In Conversation with Professor Moshe Hod, Chief Medical Advisor for PQE Group

Professor Moshe Hod is Professor of Obstetrics and Gynecology at the Faculty of Medicine, Tel-Aviv
University, Israel and visiting Professor, University of Florence, Italy. He also serves as the Chief
Medical Advisor for PQE Group.

September 28, 2023

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Professor Hod’s previous positions include serving as Director of Maternal Fetal Medicine Division, Helen Schneider Women’s Hospital, Rabin Medical, Israel Director of Mor Comprehensive Women’s Health Care Center, Tel Aviv, Israel; President of the European Association of Perinatal Medicine (EAPM);  and Chair of Pregnancy and Non Communicable Disease  Committee (PNCDC), International Federation of Obstetrics and Gynecology (FIGO). He has also been a member of the Executive Board of Directors for FIGO; the Executive Board of Directors for the Chair of the Board of the Diabetic Pregnancy Study Group (DPSG), European Association for the Study of Diabetes (EASD). He has authored multiple scientific publications and was the Editor of several Textbooks, including the Textbook of Diabetes and Pregnancy, Informa Healthcare, London, UK and New Technologies and Perinatal Medicine; Prediction and Prevention of Pregnancy Complications. He served as the Founder & President of the International Symposium on Diabetic Pregnancy (DIP) and of the World Congress on Women’s Health: Innovations & Inventions (WHII 2022): Addressing Unmet Needs. In addition, he has been involved in several industry start-ups, serving as President & Chairman of the Medical Advisory Board of Gynica Healthcare, and as Chairman of Medical Advisory Boards to Wear2B, Carmentix, and Rosetta Genomics (NASDAQ: ROSG); and Chairman of the Medical Advisory Board and Medical Director of Global Medical Networks (GMN). We spoke with Prof. Hod to learn more about his role with PQE Group and the path that led him to work closely with their CEO & Founder, Gilda D’Incerti, to become Chief Medical Advisor of the global consulting company.

You have a very impressive background, Professor Hod! You have done much of your work in Israel, and PQE Group is headquartered in Italy. How did you meet Gilda D’Incerti and become engaged with PQE Group?

Much of my career has been in Israel, but not all of it.  I have worked quite extensively in the US –  I was trained in Basic Science and MFM in leading US Centers , Northwestern University , Chicago and The University of Texas , San Antonio.  I’m highly connected to organizations that include Columbia, Brown, and Thomas Jefferson Universities in the US, and to European organizations, as well. I am also active in the International Federation of Gynecology & Obstretics  (FIGO – Homepage | Figo), the largest women’s organization in the world which includes gynecologists and obstetricians from 130 nations around the world. I’ve also worked quite extensively in Italy, as a visiting Professor at the Careggi Medical Center in Florence and as the ambassador, advisor and coordinator of the Italian Study Group on Diabetes and Pregnancy.  I have organized a few International DIP ( Diabetes in Pregnancy ) Congresses in Italy and continue to do so. Actually , the next DIP Congress – FemDIP2024, which will merge the Perinatal Medical Community with the Femtech Community – will be held in Italy in May 2024. You will see learn more about that later in this conversation.  

My collaboration with Gilda and PQE started with the launch of Gynica in Israel, a clinical-stage biotech company developing dedicated to developing safe and effective intra-vaginal solutions for Endometriosis. Gynica harnesses the therapeutic potential of cannabinoids in their formulations, recognizing their promising role in the treatment of women’s health and gynecological conditions. I’m proud of this concept for more than just its efforts and commitment to women – my son Yotam is the CEO and Founder of Gynica and I love our collaboration; he is the CEO and I am the President and Board Chair! Around the same time, PQE Group launched its new federated company, GQC (Glocal Quality Cannabis), an innovative service provider operating in the medical cannabis industry to guarantee product quality, develop new therapies and speed up cannabis product registration to reach patients more quickly.

I met Gilda during one of her visits to Israel. It was quite obvious from our first meeting that our approach to cannabinoid research and development was shared, as was our mutual desire to initiate a clinical trial as soon as possible; clearly, we need compelling data that will provide the required evidence of the safety and efficacy of this new product. So, we joined forces, which led us to enter, together, the fascinating, emerging innovative community of Femtech.

At the moment I am leading the medical services business unit at PQE Group, which offers start-ups  actual medical advisory support to work with them on their molecules and proofs of concept. This exciting new initiative combines PQE Group’s traditional business related to quality in the manufacturing environment with a new medical arm by creating a one-stop shop that will provide all required assistance to emerging start-up companies from the basic idea to the final product approval by regulatory authorities. Gilda, who I believe has the most extensive business background in this industry, is the “business” partner and I provide the medical and academic expertise that I have acquired after spending many years in Women’s Health.  

