Second Regulatory Roundtable
The Women’s Brain Project holds landmark second regulatory roundtable to advance progress towards sex and gender-considerations in precision medicine
On 27th May 2021, the Women’s Brain Project (WBP) held their second regulatory roundtable on advancing sex and gender precision medicine.
The initial roundtable was held on 17th September 2020 and successfully established a basis for debate and consideration around the importance of sex and gender considerations within regulatory practices. The key outcomes of the first roundtable can be viewed here.
WBP’s follow up regulatory roundtable, which was held virtually on the 27 May 2021, once again, brought together key regulators from across the world such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada as well as other major stakeholders to promote change in the regulatory space at an international level and to promote sex and gender specific measures in clinical trials, drug development and policy at large.
The WBP team kicked off the roundtable with an introduction to their organisation reiterating their mission to “Improve the state of medical treatment and drug development for brain and mental health through sex and gender factors analysis as a gateway to precision medicine” whilst addressing how they would achieve this.
Using specific case examples, from both Alzheimer’s and Parkinson’s, the WBP set the scene of their work.
Alzheimer’s is the most common form of dementia- 60-70% of cases worldwide are attributed to Alzheimer’s. Moreover, two thirds of Alzheimer’s patients globally are women, once diagnosed it is often observed that female patients experience poorer cognition and faster progression of symptoms in comparison to men.
WBP highlighted the sex-differences in clinical scales and in biomarkers, most notably the accumulation of Tau, a neuron specific microtubule-associated protein which forms intracellular aggregates, a significant pathological signature of Alzheimer’s. It was mentioned that tau aggregates are often found to be present in higher levels in females in comparison to their male counterparts. Interestingly, evidence suggests that Apolipoprotein E (APOE), the most potent genetic risk factor of Alzheimer’s disease confers higher risk of tau pathology in women.
All of which beg the question as to why sex and gender- considerations are not more pronounced in medical research and regulatory matters. These findings also help us to understand the need to move towards precision medicine – a method of treatment and prevention that considers individual variability.
The second case example included Parkinson’s disease. A disease more commonly associated with men, resulting in little focus on female patients. WBP presented data collected from the Women’s Parkinson’s Project which indicated that the menstrual cycle may have implications for Parkinson’s symptoms. With 73% of respondents (sample: total 200 women with early onset Parkinson’s) reporting that their symptoms such as bradykinesia were increased during the week prior to menstruation. Menstruation is a process that many women experience in a predictable way 1 in every 4 weeks, and therefore, tailoring of treatment could be planned around it. In general, more must be done to recognise the associations, if any, between neurological conditions and hormonal processes including perimenopause.
Finally, WBP gave insights into their recent research surrounding COVID-19 vaccines and the issues with regulatory guidance offered to pregnant and/or lactating women.
WBP stressed their concerns surrounding the absence of stratification by sex within the regulatory data and highlighted the implications this has for safety.
The introduction provided a holistic background of WBP and set the scene for further debate and discussion amongst roundtable attendees.
The roundtable was an invitation-only event and was held under the Chatham House Rule. In light of the rule, we cannot disclose any content attributed to individual participants, but can highlight some of the key takeaway messages and outcomes from the meeting.
Through fruitful discussion and interactive poll-style questions it was identified that the greatest short-falling in the field was surrounding ‘unestablished knowledge base’, whilst the least pressing issue was ‘untethered pharmacovigilance’.
The top four matters recognised via the poll were as follows:
- Unestablished knowledge base
- Approved therapies under-analysed
- Impact underappreciated
- Lack of awareness
These findings formed the basis of debate in smaller breakout groups, in which deliverables were formed.
We plan to hold a follow-up regulatory roundtable in Q4 2021, to discuss further actions and begin to address these deliverables.
WBP will also continue in its mission to create a sex and gender precision medicine research institute. We call upon all relevant stakeholders to join us in our efforts to further the momentum on sex and gender precision medicine. For more information or to get involved, reach out to email@example.com. We believe all marches start with first steps, and it’s important all stakeholders come together now to advance women’s health and precision medicine. This will require a truly multistakeholder and multidisciplinary approach.
About the Women’s Brain Project:
The WBP is an international non-profit organisation studying sex and gender determinants of brain and mental health to achieve precision medicine. WBP is a global leading player in the field of brain research, supporting innovative science, precision medicine, unbiased artificial intelligence (AI) and promoting gender health equity to make healthcare systems more sustainable. The vision of WBP is to create a sex and gender precision medicine research institute. Your support is extremely important to us. Please use our dedicated IBAN number to DONATE to the Women’s Brain Project. Every penny you give goes towards our ground-breaking work. IBAN NO. CH98 0483 5160 9215 9100 0