Abstract
For the last 20 years, Thomas D'Hooghe has been coordinator of the Leuven University Fertility Center at Leuven University Hospitals, Belgium, one of the largest teaching hospitals in Europe. Since 1995, he has also been Professor of Reproductive Medicine and Biology at KU Leuven (University of Leuven) and Adjunct Professor at Yale University, USA. Since 1 October 2015, he has been the Vice President and Head of Global Medical Affairs Fertility at Merck's headquarters in Darmstadt, Germany. He has published nearly 300 papers in internationally peer-reviewed journals and has contributed to reproductive health serving major international organizations such as the WHO, the European Society of Human Reproduction and Embryology, the Society of Reproductive Investigation and the World Endometriosis Research Foundation.
Keywords
For the last 20 years, I have been coordinator of the Leuven University Fertility Center at Leuven University Hospitals, Belgium, one of the largest teaching hospitals in Europe with more than 2000 beds. Since 1995, I have also been Professor of Reproductive Medicine and Biology at KU Leuven (University of Leuven) and Adjunct Professor at Yale University, USA. Since 2001, I have also served as President of the Belgian Society for Physicians in Reproductive Medicine [1] and am still Editor in Chief of Gynecologic and Obstetric Investigation (Karger, Basel, Switzerland). During the last 15 years, I was sponsored by the Flemish Research Foundation (Fonds voor Wetenschappelijk Onderzoek [FWO]) and by Leuven University Hospitals Research Foundation to devote 50% of my professional time to translational research in reproductive medicine and biology. Overall, I have published close to 300 papers in internationally peer reviewed journals and have contributed to reproductive health serving major international organizations such as the WHO (strategy report, past advisor with respect to ICD11 code revision in benign gynecology, infertility guidelines steering committee), the European Society of Human Reproduction and Embryology (ESHRE; Past Chair of Special Interest Group Endometriosis; past Chairman-elect of the European IVF Monitoring Committee) [2], the Society of Reproductive Investigation (past board member) and the World Endometriosis Research Foundation (WERF; past board member). My main contributions are related to original research in endometriosis (validation of preclinical baboon model for pathogenesis and new medical treatment of endometriosis at WHO collaborating center Institute of Primate Research, Nairobi, Kenya; various international research projects supported by WERF and EU on the cost and importance of patient centeredness of endometriosis; contributions to pathogenesis of endometriosis, surgical treatment of deep endometriosis; development of biomarkers for noninvasive or semi-invasive diagnosis of endometriosis), assisted reproduction (randomized clinical trials, clinical embryological research, based on single cell arrays, among others), psychology and patient centeredness. These contributions have been awarded by international awards, and have been achieved in collaboration with many Belgian and international PhD students and postdocs.
Indeed. At present we are evaluating whether induction of endometriosis in baboons affects their general, pain-related and sexual behavior within their own social group. We are also discovering and validating new biomarkers for endometriosis in both women and baboons, and with induced endometriosis. We are also standardizing a menstruating mouse model for endometriosis, based on our experience in the baboon model. Additionally, we are developing an integrated bioinformatics model for noninvasive diagnosis of endometriosis based on clinical history and examination, ultrasound imaging and peripheral blood biomarkers. Finally, we are just about to publish in Human Reproduction an international consensus paper, coordinated by Leuven experts, on how to conduct surgical trials in deep endometriosis.
Preclinical research in animal models has shown that nonhormonal medical treatment aimed at reducing specific inflammatory pathways (i.e., TNF-α inhibiting drugs, various kinase inhibitors) can effectively inhibit and treat peritoneal endometriosis in rodent and in baboon models [3,4]. Potential or real toxicity has been the major limitation to evaluate these drugs in women. Also, Phase II clinical research in women should be primarily aimed at women with pelvic pain and peritoneal endometriosis, not at women with deep endometriosis and adhesions. Another important development is our role in the discovery and validation of a noninvasive diagnostic blood test for minimal to moderate endometriosis in symptomatic women where endometriosis cannot be diagnosed by ultrasound [5,6]. Finally, our group also contributed significantly to the WERF international recommendations on clinical phenotyping, surgical reporting and collection of body tissues and fluids to support biomarker research by for clinical and surgical phenotyping [7,8]. This will allow the field to develop international collaboration in large consortia, which will help to improve the quality of research into diagnosis and treatment of endometriosis.
The main focus is the development of a noninvasive diagnostic test for endometriosis and of new nonhormonal treatment. Obstacles include the lack of large-scale randomized trials comparing medical, surgical and assisted reproductive technology approaches in women with endometriosis, and the lack of patient oriented outcome research with long-term follow-up after surgical and medical treatment, in order to better understand the recurrence of endometriosis. These obstacles are partially related to a lack of interest of industry in women's health in general, and in endometriosis in particular.
Infertility is related to the origin of life, and represents a very sensitive issue on a personal, relational, social, legal, political and ethical level, just like all issues linked to the start and end of life. I have had the opportunity to develop, over the last 20 years, a program in reproductive medicine at the KU Leuven, a Catholic university. We made enormous progress, and are the only Catholic university in the world offering a full range of infertility care, including medically assisted reproduction for lesbian couples. What we did is used as an example for Catholic universities in other parts of the world, that is, Latin America. We were able to make this progress based on totally transparent communication and dialogue with the Commission of Medical Ethics of the Faculty of Medicine from our University. We also did research on this topic, that is, the perspective of both sperm donors and parents raising children born after anonymous sperm reception [9,10]. That way, we have developed an evidence- and value-based approach towards reproductive ethics, and have been able to participate in the public debate and influence national regulation and legislation in the field of assisted reproduction.
