了解有关快速到诊所的更多信息，以及如何使生物制药公司评估和平衡风险，我们与 Paul Jorjorian ，Thermo Fisher Scientific Pharma Services的副总裁兼总经理。开发一种新的生物学？
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Paul Jorjorian（PJ）：< /b>生物制药公司在试图将生物制剂推向诊所时面临一些挑战。这些包括时间，缺乏资源和成本。公司需要尽快提交IND应用程序并完成I/第一阶段的人类试验。访问适当的资源以及浏览复杂而动态的监管环境所需的专业知识有助于保持开发成本降低并提高流程的速度。Thermo Fisher的快速诊所解决方案有助于生物学开发人员在转染后仅13个月内达到这些重要的里程碑，同时避免了重大风险，这些风险会破坏其目标，同时为未来的扩大成功创造强大的基础。
AB: Can you explain what the Quick to Clinic solution platform includes, and what this provides biopharma companies?
PJ: Quick to Clinic is designed for new and emerging companies in the early development phase who are developing mammalian recombinant proteins to reach Phase I/FIH trials and help file for IND as quickly as possible. This solution places emphasis on speed and flexibility and getting molecules from discovery to IND in less than 13 months. Quick to Clinic leverages Thermo Fisher’s deep scientific and technical expertise, broad capabilities and state-of-the-art technology to offer accelerated and flexible solutions to get a biopharma company’s molecule to IND quickly.
Specifically, Quick to Clinic for biologics deploys high throughput automation technologies and is enabled by use of platform cell culture and purification processes and analytical methods, careful construction and parallelization of drug substance and drug product activities. The solution streamlines drug substance and drug product handover activities and pre-qualification of common vial formats. Quick to Clinic includes a high-yield expression system and robust process platform that prepares customers for long-term commercialization success.
AB: How does Quick to Clinic leverage Thermo Fisher’s experts and facilities?
PJ: Resources and expertise play a major role in getting drugs to market faster. Thermo Fisher’s global network of drug substance and drug product facilities and scientific experts, combined with our proven track record and more than 30 years of development and manufacturing experience, make us a trusted partner committed to drug development success. Our experience spans 240 recombinant proteins and monoclonal antibody products.
AB: The Quick to Clinic solution “may help biopharma companies reach Phase I trials in as little as 13 months”. How does this compare to the current timelines for this process?
PJ: Quick to Clinic offers time savings attributed to the ability to invest in state-of-the-art tools, technology and capabilities – and a proven track record with early development programs that make it possible to file faster and get to patients sooner. The solution provides biopharma companies with the supply assurance and foundational platform they need to see their therapy through to the clinic while mitigating risk, accelerating timelines and navigating a complex and changing regulatory environment.
AB: How does Quick to Clinic enable biopharma companies to assess and balance risk?
PJ: Quick to Clinic manages risk using a carefully constructed program backed by supply security from a company with a broad technology portfolio and deep scientific expertise. This leads to an assurance that biopharma companies do not have to sacrifice quality for speed. This is enabled by avoiding high-risk activities such as using stable pool material for the tox batch or use of modular viral clearance studies. Quick to Clinic also relies on templated, pre-prepared documentation such as development report and technology transfer protocols.
Paul Jorjorian was speaking to Dr. Ash Board, Editorial Director for Technology Networks
填写下面的表格，我们将向您发送PDF版本的电子邮件“加速临床前生物制剂”
Thermo Fisher Scientific最近引入了快速到诊所TM值早期生物药物开发的解决方案。该解决方案旨在加快临床前开发，使生物制药公司能够在转染后仅13个月内完成I/第一阶段试验和研究新药（IND）审查的申请。
要了解有关快速到诊所的更多信息，以及如何使生物制药公司评估和平衡风险，我们与之交谈保罗·乔乔安（Paul Jorjorian），Thermo Fisher Scientific Pharma Services的副总裁兼总经理。
ASH板（AB）：生物制药公司在开发新生物学时面临哪些主要障碍？
Paul Jorjorian（PJ）：生物制药公司在试图将生物制剂推向诊所时面临一些挑战。这些包括时间，缺乏资源和成本。公司需要尽快提交IND应用程序并完成I/第一阶段的人类试验。访问适当的资源以及浏览复杂而动态的监管环境所需的专业知识有助于保持开发成本降低并提高流程的速度。Thermo Fisher的快速诊所解决方案有助于生物学开发人员在转染后仅13个月内达到这些重要的里程碑，同时避免了重大风险，这些风险会破坏其目标，同时为未来的扩大成功创造强大的基础。
AB：您能解释一下快速到诊所解决方案平台的包含的内容，以及这为生物制药公司提供的服务吗？
PJ：Quick To Clinic是为早期开发阶段新兴公司而设计的，他们正在开发哺乳动物重组蛋白，以达到I/FIH试验，并尽快帮助IND提交IND。该解决方案强调速度和灵活性，并在不到13个月的时间内将分子从发现到IND。快速到诊所利用Thermo Fisher的深厚科学和技术专长，广泛的能力和最先进的技术提供加速且灵活的解决方案，以使生物制药公司的分子快速地进行IND。
具体而言，快速到生物制剂的诊所部署了高通量自动化技术，并通过使用平台细胞培养和纯化过程以及分析方法，仔细的构造和并行化药物和药物产品活动来实现。该溶液简化了药物和药物产品切换活性以及普通小瓶格式的资格。快速到诊所包括一个高收益表达系统和强大的过程平台，为客户做准备长期商业化成功。
AB：诊所如何快速利用Thermo Fisher的专家和设施？
PJ：资源和专业知识在使毒品更快地销售销售方面起着重要作用。Thermo Fisher的全球药物和药物产品设施网络和科学专家，再加上我们久经考验的往绩以及超过30年的开发和制造经验，使我们成为致力于药物开发成功的可信赖的合作伙伴。我们的经验涵盖了240种重组蛋白和单克隆抗体产品。
AB：快速到诊所的解决方案“可以帮助生物制药公司在短短13个月内进行I期试验”。这与此过程的当前时间表相比如何？
PJ：快速到诊所提供的节省时间归因于投资最先进的工具，技术和能力的能力，以及具有早期开发计划的可靠记录，使得可以更快地提交并更快地提交患者。该解决方案为生物制药公司提供了所需的供应保证和基础平台，以便在诊所看到他们的治疗，同时减轻风险，加速时间表并导航复杂而不断变化的监管环境。
AB：如何快速诊所使生物制药公司能够评估和平衡风险？
PJ：快速到诊所使用由具有广泛技术组合和深厚科学专业知识的公司的供应安全支持的精心构造的计划来管理风险。这导致保证生物制药公司不必为速度牺牲质量。通过避免使用诸如使用稳定的泳池材料进行托克斯批次或使用模块化病毒清除研究之类的高风险活动来实现这一点。快速到诊所还依赖于模板的预先准备的文件，例如开发报告和技术转移协议。
Paul Jorjorian正在与技术网络编辑总监Ash Board博士讲话捷克葡萄牙直播
