In­no­va­tion by Dis­rup­tion: Break­ing Si­los Be­tween R&D and Com­mer­cial Teams to Ad­vance New Treat­ments for Pa­tients

The clin­i­cal de­vel­op­ment path­way: a high­ly cu­rat­ed, step-by-step, func­tion­al process, has re­mained large­ly un­changed for decades across the bio­phar­ma­ceu­ti­cal in­dus­try. It is a well-worn op­er­a­tion that can re­sult in 15 years be­tween drug con­cept and com­mer­cial­iza­tion, and a high at­tri­tion rate.¹ A key chal­lenge to in­no­va­tion and the ac­cel­er­a­tion of im­proved med­i­cines for pa­tients is this long-stand­ing mod­el of siloed re­search and de­vel­op­ment (R&D) and com­mer­cial teams with­in an or­ga­ni­za­tion. At Janssen, we’ve changed our par­a­digm and demon­strat­ed that more in­te­grat­ed de­ci­sion-mak­ing through­out the process can en­hance the val­ue of what we as an in­dus­try de­liv­er for pa­tients, for the health­care sys­tem, and for all stake­hold­ers.

The in­dus­try stan­dard func­tion­al ap­proach: the domi­no ef­fect

The in­sights and de­ci­sion-mak­ing of this siloed par­a­digm op­er­ates like a line of domi­nos: the process moves on­ly in one di­rec­tion, with each domi­no on­ly touch­ing the domi­nos that are ad­ja­cent to it. The “line” starts with a dis­cov­ery team that iden­ti­fies promis­ing com­pounds from a pool of can­di­dates they ad­vance to be­come new mol­e­c­u­lar en­ti­ties (NMEs). Trans­la­tion­al med­i­cine is next, prepar­ing NMEs for hu­man tri­als with phar­ma­co­ki­net­ic and phar­ma­co­dy­nam­ic mod­el­ing, and pre-for­mu­la­tion. Then, an ear­ly de­vel­op­ment team pro­ceeds with Phase 1 and Phase 2a hu­man tri­als, fol­lowed by late de­vel­op­ment, the dose find­ing Phase 2b, and con­fir­ma­to­ry piv­otal Phase 3 tri­als it con­ducts to fi­nal­ize dos­ing, end­point in­clu­sion and hi­er­ar­chy for reg­u­la­to­ry fil­ing and la­bel­ing strat­e­gy. Fi­nal­ly, the com­mer­cial team launch­es the new ther­a­py in mar­ket.

This mod­el presents a key chal­lenge: deep think­ing, in­sights and de­ci­sions hap­pen pri­mar­i­ly with­in each func­tion, as each of the spe­cial­ized teams de­scribed in­cludes ex­perts who may have lim­it­ed ex­per­tise out­side their fields.

Like the line of domi­nos, im­pact – in the form of in­sights — are trans­ferred on­ly from left to right, and some­times with con­tra­dic­to­ry in­cen­tives, or not at all. Once a domi­no goes down, it’s dif­fi­cult to go back.

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Janssen Im­munol­o­gy and the de-siloed ap­proach: New­ton’s cra­dle

At Janssen Im­munol­o­gy, we’re de­vel­op­ing and de­liv­er­ing trans­for­ma­tion­al med­ical in­no­va­tions for pa­tients suf­fer­ing from a range of dev­as­tat­ing, dif­fi­cult to treat, chron­ic im­mune-me­di­at­ed dis­eases, dri­ven by a re­lent­less dis­sat­is­fac­tion with the sta­tus quo.

We em­ploy a fun­da­men­tal­ly dif­fer­ent mod­el in how drug dis­cov­ery and de­vel­op­ment func­tion­al ex­perts from di­verse dis­ci­plines work to­geth­er and how our teams op­er­ate to ac­cel­er­ate in­no­v­a­tive med­i­cines. Our mod­el op­er­ates more like a New­town’s cra­dle than domi­nos. Each func­tion­al team, like the met­al balls of New­ton’s cra­dle trans­fer en­er­gy – or ex­per­tise and in­sights – through the balls from one end, then back again through­out the de­vel­op­ment process.² For ex­am­ple, fu­ture-back mar­ket in­sights in­form pri­or­i­ti­za­tion of bio­chem­i­cal prop­er­ties as ear­ly as hit to lead, and trans­la­tion­al med­i­cine in­sights in­form life­cy­cle plan­ning. We op­er­ate in a strate­gic de­ci­sion-mak­ing frame­work and cor­re­spond­ing op­er­a­tional mod­el with min­i­mal or­ga­ni­za­tion­al bound­aries be­tween ear­ly tar­get as­sess­ment and late life cy­cle man­age­ment. This pro­motes in­sights and ex­per­tise to flow con­tin­u­ous­ly across R&D and com­mer­cial func­tions. It is a close part­ner­ship be­tween our R&D and com­mer­cial func­tions, and a ful­ly in­te­grat­ed ap­proach to drug de­vel­op­ment, that en­ables us to har­ness in­sights across the val­ue chain.

