About Us
At Humana Biosciences, we are committed to transforming drug development by bridging the gap between preclinical models and clinical reality.
Company overview
Humana Biosciences is a tailored preclinical CRO focused to improve preclinical research efficacy.
We have a large expertise in Gastroenterology, Urology and Respiratory Pathologies. We also have additional expertise in Dermatology and Nephrology.
We regularly collaborate with Nutraceutical Companies as well as Companies specialized in Medicinal Plant Extracts.
Every study we conduct is a custom designed study tailored specifically for the client. We offer our customers the best predictive experimental models for chronic functional pathologies.
Our mission is to reduce the number of inefficacious candidates moving through to the later stages of clinical investigation by developing innovative experimental models (in vitro and in vivo). Partnering with Humana Biosciences also gives you on-demand access to ethically obtained human tissues.
Our ultimate ambition is to make your preclinical drug development more predictive and faster.
Team
The team is made up of scientists and research technicians who bring years of experience and knowledge into the preclinical research models we perform in our laboratories. Globally, our employees have more than 7 years of internal service, thereby maintaining a low level of employee turnover and guaranteeing technical stability and robustness.
Humana Biosciences Management and Scientific Advisory Board members has combined experience of over 200 years of drug discovery and development know-how, by working in Pharma companies, Biotechs as well as Academic laboratories. Together they published more than 750 papers in peer-reviewed International Journals.
Management
The Company was established in September 2017 by Dr. Stefano Palea, a scientist and entrepreneur with more than 35 years of experience in preclinical research, working on both Big Pharmas and international CROs. This double experience means that Dr. Palea knows very well the process of drug development in Pharmas and how to implement it through the best experimental models available worldwide.
Dr. Palea is titular of 3 international patents and has published 44 full papers in peer-review international Journals.
Scientific Advisor Board
Dr. Alain Kamgoué is a researcher specializing in applied mathematics in the life sciences, with work spanning the modeling of complex biological systems and data analysis, with a particular focus on image analysis. His research combines rigorous mathematical modeling with practical applications in biology and medicine, aiming to understand and simulate dynamic systems such as gene regulatory networks, cellular interactions, and multiscale physiological processes.
A central theme in his work is the quantitative analysis of biomedical and microscopic images. He develops advanced methods to extract meaningful biological insights from high-dimensional visual data, drawing on both classical image processing techniques and modern machine learning approaches.
Dr. Alain Kamgoué also demonstrates strong proficiency in the Python programming language, which he uses extensively for data analysis, algorithm development, and model implementation. His toolbox includes scientific libraries such as NumPy, SciPy, scikit-image, and TensorFlow. He is actively involved in interdisciplinary collaborations that bring together biologists, clinicians, and computer scientists to tackle major challenges in the life sciences.
After graduating from the University of Pavia in 1975, Andrea Gazzaniga served at the same university as an Assistant Professor.
In 1986, he attended the School of Pharmacy of the University of California, San Francisco (UCSF) as a Visiting Scientist. The following year, he joined the University of Milan, where he soon attained the position of Full Professor. He is also co-founder and CEO of ADD srl (Advanced Drug Delivery), a spin-off of the University of Milan.
Prof. Gazzaniga is the author of about 300 publications, including research papers, reviews and patents in the drug delivery area, and of over 500 presentations, many of which were invited lectures.
His current research interests include the design and preparation of oral solid dosage forms, with particular focus on drug delivery systems (DDS) for prolonged, pulsatile, and colonic release. He also works on the preformulation of active pharmaceutical ingredients and the study and evaluation of generic drug products. Recently, his research has expanded to include DDS intended for organ retention, such as gastro-retentive and intravesical devices, as well as the 3D printing of medicines.
Prof. Gazzaniga acts as a referee for various public agencies and served as a consultant appointed by Agenzia Italiana del Farmaco (AIFA). He has been a member of Group of Experts 12 (Galenical Products) of the European Pharmacopoeia for twenty years and has also served as an Official Expert for the Italian Pharmacopoeia.
Dr. Mitsuharu Yoshiyama is currently a Visiting Professor in the Department of Urology at the University of Yamanashi Graduate School of Medicine, Japan.
