Executive RA/QA Consultant of Drugs, Biologics, and Vaccines | Former FDA Principal Investigator/Quality (CMC)

INTRODUCTION

This Consultant is an executive regulatory and quality consultant of Drugs, Biologics, and Vaccines with over 14 years of experience as a principal investigator, group leader and Chemistry, Manufacturing and Control (CMC), labeling and compliance reviewer of Investigational New Drug (INDs), New and Abbreviated New Drug applications (NDAs, ANDAs) and Biological License Applications (BLAs) for drugs (both small and complex molecules), therapeutic proteins, enzymes, monoclonal antibodies and vaccines approved by the FDA or under clinical development for the treatment of neurological disorders, cancer, autoimmune and inflammatory diseases, and disorders of inborn errors of metabolism (rare diseases). They have conducted cGxP audits and pre-approval inspections for biologics and drug manufacturing sites both as an FDA investigator and as a consultant domestically and internationally.

WORK EXPERIENCE

Senior Industry Consultant

FDA Group LLC                                                                                                                                Jan 2015-Present

Westborough, MA 01581

1. Advise clients on regulatory strategy and clinical development of drugs, biologics, biotherapeutics, HCT/P products, combination products, medical devices and vaccines
2. Advise clients on the technical development, preparation, and evaluation of regulatory submissions, specifically by writing and reviewing quality sections of Pre-IND, IND, NDA, 510(k), PMA and BLA documents
3. Provide insight and direction to clients in understanding and resolving scientific, regulatory and compliance issues on clinical development and manufacturing of drugs, biologics and dietary supplements
4. Conduct cGxP audits to both domestic and International drugs, biologics and device manufacturing sites and assist in remediation of FDA-483s, Warning Letters, Consent Decrees and Import bans
5. Conduct scientific and technical due diligence audits for global investment firms and vendor qualification audits for drugs and biologics manufacturers
6. Advise clients on laboratory audits, QA and QC compliance, Data Integrity, Quality Systems Improvements, CAPAs, Change Controls and Complaint management, Laboratory Controls and OOS/OOT Investigations
7. Develop regulatory strateg and preparation of briefing packages for meetings with the FDA, EMA and Health Canada
8. FDA Expert witness providing regulatory support to Law firms in cases involving Patents infringement, invalidity, quality, compliance and labeling issues

Director, Regulatory Affairs (Head CMC)        Jan 2019- Nov 2019

Kashiv BioSciences, LLC

Piscataway, NJ 08854

1. Global Director for regulatory and CMC programs for the development of multiple biosimilar therapeutics
2. Responsible for the development of regulatory strategies and analytical similarity packages for biosimilars, and review and filing of BLA submissions to FDA, EMA, and DCGI India
3. Supervised a team of regulatory and analytical scientists and provided global leadership in the development of analytical methods for biosimilar characterization and development programs
4. Hosted FDA Inspections and led discussions and negotiations with the FDA during Type C meetings and BPD type 2 meetings to remediate compliance issues for multiple manufacturing sites in the US and India
5. Guided analytical research and development team in assay development, method validations, and development of reference standards and cell lines
6. Authored CMC sections (Module 3) of two BLAs for Biosimilars
7. Developed policies, SOPs, Protocols, and best practices for Kashiv’s Regulatory and Quality departments  

Senior Manager, Regulatory Affairs        Sept 2017- Oct 2018 Emergent BioSolutions, Inc. Gaithersburg, MD 20879

