"War for tal­ent is ma­jor chal­lenge be­fore APAC CROs"

-Anand Thar­marat­nam, Pres­i­dent IQVIA Asia Pa­cific, Sin­ga­pore

BioSpectrum (Asia) - - FRONT PAGE - Anand Thar­marat­nam, Pres­i­dent, IQVIA Asia Pa­cific, Sin­ga­pore

Phar­ma­ceu­ti­cal and biotech­nol­ogy com­pa­nies are in­creas­ingly out­sourc­ing clin­i­cal tri­als to con­tract re­search or­ga­ni­za­tions (CROs). In 2015, the global con­tract CRO mar­ket gen­er­ated $ 31.4 bil­lion in rev­enue, and is fore­cast to grow at a CAGR of 12.1 per cent, to reach $56.4 bil­lion by 2020 (Frost & Sul­li­van). The grow­ing de­mand for CROs un­der­scores the im­por­tance of out­sourc­ing in drug re­search and de­vel­op­ment. Ris­ing re­search costs cou­pled with the loss of rev­enue due to drugs go­ing off patent are lead­ing large bio/ phar­ma­ceu­ti­cal com­pa­nies to out­source re­search and de­vel­op­ment ac­tiv­i­ties in a more cost-ef­fec­tive man­ner. How­ever, to date, CROs pen­e­trate only about 29 per cent of the po­ten­tially out­sourced R&D bud­get. It is an­tic­i­pated that CRO mar­ket will be pri­mar­ily driven by greater pen­e­tra­tion of the out­sourc­ing R&D bud­gets. Re­cently, Anand Thar­marat­nam, Pres­i­dent, IQVIA Asia Pa­cific spoke to BioSpec­trum Asia, Sin­ga­pore re­gard­ing the cur­rent trends and chal­lenges faced by the CRO in­dus­try in APAC. Edited ex­cerpts; What are the sig­nif­i­cant trends for the CRO in­dus­try in APAC for 2018? The use of tech­nol­ogy and data to im­prove de­ci­sion­mak­ing and ex­e­cu­tion – by far the big­gest trend we’re see­ing. Most CROs are in­vest­ing heav­ily in tech­nol­ogy and an­a­lyt­ics; many have added new sources of health­care data. This con­ver­gence of tech and data is trans­form­ing how tri­als are de­signed and con­ducted. Lead­ing this are large multi­na­tional CROs with deep pock­ets for tech de­vel­op­ment and data ac­qui­si­tion. For ex­am­ple, last year we rolled out new tech tools in Asia Pa­cific to im­prove re­cruit­ing through bet­ter site se­lec­tion and iden­ti­fi­ca­tion of tar­get pa­tient pop­u­la­tions; in­ves­ti­ga­tors are adopt­ing our spe­cial­ized apps and soft­ware sys­tems to stream­line mon­i­tor­ing and au­to­mate con­sent form com­ple­tion. The use of real-world data to in­form the clin­i­cal tri­als plan­ning process is an­other trend ac­cel­er­at­ing in 2018. In­stead of re­ly­ing on data from past tri­als to de­sign new tri­als we’re using real-world data to fill in blind spots. Clients are see­ing the ben­e­fits. I be­lieve our bio­pharma client base is mov­ing to­ward an ‘early ma­jor­ity’ phase of in­no­va­tion adop­tion. Clients don’t want to be left be­hind by com­peti­tors using these new tools. Even more ex­cit­ing in­no­va­tions are com­ing. Ar­ti­fi­cial in­tel­li­gence, ma­chine learn­ing and nat­u­ral lan­guage pro­cess­ing should re­sult in short­ened cy­cle times and im­proved qual­ity at ev­ery stage of de­vel­op­ment. For ex­am­ple, it now takes weeks to trans­late study doc­u­ments into lan­guages needed. Using tech­nol­ogy this can be done in days, with hu­man trans­la­tors dou­ble-check­ing the ma­chine-gen­er­ated trans­la­tions – sav­ing money and time while im­prov­ing qual­ity.