He graduated from the Showa University School of Medicine in 1989 and obtained an M.D. Then, he received a Ph.D. from the Department of Physiology at the Showa University Graduate School of Medicine in 1993.
He received primary training in the study of the neural control of the urinary bladder and urethra activity, in the Department of Pharmacology at the University of Pittsburgh School of Medicine (directed by Prof. Dr. William C. de Groat). His research interests include neural mechanisms involved in the control of the lower urinary tract function and the dysfunction associated with spinal cord injury or nociception. Through his research career, he has published more than 80 scientific papers and 3 book chapters in the field of neuro-urology https://researchmap.jp/m-yoshiyama20422694?lang=en. He is a member of the Editorial Board of prestigious scientific journals and has been served as a frequent reviewer.
Dr. Claudio Pietra is a pharmacologist with more than 40 years of experience in pre-clinical research and development, management and execution of projects from early stage up to clinical development. His currently position is Chief Scientific Officer at Invirtuolabs SA, Switzerland, a company specialized in the applications of AI in drug discovery.
Previously he was Director of Research and Preclinical Development at Helsinn , Switzerland, bringing some compounds from lead optimization to the Phase I study. At Helsinn, he was also project manager of some clinical projects in the emesis area. Before joining Helsinn, he served as Director of Project Management in a drug delivery company, Eurand, Italy.
In his early career, Claudio served in various leadership positions of increasing responsibility in some pharma companies including Recordati, Chiesi Pharmaceutical and Glaxo Wellcome, always in Research and Development and drug discovery. In these companies he was involved in R&D management focusing on Urology, Gastroenterology and CNS pathologies. He is a co-author of more than 120 scientific papers and abstracts and of 6 international patents.
Prof. Gianluigi D’Agostino
Gianluigi D’Agostino, Ph.D., holds a degree in Pharmaceutical Chemistry at the University of Pavia (Italy) where he graduated cum laude in 1973.
He joined the Faculty of Pharmacy at the same University in 1973 where he developed his full career. From 2005 to 2008 he was Head of the Department of Experimental and Applied Pharmacology. Currently, he serves EVODIA, in Milan, Italy.
Professor D’Agostino research interest was focused on receptors pharmacology, particularly in the characterization of muscarinic and serotoninergic receptors as well as opioid receptors in the peripheral nervous system. His research was supported by grants from MIUR/NHI/DAAD in collaboration with academic laboratories at Mainz (Germany), UCLA (USA), and by international pharmaceutical companies.
During the last 30 years, in his laboratory innovative neurotransmitter release techniques were developed in animal models to characterize prejunctional receptors located at neural level in peripheral organs. In particular, their functional role was focused on the urinary bladders of humans and large mammals.
Professor D’Agostino research group identified for the first time in the human bladder the presence of M4 auto-receptors, 5-HT4, 5-HT7 and 5-HT1A heteroreceptors as well as the neuronal β3-adrenoceptors. More recently, β3-adrenoceptors and P2X3 purinergic heteroreceptor were investigated in pig detrusor too. His experimental work demonstrated the role of these receptors in the inhibitory or faciliatory control of cholinergic detrusor contractility. A logical extension of these studies is the development of novel agents for the treatment of urinary bladder disorders, such as Overactive Bladder and Interstitial Cystitis.
Prof. D’Agostino has authored or co-authored more than 50 papers on peer-reviewed international journals where he currently serves as a reviewer.
Vincent Goffin is Research Director at Inserm. He is head of the “Prolactin/growth hormone pathophysiology” laboratory at Institut Necker Enfants Malades (INEM) in Paris and head of Service Unit 24 / SFR Necker (technological core facilities of Necker site).
He obtained his PhD from the University of Liège in 1993 and was recruited as a researcher at Inserm in 1996 after his post-doctoral training as a European Community-Marie Curie fellow at the Necker Faculty of Medicine, Paris. He has over 30 years’ experience in the field of onco-endocrinology and is internationally recognized for his translational studies of the prolactin system. His current research focuses on the biology of castration-resistant prostate progenitor cells, which were discovered in his laboratory in 2017. He is developing various preclinical models to study the role of these cells in prostate cancer progression and treatment resistance.
