Observations of a market access expert

An insightful interview with NDA’s Claes Buxfeldt, HTA Director, entitled “Observations of a market access expert” featured in Aprils edition of Pharmafocus.

Reimbursement is the fourth hurdle of pharmaceutical development. Payers and Health Technology Assessment (HTA) bodies demand compelling evidence of how new interventions improve the standard of care and public health.

In the article Claes reflects on his experiences, challenges & opportunities and highlights the key trends and drivers for changes that will affect the Life Science industry in the HTA and market access space.

 

 

 

 

Europe vs USA: new drug product approvals in 2018

By Anna Leitgeb, Consultant, NDA Group

2018 was another exceptional year for the life science industry with a total of 103 new therapeutic drugs (NTDs) approved in EU and US.

Every year NDA reviews the NTD approvals in EU and US from previous year to spot trends and assess the year that has passed. The data is taken from the FDA and EMA websites on the new approved products during 2018 (i). In this review we include NTD product approvals with new active substance (chemical, biological, biotechnology or radiopharmaceutical substance), new biological entity, new drug combinations, biosimilars, new active ingredients and vaccines, but excluded generic and duplicate applications.

The following summary provides an overview of the key findings and an analysis of what the data means for the industry. The data is visually represented in an infographic below.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

This year the regulators have ruled positively on some high-profile and high-stakes project. Important new drugs for indications with unmet medical need, for neglected diseases or where exciting new technologies are explored have been approved within the area of neurology (Aimovig, Emgality, Ajovy), infectious disease (Xofluza, Trogarzo), and women health (Orilissa). Important orphan drugs were also approved within neurology (Namuscla, Epidiolex, Onpattro, Tegsedi) and hematology (Crysvita) and advancements within precision medicine have been achieved within oncology (Vitrakvi).

It’s interesting to note that the number of NTD approvals in the two markets has not changed markedly from 2017 to 2018. However, the landscape of approvals in the different markets, indications, and company features has moved somewhat over the last 12 months. Out of the 103 approvals 45 were solely FDA-approved and 9 approved only in EU, indicating an increase in dual market approvals compared to 2017.

There was a rise in the number of NTDs approved for both the US and EU markets from 36 in 2017 to 49 in 2018. This indicates that the joint application strategy was more popular than previous years.

Approvals for oncology and infectious disease products increased in 2018 whilst the number of approvals within hematology, neurology and immunology/rheumatology has decreased during the same time frame.

Successful Exploration of Novel Drugs

2018 was a significant year for approvals of novel drugs, i.e. treatments based on new active substances. Out of the 103 new drugs, 89 were based on new active substances. This number has increased since the year before when 56 approvals were for novel drugs. This high number of green lights from the agencies follows a few successful years for drug developers. The agencies involvement and support during drug development has increased which also contributes to improvements to strategy rather than to only secure compliance with existing regulations.

After decades of work on migraine prevention drugs finally an antibody-based approach has been approved. Aimovig (Amgen and Novartis) was first approved, and short thereafter came Emgality (Eli Lilly) and Ajovy (Teva). These are self-injected molecules and they all belong to a new class of drugs called calcitonin gene-related peptide receptor (CGRP-R) antagonists. They offer patients treatments that can reduce the number of days with migraine.

Other standouts include new drugs to treat infectious diseases. Xofluza (Roche), a polymerase acidic endonuclease inhibitor, is the first novel flu drug to reach the market in 20 years. This antiviral flu drug is the first that inhibit virus replication. Trogarzo (TaiMed) is a first in class antiretroviral monoclonal antibody approved for the treatment of HIV-1 infection in patients who are multidrug resistant to available treatments. Trogarzo may be able to improve patients’ outcomes when other options have run out.

Women health is historically a neglected field and has been a highly underserved market. However the field has received more attention in recent years. This year, the first new pill, Orilissa (Abbvie) for treatment of moderate to severe pain associated with endometriosis was approved. Orilissa lowers the amounts of estrogens which are expected to decrease the moderate and severe symptoms of endometriosis. It was more than 10 years since the last treatment for endometriosis was approved and there is still a lack of treatment options for this potentially debilitating condition.