Can you provide more information about the work PQE Group is doing to help raise awareness of and treatments for womens’ health issues by promoting the Femtech revolution?

Of course! Clearly, my entire career has been based on women’s healthcare, and Gilda, too, has an intense desire to identify treatments for women-specific issues that have, particularly in underserved populations, numerous unmet needs while promoting the Femtch revolution – it’s a great opportunity for the medical, business, pharma medical device and investors/entrepeneur communities. 

Femtech is the ‘New Kid on The Block.’ This term was coined in 2016 by Ida Tin, a Danish entrepreneur who founded Clue, a period- and fertility-tracking app.  The term is applied to a category of software, diagnostics, products, and services that often use technology to focus on women’s health. This sector includes fertility solutions, period-tracking apps, pregnancy and nursing care, women’s sexual wellness, and reproductive system health care.  As an industry, Femtech largely encompasses any digital or standard health tools aimed at women’s health, including wearablesinternet-connected medical devices, mobile apps, hygiene products, and others.

Women’s Health encompasses well-diagnosed and established diseases or infirmity and also incorporates issues which compromise the mental and social well-being of women including abuse, violence, discrimination, neglect and the dependency that they suffer, as well as the extent of their poverty. All of these have a negative impact on women’s physical and mental health and it is critical to develop new therapies for women who suffer from any of these illnesses or situations, without the use of surgery or other debilitating treatments.

Can you provide a specific condition in Women’s Health for which PQE Group intends to provide an innovative breakthrough solution? 

Absolutely! We intend to provide clinical evidence for new options of medical treatments and the best example will be for the treatment of a devastating condition defined as ENDOMETRIOSIS. 

Did you know that 10% of all women around the globe have endometriosis? This means that endometriosis affects 5% of the global population. Endometriosis is a benign sex hormone-dependent gynecological disease, characterized by the presence and growth of endometrial tissue outside the uterus and is associated with infertility and pain. Current treatment of endometriosis involves conservative or radical surgery and/or medical therapies based on two mechanisms: anti-inflammation and hormonal. The classical treatments carry adverse side effects and, in some cases, a negative impact on quality of life. The goals for endometriosis treatment include the relief of pain and/or the achievement of a successful pregnancy in infertile patients. Currently, no effective medical treatments exist that can cure endometriosis, and therefore, finding a medical solution to manage endometriosis is a true unmet need; a few Big Pharma companies tried and failed to do so. 

What will be your scientific innovative approach to the management of endometriosis? Do you really intend to provide clinical evidence on cannabinoids?  

You’ve absolutely hit the nail on the head! This is the reason we merged the PQE Group federated company Glocal Quality Cannabis (GQC) efforts with the Israeli-based company Gynica, which will soon launch the global first pharmaceutical clinical study with an intra-vaginal, cannabinoids-based suppository.

Recent cannabinoid research provides evidence and opens a new window of opportunity to develop an innovative solution to manage endometriosis. The endocannabinoid system (ECS) is an emerging system surrounded by the complexity of what could be called ‘endocannabinoidome’, which is a receptor involved in virtually all regulatory systems of the body by dynamic interconnections. The second main site for cannabinoid receptors is the female reproductive system, thus providing this opportunity to Gynica and GQC.  The pharmacological properties of cannabinoids are extremely promising as they provide multiple sites for intervention, all of which are involved in the pathophysiology of endometriosis; including regulation of inflammation, immunological responses, and anti-fibrotic, anti-proliferative, analgesic and anti-oxidative properties.

This is a potentially a major development for women’s health since these very systems may be intrinsically related to other conditions and unmet needs in women’s health.  Such preliminary findings represent a significant breakthrough in the cannabinoid field.                                             

Can you define the obstacles to cannabis-based pharmacology?

Yes, of course, I can define this. Currently, there is a lack of effective drug delivery platforms, and here’s why. The pharmacokinetics and bioavailability of a substance in the human body very much depends on the method of administration. Current methods used in cannabinoid drug research, whether inhaled as smoke or vapor or taken orally in food or as whole plant extracts, do not allow for the efficient uptake of active ingredients in the body.  I’ll add to this that the lack of a controlled-delivery platform – one which ensures that precise, repeatable doses of specific pharmacological ingredients are administered – is a significant impediment to establishing a cannabinoid-based drug industry. Having said that, I must say that the key obstacle to mainstream acceptance of cannabis as medical treatments is the lack of data from clinical trials that prove safety, efficacy & consistency of treatment outcomes. Thus, the only way to convince the GLOBAL medical community on the option of cannabinoids in the management of endometriosis is the performance of an outstanding clinical trial – and YES, we’ll do it! 

