For two months, as the nov­el coro­n­avirus swelled from a few ear­ly cas­es tied to a Wuhan mar­ket to a glob­al epi­dem­ic, most of the world’s fo­cus and dol­lars have flowed to­ward emer­gency ini­tia­tives: build­ing vac­cines at a record pace, pluck­ing ex­per­i­men­tal an­tivi­rals out of freez­ers to see what sticks and im­mu­niz­ing mice for new an­ti­bod­ies.

Now a new and well-fund­ed col­lab­o­ra­tion be­tween Har­vard and a top Chi­nese re­search in­sti­tute will play the long game. In a 5-year, $115 mil­lion ini­tia­tive backed by Chi­na Ever­grande Group, re­searchers from the Har­vard Med­ical School, Har­vard T.H. Chan School of Pub­lic Health and Guangzhou In­sti­tute for Res­pi­ra­to­ry Health will study the virus in an ef­fort to de­vel­op ther­a­pies against in­fec­tions by the nov­el coro­n­avirus, known as SARS-CoV-2, and to pre­vent new ones.

The Chi­nese side of the ini­tia­tive is led by Zhong Nan­shan, head of the Chi­nese 2019-nCoV Ex­pert Task­force and the sci­en­tist who iso­lat­ed the SARS virus in 2003. He is al­so di­rec­tor-gen­er­al of the Chi­na State Key Lab­o­ra­to­ry of Res­pi­ra­to­ry Dis­eases.

“Har­vard Med­ical School is unique­ly po­si­tioned to con­vene ex­perts in vi­rol­o­gy, in­fec­tious dis­ease, struc­tur­al bi­ol­o­gy, pathol­o­gy, vac­cine de­vel­op­ment, epi­demi­ol­o­gy, and pub­lic health to con­front this rapid­ly evolv­ing cri­sis,” George Da­ley, dean of the Har­vard Med­ical School, said in a state­ment.

The ini­tia­tive will fo­cus on five ar­eas. That in­cludes de­vel­op­ing tests for rapid di­ag­no­sis, vac­cines, an­tivi­ral treat­ments to short­en the du­ra­tion of the dis­ease and mit­i­gate symp­toms, and oth­er treat­ments for pa­tients with se­vere dis­ease. Re­searchers will al­so try to un­der­stand how the body in­ter­acts with the virus. The hope is that they can find bio­mark­ers that will tell doc­tors if the in­fec­tion is wors­en­ing or will lead to life-threat­en­ing com­pli­ca­tions.

These ar­eas rep­re­sent the con­stel­la­tion of needs and un­knowns for a virus pub­lic health of­fi­cials in­creas­ing­ly fear will reach pan­dem­ic lev­els, and could be­come an an­nu­al in­fec­tion like the flu. Al­though the virus may yet dis­si­pate, ex­perts have em­pha­sized the need for long-term fund­ing that can im­prove readi­ness for fu­ture out­breaks, a need Har­vard un­der­scored in its an­nounce­ment.

The “re­sponse needs to be glob­al, rapid, and dri­ven by the best sci­ence,” Har­vard provost Alan Gar­ber said. “The lessons we learn from this out­break should en­able us to re­spond to in­fec­tious dis­ease emer­gen­cies more quick­ly and ef­fec­tive­ly in the fu­ture.”

Di­ag­no­sis has proven to be a con­tin­u­al chal­lenge through­out the virus’ spread. In Wuhan and the sur­round­ing Hubei province, the num­ber of pa­tients re­port­ing symp­toms rapid­ly out­stripped the sup­ply of nu­cle­ic acid test­ing kits used to con­firm the pres­ence of a virus. De­lays in di­ag­no­sis meant de­lays in quar­an­tine and treat­ment.

At the be­hest of Chi­nese doc­tors, of­fi­cials moved to CT scans to de­tect pneu­mo­nia, a symp­tom of the in­fec­tion, and then lat­er us­ing the test­ing kits as con­fir­ma­tion. But some in­fect­ed pa­tients show up neg­a­tive in CT scans, and as the virus has spilled out be­yond Chi­na’s bor­ders, how to test pa­tients in the fastest and most ac­cu­rate man­ner has be­come an is­sue of glob­al con­cern and a ma­jor point of dis­cus­sion at the World Health Or­ga­ni­za­tion and the US Cen­ter for Dis­ease Con­trol.

Har­vard has not said what forms of treat­ments they will in­ves­ti­gate. Thus far, most of the treat­ments used are an­tivi­rals orig­i­nal­ly de­vel­oped for oth­er pur­pos­es – in­clud­ing remde­sivir, the Gilead drug orig­i­nal­ly de­vel­oped for Ebo­la and Mar­burg virus, and lopinavir, an HIV drug – but doc­tors have flung a wide range of spec­u­la­tive ther­a­pies hop­ing to see what sticks. That in­cludes plas­ma treat­ments, an­ti­bod­ies oth­er coro­n­avirus pa­tients de­vel­oped in re­sponse to the virus and a tra­di­tion­al Chi­nese rem­e­dy drawn from ex­tracts of For­syth­iae fruc­tus. The ear­li­est drugs de­vel­oped specif­i­cal­ly for the virus are at least 5 months away from clin­i­cal tri­als.

Vac­cines ap­pear clos­er, with Mod­er­na and the NIH gun­ning for a clin­i­cal tri­al to start in the spring. How­ev­er, that us­es a tech­nol­o­gy that has yet to pro­duce an ap­proved vac­cine. Oth­er ef­forts, such as Glax­o­SmithK­line’s and Clover’s new part­ner­ship, are us­ing more tra­di­tion­al ap­proach­es but have longer time­lines.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.