Canada’s Bridge Be­tween Sci­ence and Pa­tients

Policy - - In This Issue - Gor­don McCauley

The Cen­tre for Drug Re­search and De­vel­op­ment is a model of drug de­vel­op­ment and com­mer­cial­iza­tion unique to Canada. In part­ner­ship with academia, in­dus­try, gov­ern­ment and foun­da­tions, CDRD pro­vides the ex­per­tise and in­fra­struc­ture to iden­tify, test and trans­form drug dis­cov­er­ies into com­mer­cially vi­able in­vest­ment op­por­tu­ni­ties for the pri­vate sec­tor—and ul­ti­mately into in­no­va­tive ther­a­pies.

We live and op­er­ate in a global so­ci­ety, cer­tainly in busi­ness terms, but more im­por­tantly, in terms of the pos­i­tive and sub­stan­tial so­ci­etal im­pacts we look to make with the in­no­va­tions we de­velop—the dis­ease we seek to al­le­vi­ate and the lives we seek to im­prove, wher­ever they may be.

Af­ter all, we are one species shar­ing one small planet, and health in­no­va­tion in one part of our planet ought to serve pa­tients in ev­ery part of our planet.

We live in a truly ex­tra­or­di­nary mo­ment: life ex­pectancy has dou­bled in the last 100 years; en­tire dis­eases have been erad­i­cated; and the ca­pac­ity of sci­en­tific re­search to ad­dress both his­tor­i­cally per­ni­cious and un­prece­dented threats to hu­man health is demon­strated pretty much ev­ery day in both the pop­u­lar me­dia and sci­en­tific jour­nals.

It is the case, how­ever, that the de­vel­op­ment of new med­i­cal in­ter­ven­tions takes too long, costs too much, and all too of­ten ends in fail­ure. Even with ex­tra­or­di­nary ad­vances, the in­no­va­tion gap be­tween fun­da­men­tal dis­cov­er­ies and the de­liv­ery of new ther­a­peu­tic op­tions to pa­tients has re­mained stub­bornly per­sis­tent. These chal­lenges of trans­lat­ing high po­ten­tial re­search into vi­able com­mer­cial prod­ucts are global ones, so we must ad­dress them glob­ally, tak­ing re­spon­si­bil­ity to ask dif­fi­cult ques­tions glob­ally and find cre­ative an­swers glob­ally, and then, of course, take ac­tion ev­ery­where to re­duce time, re­duce cost, and im­prove out­comes.

The Cen­tre for Drug Re­search and De­vel­op­ment is Canada’s na­tional drug de­vel­op­ment cen­tre; an or­ga­ni­za­tion in­de­pen­dent of gov­ern­ment but sup­ported by gov­ern­ment to help build Canada’s life sci­ences ecosys­tem.

We are a global bridge that trans­lates dis­cov­er­ies into in­no­va­tive ther­a­peu­tic prod­ucts and im­proved health out­comes. We do this by build­ing sus­tain­able part­ner­ships—in Canada and around the world—to iden­tify and ad­vance promis­ing dis­cov­er­ies and trans­form them into val­i­dated in­vest­ments and strong Cana­dian com­pa­nies of scale.

We have an ex­tra­or­di­nary team of 100 sci­en­tists and busi­ness lead­ers, op­er­at­ing in 40,000 square feet of state-of-the-art, pur­pose-built lab­o­ra­to­ries. This team rolls up their col­lec­tive sleeves ev­ery day do­ing the hard work of drug de­vel­op­ment.

We use CDRD’s fore­sight and ex­per­tise through our global net­work of in­vestors and de­vel­op­ers to iden­tify com­mer­cial op­por­tu­ni­ties, then proac­tively mine academia and biotech com­pa­nies for nascent sci­en­tific dis­cov­er­ies that we can ad­vance col­lab­o­ra­tively. The prod­uct of this val­ueadd is typ­i­cally a novel com­pany of scale or an es­sen­tial com­po­nent of an ex­ist­ing com­pany scal­ing-up.

