Tabassum Naqvi
Hayward,CA
Summary
Combined with scientific acumen my passion is to drive innovative products to market faster by applying strategic solutions to complex regulatory challenges and play a pivotal role in improving health care worldwide. I have a passion to develop novel innovative clinical diagnostic biomarkers for precision medicine that can predict timely and informed decisions for patient care pathway and help improve outcomes.
A highly creative well-established organized and success-driven scientific leader with several years in academia/life science/ medical device/biopharma space, steeped in a variety of ideation through new product development in a phase gated design control manner including final 510K & De Novo, Break Through Device categories, CE-marked products and commercialization/launch strategies. Innate ability to integrate technical knowhow & regulations for submissions to Global Health Authorities. Launched eight 510K, De Novo/PMA, Companion Diagnostic (CDX), drug/device combination & CE-IVDD/IVDR/MDR approved products under phase gated Design Controls from proof of concept to commercialization including transfer to GMP manufacturing from R and D. Organized, authored, reviewed technical data for 510K/PMA and IVDD/IVDR/MDR/SAMD dossiers for scientific accuracy. Worked with CROs for technical oversight/logistics for clinical studies for biomarker discovery & presented to stakeholders. Demonstrated cross-functional leadership in matrix environments and drove successes with interdisciplinary inside/outside stakeholders (KOLs) including FDA combined with strong written/oral communication skills. Led teams as a New Product Introduction technical leader for new IVD/MDD product launches and proposed risk mitigation and remediation strategies in collaboration with cross functional teams for ensuring successful product launches. Led successful FDA Break Through Device Designations for innovative technologies for Biomarker precision medicine. Companion Diagnostic Development (CDX): Provided critical strategic and tactical regulatory guidance for CDX/IVD development, clinical evidence generation and CDX submission plan for globally, both before and after CDX testing, for complex projects combined with technical expertise for IHC, NGS, PCR, and/or mass spectrometry.
Overview
21
21
years of professional experience
Work History
Staff Regulatory, Scientific & Clinical Affairs (Manager level)
Danaher Opco. Beckman Diagnostics
03.2024 - Current
- Responsibility for pre market regulatory strategy to support the development of new neurogenerative biomarkers and companion diagnostic tests for precision diagnostics.
- SME for interactions with FDA for Pre-submission, Q-Submission, Break through device designation (BDD) for introducing new Neuro-biomarker marker assays for precision medicine.
- Global regulatory strategy planning for launching innovative products within USA & OUS.
- SME review of all docs for global regulatory compliance including all CMC analytical methods for chemistry manufacturing controls (CMCs), antibody chemistries and bioconjugates.
- Integrated clinical evidence strategy planning for new neuro-degenerative-biomarkers for precision medicine in collaboration with medical sciences for filing to regulatory authorities.
- Health Authority Submission Preparation: Led the preparation of pre-submission documents and respond to regulatory queries/feedback addressing regulatory questions from Global Health Authorities (HAs) during review of device submissions.
- In collaboration with companion diagnostics lead work with Dx partners to ensure robust development of assay, participate in HA interaction for drug-related companion diagnostic topics/questions, and attend device company HA meetings as appropriate.
Senior Regulatory, Scientific & Clinical Affairs (Manager level)
Danaher Opco. Cepheid
Sunnyvale, CA
08.2021 - 02.2024
- Directed the premarket regulatory affairs activities, on Molecular Diagnostics New Product Innovation for Oncology/Hematology, infectious diseases and virology programs including interactions between company and US FDA, and Notified Body as well as HA outside of the US and EU as required.
- Planned the clinical studies and contributed to the development of strategic and operational plans through sound assessments of regulatory pathways and risks. Such assessments influenced the scientific or technical direction of product design and/or development in support of worldwide registrations.
- Guided new product development teams for new updates on regulatory intelligence/compliance.
- Reviewed and authored technical dossiers for new oncology/hematology products for regulatory submissions.
- Performed gap analysis for down-classification of FDA Class III device to Class II device for a CE marked virology product for submission to FDA.
- Strategized/authored global premarket regulatory plans, intended use statements and device classification for devices.
Senior Regulatory Sciences & Clinical Scientific Affairs Lead
Tosoh Bioscience
South San Francisco, CA
03.2020 - 08.2021
- Provided scientific and regulatory technical leadership across all the stages of the product development life cycle for long term growth and success for new product launches for oncology biomarkers, fertility, diabetes, cardiac & infectious diseases for immunoassays & molecular diagnostic markets.
- Developed regulatory clinical strategy including study design, clinical protocol writing, IFU writing/labeling.
