BioPharm International - November 2024

BioPharm International - November 2024

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www.biopharminternational.com Manufacturing and Facilities eBook November 2024 BioPharm International ® 11 P atient-centric dr ug development and man- ufacturing incor porates the perspectives of patients in the design and production of medicines and is recognized as impor tant by health authorities and industr y organizations, which have developed a variet y of guidance docu- ments, tools, and methods for its implementation (1,2). Studies show that patient-centric medicines improve patient adherence (1). FDA states that incor porating the patient voice i nto d r ug de velopment i nc ludes t he u se of s y s- temic approaches for collecting and using patient input in dr ug development, identif ication of best pract ices for faci l itat i ng pat ient pa r t icipat ion i n cl i n ica l t r ia ls, capt ur i ng i n for mat ion on pat ient preferences, and identif ying information benef i- cial to patients during treatment (2). BioPhar m Inter national ® spoke wit h Jason Bock, co-fou nder a nd CEO of C T MC, about t he i mpac t of pat ie nt- ce nte r e d me d ic i ne s on t he i ndu s t r y a nd considerat ions for t he ma nufact ure of t hese products. Industry impact BioPharm: How has patient-centered medicine im- pacted bio/pharmaceutical manufacturing? Bock (CTMC): T he f ut u re of med ic i ne l ies i n p e r s on a l i z e d c e l l t he r a pie s , w he r e a p a t ie n t 's own cells are used to create powerf ul treatments. New, f it-for-pu r pose m a nu fac t u r i ng model s a re needed to de l iver on t h i s prom i se. T he sh i f t to persona lized medicines is demanding more f lex- ible a nd s t rea m l i ned m a nu f ac t u r i ng model s to en able on-dem a nd capac it y for i nd iv idu a l i z ed , single-dose batches. Cur rent ly, dema nd for cel l-ba sed t herapeut ics out paces m a nu fac t u r i ng ava i l abi l it y. E x tended w a it t i me s f or t r e at me nt a r e not a n op t ion f or pat ients w it h adva nced ca ncers. To faci litate t he product ion of autologous cel l t herapies, t he sup- The Patient-Centric Manufacturing Model Susan Haigney Jason Bock, co-founder and CEO of CTMC, discusses the industry impact and manufacture of patient-centered medicines. DIKUSHIN - STOCK.ADOBE.COM

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