Damien B.

Versatile and Experience Independent Biotech Consultant, I bring my extensive background to support companies in their R&D endeavors. I can assist to the following areas: - In vitro and in vivo Pharmacology (pharmacokinetic, pharmacodynamic and toxicity study design) - Biomarkers selection, Development and analysis - Selection, Design and Analysis of in vitro immuno-assays - Design and Analysis of Flow Cytometry assays - Selection, Design and Analysis of in vivo efficacy studies - Identification and Communication with Contract Research Organizations - Technical reports writing for internal and external communication with stakeholders or IND filings. - Other needs: Please contact me to inquire. I am eager to contribute my skills, creativity, and strategic mindset to drive success in a dynamic and growing environment. Let's connect and explore how I can bring value to your biotech initiatives.

• Directed preclinical IND-enabling and clinical pharmacology studies including biomarkers development at CROs and academic collaborators to advance cancer and chronic inflammation pipeline. • Spearheaded biomarker initiatives and pharmacology data for clinical trials and managed collaborations with key stakeholders. • Supported pharmacokinetic (PK) studies for a dual-acting prostate cancer drug in clinical trial. Performed QC data analysis, prepared reports, ensured data accuracy and storage. • Drafted and refined IB and regulatory documents for FDA and MHRA submissions (PK, biomarker and toxicology data). • CROs management for small molecules, antibody and cell therapy programs. • Presented data to stakeholders and Key Opinion Leaders during Scientific Advisory Board, Scientific Review Committee and program meetings. • Collaborated with cross-functional teams to perform due diligence on third-party vendors and suppliers, ensuring compliance with industry standards and mitigating operational risks.

From 2015 to 2023 I held various positions at Sorrento Therapeutics, progressing from Scientist to Senior Director. As my responsibilities expanded, so did my professional activities, which included, but were not limited to, the following areas: • Led the Preclinical Immunotherapy Cross-Functional Teams (from target discovery to IND filings) with the goal of supporting all stages of drug development for Oncology and Autoimmune/Inflammatory indications. • Supported Target Identification and Validation, exploring biologics and small molecules MOA, leading optimization activities and identification of translational PD markers. • Spearheaded preclinical in vitro and in vivo pharmacology efforts for several programs both internally and at CROs. • Collaborated with regulatory, Clin Ops and medical teams to successfully advanced five Therapeutic Antibodies and two Oncolytic Viruses from lead discovery into IND filings (including phase 1 clinical trial). • Supported translational research for Ph1 clinical trials by designing TK/PD studies to help guide target selection and estimate starting doses for clinical trials, and spearheading biomarker development in collaboration with the CLIA lab. • Identified and developed a series of immune modulators against various TNFR family members. • Oversaw the development and expansion of in vivo capabilities (pioneering and maintaining in-house humanized mouse colonies) • Provide scientific leadership and managed programs (timelines/deadlines, tasks delegation and final deliverables) though one-on-one and program team meetings. • Evaluate potential collaborations and in- or out-licensing deals. • Hired, led and mentored new hires for faster team integration, boosting performance and retention. Fostered positive work culture while interviewing, recruiting, and training employees to meet job needs. Recommended corrective actions to ensure quality standards. Worked closely with the legal group to patent new inventions.

• Designed and presented proposals to manage and support lead discovery efforts for two Antibody-Drug Conjugates (ADCs) and one bispecific T-cell engager against Inflammatory and autoimmune diseases as well as Cancer. • Responsible for all project-related activities from target identification & validation, budget preparation and management of internal resources to meet timelines and provide deliverables in a timely-manner. • Manage a cross-functional team (up to 2 direct reports and 8 indirect reports from the chemistry, bioanalytical and CMC groups) to design and execute in vitro and in vivo experiments for identifying and validating candidate ADC targets. • Coordinated development of a series of in vivo autoimmunity and inflammatory animal models (among which Psoriasis, Lupus, IBD, Diabetes and Skin Allograft) as well as xenograft and syngeneic tumor models for targets selection. • Involved in the strategic discussions with the management team to make Go/No-Go decisions on the programs. • Managed the biology effort of the Merck collaboration, resulting in the selection of novel cleavable linkers and publication of 2 scientific manuscripts.

• Obtained 2 research grants as Principal Investigator from the NIH and JDRF • Identified novel type 0 and type 2 biomarkers to predict efficacy of anti-CD3/oral insulin combination therapy in autoimmune diabetes. These biomarkers were validated in animal models and will be a useful tool for recruiting patients and evaluating efficacy of present and future clinical trials using anti-CD3 and/or oral insulin therapies in type 1 diabetes (T1D). • Established collaboration with Entelos Inc. a life sciences company, that has developed the T1D PhysioLab® platform, a predictive in silico model of diabetes progression in the (nonobese diabetic) NOD mouse. In this collaboration, Entelos’ biosimulation capabilities were used to accelerate the path to clinical translation through a priori in silico testing of candidate experimental protocols in “virtual” NOD mice. In particular, simulations were used to optimize experimental design and identify assumptions that are critical for the predicted therapeutic efficacy, which may be experimentally investigated to reveal key mechanisms of action. This close collaboration between ‘wet-lab’ and ‘virtual lab’ investigators enables more rational experiment design and discovery of novel biomarkers. • Developed a new approach to deliver RNA interference (small interfering RNA) specifically into the pancreas of diabetic mice with the objective to prevent autoimmune diabetes. • Trained, supervised and mentored two undergraduate students, whose project was focused on the development of RNA interference-based therapy for autoimmune diabetes.

• Discovered a new approach to expand antigen-specific regulatory T cells (Tregs) in vivo and efficiently reverse new-onset T1D by combining antigenic immunization and short-term treatment with a FcR-non-binding anti-CD3 antibody. • Identified the co-stimulatory molecule OX40 (CD134) as a key player in the survival and suppressive function of adaptive (antigen-specific) Tregs. This finding opens a new avenue for the use of OX40 agonist or OX40L blocking antibodies for modulating the immune response by expanding and maintaining the survival of either Tregs or effector T cells. • Established and improved various molecular and cellular biology techniques in the lab (western-blotting, cloning strategies, large scale production and purification of DNA vaccines, transfection primary T cells with plasmids, protein engineering and production, and siRNA). • Heavily involved in the development of 12-color high resolution flow cytometry analysis and sort in the lab. This includes the selection of conjugated antibodies and the improvement of the machine setup and filter design. • Trained and supervised three research associates involved in many aspects of my research projects.

• Identified the immuno-dominant epitope recognized by human anti-thyroperoxidase (TPO) autoantibodies (aAbs) during the pathogenesis of autoimmune thyroid diseases by using phage-displayed peptide libraries. This finding identifies the three dimensional structure of the immunodominant epitope of anti-TPO aAbs and was the basis for the development of peptide mimotopes recognized by a vast majority of these aAbs. A patent was filled to protect these peptide sequences with great diagnostic and therapeutic potentials. • Established collaboration with the group of Dr. M. Cerutti to produce, by using baculovirus insect cell expression system, large amounts of human anti-TPO aAbs for the crystallography study. • Established collaboration with the group of Dr. C. Dumas to co-crystallize the anti-TPO/TPO complex and obtain a three-dimensional structure to better localize the residues from the epitope and paratope involved in the interaction. • Developed antibody dependant cell cytotoxicity (ADCC) assay to evaluate the cytotoxic effect of human anti-TPO aAbs. • Trained and supervised one research associate and two undergraduate students involved in many aspects of my research projects.