First of all, I must say that I have enjoyed my previous role very much, up till the last day. Working in an academic medical center has offered me a great combination of clinical care, research, management, teaching, international collaboration, exposure to press and politics, etc. However, after 20 years in that role, it was time for a new challenge. I had several invitations to lead centers of reproductive medicine in other countries, but it gradually became clear to me that I was really interested in a leading role within an international organization devoted to women's health, that is, WHO, UN, EU, NIH, international globally oriented healthcare related companies or NGOs. This international perspective was imprinted when I developed the baboon model for endometriosis as part of my PhD at the WHO collaborating center Institute of Primate Research, Nairobi, Kenya (1990–1993) [11,12], followed by a postdoctoral research fellowship at Harvard Medical School in Boston, MA, USA (1993–1995), and by consultancy work for WHO since 2008 up till I joined Merck a few months ago [13]. To be honest, a senior executive role in women's health at WHO, UN, EU or NIH would also have been an option, but Merck is a truly global organization, being represented in 191 out of 193 countries belonging to the United Nations.
At Merck, I have been appointed as Vice President and Head of Global Medical Affairs Fertility and I will report to the Chief Medical Officer, while working closely together with the Global Business Franchise Fertility and with countries and regions, in collaboration with the Division of Medical Excellence within the Department of Global Medical Affairs. I will have a key responsibility in the medical and research aspects of fertility on a global level, with the aim to develop maximally the scientific and market value of the existing products, and to offer insight into the potential scientific, medical and market value of pipeline and novel drugs and technologies. During my appointment, I want to preserve and advance the global leading role of Merck in fertility, based on a scientific and medical perspective. I believe that a strong research base is absolutely essential for future developments in this field. Finally, based on my interest and background in other reproductive health problems, I hope to revive the interest of Merck in uterus related health problems like, embryo implantation failure, endometriosis, adenomyosis and uterine fibroids. After all, my first collaborative studies with Merck Serono were related to demonstrating the therapeutic value of TNF-α-binding protein and JNK inhibitors [3,4] in the baboon model for endometriosis, before being involved in Merck led international trials on embryo implantation (recombinant LIF trial) and novel recombinant gonadotrophins. Very importantly, I also want to focus on a science based patient centered approach in the development of existing and new drugs and devices [14,15].
There are several reasons.
In the first place, I think that many lack sufficient exposure to the strong research and international perspective of industry. I was lucky to be involved as a consultant advising many different companies like Merck, Ferring, MSD, Bayer, Roche, Actavis, Astellas, Teva on a variety of health economic, diagnostic, novel therapeutic, patient reported outcome and many other issues related to women's health, benign gynecological disease and infertility.
Secondly, some senior academicians really consider industry not only as ‘the other side’ (which is true), but also as ‘the dark side’ (which unfortunately has been the case, but luckily not in my personal experience). In that context, I must admit that I could not have joined any company, but only a company with a very strong track record, excellent senior leadership and future global vision in research-based innovation in infertility, like Merck. My decision was also positively influenced by the fact that Merck is the oldest pharmaceutical and chemical company in the world (with roots dating back to 1668), and the founding family Merck remains the majority owner of the company to this day.
Thirdly, although in general senior academicians feel that they could contribute significantly to scientific and medical excellence in companies that are active in reproductive health, it is a major step for many to leave behind their clinical work, teaching and research activities and to relocate to another city or country. However, in my view and experience, this can be negotiated.
Of course my main responsibility will be to serve as Vice President and Head of Global Medical Affairs Fertility with Merck. However, it has been interesting for me to find out that Merck not only values my academic background, but also wishes me to maintain my academic affiliation. In that context, I will remain Professor of Reproductive Medicine and Biology at the University of Leuven (KU Leuven) in Belgium, and Adjunct Professor of Obstetrics and Gynecology at Yale University (CT, USA). My main focus will be to complete ongoing research projects, as I still supervise 10 PhD students, and to continue some teaching. In the future, I would like to develop original win-win research-based partnerships with these universities, and of course with other academic centers and research groups on a global level. Personally, I think that collaboration between industry and academia is an essential condition to make progress in the diagnosis and treatment of infertility and women's reproductive health problems, and in global access to women's health care, also in low or middle income countries. This collaboration should be contract-based, happen within a legal context, and conflicts of interest and financial aspects of this collaboration should be made transparent and public, but other regulation is not warranted in my opinion.
Footnotes
The opinions expressed in this interview are those of the interviewee and do not necessarily reflect the views of Future Medicine Ltd.
T D'Hooghe has been Vice President and Head of Global Medical Affairs Fertility at Merck, Darmstadt, Germany since October 2015. Before October 2015, he served as Consultant to many companies including Bayer Pharma, Proteomika, Pharmaplex, Astellas, Roche Diagnostics, Actavis, Ferring, Merck Serono, Merck, Besins. T D'Hooghe has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.