Proqlea Ltd.

Josipa Ljubicic
About: Josipa Ljubicic - CEO/Clinical Trial Expert and GCP/GVP/GMP auditor

Josipa is a pharmacist with a Master`s degree in Chemical engineering from the University of Zagreb. She has over 20 years of experience working in the pharmaceutical industry, 9 years of experience working in the Clinical Trials, 4 years of experience working in Regulatory affairs, and more than 9 years of experience working in Quality Assurance. Josipa is a certified GCP, GMP and GVP auditor specializing in EMA and FDA USA requirements. For most of her carrier, she worked with pharma biotech on set-ups of quality systems for drugs and vaccines. More than 200 audits in GCP and 80 audits in GVP were performed by her with exposure to regulatory authorities. She settled more than 160 QMSs all over the globe. Josipa established her own consultancy company where she trains and educates people daily sharing her know-how. Today she is working on AI development, QMS and Clinical trial oriented, willing to give contribution in set up of different systems in health care industry.

1. To provide context, briefly describe your background and expertise in the intersection of AI and medicine, specifically focusing on your involvement in clinical trials and quality management systems.

As a pharmacist, I earned a master's degree in engineering and have been involved in manufacturing processes for both drugs and medical products since the early stages of my career. Later, through development and education, I became an expert in the field of quality and clinical trials. This means that I was directly responsible for all processes related to setting up quality systems but also conducted a certain part of the processes during clinical trials for both drugs and medical products. Becoming a certified GMP, GCP, and GVP auditor, my task was to oversee such processes at various global pharmaceutical companies and clinical trial sites. Over the years, I gained insight into all the gaps in operations and was able to better assess how to improve the system from my perspective.

2. Share a specific project or experience where you successfully integrated AI into clinical trials or quality management systems. What were the key outcomes, and how did they contribute to advancements in the field?

I can't point out a specific project because there have been over 20 so far where I was involved personally, and each has been unique in its own way. However, generally speaking, I've noticed that in the quality department, a lot of time is spent piecing together a complex system. Each client requires an individual approach, and the work done is essentially custom-made with an expert touch. Therefore, implementing such systems is both time-consuming and costly. This led me to think about how to shorten the work time to increase the number of clients, which would mean additional earnings for me at that time. I discovered a way and developed a system that now allows me to finish the work for a single client in days or sometimes even hours instead of months. In clinical trials, the system is identical. Each study, sponsor, or indication is unique, and the entire team of experts works before the study begins to customize everything, making the process even more expensive. However, during the study, as an auditor, I discovered that both sponsors and sites and sometimes even patients, face more or less the same problems, mostly of an administrative nature. You then need another team of experts to keep the system alive and ensure that you stay within acceptable limits. AI systems today, in general, and the system that I developed, have greatly facilitated this process by ensuring that you remain compliant with all EMA/FDA and local regulatory requirements, as well as various standards like ISO 9001, 27001, 17025, and various study protocols and sponsor requirements.

3. In your opinion, what specific impact can AI have on improving the efficiency and cost-effectiveness of patient recruitment and selection processes in clinical trials?

The AI system is set up in a way that, through simple and cost-effective digitization, enables tracking obligations required by any regulation or standard. By automating all processes, every employee no longer has to worry about administration but can simply read notifications and focus on their core business, etc. This allows for much greater efficiency at all levels and ultimately significant cost savings for the employer. Once we've solved the administrative problem, there will be more time for the core of the research: patients and data collection. Various AI systems also facilitate this process, such as patient recruitment, where the implementation of appropriate commands in AI allows for half the documentation and minimal error potential.

4. How do you envision AI contributing to the evolution of quality management systems in healthcare? What key factors should organizations consider when implementing AI in QMS?

Companies should be careful when choosing AI. Today, the market is large and manipulative, and various applications that may serve a purpose but are not true AI can be found in it. What they need is expertise in QA who will know how to recognize AI that can solve the problem faced by people within QA. The purpose of AI is the next item that must be clearly defined. It is necessary to define the shortcomings of the internal system and know whether you are looking for AI that will help reduce costs, speed up processes, increase production, or all of these to some extent.

5. Provide an example of how AI has facilitated real-time data analysis during a clinical trial, leading to more informed and timely decision-making.

I have one in a series of examples that I can share with you. In the process of preparing for a sponsor audit or regulatory inspection, controlling all the processes that the site has performed in the study is very stressful. Physicians and the study team often don't have time for it amidst their ongoing work and monitors then try to perform checks to identify and correct any errors in time. Sometimes, a monitor cannot conduct a detailed review in such a short time, so a quality AI can provide better insight into documents that have expired, are missing, or are 100% accurate. Another example from practice would be testing a new medical product that was implanted in a nonverbal patient who communicated with the world through AI. Such positive and useful examples abound in practice.

6. Considering the ethical implications of AI in healthcare, how do you propose balancing innovation with patient privacy? What strategies ensure transparency in decision-making processes?

AI is still controlled by humans, so a person determines which data will be collected, and the patient gives consent for the collection of those necessary depending on the purpose of AI. If it concerns business processes, this is always easily arranged through contracts, while with humans, it is still a matter of free will. I think ethics remain untouched if everyone follows the guidelines of the law and regulations.

