Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clin­i­cal is the spe­cial­ist Aus­tralian CRO, with CGT ac­cred­i­ta­tion, for in­ter­na­tion­al biotechs that lever­ages Aus­tralia’s sup­port­ive clin­i­cal tri­als en­vi­ron­ment which in­cludes no IND re­quire­ment plus a 43.5% Gov­ern­ment in­cen­tive re­bate on clin­i­cal spend.

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The cell and gene ther­a­pies (CGT) sec­tor of­fers un­prece­dent­ed op­por­tu­ni­ties for pa­tient dis­ease man­age­ment across vir­tu­al­ly all ther­a­peu­tic ar­eas. How­ev­er, find­ing the right ac­cred­it­ed clin­i­cal teams to take a ther­a­py through to the clin­ic and man­age the reg­u­la­to­ry process can be a ma­jor chal­lenge for biotechs with a CGT prod­uct.

Ac­cord­ing to a re­cent Glob­al Da­ta and the Al­liance for Re­gen­er­a­tive Med­i­cine (ARM) re­port the sec­tor raised a record $14bn in H1 2021, com­pared to $19.9bn for all of 2020.

The re­port al­so high­lights that 2021 is on track to have the high­est num­ber of reg­u­la­to­ry ap­provals of gene ther­a­py and gene-mod­i­fied cell ther­a­py prod­ucts, with Eu­rope at risk of falling be­hind the US and Asia in terms of num­ber of de­vel­op­ers and new clin­i­cal tri­als.

GCT Reg­u­la­to­ry Land­scape

As biotechs con­tin­ue to in­vest heav­i­ly in clin­i­cal re­search in this rapid­ly evolv­ing sec­tor, the glob­al reg­u­la­to­ry au­thor­i­ties are un­der pres­sure to keep up with con­sis­tent and adap­tive guid­ance.

In Aus­tralia, the Of­fice of the Gene Tech­nol­o­gy Reg­u­la­tor (OGTR) has de­vel­oped glob­al­ly com­pli­ant reg­u­la­tions and ac­cred­i­ta­tions to en­sure that deal­ings with ge­net­i­cal­ly mod­i­fied or­gan­isms (GMOs) are safe­ly man­aged in Aus­tralia. The OGTR reg­u­la­tions are very much in line with in­ter­na­tion­al guide­lines.

Avance Clin­i­cal is an OGTR-ac­cred­it­ed CRO and al­ready has a num­ber of sig­nif­i­cant clin­i­cal tri­al suc­cess sto­ries with US and APAC biotech clients. &amp


Yvonne Lunger­shausen, CEO, Avance Clin­i­cal

Avance Clin­i­cal CEO Yvonne Lunger­shausen, said OGTR ac­cred­i­ta­tion is im­por­tant for our in­ter­na­tion­al clients.

“Our clients need to know that their CRO has all the nec­es­sary cre­den­tials and is ca­pa­ble of de­liv­er­ing the high­est of clin­i­cal re­search stan­dards in this ex­cit­ing and rapid­ly evolv­ing sec­tor,” she said.

“This ac­cred­i­ta­tion rec­og­nizes that Avance Clin­i­cal has the CRO re­sources and in­ter­nal process­es in place to ef­fec­tive­ly man­age pre-clin­i­cal and clin­i­cal tri­als for prod­ucts in­volv­ing ge­net­i­cal­ly mod­i­fied or­gan­isms (GMOs).”


Gabriel Krem­mid­i­o­tis, Chief Sci­en­tif­ic Of­fi­cer

Avance Clin­i­cal’s Chief Sci­en­tif­ic Of­fi­cer Dr. Gabriel Krem­mid­i­o­tis said:

“Avance Clin­i­cal cur­rent­ly has a num­ber of CGT stud­ies un­der­way and is ex­pand­ing its ser­vices fur­ther to ac­com­mo­date in­creas­ing glob­al de­mand.”

This emerg­ing sec­tor presents a new reg­u­la­to­ry fron­tier for spe­cial­ist CROs, sites and par­tic­i­pants.

“As an OGTR ac­cred­it­ed CRO we can guide our in­ter­na­tion­al biotech clients with deep knowl­edge on the OGTR guide­lines, al­low­ing us to sup­port our clients min­i­mize de­lays and risks. In­deed, we would ar­gue the clar­i­ty around the OGTR reg­u­la­tions makes Aus­tralia one of the most at­trac­tive des­ti­na­tions for CGT re­search,” said Dr.Gabriel Krem­mid­i­o­tis.”


Clini­cReady Man­ages Reg­u­la­to­ry Process

Avance Clin­i­cal’s Clini­cReady team sup­ports biotech clients through the en­tire process.

