Is Aus­tralia the next Glob­al Des­ti­na­tion for Phase 2?

Avance Clin­i­cal is the lead­ing Aus­tralian CRO for biotechs, and a Frost & Sul­li­van Asia-Pa­cif­ic CRO Mar­ket Lead­er­ship Award win­ner. Avance Clin­i­cal is a full-ser­vice CRO with 24-years of ex­pe­ri­ence, led by CEO Yvonne Lunger­shausen who is recog­nised as co-founder of Aus­tralia’s clin­i­cal re­search in­dus­try. The com­pa­ny has deep ex­per­tise, as well as ex­ten­sive part­ner­ships with tech­nol­o­gy lead­ers in­clud­ing Me­di­da­ta, Or­a­cle, and Medrio to de­liv­er the re­gion’s best clin­i­cal tri­al ser­vices to its biotech clients. Avance Clin­i­cal grew more than 57% in 2020 and has more than dou­bled staff num­bers.

Please vis­it our web­site at https://www.avance­cro.com/ or email us at en­quiries@avance­cro.com for more in­for­ma­tion. 

Ac­cord­ing to Tri­al­Trove, there have been 1,411 in­dus­try spon­sored clin­i­cal tri­als re­cruit­ing in Aus­tralia and New Zealand since 2019, with 330 cur­rent­ly planned. Of these there are 144 Phase 2 stud­ies and 114 in Phase 3 and 4 stud­ies.

A year ago Aus­tralia was large­ly known pre­dom­i­nant­ly for its ear­ly phase ca­pa­bil­i­ties. How­ev­er much has changed with Aus­tralia be­com­ing the “COVID-19 free” en­vy of the world. Aus­tralia reg­u­lar­ly records ze­ro new dai­ly COVID-19 cas­es, backed by the world’s lead­ing con­tact trac­ing sys­tems, manda­to­ry trav­el quar­an­tine, and strict bor­ders.

Spon­sors are now stay­ing be­yond their Phase I stud­ies and start­ing their Phase 2 stud­ies in Aus­tralia as they dis­cov­er Aus­tralia is an ex­cep­tion­al med­ical re­search lo­ca­tion, es­pe­cial­ly amid a glob­al pan­dem­ic.

Hav­ing con­duct­ed sev­er­al Phase I stud­ies in Aus­tralia it made sense to con­tin­ue in the coun­try with our Phase II pro­gram, par­tic­u­lar­ly giv­en the high qual­i­ty sup­port we have re­ceived from our CRO.

Atossa Ther­a­peu­tics Inc

The Aus­tralian Shift Here to Stay

In ad­di­tion to the “COVID free” sta­tus, Aus­tralia out­per­forms in all qual­i­ty and com­pli­ance met­rics, and has demon­strat­ed it can de­liv­er the pa­tients need­ed via in­no­v­a­tive re­cruit­ment meth­ods and off-shoring part­ner­ships with pow­er­ful and proven site net­works in East­ern Eu­rope and Asia.

A key rea­son for con­tin­u­ing a study in Aus­tralia is the high­ly-re­gard­ed da­ta in­tegri­ty. Aus­tralian clin­i­cal re­search da­ta is reg­u­la­to­ry ready mean­ing it is ac­cept­ed by all ma­jor reg­u­la­to­ry au­thor­i­ties around the world.

Yvonne Lunger­shausen, CEO, Avance Clin­i­cal

“In­creas­ing­ly clients are see­ing the ad­van­tages of not on­ly con­duct­ing their Phase 1 stud­ies in Aus­tralia but then ex­pand­ing in­to Phase 2 mul­ti-sites start­ing in Aus­tralia first with rapid start-up, then out to oth­er re­gions.

Spon­sors can lever­age their strong re­la­tion­ships with PIs and KOLs for their Phase 2 ac­tiv­i­ty.

The Aus­tralian clin­i­cal and med­ical in­fra­struc­ture lends it­self to high­ly ef­fec­tive pa­tient re­cruit­ment.”