Also, assign clear accountability for the ethical use of AI in healthcare, including roles and responsibilities for data stewards, data custodians, and AI developers. It is necessary to establish independent oversight mechanisms, such as ethics committees or review boards, to evaluate the ethical implications of AI applications and ensure adherence to ethical guidelines. It is important also to regularly monitor and evaluate the impact of AI interventions on patient privacy and outcomes; and to collect feedback from patients, clinicians, and other stakeholders to identify and address any concerns or unintended consequences of AI-driven healthcare initiatives.

7. From your perspective, what emerging technologies or methodologies do you believe will significantly shape the future of AI in revolutionizing medicine, specifically in clinical trials and quality management systems?

Responses like AI-enhanced data analytics, digital health monitoring, personalized medicine, and the use of AI to optimize clinical trials could significantly transform the medical sector. Advancements in areas such as natural language processing, computer vision, and genomic analysis also contribute to better understanding diseases and individualized treatment approaches. All of this has the potential to improve the efficiency of clinical trials and quality management systems in medical practices.

8. Based on your experience, what critical challenges do organizations commonly face during the implementation of AI in clinical trials? How can they proactively address these challenges?

The biggest challenge is always to survive the period of implementation and adaptation of a new system while simultaneously carrying out routine tasks. I would say the second challenge is always the fear of the unknown and changing the mindset of people who think that technology is their enemy. The truth is, that AI changes humans to some extent, but humans also control AI systems, so no matter how many we implement, we will always need experts to set up, direct, control, and use that AI.

9. Can you provide more details on a successful collaboration or partnership that has resulted in tangible advancements in AI applications within the healthcare sector, particularly in clinical trials?

One notable collaboration in the healthcare sector that has led to tangible advancements in AI applications, particularly in clinical trials, is the partnership between pharmaceutical companies and technology firms. These partnerships often focus on leveraging AI and machine learning algorithms to improve various aspects of clinical trials, including patient recruitment, trial design optimization, predictive analytics for patient outcomes, and real-time monitoring of trial data.

10. How do you see the evolving regulatory landscape impacting the adoption and implementation of AI in healthcare? What strategies would you recommend for organizations to navigate these changes effectively?

The evolving regulatory landscape plays a crucial role in shaping the adoption and implementation of AI in healthcare. As AI technologies become more integrated into medical practices, regulatory bodies worldwide are focusing on developing guidelines and frameworks to ensure patient safety, data privacy, and ethical use of AI.

The impact of regulatory changes on AI adoption in healthcare can be both beneficial and challenging. On one hand, clear and robust regulations can provide a framework for organizations to develop and deploy AI solutions with confidence, fostering trust among healthcare professionals and patients. On the other hand, overly restrictive or ambiguous regulations can hinder innovation and slow down the adoption of potentially life-saving AI technologies.

To navigate these changes effectively, organizations in the healthcare sector should consider staying informed, collaborating with Regulators, prioritizing compliance and transparency, implementing Quality Assurance and validation processes, and investing in education and training.

11. Reflecting on your professional journey, what key lessons or insights would you share with others seeking to leverage AI in revolutionizing medicine? Can you provide specific examples or anecdotes?

As I reflect on my journey in AI development to revolutionize medicine, one anecdote stands out: the power of interdisciplinary collaboration. Early in my career, while developing an AI-based diagnostic tool for a rare disease, I realized the importance of working closely with clinicians, geneticists, and data scientists. Skepticism of colleagues around me loomed large as some of them feared job displacement and economic instability. But I refused to be deterred, firmly believing that where there's a will, there's a way.

Putting the public interest above my one, I pressed on, convinced that impossible is just a word until proven otherwise. Despite the initial pushback, I persevered, and eventually, the naysayers became my staunchest allies. As our AI solutions began streamlining workflows and enhancing patient outcomes, even the most skeptical among them couldn't deny the transformative impact.

Anyway, this collaboration not only led to a successful AI solution but also fostered a deeper understanding of the challenges and opportunities in healthcare. It taught me that by bringing together diverse expertise and perspectives, we can truly unlock AI's potential to transform medicine and improve patient care. It is changing mindset and life thing.

12. As we conclude, considering the dynamic landscape of AI in healthcare, what key piece of advice or foresight would you offer to professionals and organizations navigating the integration of AI in clinical trials and quality management systems to ensure successful and impactful outcomes?

First and foremost, foster collaboration across interdisciplinary teams, including clinicians, data scientists, regulatory experts, information technology experts and ethicists. Embrace diverse perspectives and expertise to develop AI solutions that address real-world healthcare challenges effectively.

Secondly, remain adaptable in the face of evolving technologies and regulatory landscapes. Stay informed about the latest advancements in AI and healthcare regulations and be prepared to pivot strategies and workflows accordingly.

Lastly, uphold ethical responsibility throughout the AI integration process. Ensure transparency, fairness, and accountability in AI algorithms and decision-making processes. Prioritize patient safety, data privacy, and equity in healthcare delivery.