Soar­ing R&D costs and de­clin­ing ROI are forc­ing com­pa­nies to break from tra­di­tional prac­tices. De­liv­ery ap­proaches are chang­ing too. Multi­na­tion­als are shift­ing to­ward a func­tional ser­vice provider model in ar­eas such as mon­i­tor­ing. For smaller com­pa­nies we’re see­ing a trend to­ward pure out­sourc­ing, es­pe­cially in reg­u­la­tory and study de­sign. Lastly, medtech de­vel­op­ment in Asia Pa­cific is pick­ing up steam, with growth op­por­tu­ni­ties for CROs that have this ca­pa­bil­ity in their arse­nal. This trend is fu­elled by two fac­tors: the bio­pharma in­dus­try’s in­creas­ing ap­petite for in­cor­po­rat­ing digital tech­nolo­gies into ther­a­pies, and Asia Pa­cific’s ad­van­tages in medtech de­vel­op­ment speed and costs. One can­not un­der­es­ti­mate the trend to­ward digital ther­a­pies, both stand-alone and those meld­ing mol­e­cules and digital. Many tra­di­tional bio­pharma com­pa­nies are in­ves­ti­gat­ing such com­bi­na­tion prod­ucts. The US FDA last year ap­proved the first-ever pre­scrip­tion digital ther­apy (de­vel­oped by Pear Ther­a­peu­tics) for the treat­ment of pa­tients with sub­stance use dis­or­der. A few months later No­var­tis and Pear Ther­a­peu­tics an­nounced a col­lab­o­ra­tion to bring more pre­scrip­tion digital ther­a­peu­tics and soft­ware apps to mar­ket. What are key chal­lenges? How do these chal­lenges im­pact early stage pharma com­pa­nies? Data pri­vacy and data own­er­ship will be an on­go­ing chal­lenge. Adop­tion of tech­nolo­gies pow­ered by ag­gre­gated, de-iden­ti­fied health data re­quires that the pub­lic trust that their per­son­ally iden­ti­fi­able

records will be safe­guarded. Data providers must bal­ance their roles as stew­ards of data while pro­vid­ing ac­cess to trusted par­ties and in­sti­tu­tions that will use anonymized health­care data to de­velop life-sav­ing drugs more ef­fi­ciently and im­prove health out­comes.

Spe­cific to early stage pharma I see their big­gest chal­lenge as find­ing the ex­per­tise they need. Where do they place their bets to achieve the great­est like­li­hood of suc­cess? The ear­lier the stage of de­vel­op­ment the greater the un­cer­tain­ties. These com­pa­nies need data but also the ex­per­tise to make sense of it. Do­ing that ef­fi­ciently on a limited bud­get is early stage pharma’s big­gest chal­lenge. For large multi­na­tional com­pa­nies, the chal­lenges are dif­fer­ent. They face adopt­ing new tech­nolo­gies while co-run­ning or phas­ing out legacy sys­tems. That’s an ad­van­tage for emerg­ing bio­pharma – they aren’t sad­dled with legacy sys­tems. We see emerg­ing com­pa­nies in Asia be­ing very open to in­no­va­tive ideas and adop­tion of new tech­nolo­gies. They’re not tied to past prac­tices or legacy sys­tems.

The over­all re­cep­tiv­ity of bio­pharma and reg­u­la­tors to adopt­ing and/or ap­prov­ing in­no­va­tive ap­proaches is a chal­lenge. While bio­pharma is talk­ing a lot about in­no­va­tion, some com­pa­nies are pay­ing lip ser­vice while oth­ers are ‘walk­ing the talk’. We still see con­ser­vatism as the pre­vail­ing mind­set over­all for large com­pa­nies; this is slow­ing the adop­tion of in­no­va­tion. Fi­nally, for CROs, a ma­jor chal­lenge in Asia Pa­cific is the war for tal­ent. With bio­pharma and medtech com­pa­nies in­creas­ingly using CRO ser­vices in the re­gion, ac­quir­ing and re­tain­ing top tal­ent is cru­cial. We’re using in­no­va­tive ways to do that. It’s not all about salary. In ad­di­tion to ca­reer de­vel­op­ment, to­day’s younger work­ers want to work for a com­pany that of­fers flex­i­bil­ity, work-life bal­ance, and is so­cially re­spon­si­ble. There is con­nect be­tween CROs and bio­pharma com­pa­nies achiev­ing their R&D tar­gets. How do you en­vi­sion the re­la­tion­ship of a CRO with such com­pa­nies to achieve their mu­tual tar­gets? The client is al­ways at the cen­ter of any suc­cess­ful client-CRO re­la­tion­ship. Ev­ery client is dif­fer­ent: dif­fer­ent strate­gies, dif­fer­ent short- and long-term goals, im­me­di­ate needs, etc. Most im­por­tant is for a CRO to un­der­stand those needs and de­liver against them. Achiev­ing suc­cess and build­ing trust are es­sen­tial to move from a trans­ac­tional, cost-based re­la­tion­ship to a strate­gic one fo­cused on value cre­ation. A strate­gic re­la­tion­ship with a trusted CRO al­lows a bio­pharma com­pany to keep core ca­pa­bil­i­ties in house and out­source non-core func­tions. Both par­ties align on mu­tu­ally agreed-upon ob­jec­tives. This shifts re­spon­si­bil­ity to­ward the CRO to de­liver with ef­fi­ciency, qual­ity and speed; it is ac­count­able for out­comes vs