1. Led all regulatory activities including development of regulatory strategies to support Vaccine and Anti-Infective Business Unit
2. Led the preparation of regulatory submissions including Pre-INDs, INDs, Annual reports, BLA supplements, comparability protocols, and any formal meetings or routine correspondence with the FDA
3. Regulatory lead for Emergent’s vaccine candidates for the flavivirus diseases and influenza; regulatory and CMC lead for Raxibacumab technology transfer from GSK to CIADM facility at Bayview, Baltimore
4. On-site regulatory and CMC lead for Emergent’s drug substance manufacturing facility at Bayview, Baltimore and fill-finish facility (formerly Cangene Biopharma) at Camden, Baltimore
5. Provided regulatory intelligence for project teams and product development plans
6. Managed regulatory strategy and cost projections for vaccine-related government proposals and due diligence activities
7. Planned, coordinated, prepared and led face-to-face meetings and teleconferences with the FDA and Biomedical Advanced Research and Development Authority (BARDA)
8. Monitored product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices
9. Managed and led a group of regulatory professionals within the regulatory department

Scientific Liaison        Aug 2015- Jun 2017

United States Pharmacopeia (USP) Rockville, MD 20852

1. Scientific Liaison for the Nomenclature and Labeling Expert Panel committee (NL-EC) for Drugs, Biologics, and dietary supplements; revised USP’s general chapter on labeling Chapter <7>.
2. Guided and coordinated expert committee activities and liaised with FDA, ICH, USAN council and global stakeholders for the non-propriety naming of chemical structures of drug substances and drug products, dietary supplements, excipients and impurities
3. Developed strategic initiatives and coordinated formation of Advisory groups, Expert Panels, and Subcommittees to the NL-EC
4. Evaluated and analyzed scientific data for the development of monographs for drugs and biologics and revision of general chapters and monographs of United States Pharmacopeia-National Formulary (USP-NF)
5. Represented USP on National and International Scientific meetings and policy discussions on Nomenclature and labeling of drugs, biologics, dietary supplements and excipients
6. Conducted cGMP audits for dietary supplement manufacturing plants as part of the USP verification program; reviewed manufacturing batch records and laboratory testing of product samples

Regulatory Affairs Manager        Apr 2015- Aug 2015

Medefil Inc. Glendale Heights, Chicago, IL 601392

1. Served as Medefil’s primary corporate liaison with domestic and international regulatory agencies (e.g., FDA, Health Canada, EMA and Notified Body Auditors), and maintained Medefil’s quality management system (QMS)
2. Planned, budgeted, and implemented domestic and international regulatory strategies for new and modified devices/drugs submissions
3. Supervised preparation and writing of Abbreviated New Drug Applications (ANDAs) dossiers for regulatory approval and licensing; led discussions with the FDA regarding the regulatory approval of ANDAs
4. Maintained, prepared, reviewed, and implemented regulatory affairs standard operating procedures (SOPs) and quality manual (QM) and standard test methods (STMs)
5. Managed the customer complaint program, post-marketing surveillance monitoring, establishment registration, drug listing, amendments, supplements and annual reports over the life cycle of the drug products
6. Managed the debarment list and MedWatch list review program

Research Fellow        Oct 2013-Mar 2015

Center for Cancer Research, NCI, NIH, Bethesda, MD

1. Directed a project to explore the mechanisms of glucocorticoid and estrogen receptor action in cancer to develop predictive epigenetic biomarkers for breast cancer
2. Directed a project to develop UV laser cross-linking based Chromatin immunoprecipitation sequencing (LChIP-seq) technology to study dynamic and temporal interactions of transcription factors with chromatin in cancer cells
3. Produced scientific data, wrote and submitted an NIH U0-1 grant as a co-principal investigator, filed an employee invention report (EIR) with NCI to initiate a provisional US patent application on UV laser ChIP technology

Tenure-track Principal Investigator and Drug Quality Reviewer        Nov 2005-Oct 2013