A Nobel Prize and its result in a Novel drug

One of the highlights of the year was the approval of the first drug that acts by RNA interference (RNAi), Onpattro (Alnylam). The research that lead to the 2006 Nobel Prize in Physiology or Medicine on RNAi was published in 1998 (ii) and has now, 20 years later, successfully been translated into a novel therapy for treatment of a neurology disorder. The transfer of RNAi technology into drug development has been a scientific triumph with great potential to generate treatments for many more indications in the future. Onpattro treat nerve damage caused by hereditary transthyretin (hATTR) amyloidosis and was designated an ‘orphan medicine’.

Last year Tegsedi (Akcea and Ionis), also an antisense oligonucleotide therapy developed for the same disorder, similarly won approvals by FDA and EMA. And more will come, at least six other RNAi therapeutics are in phase III clinical trials for other indications (iii).

SMEs and Approved Orphan Drug Designations

In 2018, small and medium sized enterprises (SMEs) contributed with 56% of the approved NTD. We commented on the trend that more and more SMEs are able to take their products through to regulatory approval by themselves last year, and 2018’s figures only strengthen this trend (iv). One driver for this development is the great expansion of the orphan field that provides opportunities to run much smaller late stage trials, thereby limiting the cost of development in a way that suits SMEs. The orphan market accelerated significantly during this year as compared to the previous year.

In 2018 the number of approved new drugs designated orphan status almost doubled in both EU and US, as compared to 2017. Twenty and 42 new orphan drugs were approved in EU and US, respectively, during 2018 (in 2017 12 in EU and 24 in US). Interestingly, nearly 70% of all approved orphan drugs were sponsored by SMEs. This marks great progress of options for patients living with rare diseases, and proves that the drug development companies and the agencies have continued to speed up promising drugs to markets even if the patient groups are limited.

Some of the outstanding contributions to significantly benefit patients living with rare diseases include Epidiolex (GW Research) which is approved by FDA for seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. Its attention is also due to that it is the first FDA-approved drug that contains a purified drug substance derived from Cannabis sativa plant (marijuana). Another interesting new therapy is Namuscla (Lupin).

In EU, Namuscla is the first approved treatment for symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders, a group of inherited muscle disorders where muscles are slow to relax after contraction. These disorders are chronic life-long debilitating conditions characterized by long lasting pain.

Crysvita (Ultragenyx) is an additional exciting new treatment approved in US for patients with X-linked hypophosphatemia (XLH), a rare, inherited form of rickets. Crysvita is the first and only therapy that addresses the underlying cause of X-linked hypophosphatemia.

Improvements within Precision Medicine

The ideas of precision medicine are not new, but recent advances in science and technology have helped speed up the pace of this area of research, and major efforts are being invested in the fields.

A notable new oncology drug is Vitrakvi (Loxo and Bayer), a kinase inhibitor for solid tumors in various sites of the body. Vitrakvi became the second cancer therapy to be approved by FDA treating adult and pediatric patients whose cancers have a specific genetic feature, rather than a specific location of the tumor. This approval is a continuation of the new paradigm in the development of cancer drugs that are “tissue agnostic” set by Merck’s Keytruda in 2017.

Expedited approval of novel drugs

It is obvious that the agencies are working hard to increase the patient access of important medicines where there is huge unmet medical need. In US as many as 53 NTDs were approved through fast track, breakthrough, accelerated approval or priority review approval. In EU only two expedited approvals of NTDs were granted by conditional approval last year.

The trend from 2017 remains during 2018 with more expedited approvals in US than in EU. This might be because of the eligibility to use the expedited pathways is much more limiting in the EU than in the US or that the alternatives in EU for expedited approvals are not as well established with the industry as they are in the US.

NDA supported over 40% of the approvals in the EU

NDA had a strong presence in the EU regulatory arena and supported over 40% of the new products approved from 2013 to 2018.

To read the statistics of new drug product approvals from last year click here.


