Barbara Maglione_ Redefining Biopharma R&D with Vision and Precision.pdf

As Head of Research and Development, Barbara Maglione fosters a culture of innovation that builds on the company’s many years of experience in creating high-quality, natural pharmaceutical products.

1. The pharmaceutical industry is a dynamic and challenging field where innovation
and dedication to quality are essential for success. Companies that prioritize
research drive scientific breakthroughs and make meaningful contributions to
improving people’s health and well-being. Leading the research and development at Farmaceutici Damor S.p.A.—a company known for its long history and
advanced work in bio-pharmaceuticals—is Barbara Maglione.
As Head of Research and Development, Barbara Maglione fosters a culture of
innovation that builds on the company’s many years of experience in creating
high-quality, natural pharmaceutical products. Under Barbara Maglione’s
leadership, Farmaceutici Damor continues its commitment to using scientific
advances to promote better health, combining both tradition and modern
leadership in the pharmaceutical field.
A Legacy of Innovation and Effective Healthcare Solutions

2. Farmaceutici Damor was established in Italy in 1943 as a Galenic laboratory. A
significant milestone in the company’s evolution into a pharmaceutical firm came
in 1946, with the discovery of the clinical benefits of Triticum vulgare extract.
This breakthrough was inspired by Vladimir Filatov’s theories of “Biostimulins.”
Today, Farmaceutici Damor is recognized for its science-driven innovation and
offers a diverse range of products, including medicinal specialties, medical
devices, dietary supplements, and cosmetics. The company focuses primarily on therapeutic areas such as wound healing and
tissue regeneration, metabolic and cardiovascular health, as well as overall
well-being. Farmaceutici Damor specializes in conditions where its distinctive
approach—often using natural active ingredients backed by rigorous scientific
research—can significantly enhance patients’ quality of life.
Among its portfolio, the flagship product is Fitostimoline®, well-known for its
effectiveness in aiding wound healing and tissue repair. This product addresses
the need for safe and reliable treatments for various wounds, from minor cuts
and abrasions to more serious chronic ulcers, by promoting the body’s natural
cell regeneration. Fitostimoline® is available in several forms, including creams,
gauzes, and vaginal applications.
Another key product is Bioarginina®, designed to support metabolic and
cardiovascular health. It helps provide physiological support in situations of
fatigue, metabolic stress, and general cardiovascular care by leveraging the
benefits of L-Arginine. This product is offered as an oral solution.
In addition to these, Farmaceutici Damor’s product range includes Claremase®
and Cerebrain® Forte, which further expand the company’s offering for
addressing common health needs with effective and scientifically supported
solutions.

3. Farmaceutici Damor’s Research in Drug Repositioning and
Delivery
Farmaceutici Damor focuses its research and development on repositioning
known drug substances to address unmet medical needs. This includes
customizing oral drug delivery methods and dosage forms. The company
leverages established safety profiles to shorten time-to-market.
Although specific pipeline details remain confidential, Farmaceutici Damor
advances these projects through rigorous preclinical and clinical stages, aiming to
deliver safe and effective treatments to patients promptly.
Customized Research and Development Services
Beyond product manufacturing, Farmaceutici Damor offers specialized services
to external partners, especially in research and development, leveraging its
expertise and advanced facilities.
These services are often customized to meet partner needs but generally include:
●​Formulation Development: Providing expert support in designing
advanced formulations, focusing on oral delivery systems and unique
topical products.
●​Preclinical Research Support: Assisting in preclinical research by
studying active ingredient mechanisms and conducting initial safety and
efficacy tests.
●​Clinical Trial Support: Offering guidance and participation in clinical
trial design and execution, particularly for products within the
company’s therapeutic areas.
●​Analytical Services: Conducting comprehensive testing of raw materials
and finished products using rigorous quality assurance and control
methods.

4. ●​Licensing and Collaboration: Engaging in licensing agreements and
strategic partnerships that align with the company’s mission and help
speed up the development of innovative solutions.
Farmaceutici Damor’s specialized services strengthen its collaborations and
contribute to advancing healthcare through shared expertise and innovation.
Farmaceutici Damor’s Structured Product Development Process

●​Discovery & Research: Study active ingredients targeting unmet medical
needs.
●​Preclinical Development: Lab and animal tests for safety, efficacy, and
pharmacokinetics.
●​Formulation Development: Optimize stability, bioavailability, and
patient acceptability.