Office of Biotechnology Products, CDER, FDA, Bethesda, MD

1. Directed and led an independent group involved in scientific research and review of regulatory submissions to the Agency
2. Conducted quality reviews of over 30 Investigational New Drug (IND) applications, drug-device combination products, and over 100 pre-INDs, annual reports, IND-amendments, and CMC sections (Module 3) of six biological license applications (BLAs) for therapeutic proteins, enzymes and monoclonal antibodies indicated for the treatment of rare genetic disorders caused by inborn errors of metabolism and cancer
3. Developed CMC regulatory policies for biosimilars at the FDA as part of working groups or through participation in the writing of guidance documents
4. Chaired CMC review committee for an enzyme BLA approved for an oncology indication
5. Reviewed ANDAs and NDAs for small molecule therapeutics, peptides and oligonucleotide therapeutics
6. Supervised lab personnel and led a research group to study biomarkers for breast cancer and mechanisms of hormone action in cancer
7. Managed laboratory budget; wrote and submitted grant requests to various funding agencies, including Defense Advanced Research Projects Agency (DARPA), Office of Women’s Health (OWH), FDA’s critical path initiative (CPI)
8. Awarded a cross-center (CDER-CBER) collaborative grant from HHS medical countermeasure initiative to develop potency assay for Influenza vaccine (funding amount: $0.6 million)
9. Published six peer-reviewed research articles in high-impact scientific journals
10. Served as mentor and preceptor for FDA Commissioner’s Fellowship Program and Intra Agency Oncology Taskforce Fellowship (IOTF) Program for eight years; trained over 15 researcher and reviewers at the FDA  

Postdoctoral Training

1. Studied mechanisms of hormone action and epigenetic gene regulatory mechanisms involved in Cancer; discovered that binding of Glucocorticoid receptor (GR) to chromatin is transient and periodic during ATP- dependent chromatin remodeling (Nagaich et al. Molecular Cell 14:163-174)
2. Developed a UV-laser cross-linking technology to study the dynamics of transcription factor binding to chromatin during chromatin remodeling (Nagaich et al. Science STKE 2004/256/eg11)
3. Studied structure-function relationship of tumor suppressor protein p53 using a combination of biophysical techniques, high-resolution chemical probing and molecular modeling; discovered that p53 binds to DNA as a tetramer and axially bends it by 50° (Nagaich et al. PNAS, 96, 1875-80, USA)
4. Studied unusual DNA structures and their role in gene regulation; discovered that CA/TG dinucleotide steps at the 5’ of oligo A-tracts are kinked (Nagaich et al. JBC, 269,11, (1994), 7824-7833)

EDUCATION

University of Allahabad, Allahabad, India Ph.D.: Chemistry

Bundelkhand University, Jhansi, India

Master of Science: Chemistry

Bundelkhand University, Jhansi, India

Bachelor of Science:  Chemistry and Biology

CERTIFICATION

Certified Quality Auditor from American Society for Quality (ASQ-CQA)        Certificate # 65411054

                    Expires: 06/20/2020

MEMBERSHIPS

1. Member, Regulatory Affairs Professional Society (RAPS)
2. Senior Member, American Society of Quality (ASQ)

REGULATORY COURSES AND TRAINING

1. USP Course on GMP compliance in Quality Operations for Dietary Supplements, June 2016
2. USP Courses (over 60 Courses) on compliance with numerous USP general chapters and drug regulation 2015-2017
3. CDER’s regulatory science and reviewer training: bi-weekly seminars on number of regulatory and CMC issues about protein characterization, quality by design (QBD) in protein manufacturing, biosimilars, glycosylation of proteins and vaccines, viral clearance, risk-assessment studies, mechanisms of actions and potency assays, impurities in biotherapeutics manufacturing, assay validations, protein aggregation and process analytical technologies (PAT) 2005-2013
4. Immunogenicity Training: Cut-point and related consideration for immunogenicity test methods, 2013
5. CDER training on basic drug substance, 2013
6. Good review management principles for INDs, CDER, FDA, 2013
7. The review process for NDA, ANDA and BLA product quality supplements, 2013
8. Process for conducting biological product deviation report review, 2013
9. Review of Labeling, 2013
10. NIH course on Principles of Clinical Pharmacology, 2012
11. Course work on the Fundamentals of epidemiology, 2010
12. Introduction to Clinical Trials, 2010
13. Topics in Clinical Trials, 2010
14. Clinical Pharmacology/Pharmacokinetics, 2011
15. Introduction to Toxicology, 2011
16. Post-translational modifications of biopharmaceuticals: challenges and possibilities, 2007
17. Productive conflict management course, CBER, 2006
18. Situational leadership training, CBER, 2006
19. CDER cGMP and PAI Inspection Training, 2006

