An Interview with Prof Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals
Written by James Coker | Reporter, European Medical Journal | @EMJJamesCoker
Disclosure: This is a non-commercial feature.
The field of reproductive medicine is one that is increasing in prevalence and stature. Some estimates have shown that as many as one in six couples have difficulty conceiving,1 and demand for infertility treatments has continually grown in recent decades as a result.2 Ferring Pharmaceuticals are a very important player in this area of medicine, having developed a number of products and services aimed at helping infertile couples achieve their desire to have children.3 During the recent European Society of Human Reproduction and Embryology (ESHRE) annual congress, which took place from 1st–4th July 2018, we caught up with Prof Klaus Dugi, Chief Medical Officer (CMO) of Ferring, to discuss the company’s extensive work in this area. Topics included their commitment to advance individualised fertility care, results of a study they presented regarding the efficacy of measuring women’s anti-Müllerian hormone (AMH) levels to predict response to treatment, and initiatives they have taken to place patients at the centre in this area of medicine. Appropriately, the interview took place during the same month as the 40th birthday of Louise Brown, the first child born after conception through in vitro fertilisation (IVF).
Growing Area of Medicine
Prof Dugi began by making it clear why it is so vital there are continuous improvements in fertility treatments for patients. He outlined societal and demographic changes as the key factors in this. “Due to career choices, couples often leave it [conception] later and unfortunately as people get older it becomes more difficult to start a family. But it’s still a wish that’s out there that we’re committed to help couples fulfil,” he commented. He added that increasing globalisation has meant there are more regions in which couples have become aware of this option. An example he gave was that of China, which has seen a significant rise in demand since the scrapping of their one child policy back in 2015.4
Individualised Care
A particular focus of Ferring in this field is to promote a more personalised approach to care for patients, ensuring that treatment is tailored to suit an individual’s personal characteristics. “We have learned more and more that the one-size-fits-all approach in some areas of medicine doesn’t work because people are different, they have different ages, different body weights, different genetic make ups, so it’s important to cater treatment to the individual,” explained Prof Dugi. “The same is true for fertility; the idea of fertility treatment is to use hormones to induce or stimulate ovaries to produce oocytes or eggs, and we know that the response can differ quite significantly depending on certain factors, such as a woman’s age and AMH levels. We want to make sure that we don’t underdose because that may not have the necessary efficacy of the treatment and also not overdose because that could compromise safety and tolerability. Therefore, to individualise treatment and make it more predictable will be important for the fertility doctors as well as for the women trying to conceive.”
Measuring AMH Levels
On 2nd July, Ferring announced results of a new analysis of data from the Phase III ESTHER-1 trial, which underlines this mission. The findings reinforce that measuring AMH levels is an accurate predictor of a woman’s ovarian response to ovarian stimulation, and therefore a good way of determining the appropriate dosage of the drug Rekovelle® (Ferring Pharmaceuticals, Saint-Prex, Switzerland) to each individual patient. Rekovelle (follitropin delta) is a human recombinant follicle stimulating hormone with an individualised dosing algorithm based on a woman’s AMH level and body weight. This new study found that natural variations in AMH levels during and between a woman’s menstrual cycle had no clinically relevant impact on ovarian response in 95% of the 1,326 patients included in the ESTHER-1 trial. This should serve to increase the confidence physicians have in using AMH levels to decide on the dose of Rekovelle they prescribe.5
Prof Dugi further elucidated how the method works: “There are decades of research in this area, showing that there can be a substantially different response to hormonal treatment amongst women; some will only produce a few eggs whereas others will have 15–20 and potential side effects. So the idea was to tailor the treatment by deciding on the individual dose based on the body weight of the woman and on their level of AMH, and find the optimal dose for an individual woman. This makes a very important tool for the fertility doctor to make the treatment more predictable so he or she can expect with piece of mind that, within a certain dose, there will likely be a certain response from the ovaries.”
Ferring’s CMO did however acknowledge that there is likely to be, as is seen in other areas of medicine, a period of time before guidelines change and doctors ultimately adapt the way they treat their patients in light of these findings. Nevertheless, he stated that the feedback received from the healthcare community in terms of prescribing Rekovelle doses based on AMH levels has been very positive, and none more so than during interactions Ferring had with healthcare professionals during the recent ESHRE Congress.
