Break­ing bar­ri­ers to in­no­va­tion: In­te­grat­ing Re­search and Busi­ness De­vel­op­ment to ac­cel­er­ate nov­el ther­a­pies

Life sci­ence lead­ers, in­no­va­tors and the in­vest­ment com­mu­ni­ty will con­vene in San Fran­cis­co this Jan­u­ary for what is ar­guably the biggest week of the health­care part­ner­ing cal­en­dar. Ahead of this, Astel­las’ Chief Sci­en­tif­ic Of­fi­cer, Yoshit­sugu Shi­ta­ka, Head of Busi­ness De­vel­op­ment, Is­sei Tsukamo­to, and Pri­ma­ry Fo­cus Lead for Tar­get­ed Pro­tein Degra­da­tion, Chi­nat­su Saka­ta-Saku­rai, share their per­spec­tives on how the close re­la­tion­ship be­tween in-house Re­search and Busi­ness De­vel­op­ment (BD) teams, along­side ex­ter­nal part­ners, is in­creas­ing­ly im­por­tant for in­no­va­tion suc­cess.

With new drug modal­i­ties and tech­nolo­gies con­tin­u­ing to dri­ve in­dus­try growth, what are the biggest chal­lenges in­no­va­tors are fac­ing to­day? 

Yoshit­sugu Shi­ta­ka: It’s an ex­cit­ing time for us in re­search, know­ing we’re con­tribut­ing to a new wave of in­no­va­tion across the in­dus­try. Ad­vanced tech­nolo­gies and modal­i­ties, such as cell and gene ther­a­pies, have im­mense po­ten­tial to de­liv­er trans­for­ma­tive treat­ments for dis­eases with high un­met need. Trans­lat­ing these in­no­va­tions from idea to clin­ic in­to the ap­proved treat­ments pa­tients are wait­ing for, how­ev­er, is no small feat.

We have to ac­knowl­edge that many sci­en­tif­ic ad­vances be­ing in­ves­ti­gat­ed to­day are in their rel­a­tive in­fan­cy. They de­mand an in­tri­cate un­der­stand­ing of the com­plex na­ture of dis­ease and var­i­ous bi­o­log­i­cal mech­a­nisms. At­tri­tion rates re­main high, par­tic­u­lar­ly in ear­ly-stage re­search where many pro­grams don’t make it out of the lab, and those that do of­ten re­quire spe­cial­ized man­u­fac­tur­ing strate­gies that are yet to be in­vent­ed.

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We are deal­ing with a lot of un­knowns, but the ex­cit­ing po­ten­tial for pa­tients in need dri­ves us for­ward. We can on­ly tack­le these chal­lenges by build­ing part­ner­ships, across in­dus­try and work­ing to­geth­er.

Is­sei Tsukamo­to: The oth­er crit­i­cal fac­tor when deal­ing with this lev­el of com­plex­i­ty is close col­lab­o­ra­tion be­tween in­ter­nal teams and di­vi­sions – par­tic­u­lar­ly be­tween your Re­search leads and BD scouts. By tak­ing a holis­tic, in­te­grat­ed ap­proach, guid­ed by a clear, long-term strat­e­gy, we can best iden­ti­fy the op­por­tu­ni­ties and part­ner­ships to help close the gaps and ac­cel­er­ate our work in ar­eas with the great­est po­ten­tial for pa­tients.

How do you bal­ance the need to ex­plore the po­ten­tial of emerg­ing tech­nolo­gies with your longer-term in­no­va­tion goals?  

Is­sei Tsukamo­to: We’re see­ing an in­creased em­pha­sis on ear­ly-stage in­no­va­tion as or­ga­ni­za­tions dou­ble-down on their pre-clin­i­cal pipelines. This re­flects the op­por­tu­ni­ty of new bi­ol­o­gy and modal­i­ties to ad­dress un­met med­ical needs, as well as a shift to­ward sus­tain­able, long-term growth.

We all want to ex­plore what these new ap­proach­es can de­liv­er for pa­tients, but we have to be strate­gic in how we use our time, re­sources and ex­per­tise. If we’re to suc­ceed, it must be a co­or­di­nat­ed ef­fort – not just at a deal or part­ner­ing lev­el, but al­so in­ter­nal­ly.

Which is why, at Astel­las, we fo­cus our in­ter­nal and part­ner­ing ac­tiv­i­ties in spe­cial­ist ar­eas where we be­lieve we have the great­est op­por­tu­ni­ty to de­liv­er sig­nif­i­cant and mean­ing­ful val­ue, in­clud­ing im­muno-on­col­o­gy, cell and gene ther­a­py, tar­get­ed pro­tein degra­da­tion, blind­ness and re­gen­er­a­tion, and mi­to­chon­dria.

In to­day’s com­pet­i­tive BD en­vi­ron­ment, how do you choose the right ex­ter­nal in­no­va­tion part­ner and set your teams up for suc­cess?

Is­sei Tsukamo­to: The right part­ner isn’t nec­es­sar­i­ly the one with the newest plat­form. It is the part­ner who shares your long-term vi­sion. If a part­ner­ship is the right fit, it will en­able both par­ties to unite com­ple­men­tary ca­pa­bil­i­ties and as­pi­ra­tions so they can ac­cel­er­ate to­ward a shared goal.