SCIENTIFIC COURSES AND TRAINING

1. Two-hybrid selection: Identification and characterization of protein-protein interaction, 2007
2. Proteomics: Principles and methods, 2007
3. Expression detection & purification of recombinant proteins, 2006
4. Conformational and structural aspects of biopolymers and molecular modeling, 1992
5. Macromolecular crystallography, 1992
6. Introduction to biophysical chemistry, 1992
7. Enzyme kinetics, 1992
8. Protein structure, folding and design, 1991
9. Introduction to X-ray crystallography, 1991
10. Biomolecular NMR spectroscopy, 1991
11. DNA-protein interaction and regulation of gene expression, 1991

MANAGERIAL/LEADERSHIP SKILLS

1. Managed a staff of up to four employees, recommended hiring, performance evaluations, salary increase, and promotions, CDER, FDA, 2005-2013
2. Ad-hoc member, CDER Committee for Advancement of Science and Education (CASE), FDA, 2011-12
3. Member, CDER-CASE Seminar sub-committee, evaluated wide-range of activities supporting CDER’s continuing education (CE) mission, including scientific rounds, seminars, courses, developing workshops and journal clubs, and inviting speakers for scientific rounds, 2011-12
4. Judge, Fellows Awards for Research Excellence, FelCom, NIH, 2005-13
5. Preceptor, FDA Commissioner’s Fellowship Program, 2010-2012
6. Research Mentor, Oak Ridge Institute for Science and Education (ORISE) Postdoctoral Fellowship Program (2005-2013)
7. Preceptor, FDA’s Summer Student Internship Program (2005-2013)
8. Preceptor, NIH-FDA Intra-Agency Oncology Taskforce (IOTF) Program, 2006-2012
9. Instructor, Graduate Course in Biophysical Chemistry and Molecular Biophysics at the Indian Institute of Science, Bangalore, India, 1992

PUBLICATIONS, PRESENTATIONS AND GRANT REVIEW

1. Published 27 research articles in high-impact journals including Molecular Cell, PNAS, Science Signaling, and Cancer Research, JBC and MCB
2. Presented over 30 talks at national and international meetings
3. Ad-hoc reviewer of over 12 national and international grants
4. Ad-hoc reviewer of over 100 scientific manuscripts submitted to 20 different scientific journals

AWARDS

1. Individual Cash Award, NCI, NIH (based on outstanding performance rating), 2014
2. Individual Cash Award (based on performance rating) CDER, FDA each year from 2008 to 2011
3. Distinguished Lecturer, Center for Prostate Disease and Research (CPDR), Rockville, MD, 2006
4. NIH Director’s Performance Award, Center for Cancer Research, NCI, NIH, Bethesda, MD, 2005
5. Fellows Award for Research Excellence (FARE), NIH Bethesda, MD, 2004

TECHNICAL SKILLS

1. Regulatory Operations: Proficient in preparation of regulatory dossiers in eCTD format and management and publication of regulatory dossiers using Veeva RIM Vault and electronic submission portals (ESG) and DocuBridge software
2. Biochemistry, Immunology, and Virology: Protein expression and purification in bacteria, baculovirus and mammalian cells, FPLC, Western blotting, Flow-cytometry, ELISA, construction of Adenovirus and Lentiviral vectors
3. Cell Biology: Cell culture, development of stable cell lines, cell cloning, immunofluorescence, live-cell imaging and reporter assays using transient transfections
4. Biophysical and Spectroscopic: Analytical ultracentrifugation, circular dichroism, 1H-NMR, 31P-NMR, mass spectrometry