5. ●​Clinical Development: Conduct Phase I-III trials following international
GCP standards.
●​Regulatory Affairs: Ensure compliance with EMA, AIFA; manage
documentation and submissions.
●​Quality Assurance & Manufacturing: Apply GMP standards from raw
materials to the final product.
●​Market Access & Commercialization: Align science with patient delivery
via commercial teams.
Integrated, ethical, cross-functional process balancing innovation and
responsibility.
The Approach to Identifying Key Research Priorities
Farmaceutici Damor employs a dynamic and thorough process to identify and
prioritize its research focus. This approach combines careful scientific study with
a strong awareness of unmet medical needs. The company closely monitors
global scientific advances, particularly in natural compounds and their biological
effects, to stay at the forefront of innovation.
Engagement with healthcare professionals and patient communities plays a
critical role in recognizing gaps where current treatments are insufficient or
where diseases cause significant challenges without effective solutions.
Farmaceutici Damor builds on its core expertise in wound healing and metabolic
support, leveraging its knowledge of key natural ingredients such as Triticum
vulgare and L-Arginine.
Regulatory requirements and patient safety are central to decision-making,
ensuring that development pathways are both efficient and adhere to the highest
standards. Additionally, the company considers market potential to maintain
sustainability and ensure that new innovations are accessible to a broad patient
population.

6. This balanced and agile approach allows Farmaceutici Damor to respond swiftly
to emerging ideas and focus on early-stage drug discovery, maintaining a strong
commitment to meaningful and responsible innovation.
Enhancing Treatments
Farmaceutici Damor takes pride in its innovative formulations and drug delivery
systems that improve product effectiveness, safety, and ease of use. While
flagship products like Fitostimoline® and Bioarginina® already have optimized
formulations, the company’s research and development team continually pursues
new improvements.
Integrating Farmaceutici Damor Products with Medical Therapies
Farmaceutici Damor develops its products to integrate seamlessly with existing
medical treatments, either as standalone therapies or as complementary options.
For instance, Fitostimoline® is widely used by healthcare professionals as a
primary treatment for various types of wounds. It also supports other wound care
methods by accelerating healing and helping to prevent complications.
Similarly, Bioarginina® is frequently recommended as a dietary supplement or
medical food to promote metabolic and cardiovascular health. It can be used
alone or alongside conventional treatments when L-Arginine supplementation is
beneficial.
The company’s objective is to provide solutions that enhance overall treatment
outcomes by filling gaps in care, supporting patient recovery, and promoting
general health and well-being.
Building Global Partnerships for Sustainable Healthcare Impact

7. Farmaceutici Damor has a strong presence in Italy and actively exports its
products to several international markets. From February 2024 to January 2025,
its products reached countries including Colombia, Turkey, India, and Mexico,
reflecting significant export growth.
The company continually seeks opportunities for global expansion by carefully
assessing new geographic markets and therapeutic areas where its science-based
products can address unmet medical needs. Farmaceutici Damor aims to
collaborate with partners who share its commitment to quality and patient care,
ensuring ethical and successful market entry.
While specific plans for expanding into new therapeutic areas remain
confidential, ongoing research in ophthalmology and immunology suggests
potential future diversification. This strategic approach supports the company’s
goal of sustainable growth and broader global impact.
Collaborations and Partnerships

8. ●​Academic Institutions: Access to cutting-edge research.
●​Hospitals & Clinical Centers: Clinical trials and real-world insights.
●​Contract Research Organizations (CROs): Support in preclinical &
clinical development.
●​Biotech Firms: Partnerships for innovative technologies and early-stage
compounds.
●​Social Commitment: Partner of Soleterre, supporting patient rights and
global health.
Combining Science and Strategy for Faster Drug Development
Farmaceutici Damor’s dedication to research and innovation significantly
improves its time-to-market and success rates. The company’s strategic focus on
drug repositioning and expertise in natural active ingredients play a central role
in this.

