The presence and leadership of women are growing across different sectors, from technology to craftsmanship and law, highlighting their strength and influence in today’s business landscape.

This does not mean that all the work has been done to achieve parity in entrepreneurship, but entrepreneurship is the path many women choose to pursue their dreams.

Marisa Berenguer: Farmalider and Idea Therapeutics

Since 2022, Marisa Berenguer Muñoz has been the CEO of Farmalider, a 100% Spanish pharmaceutical and biotechnology company that has been operating since 1986.

Berenguer has been linked to the company’s board since 1997, initially as an advisor and also involved in governance matters. Now, as CEO, she leads the strategy, development, and international expansion of prescription medicines, over-the-counter drugs, and everyday pharmaceutical products for health care (divisions also known as MED (Rx), OTC, and Consumer Health). She is also responsible for coordinating all actions related to licensing and partnerships.

In addition, Berenguer is leading an innovative initiative to diversify the company. She is the CEO and founder of Idea Therapeutics, focused on advanced therapies. Through this company, AGAcell is being developed — a cellular platform currently in the research phase aimed at offering a treatment for androgenetic alopecia. Thanks to this work, she was recently recognized by the Spanish Association of Women Entrepreneurs (ASEME) as Entrepreneur of the Year.

Research into a new therapy based on the use of stem cells to treat the most common type of baldness—caused by genetic factors—has been one of the main highlights of the FUE ASIA congress, held in India from last Friday through Monday. The principal investigator of the AGACell project, Dr. Eduardo López Bran, participated in the congress as one of the guests of honor, where he delivered a lecture presenting his methodology, the current status of the research, and the results he expects to achieve.

“Androgenetic alopecia (AGA) can be reversed with cell therapy.” This is demonstrated by the successful results of the research I lead at the San Carlos University Clinical Hospital in Madrid,” said the head of the hospital’s Dermatology Department and director of the specialized IMEMA clinic, as reported to EFE Salud.

Held in the Indian city of Hyderabad, FUE ASIA is considered the world’s most important global meeting of medical specialists dedicated to combating hair loss, bringing together around 700 medical and academic representatives from more than 20 countries across Asia, North America, Ibero-America, and Europe.

Many people try to prevent or alleviate it, but that is not always possible. For everyone who is losing hair and worried about alopecia, the nurse and well-known social media content creator with six million followers on TikTok, Jorge Ángel, answered the most frequently asked question: “Is the end of baldness approaching? Possibly.” He explained the most common type of baldness and revealed a Spanish study in a video on the platform.

Read more: La Razón

“Among the different options dermatologists have to address androgenetic alopecia, oral finasteride 1 mg, topical finasteride, and oral dutasteride 0.5 mg are surrounded by controversy due to the possible appearance of adverse side effects, which can be very serious for some patients,” he explains.

“For this reason, specialists in the field feel the need to share the information currently available, as indicated by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) and the Spanish Agency of Medicines and Medical Devices (AEMPS),” he adds.

Last May, the AEMPS reported cases of suicidal ideation in patients treated with oral finasteride 1 mg and topical finasteride, mainly in those receiving treatment for male androgenetic alopecia; although the evaluation also included finasteride 5 mg and dutasteride 0.5 mg in patients with benign prostatic hyperplasia.

The European database of suspected adverse drug reactions (EudraVigilance) reviewed 325 reported cases of patients with depressed mood, depression, or suicidal ideation: 313 were associated with finasteride.

The remaining 13 cases, linked to dutasteride, do not allow a causal relationship with suicidal thoughts to be confirmed. However, due to its mechanism of action—similar to finasteride, as both inhibit 5-alpha-reductase—it is considered a possible class effect.

At the same time, and despite being listed in the package leaflet for finasteride 1 mg, this medicine may cause sexual dysfunction, which could contribute to the development of mood disorders in patients.

In fact, the PRAC concluded that the level of evidence for these risks varies depending on the indications, active substances, and formulations evaluated.

