Outsourcing-Pharma (OSP) spoke with Joe DiMartino (JDM), Luminata solution manager for R&D software specialists ACD/Labs, about current supply chain challenges and vulnerabilities, and how stakeholders can harness technology to help deal with these issues.
OSP: What do you view as the most significant challenges to the pharmaceutical supply chain?
JDM: The top challenges in the pharmaceutical supply chain today involve addressing bottlenecks within the drug development process and reducing the time of various drug assessments. Based on past trends, only 5 out of 5,000 investigational new drugs make it to clinical trials, and subsequently it takes 10 to 15 years to release a drug to market.
There are exceptional drugs that have been fast tracked, but for the majority, pharmaceutical organizations continue to look for ways to accelerate the drug approval process through digitalization efforts. These efforts are expected to improve collaboration and data exchange between partner organizations while assuring data integrity.
One of the most significant challenges related to this is the lack of systems to effectively manage process development and batch data. This lack of systems leads to many organizations continuing to use Microsoft Excel and other non-scientific and unideal products.
While organizations have learned to work around the limitations of their current systems through data transcription between multiple software interfaces, this does nothing to help adequately map and share data throughout the supply chain, accelerate decision-making or assure data integrity.
OSP: Can you share what points pose the greatest vulnerabilities?
JDM: In order to deliver a drug product to clinicians, pharmaceutical development organizations deploy a variety of quality assurance practices. The underlying quality management systems which support adherence and compliance with established QA practices require extensive document preparation efforts by the development project team stakeholders.
This project timeline can be a significant risk factor for completing pivotal clinical trials, and ultimately bringing safe and effective medicines to patients in need. This is especially pertinent today considering the goal of reducing the clinical trial and regulatory submission/approval timelines to support urgent patient needs.
From a security perspective the exchange of digitalized data (with original files that can be interrogated regardless of the instrument the analytical data was collected on) via a managed process is far better than document and report exchange that is the current norm in drug development. In addition, audit trails in such systems further assure data security and integrity.
OSP: What are the most important attributes/components of a successful pharmaceutical ‘ecosystem’?
JDM: Sponsor companies and contract manufacturers need to ensure they have a sufficient supply of API and raw materials to sustain production during a potential disruption to the supply chain. To do this, they need a communication plan with the ability to measure what has been completed with data driven documentation.
OSP: What role can data and associated technology play in streamlining and securing the supply chain?
JDM: Disruptions in the supply chain can be prevented by using software technology that focuses on all the relevant chemical and analytical data associated with each batch of material. Specifically, the quality of material is just as important as the quantity. While some systems may help organizations with quantity, the way batch data is currently managed means there is a disconnect with the analytical data that can speak to quality of batches which is equally important; software technology can help manufacturers determine if all batches are consistent in their content.
OSP: How effectively in general do you think stakeholders do in harnessing advanced technology to help drive data-driven decisions along the line?
OSP: Modern informatics technologies can help reduce both the reliance on document driven decision making and human effort dependent decision/approval points. Overall, stakeholders who harness advanced software and technology within their pharmaceutical development ecosystem can make better and more informed decisions based on quality data.
OSP: Let’s talk about Luminata—how does that solution work in helping increase efficiency and accelerate product development?
Luminata is a chemistry, manufacturing, and controls (CMC) development decision support tool that provides the capability to consolidate and connect all the related chemical and analytical data in one place for interrogation and review in support of decision-making.
The process maps (one way that the data can be visualized for pharm dev projects) enable users to visualize all related spectroscopic or chromatographic data in a single environment, streamlining molecular composition comparisons. It’s also flexible and can represent the synthetic route of the API or a representation of the batch family tree, visualizing the relationships between batches; this further enables rapid assessment and decision-making around the effectiveness and efficiency of impurity control measures.
Within the batch family tree, connection of live analytical data facilitates easy visual confirmation of the veracity of numerical/textual interpretations, and access to processed results without the need to use multiple software applications.
By visualizing all batch analytical data in a dynamic process scheme and batch family tree maps, Luminata allows for rapid visual comparisons of analytical data on a batch-to-batch, campaign-to-campaign basis, and risk assessment pertaining to impurity onset, fate, and purge. By storing all batch analytical information that would otherwise be locked into chromatography systems and various ELNs, the software empowers process development teams to make the right decision the first time around.
OSP: How do you think COVID-19 is impacting the process—and how are pharmaceutical companies and their partners adapting?
JDM: Drug substance supply chain timelines are shrinking and are being intensified by the race to get through the clinical trial process so COVID-19 treatments can be given to patients. Due to this, pharmaceutical companies are looking at their digital transformation strategy as related to supply chain efficiency – and how the current pressures and demands on the industry can be addressed.
The current ecosystem behind delivering effective drug products to patients includes the exchange of important information via documents between multiple parties. Such as, suppliers and CMOs, health authorities, healthcare market intermediaries, hospital systems, insurance providers, to name a few.
Instead, organizations can reduce the reliance on human review of data contained within documents by “streaming” data from relevant sources to a digital solution used by stakeholders in an automated and secure manner. For this reason, Luminata is designed to help organizations accelerate drug process and product development through data-driven decision support and aid in regulatory filing efforts.