The Fu­ture of Vac­cine Re­search: the Evolv­ing Glob­al Land­scape

In just over 2 years the vac­cine de­vel­op­ment win­dow has gone from 8-10 years to 260 days. Now the in­dus­try is look­ing at a 60-day turn­around tar­get. Post-COVID-19 the sec­tor is po­si­tioned to rapid­ly de­vel­op ther­a­pies across al­most all ther­a­peu­tic ar­eas in­clud­ing in­fec­tious dis­eases, on­col­o­gy, rare dis­eases, CNS, au­toim­mune dis­eases, and more.

Novotech re­cent­ly brought to­geth­er lead­ers in the vac­cine sec­tor to share lessons learned and what the fu­ture holds for vac­cine de­vel­op­ment.

The pan­el com­prised:

• Sushant Sa­has­tra­bud­dhe, As­so­ciate Di­rec­tor Gen­er­al with the In­ter­na­tion­al Vac­cine In­sti­tute, Ko­rea.
• Paul Grif­fin, in­fec­tious dis­ease physi­cian and Clin­i­cal Di­rec­tor of In­fec­tious Dis­eases at Mater Health Ser­vices, and As­so­ciate Pro­fes­sor at the Uni­ver­si­ty of Queens­land Med­ical School.
• Baba­ji Ya­dav, Se­nior Con­sul­tant with Novotech Drug De­vel­op­ment Con­sult­ing.
• Jen­ny Arel­lano, Novotech’s Di­rec­tor of Clin­i­cal Ser­vices in the Philip­pines.

The pan­elists agreed that COVID-19 has been the cat­a­lyst for mas­sive change in vac­cine de­vel­op­ment in­clud­ing rapid glob­al tri­als, FDA ap­proval process­es, and ad­vanced man­u­fac­tur­ing so­lu­tions. Most im­por­tant­ly many of these new process­es have been per­ma­nent­ly adopt­ed by Gov­ern­ments and reg­u­la­to­ry au­thor­i­ties mak­ing new vac­cine de­vel­op­ment faster and more re­spon­sive to health chal­lenges.

They al­so said that the rapid de­vel­op­ment of mR­NA tech­nolo­gies has been key to ac­cel­er­at­ed vac­cine de­vel­op­ment, say­ing the plug-and-play ap­proach of­fers a fu­ture of ex­po­nen­tial growth at rapid speed and low cost.

The pan­elists not­ed that the fu­ture is al­ready see­ing new de­liv­ery sys­tems in­clud­ing in­tranasal and patch­es, many of which of­fer at-home ad­min­is­tra­tion.

Part­ner­ships in De­vel­op­ment

A pri­or­i­ty for vac­cine de­vel­op­ment ac­cord­ing to Jen­ny Arel­lano is the care­ful se­lec­tion of part­ners with a strong foot­print across the ge­o­gra­phies, and ex­per­tise band­width to sup­port the en­tire drug de­vel­op­ment pro­gram on a lo­cal and glob­al scale.

Per­ma­nent Changes at Reg­u­la­to­ry Au­thor­i­ties

Dr. Sushant Sa­has­tra­bud­dhe said: “One pos­i­tive point that we have seen dur­ing COVID-19 is the way the reg­u­la­to­ry agen­cies showed flex­i­bil­i­ty in terms of re­view­ing the pro­to­cols, giv­ing clear guid­ance to the man­u­fac­tur­ers, de­vel­op­ers, and gov­ern­ments, and hav­ing a very clear strat­e­gy in terms of how and when to li­cense the prod­ucts.”

Jen­ny Arel­lano said: Like the rest of the world, Asia Pa­cif­ic reg­u­la­to­ry bod­ies have al­so re­spond­ed pos­i­tive­ly to rapid vac­cine re­view process­es. “The reg­u­la­to­ry and ethics bod­ies quick­ly put an in­fra­struc­ture for con­tin­ued ser­vice to re­view clin­i­cal tri­al ap­pli­ca­tions dur­ing the pan­dem­ic. More­over, for COVID-19 in par­tic­u­lar, reg­u­la­to­ry au­thor­i­ties in Asia Pa­cif­ic have ac­tu­al­ly opened the doors for rapid re­view and put in place, tech­ni­cal ex­perts to sup­port the re­view process.”

New ap­proach­es to clin­i­cal tri­als – re­mote mon­i­tor­ing

Dr. Sushant Sa­has­tra­bud­dhe said un­til last year, “al­most 75% of our re­search was on COVID-19 vac­cine. Oth­er vac­cines got de­pri­or­i­tized. Now I think we are com­ing back to the vac­cine pri­or­i­ties. We are di­ver­si­fy­ing, again on the dis­eases that are im­por­tant for glob­al pub­lic health.”

One of the new ap­proach­es to tri­al de­sign that we will see more of in vac­cine de­vel­op­ment is re­mote mon­i­tor­ing, she said.

“There are some spon­sors, and some CROs like Novotech, who are us­ing this op­tion. I think dur­ing COVID-19, we re­al­ized that we can do much more by man­ag­ing things re­mote­ly, as much as we were do­ing be­fore.”