References

i. The data was gathered from the EMA and FDA official websites, as reported on the FDA and the EMA official websites on January 2019.
ii. Fire A., et al. Potent and specific genetic interference by double-stranded RNA in Caenorhabditis elegans. Nature 1998; 391:806-811.
iii. Mullard A. FDA approves landmark RNAi drug, Nature Reviews Drug Discovery 2018;17:613
iv. https://www.ndareg.com/europe-vs-usa-new-drug-product-approvals-in-2017/


 

Design and optimisation of a quality target product profile for ATMPs


The quality target product profile (QTPP) is an inherent part of product development and provides an overview of all the elements that have an impact on the quality, safety and efficacy of the product in a given clinical indication. The concept is defined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guideline Q8 and may be more familiar for those developing conventional pharmaceuticals.

However, it also provides an excellent tool for advanced therapy medicinal product developers and should be used to consider all elements that have an impact on the ultimate quality of the product and, consequently, the safety and efficacy in clinical and commercial use. Building up the QTPP should start at the research phase and continue up to the marketing authorisation application (MAA) phase; if it is put together properly and regularly updated, it provides the skeleton for the entire chemistry, manufacturing and control module of the MAA.

To find out more read the full article written by NDAs Director of Biopharmaceuticals and ATMPs Paula Salmikangas. The article is also featured in Regulatory Rapporteur – Vol 16, No 2, February 2019.

 

 


By Paula Salmikangas – Director of Biopharmaceuticals and ATMPs, NDA Advisory Board

 

 

 


 

 

Rare Diseases and FDA Advisory Committees: Be the Experts in the Room


checkWhen it comes to advisory committees that are convened for rare diseases, everyone must become an ‘educator’. This includes the applicant, external experts and open public hearing participants.

By definition, a disease is considered rare if it affects fewer than 200,000 people in the United States. However, an estimated one in ten Americans has a rare disease and about one third of all new drugs approved by FDA are now for rare diseases. In fact, in 2017 the FDA approved a record 80 new treatments for are diseases.

Whenever an FDA advisory committee is convened as part of the approval process, the stakes are high and there can be communication challenges. However, for applicants preparing for an advisory committee that is for a rare disease, the challenges are unique.

Read the full article written by Neelu Agrawal, expert in high stake meeting preparations, including FDA Advisory Committees, Oral Explanations, and Scientific Advisory Groups, to learn about some of those challenges, along with key factors for success.

 

 

 

By Neelu Agrawal – Principal, NDA Group/PharmApprove

 

 

 

 


 

 

Effective presentation of immunogenicity related data in regulatory dossiers

NDAs Paul Chamberlain, Biopharmaceuticals & Immunogenicity Expert and NDA Advisory Board member, provides practical advice about how to present immunogenicity-related information in regulatory dossiers, with a particular focus on a model for an Integrated Summary of Immunogenicity to be submitted in the marketing authorization application for novel biopharmaceutical products in ICH regions (EU, USA and Japan) in the latest publication of Bioanalysis.

A format that links the analysis of potential risk factors to a justification of the methodology applied for risk evaluation and conclusions for riskmitigation is presented as a model that can be adapted according to the weight of evidence to be submitted in support of the assessment of impact on overall clinical benefit versus risk for the particular situation.

 

 

 

If you are interested in hearing more from Paul he will be presenting at the following events in March:

DDF Summit on; Biosimilars – Regulatory Primer for Formulation Scientists 12th March in Berlin. To learn more click here.

NDAs breakfast seminar; Immunogenicity for investigational biopharmaceutical products – Start with the goal in mind, 14th March in Munich. To learn more and to sign up for the event click here.

 

 

A New Oncology Era

Dr Terese Johansson, Regulatory Consultant, NDA Group has written a new article on tissue-agnostic drug development: A New Oncology Era 

Read about how recent developments in tumourigenesis genomics have paved the way for a molecular marker defining a disease that spans multiple histology-based tumours in a tissue-agnostic manner, in an article written by Terese Johansson, published in European Biopharmaceutical Review October 2018 pages 32-37.

To learn more please click on the brochure below and flick to pages 32-37.

Healthcare White Paper published

On Thursday 4th October, at the prestigious Royal Society of Medicine in London, the Chartered Institute of Ergonomics & Human Factors (CIEHF), launched their much-awaited White Paper setting out CIEHF’s vision for the integration of Human Factors in Health & Social Care.

