A Fast Way to Curb Drug De­vel­op­ment Costs? Make Fail­ure a Strat­e­gy.

When it comes to rapid prod­uct de­vel­op­ment, the high-tech sec­tor is tak­ing the lead. Biotech and phar­ma com­pa­nies look­ing to slash costs, speed drug de­vel­op­ment, and get prod­ucts to mar­ket ahead of the com­pe­ti­tion can take a page from the tech-de­vel­op­er’s play­book.

We spoke with Mit­ja-Alexan­der Linss, Di­rec­tor of Mar­ket­ing at Re­search So­lu­tions, a lead­ing provider of on-de­mand sci­en­tif­ic lit­er­a­ture ac­cess, about the mer­it of the ‘Fail Fast’ method­ol­o­gy for bio­phar­ma­ceu­ti­cal com­pa­nies.

What is ‘Fail Fast’?

ML: In the fast-paced tech­nol­o­gy land­scape, many com­pa­nies ad­here to a de­vel­op­ment phi­los­o­phy that’s fo­cused on min­i­miz­ing costs and ac­cel­er­at­ing prod­uct re­leas­es. In­stead of in­vest­ing a huge amount of time and mon­ey in­to test­ing and “per­fect­ing” the prod­uct up-front, the com­pa­ny will re­lease a first it­er­a­tion as quick­ly as pos­si­ble—and then con­tin­ue to make in­cre­men­tal im­prove­ments, bug fix­es, and in­no­v­a­tive up­dates af­ter the prod­uct is on the mar­ket.

The Fail Fast method­ol­o­gy is not unique to the high-tech in­dus­try, and the ap­pli­ca­tion for each use case will vary. But the core con­cept be­hind Fail Fast, no mat­ter the in­dus­try, is to quick­ly iden­ti­fy any­thing that isn’t work­ing, and then use the knowl­edge gained to piv­ot in an­oth­er di­rec­tion.

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Why Does Fail Fast Mat­ter for Drug De­vel­op­ment?

ML: The av­er­age time to launch a suc­cess­ful drug to mar­ket is 10-15 years, with on­ly 9.6 per­cent ap­proved by the FDA. Drug de­vel­op­ment fail­ures ac­count for a stun­ning 75 per­cent of R&D costs and over­all ex­pen­di­tures can be as­tro­nom­i­cal. A 2014 re­port by the Tufts Cen­ter for the Study of Drug De­vel­op­ment es­ti­mat­ed the cost of bring­ing a sin­gle drug to mar­ket at near­ly $2.6 bil­lion.

Phar­ma and biotech com­pa­nies that adopt—and adapt—the Fail Fast ap­proach can trans­form the ef­fi­cien­cy of their drug de­vel­op­ment process­es to re­duce R&D costs and speed over­all suc­cess. Giv­en the ex­tra­or­di­nary costs, they stand to gain big by de­tect­ing po­ten­tial is­sues ear­ly: not on­ly can they im­prove ef­fec­tive­ness of drugs in the con­text of com­bat­ing dis­eases or im­prove pa­tient safe­ty by elim­i­nat­ing ad­verse side ef­fects; by iden­ti­fy­ing cost­ly dead ends ear­ly, they can pull the plug be­fore costs get out of hand.

What Are the Risks of Fail Fast in Drug De­vel­op­ment?

ML: In the high-stakes en­vi­ron­ment of the phar­ma­ceu­ti­cal in­dus­try, drug de­vel­op­ment is in­tend­ed to save lives of pa­tients. Con­verse­ly, im­prop­er drugs can en­dan­ger pa­tients’ lives. A flaw in your iPhone might cause some frus­tra­tion, but a flaw in a drug or even a dosage lev­el could be fa­tal.

That’s why the ob­jec­tive of a Fail Fast strat­e­gy in drug de­vel­op­ment is to iden­ti­fy road­blocks long be­fore a drug ever hits the mar­ket. In prac­ti­cal terms, that means iden­ti­fy­ing the right mix of pa­tient pop­u­la­tions, tar­gets, and cell tis­sues be­fore go­ing in­to large-scale hu­man test­ing of clin­i­cal tri­als. Most drugs fail in the phase II of clin­i­cal tri­als with a sam­ple size of 100-300 pa­tients, and a suc­cess­ful Fail Fast gets ahead of that.

How Can Drug Com­pa­nies Im­ple­ment Fail Fast?

Bio­phar­ma­ceu­ti­cal com­pa­nies need to lever­age tech­nol­o­gy and in­for­ma­tion ear­ly on in the drug de­vel­op­ment process to be suc­cess­ful with a Fail Fast ap­proach. That in­cludes lever­ag­ing au­toma­tion wher­ev­er pos­si­ble in bio­med­ical re­search, for in­stance with find­ing peer-re­viewed sources, us­ing ar­ti­fi­cial in­tel­li­gence (or AI) to process in­for­ma­tion, or con­duct­ing ex­per­i­ments in-sil­i­co.

At Re­search So­lu­tions, we are ex­perts in the dis­cov­ery and ac­cess of peer-re­viewed sci­en­tif­ic lit­er­a­ture, and we serve 70 per­cent of the top phar­ma­ceu­ti­cal com­pa­nies. We have put to­geth­er some use­ful re­sources, such as a white pa­per and 10-step slide deck for re­search prac­ti­tion­ers to get start­ed with a Fail Fast ap­proach. We will al­so be con­duct­ing a we­bi­nar on the top­ic fea­tur­ing lead­ing in­dus­try speak­ers in June 2020.

Want to learn tan­gi­ble tac­tics for ap­ply­ing Fail Fast method­ol­o­gy to drug de­vel­op­ment—and the top ben­e­fits of do­ing so?

Read the white pa­per: Fail Fast. Suc­ceed Faster.

• The top ben­e­fits of a fail fast method­ol­o­gy
• How to use tech­nol­o­gy to im­prove re­sults
• Sim­ple tips for get­ting start­ed

Re­spon­dents who down­load the white pa­per, will re­ceive a 10-step slide deck to kick start­ing a Fail Fast strat­e­gy and an in­vi­ta­tion to the we­bi­nar in June 2020.

Get the whitepa­per