Of course, the re­al work starts once the part­ner­ship agree­ment has been signed. At Astel­las, we view part­ner­ships as dy­nam­ic. Pri­or­i­ties and needs can evolve over time, and our deal struc­tures must fa­cil­i­tate that, pro­vid­ing the flex­i­bil­i­ty and space to build and main­tain trust­ed re­la­tion­ships.

We find mul­ti-touch­point al­liances to be a strong mod­el. This it­er­a­tive ap­proach has en­abled us to en­gage with prospec­tive part­ners ear­ly, nur­ture great think­ing to­geth­er and then evolve our part­ner­ship as the work pro­gress­es.

Yoshit­sugu Shi­ta­ka: Speed and adapt­abil­i­ty are crit­i­cal in to­day’s in­no­va­tion en­vi­ron­ment, and we have pur­pose­ful­ly evolved the way we work to en­sure our peo­ple can op­er­ate as rapid­ly and flex­i­bly as our part­ners – many of which are small, ag­ile biotechs. We have cre­at­ed an en­vi­ron­ment where our teams col­lab­o­rate ef­fec­tive­ly across di­vi­sions, in­te­grat­ing di­verse tech­nolo­gies and em­brac­ing cal­cu­lat­ed risks to make smarter de­ci­sions faster.

Astel­las has iden­ti­fied tar­get­ed pro­tein degra­da­tion (TPD) as a pri­ma­ry fo­cus area for re­search and in­vest­ment. How are you blend­ing in-house and ex­ter­nal in­no­va­tion in prac­tice here? 

Chi­nat­su Saka­ta-Saku­rai: TPD is a field of in­no­va­tion that could re­shape treat­ment ex­pec­ta­tions for many dis­eases, and we are al­ready see­ing how bring­ing to­geth­er in-house ex­per­tise and ex­ter­nal in­no­va­tion ca­pa­bil­i­ties can open new doors.

Our Re­search team be­gan in­ves­ti­gat­ing KRAS G12D de­graders in 2020, iden­ti­fy­ing a po­ten­tial­ly first-in-class ther­a­py at un­prece­dent­ed speed, fol­lowed by rapid study ini­ti­a­tion and en­roll­ment.

What is re­al­ly fas­ci­nat­ing about het­er­ob­i­func­tion­al de­graders is that they are ex­pand­able tech­nolo­gies: by chang­ing parts of the struc­ture, we can quick­ly in­crease the num­ber of pro­teins we can po­ten­tial­ly tar­get, in­clud­ing pro­teins which were con­sid­ered his­tor­i­cal­ly “un­drug­gable.” This is where strate­gic col­lab­o­ra­tions play a piv­otal role in help­ing us max­i­mize the po­ten­tial of TPD ther­a­pies for pa­tients.

In 2023, we en­tered a part­ner­ship with spe­cial­ist bio­phar­ma, Cull­gen, to en­hance our col­lec­tive abil­i­ty to dis­cov­er mul­ti­ple in­no­v­a­tive pro­tein de­graders. We be­lieve this col­lab­o­ra­tion will bring syn­er­gies be­tween our cut­ting-edge re­search to de­vel­op pro­tein de­graders with tar­gets that have nev­er been suc­cess­ful with oth­er modal­i­ties, with the aim of de­liv­er­ing trans­for­ma­tive ther­a­pies for pa­tients in need.

What makes this part­ner­ship stand out is that we are al­ready dis­cov­er­ing new ways to po­ten­tial­ly en­hance the ef­fec­tive­ness of TPDs, re­duce tox­i­c­i­ty, en­hance tis­sue se­lec­tiv­i­ty and over­come drug re­sis­tance.

What does the fu­ture hold for a more in­te­grat­ed in­no­va­tion ap­proach?

Is­sei Tsukamo­to: With the cur­rent in­dus­try-wide fo­cus on ear­ly-stage in­no­va­tion, blend­ing in­ter­nal and ex­ter­nal ex­per­tise to dri­ve re­search for­ward and over­come the chal­lenges of the day is crit­i­cal. Re­search and BD func­tions, and their ex­ter­nal part­ners, will need to be more con­nect­ed than ever to un­lock the po­ten­tial of next-gen­er­a­tion ther­a­pies and de­liv­er sus­tain­able growth.

Yoshit­sugu Shi­ta­ka: It’s im­por­tant to rec­og­nize that the more we col­lab­o­rate in­ter­nal­ly and ex­ter­nal­ly, the more we ex­pand our think­ing, broad­en our per­spec­tives and cre­ate con­di­tions for in­no­va­tion to thrive – not just with­in our own or­ga­ni­za­tions, but in the wider in­no­va­tion ecosys­tem. Ul­ti­mate­ly, more in­te­grat­ed in­no­va­tion will de­liv­er more progress and val­ue for pa­tients.

Con­trib­u­tors:

Yoshit­sugu Shi­ta­ka,
Chief Sci­en­tif­ic Of­fi­cer,
Astel­las Phar­ma Inc

Is­sei Tsukamo­to,
SVP, Head of Busi­ness
De­vel­op­ment,
Astel­las Phar­ma Inc

Chi­nat­su Saka­ta-Saku­rai,
VP, Pri­ma­ry Fo­cus Lead Tar­get­ed Pro­tein
Degra­da­tion,
Astel­las Phar­ma Inc