New Hypotheses
Prof Dugi informed us that there will now be further analysis into the Rekovelle treatment, which has been approved in 37 countries across the globe. In particular, Ferring hope to identify new areas in which personalised approaches to care can be enhanced further. “We are currently conducting trials with Rekovelle in Asia, we’re hoping to start trials later in the year in the USA, and we have an ongoing real-world evidence trial with Rekovelle,” he said. “And by looking at the data of the ESTHER trials we can generate new hypotheses about individualisation and identify other avenues to improve treatment success, which obviously would be important for couples and fertility clinics. We even want to look to other areas such as genomics, the microbiome, and big data that we can use to help fertility clinics and patients to optimise therapy and increase success rates.”
Support for Patients
In addition to Ferring’s ongoing Research and Development programmes in the field of reproductive health, the company also has a major focus on helping infertile couples as they consider their next steps. Prof Dugi explained how in the modern era, with medical information increasingly more accessible in the age of the internet, patients are becoming far more educated and empowered than ever before. To take this into account, Ferring looks for ways to educate patients about fertility and support couples thinking about beginning IVF; in the USA, for example, this includes providing insights into what the procedure would involve and the best places for them to access treatment.6 “Not all couples have access to fertility treatment,” said Prof Dugi. “That may be because they live far away from a fertility centre or because they are not aware of the options that are out there. It is important for us to support patients with information material to help them learn where they can find help and that there are options for them to get support and improve their chances of starting a family.”
Ferring also collaborates with a number of patient organisations to assist with this goal of improving access to information and treatment. This includes support with events and educational campaigns. “There are also some areas where there is an even bigger stigma for couples not being able to start a family, so it’s important for us to work with these patient advocacy groups and use the internet to make information available to all patients,” added Prof Dugi.
New Areas of Research
There are also lots of new avenues Ferring are exploring in reproductive medicine. One of the most exciting of these, in the view of Prof Dugi, is the work they are involved in to discover more about the impact microbes have on human health and disease. For example, they are supporting research looking into the role of the microbes in causing premature labour, which is the leading cause of death in children before the age of 5 years.7 The ways in which innovative technologies, such as artificial intelligence and big data, can improve fertility treatments are also of great interest to Ferring. Prof Dugi explained the exciting opportunities that are now available to use big data to combine information on the microbiome and genetics in a number of trials they are currently conducting or planning to conduct. “We have started a number of collaborations in this area and we’re optimistic that we can find new scientific data that can help improve success rates and help more couples start a family than in the past,” he commented.
From speaking to Prof Dugi it is clear that reproductive health is a field in which rapid progression is occurring; this is something that is required in order to meet the growing demand for fertility treatments across the world. Ferring is an organisation that is at the forefront of these developments, and here at the European Medical Group we look forward to seeing how their products and services continue to benefit couples who are unable to conceive by natural means.
EMJ Reproductive Health
We recently published this year’s edition of the EMJ Reproductive Health eJournal, an open-access edition which is available to read here on our website. The journal includes a review of the recent ESHRE Congress in addition to abstract and symposium reviews presented at the event, interviews with leading experts in the field, and a range of peer-reviewed articles.
REFERENCES
- Pittman G. Almost one in six couples face infertility: Study. 2013. Available at: https://www.reuters.com/article/us-couples-infertility-idUSBRE90A13Y20130111. Last accessed: 22 August 2018.
- Christensen J. Record number of women using IVF to get pregnant. 2014. Available at: https://edition.cnn.com/2014/02/17/health/record-ivf-use/index.html. Last accessed: 22 August 2018.
- Ferring Pharmaceuticals. Reproductive Medicine & Women’s Health products. Available at: https://www.ferring.com/en/products/reproductive-medicine-womens-health/. Last accessed: 22 August 2018.
- Jourdan A. China struggles with IVF demand as one-child policy ends. 2015. Available at: https://uk.reuters.com/article/us-china-population-ivf-idUKKBN0TJ2OW20151201. Last accessed: 22 August 2018.
- Ferring Pharmaceuticals. New analysis of Rekovelle® data further supports use of AMH to personalise fertility treatment. 2018. Available at: https://www.ferring.com/en/media/press-releases/new-analysis-of-rekovelle-data-further-supports-use-of-amh-to-personalise-fertility-treatment/. Last accessed: 22 August 2018.
- Ferring Fertility. Delivering Support on Your Journey to Parenthood: Helpful information about fertility and IVF treatment. Available at: https://www.ferringfertility.com/. Last accessed: 22 August 2018.
- Imperial Biomedical Research Centre. Mother’s microbiome as a predictor of premature labour. 2018. Available at: https://imperialbrc.nihr.ac.uk/2018/02/23/microbiome-premature-labour/. Last accessed: 22 August 2018.