A former laureate of the Inserm-hospital interface award (2005-2010) and the translational research award (2010-2013), he is highly skilled in translational/clinical research (4 MD-urologists are currently members of his laboratory). As former consultant for several pharmaceutical companies (Ipsen, Novartis, Bayer, Lumos Pharma), expert in R&D processes for the French Ministry of Research (2007-2009), PI for several collaborative industrial partnerships, inventor on 4 patent families and supervisor of 4 academic-industrial CIFRE PhD students, he also has extensive experience of academic/industrial research.
Bruno DAVID PhD
Bruno DAVID PhD, HDR, DPharm is a French phytochemist who has had an academic (1984-1990) and industrial career (1990-2020) in the Pharmaceutical Industry at Pierre Fabre (Natural products drug discovery).
Bruno is a pharmacist and chemist by training. He holds a DPharm from Dijon University and a PhD in Phytochemistry (CNRS Gif sur Yvette – the Institute of Chemistry for Natural Substances) + Pharmacology (CNRS Toulouse – Laboratory of Fundamental Pharmacology). He began his career asa visiting lecturer at the University Malaya (Kuala Lumpur, Malaysia) and as a lecturer at the Faculty of Pharmacy at Paris XI. Member of the French National Academy of Pharmacy, he has coauthored more than 100 publications, books and patents.
When Bruno joined Pierre Fabre in 1990, he led the Natural Products Drug Discovery Group. During all these years, he has also often worked in the field, mostly in tropical countries, thus developing a passion for biodiversity issues. He has been active in the field of ABS (Access an Benefit Sharing) at Pierre Fabre and at many professional federations and associations dealing with genetic resources and legal certainty issues (LEEM, FEBEA, Cosmetics Europe, UNITIS, ICC…). He was also member of the Strategic Orientation Council of the French Foundation for Research on Biodiversity.
Retired since 2023, he advises on pharmacognosy and phytochemistry.
Our mission
Our mission is to develop and validate innovative experimental models in vitro, ex vivo and in vivo, specifically conceived to reduce the gap between preclinical research and clinical reality.
These models, based on the Translational Research Approach, can contribute to selecting the best drug candidates, so decreasing current high rates of clinical failures.
Understanding Clinical Failure Rates
In a recent paper, analyses of clinical trial data from 2010 to 2017 showed 4 possible reasons for at least 90% of clinical failures:
- Lack of clinical efficacy (40%–50%),
- Unmanageable toxicity (30%)
- Poor drug-like properties (10%–15%)
- Lack of commercial needs and poor strategic planning (10%).
If drug candidates in the preclinical stage are also counted, the failure rate of drug discovery/development is even higher than 90%.
Reference : Why 90% of clinical drug development fails and how to improve it ? Duxin Sun et al. Acta Pharm Sin B. 2022;12(7):3049–3062. doi: 10.1016/j.apsb.2022.02.002
Failures in clinical trials are, at least in part, explained by the fact that the preclinical pharmacology of drug candidates was established on human cancerous cell lines, not directly related to the pathology, an oversimplified physiological microenvironment.
At Humana Biosciences we believe that the selection of a drug candidate can be improved with the use of human primary cells ideally derived from patients and then cultured in the most physiologically relevant conditions (3D cultures and co-cultures). Moreover, in our laboratories, we are constantly working to set up the most relevant models of experimental pathologies to be used for in vivo proof of concept, based on the best predictive animal species and phenotypes, including transgenic animals.
Laboratory Facilities
Humana Biosciences offers state-of-the -art preclinical CRO facilities to provide the highest quality in preclinical services to our customers :
- Animal house surface area: 300 m², with a quarantine area and a Specific Pathogen Free (SPF) area. To ensure animal wellbeing, the housing cages are ventilated and enriched. Animals are housed in groups with controlled environmental parameters in the housing zone: temperature, pressure, humidity, brightness, and light cycle.
- PHOTO de l’animalerie
- Laboratories (100 m2) for cell culture, biochemistry and histological preparations
Partners
