Understanding pregnancy: baby steps to developing drugs for pregnancy-specific conditions

^{On Monday 25 September, the Academy of Medical Sciences' FORUM is hosting a workshop on ‘understanding pregnancy: baby steps to developing drugs for pregnancy-specific conditions’, in partnership with Birmingham Health Partners and the Concept Foundation.}

Pregnancy-specific conditions – conditions that affect pregnant people (women and individuals who do not identify as women)* because they are pregnant – can be life-limiting and in some cases fatal. These conditions include (but are not limited to) pre-eclampsia, pre-term birth, gestational hypertension, gestational diabetes, postpartum haemorrhage and hyperemesis. Although such conditions carry a risk of serious short-term and long-term complications, there is a lack of safe and effective drugs: only two drugs have ever been approved for the treatment of pregnancy-specific conditions since the 1990s.

Although there is some evidence that many women who suffer from pregnancy-specific conditions are willing to participate in drug trials, there are barriers to pregnancy-specific drug development throughout the pipeline, including in pre-clinical research. To address these early barriers, this workshop will bring together people with lived experience of pregnancy, industry, academia, healthcare professionals, regulators, and funders to consider the challenges and opportunities in pre-clinical research and experimental medicine for pregnancy and pregnancy-specific conditions. Participants will explore what tools need to be developed and what questions need to be answered to take promising drug candidates safely and effectively forward to clinical trials for pregnancy-specific conditions.

More specifically, the aims of this workshop will be to:

• Identify the key research priorities, opportunities and challenges in pregnancy research, in relation to the preclinical space, experimental medicine, and the use of health data, through cross-sector collaboration.**
• Explore novel tools and assays to model drug efficacy, mechanism of action, toxicity and pharmacokinetic, and pharmacodynamic properties (of the mother and foetus/neonate) in pregnancy.**
• Consider the role of a research-enabled healthcare system to enable preclinical pregnancy research and experimental medicine, by providing access to patient samples with sufficient joined-up data and improving recruitment through trust and communication.

This workshop will take place in-person at the Edgbaston Park Hotel & Conference Centre, Birmingham on Monday 25 September from 10.00 - 16.30. Attendance at this workshop is by invitation only.

For further information, please contact: FORUM@acmedsci.ac.uk

The Academy’s FORUM provides a neutral and independent platform for individuals from across academia, industry, the NHS and Government, and the charity, regulatory and wider healthcare sector, to meet and take forward national discussions on scientific opportunities, technology trends and associated strategic choices for healthcare. Find out more.

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* The Academy acknowledges that not all pregnant people identify as women. While we use the terms ‘woman’ and ‘mother’ here, we expect that many of the learnings from this workshop about obstetric/pregnancy-specific conditions will be widely applicable. We recognise that there will be specific experiences and challenges associated with obstetric conditions among pregnant individuals who do not identify as women that we will not be able to explore in detail in this workshop given the lack of specific research in this area. Our experience of organising this workshop has highlighted how little is known about any specific experiences and challenges associated with obstetric conditions among pregnant individuals who do not identify as women. 

** For an explanation of the terms in bold, please see the glossary below.

Glossary

Preclinical: Preclinical development is the stage of research before clinical trials. Preclinical studies assess the safety and effectiveness of a product so it can then be tested in humans.

Drug efficacy: Drug efficacy measures a drug’s desired effect under ideal conditions, particularly whether the drug offers a health benefit over a placebo or other intervention.

Mechanism of action: The process by which a drug functions to produce an effect.

Toxicity: The degree to which a drug can poison the body and cause damage to an organism.

Pharmacokinetics: The study of how the body interacts with a drug for the entire duration of exposure, including the movement of the drug into, through, and out of the body.

Pharmacodynamics: The study of how drugs affect the body, including potential biological and physiological effects and potential toxicologic responses.