Quality Assurance Transformations and Innovations in Pharma Tech

Quality Assurance (QA) in Pharma Tech has undergone substantial transformation, with a strong focus on regulatory compliance, data integrity, and risk management. Tony Johnson, Senior Director, Global Clinical Quality Assurance, Mallinckrodt Pharmaceuticals, discusses how emerging technologies like blockchain, AI-powered analytics, and automated validation are becoming integral to quality systems.

Global Clinical QA for Innovation and Compliance

With the understanding that the objective of emerging technologies such as blockchain and AI-powered analytics is to gain a suitable assessment of activities promptly, Global Clinical Quality Assurance can use the technologies to prioritize assessments in those areas where the risks can compromise patient safety or data integrity. For example, there may be a dependence on clinical site personnel and CRAs to ensure the investigational product (IP) is always stored within the appropriate temperatures. Blockchain technology can provide temperature data in real-time to promptly alert those that the IP may have been impacted before the product’s administration.

Navigating QA Technology Challenges for Business Success

The biggest benefit for an organization when QA implements new technologies is the ability to monitor clinical research activities more expeditiously than the typical monitoring process, which can lead to minimizing the impact of identified concerns. However, the challenge with using new technologies is the financial, time commitment, and resources needed to properly implement the processes and systems to realize their benefits. To overcome these challenges is to analyze and convey that the ability to identify and address concerns will translate into regulatory applications submitted earlier, and the increased probability of marketing approval means will provide patients with access to the therapies sooner than the historical approaches commonly used.

Patient-Centric Approaches in Pharma Tech

The prioritization of patient-centric approaches by the Quality Assurance function requires the willingness of the Sponsor to engage with patients to understand their needs. This can be accomplished by establishing a patient advocacy function and reviewing real-world evidence used in the protocol development process. The QA function can then assess compliance with the protocol and communicate the assessments on time.

Essential KPIs for Clinical Quality Assurance

Key performance indicators must prioritize patient safety measures, data integrity, regulatory compliance, and operational efficiency. These indicators should be determined prior to the screening process and documented. This includes ensuring

• Subjects have properly consented

• Subjects have met all eligibility criteria

• The investigational product is properly stored, prepared, and administered

• Serious adverse events are promptly identified and handled appropriately

• Adherence to the protocol, e.g., visit schedule and assessments are performed as required

• Data is adequately documented and entered into the respective databases (e.g., Clinical and Safety databases)

• Issues are promptly identified and addressed

Quality Assurance should conduct audits throughout the study’s life to identify the highest areas of risk, the scope of the risk, and whether the actions have minimized recurrence.

Exciting Innovations in Global Clinical Quality Assurance

When thinking of emerging technologies or methodologies in Global Clinical Quality Assurance, I first think of how clinical research wants to foster diversity with subject enrollment. This has allowed for the QA function to hear directly from patients and patient advocacy groups on the outcomes that will truly benefit patients and minimize the burden for subject participation. Another significant improvement in the clinical space is the mindset to implement a proactive approach to quality, and this has resulted in the Quality Assurance function being involved with the clinical study protocol at the final draft stage to provide input solutions on potential risks rather than a reliance on identifying concerns during the study.

Past Roles Shaping Current Responsibilities

My professional journey in the R&D space started as a research scientist for a chemical organization and then transitioned into analytical chemist roles for several pharmaceutical companies. From this, I was moved into a GMP auditing role and was fortunate to have responsibilities for conducting GxP audits (GCP, GLP, and GMP) over an 11-year period. Following years of performing audits, I was lucky to lead a Clinical Compliance role for approximately seven years where this function determined appropriate strategies for addressing significant concerns noted during clinical studies and regulatory inspections.

"The biggest benefit for an organization when QA implements new technologies is the ability to monitor clinical research activities more expeditiously than the typical monitoring process, which can lead to minimizing the impact of identified concerns"

In my current role as the Head of the Clinical Quality function at Mallinckrodt Pharmaceuticals, I have led efforts over the past five years to implement clinical audit programs across Sponsored studies, lead inspection readiness activities, and host regulatory inspections in the clinical space.

I am proud to say the journey leading up to my role at Mallinckrodt has helped me tremendously to understand the requirements that must be met for ensuring patient safety, whether it is determining whether an investigational product is suitable for administration or properly handling a Serious Adverse Event along with the ability to assess whether data integrity principles have been maintained with clinical data, safety data, and laboratory data, which will support a marketing application. I have implemented action plans that have significantly contributed to the regulatory approval of patient therapies across the globe.

Key Initiatives at Mallinckrodt Pharmaceuticals

Firstly, I want to express that the learnings from my journey are the importance of stakeholder collaboration and clear communication of meaningful information. When considering how the initiatives I’ve spearheaded at Mallinckrodt Pharmaceuticals have made a difference for consumers in the industry, I want to briefly cover a process to enable effective communication of potential concerns and timely resolution. This has been proven to give a proper interpretation of the regulatory requirements, a reasonable approach to minimizing the concern, and a mechanism to ensure consumers are informed of meaningful metrics and trends.

Unlocking the Power of Emerging Technologies

The advice that I can give to other senior leaders and CXOs is that there must always be a channel to freely provide input from all levels of the organization on current processes, as this information is invaluable for continually improving technologies and methodologies. Another valuable exercise is to implement a program where those in the organization can attend external meetings on offerings of emerging technologies or methods, have colleagues communicate their learnings, and look for opportunities for involvement in technological updates or process revisions when possible.