About Us
At Humana Biosciences, we are committed to transforming drug development by bridging the gap between preclinical models and clinical reality.
Our story since 2017
Origins and Leadership
The Company was established in September 2017 and is based in Prologue Biotech, Labège, France. The founder, Dr. Stefano Palea is 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.
Understanding Clinical Failure Rates
In a more 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%)
- Ppoor 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).
Therefore, our mission is to develop and commercialize experimental models based on the use of human cells and tissues coming from patients having the pathology of interest.
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.
In recent years, the reasons for failure of drug development programs have been the subject of much discussion. Although adverse effects, toxicity, or pharmacokinetic features are often cited as reasons for arrested drug development, a review of the portfolio performance of AstraZeneca (Cook D, et al.. Nat Rev Drug Discov. 2014; 13:419–431) suggests failures in Phase II studies are caused by a lack of efficacy. This probably results from differences in behavior of the drug target in the assay systems compared with the target behavior in patients. Most of the time, the pre clinical pharmacology for many of these agents is established in cell culture, an oversimplified physiological microenvironment.
At Humana Biosciences we believe that drug screening can be improved with the use of human cells ideally derived from patients and then cultured in the most physiologically relevant conditions.
That is why our mission is to develop and commercialize in vitro experimental models based on the use of human cells and tissues coming from patients having the pathology of interest.
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.
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.
Since 2004, he has been a Fellow of the American Association of Pharmaceutical Scientists (AAPS). He is a member of the scientific boards of the association AFI (Associazione Farmaceutici Industria). Prof Gazzaniga serves as a peer reviewer for the leading journals in the field and is a member of the editorial boards of International Journal of Pharmaceutics, Die Pharmazie, European Journal of Pharmaceutics & Biopharmaceutics, Journal of Drug Delivery, Drug Development and Industrial Pharmacy, Journal of Drug Delivery Science and Technology. He was Field Editor (Drug Delivery section) of Pharmacological Research.
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.
