Start­ing your clin­i­cal jour­ney with the end in mind – the val­ue of a drug de­vel­op­ment plan

Es­tab­lish­ing an in­tel­li­gent clin­i­cal de­vel­op­ment pro­gram path­way from the start is vi­tal for clar­i­ty around the com­plex process­es re­quired to achieve prod­uct reg­is­tra­tion.

The Drug De­vel­op­ment Plan (DDP) plan in­forms every part of the jour­ney from bud­get­ing, time­lines, clin­i­cal phas­es, re­search part­ners, re­search lo­ca­tions, reg­u­la­tor en­gage­ment, staff hires and much more.

Ul­ti­mate­ly a DDP de­scribes the steps that are re­quired to gen­er­ate the ev­i­dence to sup­port mar­ket­ing au­tho­ri­sa­tion and re­im­burse­ment.
An ex­ter­nal DDP ad­vi­so­ry team needs to be ex­pert across all reg­u­la­to­ry af­fairs and prod­uct de­vel­op­ment in­clud­ing man­u­fac­tur­ing, tox­i­col­o­gy and med­ical writ­ing, and plan­ning should start from the pre-clin­i­cal de­vel­op­ment phase.

The plan­ning process cuts risks in­clud­ing un­ex­pect­ed reg­u­la­to­ry hur­dles and cost, and en­sures the drug’s progress aligns with in­vestor ex­pec­ta­tions, as well as op­ti­miz­ing re­sources through­out the clin­i­cal pro­gram.

It al­so cov­ers CMC qual­i­ty re­quire­ments, non-clin­i­cal re­quire­ments, the non-clin­i­cal an­i­mal stud­ies re­quired, and the type and scope of clin­i­cal stud­ies need­ed to sup­port the prod­uct reg­is­tra­tion.

In ad­di­tion to the typ­i­cal Phase I, II and III pro­gram, the DDP can high­light any ex­tra re­quire­ments, or stud­ies that might be need­ed to sup­port the ap­pli­ca­tion, such as clin­i­cal stud­ies in spe­cial pop­u­la­tions, or drug in­ter­ac­tion stud­ies.

One of the most im­por­tant process­es is a com­mer­cial or com­peti­tor analy­sis of prod­ucts on the mar­ket, or cur­rent­ly in de­vel­op­ment. This in­forms the kind of stud­ies and in­for­ma­tion that will be need­ed to sup­port the mar­ket­ing au­tho­ri­sa­tion of the prod­uct.

A ro­bust DPP al­so iden­ti­fies ways to ac­cel­er­ate drug ap­proval. There are a range of process­es that reg­u­la­tors of­fer in or­der to speed up drug de­vel­op­ment and ap­provals. They in­clude or­phan drug des­ig­na­tion for a rare in­di­ca­tion, and for tru­ly ex­cit­ing prod­ucts that are im­pact­ing life-threat­en­ing dis­ease there are op­tions in­clud­ing break­through ther­a­py and fast track des­ig­na­tion pro­grams.

DDP Key Points In­clude:


Start­ing off with a sci­en­tif­ic ra­tio­nale for the de­vel­op­ment of the prod­uct, which in­cludes a brief sum­ma­ry of the tar­get in­di­ca­tion, and why the prod­uct is be­ing de­vel­oped. This sets the scene for the prod­uct de­vel­op­ment.


An analy­sis of sim­i­lar com­peti­tor prod­ucts that are on the mar­ket or are cur­rent­ly in de­vel­op­ment. This is an im­por­tant part of com­mer­cial analy­sis, but al­so pro­vides use­ful in­for­ma­tion on the kinds of stud­ies and in­for­ma­tion that will be need­ed to sup­port the mar­ket­ing au­tho­ri­sa­tion of the prod­uct.

Tar­get Mar­kets

The prod­uct tar­get­ing could be for glob­al reg­is­tra­tion or a sin­gle re­gion such as the Asia-Pa­cif­ic with oth­ers such as the US and Eu­rope to be added lat­er in the de­vel­op­ment pro­gram.


An as­sess­ment of the man­u­fac­tur­ing qual­i­ty re­quire­ments at the dif­fer­ent stages of de­vel­op­ment. Start­ing off with Phase I GMP, and then mov­ing through to process val­i­da­tion for mar­ket­ing au­tho­ri­sa­tion.

Clin­i­cal Strat­e­gy

The clin­i­cal tri­al strat­e­gy com­pris­ing Phase I, Phase II, Phase III, may ex­pand if say oth­er pop­u­la­tions need to be con­sid­ered, or there may be an op­por­tu­ni­ty for a com­pressed clin­i­cal de­vel­op­ment strat­e­gy.

Talk to our spe­cial­ist BioDesk team.