It is no ac­ci­dent that CDRD, a unique model in the world, emerged in Can-

Life ex­pectancy has dou­bled in the last 100 years; en­tire dis­eases have been erad­i­cated; and the ca­pac­ity of sci­en­tific re­search to ad­dress both his­tor­i­cally per­ni­cious and un­prece­dented threats to hu­man health is demon­strated pretty much ev­ery day.

ada. Canada is an eco­nomic pow­er­house with a sta­ble and strong econ­omy fore­casted to lead the G7 in real GDP growth in 2018. It has strong jobs growth, bet­ter fis­cal per­for­mance than most of the G7; low­est net debt; low in­fla­tion; and leads on both the pros­per­ity in­dex and the so­cial progress in­dex.

In ad­di­tion to ex­cel­lent eco­nomic fun­da­men­tals, Canada is a busi­ness­friendly, highly com­pet­i­tive en­vi­ron­ment that en­cour­ages suc­cess. Canada has been a trad­ing na­tion since be­fore it was a coun­try, and that his­tory con­tin­ues to this day. Over the past decade, Canada has wit­nessed sub­stan­tial growth in both in­ward and out­ward for­eign di­rect in­vest­ment, re­flect­ing its strong con­nec­tion to global busi­nesses.

Canada’s tech­nol­ogy and life sci­ences firms are draw­ing in­creas­ing in­ter­est from ven­ture cap­i­tal around the world. In 2017, that in­ter­est amounted to about $3.5-bil­lion in­vested in al­most 600 transactions, the bet­ter part of $1-bil­lion of that go­ing into life sci­ences com­pa­nies. Ven­ture cap­i­tal ac­tiv­ity is am­pli­fied by a further $26.3-bil­lion of pri­vate eq­uity ac­tiv­ity.

And, CDRD emerged in Canada be­cause, in ad­di­tion to be­ing an eco­nomic pow­er­house, Canada is a re­search pow­er­house.

With just 0.5 per cent of the world’s pop­u­la­tion, Canada gen­er­ates 5 per cent of the world’s re­search out­put— and that 10x mul­ti­plier holds pretty much re­gard­less of which met­ric you chose. With a highly en­tre­pre­neur­ial pop­u­lace, we also lead the world on a rel­a­tive ba­sis in start­ing-up com­pa­nies, and we lead the world in univer­sity-based start-ups too. These strengths have been further en­hanced by even greater com­mit­ment by our fed­eral gov­ern­ment, in­clud­ing his­toric new fund­ing largely fo­cused on scal­ing-up re­search based en­ter­prises.

Build­ing on the fed­eral gov­ern­ment’s suc­cess in last year’s In­no­va­tion and Skills Plan, the 2018 bud­get com­mit­ted a further $4-bil­lion in re­search, de­vel­op­ment, and com­mer­cial­iza­tion sup­port, with new mea­sures that will im­prove ac­cess to fi­nanc­ing, en­cour­age in­vest­ment, and sup­port the demon­stra­tion of tech­nolo­gies.

It is in­cred­i­bly im­por­tant that Ot­tawa com­mit­ted not just to ba­sic re­search—no doubt crit­i­cally im­por­tant in its own righ—but also to the trans­la­tion of that re­search through CDRD specif­i­cally and the ul­ti­mate cap­i­tal­iza­tion of com­pa­nies through ef­forts such as the Ven­ture Cap­i­tal Cat­a­lyst Ini­tia­tive, part of a $1-bil­lion plus com­mit­ted to en­hance the coun­try’s ven­ture cap­i­tal ecosys­tem. In the global eco­nomic marathon of in­no­va­tion, Canada is run­ning hard and smart.

What does all that mean in the con­text of the global drug de­vel­op­ment chal­lenges to which I re­ferred at the out­set? First, this busi­ness is driven by peo­ple. Strong, re­spect­ful and pro­duc­tive part­ner­ships are our sin­gle most valu­able as­set. So as var­i­ous life sci­ences clus­ters emerge on the world health care in­no­va­tion stage, let’s recom­mit to strong foun­da­tional re­la­tion­ships be­tween peo­ple, with a clear and un­wa­ver­ing fo­cus on our shared pur­pose and ob­jec­tive.

Sec­ond, do­mes­tic col­lab­o­ra­tion is not good enough in a global in­dus­try. In this light, we are also proud to have led the es­tab­lish­ment of Trans­la­tion To­gether, a con­sor­tium of the six top trans­la­tional re­search or­ga­ni­za­tions in the world, to break down bor­ders, share best prac­tices, col­lab­o­rate on mu­tu­ally ben­e­fi­cial projects, cap­i­tal­ize on in­ter­na­tional fund­ing op­por­tu­ni­ties and bring new re­sources and in­no­va­tions to bear in re­search trans­la­tion.