“Hopefully, the different studies already underway will help clarify the reality of the relationship between the adverse effects reported and the use of these drugs. As professionals, we have the obligation to provide truthful and rigorous information, with common sense, to our patients,” Dr. López Bran emphasizes.

Read more: EFE:Salud

At Ideeea Therapeutics and Farmalider, projects such as AGAcell—our preclinical research in cell therapy for androgenetic alopecia—illustrate this reality well: early stages, uncertainty, and a commitment to move forward step by step. Today, AGAcell is under evaluation by our scientific and clinical teams, and any future progress will be determined by the evidence and by regulatory authorities. In biotechnology, the narrative must always follow the data, never lead it. Another key aspect of this kind of leadership is managing diverse teams. Within a single project, researchers, clinicians, quality experts, regulatory specialists, finance, business, and intellectual property professionals all work side by side. Often, my role is one of translation: turning scientific language into strategic and financial language—and vice versa.

There is also an ethical dimension that cannot be ignored. Biotechnology must serve humanity and be developed with responsibility and with the fairest possible access. This requires prudence in communication, transparency regarding risks, and absolute respect for regulations at every stage. Ideeea Therapeutics, beyond embracing these principles, was founded with the purpose of contributing to the democratization of advanced therapies, working so that in the future they can be made safely and rigorously available to an ever-growing number of patients. Ultimately, this is the true north of leadership in biotechnology: not only building companies, but leaving a legacy of useful science, demanding ethics, and teams willing to think in decades while others remain focused on the next quarter. Entrepreneurship in biotech means accepting that you may never see all the fruits of your work, yet choosing every day to plant the best science and the best leadership in the service of human health. This is the kind of impact worth pursuing in the decade ahead.

Read more: El Economista

Gaceta de Salud has interviewed Marisa Berenguer, CEO of Farmalider and Ideeea Therapeutics, who was recently awarded the Entrepreneur of the Year Prize at the Spanish Association of Women Entrepreneurs Awards for her work on AGAcell—an unprecedented preclinical treatment for androgenetic alopecia that has shown promising results.

Read more: Gaceta de Salud

Mesenchymal stem cells (MSCs) are stromal cells which self-renew and differentiate to mesodermal lineages. In addition, their capacity to enhance tissue restoration has made them become a central focus in regenerative applications. Their main positive effects are based on immunomodulation and paracrine factors involved in tissue homeostasis, angiogenesis, wound healing and antiapoptosis. MSCs secrete anti-inflammatory factors such as interleukin 10, transforming growth factor 1 and prostaglandin E2. MSCs also induce regulatory dendritic cells and T cell populations and promote anti-inflammatory macrophage polarization.

According to paracrine activity, MSCs secrete growth factors such as vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factor (IGF), platelet-derived growth factors (PDGF) or fibroblast growth factor (FGF). All of them enhance tissue restoration and their benefits are well known in the treatment of multiple indications.

For these reasons, adipose-derived stem cells (ADSCs) whose extraction from adipose tissue is less complex than other sources and provides a high cell yield, are being widely researched in the dermatological field, particularly in tissue regeneration, psoriasis, alopecia and skin burns.

Specifically in the treatment of androgenetic alopecia (AGA), SVF derived from adipose tissue and ADSCs derivative products have demonstrated significant improvement in hair density and diameter according to the latest reported outcomes. Growth factors that ADSCs release enhance vascularization and skin regeneration and promote dermal papilla cells functionality, a key population of resident stem cells in the hair follicle. In fact, IGF and FGF are directly involved in the anagen phase, the active growth phase of the hair cycle, when DPCs start proliferating and hair growth onset takes place.

In addition, microinflammation is also one of the etiopathological features of AGA, as evidenced by the lymphocytes and mast cells infiltration around the bulge, an area implicated in the correct hair cycle dynamics. In this context cytokines and anti-inflammatory factors released by ADSCs can immunomodulate the niche and promote the hair cycle restoration.

