CURRICULUM VITAE

Clara Brando

Residence: **** Fox Drive Plainsboro, NJ

Citizenship: USA

Mobile 240-***-****

Email: adta61@r.postjobfree.com

Education:

**** ****** ****** ** ************** Chemistry University of Torino (Doctor in Pharmacy) (Turin-Italy) 1990 PhD in Immunology University of Torino (Turin-Italy) Key words/Summary:

Laboratory Experience as “hands on” and as “Team Leader” Cellular Immunology, Immunogenicity assays, PK assays (MSD, ECL, Nab Assay, Cell Based Assays, Flow Cytometry, Elispots, Luminex), Bioanalysis for Gene Therapy and Cell Therapy. Assessment of vaccines efficacy.

Managerial / Study Director Experience: authoring SOPs, IND, BLA, Regulated work GLP and GCP: Interaction with FDA, and other Regulatory Agencies CRO/ Pharmaceutical experience: interacting with Clients (Pharmaceutical Companies and Academia), supervisor experience (up to 5 people).

Projects Management: Managing multiple Clients and multiple Studies Communication/Mentoring skills: Awarded for best Mentor 2010 and 2019 Meeting Presentation: Second Best Presentation at the AAPS Nov 2019 Employments:

Associate Director ( Bioanalytical- Large Molecules) March 22- Present Assistant Director (Bioanalytical Large Molecules) April 2021- March 22 Wuxi AppTec Plainsboro, NJ

Dr. Brando supervises the Development/Transfer and Validation of assays for the evaluation of Bio- distribution and immunogenicity of experimental drugs and for the quantitative determination of Biomarkers in biological matrix.

Dr. Brando is responsible for assuring compliance to FDA regulations of procedure and instrumentation

(Instrument Owner)

Dr. Brando is responsible for monitoring emerging requests from the pharmaceutical industry and assuring preparedness to opportunities:

Performance and training of direct Reports (5)

Identifying business opportunities

Pursuing business expansion

Implementing new technologies

Assuring the highest Scientific and Regulatory-complainant standards in response to the pharmaceutical Industry demand for Bioanalyses (See section major accomplishments)

Clients communication/interaction

Mentoring Scientist/Analyst/PI to perform new tasks

Scientific Presentations for large scientific audience

Presentation for NON Scientific Audience

Authoring Standard Operation Procedures (SOPs)

Generating timelines

1. assuring realistic planning, back-up-plans in place, 2. Risk assessments

Principal Scientist July 2020- February 2021

Alliance Pharmaceutical, Malvern PA

Dr. Brando supervises the Development/Transfer and Validation of assays for the evaluation of Bio- distribution and immunogenicity of experimental drugs and for the quantitative determination of Biomarkers in biological matrix.

Dr. Brando is responsible for assuring compliance to FDA regulations of procedure and instrumentation

(Instrument Owner)

Dr. Brando is responsible for monitoring emerging requests from the pharmaceutical industry and assuring preparedness to opportunities:

Implementing new technologies

Assuring the highest Scientific and Regulatory-complainant standards in response to the pharmaceutical Industry demand for Bioanalyses (See section major accomplishments)

Clients communication/interaction

Mentoring Scientist/Analyst/PI to perform new tasks

Presentation for NON Scientific Audience

Authoring Standard Operation Procedures (SOPs)

Generating timelines

3. assuring realistic planning, back-up-plans in place, 4. risks assessment

Scientific Director

Eurofins, St Charles, MO July 2018-May 2020

Dr. Brando has directed the Development/Transfer and Validation of assays for the evaluation of Bio- distribution and immunogenicity of experimental drugs and for the quantitative determination of Biomarkers in biological matrix.

Dr. Brando was responsible for identifying emerging demands from the Pharmaceutical Industry and Implementing new line of business supporting Gene Therapy and Cell Therapy. Dr. Brando was responsible for monitoring emerging requests of the Pharmaceutical industry and assuring preparedness to opportunities:

Identifying business opportunities

Pursuing business expansion

Implementing new technologies

Assuring the highest Scientific and Regulatory-complainant standards in response to the pharmaceutical Industry demand for Bioanalyses (See section major accomplishments)

Clients communication/interaction

Mentoring Scientist/Analyst/PI to perform new tasks

Scientific Presentations for large scientific audience

Presentation for NON Scientific Audience

Generating timelines

5. assuring realistic planning, back-plans in place, 6. risks assessment

Principal Investigator

COVANCE, Chantilly, VA January 2015-July 2018

Dr. Brando was the Responsible Scientist for the validation of assays designed to evaluate the pharmacokinetic (PK) profile via quantitative PK assays and immunogenicity of experimental drugs via anti-drug antibody (ADA) or neutralizing antibody (NAb) assays, respectively. Dr. Brando was \directing the use of the validated PK and immunogenicity assays in sample analysis. Dr. Brando created the study plans that govern the conduct of validation (Validation Protocol) and sample analysis studies (Sample Analysis Outline) in accordance with Sponsor requirements and GLP guidelines. Following initiation of a study, Dr. Brando supervised sample receipt and accessioning as well as schedules and directs analysts for completion of validation and sample analysis activities. Dr. Brando analyzed the resulting data and is responsible for data integrity and correct interpretation throughout the process of reporting the data to Management and to the Sponsor.

