Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for COVID-19 vaccines have evidently been top of their priority lists, other key topics discussed included the potential of data and AI to change the drug approval paradigm; the need to update regulatory frameworks for the new generation of cell and gene therapies; and the sometimes complicated issue of international collaboration.


Choong May Ling, Mimi, CEO of the Health Sciences Authority (HSA) in Singapore on greater AI utilisation

“AI is a key enabler for healthcare innovation. It can analyse large amounts of health data to derive meaningful insights for improving medical care including diagnosis, disease management and treatment monitoring. Currently, one of the most common use of AI is in improving diagnosis from images generated using various imaging modalities (e.g. CT scans, MRI, X-ray images).

“In 2017, we set up a pre-market consultation pathway where researchers and innovators could seek our scientific and regulatory advice in the early phases of medical device development. This facilitated regulatory compliance and enabled faster access to safe innovations for patients and healthcare providers. Over 40 percent of the consultation applications were for software and AI medical devices. Such medical devices, especially those that function by themselves without any hardware equipment (i.e. standalone software), have unique challenges. They undergo frequent upgrades and may need to continuously learn and change post deployment. Therefore, a fit-for-purpose regulatory approach that includes more process-based controls on top of the traditional product controls is necessary to be able to regulate these products effectively and efficiently.

“In April 2020, we published comprehensive regulatory guidelines specifically for innovators of software medical devices. Aside from providing clarity on our regulatory requirements and licensing, it covered risk management topics such as cybersecurity, “continual learning” algorithms, as well as additional process controls and risks that should be carefully considered in designing and validating these medical devices. To date, we have evaluated and registered over 30 AI-based medical devices with a significant number of them being first-in-world approvals, including Selena+ deep learning system for eye screening, See-Mode Augmented Vascular Analysis software and Kronikare Wound Scanner. After receiving our scientific and regulatory advice during consultation and obtaining HSA regulatory approval, many of these devices have successfully gone on to receive regulatory approvals in other markets (e.g. EU, Australia, USA).”

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Ana Hidalgo-Simon, Head of Advanced Therapies at the European Medicines Agency (EMA) on the importance of increased global regulatory harmonization for the development of the overall advanced therapy field

“This is something that sponsors constantly speak to us about, and we are definitely moving towards that. However, this is not going to be easy because all these regions are not starting from a blank slate, they already have their own established systems that differ, sometimes significantly. No regulator can step in and say, change how things are done. Also, it is not always clear which is the right way of doing something. The European system is very much based on consensus, but we have a committee of 27 member countries, all with their own interests and systems. Therefore, our machinery is one of consensus and sometimes moves slower than we would like, but at the end of the day, it generates extremely solid decisions that take into account different perspectives. The US FDA, on the other hand, is a single institution representing a large country, so it has significantly more autonomy in its operations and decision-making.

“However, global regulatory harmonization is key in advanced therapies because we are looking at patient populations that may comprise only a few hundred in the entire world. In general, in any case, drug development is so global these days. We have to work with our fellow regulators globally, and we are already doing so, of course. EMA accepts dossiers with clinical data outside of Europe, as long as they meet our regulatory standards. We are not lowering the bar, certainly, but we do offer flexibility. We are still not at the point where one single dossier can be accepted by multiple global regulators, but we are in conversation regarding more regulatory alignment.”

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Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at the US FDA on his learnings around regulatory science for vaccines

“First, and particularly as a result of COVID-19, we clearly see the fundamental importance of quality manufacturing for vaccines. There is essentially a new interest in vaccine manufacturing – and more efficient vaccine manufacturing. People have once again realized that if we are having a problem like this today and we lack ways to manufacturing vaccines quickly and in large quantities currently, we are likely to run into the same problem again in the future. Vaccine manufacturing has typically been dominated by batch manufacturing but this pandemic might ultimately advance vaccine manufacturing technologies to include components of continuous and semi-continuous manufacturing in the future.

“Secondly, we can use immune correlates of protection in areas to speed clinical trials. Once we have immune correlates of protection for COVID-19, that would facilitate new trials. We are using clinical endpoints as a starting point right now since we lack those.

“Thirdly, especially with COVID-19, we can see novel vaccine technology, which had previously been used only in smaller trials, coming to the forefront. There are two mRNA vaccines in large Phase III trials, for instance. There are some interesting configurations that could advance the field.

