Green­Light Bio­sciences has come a long way from try­ing to shake up the pes­ti­cides mar­ket.

The Med­ford, MA biotech signed a deal Mon­day with the Serum In­sti­tute of In­dia to de­sign three mR­NA prod­ucts, in­clud­ing a shin­gles vac­cine, for de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion in a num­ber of mar­kets around the world.

Green­Light will re­tain the rights to North Amer­i­ca, Eu­rope, Aus­tralia, New Zealand, Chi­na, Japan and South Ko­rea, while SII will get a tech trans­fer to work in Africa, Latin Amer­i­ca, the Mid­dle East and much of Asia. The deal pig­gy­backs off of a $10 mil­lion in­vest­ment made by Serum Life Sci­ences in No­vem­ber 2021.

Green­Light will re­ceive up­front pay­ments and is el­i­gi­ble for ex­clu­siv­i­ty, de­vel­op­ment mile­stones, and man­u­fac­tur­ing tech­nol­o­gy trans­fer pay­ments. Mean­while, SII will pay for the de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial­iza­tion for each emerg­ing mar­ket, as Green­Light will re­tain a per­cent­age of those prof­its.

“Green­Light’s ap­proach res­onates with our mis­sion to make health­care eq­ui­table for all,” SII CEO Adar Poon­awal­la said in a state­ment. “Mes­sen­ger RNA tech­nol­o­gy will play a key role in re­duc­ing the bur­den of hu­man suf­fer­ing caused by vac­cine-pre­ventable dis­eases across LMICs.”

There is an op­tion to ex­pand the li­cense to two ad­di­tion­al vac­cines or ther­a­pies to be named lat­er, Green­Light said in a re­lease, and the shin­gles vac­cine man­u­fac­tur­ing process will be trans­ferred to the SII fa­cil­i­ty in Pune, In­dia.

The com­pa­ny was found­ed in 2008 to use its mR­NA tech­nol­o­gy most­ly on agri­cul­ture, in­clud­ing hon­ey­bees and crops. Since an Au­gust re­verse-merg­er, the com­pa­ny has been work­ing on a vac­cine for sea­son­al flu and a treat­ment for sick­le cell dis­ease.

It al­so land­ed a $1.5 bil­lion val­u­a­tion, and has pro­posed build­ing sev­en new mR­NA man­u­fac­tur­ing fa­cil­i­ties to bring glob­al ca­pa­bil­i­ties up to snuff. Green­Light’s plat­form com­bines two mR­NA ap­proach­es — one that in­volves fer­men­ta­tion-based process­es and an­oth­er uti­lized by high-pro­file com­pa­nies like Mod­er­na and BioN­Tech in­volv­ing tran­scrip­tion, and that helps pro­duce prod­ucts at a high­er scale in a more af­ford­able man­ner.

In De­cem­ber, Green­Light inked a deal with Sam­sung Bi­o­log­ics to man­u­fac­ture its mR­NA Covid-19 vac­cine com­mer­cial­ly. Right around that same time, SII an­nounced that it would waive its pro­tec­tion from le­gal li­a­bil­i­ties for any As­traZeneca-Ox­ford dos­es it pro­vid­ed to CO­V­AX, in an ef­fort to pro­vide mil­lions of mi­grants with ac­cess to the Covid-19 jab.

Many man­u­fac­tur­ers re­quire pro­tec­tion from any side ef­fects. That is not able to be guar­an­teed if there is no gov­ern­ment, as in a sit­u­a­tion with a non­prof­it al­liance such as Gavi. Asy­lum seek­ers, refugees, de­tainees, and peo­ple who are state­less are all el­i­gi­ble.

SII was found­ed in 1966 with the goal of mak­ing life­sav­ing drugs across the world, and ben­e­fit­ing glob­al health as well.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.