We’re equally proud of the fi­nan­cial in­vest­ments global pharma has made in CDRD—specif­i­cally Merck, GSK, Pfizer, J&J, Roche, and As­tra Zeneca. We have sim­i­lar fi­nan­cial part­ner­ships with the Mul­ti­ple Sclero­sis So­ci­ety, The Ju­ve­nile Di­a­betes Re­search Foun­da­tion, the Helm­s­ley Trust, LifeArc, and Can­cer Re­search UK.

Third, we are busi­ness peo­ple. I have spent most of my ca­reer as a biotech CEO and ven­ture cap­i­tal­ist, so I cer­tainly haven’t for­got­ten that we do all need to make money. There are a hand­ful of spe­cific things we need to em­brace as an in­dus­try to make money, but more im­por­tantly to do so faster, cheaper, and with less risk.

Canada’s tech­nol­ogy and life sci­ences firms are draw­ing in­creas­ing in­ter­est from ven­ture cap­i­tal around the world. In 2017, that in­ter­est amounted to about $3.5-bil­lion in­vested in al­most 600 transactions, the bet­ter part of $1-bil­lion of that go­ing into life sci­ences com­pa­nies.

With just 0.5 per cent of the world’s pop­u­la­tion, Canada gen­er­ates 5 per cent of the world’s re­search out­put— and that 10x mul­ti­plier holds pretty much re­gard­less of which met­ric you chose.

For ex­am­ple, it ought to be ax­iomatic that fo­cus, scale, and depth of re-

search are pre-con­di­tions to suc­cess. Over the past 20 years, the num­ber of new ther­a­pies ap­proved by the U.S. Food and Drug Ad­min­is­tra­tion, has seen no mean­ing­ful up­ward or down­ward trend. At the same time, R&D spend­ing has sig­nif­i­cantly in­creased, re­quir­ing more re­sources to bring each drug to mar­ket. Fight­ing these com­pet­ing trends, com­pa­nies have fo­cused on try­ing to re­duce costs per drug com­ing to mar­ket, and there has been in­creas­ing scru­tiny from pay­ors to as­sess the value of the drugs.

But here is the in­ter­est­ing part, the “how”. There was a won­der­ful pa­per in Na­ture, the in­ter­na­tional sci­ence jour­nal, a few years ago that looked at the ap­proval of about 400 drugs from about 200 com­pa­nies and ranked the de­ter­mi­nants of suc­cess in get­ting a drug ap­proved. The sin­gle largest de­ter­mi­nant of suc­cess in drug de­vel­op­ment: killing a pro­gram early. Not be­cause you do, but rather be­cause of what it says about you as a de­vel­oper: you in­vest the re­quired time and money up­front to an­swer the crit­i­cal ques­tions, gen­er­ate ro­bust data as un­equiv­o­cal as pos­si­ble, and fol­low those data.

Of course, with pos­i­tive data the first crit­i­cal step is repli­ca­tion. Our ex­pe­ri­ence at CDRD mir­rors pretty closely the lit­er­a­ture in this re­gard: we can­not repli­cate the data pre­sented to us about two thirds of the time. We all know ex­per­i­ments and as­says can be tricky. Yet the fact re­mains that if we want to com­mer­cial­ize some­thing glob­ally, the un­der­ly­ing data need to be repli­ca­ble over and over and over again, and in any­body’s hands. Just as data must be repli­ca­ble, it must be ro­bust and deep. The or­ga­ni­za­tions that prove able to rise to these chal­lenges—and my col­leagues at CDRD strive to meet them all—will rapidly in­crease their prob­a­bil­ity of suc­cess.

And that prob­a­bil­ity of suc­cess is crit­i­cal, not just be­cause it de­fines whether or not we make money with an as­set, or get recog­ni­tion (and money) as a re­searcher, but be­cause of the fourth and most im­por­tant of the chal­lenges I want to ad­dress: the pa­tient. Each of us is ul­ti­mately serv­ing a pa­tient, a fam­ily mem­ber, a care­giver, some­one’s fa­ther, sis­ter, grand­par­ent, child. Our greater pur­pose, the one that de­fines this in­dus­try more dis­tinctly than any other in­dus­try in the world, is serv­ing the pa­tients who will ul­ti­mately re­ceive the treat­ments that we strive to de­velop.

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