Given these findings AGAcell® aims to harness all these multiple regenerative benefits and to combine ADSCs with an energy booster intended to enhance their intrinsic potential. Currently AGAcell® is being undergone in a robust preclinical development in order to facilitate its rapid translation into clinical application for AGA subjects.

We at Ideeeatx are committed to its development and excited to lead such a challenging and fulfilling project.

We are pleased to announce that Ideeea Therapeutics has been recognized by Diario El Referente as one of the 15 startups that are redefining the biotech landscape in Spain.

This recognition highlights our contribution to the advancement of advanced therapies (ATMPs) through an innovative, rigorous, and patient-centered approach.

Leading Innovation in Regenerative Dermatology

From Spain, Ideeea Therapeutics researches and develops cutting-edge biotechnological solutions in regenerative dermatology. Our AGAcell® program, focused on the treatment of androgenetic alopecia, continues to advance with the potential to extend to other skin conditions where regenerative medicine can make a meaningful difference.

A Model Based on Open Innovation and Collaboration

We strongly believe in an open innovation model, working closely with hospitals, clinical teams, universities, and strategic partners. This collaborative network enables us to bring advanced biotechnology closer to clinical practice, ensuring scientific excellence, safety, and real-world applicability for patients.

A Recognition That Strengthens Our Vision

Being part of the TOP15 reinforces our mission:
to develop high-impact therapeutic solutions that improve patient health, combining scientific robustness, regulatory rigor, and long-term strategic alliances.

At Ideeea Therapeutics, we remain committed to driving a new generation of advanced therapies that will transform the future of regenerative dermatology.

Read more: El Referente

Alopecia is a condition that affects a significant portion of the global population, impacting not only on physical appearance but also on self-esteem, mental health and overall quality of life. Studies have shown that affected individuals often experience increased levels of anxiety, depression and social withdrawal due to negative self-perception. The psychological impact is particularly marked in young subjects who are more likely to struggle with self-confidence in social contexts. Furthermore, emerging evidence suggests that hair loss is associated with an increased risk of scalp melanoma and with the risk of developing metabolic syndrome. A higher quality of life which allows a higher focus on physical aspects as well as exposition to stressful agents which can enhance hair loss, are responsible of a higher demand of therapeutic solutions. A multidisciplinary approach which considers all these factors is crucial in order to improve subjects’ conditions. Current market is aware of these needs and aims to offer solutions considering all the aforementioned concomitant disorders. 

According to American Hair Loss Association, published data reported that over 95% of hair loss in men is caused by androgenetic alopecia. Similarly, International Society of Hair Restoration Surgery reported that nearly 40% of men shows some degree of hair loss by the age of 35 years old, 65% at 60 years old, 70% at 80 years old, and 80% by the age of 85. Moreover, around 2% of the global population is at risk of developing alopecia areata in their lifetime. Considering these factors, androgenetic alopecia market size in terms of revenue is estimated to grow significantly during the forecast period.

The global alopecia treatment market has showed a sustained growth during last years. In 2023, it was valued at $8.77 billion and currently a compound annual growth rate of 9.1% is projected. This rise is driven by factors such as the increasing awareness of available treatments, technological advances in trichology and a rising demand for aesthetic solutions.

Conventional Market Treatments: Benefits and Limitations  

Traditional therapeutic options for alopecia include:

• Minoxidil: topical vasodilator that promotes hair growth and enhance blood flux in hair follicles. Although effective, continuous application is required to maintain beneficial results and side effects such as scalp irritation may occur.
• Finasteride: inhibitor of the 5-alpha reductase enzyme that reduces the conversion of testosterone into dihydrotestosterone, the main responsible androgen of androgenetic alopecia. It is associated with side effects like sexual dysfunction.
• Hair Transplant: surgical procedure that relocate hair follicles from donor areas to bald regions. Although it offers permanent results, it is invasive and costly.
• Platelet-Rich Plasma Therapy:  regenerative treatment against hair loss that has gained popularity due to its potential for stimulating hair follicle growth and improving hair density through platelets growth factors release. Platelet-Rich Plasma therapy involves concentrating platelets from patient blood resulting in a platelet-rich plasma which is injected into the scalp. Although it is a natural and well-tolerated option, its efficacy varies among individuals and requires multiple sessions for noticeable results and maintenance to sustain those benefits. Additionally, this therapy is costly and it is not covered by insurance.

