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International Clinical Trials

Phase 1 and 2a Clinical Trials

 

Graham Hughes reviews Informa’s 13th Annual Phase 1 and 2a Clinical Trials conference held in London, highlighting key presentations on proof of concept and venture capital initiatives.

Subtitled ‘Accelerating the journey to proof-of-concept’, one of the defining themes of the event was ‘what is proof-ofconcept?’ This was examined not only in plenary sessions but also in the three parallel streams which comprised the majority of the conference. The first presentation in the plenary session was by Greg Simon, former Senior Vice President of Pfizer. He discussed re-engineering the R&D process – which everyone in the 280-strong audience would have agreed is a necessary evil. The proof-of-concept paradigm was discussed in some detail by Paul de Koning of Astellas. He bewailed the fact that so many promising candidates were abandoned in Phase 3 for either efficacy or, worse still, commercial reasons. He noted that the earlier proof-of-concept can be established the better, and that this especially holds true for biologicals. He discussed further the concept of precision medicine, defined as being the right target plus diagnostics. The crucial element in successful drug development, he felt, was selection competence, which must be derived from experience.

Steve Street, Vice President of Research and Head of Pfizer’s R&D Continuous Improvement programme, discussed the productivity gap and noted that increased expenditure has not resulted in increased numbers of new chemical entities. In fact, with soaring budgets, the number of new chemical entities has declined, although 2011 may have been a better year – but is this just a blip? He felt action reviews are essential after the success or otherwise of a new drug candidate. He noted further that pharmaceutical R&D is an industry where past performance does not predict future success, but where not learning from past performance will guarantee failure. So you need data analysis, interpretation and insight, but perhaps most of all people. Pfizer believes that three pillars of survival exist in Phase 2: exposure of the drug to the target site of action, binding to the pharmacological target and expression of the pharmacological activity commensurate with demonstrated target exposure binding. Without these three pillars drugs fail; two out of three are not enough. His tip for the day, however, was that good drugs discover themselves early.

Stephen Meggitt of Immunocore discussed the small biotech’s perspective and laid out some rules of thumb as to how financial bonanzas can be generated from the small beginnings of the biotech company. How fortunes can be achieved was exemplifi ed from the venture capital (VC) viewpoint by Kate Bingham of SV Life Sciences. She discussed how commitments to both European and US VC funds have dropped over the last few years, and how the VC industry has underperformed over the past decade in comparison to much of the rest of the investment community. However, over a 15 year period it has done well. Her company looks for a minimum return of two to three times their initial investment; unfortunately 44 per cent of the deals she discussed (mainly from other VCs) lost money. Her conclusions were that only the very best funds turn a profit.

All in all this was a very good conference; there was a good blend of case studies and general principle presentations. The overall message was that the borderline between Phase 1 and Phase 2a is becoming increasingly blurred and in many cases complex adaptive signs are being undertaken by both CROs and Pharma companies. Some may think that 13 is an unlucky number but in this case the 13th conference on Phase 1 and Phase 2a was particularly fortunate. I would commend conference 14 to anybody who was unfortunate enough to miss this year’s.


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