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"We currently support several clinical Covid-19 studies"

Elisabeth Lackner, CEO ABF Pharmaceutical Services and GBA GroupPharma, in an interview about speeding up the approval process, shortages of needed drugs and ethical principles

ABF currently supports several clinical Covid- 19 studies - in total ABF is currently conducting more than 120 clinical studies. LEADERSNET met Elisabeth Lackner, CEO of ABF Pharmaceutical Services and GBA GROUP Pharma, for an interview.

LEADERSNET: How long does the production of drugs and vaccines actually work in Austria?

Lackner: To be honest, not at all on its own. Austria supplies components for joint international developments in cooperation with other countries.

LEADERSNET: What time does production normally take?

Lackner: A vaccine cannot be produced in a chemical laboratory, but has to be produced biotechnologically - that takes a lot of time. Normally, it takes 10-15 years to develop a vaccine - the flu vaccine took 30 years to develop, HPV 15 years.

However, it is never known whether it will ever be possible to develop a vaccine. With Covid-19 it is also uncertain. For example, it has never been possible to find a vaccine against HIV, malaria or Ebola. The development of drugs is also a lengthy process and also takes on average 10-15 years.

LEADERSNET: Can a remarkable acceleration be achieved in a crisis?

Lackner: Conditionally, there are strict guidelines from the drug approval authorities that must be observed. Even in times of a pandemic, ethical principles must be observed. Patient safety always comes first - even in times of crisis.

What is often done now, however, is to draw on previous knowledge from existing developments, such as SARS-1. Or the drug Remdesivir, which was actually developed for Ebola and is already in an advanced phase, is being tested to see whether it is also effective against corona. For example, RoActemra (from Roche) is already on the market and we are now looking to see whether it is effective for covid-19.

Furthermore, the Committee for Medicinal Products for Human Use (CHMP) of the EMA (European Medicines Agency) has also published a statement urging the EU research community to give priority to large randomised controlled trials. This means that studies where it is ethically justifiable for them to be on hold will give priority to Covid-19 studies.

LEADERSNET: So clinical research is an expensive process?

Lackner: Yes, on average, the total duration of drug development is 10-15 years. For every drug there are usually four different phases in the approval process.

If a drug becomes promising after laboratory tests, then the effect is first investigated in a small number of people (phase I). Doctors check how and whether the drug is tolerated and what side effects occur. Phase II then begins, in which the dosage and side effects are determined. In phase III, the safety and effectiveness of the drug is investigated. Effectiveness can only be measured by controlled randomized studies. For example, the drug is also tested against a placebo. Then the drug is approved. In the subsequent phase IV, the drug is further observed in a large number of patients, the so-called phase of long-term observation studies. In each phase, studies are carried out and the very strict regulations of the German Drug Law apply in order to maximise safety. The EMA already made separate procedures possible in 2005 - at that time, by the way, precisely with a view to pandemics.

LEADERSNET: What does this mean?

Lackner: The approval authority can start a preliminary approval test on its own initiative if there is an overriding public interest. This means that the EMA is already working on the evaluation of a drug at an earlier stage, which means that applications can be processed much faster in an emergency - in addition, accelerated approval procedures are possible.

LEADERSNET: What are the special channels for faster approval?

Lackner: Conditional approval is an accelerated but limited approval. It is initially possible to obtain conditional approval without the strict examination of efficacy and safety in the case of life-threatening diseases, in a crisis situation in which public health is threatened (e.g., a pandemic) or in the case of rare diseases (orphan drugs). For the latter, however, there is still a separate approval process. It is initially limited to one year and is subject to the condition that manufacturers provide evidence that should ultimately lead to regular approval.

LEADERSNET: Can there also be bottlenecks in Austria with regard to required drugs? Which ones are currently affected? What can be done to remedy the situation?

Lackner: There have already been bottlenecks, but not because of Covid-19, that has other reasons.

Austria, for example, is a so-called middle-price country in terms of the selling price of drugs. Here we have the problem, partly due to import and export, that medicines were bought up because they were sold more expensively in higher-priced countries. It is true that this has sometimes led to bottlenecks - but it must be said that for most medicines there are also substitutes (generics).