The key to a suc­cess­ful drug or ther­a­py de­vel­op­ment pro­gram is the foun­da­tion work by our ex­pe­ri­enced Clini­cReady reg­u­la­to­ry and sci­en­tif­ic af­fairs team who un­der­stand the guide­lines and path­ways for ap­proval for CGT prod­ucts in de­vel­op­ment.

The CTN path­way with the TGA may be uti­lized for gene ther­a­py clin­i­cal tri­als that are sup­port­ed by ev­i­dence from pre­vi­ous clin­i­cal use or ap­proval from com­pa­ra­ble reg­u­la­to­ry agen­cies.

Clin­i­cal tri­als of CGTs in­volv­ing GMOs are con­duct­ed un­der a prod­uct-spe­cif­ic DNIR (Does Not in­volve In­ten­tion­al Re­lease – 90 day time­frame to ob­tain li­cense) or DIR (Does in­volve In­ten­tion­al Re­lease – 150 days) li­cense from the OGTR. Avance Clin­i­cal ob­tains the li­cense on be­half of our client, pre­pares an OGTR Com­pli­ance Mon­i­tor­ing Plan, and mon­i­tors and man­ages the clin­i­cal site ac­tiv­i­ties to en­sure com­pli­ance with the li­cense con­di­tions. This ef­fec­tive­ly stream­lines the ap­proval process.

One of the most re­cent case stud­ies was Teth­erex Phar­ma­ceu­ti­cals, a US-based com­pa­ny de­vel­op­ing a sin­gle-cy­cle ade­n­ovi­ral vec­tor vac­cine (a ge­net­i­cal­ly mod­i­fied or­gan­ism prod­uct) for the treat­ment of COVID-19. The treat­ment is de­signed for in­tranasal de­liv­ery which is ex­pect­ed to pro­vide a more ef­fi­cient front-line de­fense against COVID-19 in air­way tis­sues, the site of virus en­try in­to the body. The vac­cine is cur­rent­ly un­der­go­ing safe­ty test­ing in healthy vol­un­teers.

The Avance Clin­ic Ready team worked with Teth­erex in the de­vel­op­ment of the study pro­to­col and the In­ves­ti­ga­tor’s Brochure while con­cur­rent­ly work­ing with the Of­fice of Gene Tech­nol­o­gy Reg­u­la­tor (OGTR) in ob­tain­ing the nec­es­sary li­cens­es to en­able im­por­ta­tion of the prod­uct to Aus­tralia for the pur­pose of clin­i­cal tri­al eval­u­a­tion.

“The Avance Clin­i­cal team demon­strat­ed flex­i­bil­i­ty and a so­lu­tion-ori­ent­ed at­ti­tude in work­ing with us to­wards ob­tain­ing rapid ethics ap­proval, there­by fa­cil­i­tat­ing tri­al ini­ti­a­tion in a time­ly and ef­fi­cient man­ner.”

Dr. Rus­sell Rother, Pres­i­dent and Chief Op­er­at­ing Of­fi­cer, Teth­erex Phar­ma­ceu­ti­cals

Clini­cReady – Case Study

Teth­erex Phar­ma­ceu­ti­cals
Teth­erex Phar­ma­ceu­ti­cals is a US-based com­pa­ny de­vel­op­ing a sin­gle-cy­cle ade­n­ovi­ral vec­tor vac­cine (a ge­net­i­cal­ly mod­i­fied or­gan­ism prod­uct) for the treat­ment of COVID-19. The treat­ment is de­signed for in­tranasal de­liv­ery which is ex­pect­ed to pro­vide a more ef­fi­cient front-line de­fense against COVID-19 in air­way tis­sues, the site of virus en­try in­to the body. The vac­cine is cur­rent­ly un­der­go­ing safe­ty test­ing in healthy vol­un­teers.

The Avance Clin­ic Ready team worked with Teth­erex in the de­vel­op­ment of the study pro­to­col and the In­ves­ti­ga­tor’s Brochure while con­cur­rent­ly work­ing with the Of­fice of Gene Tech­nol­o­gy Reg­u­la­tor (OGTR) in ob­tain­ing the nec­es­sary li­cens­es to en­able im­por­ta­tion of the prod­uct to Aus­tralia for the pur­pose of clin­i­cal tri­al eval­u­a­tion. No­tably, Avance is ac­cred­it­ed by the OGTR, which en­ables it to sup­port the ex­e­cu­tion of tri­als eval­u­at­ing ge­net­i­cal­ly mod­i­fied or­gan­ism prod­ucts in Aus­tralia. This sup­port in­volves the ap­pli­ca­tion and ac­qui­si­tion of a prod­uct spe­cif­ic li­cense from the OGTR and the mon­i­tor­ing and man­age­ment of the clin­i­cal site’s com­pli­ance with that li­cense.

AUTHOR

Meridee Arthur

Principal Scientific & Regulatory Affairs Specialist, Principal GCP Advisor