9. By working with known drug substances, Farmaceutici Damor leverages existing
safety data, which helps reduce the time and cost of preclinical and early clinical
development. This approach accelerates progress through regulatory pathways,
enabling faster market entry. The company’s agile decision-making and efficient
processes further support the rapid advancement of promising drug candidates.
Moreover, Farmaceutici Damor combines rigorous scientific methods with a
patient-centered approach. This ensures that its pipeline products address
genuine unmet medical needs and are backed by strong scientific evidence. This
blend of focused innovation and efficient development enhances the likelihood of
success and strengthens the company’s overall performance in bringing effective
treatments to patients.
Upcoming Launches & Expansions (2025+)

10. ●​Ophthalmology & Metabolic Support: Promising pipeline addressing
unmet needs.
●​Advanced Wound Care: Next-gen solutions building on Fitostimoline®
success.
●​Targeted Nutritional & Metabolic: New Bioarginina®-based
formulations.
●​Specialty Pharmaceuticals: Progress in ophthalmology, CNS, and
immunology.
●​Digital Health: Exploring solutions to boost adherence and outcomes.
Focused on patient-centered innovation for meaningful health improvements.
Continuous Improvement Through Feedback and Engagement
Farmaceutici Damor values feedback from healthcare professionals (HCPs) and
patients as a vital source for continuous product and service improvement. The
company collects feedback through several methods:
●​Medical Science Liaisons (MSLs): Regularly engage with HCPs to
discuss clinical results, understand product use, and identify
improvement opportunities.
●​Pharmacovigilance Systems: Monitor adverse events and safety data to
assess product performance.
●​Market Surveillance and Post-Market Studies: Gather real-world
evidence on product effectiveness and patient experiences.
●​Direct Patient Engagement: When appropriate and ethical, interact with
patients via advocacy groups or surveys to better understand their needs
and journey.
For example, early feedback from dermatologists and wound care specialists on
Fitostimoline® highlighted the need for varied application methods. This led to
the creation of multiple formulations, including medicated gauzes and sprays,
beyond the original cream. These enhancements increased product versatility,
improved patient compliance, and boosted treatment outcomes.

11. Trusted Solutions and Future Therapies
Farmaceutici Damor operates on a large scale with a diverse product portfolio
that includes medicinal specialties, medical devices, dietary supplements, and
cosmetics. Its flagship products, Fitostimoline® and Bioarginina®, are available
in various forms such as creams, gauzes, oral solutions, and sugar-free options.
The company actively conducts multiple preclinical and clinical programs in key
therapeutic areas, including ophthalmology, central nervous system disorders,
respiratory conditions, and immunology. This demonstrates its ongoing
commitment to developing new drugs and repositioning existing ones.
Farmaceutici Damor’s products mainly focus on wound healing, tissue
regeneration, metabolic and cardiovascular support, and overall well-being.
Research efforts continue to expand into new fields like ophthalmology, CNS,
respiratory, and immunology.
Fitostimoline® has been trusted by millions worldwide for decades, proving its
effectiveness in wound healing and recovery. Similarly, Bioarginina® has helped
many individuals improve metabolic and cardiovascular health and recover from
fatigue and metabolic stress.
Ensuring Quality, Accessibility, and Care in Healthcare Solutions
Farmaceutici Damor’s vision of patient-centered innovation is central to its
culture. From early research to post-market monitoring, the company prioritizes
the needs and experiences of patients throughout the development process.
Its long-term goal is to be a trusted healthcare partner by delivering effective and
safe products that are scientifically proven and meet the highest quality
standards. Beyond treating symptoms, Farmaceutici Damor strives to create

12. solutions that support the body’s natural healing and enhance overall quality of
life.
The company is dedicated to advancing scientific knowledge with integrity,
upholding strict ethical and regulatory standards. Additionally, Farmaceutici
Damor works to ensure that its treatments are accessible to those who need them
most.
By building on its legacy of science-backed innovation, Farmaceutici Damor aims
to deliver meaningful progress that improves lives and fosters a healthier future
for all.
Key Takeaways from Barbara Maglione’s Vision for Farmaceutici
Damor
1.​Innovation Rooted in Tradition: Under Barbara Maglione’s leadership,
Farmaceutici Damor combines its long history of using natural
ingredients with modern scientific research to create effective,
high-quality pharmaceutical products. 2.​Strategic Focus on Drug Repositioning: The company is efficiently
developing new therapies by repositioning existing, well-understood
drugs. This smart approach uses established safety data to speed up the
time it takes to get new treatments to patients. 3.​A Diverse and Expanding Product Portfolio: While known for flagship
products like Fitostimoline® and Bioarginina®, the company is actively
expanding its research into new and important areas such as
ophthalmology, central nervous system disorders, and immunology to
address a wider range of unmet medical needs.
4.​Commitment to Patient-Centered Care: Farmaceutici Damor’s entire
process, from research to market, is guided by a focus on patient
well-being. It actively gathers feedback from healthcare professionals
and patients to improve its products, ensuring its solutions truly
enhance quality of life.