Drug development goes digital

Rapid­ly age­ing pop­u­la­tions liv­ing with increased co-mor­bidi­ties and stretched finan­cial resources are plac­ing huge strains on health­care sys­tems.

Tra­di­tion­al drug devel­op­ment is slow, unpre­dictable and cloaked with pro­hib­i­tive costs, but the dig­i­tal­i­sa­tion of clin­i­cal tri­als, use of data and appli­ca­tion of new tech­nolo­gies is now pro­vid­ing accel­er­at­ed path­ways to new treat­ments and ener­gis­ing sci­en­tif­ic poten­tial.

It takes an aver­age of ten years and between £1–2 bil­lion to get a drug to mar­ket. By col­lect­ing, analysing and har­ness­ing clin­i­cal and patient data more effi­cient­ly, we can dras­ti­cal­ly reduce time and cost while also pro­vid­ing enhanced scope to find nov­el ther­a­pies.

“We are start­ing to see what is pos­si­ble and there is a great future ahead,” says Chris­t­ian Heben­stre­it, senior vice pres­i­dent and gen­er­al man­ag­er of Medi­da­ta, EMEA.

Medi­da­ta, a Das­sault Sys­tèmes com­pa­ny, is the lead­ing soft­ware provider for man­ag­ing and run­ning clin­i­cal tri­als and stream­lin­ing drug devel­op­ment. The company’s inno­v­a­tive plat­form has pow­ered 19,000 tri­als involv­ing more than five mil­lion patients.

“Our sci­ence and tech­nol­o­gy is gen­er­at­ing a huge amount of data that is then trans­lat­ed into val­ue in the quest to get the right drug to the right patient at the right time,” says Mr Heben­stre­it.

“We are see­ing tremen­dous progress in a num­ber of ther­a­peu­tic areas, espe­cial­ly as we are look­ing into rar­er dis­eases and dif­fer­ent areas of can­cer. This is thanks to the pow­er of data and the abil­i­ty to dig­i­talise the drug devel­op­ment process and man­age a clin­i­cal tri­al from one stream­lined plat­form, from tri­al design and patient recruit­ment to reg­u­la­to­ry sub­mis­sion and approval.”

Recruit­ing suit­able patients for clin­i­cal tri­als is a pon­der­ous process and retain­ing them can be an issue that mas­sive­ly impacts the out­come. Dig­i­tal­i­sa­tion has helped to iden­ti­fy the right patients, made it eas­i­er for them to take part, and has also opened up a wider and more diverse patient pop­u­la­tion.

A promis­ing 28 per cent of clin­i­cal tri­als can now be com­plete­ly vir­tu­alised with data col­lect­ed and inter­ro­gat­ed to pro­vide the key find­ings across effi­ca­cy and safe­ty, while often reveal­ing fresh areas of research and patient ben­e­fit.

“We work in a high­ly reg­u­lat­ed envi­ron­ment for very good rea­sons as we are deal­ing with people’s lives and some test­ing will not change,” says Mr Heben­stre­it. “But find­ing the right patients to fit the cri­te­ria of a tri­al is one of the biggest issues for com­pa­nies. It is com­pli­cat­ed and can take months to recruit, par­tic­u­lar­ly as many patients might face geo­graph­i­cal, cul­tur­al or finan­cial bar­ri­ers.

“Open­ing it up to home-mon­i­tor­ing for patients, who may live 200 miles away or even in a dif­fer­ent coun­try, is a game-chang­er. Patient recruit­ment, enrol­ment and reten­tion is sud­den­ly more effi­cient. We are also able to repli­cate con­trol groups for clin­i­cians using his­tor­i­cal data, auto­mate process­es, remove duplica­tive data entry and spot errors imme­di­ate­ly. It saves time, reduces costs and is eth­i­cal­ly very pos­i­tive as more patients can par­tic­i­pate in the tri­als and there­fore get access to new drugs and bet­ter treat­ments much soon­er.”

Dig­i­tal­i­sa­tion is also act­ing as a research cat­a­lyst pro­mot­ing col­lab­o­ra­tion across big phar­ma and net­works of research insti­tu­tions and star­tups that now have an open land­scape to test nov­el ideas once restrict­ed by silo men­tal­i­ties and pro­hib­i­tive project costs.

Reg­u­la­to­ry author­i­ties are ful­ly behind dig­i­tal­i­sa­tion and we are see­ing more col­lab­o­ra­tion between the pub­lic and pri­vate sec­tors with­in life sci­ences than ever before. Medi­da­ta reg­u­lar­ly engages with reg­u­la­tors around the world with com­mon goals of improv­ing patient expe­ri­ences and clin­i­cal tri­al out­comes.

The Ger­man gov­ern­ment, for exam­ple, has recent­ly tak­en it a stage fur­ther by includ­ing dig­i­tal­i­sa­tion in clin­i­cal tri­als in new leg­is­la­tion designed to advance drug devel­op­ment and improve health­care.

“The indus­try con­tin­ues to push for more inno­v­a­tive solu­tions and the use of data sci­ence, big data and new tech­nolo­gies. And the encour­age­ment from reg­u­la­tors is strong because they can see the oppor­tu­ni­ties com­ing from dig­i­tal­i­sa­tion,” says Mr Heben­stre­it.
“It ben­e­fits providers, physi­cians, hos­pi­tals, phar­ma­ceu­ti­cal and biotech com­pa­nies and, most impor­tant­ly, will help us to improve the lives of patients.

“Europe, and espe­cial­ly the UK, is well placed to make the best of dig­i­tal­i­sa­tion, espe­cial­ly as we explore the phe­nom­e­nal poten­tial from new tech­nol­o­gy, arti­fi­cial intel­li­gence and machine-learn­ing. The change is already here. There is a lot of work to be done, but the future is excit­ing.”

For more infor­ma­tion please vis­it www.medidata.com