- Authored & reviewed technical dossiers for FDA submission, BSI and other notified bodies including gap analysis for IVDD/IVDR.
- Employed a strategic approach to life cycle management to maximize the potential of the products through line extensions or additional indications.
- Communicated/collaborated with all levels of cross functional teams for IVDD/IVDR technical file compilation including Declarations of Conformity, Certificates to Foreign Government, and Certificates of Origin used for global product registrations.
Director IVD Diagnostic New Assay/MDR Product Development
Melio Labs (Private Biotech)
Santa Clara, CA
10.2019 - 02.2020
- Strategized and employed technical knowhow for system integration of optimized PCR assay reagents for a new microfluidics platform for a point of care (POC) device development that can be used in CLIA waived or near patient (NPT) settings.
- Led a team of scientists that utilized digital PCR for detection of bacterial pathogens in neonate blood that are AMR resistant by capturing real time melt curve analysis using AI/ML software tools.
- Led technical assay optimization for enhancing cost effectiveness for minimum reagent use for master mixes for qPT-PCR and Isothermal amplification including primer design for FRET pairing & NGS.
New Product Development Scientific Sr. Manager
Thermo-Fisher Scientific
Fremont, CA
01.2015 - 10.2019
- Led a team of scientists (Masters & PhD) for new chemistry IVD product development and launch of seven new immunoassays for toxicology, pain management opioid drugs, therapeutic drug monitoring markets from proof of concept to commercialization using FDA phase gated design control process including transfer to GMP manufacturing.
- Strategized with cross functional team leads design transfer plans for smooth transfer of products from R & D to GMP manufacturing under FDA Design Controls and ISO 1485 guidelines and process validation controls.
- Collaborated with cross -functional groups to implement new techniques to improve/enhance process workflows for new product introductions including RUO products as a short term go to product strategy for short term ROIs.
- Resolved technical issues and established pre-GMP testing for FDA- regulated products to minimize CAPA and NCARs for existing products including advertising and marketing collaterals for appropriateness and compliance to regulatory requirements and laws.
- Authored & reviewed critical key documents (scientific/technical product labeling, promotional marketing collateral materials, sales training materials, SOPs, manufacturing documents, clinical & V/V protocols) for completeness, accuracy and regulatory compliance.
- Participated/drafted pre-submissions with FDA to determine if clinical protocols and data collection meet the agency's needs including 510K submission summaries for FDA, ROW and EU launches.
- Supported regulatory compliance activities for post market vigilance reporting (PMVR), and help update labeling to meet FDA and international requirements.
- Reviewed design history files for clarity, accuracy and compliance with US, Canadian, EU, ROW regulations.
- Clinical Diagnostic Division
Gr. Leader Senior Staff Scientist
Thermo-Fisher Scientific
Fremont, CA
01.2009 - 12.2014
- As a hands-on technical leader developed and launched new 7 CE and 510 K (FDA)-cleared products including De Novo product for a companion diagnostic.
- Employed phase gated FDA Design Controls that included plan, protocols/SOPs writing/V/V studies and specs for transfer of products to GMP manufacturing.
- Worked with product managers for marketing collateral for sales training on new product launches.
- Acted as a go-to-person for all technical challenges across matrix environment such as QA, RA, QC, Tech support, marketing, product transfer and manufacturing.
- Clinical Diagnostic Division
Scientific Manager-R & D
DiscoverX Corporation
Fremont, CA
01.2005 - 11.2009
- Multistep small molecule synthesis, analytical characterization & bioconjugation chemistries for various antibodies.
- Developed/designed novel methodologies/technologies for HTS multi-well (384 & 1536) biochemical & cell-based assays for high throughput screening life science markets with robotics/lab automation for drug discovery.
- Developed 'liquid ready to use reagents' to avoid the need for 'lyophilization' for the ease of use for customers.
- Developed series of kinase binding inhibitor conjugates (including multi-step linker chemistry) & protease-based enzyme substrates as robust tools for high throughput screening (HTS) of inhibitors using Enzyme Fragment Complementation Technique.
- Developed synthetic strategies to make cell permeable fluorescent dyes including development of novel methods for bio-conjugation, linker chemistries, peptide chemistries and epitope selection of antibodies for biomarker discoveries.
- Completed patent filings, book chapters and publications that revolutionized the technology giving recognition and credence to the scientific community. This was a rare feat for a young start-up as it needed a breakthrough to rise above the failing start-ups during that era (2000).
