Walking the Walk: Stories of Drug Development

When I first started writing here in 2011, I thought that the time was near for the biotech industry to adopt the social media tools that the tech venture capitalists and entrepreneurs were using to talk about their investment strategies, product launches, development strategies, etc.* At the end of 2013, I considered telling the story of Quintessence, my version at least, here on this blog. The ensuing, sometimes spirited, discussions with colleagues sparked my recent posts about communication and risk, from the company and personal perspectives.

My interest doesn’t really revolve around the tools but on the idea that any person or organization can tell their own story. Science stories, which pharma/biotech stories are at their heart, are difficult to tell. The scientific method is iterative, not linear, perhaps making the introduction straightforward but the conclusions elusive. Despite their popularity, science stories are not hero’s journeys. Science is a collaborative endeavor and drug development is no exception.

Why is This Interesting?

Apparently I’ve been pondering that question since 2008 when I started a WordPress blog called whyisthisinteresting. Part of exploring this question has been accepting that my professional path, while not unique, has to date been exceptional. I’ve been closely connected to the development of a drug from discovery to treating patients in the clinic. From planning in vitro assays to lead selection to IND writing to protocol changes to financing all of the above, I’ve had an active role in each part of the project. The Quintessence story is also different than most biotech drug development as it lacks a key character, venture capital, as all of our funding has come from individual investors.

Why Now?

About two years ago, I wrote a blog post called “What is Success?” and came to a working definition for my work here at Quintessence:

If we 1) develop a cancer drug that is enticing enough to be advanced to FDA approval and 2) convert that implicit value into a solid return for shareholders, then we will have succeeded for all of our stakeholders.

Currently, we have wrapped up dose escalation in our Phase I trial of our lead cancer drug. Thus, my short term goal is to convince a partner that our drug is worthy of investment for the next stage of clinical development, and we have undertaken the standard processes to achieve this goal. While I am fairly certain our eventual partner will not learn about Quintessence from this blog, I have been consistently surprised by the positive impact of my participation in social media. Most of these things are behind the scenes – key introductions, inclusion in events – but they have been impactful and helpful.

Why Not?

Here in Wisconsin, I know a variety of folks in management positions in traditional businesses, such as manufacturing. When a manufacturing company is sold from one private equity group to another, the assets are tangible (buildings, machines, order backlog) and valuation is relatively straightforward. The process of selling a pre-clinical or early clinical stage drug development program is more akin to selling futures. Each deal is different than the next because each program differs: small molecule vs. antibody, validated target, biomarkers, etc., etc. Each variable entails different risks. For example, pursuing a validated target may reduce your technical risk relative to a novel target but increases the risk that your drug can be differentiated from the competition during clinical trials.

For these biotech deals, what is the key asset – the deal driver? Is it the drug? The platform? The team? In my experience to date, the key is some mosaic of these things that gives the buyer comfort that value can eventually be recognized. My credibility as the architect and lead sales person is inextricably linked to the fate of our program.

Naturally Risk Averse

While I tend to avoid risk when possible, my time at Quintessence has required me to develop a process to handle risk.  Although the inflection points in the traditional drug development pathway are clear to many, there are many more pain points in the process that aren’t clear if you haven’t faced them. Dosing days for the patients in our Phase I trials. Waiting to see if our bacteria would grow as expected at the contract GMP lab. Conversations with the FDA about what our IND package supported. Tallying the dollars on the day a financing round is scheduled to end. So we are again at a critical, decisive point for Quintessence. But this reality is one I have faced over and over on this path to market.

Figure from Br J Pharmacol, 162, 1239.

Figure from Br J Pharmacol, 162, 1239.

Next Steps

Hopefully this draft is the final one that makes it to the website. What comes next? I’m telling a story from the middle from a single viewpoint. I’ll be limited in the characters I can introduce based on confidentiality and other factors. But my goal here is to tell you how we made it here and how we are getting to the next stage.

*As I’ve contemplated this step, life science venture capitalist Bruce Booth has assembled the “Atlas biotech gang of eight” to contribute “From the Trenches” on his blog. You should go read the first post from Mike Gilman on The Awesome Power of Risk, which came out this week. I appreciate Bruce’s initiative and look forward to the series. If you wonder what I might bring to the table, I noticed this comment on Bruce’s announcement post. While I don’t relish the idea of representing “the less glamorous side of things”, I think it fits for this situation.

CommentBBPost

Postscript

As a window into this post, here are a couple of things that didn’t make it.

From the Near Emmaus blog, an appreciation for the impact of time on the written word.

Also, please consider the date of each blog entry. The author’s opinion may have changed since its composition.

From Nassim Taleb’s book Fooled by Randomness: The Hidden Role of Chance in Life and in the Markets

When you look at the past, the past will always be deterministic, since only one single observation took place. Our mind will interpret most events not with the preceding ones in mind, but the following ones. Imagine taking a test knowing the answer. While we know that history flows forward, it is difficult to realize that we envision it backward.

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  1. Biotech: Outside Looking In | The Next Element - July 2, 2014

    […] a post in March, I suggested that I would represent the “less glamorous side of things” in the biotech […]

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