Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An in­crease in de­mand of up to 79% for clin­i­cal tri­als in Chi­na has prompt­ed Novotech the Asia-Pa­cif­ic CRO to rapid­ly ex­pand the Chi­na team, ap­point­ing ex­pert lo­cal clin­i­cal ex­ec­u­tives to their Shang­hai and Hong Kong of­fices. The com­pa­ny is plan­ning to ex­pand their team by 30% over the next quar­ter.

Dr John Moller, CEO, Novotech

Novotech Chi­na has seen con­sid­er­able de­mand re­cent­ly which is borne out by re­search from Glob­al­Da­ta:

A glob­al mi­gra­tion of clin­i­cal re­search is oc­cur­ring from high-in­come coun­tries to low and mid­dle-in­come coun­tries with emerg­ing economies. Over the pe­ri­od 2017 to 2018, for ex­am­ple, the num­ber of clin­i­cal tri­al sites opened by biotech com­pa­nies in Asia-Pa­cif­ic in­creased by 35% com­pared to 8% in the rest of the world, with growth as high as 79% in Chi­na.

Novotech CEO Dr John Moller said Chi­na of­fers the largest pop­u­la­tion in the world, rapid eco­nom­ic growth, and an in­creas­ing will­ing­ness by gov­ern­ment to in­vest in re­search and de­vel­op­ment.

Novotech’s 23 years of ex­pe­ri­ence work­ing in the re­gion means we are the ide­al CRO part­ner for USA biotechs want­i­ng to tap the re­search ex­per­tise and op­por­tu­ni­ties that Chi­na of­fers.

There are over 22,000 ac­tive in­ves­ti­ga­tors in Greater Chi­na, with about 5,000 in­ves­ti­ga­tors with ex­pe­ri­ence on at least 3 stud­ies (source Glob­al­Da­ta).

De­loitte re­search al­so point to the ben­e­fits of new Chi­na Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion  fast-track ap­proval process­es “and a po­ten­tial lo­cal-study waiv­er for prod­ucts tar­get­ing rare dis­eases or dis­eases with sub­stan­tial un­met needs, lead­ing to strong pro­gres­sion in new drugs ap­provals for both lo­cal and MNC com­pa­nies”.

Dr Moller said the key to Novotech’s suc­cess across the re­gion is a proven ap­proach to de­liv­er­ing qual­i­ty re­search that lever­ages lo­cal on the ground ex­per­tise.

“Our mis­sion in Chi­na is to de­liv­er the best re­search teams and in­ves­ti­ga­tors as well as the com­pli­ance and reg­u­la­to­ry ex­per­tise that is de­mand­ed and ex­pect­ed by the NM­PA and the FDA,” he said.

“We use the very lat­est in Or­a­cle and Me­di­da­ta tech­nol­o­gy, so seam­less­ly con­nect across all our of­fices and with glob­al clin­i­cal part­ners.”

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Yooni Kim Ex­ec­u­tive Di­rec­tor, Asia Op­er­a­tions, Novotech

Q&A with Yooni Kim Ex­ec­u­tive Di­rec­tor, Asia Op­er­a­tions

How does the US biotech sec­tor per­ceive the Asia-Pa­cif­ic re­gion and how has it been evolv­ing?
(Yooni Kim) The biotech sec­tor has now a sol­id grasp of the ben­e­fits of run­ning tri­als in Asia, which re­mains one of the fastest grow­ing re­gions for biotech-spon­sored tri­als. While Asia still of­fers com­plex­i­ties for the man­age­ment of clin­i­cal tri­als, with dif­fer­ing cul­tures and reg­u­la­to­ry re­quire­ments, part­ner­ing with a re­gion­al spe­cial­ist CRO can as­sist in match­ing spon­sor needs to coun­try char­ac­ter­is­tics.Across Asia you get ac­cess to 1.4 bil­lion of­ten treat­ment-naive pa­tients in easy and ac­ces­si­ble ur­ban ar­eas.

Many changes have oc­curred re­cent­ly in Chi­na. Could you tell us more about how it is af­fect­ing for­eign biotechs?
(Yooni Kim) The NM­PA (pre­vi­ous­ly Chi­nese FDA) is­sued a se­ries of reg­u­la­to­ry re­forms to ad­dress con­cerns around the pro­mo­tion of R&D ac­tiv­i­ty in Chi­na, es­pe­cial­ly from for­eign com­pa­nies. The main goals of the new re­forms were most­ly fo­cused on im­prov­ing the drug re­view process, short­en­ing the In­ves­ti­ga­tion­al New Drug (IND) and New Drug Ap­pli­ca­tion (NDA) re­view time­lines and en­cour­ag­ing new drug in­no­va­tion. Greater Chi­na has a pool of over 22,000 ac­tive in­ves­ti­ga­tors and a tri­al den­si­ty that is much low­er than in North Amer­i­ca. As spon­sors are fac­ing in­creased com­pe­ti­tion in the US and Eu­rope for in­ves­ti­ga­tors, sites, and pa­tients, we see an in­creased de­mand from our clients to ex­pand their clin­i­cal de­vel­op­ment over there.

Key Chi­na Facts

• Rel­a­tive­ly ho­moge­nous pop­u­la­tion (92% Han Chi­nese)
• Over 750 glob­al com­pa­nies have re­search cen­ters in Chi­na
• Reg­u­la­to­ry frame­work in­creas­ing­ly em­u­lat­ing the FDA struc­ture
• Gov­ern­ment pledge to ded­i­cate USD18 bil­lion to emerg­ing biotech­nolo­gies in lat­est five year plan
• Largest clin­i­cal re­search mar­ket in Asia and 5th largest clin­i­cal re­search mar­ket in the world.
• The Chi­na Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (pre­vi­ous­ly CF­DA) is the main reg­u­la­to­ry body in Chi­na.
• Eval­u­a­tion of bi­o­log­ics is strin­gent re­quir­ing as­sess­ment by and ap­proved eval­u­a­tion cen­ter.
• The av­er­age time­line for reg­u­la­to­ry ap­proval is now about 8 months com­pared with up to 24 months pre­vi­ous­ly.

About Novotech CRO

Head­quar­tered in Syd­ney, Aus­tralia Novotech is in­ter­na­tion­al­ly rec­og­nized as the lead­ing Asia-Pa­cif­ic re­gion’s full-ser­vice con­tract re­search or­ga­ni­za­tion (CRO). Novotech has been in­stru­men­tal in the suc­cess of hun­dreds of Phase I – IV clin­i­cal tri­als in the Asia Pa­cif­ic re­gion.

Novotech has been based in the Asia Pa­cif­ic re­gion for more than 24 years and is well es­tab­lished with of­fices in 11 coun­tries and more than 600 staff.

Novotech pro­vides clin­i­cal de­vel­op­ment ser­vices across all clin­i­cal tri­al phas­es and ther­a­peu­tic ar­eas in­clud­ing: fea­si­bil­i­ty as­sess­ments; ethics com­mit­tee and reg­u­la­to­ry sub­mis­sions, da­ta man­age­ment, sta­tis­ti­cal analy­sis, med­ical mon­i­tor­ing, safe­ty ser­vices, cen­tral lab ser­vices, re­port write-up to ICH re­quire­ments, project and ven­dor man­age­ment. Novotech’s strong Asia Pa­cif­ic pres­ence in­cludes run­ning clin­i­cal tri­als in all key re­gion­al mar­kets. Novotech al­so has world­wide reach through the com­pa­ny’s net­work of strate­gic part­ners.