在治疗多样性和投资方面再生医学报告联盟almost 200 new therapy developers in 2021 and over 2600 active clinical trials. This is largely down to the success of early approved treatments such as Provenge (2010) in treating prostate cancer and subsequent successful ATMPs treating conditions like pediatric leukemia with long term success for patients, showing the potential to not only treat but cure what would otherwise be fatal illnesses. Scientists are now looking at the potential for these therapies to treat cancers, auto-immune diseases, rare genetic conditions as well as assisting with tissue regrowth.

What is involved in bringing advanced therapies to patients?

The potential of these therapies is massive and could positively impact many lives, but delivering these therapies successfully relies not only on the innovative science behind them, but an infrastructure and supply chain more complex than initially apparent. This is because many of these therapies are truly personalized, derived from patient blood, marrow, tumor or tissue samples, where cells may be extracted and altered or genetically mapped to create a treatment specific to the originating patient. The financial cost of each therapy is high, but an error leading to the wrong therapy being administered would trigger a potentially fatal cell rejection in the patient.

这个过程很复杂，并涉及多个专家伙伴进入独特的疗法旅程，该疗法以患者的身份开始并结束。供应链中“协调”供应链中的组件和合作伙伴的需求是由温度控制运输和细胞可行寿命的关键要求更加复杂的。如果在临床试验期间，开发人员无法证明他们可以安全地将样品从患者运送到实验室，制造单个疗法，并在关键条件和时间范围内将其转移回患者，那么该科学是未挑选的，并且不会批准该产品。

传统供应链管理的挑战

跟踪ATMP患者旅程的传统解决方案通常是基于纸张的，并且非常密集，需要手动核对患者注册表格，运输详细信息，制造信息，批次和输液记录，以及患者详细信息，产品标签和质量记录。由此产生的纸质拖网在地理上可能是多样的，难以报告和审核，并且需要广泛的资源来管理。随着疗法通过临床试验阶段的进展，患者人数增加了管理，使管理繁琐且容易出错。这是FDA在Provenge批准过程, stating that consideration needed to be made of supply chain orchestration for the product to remain safe post-approval.

此外，上述许多信息需要进行审查以及记录，以确保在整个过程中可以接受所有元素的质量和条件。为每种治疗方法手动检查这些数据都是难以维持的，甚至更难快速执行。诸如CAR-T之类的晚期疗法的可行寿命短，即使正确处理，细胞培养物可能会花费数周才能生长，并且在整个过程中，早期的培养细胞衰老。这将压力转移到供应链上，以最大程度地减少延迟，确保疗法通过质量检查，并在患者失去疗效之前将其交付给患者。

Furthermore, the patient’s role in the supply chain means that in addition to the need to record all partners that have handled the therapy and samples (chain of custody), what is known as the chain of identity (mapping the therapy to the right patient) creates a data protection consideration that does not exist in a traditional pharmaceutical supply chain.

Utilizing digitization and automation

It is in answer to the above challenges that the distinctions between simple digitization and an automated digital solution become important. Whilst switching to electronic records solves part of the paper-trail challenge, there is still considerable effort and margin for error in consolidating, storing, auditing and retaining records. ATMP trial records may have to be kept for up to 15 years after a trial ends and for a trial to lead to successful commercial release hinges not only on medical success but on successful audits (withFDA记录提示最多三分之一的审计失败是记录不准确的结果）。

The speed required in the decision-making process also drives towards a more automated system where pre-planned workflows can analyze the massive data volumes quickly and flag instances requiring action or decision to critical decision makers quickly. Where exceptions are identified quickly, product loss (estimated cost to the biopharma sector of product lost to temperature excursions alone wasover $15b in 2014可以避免），召回最小化的危险错误的机会大大减少。此外，此过程背后的细节将被捕获，电子签名并盖章日期，以进行未来的审核或审查。

供应链合作伙伴之间的集成在这张照片中也有很大的作用，因为它允许实时的准确信息自动流动，因此在整个过程中关键的利益相关者可以迅速做出明智的决定。从快递员或制造合作伙伴等第三方中提取信息意味着患者数据仍在开发人员控制的系统中，并已与匿名患者ID结婚，确保可以验证身份链，而不会损害数据安全或隐私。

Designing solutions that last

作为科学最前沿的行业，变革的节奏快速，而开发的疗法在生产步骤中差异很大。在要求医疗保健专业人员和供应链合作伙伴遵循多种疗法的不同过程的情况下，该系统可以帮助自动化，及时和执行这些流程，可改善患者的安全性，医疗保健提供者的可管理性，并最终降低交付成本治疗。在2021年，55％FDA记录了召回生物制剂是由于过程失败而产生的，另外39％是由于记录或标签不足。在这种情况下，召回很可能会将患者归还到周期的开始，这可能会造成重症患者的毁灭性。避免这些召回会导致更流畅，更具成本效益的患者旅程，并为更好的治疗结果铺平了道路。

结果，编排解决方案必须放在可以在安全性和连接性方面充分维护的平台上添加。

ATMP行业的相对“新”性质意味着开发人员仍在确定最佳实践方法，以促进将疗法送入患者。结果，云托管的多租赁解决方案具有特征，特别适合ATMP编排，尤其是在供应商可以支持用户支持和软件验证的情况下。这些类型的解决方案通常会促进安全和稳健的连接性以及快速配置和部署，即使过程受到高度量身定制。多租户环境分享了保持平台安全和当前的成本，并促进疗法甚至协作开发人员之间的最佳实践共享。

Whilst both supply chain and digitization may seem like small cogs in the mechanism of utilizing cutting edge science to progress the fight against previously untreatable conditions; there is a vital role to play in ensuring that patients can safely and cost-effectively gain access to these therapies. As such, the partners involved in the supply chain continue to collaborate on therapy orchestration to improve patient access to and safety of these life changing ATMPs.