“One of the things that is hard for the public to understand is that infectious diseases are each somewhat unique. Our bodies have learnt to generate immune responses to certain pathogens better than others. It so happens that for respiratory viruses like COVID-19, the body does seem to ultimately generate a good immune response, so we are lucky in some ways. It may even be that the immune response is exuberant in elderly people, which is why they become more severely ill, or perhaps the immune response is not quite right. But in contrast, there are pathogens like HIV that directly harm the cells involved in the immune response, in which case it has proven much harder to find vaccine targets. Personally, I do have more hope that we will get there much more quickly with a COVID-19 vaccine than with vaccines for other diseases like HIV, which, as you know, has been a target for the vaccine sector for over a decade now.”

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Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA) on the Authority’s international collaboration initiatives

“We have around 14 MOUs signed with different countries, and we are also participating actively in international organizations. For instance, we led the global harmonization working group for medical devices and we are part of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). We lead the Near East Committee for the Codex Alimentarius, a collection of international food standards set by the Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization.

“We have also established a new forum for food standards in collaboration with the food authorities in Australia and Ireland, which aims at gathering heads of distinctive food agencies around the world to discuss and promote public health and food safety. The first forum was held in Riyadh in January 2020, and the forum now has many members and observers such as the US, France, South Korea, Japan, China, Kuwait and Morocco. Also, many international organizations have joined the forum as observers such as WHO, the FAO and the Codex.”

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Tolga Karakan, President of the Turkish Medicines and Medical Devices Agency (TITCK) on Turkey’s domestic COVID-19 vaccine programs and how its previous experience of approving foreign researched vaccines can help to accelerate the review of these programs

“The importance and urgency of developing a vaccine during the COVID-19 pandemic is obvious. During the COVID-19 vaccine development process, authorities including the WHO, EMA and US FDA provided various exceptions due to the “Public Health Emergency Situation”. These exceptions are also valid in Turkey. TITCK closely follows all scientific developments and conducts guiding activities for groups developing vaccines in parallel with international practices. The Agency has prepared a “Table of Requirements for the Transition of Viral Vaccine Candidates to Clinical Trials”, which contains very detailed information to guide the research groups that conduct and will conduct the COVID-19 vaccine study and shared with all stakeholders.

“In addition, it guided the vaccine development groups regarding the studies that should be completed before transitioning to the clinical trial phase by publishing “The Guidelines for Non-Clinical Evaluation of Human Vaccines.” The WHO were also consulted during the publication of all these guidelines. The publication of regulatory and guiding documents in the early period and the establishment of scientific commissions to carry out these processes reveal the knowledge on this subject.

“The Sinovac and Biontech/Pfizer vaccines, the Phase III research for which was conducted in Turkey, have been approved for use in Turkey. These vaccines are also included in the emergency use list by the WHO. This shows that Turkey’s evaluation processes are in line with internationally accepted standards.

“Following and directing the vaccine development processes from the very beginning and including Turkey in international clinical trials provide many advantages in terms of evaluation processes. In this process, the experience gained in the existing knowledge and evaluation processes can be transferred to local vaccine development programs. This naturally accelerates the evaluation processes as of the current period.”

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Lars Bo Nielsen, incoming Director General of the Danish Medicines Agency on striking the right balance in terms of private sector collaboration

“We must engage in a close dialogue with the industry in terms of regulatory framework, speed and professionalism in order for them to fulfil their tasks and missions, bringing medicines to market as fast as possible.

“Bio-innovation is very strong here in Denmark and we have many start-ups doing excellent work with whom we must continue to engage in dialogue. I have seen many researchers make wonderful discoveries and attract substantial venture capital, but unfortunately not fully understand the exact regulatory framework around their science.

“While dialogue with the private sector is crucial, at the same time we are a public institution with the mission of safeguarding the health of the population. We must be open about our mission when engaging in dialogue because we are not here as a service organ for the industry, our primary focus is the health of the Danish people.

“The Agency’s mission for the future is to continue the path that has been paved over the last five years as it relates to engaging with the public and patient organisations in discussions. This will help us to better understand the level of security that society expects and weigh that against new treatments for rare diseases that might be expensive but also might help people in grave need of treatment. We want to bring people to a situation where they have the information at hand to make a qualified choice.”

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