Emerging Therapies: A Promising Future  

The limitations of conventional treatments have prompted the development of new innovative therapies increasingly diverse, reflecting the complexity of hair loss conditions. Recent therapies focus on compensating cellular function loss, addressing androgen sensitivity, hormonal imbalances and genetic background and mitigating the microinflammation observed in patients with alopecia as well as aim to a long-lasting solution with minimum adverse events. Among these innovative approaches are:

Hair growth stimulators. They are believed to restore hair growth by reactivating dormant follicles and promoting a healthier environment for the scalp.

• Prostaglandin (PG) F2α antilogsues.  Prostaglandin analogues were originally used to reduce intraocular pressure in glaucoma and unexpected concomitant effects on eyelash growth suggested a specific effect on hair follicle activation. Bimatoprost, approved by the FDA for the treatment of eyelash hypotrichosis, is awaiting clinical validation for androgenetic alopecia. In addition, DLQ01, a liquid topical formulation of a prostaglandin (PG) F2alpha analogue, is being clinically investigated (Phase2A).
• Multiple pathway activators involve in hair cycle: AMP-303 and AMP-506 are known to act on multiple pathways involved in hair follicle cycling and regeneration and therefore may stimulate hair follicle regrowth. They are currently being investigated in clinical trials.
• Prolactin receptor blocking antibody: Because prolactin promotes catagen in the hair cycle, blockade of the prolactin receptor may promote hair growth. A monoclonal antibody targeting the PRL receptor (HMI-115) is under assessment in several clinical trials with promising results, as this antibody almost doubled the number of terminal hairs in animal models.
• Thyromimetic drug: TDM–105795 is a small molecule being developed as a topical drug and it is believed to stimulate hair growth in a dose-dependent manner when applied topically as previously shown in animal models. It is currently being tested in clinical trials.

Androgen blockers:

• Selective androgen receptor inhibitors (SARIs): targeting androgen receptors in the scalp thereby inhibiting the effects of androgens on hair follicles is currently being studied for the treatment of androgenetic alopecia. Breezula ® (Clascoterone solution), showed promising results after 12 months treatment in a phase II clinical trial. Currently, phase III trials are being under evaluation. Its localized action Reducing the risk of systemic side effects, positioning it as a promising solution for androgen-related hair loss.
• Selective inhibitors of the 5α-reductase type 1 enzyme:KX-826 is a topical treatment that has been tested in Phase 2 clinical trials. Early results have shown promise, with patients demonstrating improvements in hair count and density compared to placebo.
• CosmeRNA ARI (ARI, androgen receptor inhibitor) CosmeRNA ARI, which uses self-assembled micelle inhibitory RNA technology to inhibit androgen receptor mRNA, is applied topically and selectively targets the androgen receptor, effectively downregulating its overexpression and significantly increasing hair growth, as reported in clinical studies.

Targeting Immune-related pathways: JAK Inhibitors: Originally used to treat autoimmune diseases, these inhibitors have shown beneficial outcomes in treating alopecia areata, a condition characterized by patchy hair loss. The FDA approved Baricitinib as the first systemic treatment for severe alopecia areata and, more recently, Ritlecitinib, which has shown promising results, also in severe alopecia areata.

