School of ManagementSEMINAR SEMINAR

Risky Time Reckoning and its Impact on Biomedical Innovation

Maxine Robertson & Peter Clark

Queen Mary University of London

Background

Development times & costs across most therapeutic areas increasing (US, CBO 2006)

Agreement that biotechnology sector ‘has not delivered on its promise’ (Pisano, 2006, Hopkins et al, 2007)

UK & US dominant position threatened as sectoral transformation occurring – new entrants e.g. India, China, Eastern Europe - where trial costs significantly lower

To date an emphasis largely on structural problems within the sector and a requirement for development of hybrid models

A temporal analysis of biomedical innovation in the UK& US may provide further explanatory power for the current situation

Overview of time

Abstract sequences of states: Rogers; Rostow, Eisenstadt CPM

Time-geography: Hagerstrand -> Giddens

Pugh & Hickson (1976): enduring versus flux

Clark & Nowotny: Time reckoning & structural repertoires (IIST 1976)

Structuration orientation – most recently Barley, 1986, 1988; Orlikowski & Yates, 2002

Calender & clock time

CCT as commonsense

History and dating: anachronism

Clock time & Euro-capitalism to 1780s

Role of American engineering professions

Organizations = temporal inventories

SOROKIN(1943), NADEL (1957)GURVITCH (1964)

Homogeneous time reckoning

Heterogeneous time reckoning ubiquitous, extensive and being intensified

Singular homogeneous CCT combined with multiple heterogeneous times

HETEROGENEOUS EVENT TIME RECKONING

Event trajectories with temporal units

Durational expectations & PPF mix

Time frames: open, closed & recurrent

Time ordering: pre-emptory claimants

Strategic roles (e.g. engineering versus marketing in Fiat)

Conflict and mechanisms of segregation

Orlikowski & Yates (2002)

Practice based perspective grounded in ‘temporal structuring’ combines CCT and event based time “Time is instantiated in organizational life through a

process of temporal structuring where people (re) produce (and occasionally change) temporal structures to orient their ongoing activities (:685)

Emphasis on development of shared temporal structures within communities / groups

What happens when innovation demands collaboration across groups?

FDA Time Reckoning system

Linear and event based

Time Reckoning Systems compared

Stakeholder TRS Perception of Time

AnticipationOf futureevents

Attitude to Risk

Attitude touncertainty

Alignment

FDA EventBasedlinear

Control Future eventscontrolled

Riskaverse

Uncertaintyeliminated

N/A

Biotech Drawingback the distantfuture

Commodify

Compress

Colonize

Positive

e.g. politicsof hope

Riskmanaged

UncertaintyMinimised

DiscursiveAlignment WithFDA

PunctuatedAlignmentWith VC

Time Reckoning Systems compared

Stakeholder TRS Perception of Time

AnticipationOf futureevents

Attitude to Risk

Attitude touncertainty

Alignment

Clinicians Groundin the presentref. to the past

Commodify

LargelyNegativew.r.t.RCT’s

Riskaverse

UncertaintyAvoidance

NonAlignmentwith biotech

VentureCapitalists

CyclicalFocuson a nearfuture

Commodify

Compress

Colonize

Positive Riskaverse -managedthroughportfolio &syndication

Uncertainty inevitable

Punctuatedalignmentwithbiotech &FDA

What generates risky time reckoning?

“I don’t know where this number comes from, but the number that is always quoted is every day you’re not on schedule, it costs you a million pounds. So every day that you’re not progressing with your project, it’s costing the company, at peak sales, around about a million pounds. So time is of the essence.”

Risky Time Reckoning in action

“We’re looking at various scenarios for how we will develop the product and what they mean in terms of expenditure, and because we are going to partner the product, we’re looking at what is the package of information we’re going to give to a partner and how much money will we get back in the time available whilst negotiations are ongoing. It’s all about if we spend X we get Y back. If we spend X + £100K, we still only get Y back, so why are we spending that?

……….Scientifically we know what we’d like to know best, but there’s a business case. When you move into development the science is still there, but there are other pressures in the project. And if we were going to take it all the way through ourselves as a company, we would do it very differently because we would probably be much more likely to take a scientific approach because what that gives you is the ability to kill the project early if it’s really not going well. But we don’t want to kill it early until someone’s given us a fat cheque

(Clinical Trials Manager)

Conflicting time reckoning Linear TRS of the FDA imposed on non-linear project level activities

FDA assumes entrainment in practice the FDA TRS is largely deployed by biotech’s as a discursive

device which generates a sense of order around what is often managed chaos

necessary in order to attract investment?

Time reckoning systems of biotech’s (pharma) and clinicians in contention

Power vested in FDA and clinicians suggests compatibility may be difficult to achieve

Venture Capitalists engage cyclically with the FDA TRS and time frames differ significantly across venture capitalists and biotech’s

Critique of Orlikowski & Yates

Privileges agency over structure - “conscious choices unambiguously shape the temporal structuring that occurs” (pg.)

Assume temporal symmetry / collective time coordination achievable

Over-riding temporal orientation of different groups largely missing shapes perceptions of risk & uncertainty

Invokes romantic and over-stated notions of ‘community’

Power ignored – suggest new temporal structures need to be legitimated by the community but no unpacking of the origins of legitimation

What policy initiatives might improve the current situation?

Need & scope for institutional entrepreneurship? Deemphasise linearity in FDA TRS

Simultaneous phasing, recognition of inherent recursivity etc. Negotiation required between FDA, academe, industry,

clinicians aimed at generating better temporal representation and governance of development process

But Many ‘new’ initiatives e.g. fast-tracking, critical path initiative, EU

New Safe Medicines Faster etc. reinforce linear approach

Introduce mechanisms that might blur the relationship between milestones and the value of IP which may help to reduce the effects of the ‘moneytization of IP’ which serves to reinforce the politics of hope and risky time reckoning

Introduce incentive mechanisms for clinicians to promote a more future temporal orientation and engagement with RCT’s e.g. career paths, resources etc.

Development of HIV/ AIDS drugs an exemplar of the way in which diverse communities’ interests can be bridged and development times reduced

‘Patients’ were simultaneously development scientists, regulators and clinicians (Maguire et al., 2004)

School of ManagementSEMINAR SEMINAR