Afshan N. Hashmi

Afshan Hashimi

Regulatory, business development, healthcare and scientific professional, with over ten years experience with a PhD in biochemistry, medical technologist licensed to practice clinical chemistry aspects of medical technology, MT(ASCP)C and is Regulatory Affairs Certified (RAC) US. Dr. Hashmi has a comprehensive understanding of science, FDA related US laws, regulations, policies and guidelines, and clinical chemistry tests and procedures.

Her previous positions include:

Research Associate, Human Genome Sciences, Inc.; Medical Technologist, University of Maryland Medical Center; Public Health Scientist, Laboratories Administration, Maryland State Department of Health and Mental Hygiene; Johns Hopkins University as postdoctoral fellow; Research Assistant, University of Maryland Cancer Center. Also served as the ToxLogic LLC, Consulting Liaison to companies located in Asia and US.

  • Performed regulatory strategic planning, regulatory advice and business development in US and Asia.
  • Communicated both orally and in writing with international food and drug companies compliance requirements for exported products to the US.
  • Performed business development in both public and private sectors in the international arena.
  • Established a solid, professional network. and relationships in public and private sectors that are required to launch initiatives.
  • Ability to think analytically and conceptually.
  • Achieved various awards and fellowships related to science.
  • Attended many scientific conferences and seminars and presented papers in conferences.
  • Worked independently with minimal guidance and also collaborated effectively as part of a team.
  • Gathered, assessed, evaluated, interpreted and communicated technical and scientific data.
  • Prepared interesting, creative and informative presentations which targeted diverse audiences.
  • Developed and presented reports and materials.
  • Prioritized assignments to meet deadlines and effectively planned/managed time, data and resources.
  • Motivated others to achieve the objectives and timeframes of the team.
  • Identified, planned and contributed to the goals of a team/project.
  • Coordinated and contributed to a project from beginning to end including determining outcomes, planning details, making decisions, assigning roles and completing targets.

Technical Skills

  • Conducted bioanalytical method development by immunoassays and analytical method development by reversed-phase HPLC, ion-exchange HPLC and SDS-PAGE and tested GMP samples by these HPLC. Performed qualification and validation of these analytical methods and qualification of these bioanalytical methods. Developed methods for Immunogenicity and PK Assays. Trained to work in GMP/GLP, expertise in regulatory and ICH guidelines. At Human Genome Sciences Inc., was PLM Manager in Analytical Sciences Group, In-charge of Waters HPLC Qualification and Scheduling of HPLCs. Wrote SOPs for these methods and presented data at group meetings. Tested clinical trial samples by immunoassays and performed analytical and bioanalytical tests under GMP environment.
  • Extensive experience in conducting scientific literature search and wrote scientific papers.
  • Vast knowledge and understanding of protein and clinical chemistry techniques: Polyacrylamide Gel Electrophoresis ( Disc and Slab Gel Electrophoresis simple as well as Gradient), Densitometer ,Western Blotting and Immunoblotting , ELISA, Electroelution, Accessioning and processing of specimens in Clinical Labs ,Urinalysis ,Atlas, Microscopes, Digital Refractometer, T.S. Meter ,Gastroccult Blood and pH , Buffer Blood and pH, Stool Blood, Scalp pH, CX7, Dimension,Ektachem 500 and 700, Glycohemoglobin Assay, Hemoglobin A+ F Assay, Blood Gases, Axsym, Toxicology, Rapimat, Clintex 50 and 200, Biorad Auto Dilutor, Laboratory Information System ( Cerner), Atomic Absorption, Blood Lead Testing, Guthrie Microbial Assay, Microbial agar Plate Making, Punch Indexer Machine, Colorimetry, Ultraviolet and Visible Spectroscopy, High speed Centrifugation, Ultra-centrifugation, Scintillation Counter, Thin Layer Chromatography, Total Fatty Acid Analysis, Lipid Extraction and its Quantitative Estimation in Biological Samples.
  • Worked as a public health scientist in Lead Laboratory and Newborn Screening Laboratory (Detected inborn errors of metabolism).

Education

  • Johns Hopkins University( Rockville, Maryland) : Educated as a regulatory affairs specialist in the Zanvyl Krieger School of Arts and Sciences, advanced academic programs, Department of Biotechnology, Fall 2004.
  • University of Maryland (Baltimore, Maryland), School of Medicine, Department of Medical and Research Technology :Categorical Course in Clinical Chemistry, 1997.
  • Aligarh University, Aligarh, India

PhD - Biochemistry, 1991
Dissertation Title: Studies on the Effect of Phenylhydrazine on Red Blood Cell Membrane

M.Phil - Biochemistry, (a pre-PhD requirement), 1988
Dissertation Title: Organization of Membrane Proteins in Normal and Abnormal
Erythrocytes (Effect of Phenylhydrazine)

M.Sc. - Biochemistry, 1985

B.S. (Honors) - Chemistry, 1983


Workshops, Webcasts and Conferences attended related to Regulatory Affairs

  • Regulatory Affairs Professionals Society (RAPS)

    Attended the Annual RAPS Conference and Exhibition, October 2006

    Attended a workshop on: Effective Medical Writing, October 2006

    Attended a workshop on : The Essentials: EU Regulatory Affairs, October 2005

    Attended the Annual RAPS Conference and Exhibition, October 2005

    Attended the Combination Products: Key issues for each stage of the combination product Lifecycle and working Effectively with FDA Webcast Series, July 2005

    Attended the Annual RAPS Conference and Exhibition, October 2004

    Attended the Prepare for the RAC(US) Exam Webcast Series, March 2005

    Module 1: Strategic Planning, Design and Development, Review Areas Included: Product Classification, Regulatory Pathways/Regulatory Options, Documentation, Testing Requirements/ Compliance

    Module 2: Premarketing/Regulatory Review and Manufacturing/Quality System, Review Areas Included: Regulatory Authorities, Vendors and Subcontractors, Submission/ Listing/Registration/Obtaining Approval, Documentation, SOPs, Training, Regulatory Compliance

    Module 3: Marketing/Post Approval and Interfacing, Review Areas Included: Advertising, Promotion and Labeling, Postmarketing Surveillance/ Vigilance, Distribution, Postmarketing/ Maintenance, Crisis Management, Interfacing with Regulatory Agencies, Inspections, Government and Public Relations

Attended a workshop on: Principles & Practices of US Regulatory Affairs, September 2004

  • Attended FDLI’s 49th Annual Conference: Celebrating the Centennial of the 1906 Pure Food and Drugs Act ,Washington DC, April 2006

Professional Memberships

  • Regulatory Affairs Professionals Society(RAPS)
  • American Society for Clinical Pathology (ASCP)