How does PQE Group plan to establish itself as a Global leader in Femtech?

We plan to grab this new opportunity and provide a complete PQE package to any new idea and/or startup initiative and lead these teams all the way to the regulation processes that we have excelled in for the past 25 years.  This is why PQE Group launched its own internal CRO named ReSQUP, which is an entirely new concept. CRO stands for Contract Research Organization and is sometimes also known as a Clinical Research Organization. It is an organization contracted by another company to take the lead in managing that company’s clinical trials and complex medical testing responsibilities.

ReSQUP aims to provide a full CRO service for the execution of Interventional Trials for Phase I-II studies, Observational studies within Research Institutes, pre- and post-marketing clinical investigation and First in Human (FIH) medical device support. We don’t want to compete with the big CROs that are running studies on bigger groups of patients, that’s why we selected this uncovered niche of start-ups in the field of women’s health, medical device and medical cannabis innovate products in order to deliver the highest quality standards and allowing businesses to reach the Phase III with maximum efficiency.

I’d like to emphasise that PQE Group has an established medical advisory board composed of global key opinion leaders in women’s health, who will actively work to identify various solutions for women’s health issues including pregnancy, prenatal and post-partum care, menopause, infertility, sexual health and oncology. Our interest extends beyond cannabinoids and we’re aiming to expand the PQE medical arm to all topics related to Femtech and women’s health. We plan to establish ourselves as the leading company in the Femtech community providing solutions to many other conditions and unmet needs.   

We plan to take a leading part in innovative innitiatives intended to provide digital solutions to pregnancy management. Femtech, which refers to technology-based products and services designed specifically for women’s health, can also address some of the debilitating mental health issues such as post-partum depression. By developing innovative solutions tailored to women’s needs in these contexts, Femtech can contribute to improving women’s health outcomes and strengthening health systems sustainably. In addition, by engaging with local communities and healthcare providers, Femtech companies can ensure that their solutions are relevant and effective in addressing women’s specific needs and challenges in these contexts. And while developed countries do provide options, many diseases that are specific to women currently have limited treatment options, particularly in low- and middle-income countries, where access to treatment is often difficult to obtain. We all need to work together to strengthen and test models that guide health systems to be more responsive to the health needs of all communities, and we need to identify opportunities for intersectionality and address diversity, equity, social inclusivity and a sense of patient belonging for all.

Is there a way for readers to learn more about the Femtech movement?

Yes – we are in the process of holding a series of roundtables on Femtech. Panelists for the first in the series included notable professionals in the industry, including the president of FIGO, Frost & Sullivan’s Partner and Senior Vice President for Global Healthcare and Life Sciences, OCON’s CEO & Director/Board Member, President-Elect of FIGO, Gilda and myself. The next Femtech round table, being held on September 28th, will be provided in partnership with the Federation of Obstetric and Gynecological Societies of India and will focus on pregnancy, maternity, and the role of Femtech from both industrial and medical perspectives, as well as its applications and the future of the movement. I hope you will join us for this interesting, highly informative and very important event! Link to roundtable here.

In addition, Gilda and I have created a new DIP & FemTech Symposium (FemDIP), Innovative Perinatal Medicine: Improving Global Maternal Offspring Health, being held May 23rd-25th, 2024 in Sorrento, Italy The Bridge Connecting Medical/Scientific and FemTech Communities. This 12th FemDIP Symposium aims to highlight the progress of pregnancy – from pre-pregnancy, trimester by trimester, to labor, delivery and post-partum care – the 4th Trimester. The Symposium will serve as a platform to connect pharma, biotech, medical device companies, start-ups, investors, researchers, and healthcare providers as they drive innovation, investment, research, and partnerships to improve health outcomes for women worldwide. At the FemDIP meeting, the Medical/Scientific community will define the “unmet needs” and together with the Femtech community, aim to provide solutions. FemDIP Sorrento meeting will serve as an excellent platform to push forward a phrase I always like to quote “Women’s health is a nation’s wealth.”  Moreover, for the first time we are going to have an entire pavilion dedicated to start-ups who want to be recognized in the field of FemTech. 

This is all very interesting and very exciting work that you are doing.

These companies will have the chance to network and provide their commercial pitches to a crowd of venture capitals and investors, while competing for a dedicated Start-Up Award!

What do you see as the greatest opportunities and challenges moving forward?

After all I’ve said above, I think that challenges present opportunities. As we move forward performing clinical trials to identify the pharmacological properties of medical cannabinoids, which we have learned are perfect for successful pharmacologic, non-surgical treatment for endometriosis, we’re excited about all of the future innovative treatments for women’s health we will be able to uncover and develop for better women’s health around the world.