New Skunkworks Company Seeks to Accelerate Drug Development

With the launch of Protodigm, Founder and CEO Mike Rea (also Founder and CEO of sister company IDEA Pharma) hopes to “revolutionize” the field of drug development. The company has brought together a diverse group of professionals (including scientists from Oxford and Cambridge, a Harvard Business School graduate), a member of the FDA Science Advisory Board, a widely published scientific author, and others) to offer diverse skill sets, perspectives and expertise. to foster innovation.

Rea discussed the new organization with Outsourcing-Pharma, explaining his commitment to innovation, an innovative approach and the benefits of the colorfully named “ skunkworks ” approach.

OSP: Could you please share a description of Protodigm’s “elevator presentation”?

MR: Protodigm is two very new things: a contracted skunkworks and a next generation contract research organization (CRO), bringing a disruptive new approach, rather than a version of what already exists. At IDEA, our go-to-market consultancy, we have supported eight of the fifteen biggest drug launches over the past five years and conducted the longest-ever study on innovation in pharmaceuticals, the innovation and pharmaceutical invention index.

Protodigm is the natural next stop on this journey, born from the in-depth knowledge gained from studying the effects of premature drug specialization and linear step-by-step decision making in R&D that significantly inhibits innovation.

Protodigm provides industry with a solution; we are a drug development partner, not only by doing what is asked of us, but by increasing the opportunities for early stage drug development by providing a multitude of go-to-market options and increasing quality evidence in exploratory phases – Phase I and Phase II.

Also, when it comes to new possibilities – imagine you wanted to create a combination product – a new formulation-device-diagnostic-digital-endpoint combination solution, for example. This is something any pharmaceutical company would struggle to do internally. Protodigm’s skunkworks can prototype, develop and iterate a solution faster and more efficiently.

How it works in practice can take many forms – central to our thinking is our Options, Evidence and Decisions (OED) framework, which embodies our belief in learning by doing – laying the groundwork for question, design a plan to learn, generate the evidence using the universe of new and emerging technologies (e.g. artificial intelligence, panomic profiling, simulation and modeling) that we have, as well as our knowledge (e.g. example, reimbursement, regulation), then revisit the original question. A poorly understood fact in our industry is how much chance lies in our marketed drugs – chance is about seeing opportunities faster than others, so we started a company to do it by design.

What sets Protodigm apart is the full range of our services. There isn’t another biotech and pharma company that will take and can take your pipeline and give you new possibilities to use your pipeline, then prototype and test those possibilities for you, and finally give you the full picture. with quality evidence as to which are your best options.

We are willing to accept uncertainty – which we don’t know – and have the ability to generate the right evidence to improve decision-making capacity early, efficiently, and reliably. We are a focused hub for the thousands of solutions seeking applications.

OSP: Could you please tell people who don’t know what a “skunkworks” approach is, and why it might be of interest to pharmaceutical companies and their research partners?

Mike Rea, Founder and CEO of Protodigm

MR: The Wikipedia definition of skunkworks is quite appropriate: “The designation “ skunk works ” or “ skunkworks ” is widely used in business, engineering and technical fields to describe a group within an organization with a high degree of autonomy. and without bureaucracy, with the task of working on advanced or secret projects.– developed as an idea by Lockheed Martin, it was a way to go faster, with more agility and creativity than the main organization could.

It’s a term we borrowed from the engineering and tech industries – which embodies the idea of ​​reinventing what’s possible, by a team designed to innovate. We want to bring the disruptive thinking that has been so successful in the tech industry to the healthcare industry.

We will work alongside our biotech and pharmaceutical partners to prototype innovative solutions, for example a digital drug device, which may not necessarily be suitable for in-house development due to a lack of awareness or rigidity that is often the consequence of a rigid reflection in more mature industries.

OSP: Please tell us more about the impressive team of scientists you have assembled at Harvard, Oxford, Cambridge and other corners.

MR: We like to think of ourselves as a next-gen CRO, not just actors, but a team of hypothesis and evidence generators, leveraging the best minds in “ decision science ” and the hottest technologies. cutting edge to shed light on a unique universe of possibilities for a given asset. The breadth of experience within our team gives us a “range” and the ability to bring outside perspectives to internal challenges.

OSP: You mention in your launch announcement that one of your goals is to help customers avoid “premature specialization in drug development”. Could you please share how businesses might fall into this, what are the issues with such limitations and exactly how Protodigm will work to help them not take too narrow a view?

MR: The selection of indications is something that the industry has widely accepted as the reasonable thing to do in order to move a drug to phase I and beyond. In our opinion, it is not realistic to select an indication, and certainly the place in that indication, at this stage, before having proof. You can choose any indication, but you usually choose the simpler or more obvious, with the belief that you can refine the positioning later once you collect the evidence. This seemingly harmless decision will forever remain a “sliding door” moment in the development plan.

Here’s an analogy: you decide New York is the best place for your new business. If you can do it, you can do it anywhere. Once you’ve decided, there are still a lot of decisions to make: neighborhood, type of business, etc., but all the thousand things that matter – recruiting, services, overhead, pricing, investment, etc. – would be different if you had only chosen San Francisco, Miami, Pittsburgh or Basel. But, in addition to wondering, you’ll be left in New York, facing the sunk cost of your decision. If you had done all this assessment before choosing, you may have made it to New York afterwards, but you may not have started there.

If you entrust your new molecule to the Immunological Therapeutic Area for evaluation, it would be like asking a New Yorker to assess your choice of location. The answer will be New York, or rheumatoid arthritis, and there may even be a lot of attractive details sitting next to it. But the answer will never be Tokyo or cancer.

The problem with “indication selection” lies in “selection”. If you don’t know enough to make a decision, your selection is premature. Knowing this, you have to stick with the crowds and hope you can fix it later, or you can do more exploration before committing. It should involve a little imagination, some “what ifs” and a lot of guesswork, but when you make your “pick” you will already have a competitive edge over those who roam Times Square, wondering what. who will follow.

At Protodigm, our mission is to ask questions, identify options, and provide evidence to support this early decision-making process.

OSP: Do you have anything to add?

MR: The kind of explosion of possibilities we’ve seen in new discovery platforms is also happening in development, but largely outside of the pharmaceutical industry. Protodigm provides a hub through which new solutions – formulation science, device and material science, digital, AI that helps design better clinical trials, end point solutions, innovative business solutions, etc. – are all included in our offer.

Rather than doing the same things a little better, Protodigm is doing something different. In addition to doing the right things and getting it right, we’re helping businesses understand what the right things are, faster and more reliably than ever before.

About Geraldine Higgins

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