sim­ply pro­vid­ing ser­vices on a fee-for-ser­vice ba­sis. The fu­ture be­longs to CROs that are tech-savvy, datarich, client-cen­tric, flex­i­ble and ea­ger to share risks and re­wards. For some clients the tra­di­tional fee-forser­vice, ‘ex­tra hands for hire’ CRO model is fine; it’s be­ing trans­formed for the bet­ter by tech and data too. Other clients are ea­ger to in­no­vate. They want to ac­cess the full range of what lead­ing global CROs can of­fer – ther­a­peu­tic ex­per­tise, trans­for­ma­tive tech, data-driven in­sights, global in­fra­struc­ture, etc.

Ten years ago, most of our clients in Asia were large multi­na­tion­als. While each had spe­cific needs, they were more alike than dis­sim­i­lar. Now home-grown emerg­ing bio­pharma com­pa­nies – par­tic­u­larly in Greater China, Korea, Sin­ga­pore and Aus­tralia – ac­count for a large por­tion of our clients. These com­pa­nies are di­verse; they are open to in­no­va­tion; they lack deep pock­ets; they want a sin­gle point of con­tact and fast de­ci­sion­mak­ing. To com­pete ef­fec­tively across that client spec­trum re­quires a model that is ex­tremely flex­i­ble and nim­ble. Win­ning CROs must be able to show they can de­liver out­comes bet­ter than the com­pe­ti­tion – faster, bet­ter, cheaper, with high qual­ity. It’s im­por­tant to re­mem­ber that our tough­est com­peti­tors are our clients them­selves. Per­haps most im­por­tant for in­no­va­tion support is the abil­ity to lever­age third-party tech­nol­ogy. Tech solutions are con­stantly emerg­ing. The abil­ity to find and adopt in­no­va­tive third-party tech­nolo­gies to ad­dress client needs is es­sen­tial to a suc­cess­ful 21st cen­tury CRO busi­ness model. The ac­qui­si­tion and merg­ing of com­pa­nies within the phar­ma­ceu­ti­cal in­dus­try has de­creased dras­ti­cally. Do you think this is im­pact­ing the CRO in­dus­try? How? With merger ac­tiv­ity hav­ing slowed, we’re see­ing de­mand from large multi­na­tion­als for func­tional ser­vice provider (FSP) agree­ments. The FSP model gives these com­pa­nies greater over­sight of staff that we pro­vide to carry out a func­tion for the client – a com­bi­na­tion of staff, con­trol and flex­i­bil­ity. On the flip side, we’re see­ing greater de­mand from emerg­ing bio­pharma com­pa­nies for out­sourc­ing en­tire clin­i­cal pro­grammes. These re­quests can ex­tend be­yond de­sign and ex­e­cu­tion of stud­ies to com­mer­cial­iza­tion and li­cens­ing. The issue these com­pa­nies want ad­dressed is ‘How can we max­i­mize the value of our port­fo­lio?’ They see it holistically across the clin­i­cal-com­mer­cial con­tin­uum vs ‘How do we get to the next stage of de­vel­op­ment for this as­set?’

Priyanka Ba­j­pai priyanka.ba­j­[email protected]­tiv.com What kind of a CRO-spe­cific busi­ness model best sup­ports in­no­va­tion?

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