow and says, ‘I’ve just read a book on global warming,’ and this whole global-health thing is done?”), but because it literally takes more than a few billion dollars to make some of this stuff happen:

With more than 70 vaccines, drugs and other health technologies in development, the foundation is putting more thought — and money — into what it will take to manufacture those new products affordably, and have them accepted and approved by governments and distributed to people in developing countries…The foundation always envisioned that many of the projects would receive future funding from other sources, including the private sector.

So, there you have it. From live webinars to why the public-private partnership work of Global Health Nexus is so important. Just another neat package of economic development policy wrapped in a bow of Prosperity Blog insightfulness. See you next week.

 

 

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