Intro
This is part of a series of articles covering past projects to help existing and potential clients understand the journey of a project beyond the traditional case study you would get in a proposal (Here is the previous one).
This history is from a project a few years ago and is somewhat of a warning about the dangers of conducting external research “too late.” Whenever I write a project history, I keep parts vague to keep the client and interests blinded.
Client Need – Situation and Request
We were working with a company that had already committed to developing a new reformulation of a drug to fill an upcoming LOE portfolio gap. Taking a typical play from the life cycle management playbook, the company was looking at making a minor change to one of its older drugs to improve convenience through more extended release.
The company wanted to explore how it could expedite approval through novel clinical trial designs. It had hired a coalition of smaller vendors, including myself, to test and understand the feasibility of their planned approaches.
I was tasked with secondary research and a few expert interviews as the first stage of a larger project involving qualitative and quantitative market research components.
The initial findings were not promising…
I launched into the secondary research, and it was clear after the first day that a soon-to-launch treatment would be paradigm-shifting, the first disease-modifying treatment that would reverse damage to the affected Organ.
Before speaking to anyone, it was clear from reviewing the current treatment algorithm and efficacy of existing drugs that it would make several of the commonly prescribed older drugs, including Drug X, the one being reformulated, much less critical in any future treatment algorithm.
Even the position for Drug X as an additivie/supportive therapy to the new DMT was under threat as LOE approached for multiple products, meaning cheaper generics would be available.
After a detailed outlining of current options, the existing treatment algorithm, impacting factors, and a hypothetical future algorithm I set out to speak to several HCPs to confirm findings, get nuance on a few topics not in the secondary, and test hypotheses.
As we worked on a rare disease, tracking down and speaking to several of the top KOLs in the US and Europe was relatively easy. The findings in the US were, at best, neutral, but the EU KOLs were overwhelmingly negative… along the lines of “Why would you even bother to do this?”.
“Why would you even bother to do this?” – KOL in an interview discussing reformulation of a legacy therapy.
It was pretty tough presenting this back to the client, but as we had multiple similar verbatim responses, they couldn’t be argued with.
Going through the motions
The rest of the project was conducted by testing the different scenarios, gauging the perception of different endpoints and biomarkers, and providing other information to help the client with their decision-making.
Throughout, all I could think about was that had the company conducted the KOL research with a simple target product profile as an earlier piece of stand-alone research, they might have realized that the concept of reformulating was flawed.
This could have saved time and money spent developing different clinical trial scenarios, engaging market research agencies, and conducting detailed research, and instead been used to identify other pipeline products/companies that could be acquired/partnered or invested into R&D to look for more novel treatments.
Wrap Up
It is easy, with hindsight, to say a particular project could have been done better or earlier. Several years later, as far as I can tell from public information, there has been limited movement, and maybe the product is on the cutting block for the next strategic review.
That is why, with repeated delivery of projects assessing pipeline therapies or medical devices, you begin to develop an approach to determine when is a suitable time to test a concept and how many respondents should be targeted.
From a very early stage, speaking to a few well-placed experts can be highly effective in providing information to support development, and it doesn’t cost a considerable amount. Later on, you can spend more and target a more extensive sample as you get closer to launch and need to understand different stakeholders and their behaviors.
Hopefully, this will serve as a good learning experience for anyone looking after a pipeline drug, medical device, or concept. My advice, get out early and speak to a few experts (and ideally repeat this peridoically).
If you need an external perspective to talk about when might be a good time to conduct a piece of work assessing your new drug, medical device, or software, you can get in touch through linkedin or by email at SV@sivan-consulting.com.