Other major Responsibilities included:

Client Interaction

Matrix Management of Scientist/Analysts

Data presentation in Scientific Meetings

Generation of timeline

Risks assessment

Risks mitigation

.

Research Assistant Investigator

QUINTILES, Marietta, GA August 2013- December 2014 Dr. Brando was the Responsible Scientist for the development of assays designed to evaluate the pharmacokinetic (PK) profile via quantitative PK assays and immunogenicity of experimental drugs via anti-drug antibody (ADA) or neutralizing antibody (NAb) assays, respectively. Dr. Brando designed assays to assess inhibition of the potency of experimental drugs by neutralizing antibodies and was responsible for the associated cell culture maintenance in compliance with GLP regulation. Dr. Brando authored SOP and analytical methods prior to transferring the methods to analysts for validation and sample analysis. Dr. Brando was responsible for communicating plans and results to Management and program Sponsors. Dr. Brando also prioritized the career development of the analysts under her direction, serving as a mentor to junior personnel.

Other major Responsibilities included:

Client Interaction

Matrix Management of Scientist/Analysts

Data presentation in Scientific Meetings

Generation of timeline

Risks assessment

Risks mitigation

.

Senior Immunologist

WALTER REED ARMY INSTITURE OF RESEARCH (WRAIR), Silver Spring, MD from January 2002-to 2013

Dr. Brando was responsible for the development of assays to assess the efficacy of experimental vaccines. Dr. Brando worked with multiple animal models to elucidate the immune response to Malarial pathogens and vaccine candidates; she developed a flow-cytometry method to investigate the immune response of mosquitoes of the Anopheles species (vector of Malaria infection) to Plasmodium (etiologic agent of Malaria) infection, as well as generated murine models to investigate the mammalian immune response to several Malaria vaccine candidates. Dr. Brando developed multiple enzyme-linked immunosorbent assays

(ELISAs) and ELIspots for multiple targets to assess antibody generation, and developed flow cytometry- based assays to assess T-cell response in murine models. Dr. Brando responsibilities included 1) ensuring that the projects were in line with the Institute’s mission, coordinating studies among researchers, and supervising short- and medium-term research plans. 2) Designing and conducting experiments, developing assays for routine immunological testing (murine models and human volunteers), analyzing and interpreting results. 3) Advising/Mentoring colleagues (Ph.D.) in designing in vivo and in vitro experiments to assess vaccine candidates.

4) Supervising students and technicians.

5) Writing animal protocols and human subject use protocols, preparing - and supervising proposals for submission to FDA, NIH and other Founding Institution ( Gate foundation, MDRAP) Supervising and executing toxicological assays, preparing reports on safety and immunogenicity for intramural evaluation, preparing SOP for submission to FDA, NIH and other Institutions. 6) Coordinating scientific activities between laboratories and partner Industries.

Sponsor Interaction

Data presentation for scientific audience

Mentoring Scientist

Managing up to 5 people

Scientist

THE WISTAR INSTITUTE, Philadelphia, PA from September 1998 to January 2002 Dr. Brando developed several cell-based assays to assess the mechanism by which Natural Killer (NK) and Natural Killer T Cells (NKT) attack and kill cancer cells. Dr. Brando developed novel flow-cytometry- based cytotoxicity assays based on the incorporation and release of vital dyes. Dr. Brando's responsibilities included the validation of the novel assays by comparing performance with the established Chromium release assay to evaluate sensitivity and precision. Dr. Brando supervised the analysis of samples from Clinical trials (patient biopsies) and from Toxicology experiments (mice experimental tumors, spleen, lung and pancreas) for the presence of infiltrating NK and NKT cells. Dr. Brando was responsible for supervising the cell culture facility that produced NK and NKT cell lines to be used in Clinical Trials evaluating experimental Cell therapies for cancer.

Directing Students and Technicians

Mentoring junior personnel

Data analysis and presentation for scientific audience

Research Assistant Professor

TEMPLE UNIVERSITY, Philadelphia, PA from September from 1994 to September 1998 Dr. Brando was responsible for the development of assays leading to the characterization of the T lymphocytes invading the salivary glands of Non-Obese Diabetic mice (an experimental model of Sjogren's syndrome, a T cell mediated autoimmune disease of the salivary glands). Dr. Brando derived several epithelial cell lines from salivary glands of mice to investigate the mechanism of T cell invasion of salivary glands in vitro. Dr. Brando also contributed to the development of an assay for the early diagnosis of Sjogren’s syndrome. Post-Doctoral Fellow

NIAID-NIH- Bethesda, MD, from January 1990 to July 1994 Dr. Brando was trained in basic immunology at the Institute of Allergic and Infectious Disease (NIAID at the National Institutes of Health). Her training included cellular immunology with emphasis on T cell activation. Dr, Brando contributed to the investigation of the biochemical pathway following the triggering of cell membrane ligands for adhesion molecules on T cells.

