Alfasigma

Claudia Casalino

In an interview, Claudia Casalino, corporate compliance manager at Alfasigma, discusses her opinions on the latest trends and challenges affecting the life sciences industry.

What are some of the major challenges and trends that have been impacting the Life Sciences space lately?

The COVID-19 pandemic highlighted the significance of digital advancements. However, with increased competition, evolving regulations, and growing expectations from patients and healthcare professionals, companies in the life sciences sector are facing significant challenges and need to devise strategies to differentiate themselves and maintain a competitive edge.

Some of the main challenges in the industry include:

● Adoption of digital technologies to streamline internal processes and respond more effectively to the needs of stakeholders, especially patients;

● Navigating a complex, layered, and ever-changing regulatory landscape.

The pandemic has accelerated the digitalisation of operations for many companies. Through the implementation of new technologies and cloud-based platforms, employees have been able to work and collaborate remotely, sharing data through networks. However, there is still much to be done in terms of investments in artificial intelligence (AI) and machine learning (ML).

AI and ML applications in the life sciences field are diverse, including:

● Improving drug discovery timelines and simplifying activities in clinical trials;

● Enhancing quality control processes;

● Optimising production timelines, predictive maintenance, and supply chain management;

● Predicting and analysing behaviours of key external stakeholders (especially healthcare professionals) and internal staff, which can be utilised in sales and marketing functions as well as staff functions such as HR, legal, ethics and compliance.

Digitalisation has made significant strides in the healthcare sector, giving rise to the concept of digital health or e-health. This entails the application of digital technologies and innovative processes to healthcare and medicine. Digital health encompasses electronic health records, telemedicine, mobile health, the use of big data, AI, ML, and even the frontier of digital therapeutics (DTx). DTx refers to virtual drugs, often software installed on smartphones, tablets, or wearable devices, which daily guide patients with tailored strategies for their specific conditions (such as diabetes, depression, hypertension, obesity, addiction, and other chronic or long-term conditions).

The adoption of these applications allows companies to respond more rapidly and custom-tailor their services to meet patient needs. Patients now play an active role in every stage of their healthcare journey, transitioning from being passive targets to being actively involved in the design and delivery of healthcare services (that is, we have moved from "patient-centred medicine" to "patient-managed medicine" or "with the patient engagement").

In this scenario, the challenge for companies operating in the sector is also to involve patients in order to better understand their needs and be able to collect the necessary data for the development of increasingly innovative and customised therapeutic solutions.

Another of the main challenges for companies operating in the sector is overcoming the complexity of the regulatory sources that govern the industry. There are various levels of regulations – European, national, and regional (for example, in Italy, regions have direct responsibility for governing and funding local health services and hospitals). Many of these regulations are also outdated; for instance, the European directive on human-use medicinal products from which national regulations are derived dates back to 2001. Often, regulations struggle to keep pace with the changing landscape and technology usage (e.g., social media\'s development and its use for communication and advertising).

Regulations on telehealth or digital health are also inconsistent across Europe. Germany already has laws on digital therapies, which include an accreditation and reimbursement pathway for therapies. In contrast, Italy has only guidelines from the Ministry of Health on telemedicine and recent ministerial decrees, including using telehealth for domestic services (decree of 23 May 2022) and outlining procedures for approving telehealth projects at the regional level (decree of 30 September 2022).

What keeps you up at night when it comes to some of the major predicaments in the Life Sciences space?

The advancement of digital technologies and AI in the life sciences sector and business processes is a topic that keeps me awake at night. As someone in a compliance role, it is essential to understand the processes thoroughly. How well do I understand the new technologies? Is it necessary for me to acquire new skills in this field? If so, what courses should I take?

The answer is a resounding ‘Yes’ to all these questions. I try to read and stay updated on the latest developments to understand how the use of new technologies is changing the life sciences sector, how regulators are responding to these new demands, and what guidelines and benchmarks are in place. 

At the same time, I must find ways to acquire more specialised training on certain topics, although I haven't yet pinpointed the exact areas to focus on. However, I have noticed that the topic is becoming increasingly relevant in compliance groups and in conversations with my colleagues from other companies, so I believe progress will be made in guidelines for the knowledge and use of AI for compliance professionals.

On the other hand, I also wonder how I can utilise these systems to my advantage. The use of new technologies and AI can offer significant support to compliance operators in life sciences companies. For example:

● In document management, AI can automatically analyse and categorise documents based on their content.

● In risk management, ML can be used for predictive analysis to anticipate potential compliance issues based on historical data and behavioural patterns. This allows focus on areas requiring greater attention to prevent compliance violations.

● AI can automatically track updates to regulations and relevant laws in monitoring regulatory changes.

● These are some areas where I am working on.

Can you tell us about the latest project that you have been working on and what are some of the technological and process elements that you leveraged to make the project successful?

One project I have worked on during my career is the digitalisation of the onboarding process. Onboarding is a critical training process for new employees immediately after they are hired. It is essential as it allows new hires to understand the company in terms of organisation, functions, colleagues, corporate culture, and major processes and procedures. Through this training, which typically spans the first days of employment, new employees gain the necessary tools to perform their job well and comply with company rules, as well as the information needed to integrate quickly into the company.

Traditionally, the onboarding process took two to three weeks, involving face-to-face meetings, training, and learning assessments.

Through a company-wide digitalisation project, we managed to shorten the onboarding process and minimise the impact on colleagues' calendars while maintaining its effectiveness and receiving better participant feedback.

In summary, we created a digital platform containing, among other things:

● A digital tour of the company\'s offices (helpful for on-site orientation);

● Video presentations from the leadership team and function representatives;

● All mandatory e-learning courses on key company processes with Outlook reminders for their completion;

● A repository of documents to be filled out/read/signed (except for HR documents related to hiring).

New hires accessed the platform during their first week of work and completed the necessary training from home. We still kept individual face-to-face or remote meetings because we believe that interaction between people is essential for effective training, but these meetings were used for in-depth discussions and addressing any doubts. The face-to-face compliance meeting was reduced from a full day of face-to-face training to a three-hour session.

All this was made possible by implementing a system that integrated training delivery (based on a training matrix initially set based on company functions), as well as monitoring and reminders.

What are some of the technological trends which excite you for the future of the Life Sciences space?

I am particularly excited about the development of digital health and digital therapies, both as a professional and as a citizen. I believe that the advancement of these systems can improve access to healthcare, reduce waiting times, optimise interactions with healthcare professionals, enhance health monitoring, and shorten recovery times, leading to greater patient satisfaction, adherence to treatments, and, ultimately, a reduction in overall healthcare expenses.

Biography

Claudia Casalino holds a degree in Business Administration and worked in the Finance sector for the first 6 years of her career. In the past 6 years, she has worked in the pharmaceutical industry, progressively taking on roles of greater responsibilities within Compliance function. She is currently the Corporate Compliance Manager at Alfasigma.

Claudia is also a member of the Executive Committee of “Osservatorio 231 farmaceutiche”, an association of Italian professionals operating in the Life Science sector. The association’s aim is to deepen knowledge of regulations, case law, and best practices related to Compliance in pharmaceutical and healthcare companies.