The Silicon Review
The world we live in is filled with enormous scientific innovation. There is a promising vision for improved human health in this world due to the fact that our understanding of biology is rigorously expanding. Identification of novel targets and their associated modalities are also on the rise with the irruption of artificial intelligence and health data mining. Even with all the achieved growth in technology, the drug-development timelines and costs are significantly on the higher side. Experts believe that this is the right time to bring a change in development, and to make this a reality, all we need is holistic information. Innovation accelerators can be used as a silver bullet to integrate multiple innovations to transform the development process completely.
An innovation accelerator biotech company called 4P-Pharma is reimagining the R&D transformations of the traditional approach to drive innovation in the drug development process. The company is a French biotech firm specializing in the development and the repurposing of therapeutics addressing unmet medical needs for Human and Animal Health, from drug discovery level to clinical phase I/II. 4P-Pharma detects innovative, breakthrough projects in Universities and research centers, SATTs and TTOs, in order to accelerate their development as novel drug candidates by a de-risking and partnership approach. The company is open to novel opportunities and has recently initiated collaborations with biotech companies specializing in in-silico drug screening to bring health products to the patients faster.
In conversation with Revital Rattenbach, Founder and President, and Patrice Denèfle, Chief Scientific Officer of 4P-Pharma
Q. Explain your activities in brief.
Revital: 4P-Pharma is an innovation accelerator biotech company, based in the Pasteur Institute of Lille (France). We built it as a professional collaborative translational R&D platform focusing our ambitions to bring disease-modifying treatments addressing serious chronic diseases as Osteoarthritis and Alzheimer mostly associated with aging. We partner with TTOs (Technology Transfer Offices) and drug discovery biotech companies to identify disruptive and promising therapeutic molecules on which we perform a due-diligence and technological assessment applying stringent criteria. We bring together all the relevant actors from the clinic, drug development, finance, and business fields to move therapeutic concepts and technologies through developmental decisions, building bridges to bring innovations to clinical phases and closer to patients’ bedsides. Therefore, our business model is able to minimize risk and optimize return on investment with the aim of offering patients efficient, safe, and affordable treatments for serious chronic diseases for which no treatment exists.
Q. What are the challenges that you are addressing?
Revital: I was trained as an academic researcher, and as such, I experienced first-hand how the innovation ecosystem could benefit from a strong public-private partnership. Indeed, the most disruptive innovations in medicine are thriving in universities and hospitals. However, pharmaceutical companies are often unwilling to invest in early-stage discoveries made in public laboratories that have not been validated in an independent manner. In this condition, a lot of projects are lost, despite their great potential. Therefore, I founded 4P-Pharma to find these gem projects and develop these technologies from an industry point of view. I envisioned 4P-Pharma as a bridge between basic public science and industrial development; this way, we create the condition for innovation to arise and bring better human health products for the people.
Q. What are the different stages in drug development process?
Patrice: Underlying mechanisms and pathophysiology of many disorders are still unknown, which makes the drug development processes challenging. Before a drug gets regulatory approval, it has to go through rigorous testing. The journey begins in universities and institutes, where scientists undertake fundamental research to understand disease mechanisms, processes, and targets. Once a potential target has been identified, scientists are looking for a drug candidate that acts on it. Then, the candidate goes through different stage-gates: lead optimization, preclinical evaluation, and clinical evaluations (divided into three main trials) during which the drug candidate is tested for safety and efficacy in cells and animals before the administration to humans.
All of this process, from discovery to market, generally takes about 8-15 years depending on the indication, and most of the drug candidates fail during the preclinical evaluation leaving a small portion entering into clinical trials and even smaller into the market. Thus, drug development is a very risky and expensive process.
At 4P-Pharma, we are a team of strong professionals who master these steps, from lead optimization to early clinical trials, using modern in-silico techniques together with wet lab capabilities, so as to significantly derisk these stage-gates, and find and develop the best drug candidate as early as possible.
Q. What are the critical concerns in making a pharmaceutical product?
Patrice: There are different types of challenges. First, the ratio between the risk and the benefit has to be balanced. This is achieved through a structured and meticulous series of safety and efficacy tests of the drug candidate combined with the use of massive data analytics. Secondly, all the results obtained during the preclinical phase and the clinical trials are reviewed by experts from the national regulatory authorities as EMA (European Medicines Agency in Europe) or FDA (Food and Drug Administration), who decide whether sufficient preliminary research has been conducted to allow testing in humans. Third, the primary mechanism to secure value from innovation for the pharmaceutical industry patents. Intellectual property protection prevents copying and allows a marketing exclusivity to ensure a return on investment, cover expensive drug development costs, and invest in future innovative drugs.
Our role and core business is to go through these challenges by optimizing the drug development plan, get advice from regulatory agencies early in the drug development process, and design the best intellectual property protection strategy. We achieve this through efficient networking with the best experts from the clinic, drug development, finance, and business fields, with the aim to derisk and create value as early as possible.
Q. Do you have any breaking news on your pipeline?
Revital: 4P004 is our main project for the moment. It is a treatment for Osteoarthritis, the most invalidating disease for the elderly population due to chronic and progressive inflammation and destruction of the main component of the joints, the cartilage, that leaves the patients to go through long-lasting pain, impaired function and loss of mobility. The idea and the underlying strength of 4P004 come from the clinical observations of one of the most well-known rheumatologists worldwide, Prof. Francis Berenbaum, on his OA patients at Saint-Antoine Hospital in Paris, France. Together, and with the support of the SATT Lutech, we have shown that the major breakthrough innovative feature of our 4P004 product is its DMOAD properties. It has the potential to stop and reverse the course of the disease in patients and improve their quality of life not only by reducing the pain but also by regenerating cartilage.
We are raising funds from investment funds, mutual societies, and banks to finance clinical trials planned for 2021 and will be led by a spinoff of 4P-Pharma.
Meet the leaders behind the success of 4P-Pharma
Revital Rattenbach is an entrepreneur really passionate about Science. She founded 4P-Pharma in 2014 with the aim to establish a biotechnology company able to promote and accelerate innovative drug for patients. She envisioned her company as a bridge between academic research and industrial development, bringing together the driving forces of the public and private sectors to develop the therapies of tomorrow for the Patients.
Patrice Denèfle joined Revital and her team in May 2020 as Chief Scientific Officer, aligned with his personal goal to bring life-changing and disease-modifying therapeutics to Patients. He has over 35 years of R&D experience in large pharmaceutical and biotechnology companies in France and the USA.