The launch event was a great opportunity for individuals working in Health and Social Care, both clinical and non-clinical, to understand how human factors expertise can help and benefit patients, staff and their organisations.

Dr Brian Edwards, Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group gave a talk, outlining the multi-faceted work of CIEHF’s unique Pharmaceutical Sector Group and its growing influence in a number of important areas such as manufacturing, technology and device design.

Click here to find out more

The White Paper is now available as a digital download. Get your copy here.

 

 

 

 

Dr Brian Edwards, Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group

How to commercialise ATMPs in the EU

NDA’s Paula Salmikangas, Director for Biopharmaceuticals and ATMPS, NDA Advisory Board and Steffen Thirstrup, Director NDA Advisory Board, have co-authored the article ‘How to commercialise ATMPs in the EU’.


Cell and gene therapy medicinal products, together with tissue engineering products (so-called advanced therapy medicinal products, ATMPs) are under active research globally. In the EU the legal and regulatory framework
has been in place for a decade.

However, the speed of scientific progress is challenging the available guidance and existing rulesets for ATMPs. This discrepancy has been noted by the European Commission (EC) and the European Medicines Agency (EMA), which, together, released an action plan for ATMPs in December 2017.

This article addresses recent findings from the EMA PRIME scheme and provides information about procedural updates and evolving guidance in the ATMP area.

The article is also featured in Regulatory Rapporteur – Vol 15, No 7/8, July/August 2018. Regulatory Rapporteur is TOPRAs respected, peer-reviewed journal and it is published 11 times per year and is free to TOPRA members.

 

 

 


 

Regulatory authorities expand their contribution to successful drug development

In recent years, the support from regulatory authorities available to pharmaceutical companies has increased significantly, with a particular focus on SMEs.

In the latest SwedenBio’s fact sheet (in Swedish), Eva Lilienberg, Service Area Lead Global Development NDA Group, details the levels of support pharmaceutical companies can expect to receive from the authorities and how to best prepare for any agency interactions.

 

 

 


 

Regulatory strategies for value maximisation of early clinical stage assets

Prepare for partnering – Optimizing value in early development

There are many important reasons why a company would choose not to develop and commercialise a product on their own. The cost of development increases exponentially, making the final stages impossible to finance for many companies. Building a commercial organisation covering vast territories can be an equally daunting task.

Companies we work with have a clear definition of what it is they want to do and often their strategy is limited to discovering and developing proofs of concepts of products in a certain region; the rest is simply not part of their focus. Whatever the reason, the goal for many companies we work with is often to develop the product to a stage where partnering or out-licensing becomes feasible.

This white paper written by Niamh Kinsella, Biologics Expert, Paul Chamberlain, Biopharmaceuticals Expert, Josi Holz, Clinical Strategy Expert and Eva Lilienberg, Service area lead Global Development, focus on how you can strengthen your partnering negotiation position, reduce the time to the clinic and to help you determine value-adding regulatory milestones by applying integrated regulatory strategies, ultimately optimising the value of your asset at the point of exit.

 

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By:

Niamh Kinsella
Paul Chamberlain
Josefin-Beate Holz
Eva Lilienberg

 

 

 

 

 

 

 

Europe vs USA: new drug product approvals in 2017

By Terese Johansson PhD, Consultant, NDA Group

It’s been an exciting year for new drug approvals! Many of the new drugs approved during the year address significant and meaningful needs or give additional therapeutic choices for patients and physicians. In the US we have seen a ground breaking approval in oncology that changes the way we look at and relate to indications; in addition the first digital pill has seen the light of day.

The following summary provides an overview of the key findings and an analysis of what the data means for the industry. The data is visually represented in an infographic below.

 

More approvals and more novel drugs

Last year there were a total of 103 new drug approvals granted in US and EU together that meet our selection criteria (i). Of these new products, 15 were approved only in the EU, 52 only in the US, and 36 were granted approval in both regions. It’s a large improvement compared to last year’s figures that showed 19 only in EU, 19 only in US and 36 in both regions, with a total 74 new approvals. In addition, 56 of the new approvals in 2017 were classified as novel drugs (ii). Our data show that the trend to apply for approval in the US prior to registration in the EU is, as usual, still a regular practice.