Education
Dual Regulatory Affairs Certificate - Medical Device and Pharmaceuticals
RAPS Online University
04.2021
Project Management -
University of California, Berkeley
Post-doctoral Fellow -
Department of Growth and Development
San Francisco, CAPost-doctoral Fellow -
Department of Pharmacology & Toxicology
Chicago, ILPh.D. - Synthetic Peptide Organic Chemistry
Central Drug Research Institute
INDSkills
- Technology/Product Innovation
- AI/ML
- Team Leadership
- People Management
- Facilities Management
- Project Management
- Customer Value Driven Product Design
- Stakeholder Engagement
- Cross-Functional Collaboration
- Business Acumen
- Financial Acumen
- Change Management
- Critical Thinking
- Strategic Analysis
- Decision Making
- Interpersonal Effectiveness
- Talent Development
- Resource Management
- Regulatory Experience
- IVD Product Development
- Phase-Gated Design Control
- ISO Standards
- GCP
- GLP
- CLIA
- HIPAA
- Software Validation
- SOP Writing
- Protocol Writing
- Risk Analysis
- FMEA
- Technical File Reviews
- DHF Gap Analysis
- NCAR Investigations
- CAPA Investigations
- Handling Biological Matrices
- Global Product Regulations
- Companion Diagnostics Development
- Point of Care Diagnostics
- QPCR
- Multiplex PCR
- Nucleic Acid Quantitation
- NGS
- Fragment Analysis
- Statistical Tools
- R Programming
Professional Skills
Leverage deep knowledge of various biotechnologies to spearhead new complex projects including software validation for technology advancement such AI/ML., Build mission-driven teams and inspire them to go above/beyond with strong leadership including people management., Establish modern facilities for productive workflow and keep them compliant for audits., Establish plans and socialize them for buy-in. Deliver the exceptional, not merely the expected combined with project management & people skills.
Publications
Six US/International patent granted, Several scientific abstracts/posters in Intl. and national conferences., Two book chapters in assay development hand book., Sixteen publications in peer reviewed journals (can be shared upon request)
Leadership Profile
A highly creative well-established organized and success-driven scientific leader with several years in academia/life science/ medical device/biopharma space, steeped in a variety of ideation through new product development in a phase gated design control manner including final 510K & De Novo, Break Through Device categories, CE-marked products and commercialization/launch strategies. Innate ability to integrate technical knowhow & regulations for submissions to Global Health Authorities. Launched eight 510K, De Novo/PMA, Companion Diagnostic (CDX), drug/device combination & CE-IVDD/IVDR/MDR approved products under phase gated Design Controls from proof of concept to commercialization including transfer to GMP manufacturing from R and D. Organized, authored, reviewed technical data for 510K/PMA and IVDD/IVDR/MDR/SAMD dossiers for scientific accuracy. Worked with CROs for technical oversight/logistics for clinical studies for biomarker discovery & presented to stakeholders. Demonstrated cross-functional leadership in matrix environments and drove successes with interdisciplinary inside/outside stakeholders (KOLs) including FDA combined with strong written/oral communication skills. Led teams as a New Product Introduction technical leader for new IVD/MDD product launches and proposed risk mitigation and remediation strategies in collaboration with cross functional teams for ensuring successful product launches. Led successful FDA Break Through Device Designations for innovative technologies for Biomarker precision medicine. Companion Diagnostic Development (CDX): Provided critical strategic and tactical regulatory guidance for CDX/IVD development, clinical evidence generation and CDX submission plan for globally, both before and after CDX testing, for complex projects combined with technical expertise for IHC, NGS, PCR, and/or mass spectrometry.
Personal Information
Citizenship: USA
Timeline
Staff Regulatory, Scientific & Clinical Affairs (Manager level)
Danaher Opco. Beckman Diagnostics
03.2024 - Current
Senior Regulatory, Scientific & Clinical Affairs (Manager level)
Danaher Opco. Cepheid
08.2021 - 02.2024
Senior Regulatory Sciences & Clinical Scientific Affairs Lead
Tosoh Bioscience
03.2020 - 08.2021
Director IVD Diagnostic New Assay/MDR Product Development
Melio Labs (Private Biotech)
10.2019 - 02.2020
New Product Development Scientific Sr. Manager
Thermo-Fisher Scientific
01.2015 - 10.2019
Gr. Leader Senior Staff Scientist
Thermo-Fisher Scientific
01.2009 - 12.2014
Scientific Manager-R & D
DiscoverX Corporation
01.2005 - 11.2009
Dual Regulatory Affairs Certificate - Medical Device and Pharmaceuticals
RAPS Online University
Project Management -
University of California, Berkeley
Post-doctoral Fellow -
Department of Growth and Development
Post-doctoral Fellow -
Department of Pharmacology & Toxicology
Ph.D. - Synthetic Peptide Organic Chemistry
Central Drug Research Institute