Target Product Profile: Definition of your product’s key features to guide the creation of your industrial development roadmap.
From Academic Research to Patients: Advancing methods to ensure a smooth transition from academic work to the first industrial and regulatory data.
Regulatory Landscape: Build the interaction plan and strategy of communication with the EMA & FDA.
Nonclinical Development: Choose the right model for your evidence-based strategy.
Clinical Plan: The backbone of your development program.
CMC Accelerated Development: Help in achieving scale-up for your production method.
Access to Market: Identify the target population and potential price.
Small Molecules Option
Strategic help on sub-contractor interactions and technical challenges.
Biologics Option
New innovative processes exist to develop and bring small molecules onto the market, such as setting up clinical trials “in silico.” Let us coach you on the ever-evolving validation strategies for accelerated production methods.
ATMP Option
With our colleagues at VCLS – who worked hand in hand with the EMA to create the first regulatory guidance on ATMP in 2000 – we provide end-to-end solutions and targeted services including:
- regulatory strategy
- CMC/quality, nonclinical, and clinical development
- market access strategy
- post-approval regulatory life cycle management
DEDICATED TEAM
Lionel Mavoungou, PhD
Associate Director, Chemistry, Manufacturing and Controls (CMC) & Advanced Therapy Medicinal Product (ATMP)
Associate Director, Chemistry, Manufacturing and Controls (CMC) & Advanced Therapy Medicinal Product (ATMP)
As an Associate Director in the CMC and ATMP Team, Lionel is responsible for the preparation, writing and reviewing of a wide variety of regulatory documents. These include CMC MAA/IMPD/BLA/IND summaries (pharmacology, efficacy and safety), clinical study reports and amendments, investigator brochures, clinical study protocols and amendments, informed consent forms, conference abstracts and publications. He designs clinical development strategy from the manufacturing point of view. He is also responsible for conducting gap-analysis of CMC development plans and supporting requests for Scientific Advice from Regulatory Authorities.. Lionel brings to the role more than 10 years’ experience in the pharmaceutical and medical device industry. During that time, he developed an expertise in project management, writing and editing high quality regulatory and clinical documents. He has a background working in different medical fields with various products including ATMPs such as mRNA technologies, Cell and Gene Therapies, Tissue Engineered Products and Microbiome products. He also worked as a Medical Writer preparing various clinical documents to support the development of a monoclonal antibody used to treat different inflammatory pathologies. He initially started his career as a Gene Therapy Project Manager, coordinating projects from preclinical stage to clinical stage and interacting with competent authorities. Lionel has a Ph.D. in Biomedical Sciences, University of Montreal, Canada (2014) M.Sc. in Cell and Molecular Biology, University Paris VI, France (2008). He is based in our Lausanne office.Neighbors
OP2LYSIS
Op2Lysis develops the first treatment for hemorrhagic stroke a life-threatening disease that affects >1,5M people every year worldwide.
Op2lysis program aims at demonstrating the clinical efficacy and safety of its therapeutic solution to be ready to enter advanced phases of development by 2023.
Op2Lysis is a biotech company dedicated to the development of innovative products to improve the benefit of thrombolytic treatment in stroke, the first cause of acquired disability worldwide. Christophe GAUDIN and Jérôme PARCQ are the co-founders of Op2Lysis, which benefits from their complementary experiences and skills.
Neurophoenix
Neurophoenix is a biotechnology company developing a revolutionary treatment for chronic and acute optic neuropathies such as glaucoma or retina ischemia. This novel approach is based on a molecule derived from a virus that has the remarkable property of reactivating the survival mechanism of injured neurons.
Our molecule is the result of many years of academic research carried out by Monique Lafon, director of the Viral Neuro-immunology laboratory at Institut Pasteur.
This research identified a molecule produced by the rabies virus with the remarkable capacity to both keep neurons alive (neuroprotection) and also stimulate axon regrowth from damaged neurons (neuroregeneration).
HEMERION
Each year, in Europe and in the US, more than 20,000 patients undergo surgery for a brain cancer. This condition remains incurable, but the quality of surgery significantly improves survival. The combination of a photosensitizer drug and a laser illumination device makes it possible to treat disseminated and inaccessible cancer cells during surgery. This technology offers new perspectives and developments on brain cancer therapy are already under clinical evaluation.
The proof of concept is established, the absence of toxicity is demonstrated and the first trials in humans show an improvement in patient survival. In this context, Hemerion aims to market this new modality for 2026.
Glaucome
Paris, France
BIOPHTA
Lack of adherence to Rx eye drops is the #1 Unmet Medical need in Ophthalmology. Poor treatment compliance leads to a worse progression of Eye Diseases. We will change lives of patients suffering from chronic eye diseases by creating a best-in-class solution reducing treatments burden.
Antibiotic Resistance
Paris, France
Diotheris
Diotheris develops anti-infective microbes to prevent bacterial infections and reduce the spread of antibiotic resistance. Our two lead products target intermittent and persistent Staphylococcus aureus nasal carriage. Fields of application include prevention of peri-operative S. aureus infections, prevention of catheter infections in dialysis patients, prevention of severe infections in chronic carriers of MRSA (Methicillin Resistant S. aureus)
SoXtra
Fragile X Syndrome (FXS) is the first cause of monogenic autism and the second cause of intellectual disability after Trisomy 21. The pathophysiological pathway of BKCa channel is a major therapeutic pathway with a high level of proofs in the human clinical genetics, in vivo and in vitro. SoXtra develops the first treatment that acts as BKCa channel activator and offer a personalized approach for each patient with:
Cartilages regeneration
Paris, France
Vanarix
We solved a key problem encountered in cell therapy using chondrocytes (cartilagecells): the dedifferentiation and loss of function of cells during expansion in culture. Thanks to our patented technology, dedifferentiated chondrocytes regain their full capacity to synthesize a hyaline matrix.
TreeFrog Therapeutics
Allogenica
Allogenica is a biotechnology start-up, evolving in the world of Immuno-oncology with a focus on blood cancers.
Allogenica develops universal cell therapies with the potential to treat all
eligible patients, safer and at drastically reduced manufacturing costs.
Ilonov
ILONOV develops first-in-class biotherapies to prevent and cure diabetes based on the action of a muscle-secreted hormone, which has shown outstanding therapeutic potential in protecting pancreatic islets in islet transplant and in Type 2 Diabetes.
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