Raphaël Rousseau, Md, Phd Email & Phone Number

Los Altos, Ca, Us

Los Altos, Ca, Us

I am a clinical drug development consultant with over 25 years of hands-on experience designing and executing phase 1 to phase 4 clinical trials, across a wide array of therapeutics. I specialize in helping biopharmaceutical companies develop and implement a realistic clinical development plan based on unmet medical and market needs, with the "end in mind": provide access to patients and create value for the company. I can project-lead, coordinate, and/or advise on the practical design and execution of the CDP, from investigator brochures to clinical study reports. I can also assist with presentations to boards and fundraising efforts.My medical expertise is chiefly in oncology and hematology, from neonates to the elderly. I am also familiar with auto-immune, infectious, coagulation, and metabolic/congenital diseases. I prioritize patient safety and strive to optimize R&D expenses through innovative trial designs, without compromising data quality.

Brookline, Massachusetts, Us

Paris, Île-De-France, Fr

New York, Ny, Us

"Getting a taste of my own medicines" and experiencing the patient's side of things, ironically for an aggressive malignancy I know all too well as a trained hemato-oncologist and drug developer. I used to say I was "missing my time on the wards" since I joined biotech!A big thank you to the wonderful medical and nursing staff at Stanford Hospital's lymphoma service, all my consulting clients for their trust and patience, and my friends and family in France and the US for their lovely support.Onwards!

Brisbane, California, Us

Brisbane, California, Us

I joined Day One on a short-term mission to support the R&D organization's transition from late-stage clinical research to commercialization, its first BLA submission for tovorafenib in children with relapsed low-grade gliomas with BRAF alterations, the subsequent FDA review, and the organizational readiness for the US commercial launch.

Amsterdam, North Holland, Nl

I joined Neogene post-Series B and prior to the first CTA & IND submissions. Neogene Therapeutics is a global, clinical-stage biotechnology company pioneering the development of next generation, fully individualized engineered T cell therapies for a broad spectrum of cancers. As the CMO, I was responsible for building the development team, leading Neogene's strategic vision for its therapeutic portfolio, overseeing the design of Neogene’s medical plan and executing its clinical program of multispecific and potency-enhanced neoantigen-targeting TCR T-cell therapies, either personalized to each patient's tumor, or targeting variants of oncogenic drivers such as TP53 and KRAS. In January 2023, Neogene Therapeutics was acquired as a wholly-owned subsidiary of AstraZeneca.

Emeryville, California, Us

I joined Gritstone post-Series A, built and led its development organization, and was responsible for the design and execution of the clinical development strategy in personalized and shared neoantigen therapeutic cancer vaccines (phase 1-2 and randomized phase 2-3 clinical trials). I was a member of the executive leadership team, participating in fundraising, including the IPO. Starting 2020, I oversaw the rapid initiation of several phase 1 clinical trials of second generation prophylactic vaccines against SARS-CoV-2. Both programs use innovative prime-boost vector systems comprising of recombinant adenoviruses and self amplifying mRNA with the aim of generating and sustaining strong, durable T cell responses against predicted neo epitopes (cancer vaccines) or viral structural epitopes beyond Spike.

South San Francisco, California, Us

I created and lead the innovative pediatric drug development group (iPODD, now a 60+ member team), oversaw Roche’s pediatric strategy and ensured optimized design & execution of pediatric investigational plans (phase 1 to phase 3 clinical trials) across the company’s oncology portfolio. I chaired the development review committee for all pediatric oncology and hematology programs. With the iPODD team and in close collaboration with FDA and EMA, we designed and launched the iMATRIX master trial concept, an innovative Phase 1-2 multi-tumor, multi-drug, collaborative drug development platform for patients with high-risk pediatric malignancies. I was the clinical development lead or co-lead on several submissions under PREA and PIP regulations, in particular, the pediatric clinical development program and registration of Avastin® (with the successful obtention of a 6-month exclusivity extension in the US), MabThera® and Xeloda®. I initiated the pediatric development of Cotellic® and Tecentriq®, which subsequently were submitted to regulatory authorities.