Yvonne Lunger­shausen, CEO, Avance Clin­i­cal

At­trac­tive Gov­ern­ment Re­bate

As­sured con­ti­nu­ity, speed, and lever­ag­ing the Aus­tralia Gov­ern­ment’s 43.5% re­bate in­cen­tive mean spon­sors are chos­ing to stay in Aus­tralia for their lat­er Phas­es, even to Phase 4.

There are some key ther­a­peu­tic ar­eas that are ide­al­ly suit­ed for Aus­tralia clin­i­cal re­search in­clud­ing on­col­o­gy, cen­tral ner­vous sys­tem, oph­thal­mol­o­gy, al­ler­gies and der­ma­tol­ogy.

Pa­tient Re­cruit­ment

Un­like most oth­er parts of the world right now, pa­tients in Aus­tralia can vis­it clin­ics and hos­pi­tals for study ap­point­ments with­out fear of con­tract­ing COVID-19. Al­so, med­ical fa­cil­i­ties are at their pre-COVID-19 pa­tient num­bers so are open for busi­ness as usu­al.

Gabriel Krem­mid­i­o­tis, PhD, BSC Hon., Chief Sci­en­tif­ic Of­fi­cer, Avance Clin­i­cal

“Ac­cord­ing to a re­cent re­port pub­lished by MT­P­Con­nect, there are 37 clin­i­cal tri­al net­works op­er­at­ing in Aus­tralia.

These net­works are led by high­ly ex­pe­ri­enced clin­i­cians and clin­i­cal re­search staff of­fer­ing a tri­al-ready in­fra­struc­ture with ac­cess to pa­tient groups in a wide range of ther­a­peu­tic in­di­ca­tions”

Gabriel Krem­mid­i­o­tis, Chief Sci­en­tif­ic Of­fi­cer, Avance Clin­i­cal

Aus­tralia is home to some of the most ad­vanced dig­i­tal re­cruit­ment com­pa­nies in the world. Com­pa­nies that of­fer dig­i­tal mi­cro-match­ing and screen­ing to speed up the en­roll­ment process at sites. Aus­tralian sites work close­ly with these in­no­v­a­tive firms, as well as hav­ing their own re­cruit­ment tools tap­ping spe­cial­ist physi­cian re­fer­rals and pa­tient ad­vo­ca­cy groups.

“Plexus Re­search, a Site Man­age­ment Or­gan­i­sa­tion, is build­ing a com­mu­ni­ty based clin­i­cal tri­al net­work in Aus­tralia to en­able Spon­sors to con­duct tri­als across Aus­tralia. To sup­port Phase II, in the time of Covid, Plexus has a de­cen­tralised clin­i­cal tri­al op­er­at­ing mod­el that en­ables Spon­sors and CROs to reach and con­duct tri­als near­er to tri­al par­tic­i­pants and en­abling bet­ter out­comes and low­er costs.”

Suhit Anan­tu­la, Founder & CEO, Plexus Re­search

In ad­di­tion, com­pa­nies like Avance Clin­i­cal have col­lab­o­ra­tions with off-shore sites in es­pe­cial­ly high pop­u­la­tion re­gions in Asia and Eu­rope. One of these is Cro­mos Phar­ma which has ac­cess to 2,000+ sites in East­ern Eu­rope. Avance Clin­i­cal and Cro­mos Phar­ma have suc­cess­ful­ly col­lab­o­rat­ed on stud­ies where there is lo­cal site and pa­tient in­volve­ment and oth­er func­tions such as med­ical writ­ing, da­ta man­age­ment and sta­tis­ti­cal analy­sis re­mains in Aus­tralia and ex­pand­ed rapid re­cruit­ment hap­pens in East­ern Eu­rope.

The Cost of Mov­ing

Mov­ing the next Phase of a study to a new lo­ca­tion rather than stay­ing with the same CRO and sites in­to Phase 2 can cost valu­able time and hun­dreds of thou­sands of dol­lars.

When the stakes are high and costs can spi­ral it makes sense to max­imise the time and cost ad­van­tages of the Aus­tralian en­vi­ron­ment to de­liv­er high qual­i­ty, reg­u­la­to­ry ready da­ta.