Cellular based therapy 

• By administering cells to the scalp, this approach focuses on the regeneration/reactivation of hair follicle (HF) by restoring miniaturised HFs into fully developed terminal HFs. Different cellular products have been used in the treatment of AGA<

Stromal Vascular Fraction (SVF) extracted from adipose tissue, micrograft solutions, dermal papilla cell-based, like expanded autologous dermal papilla, or dermal sheath cup cells are some of the cell products administered and being currently used in clinical trials. Promising results have been observed hence holding an innovative approach for treating AGA.

Other treatments:

• Drug delivery technologies:

Liposomal formulations, hydrogels and nanotechnology-based carriers are being designed to enhance dermal absorption and minimize systemic adverse effects while ensuring long-lasting effects. A long-acting injectable Finasteride formulation in lipid nanoparticles has shown pharmacological efficacy using monthly administration although long-term acting formulation presented some systemic side effects. Currently early phase clinical assessments are being undergone. 

Low-Level Laser Therapy: a non-invasive treatment that uses low-intensity laser which stimulate hair follicles. Clinical trials have shown its efficacy in increasing hair density in individuals with androgenetic alopecia.

The Role od AGACELL-19 in the Advanced Therapy Landscape  

Within this context of innovation, the AGACELL-19 project emerges as a pioneering initiative aimed at developing a new advanced therapy medicinal product (ATMP) based on allogeneic mesenchymal stem cells combined with a molecule energy booster for the treatment of androgenetic alopecia. This therapeutic approach seeks to provide a safe and effective alternative to existing treatments, addressing the current gaps in efficacy and durability. The internationalization plan for AGACELL-19 focuses on maximizing the global impact of the product, ensuring its commercial viability, and strategically positioning it in key markets. The strategy includes:

• Scientific Communication. Publishing results in high-impact journals and presenting at international conferences to engage the scientific and medical communities.
• Industrial and Commercial Outreach<. Participating in technological fairs and organizing specialized webinars to attract industrial partners and investors.
• Regulatory Compliance Adapting to local regulations in target markets and obtaining necessary certifications to facilitate market entry.
• Strategic Collaborations Ebuilding partnerships with global entities to enhance research, join forces and expand market reach.

  Conclusion  

The landscape of alopecia treatment is undergoing a significant transformation, driven by an increasing demand of more effective and long-lasting solutions. Advanced therapies, such as those currently under development in the AGACELL-19 project, represent a promising therapeutic solution for subjects with androgenetic alopecia pursuing niche restoration and hair follicle intrinsic mechanisms enhancement By integrating cutting-edge scientific research with strategic market positioning, these innovative treatments will have the potential to redefine standards of care in alopecia management, offering renewed hope to millions of people affected by this condition worldwide.

In general terms, genetic background is especially relevant in the AGA onset. As we know, AGA is triggered when dihydrotestosterone interacts with androgen receptors (ARs) in dermal papilla cells located in hair bulbs. ARs expression is determined by AR gene which is located on the X chromosome, hence maternal grandfather`s AGA history increases hair loss likelihood. 5alfareductase enzyme, responsible of testosterone to dihydrotestosterone transformation, also plays a significant role.

Nevertheless, although genetic heritage seems to be the main causative factor, habits such as smoking and saturated fats intake can accelerate AGA onset or exacerbate its progression. In fact, relation between AGA and unhealthy diets is plausible particularly given the association of AGA with comorbidities such as metabolic syndrome, a high body mass index, insulin resistance, cardiovascular disease and dyslipidaemia. The reasons that explain this matter are based on common factors as oxidative stress and microinflammation, which in their chronic form, could lead to premature AGA onset by impairing hair follicle functionality.

As mentioned, AGA onset has a huge impact particularly at younger ages for whom aesthetic concerns are especially significant. Therefore, new drugs aimed at preventing it are urgently needed. Meanwhile increasing awareness of the environmental and lifestyle factors impact on our hair health can help us to avoid its onset or to delay its progression. At the same time, the management of its related comorbidities should be a top priority, forming part of a comprehensive and multidisciplinary treatment approach. Such an integrated strategy will also contribute to more effective outcomes in the management of AGA.