In a recent web­cast, ​“Advanc­ing Life Sci­ences: SAP Strat­e­gy, Busi­ness AI, and the Future with SAP Busi­ness Data Cloud,” indus­try and SAP experts shared what’s com­ing up in the life sci­ences solu­tion port­fo­lio, how SAP Busi­ness Data Cloud is advanc­ing cell and gene ther­a­py solu­tions, and a cus­tomer sto­ry from Hik­ma Phar­ma­ceu­ti­cals. The full web­cast is avail­able on demand. 

An SAP rep­re­sen­ta­tive start­ed off by shar­ing updates from SAP on how the orga­ni­za­tion is sup­port­ing track and trace for life sci­ences com­pa­nies. Man­dar Par­alkar, VP of Life Sci­ences, Glob­al Indus­try Advi­so­ry, SAP Indus­tries & Expe­ri­ences, explained that SAP Busi­ness Suite is the foun­da­tion of the indus­try, with line-of-busi­ness assis­tants embed­ded and exten­si­ble, along with indus­try-spe­cif­ic assis­tants, agents to sup­port life sci­ences spe­cif­ic processes.

The past 10-plus years have been focused on track-and-trace require­ments in the Bio-phar­ma­ceu­ti­cal seg­ment and fol­low­ing the Drug Sup­ply Chain Secu­ri­ty Act (DSC­SA) time­lines, these require­ments are well deployed, even in mid-mar­ket com­pa­nies, Par­alkar said. Track-and-trace process­es have many man­u­al sys­tem errors that arise in busi­ness process, and SAP sup­ports automa­tion by detect­ing issues and resolv­ing them. AI capa­bil­i­ties for this automa­tion come out of SAP Life Sci­ences port­fo­lio solu­tion – Advance Track and Trace for Phar­ma, Trace­abil­i­ty Hub lever­ag­ing the SAP Busi­ness Tech­nol­o­gy platform. 

Mov­ing for­ward, SAP is dri­ving the cus­tomers’ busi­ness chal­lenges across the val­ue chain, start­ing with R&D, logis­tics, man­u­fac­tur­ing, sourc­ing, sales, and ser­vice. ​“It’s impor­tant to see a com­bi­na­tion of SAP S/4HANA agents, line-of-busi­ness agents, and the indus­try agents work­ing togeth­er,” Par­alkar said, going on to high­light the agents that SAP has on the road map for this indus­try. For more info, please check the web­cast link above.

Repeat­able Archi­tec­ture Sup­ports Future Processes

At Hik­ma Phar­ma­ceu­ti­cals, all 29 of its glob­al man­u­fac­tur­ing plants are in com­pli­ance with DSC­SA accord­ing to Man­ish Kumar Garg, PMP, PSM Asso­ciate Direc­tor, IT Appli­ca­tions — Seri­al­iza­tion & Track and Trace at Hik­ma Phar­ma­ceu­ti­cals, a rec­og­nized indus­try speak­er and con­trib­u­tor on phar­ma­ceu­ti­cal seri­al­iza­tion, sup­ply chain trace­abil­i­ty, and emerg­ing reg­u­la­to­ry standards.

“Every small process which we use in SAP mat­ters to us because of our com­mit­ment to sup­ply health­care providers and mil­lions of patients with hun­dreds of essen­tial drugs,” he said. ​“For this rea­son, we view seri­al­iza­tion as more than an IT or a process project.

Plan­ning began in 2013, and with SAP’s col­lab­o­ra­tive help, the com­pa­ny now con­nects its man­u­fac­tur­ing, ERP seri­al­iza­tion, and reg­u­la­to­ry sys­tems. Hik­ma uses SAP Trace­abil­i­ty Hub and SAP Advanced Track & Trace for Phar­ma­ceu­ti­cals — ATTP for enter­prise seri­al­iza­tion. For enter­prise busi­ness process­es, the com­pa­ny uses SAP Enter­prise Resource Plan­ning, and SAP Mas­ter Data Gov­er­nance guides enter­prise data gov­er­nance. By hav­ing a uni­fied archi­tec­ture on SAP, the Hik­ma team expe­ri­ences a fast con­nec­tion to their data and can scale quickly. 

Hik­ma also uses out-of-the-box func­tion­al­i­ty instead of cus­tom, help­ing with con­tin­u­ous upgrades and stay­ing cur­rent on the plat­form, as well as abil­i­ty to com­mit to time­lines. The shared, com­mon lan­guage of SAP also helps with cus­tomer adop­tion and use. ​“Today we are con­nect­ed with more than 200-plus busi­ness part­ners via SAP ICH and that fast onboard­ing comes from the seam­less integration.”

The result of this uni­fied archi­tec­ture and its effi­cien­cies include the abil­i­ty to onboard part­ners more quick­ly, Man­ish said. 

Hik­ma can reuse the sys­tem any­where, and it will be valu­able in help­ing the com­pa­ny com­ply with major reg­u­la­to­ry changes. Now with the U.S Food and Drug Administration’s Nation­al Drug Code soon requir­ing a 12-dig­it code (as opposed to the pre­vi­ous 10-dig­it code) by 2033, every cor­ner of phar­ma­ceu­ti­cal man­u­fac­tur­ing and sup­ply chain — from where a prod­uct is cre­at­ed to where the infor­ma­tion is stored — will be affected. 

Advanced Ther­a­pies Updates 

Moni­ka Bir­di, Prod­uct Man­ag­er of SAP Advanced Ther­a­py Orches­tra­tion, cov­ered the co-inno­va­tion that has been occur­ring since 2021 with Roche Genentech. 

SAP devel­oped a BTP-based solu­tion with the biotech­nol­o­gy com­pa­ny to best under­stand how these busi­ness­es are run and what would be most use­ful to customers.

The orches­tra­tion solu­tion sits on the BTP lay­er and native­ly inte­grates with SAP S/4HANA ERP and Extend­ed Ware­house Man­age­ment, orches­trat­ing the full jour­ney of an order, start­ing from the spec­i­men col­lec­tion to the man­u­fac­tur­ing and even­tu­al­ly to the deliv­ery of the order. SAP cus­tomers in this indus­try can con­fig­ure the sys­tem to run their sup­ply chain and then auto­mat­i­cal­ly cre­ate the rel­e­vant objects. After con­fig­ur­ing the sys­tem, the SAP Advanced Ther­a­py Orches­tra­tion (for­mer­ly SAP Cell and Gene Ther­a­py Orches­tra­tion) will auto­mat­i­cal­ly take care of the com­plete exe­cu­tion of the process. Trace­abil­i­ty reports and ana­lyt­ics are also avail­able, con­fig­ured to each spe­cif­ic business. 

This solu­tion sup­ports any kind of ther­a­py in cell and gene today, whether you are in the clin­i­cal phase, com­mer­cial cell, cell ther­a­py, gene ther­a­py, autol­o­gous, or aller­genic in mat­ter. New poten­tial tar­get mar­kets include allo­gene­ic ther­a­pies, med­ical device inte­gra­tion, radio lig­and ther­a­py, and plas­ma-derived biologics. 

“We want to solve your sup­ply chain chal­lenges by giv­ing you end-to-end vis­i­bil­i­ty,” Bir­di said. ​“And at the same time, we make sure that the reg­u­la­to­ry com­pli­ance is fol­lowed. And even­tu­al­ly I think what we all want is that the right ther­a­py reach­es the right patient along with cost of these ther­a­pies to come down.”

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