This phenomenon has not led to any emergencies, but coupled with the panic buying that were triggered at the beginning of the Covid 19 crisis, it could be that one or the other drug was briefly out of stock in a pharmacy. However, the Federal Ministry is already considering banning these parallel imports.

It is a completely different story that, for example, an antibiotic once experienced a shortage due to a plant closure in India. But that was independent of Covid-19

LEADERSNET: Especially with the current corona crisis, the question arises as to what measures are needed to develop drugs as soon as possible?

Lackner: The pharmaceutical industry needs a lot of money because research and development is simply very expensive. Governments of more than 40 countries have announced at the donor conference their financial contribution to support the fight against the corona virus. In the end, 7.4 billion euros were raised for the "Global Response" initiative of the World Health Organization (WHO) and other partners. The initiative aims to pool all international efforts to research, produce and then distribute Covid-19 diagnostics, drugs and vaccines on an equitable basis. The aim is to develop a vaccine, produce it and make it immediately available in every corner of the world at an affordable price. There has never been such a task before.

LEADERSNET: Is ABF also involved in the development of a drug against corona?

Lackner: We are involved in several clinical Covid19 trials. APEPTICO and APEIRON, among others.

Apeiron Biologics-APN01 is a recombinant human protein that is designed to prevent the introduction of SARS-CoV-2 and has an anti-inflammatory and pulmonary oedema attenuating effect. Clinical trials are ongoing in Europe and are in preparation in China. Apeptico-Solnatide is a synthetic peptide being developed for the treatment of acute respiratory failure.

LEADERSNET: Can clinical trials be successfully conducted even in the current crisis situation? What effort is generally involved in such studies?

Lackner: It is very difficult due to corona, because many hospitals are closed or wards are reserved for corona. Many medical practices are also closed. Nevertheless, studies in which it is not ethically justifiable to stop them are still ongoing. FDA and EMA have developed guidelines on how we can treat patients in clinical trials despite the situation.

Clinical trials are incredibly time and resource consuming. Hospitals, physicians, patients (in the case of drugs) or volunteers (in the case of vaccines) are involved and everything has to be coordinated.

LEADERSNET: ABF has been classified as a critical infrastructure in Austria, what does this assessment mean for you?

Lackner: It is very important for us. Above all, it means that we can continue to work as normal even in a crisis or now specifically in the event of a lockdown and that our company will not be closed down. The employees can come into the company as normal and in an emergency even the Austrian Army would be deployed to support us.

LEADERSNET: What services are generally provided for customers? Who are they actually?

Lackner: Our clients are the international pharmaceutical and biotech industry. As a unique one-stop solution, the company supports the comprehensive process of drug development and marketing, from preclinical to clinical services, including analysis services, the provision of clinical trial goods, central laboratory services, QP services and the support of release processes as well as the import, export and distribution of approved products.

LEADERSNET: What challenges do you see for yourself and the pharmaceutical industry in general in the future?

Lackner: Development is becoming more and more expensive and the complexity of regulations is increasing. The last really big quantum leap (e.g., penicillin, antibody therapy) was a long time ago.

We need to understand the diseases that have not yet been solved. We have to get to know SARS better, but we have not really understood cancer either, there is still a lot to do. In any case, the pharmaceutical industry will always be there.

LEADERSNET: For what reason have you actually settled in Austria? Can you draw a first conclusion?

Lackner: At that time in 2004 all founders (there were several at that time) lived in Austria, or were Austrians.

ABF has developed greatly, and we then sold it in 2016 to the GBA Group, which is mainly active in the food and environmental technology sectors. In the Pharmaceuticals Division, which has six GBA Group locations, I am now also back as CEO and managing director in GBA Holding

LEADERSNET: What do you offer, where is the core expertise?

Lackner: GBA Group Pharma is one of the largest and most experienced service providers in the European pharmaceutical and biotechnology sector. As a unique one-stop-solution, the company supports the comprehensive process of drug development and marketing, from preclinical to clinical services, including analysis services, provision of clinical trial goods, central laboratory services, QP services and support for release processes as well as import, export and distribution of approved products.

LEADERSNET: You are backed by a large group of companies. What are their fields of activity?

Lackner: In addition to its services in pharmaceuticals, GBA Group also provides analysis in the food and environmental sectors.

www.gba-group.com/en/

Opinion Leaders Network 20.5.2020

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