Major accomplishments:

CRO related: 2018- present Opening a new line of service for bioanalytical requests in the field of Gene Therapy and Cell therapy

2019: Opening a new line of service in Vaccines

2019: Expanding the line of service in cell-based assays, 2019: Expanding the flow cytometer capabilities and services 2019: Second best presentation at the AAPS Saint Antonio Texas (November 2019) Research:

1) double color ELIspots for the simultaneous determination of IFN and IL-5 on human PBL, 2) development of a flow-cytometry assay for the determination of cytotoxicity in vivo (mouse), 3) use of multicolor flow-cytometry for the determination of lymphokines in vivo, 4) identification of the role of adhesion molecules in Plasmodium infection of Anophele mosquitoes. HPLC separation of biologically active proteins from Anophele salivary glands.

5) Generation of mice model for tumor studies, xerograph transplant on SCID mice, generation of humanized mice.

Grants:

1996-1998: NIH RO3: Role of adhesion molecules in Sjögren‘s syndrome 1998: Tutor for student fellowship: Generation of antigen specific cells clones from salivary glands on NOD mice, awarded by The Sjögren’s syndrome Foundation. Patents: anti-diabetogenic effect of TALL-104 cell. Teaching and Tutorial experience:

1995-1998: Director: General Immunology- School of Dentistry, Temple University –North Broad Philadelphia, PA 19140

1996-1997: Tutor in a Research project Founded by The Sjögren’s syndrome Foundation: Cloning of antigen specific cells in Sjögren’syndrome patients 1997-1998: Tutor in a Research project sponsored by Temple School of Dentistry: Cellular components in Sjögren’s syndrome

2002-present: Mentor: SCIENCE AND ENGINEERING APPRENTICE PROGRAMS University of Pennsylvania-WRAIR program

August 2010: Award for dedicated mentoring, WRAIR Silver Spring MD. Courses and Special Training:

January 2004: Good Laboratory Practice Regulation: Introduction and Practical- WRAIR- Silver Spring- MD

March 2005: Multiparameter Flow Cytometry

Naval Medical Research Center-WRAIR Silver Spring, MD Additional information:

People supervised to date : 40 from 1998-date, max of 10 Selected Publications:

2022 June, SAPA presentation “ Bioanalysis in cells and Gene therapy” Oral Presentation”

Philadelphia, PA June 2022

2019 November 3-5 AAPS San Antonio, TX:

Oral Presentation: “Overcoming matrix effects in Cell Based Nab Assay” Presentation awarded with “Second place for innovation and practical application” Brando C, and Kamau E.

CD8+KLRGDhigh+CD27low, CD62low,CD44high is the phenotype of CD8+cells protective against Plasmodium Berghei challenge in C57 mice.

Accepted for publication Malaria J 2014

Kaba S, Brando C et al. A non adjuvant vaccine confers protection against rodent malaria J. Immunol, 2009, 183: 7268-7267.

Polhemus ME, Magill AJ, Cummings JF, Kester KE, Ockenhouse CF, Lanar DE, Dutta S, Barbosa A, Soisson L, Diggs CL, Robinson SA, Haynes JD, Stewart VA, Ware LA, Brando C, Krzych U, Bowden RA, Cohen JD, Dubois MC, Ofori-Anyinam O, De-Kock E, Ballou WR, Heppner DG Jr. Phase I dose escalation safety and immunogenicity trial of Plasmodium falciparum apical membrane protein (AMA-1) FMP2.1, adjuvanted with AS02A, in malaria-naive adults at the Walter Reed Army Institute of Research. Vaccine, 2007, 25(21): 4203-4212.

Brando C, Ware LA, Freyberger H, Kathcart A, Barbosa A, Cayphas S, Domoitie M-A, Mettens P, Heppner DG, and Lanar DE. Murine immune responses to Liver Stage Antigen-1 (FMP011), a malaria vaccine candidate, delivered with adjuvant AS01B or AS02A. Infect Immun. 2007, 75(2): 838-845. Brando C, Sunil M, Kovac E, Campbell K, and Santoli D. Receptors and Lytic mediators regulating anti tumor activity by the leukemic killer T cell line TALL-104. J of Leukocytes Biology 2005 vol 78, 359-371

Brando C, Marcinkiewicz C, Goldman B, McLane MA, Niewiarowski S. EC3, a heterodimeric disintegrin from Echis carinatus, inhibits human and murine alpha4 integrin and attenuates lymphocyte infiltration of Langerhans islets in pancreas and salivary glands in nonobese diabetic mice.

Biochem Biophys Res Commun. 2000 Jan 7;267(1):413-7.

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