PSI Webinar: Drug Development in Women's Health

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Date: Wednesday 15th May 2024
Time: 15:00-16:30 BST | 16:00-17:30 CEST
Location: Online via Zoom
Speakers: Elizabeth Garner (Ferring Pharmaceuticals US), Christoph Gerlinger (Bayer), Radu Cimpeanu (University of Warwick) and Jack Wilkinson (Manchester University).

Who is this event intended for? Statisticians with an interest in understanding the challenges and opportunities in drug development for Women’s Health.
What is the benefit of attending? 
Learning from the experiences of a clinician and statisticians working in the field of women’s health.


This event is free of charge to both Members of PSI and Non-Members. To register your place for this event, please click here


This multidisciplinary webinar will cover the latest insights in women's health. Clinicians and statisticians will provide valuable perspectives on current challenges and opportunities in the field covering recent developments in women’s health drug development, statistical complexities of in vitro fertilization (IVF) and insights into the statistical considerations surround the menstrual cycle and menstrual bleeding measurements.

Our esteemed panel will present on the following topics:
● Opening on drug development in women’s health - Elizabeth Garner (Ferring Pharmaceuticals US)
● Menstrual cycle and Measurement of menstrual bleeding - Christoph Gerlinger (Bayer)
● A new flow-based design for double-lumen needles in IVF - Radu Cimpeanu (University of Warwick)
● ‘IVF – statistical challenges in complex, multistage interventions’? - Jack Wilkinson (Manchester University)

Speaker details




Elizabeth Garner

Elizabeth Garner is a seasoned pharmaceutical executive with a career-long focus on addressing unsolved issues and conditions that affect women’s health and quality of life. Dr. Garner is currently Chief Scientific Officer of Ferring Pharmaceuticals US and has held previous positions as Chief Medical Officer of ObsEva and Agile Therapeutics, and senior positions at Myriad Genetics, Abbott Laboratories, and Merck Research Labs. Beth is on the Boards of Directors of Kezar Life Sciences and Sermonix Pharmaceuticals and is the Chair of the Board of NUA Surgical. She is also the Immediate Past President of the American Medical Women’s Association (AMWA), a professional organization whose mission is to advance women in medicine, advocate for equity, and ensure excellence in healthcare. Dr. Garner received her M.D. and M.P.H. degrees from Harvard Medical School and the Harvard School of Public Health and trained in Obstetrics and Gynecology and Gynecologic Oncology at Brigham and Women’s and Massachusetts General Hospitals and the Dana Farber Cancer Institute. Beth is a frequent speaker on a range of topics including the health of women, women’s leadership, and clinical trial diversity; she is a 2019 and 2023 awardee of the PharmaVoice 100 Most Inspiring Individuals in the life sciences industry and was the 2022 recipient of the Woman in Science Award from AMWA.

Opening on drug development in women's health

Women’s health is defined as conditions that 1) affect women distinctly (e.g., endometriosis), 2) affect women differently (e.g., heart disease), and 3) affect women disproportionately (e.g., autoimmune disease). Although women make up half of the world’s population, inclusion of women in clinical trials in the US has only been required since 1993. Furthermore, there has been a lack of investment in women’s health research. According to McKinsey, in 2020, only 1% of the almost $200 billion in investment in healthcare research and innovation went toward female-specific conditions beyond oncology. The consequence of these factors is that despite the exponential increase in the generation of data in health, substantial data gaps in women’s health persist. In November 2023, the White House announced a new initiative focused on Women’s Health Research. In February of this year, Jill Biden, who is leading the White House Initiative, announced $100 million in federal funding for research and development in women’s health, opening up a new era in which women’s health is no longer considered a “niche” market.


Christoph Gerlinger

Christoph works since more than 30 years as a statistician in the pharmaceutical industry. He is Bayer’s expert statistician for Womens’ Healthcare and for Health Technology Assessment. Christoph is an EFSPI council member and since over 10 years the regulatory chair of EFSPI. He is also member of several scientific advisory groups for EMA and the European Commission. In his spare time Christoph teaches experimental gynaecology at the Saarland State University and leads the local chapter of the pan-European party Volt.


Christoph’s involvement in women’s health started when he joined Schering AG in 1996. His Ph.D. thesis was entitled “Development of two methodological guidelines for the evaluation of bleeding patterns – A tool for registration and prescription on the basis of an empirical analysis”. Christoph (co-)authored many papers on methodological topics in women’s health and he is also a co-developer of several PRO instruments in the field of women’s health.

