Statitec is delivering clinical studymethodology, health economics and trialconduct with an extensive experience inoncology, immunotherapeutics andepidemiology.
2012 perspective, published March 21
Gearing up life sciences
innovation to today’s economic twist
The previous dramatic pharma
trouble to struggle with wasthe difficulty to rejuvenate products pipelines (patent cliff andinnovation gap). Now, current economic downturn is forcingcountries to contain health care expenditures. This new trend consistsin a new challenge that life sciences innovation companies have toadapt to. The objective of this work using lean modeling methods isto identify dawning responses to this new situation.Seven cases have been analyzed. Each is definedby pipeline profile of 20 projects (frompreclinical to phase III clinical project) withexternal factors as price, trial cost, attrition rateand market drop-out rate. Cases simulation isperformed on a 20 years basis (cf modelingmethod). These cases represent several drugdevelopment strategies and have been analyzedwith
previous economic model (1990’s) and
current model (2012).
Figure 1 :
Cases mapping by Internal Return Rate (%, EBITDAcomputed as net benefit cash flows) and time to break-event(debt=0, expressed in years).
Impact of changeResults :
when we look at this exploratoryresults (figure 1), life science innovation modelstays attractive. Noticeable issue for biotech isphase II pipeline size regarding current attritionrates. In fact with 7 phases II projects thecompany has great probability to put a producton the market, inversely smaller biotech firmschances are limited to phase II pipeline size. ThePharma, Biotech and Mee-too models are heavilyaffected by new government policies as shownby the slide movement from upper left corner tobottom right corner. It is especially true for theMee-too model of drug development whichseems jeopardized by new measures(comparative trials which lead to huge clinicaltrials, price rebate, and generic competition).
To preclude value erosion innovative companies will continue to have cost containment strategies(access to university basic research, CROs, shared protocol)
Me-too development needs new statistical methodology to be attractive again or will shift to life cyclemanagement (me-too development in princeps drug near indications)
Personalized medicine seems a robust model of development despite some limits  furthermoremonoclonal antibody strategy has a high success rate with still today an investment barriers (cost of phase III) preventing biosimilars entry.
G. Theze Msc. MBA
Oncology drug development is very effectivenowadays because trials are beginning in phase IIprecluding healthy
trials. In additiononcology product approval rate is stable. The oncologypersonalized medicine seems robust as it really cuts thecost of clinical development. With the idea that aspatient will more benefit of the treatment; usual averagedrug turnover is expected. Biomarker diagnosisdevelopment model has been investigated as well and itappears that this approach is yielding to so much profitsfor oncology drug developments that pharma companiesshould be keen on paying the diagnosis test to patientsin exchange of state treatment reimbursement.
Statitec perspective paper,