In the US expedited drug development and nonstandard review approval pathways are the new normal. In 2017 special approval and designation procedures like Fast Track, Breakthrough (BTD), Accelerated Approval and Priority Review was used for 37 of the new approvals, in many cases more than one of these approval pathway designations was granted per product. FDA has a higher rate of granting special approval status compared to EMA, 37 vs 10. One can only conclude that the policy groundwork laid by FDA in the past years to speed up drug approvals with the introduction of shorter nonstandard approval pathways has a clear overall effect on shortening the mean approval timelines.

Ground Breaking Oncology approval and the rise of CAR-T therapies

It’s been an exciting year for oncology with a total of 27 new approvals, so far 12 of these are only approved in the US and one of them were rejected by the EMA in 2008 (Mylotarg, gemtuzumab ozogamicin), however EMA now granted approval during 2018. A ground breaking approval was granted in the US where FDA (CDER) approved Keytruda (pembrolizumab) by Merck & Co Inc as the first drug ever where a biomarker (PD-1 (programmed death receptor-1) defines the indication (iii). The scientific rationale underpinning the Keytruda approval has effectively created a single therapeutic approach for patients with different tumour types, allowing extrapolation of the observed treatment effect to diverse tumours. The approval is likely to have implications for how the drug development process is pursued in the future, in oncology, but most likely also for other therapeutic areas as science progress.

Furthermore, also in oncology, the two first chimeric antigen receptor T-cell (CAR-T) therapies have been approved by FDAs CBER unit, its Novartis Kymriah (tisagenlecleucel, for the treatment of B-cell acute lymphoblastic leukemia) and Gilead’s Yescarta (axicabtagene ciloleucel, for the treatment of relapsed or refractory large B-cell lymphoma). Both drugs are currently under assessment in EU with Kymriah being granted an accelerated assessment by CHMP.

The Approval of a Pill with a Digital Sensor

Other noteworthy approvals from the US includes Abilify MyCite, the first pill with a sensor that digitally tracks if patients have ingested their medication (aripiprazole, for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar disorder and as an add-on treatment for depression) (iv).

Noteworthy Orphan Approvals

Several important ultra-orphan medicines have been approved in the US and EU, Mepsevii (vestronidase alfa-vjbk, for the treatment of the inherited metabolic condition mucopolysaccharidosis type VII, also known as Sly syndrome, approved in the US only) and Brineuria (cerliponase alfa, an enzyme replacement therapy for the treatment of Batten’s Disease, approved in both regions). With more treatments for orphan diseases hitting the market the debate on the pricing of these drugs intensifies: Drug developers are increasingly meeting the treatment demand from the patients and physicians but are the payers willing to pay the price? Drug developers will benefit from being prepared early on to develop strategies to ensure patient access to and affordability of their orphan agents.

The Birth of EU Public Hearings

2017 is also the birth year of public hearings at EMA. The EU Pharmacovigilance legislation enabled the Pharmacovigilance Risk Assessment Committee (PRAC) to hold public hearings during certain safety reviews of medicines allowing the committee and EMA to engage with citizens in the EU. Unlike the US, where public hearings for new drugs approvals has been going on for years, the system in EU focuses on post approval hearings in the context of urgent safety procedures / referrals and public hearings for new drug approvals is out of scope for now.

In the US public hearings of new drug approvals and how to deal with them can be an important part of drug developers planning for success. Drug developers aiming for US approval should consider building awareness of public hearings into their planning and ongoing relations with medical societies, patient organisations, physicians and other healthcare professionals. The perspectives from these groups can provide an important context for the safety and efficacy data submitted by drug developers and have additions to the severity and impact of a condition and the limitations of current standards of care. The Sarepta Exondys 51 approval in 2016 (for the treatment of Duchenne muscular dystrophy, only approved in the US, a review decision from EMA is expected during 2018) is an excellent example of a public hearing playing an important role in the approval process of a new drug. The approval showed the US Advisory Committees receptiveness to public perspectives as they evaluate the benefit-risk of new drug under review.

