I received my invitation to present at last week’s Conference on Phase I and II clinical trials back in September last year. Apparently I was recommended by the Conference Advisory Board. Flattery is always a good strategy – I was delighted and I accepted. February seemed a long way away in September, but it came round soon enough. Although I had a few moments of panic (albeit quite large panic) whilst working out what messages to share, themes to highlight and opportunities to describe, last week arrived and I was ready.
I was third to present in the plenary session on the first day. This is always a great time to present. Everyone sees and hears you. Conversations are much easier to start in all the subsequent coffee and lunch breaks. I really enjoyed the presentation – there were some excellent questions (which is always a good sign) and some excellent ideas I hadn’t thought about before (which is always fantastic).
A big component of my talk was on Three Pillars – a section helped by the recent publication on our work. But I also majored on the importance of diagnostics (patient selection) and biomarkers (efficacy and pharmacology) in enabling Phase I and II speed and survival – aka success!
Many of the conference attendees were from Pharma and Biotechs. All the sponsors were CROs. And there were a handful of VCs, financial analysts and even regulators. This was an eclectic mix but it worked well. I bonded with industry colleagues. I was impressed by high quality CROs. I learned about the world of VCs. At last I understood the work of an analyst. I was reassuringly impressed by the regulators.
Over and above networking, the two highlights for me were unexpected and expected. The unexpected highlight was in one of the afternoon parallel sessions. This featured a presentation from a big Pharma colleague who described an explicit strategy to include patients in Phase 1 (sic) trials for new Allergy & Respiratory agents. The goal is to collect quality, decision making data in Phase I. Other than in cancer trials, I had not heard this strategy being described before. Time will tell whether this is genius or folly, but either way it was noteworthy, not least because it challenges our assumptions and beliefs.
The expected highlight was the last but one plenary presentation. This was a superb presentation, but an unattractive slot. The same auditorium that was full at the start of the first day was two thirds empty at the end of the last day. The early leavers missed a treat. As an aside the presenter had been at the conference throughout, but his time had been relatively quiet – the other downside of being last on the agenda.
The speaker was also from a big Pharma, where he worked in a team dedicated to transformation of Phase I & II drug development. He defined himself as a ‘Truth Seeker’. He exemplified by holding up his drink and asking the audience whether we saw a glass ‘half full’ or ‘half empty’. We all voted. His answer? All he saw was a glass with water in it. The truth. Anything else is bias.
His team have undoubtedly achieved some minor miracles in Phase I & II. Their philosophy is to celebrate positive and negative POCs equally – a manifestation of truth seeking. All of their projects have biomarkers – efficacy and pharmacology – and well characterised target patient populations. So, for example, they have yet to apply their skills to less well understood diseases such as Alzheimers’. Nevertheless it was still jaw-dropping performance.
There’s a theme in here somewhere…..