Switzerland 🇨🇭 , Ch

Switzerland 🇨🇭 , Ch

I joined the Hematology Franchise Team (Basel) and was a member of the Rituxan®/MabThera® joint life cycle team (Genentech and Roche), which successfully launched a label extension in the EU and US for adult patients with newly diagnosed follicular lymphoma. I co-led the phase 4 program, which ultimately supported the launch of subcutaneous Rituxan®/Mabthera®I also provided key medical contributions to the initial development plan for Gazyva® (obinutuzumab), a third-generation, type II anti-CD20 monoclonal antibody in non-Hodgkin lymphomas and chronic lymphocytic leukemia. Medical affairs, as my first experience in the pharma industry, provided me with a broad overview of a global, cross-functional organization with strong interactions with the clinical development, regulatory, and marketing teams. I also acquired solid experience interacting with key opinion leaders/therapeutic area experts through advisory boards, symposiums, and investigator-supported and cooperative group trials in the US and EU. In particular, in collaboration with our clinical operation colleagues, I proposed and implemented a concept of a fit-for-filing approach to optimize the costs and efforts of converting investigator-initiated trials for regulatory submissions.

Villeurbanne, Fr

tenured.I co-led the medical oncology curriculum for 3-4th year medical students and the launch of a new national medical school requirement for students to acquire proficiency in the critical analysis of peer-reviewed scientific publications.I launched a simulation-based learning approach for training medical students and residents in shared decision-making with patients with cancer.

Houston, Texas, Us

Lyon, Fr

I joined Léon Bérard Comprehensive Cancer Center (CLB) as part of the merger between the pediatric oncology departments at CLB and Hospices Civils de Lyon, France. The Institute of Pediatric Hematology & Oncology (HOPE) was, at the time of its inception, the largest pediatric onco-hematology department in Europe. I was the group leader of the laboratory of experimental therapeutics and clinical research unit, and attending physician and chief, neuroblastoma clinic and pediatric intensive chemotherapy unit.My translational research focused on immuno-oncology, CD33 and CD19 CAR T cells, and nanovectors for drug delivery, from bench to bedside:I obtained and managed large grants, including a EU FP6 STREP grant (€3.4M, coordinator, chimeric T cell therapies of CD19+ high-risk pediatric leukemias) and ASCO's ACRA award ($450K, nanotherapeutics for the treatment of sarcomas).I created and led the first European academic consortium for the conduct of a phase 1 study using CD19-targeting CAR T cells for the treatment of pediatric high-risk leukemias.

Houston, Tx, Us

In parallel to my research fellowship, I obtained the United States Medical Licensure (USMLE) and the certification from the Educational Commission for Foreign Medical Graduates (ECFMG), and joined Texas Children's Cancer Center and Hematology Services (including bone marrow transplantation) as a clinical fellow.

Houston, Texas, Us

At the Center for Cell and Gene Therapy, under the mentorship and supervision of Dr Malcolm Brenner, and with the support and collaboration of the CAGT team, I co-developed a translational, GMP-grade, FDA-approved antitumor approach using genetically modified autologous and allogeneic tumor cells to treat high-risk pediatric acute leukemias, chronic lymphocytic leukemia, and neuroblastoma.

Paris, Île-De-France, Fr

I trained in pediatrics, with a focus on pediatric intensive care, pediatric cardiology and pediatric hemato-oncology.I was elected chair of the Paris University Hospitals residents’ union (Syndicat des Internes des Hôpitaux de Paris, SIHP)

Clinical Fellow, Pediatric Hematology-Oncology

Habilitation À Diriger Des Recherches (Tenure), Therapeutic Biotechnologies

Phd (Docteur Ès Sciences), Therapeutic Biotechnologies

Pediatric Oncology Sub-Speciality (Diplôme Universitaire D'Oncologie Pédiatrique)

Pediatric Specialty (Diplôme D'Etudes Spécialisées En Pédiatrie)

Md (Docteur En Médecine), Medicine

Medical Ethics, Philosophy

Baccalaureate, Mathematics And Biological Sciences

Education record