New De­liv­ery Sys­tems

Dr. Paul Grif­fin said: “I re­al­ly think in­tranasal vac­cines are go­ing to be an im­por­tant part of not on­ly what we do with COVID, but oth­er res­pi­ra­to­ry pathogens as well. There are some re­al­ly good ap­proach­es that are pro­gress­ing well through clin­i­cal tri­als with in­tranasal vac­cines.

I al­so think that vac­cines in­to the skin via patch­es are go­ing to be a re­al­ly im­por­tant part of our strat­e­gy mov­ing for­ward. They have a lot of re­al­ly in­ter­est­ing prop­er­ties in­clud­ing be­ing sta­ble at room tem­per­a­ture for long pe­ri­ods of time.”

Plat­form Tech­nolo­gies

Dr. Baba­ji Ya­dav said: “Plat­form tech­nolo­gies can cer­tain­ly be used to lever­age some of the clin­i­cal safe­ty and ef­fi­ca­cy da­ta es­tab­lished with your pro­to­type vac­cines to sup­port or ac­cel­er­ate the clin­i­cal de­vel­op­ment of your mod­i­fied vac­cines or sub­se­quent vac­cines. Plat­form tech­nol­o­gy is ba­si­cal­ly a ma­chin­ery or a tool that ef­fec­tive­ly de­liv­ers an anti­gen, and en­hances its im­muno­genic­i­ty.

From my ex­pe­ri­ence here at Novotech where I am cur­rent­ly work­ing with a num­ber of clients, we have seen this ap­proach be­ing very well-ac­cept­ed by reg­u­la­to­ry agen­cies around the globe, for mR­NA vac­cines, DNA vac­cines, even per­son­al­ized can­cer vac­cines that used plas­mid DNA or lipid nanopar­ti­cles as a plat­form tech­nol­o­gy.

USF­DA ac­tu­al­ly al­so has pub­lished a guid­ance on pub­lic health emer­gency use of vac­cines where they have stat­ed that if you are de­vel­op­ing a mod­i­fied form of vac­cine against a new vi­ral strain, and as long as you keep the man­u­fac­tur­ing process the same, then you can sub­mit an ab­bre­vi­at­ed da­ta pack­age with just the phar­ma­col­o­gy and im­muno­genic­i­ty stud­ies with your mod­i­fied vac­cine with­out hav­ing to re­peat con­cepts of tox­i­col­o­gy stud­ies, which may take time and it costs some mon­ey as well.”

Ac­cel­er­at­ing tri­als – Pa­tient Re­cruit­ment

Jen­ny Arel­lano said: We know that the Asia Pa­cif­ic re­gion has more than 4 bil­lion peo­ple, which rep­re­sent 60% of the world’s pop­u­la­tion. There’s al­so a large num­ber of treat­ment-naive par­tic­i­pants or in­di­vid­u­als. If you com­bine this with the pres­ence of a het­ero­ge­neous pop­u­la­tion, it makes these char­ac­ter­is­tics at­trac­tive for vac­cine tri­als. Cou­ple this with al­so the re­search en­vi­ron­ment for vac­cines re­quir­ing a large study pop­u­la­tion as well as a rich tri­al ex­pe­ri­ence in these re­gions.

The re­gion al­so of­fers a high suc­cess rate in re­cruit­ment de­liv­ery, high re­ten­tion of par­tic­i­pants in the clin­i­cal tri­al, and as such, high com­pli­ance to pro­to­col-re­quired vis­its. In par­al­lel, the im­prove­ment in the reg­u­la­to­ry land­scape and in­creas­ing in­vest­ment in tri­al in­fra­struc­ture and the low­er cost of run­ning clin­i­cal tri­als, are all con­trib­u­to­ry fac­tors in the at­trac­tive­ness of the re­gion for vac­cine tri­als.

About Novotech CRO

Novotech is the lead­ing Asia Pa­cif­ic-cen­tered biotech CRO with glob­al ex­e­cu­tion ca­pa­bil­i­ties. Novotech has ex­pe­ri­ence in ~100 vac­cine tri­als across all phas­es of de­vel­op­ment and has es­tab­lished strong site col­lab­o­ra­tion with over 800 vac­cine tri­al sites glob­al­ly. Vac­cine tri­als in Asia Pa­cif­ic have grown 2x faster than the ROW at 15.7% CA­GR be­tween 2018 and 2022 and con­tributed the ma­jor share of ~40% of glob­al vac­cine stud­ies from 2018 – 2022. Chi­na, Aus­tralia, In­dia, Japan, and South Ko­rea are the top lo­ca­tions for vac­cine tri­als.

Novotech is a clin­i­cal CRO with labs, phase I fa­cil­i­ties, drug de­vel­op­ment con­sult­ing ser­vices and FDA reg­u­la­to­ry ex­per­tise and has ex­pe­ri­ence in over 5,000 clin­i­cal projects, in­clud­ing Phase I to Phase IV clin­i­cal tri­als and bioe­quiv­a­lence stud­ies. Novotech is po­si­tioned to serve biotech clients con­duct­ing clin­i­cal tri­als in Asia Pa­cif­ic, the US, and Eu­rope. Novotech has over 3,000 staff glob­al­ly and 34 of­fice lo­ca­tions across the US, Eu­rope, and Asia Pa­cif­ic.

For more in­for­ma­tion vis­it https://novotech-cro.com/con­tact