There are five core tenets of the Janssen Im­munol­o­gy drug de­vel­op­ment mod­el:

1. Shared joint R&D and com­mer­cial lead­er­ship com­mit­ment to a de-siloed, end-to-end op­er­at­ing mod­el: all func­tions are com­mit­ted to struc­tur­ing their teams around this mod­el.
2. Sin­gu­lar shared vi­sion and mis­sion from dis­cov­ery through com­mer­cial­iza­tion.
3. Joint gov­er­nance mod­el: a dis­ci­plined ap­proach is crit­i­cal­ly im­por­tant to op­er­at­ing with an in­te­grat­ed port­fo­lio lens. We don’t just ques­tion whether a pro­gram, or pro­gram pro­gres­sion can tech­ni­cal­ly hap­pen. Rather, we chal­lenge pro­grams to iden­ti­fy which have the great­est po­ten­tial for sub­stan­tial­ly ad­vanc­ing treat­ment par­a­digms vs. all avail­able ther­a­pies at time of ap­proval.  We be­lieve op­por­tu­ni­ty costs mat­ter as much as di­rect pro­gram costs.  We de­ploy deep in­sights in­to ac­tion­able sci­ence and un­met need to quick­ly in­form ‘killer ques­tions’ and to im­ple­ment strin­gent pri­or­i­ti­za­tion cri­te­ria in our port­fo­lio de­ci­sions.
4. Tal­ent: among se­nior lead­ers, our aim is to hire “learn­ers” ver­sus “know­ers.” Learn­ers are will­ing to chal­lenge the sta­tus quo and to gath­er learn­ings from ar­eas out­side their own ex­per­tise. Know­ers, con­sid­ered “ex­perts” be­cause they’ve been in the job for a long time, tend to base de­ci­sions square­ly on their own ex­pe­ri­ence.
5. Clear ac­count­abil­i­ty with “brain cur­ren­cy” ori­en­ta­tion: be­cause there are broad in­puts to any de­ci­sion, ul­ti­mate ac­count­abil­i­ty for each de­ci­sion must be crys­tal clear. When ac­count­able lead­ers make a de­ci­sion, they ei­ther view the “brains” around them as im­ped­i­ments or as cur­ren­cy to work to­ward a so­lu­tion.

In our de-siloed mod­el, each func­tion­al group still makes de­ci­sions, but they are made with in­sights in­to im­pli­ca­tions up and down the drug de­vel­op­ment process. The re­sult is a clear­er and more aligned pri­or­i­ti­za­tion, smarter tri­al de­sign, and more dif­fer­en­ti­at­ed as­sets. This has made Janssen Im­munol­o­gy unique­ly poised to de­vel­op med­i­cines for con­di­tions across dis­ease ar­eas: those that are rare, such as he­molyt­ic dis­ease of the fe­tus and new­born, and preva­lent, as ev­i­denced by our long-stand­ing com­mit­ment to de­liv­er treat­ments for peo­ple with rheuma­toid arthri­tis.

How do these dif­fer­ing func­tion­al ap­proach­es af­fect drug de­vel­op­ment suc­cess rates?

Since 2005, across the in­dus­try, im­munol­o­gy re­search has seen about a 31% suc­cess rate in Phase 2 tri­als, and an 81% suc­cess rate in Phase 3.³ Com­par­a­tive­ly, Janssen Im­munol­o­gy has seen a 45% suc­cess rate and 92% suc­cess rate in Phase 2 and Phase 3 tri­als over the same time frame.³ We’ve al­so achieved more than two decades of con­tin­u­ous growth and in­no­va­tion on be­half of pa­tients, with five in­ter­nal­ly de­vel­oped, mar­ket­ed prod­ucts, and more than 31 in­di­ca­tion ap­provals, 18 of which are first-in-class, and four block­buster ther­a­pies that have helped to re­de­fine stan­dard of care in chron­ic im­mune-me­di­at­ed dis­eases.

By break­ing si­los through­out the dis­cov­ery, de­vel­op­ment, and com­mer­cial­iza­tion process, we have re­vealed ef­fi­cien­cies and pro­duced re­sults for pa­tients who need them. This has led us to sci­en­tif­ic dis­cov­er­ies, new da­ta in­sights, and treat­ments that were con­sid­ered im­pos­si­ble 10 years ago. Pa­tients are wait­ing.

Ref­er­ences:

1. Hugh­es JP, Rees S, Kalind­jian SB, Philpott KL. Prin­ci­ples of ear­ly drug dis­cov­ery. Br J Phar­ma­col. 2011;162(6):1239-1249. doi: 10.1111/j.1476-5381.2010.01127.x
2. Schulz, C. How­Stuff­Works: How New­ton’s Cra­dles Work. Up­dat­ed: Apr 8, 2021. https://sci­ence.how­stuff­works.com/in­no­va­tion/in­ven­tions/new­tons-cra­dle.htm#pt2
3. CMR Glob­al R&D Per­for­mance Met­rics Pro­gramme. CMR In­ter­na­tion­al is a Clar­i­vate An­a­lyt­ics busi­ness

Au­thors:

David M. Lee, M.D., Ph.D.,
Glob­al Ther­a­peu­tic Area Head, Im­munol­o­gy

Teri Lawver,
World­wide Vice Pres­i­dent, Im­munol­o­gy