The Era of New Designation Pathways Continues

It’s also been an exciting year for drug developers in advanced medicines (e.g. ATMP in EU and Regenerative Medicines in US). FDA has during 2017 launched its new designation pathway Regenerative Medicine Advanced Therapy (RMAT) to further enable the development of these drugs. RMAT may be considered as analogous to BTD for regenerative medicines, with some additional advantages in comparison: it does not require evidence to indicate that the drug may offer a substantial improvement over available therapies. The RMAT designation gives drug developers access to increased meeting opportunities in a manner comparable to BTD therapies.

In EU, special designation pathways and approval procedures is not as common as in the US. In March 2016, EMA launched PRIME (PRIority MEdicines), the EU counterpart to FDAs BTD. Last year the NDA Group published data showing that most products approved for PRIME was from companies based in US and most of the companies also already had BTD (v).

It is too early to tell if RMAT and PRIME will add to the strategies used by some companies that see cumulative advantages and/or benefits from obtaining multiple designation pathways, a phenomenon used mainly in the US and known as ‘layering,’ or ‘stacking’ of special designations with the intent to increase overall product value.

Continued Negative Trend of First-in-class Medicine Approvals

The approvals for targeted novel, first-in-class mechanism of action drugs continue to decrease, a trend that has been going on for years. Is it a sign of drug developer’s increasingly competitive nature around targets that “work” in specific diseases? If this is the case, drug developers can expect the competition on pricing amongst innovator products to increase and become the norm from the beginning. Historically, price competition has been occurring later on during the life cycle. In an environment where it becomes increasingly important to distinguish oneself, drug developers should focus on creative clinical strategies for differentiation. This could include co-development of biomarkers and tests to target sub-populations, companion diagnostics and innovative designs for dosing and patient follow-up.

Small and Medium Sized Pharma Dominate

For the first time since we started mapping the new drug approvals small and medium sized pharma have surpassed big pharma (vi) – quite an achievement! In total small and medium sized pharma contributed with 51% of the new drug approvals, to be compared to 49% from big pharma.

NDA supported over 40% of the approvals in the EU

NDA had a strong presence in the EU regulatory arena and supported over 40% of the new products approved from 2013 to 2017.
To read the statistics of new drug product approvals from last year click here.


Data collection and disclaimer

(i) The data was gathered from the EMA and FDA official websites, as reported on the FDA and the EMA official websites on January 2018, The data collected contains drug approvals for new active substances (chemical, biological, biotechnology or radiopharmaceutical substance), new molecular entity, new biological entity, new drug combination, biosimilars, new active ingredient and vaccines, excluding only generic and duplicate applications from the data. As it is challenging to pull together data from two regions with different classification and reporting styles some general inclusion and exclusion criteria to create consistent indicators of the yearly trends in the EU vs the US has been applied. The above article provides an overview of the key findings and an analysis of what the data means for the industry. The data is also visually represented in an infographic. As experience tells us, the final number of approvals reported normally fluctuates for some time after the end of the year, as the Agencies go through their house keeping processes. There could therefore be some slight changes to the findings outlined in this report before the data is completely finalised. The PRIME analysis was based on publically available data from the EMA website and by mapping publically disclosed BTD.

(ii) FDA Novel Drug Approvals for 2017
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm547553.htm

(iii) First FDA Approval Agnostic of Cancer Site – When a Biomarker Defines the Indication. Lemery S, Keegan P, Pazdur R. N Engl J Med. 2017 Oct 12; 377(15):1409-1412

(iv) FDA approves pill with sensor that digitally tracks if patients have ingested their medication
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm

(v) PRIME time for early designation pathways in Europe, T Johansson, Pharmafocus June edition 2017

(vi) The list of the top 50 pharma companies in 2017 was obtained from: EvaluatePharma 2017 Evaluate Ltd www.evaluate.com


 

 

Assessing the consequences of the EMA’s relocation

The EMA is relocating to Amsterdam – but what are the consequences to the Agency’s priorities and to the industry?

In this commentary NDA’s CEO Johan Strömquist and Strategic Advisor Thomas Lönngren, formerly Executive Director at the EMA, assess the impact on the Agency in light of its business continuity plans.

 

 

By:

Thomas Lönngren
Johan  Strömquist