Nandini Arunkumar, Ph.D. Email & Phone Number

Washington, DC, US

Bethesda, Maryland, United States

• Develop strategic initiatives, program evaluation strategies; and manage program priorities in Office of Strategic Initiatives, Office of Director, NIAMS.
• Key role in developing new strategic initiative - Accelerating Medicines Partnership in Autoimmune and Inflammatory Diseases (AMP AIM), a > $55M private public partnership.
• Develop program priorities and execution of key milestones and deliverables for trans-NIH initiatives including, NIH Accelerating Medicines Partnership in rheumatoid arthritis and systemic lupus erythematosus (AMP.
• Develop guidelines, models and funding plans for a budget of over $17M.
• Lead evaluation and analysis of research portfolio to enable data-driven decision making of scientific, policy and management actions.

• Developed recommendations for new strategic initiatives in female contraceptive technologies.
• Conducted a comprehensive evaluation, generated and prioritized list of female contraceptive targets through literature and KOL research.
• Provide technical knowledge and product development expertise to identify novel technology platforms to catalyze target discovery.

• Drive growth of companies in BHI’s portfolio and Incubation programs.
• Develop and implement strategies to build and maintain a dynamic portfolio of technology and product-based companies in incubators.
• Evaluate new companies, track company milestones, engage with strategic BHI partners and execute programming activities.

Gaithersburg, Maryland

• Responsible for development and characterization of cell culture product development processes for clinical manufacture of first-in-class biological products. Engaged in business development projects.
• Supported Business Development activities to identify strategic partners for Amplimmune’s product pipeline in immuno-oncology.
• Conducted IP and competitive landscape analysis to help prioritize resources for projects in pipeline.
• Initiated transfer of novel technology for transient transfection for production of reagent quality protein products, achieving nearly 100-fold increase in production.
• Optimized processes for large scale DNA preparation, to support transient transfection activities, establishing control over source DNA within the development team.
• Executed analytical methods for protein products including HPLC analysis, protein quantification methods, ELISA, electrophoresis, endotoxin quantification etc. under GMP conditions and prepared Certificate of Testing.

NCBS, Bangalore

• Managed Project Management, Business Development and Training programs.
• Implemented processes to track projects, timelines, milestones and deliverables for Genomics services, resulting in decreased turn-around time for project delivery and ~2X increase in the number of projects.
• Spearheaded business development and customer relationship management activities, as the primary point of contact, including technical evaluation of projects, preparing and closing business proposals, and coordinated.
• Led a cross functional team of scientists and project managers to define requirements and design for a laboratory management system. Evaluated, finalized and coordinated implementation of the organization-wide software.
• Evaluated and coordinated with third party service providers to ensure on-time project delivery.
• Established and revised cost of various services semi-annually, based on budget and expenses. Worked closely with finance and scientific team to track expenditure and income inflow.

Bangalore, India

• Provided technical and business development advisory services to CEO for Biologics manufacturing facility.
• Identified potential clients for biopharmaceutical development and manufacturing services.
• Supported lab design and instrumentation needs for a new Process Development lab.

Gaithersburg, Maryland

• Worked with Founding team to develop production Processes for first-in-class biological molecules targeting checkpoint inhibitors (PD-L1 and PD-L2).
• Initiated and drafted regulatory documents including, pre-IND briefing document and IND (CMC section) for FDA submission of Amplimmune’s first oncology product, which contributed to a strategic partnership with.
• Authored technical study reports by collating data from scientists in Research and Development teams to expedite pre-IND filing timelines.
• Cell line development and selection of lead products against checkpoint inhibitor proteins.
• Handled manufacture of early stage cell banks, prepared pre-master and development cell banks and developed early stage cell culture seed train.
• Designed and carried multiple DOE studies, including establishing culture conditions to increase availability of material for early analysis of product quality and quantity, improving the efficiency of selecting lead.

Rockville, Maryland

• Worked on a therapeutics program using gold nanoparticles to develop a semi-synthetic human immune system capable of generating fully human monoclonal antibodies to self and non-self antigens.
• Developed a set of fully human mAbs against TNF- and IL-2 receptor, and against two key toxins regulating Clostridium difficile infections, resulting in initial interest from two leading pharmaceutical companies.
• Established assays to characterize lead antibody candidates, including antigen specificity, concentration, isotyping and functional activity.
• Set up systems for automated screening and characterization of hybridomas.

• Studied the effect of antigen valency on B cell antigen receptor functions and cellular responses.
• Investigated the differential effects of CpG oligonucleotides on primary B lymphocytes and B cell lymphomas.
• Taught undergraduate lab courses - Immunology, Cell Biology, Microbiology - for 10 semesters. ADDITIONAL PROFESSIONAL EXPERIENCE
• Venture Capital Consultant, Indian Angel Network, Mumbai
• Venture Capital Consultant, India Venture Partners, Annapolis, MD
• Guest Lecturer, Immunology, Institute of Bioinformatics and Applied Biotechnology, Bangalore

Education record

• Completed MBA level Technology Entrepreneurship course at Smith School of Business, University of Maryland

Ph.D., Cell Biology, Immunology

Activities and Societies: •Treasurer, Students Council of India, University of Maryland (2003-2004). •Member of Organizing Committee for.

M.Sc. (Hons), Biological Sciences

Activities and Societies: •Student organizer for Symposium on Recombinant DNA Technology, BITS, Pilani, India, 1999. •Executive Committee.