Menstrual cycle and Measurement of menstrual bleeding

The talk will start with a brief introduction into the female menstrual cycle aimed primarily at the layMEN. The assessment and statistical analysis of the normal menstrual bleeding pattern will be described. Special attention will be given to changes in bleeding patterns introduced by hormonal birth control products. First, analyses of bleeding patterns for products with scheduled bleeding, such as the classical “pill”, will be addressed. Then, bleeding pattern analyses for products without scheduled bleeding, such as intrauterine devices, aka “the coil”, will be discussed. While bleeding pattern analyses for contraceptives are typically based on simple questions like bleeding “yes” / “no”, for the investigation of abnormal menstrual bleeding the actual amount of the bleeding in mL (or in uk fl oz) is of interest. Previously, this required the collection of all items for sanitary protection, i.e., pads and tampons, used during a cycle and shipping them to a laboratory for chemical analysis. Today, a validated pictogram is available where the woman rates on a simple Likert scale how soiled her sanitary protection item was. The elaboration and validation of this method will be presented.

Radu Cimpeanu

Dr. Radu Cimpeanu is Associate Professor (Reader) in Applied Mathematics at the University of Warwick, specialising in the mathematical modelling of real-world systems. His primary research interests lie at the interface between fluid mechanics, scientific computing and numerical solutions for partial differential equations, with a particular interest in knowledge transfer and industrial mathematics (and a keen supporter of the Study Groups with Industry format). Radu has so far developed methodologies used to address technologically relevant problems in areas such as microfluidics, aircraft surface de-icing and spray atomisation. He is currently Deputy Director of the Warwick Fluid Dynamics Research Centre, and Executive Committee member of the UK Fluids Network, while also supporting the UKRI National Fellowships in Fluid Dynamics (NFFDy) programme.

A new flow-based design for double-lumen needles in IVF

Oocyte retrieval forms a crucial part of in vitro fertilisation treatment and its ultimate outcome. Standard double-lumen needles, which include a sequence of aspiration and flushing steps, are characterised by a similar success rate to single-lumen needles, despite their increased cost. In this talk I will present a novel hydrodynamics-based needle called the OxIVF needle, with design features that enablethe generation of an internal flow field within the full follicular volume via laterally, rather than frontally, oriented flushing, leading to successful retrievals with no additional stress on the oocyte. An in-silico mathematical model (J. Biomechanics 160, 111832, 2023) based on multi-phase flow direct numerical simulation provides new insight into the internal flow movement as part of the constructed digital twin, while forces measured during these tests showcase how the oocyte experiences stresses which are no larger than at the aspiration point, with the flow field providing a gentle steering effect towards the extraction region. We found that the proposed framework increases oocyte yield to up to 100% in computational studies, marking a significant improvement over the traditional double-lumen design whose success rate of no more than 75% in like-for-like comparisons was also highly dependent on the location of the needle tip inside the follicle. This design unlocks new capabilities in both human and veterinary contexts, with preliminary studies showing significant promise (Animal - science Proc. 14 (3), 468-469, 2023). The interdisciplinary approach and research team dynamics, which underpinned many of the advances above, will also be brought to the forefront as the scientific milestones of the study are expanded upon. Acknowledgments: Alfonso A. Castrejón-Pita (University of Oxford), Lee Nai Lim (Oxford University Hospital), Manu Vatish (University of Oxford) and Ektoras X. Georgiou (Oxford University Hospital).

Jackedit Jack Wilkinson

Jack Wilkinson is a Senior Lecturer in the Centre for Biostatistics, University of Manchester. His research interests cover both the application, development, and criticism of methods for the evaluation of health interventions, with a particular interest in interventions for the treatment of subfertility, including assisted reproductive technologies (ART). He holds Statistics or Methodological Editor roles for Cochrane Gynaecology and Fertility, BJOG: An International Journal of Obstetrics and Gynaecology, Fertility and Sterility and Reproduction and Fertility. He is currently leading the NIHR-funded INSPECT-SR project, which aims to develop a tool for identifying ‘problematic’ randomised controlled trials, including those subject to data fabrication or falsification.

IVF – statistical challenges in complex, multistage interventions - Jack Wilkinson (Manchester University)

Assisted Reproductive Technologies (ART) are complex multi-stage interventions, typically involving stimulation of ovaries and collection of eggs, the fertilisation of eggs to make embryos, the culture and subsequent selection of embryos using some form of algorithm, followed by an embryo transfer with the aim of producing a pregnancy and subsequent live birth of a healthy infant. The multistage nature of ART introduces a number of challenges for the design and analysis of both randomised and non-randomised studies of fertility interventions, and some apparently ‘common-sense’ analysis choices correspond to no clinically relevant estimand. In this talk, I will give a non-technical overview of some recurring methodological pitfalls in ART intervention research.


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