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Special Report


       underwent  thorough  experimental  that cater to specific therapeutic areas  and remote clinical trial monitoring to
       validation by  AstraZeneca, involving  or patient populations. CROs offering  reduce the burden on patients, reduce
       CRISPR screening in primary human  specialized services in niche areas like  the cost, enhance recruitment rates, and
       lung fibroblasts and validation via SRF  medical devices, rare diseases and per-  increase geographical diversity in clini-
       gene silencing or pharmacological SRF  sonalized medicine are well-positioned  cal trial populations, which highlighted
       pathway inhibition. The presented data  to capitalize on this trend.  the  need  for  flexible  and  remote  trial
       indicates that inhibiting SRF-driven                               designs.
       transcription  of  pro-fibrotic  genes  in  Emergence of Medical Device CROs
       lung  fibroblasts  could  potentially  lead   As per a recent report of Grandview  Bioprinting
       to antifibrotic efficacy in IPF. To date,  Research, the global medical  device   Clinical testing on human beings is
       the collaboration between BenevolentAI   CRO market size was valued at $7.21-bn   a lengthy and tedious process, which is
       and  AstraZeneca  has  resulted  in  five   in 2022 and is expected  to grow at a  affecting the pharmaceutical  business.
       AI-generated targets selected for   CAGR of 8.8% from  2023 to  2030.  A new substitute called  bioprinting is
       portfolio entry, three of which are for  The market growth  can be attributed  emerging to replace it where proce-
       IPF.  This successful partnership was  to an increase in the number of medi-  dures comparable to 3D printing, may
       expanded in January 2022 for another  cal  device-specific  clinical  trials,  the  manufacture  human  organs and tissue
       three years, including two new disease  growing demand for advanced medical  replicas. In clinical studies, these
       areas  – systemic lupus erythematosus  devices, and a rise in the focus among  organs can be used to substitute living
       and heart failure.                medical device companies to reduce  participants.
                                         the  cost associated  with research.
       Increased outsourcing             During the COVID-19 recovery period,   Increasing Operational efficiencies of
          Conventional global pharmaceuti-  the  pipeline of medical  devices wit-  the Clinical CROs
       cal companies have been dependent on  nessed a steady rise.  The growing    The CROs offering the clinical ser-
       their inhouse R&D centres to provide  demand for novel technologies  and  vices are increasingly utilizing data
       the services related to discovery, pre-  the increasing need to make  devices   analytics to improve clinical trial
       clinical and clinical development for  patient-friendly are expected to improve  design, patient recruitment, site selec-
       developing innovative molecules. But  the pipeline of medical devices.  tion, and overall regulatory compli-
       over the last two decades, companies                               ance.  The CROs are using complex
       have  been increasing  outsourcing  at  Increase in global footprint of CROs  algorithms to analyse large volumes
       various stages of their drug develop-  The pharmaceutical CRO market has  of patient data, including electronic
       ment processes to CROs.  This trend  been expanding into emerging markets,  health records (EHRs), to identify
       allows pharmaceutical  companies to  such as Asia-Pacific, Latin America, and  eligible candidates for clinical trials.
       leverage the expertise and resources  Eastern Europe. CROs are establishing  Additionally, real-world data and
       of specialized  CROs, leading  to  cost   or expanding their presence in global  evidence are being integrated into the
       savings, faster development timelines,  markets to cater to the rising demand  drug development process of global to
       and access to advanced technologies.  for contract research  services.  These  provide more robust insights into drug
                                         regions offer cost advantages, large  safety and efficacy.
       Focus on specialized service CROs   treatment-naïve patient populations, and
       for niche areas                   a growing number of clinical trial sites  Ever increasing Regulatory Complexity
          With the complexity of drug deve-  with adequate infrastructure.   The  pharmaceutical industry  is
       lopment increasing,  pharmaceutical                                facing evolving regulatory landscapes,
       companies  have been seeking CROs  Acceptance of remote clinical trial   with stricter requirements for drug
       with specific expertise and capabilities.  services                development and clinical trial conduct.
       There is rising demand for specialized   The adoption and acceptance of vir-  CROs are adapting to these complexi-
       preclinical  services,  such as toxico-  tual and decentralized clinical trials by  ties by strengthening their regulatory
       logy studies, safety assessment studies,  pharmaceutical companies and regula-  expertise and ensuring compliance
       multi-drug and metabolite-based bio-  tory agencies has gained momentum  with regulations across multiple juris-
       analysis and complex pharmacokinetic  in recent years and this trend has been   dictions.  This trend highlights the
       studies. Similarly in the clinical deve-  accelerated by the COVID-19 pandemic.   importance of  regulatory knowledge
       lopment domain, there is growing de-  Virtual trials leverage technologies  and capabilities for successful contract
       mand for tailored clinical trial solutions  like telemedicine,  wearable devices,  research partnerships.


       172                                                                Chemical Weekly  September 24, 2024


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