Nicola Beltraminelli Email & Phone Number

Caluire-Et-Cuire, Fr

Marseille, Provence-Alpes-Côte D’Azur, Fr

Innate Pharma S.A. is a clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.Responsibilities:- Global supervision of the Research & Early Development (RED) activities of the company, including NBE discovery and enginieering, in vitro and in vivo pharmacology, translational and flow cytometry platforms, safety, bioanalytical, supply and CMC operations up to Phase 2- Supervision of 7 teams with a global headcount of ~100 FTEsType of assets currently in development:- Engineeered antibodies- Proprietaly multispecific NK cell engagers (ANKETs)- ADCsMember of the MabDesign board since Septembre 2021

Marseille, Provence-Alpes-Côte D’Azur, Fr

Innate Pharma S.A. is a clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.Responsibilities:- Global supervision of the non-clinical development activities company wide including safety, bioanalytical, supply and CMC operations - Supervision of 4 teams with a global headcount of ~50 FTEsMember of the MabDesign board since Septembre 2021

Lysogene is a public company aiming at developing novel gene therapies against neurological disorders. Lysogene’s lead programs are in neurodegenerative lysosomal storage disorders that affect children.Responsibilities: - Global supervision of the CMC activities for the late-stage development of 2 assets (Phase 1-2-3 and Phase 2-3) with the objective to achieve commercialization by 2023.- Process development to adapt an adherent process to a cell suspension for the manufacture of AAV - Supervision of a small CMC team (3 headcounts)

Cambridge, Massachusetts, Us

Scientific supervision of the French Immuno-Oncology Research activities including: - The selection of new immuno-oncology targets - The definition of a general work plan for each project, as well as for the French research site with objectives, deliverables, go/no go decision points, and budget - The antibody discovery activities leading to the isolation of pre-clinical candidates - The in vitro characterization of the best candidates and their humanization/engineering - The evaluation of the lead on a panel of in vivo models (syngeneic, xenograft, Kin) - The setup of collaborations to evaluate the role of the target and of the lead ex-vivo (translational aspects) - The scientific support on the design of non-GLP and GLP tox studies in NHP, as well as on the review of the non-GLP and GLP regulatory packages - Contribution on the preparation of the IND filing Supervision of all CMC activities companywide including: - The selection of the CDMOs (cell line development & manufacturing organization) - The setup and negotiation of the contract (budget, timelines, deliverables) - The direct supervision of the operations for all CMC projects (currently 3 ongoing) - The supervision of the CMC regulatory documentationAchievement of a project from DNA to PhI clinical DP delivery (500L scale) in less than 6 months. This included the supervision of all the CMC activities, such as cell line generation, analytical methods qualification, USP and DSP development and scale up, 200L non-GMP run and 500L GMP run, QC release testing (DS and DP) and Viral Clearance studies. Member of the company executive team

Cambridge, Massachusetts, Us

My role covers a global position over the Paris, China and Cambridge-US sites, including the management of teams in the US, China and Paris sites (15 headcounts)Activities: - Design of immunizations strategies for the discovery of antibodies- Characterization of monoclonal antibodies along their development path including but not limited to: - In silico assessment of their liabilities / developability profiles - mAb humanization and engineering - assessment of their physico-chemical attributes - mAb stability measurements under accelerated stress conditions- Coaching Project of Leaders for the development path of antibodies from discovery to clinic- Scientific / Technical support on HiFiBiO's HT single cell screening technology- Scientific support on the evaluations of in-licensing opportunities on immuno-oncology programs- Coordination of the BioIT activities- All CMC activities company wide (from gene synthesis to Final Drug Product release)- Member of the company management team

Cambridge, Massachusetts, Us

My role covers a global leading position over the Paris, China and Cambridge-US sites on antibody protein science, binding/functional assays development activities, as well as all CMC activitiesThe activities are structured as follows: - Management of the US, China and Paris teams (15 headcounts)- Characterization of monoclonal antibodies along their development path including but not limited to the assessment of their quality attributes, developability profiles, liabilities, humanization, engineering,... - Project management from antibody discovery to pre-clinical POC and beyond- Scientific / Technical support on HiFiBiO's HT single cell screening technology- Scientific support on the evaluations of in-licensing opportunities on immuno-oncology programs- Coordination of the BioIT activities- All CMC activities company wide

Company OverviewBliNK Biomedical is a therapeutic antibody company focused on immune-oncology. The company has been founded in January 2015 from the assets of the Valneva antibody discovery platform (in Lyon) and the shareholders of BliNK Therapeutics Ltd in Stevenage, UK.The company leverage its B cell technology to develop proprietary antibody programs from early discovery to clinic. BliNK Biomedical SAS' powerful technology is aimed at isolating antibody producing cells for difficult targets for which other platforms have failed to deliver.The company is based in Lyon with an >20 persons team.www.blinkbiomedical.com

The main goals of the VIVA|Screen platform are:- Discovery of antibodies for customers (infectious diseases and autologous targets) until the early preclinical phase- Research and discovery of antibodies for proprietary programs until late preclinical phase- Continuous optimization of the platform development

Fr

Vivalis’s VIVA|Screen® technology enables the discovery of fully human therapeutic antibodies. Based on the combination of Humalex®, a technology enabling to immortalize human B-lymphocytes producing antibodies from selected donors exposed to the pathology of interest and ISAAC, a novel technology enabling to screen individual B lymphocytes on microarray chips, B lymphocytes secreting antibodies of interest can be individually selected and their VH and VL can be efficiently isolated. The resulting recombinant antibodies are produced and characterized according to the selected target.

Fr

The main goals of this department are:- Develop the EB66 plateform (avian cell line producing monoclonal antibodies with superior ADCC activity) by increasing the productivity of the cell line - Obtain producing cells of the candidate product (monoclonal antibody or recombinant protein) for clients and/or for the internal pipelineMy activities covered also the project management for the USP, DSP and analytical development of a therapeutic antibody for an application in oncology

Supervision of a 7 person team for the process dev of 2 glycoproteins of 192kDa and 272kDa. The work was divided as follows:1 Construction of the plasmid, cloning in CHO, screening and selection of clones to obtain a pre-MCB2 Screening of media and cell culture parameters in bioreactors 3 Dev of DSP steps (IEX, HIC,SEC, TFF) including viral removal/inact. steps. Scale up and writing of SOP4 Dev and pre-validation of analytical tools5 Formulation dev for parenteral administration of the DP. Stability studies of both DS and DP6 Tech. transfer of the process to the production site and coordination of the Apoxis team with the subcontractor team to successfully obtain GMP grade material7 Characterization of the DS (N- and C-terminal sequ., peptide mapping, glycoanalysis, MALDI-TOF, light scattering, UF)Dev of a process for a 67 kDa protein produced in bacteria. Dev and pre-validation of product specific analytical methods. This process included the dev of a refolding step

The goal was to produce recombinant proteins for new vaccines to be tested in preclinical trials, as well as for customers asking for pure proteins at mg amounts. The recombinant proteins were produced and purified with amounts ranging from 2 mg to 20 mg. Most of them (glycosylated) have been produced in the 293T mammalian line, the rest in E. coli. Optimizations were carried out to improve the cell productivity of CHO cells in serum-free and protein-free media.

Ph.D, Biochemistry

Education record

Education record

Diplom Bio Ii