Project Manager

Alok Bandyopadhyay, Ph.D., RAC

P.O. Box *** Phone: 215-***-****

Lansdale, PA 19446 *******@*****.***

SUMMARY

Dynamic R&D professional with experience in project management advancing product innovation from conception through commercialization. Strong background in Quality, Regulatory, and Drug Development with expertise in regulatory writing, compliance, and submission of IND, NDA, ANDA, pre- approval, and post approval. Experienced in CNS, endocrinology, urology and oncology Proficient in US and EU regulations and successful interfacing with FDA reviewers. Performed FDA/GMP compliance audits and participated in FDA inspections. Experienced in documentum (EDMS, GDMS) and eCTD.

PROFESSIONAL EXPERIENCE

AB CONSULTING, LANSDALE, Pa 9/2015-present

Senior Regulatory Global Consultant

Provide regulatory strategies associated with the drug development of pharmaceutical and biological products. Provided regulatory strategies for the development of therapeutic compounds by IND submission and IND amendments (e.g. new investigators, protocol amendments, safety and annual report)

Advise on technical or medical writing and their arrangement in the preparation or submission of document as per regulation

Discus safety issues of the drug development project and provide an outline of the risk based

approach

CLINICAL SOLUTION GROUP (CSG) 9/2013-8/2015

CSG-BRISTOL-MYERS-SQUIBB, Hopewell, NJ

Senior Regulatory Global Consultant,

Provide regulatory strategies associated with the Chemistry, Manufacturing, and Controls sections (CMC, Module 2.3 and Module 3) of drug development of new biological and immunological products in CTD format to promote into quality documents followed by electronic transfer for BLA filing

Provide regulatory strategies in CMC on global post approval submission with medical device. Write sections for maintaining consistencies and review the documents and prepare for submissions as per timeline. Provide the strategies for Agencies’ queries.

Project management and translate the drug development project into smaller manageable segments with time lines into MS project. Follow, monitor, and manage the project with project team up to completion within the time-line

TCS-GENENTECH-ROCHE PROGRAM, Mi

DESIGN SPACE INPHARMATICS, Sumneytown, Pa 5/2010- 9/2013

Senior Regulatory Global Consultant,

Provided regulatory strategies in IND safety report of biological and immunological products including monoclonal antibodies and a large number of oncologic drugs

Performed safety reporting in Pre-approval and Post-approval submissions (paper and electronic). Provided global regulatory strategies for DSUR, PSUR/PBRER ASR, IND amendments, IND Annual Report in NDA/BLA products. Participated in project meetings. Tracked global clinical trials and regulatory questionnaire.

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Organized, managed and collated the drug development and clinical studies’ information from Global Affiliates for the preparation of DSUR. Participate in IND and NDA/BLA submission process.

Supported and provided the guidance to the regulatory publishing in various amendment submissions e.g. new investigators, new protocols, protocol amendments, informational amendments, CCDS, labeling, labeling update(USPI), SmPC, variations and renewals of new drug applications (NDA/NDA/BLA)

Reviewed and provided regulatory comments on various documents of biological and immunological products in CTD format (various Modules) to promote into quality documents followed by electronic transfer for initial IND/IND amendments/ NDA/BLA filing. Provided feedback on investigations and deviations

Wrote article on regulatory aspects. Review literature and maintain a regulatory Intelligence base

DAINIPPON SUMITOMO PHARMA, Fort Lee, NJ 1/ 2008 – 4/2010

Senior Global Regulatory Associate (Manager), Regulatory Affairs

Provided regulatory strategies for the development of therapeutic compounds by IND submissions (e.g. initial, new investigators, new protocols, protocol amendments, safety reports and Annual Reports etc.) through project management. Involved in drug shipment for clinical studies

Supported clinical trial (phase 1, 2, 3) under GCP. Reviewed clinical study report (CSR), CMC related documents, preclinical study reports, Validation reports, Clinical trial protocol & protocol amendments to promote into quality documents.

Participated in writing and reviewing question by review (QBR), summaries (Quality, Biopharmaceutics, Clinical pharmacology, Clinical overview) and various other sections of schizophrenia NDA to gain

timely submissions. Performed QC Check to NDA documents in eCTD format

Provided regulatory strategies for FDA contacts and interfaced with FDA reviewers. Prepared Briefing books consulting with various experts to achieve most persuasive and effective presentation.

Participated in developing strategies for IND submission of new indications/line extensions through project team, project meeting (teleconference and videoconference) and project planning.

Participated in selecting eCTD vendor. Performed a regulatory compilation of documents and assured the compliance with regulations. Sent the pertinent documents to vendor for publishing in eCTD format. Submitted by co-leading initial IND for diabetes and bipolar depression. Wrote pertinent SOPs.

Proficient in US and EU regulations. Informed project team of new regulatory initiatives and summarized key point from new FDA guidance, conferences or lectures. Provided new information and new regulations/guidelines to global team members supporting the environment for developing globalization process.

Led CMC sections in all regulatory submissions (Module 2.3 and Module 3). Reviewed, coordinated regulatory strategies in various CMC activities including formulations, stability, quality, process development, scale-up, validations of manufacturing process, change controls, comparability and bridging studies. Reviewed API testing, manufacturing processes, executed batch records. Micro tests and related CAPA

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Independent consultant, Philadelphia, Pa 4/2007- 11/2007

Medical Writer Consultant, (contract),

Reviewed papers and publications. Wrote abstracts and reports. Prepared presentations. Collaborated

with scientists for style, organizations and content. Oral presentation of the reports, papers

and publications. Maintained a writing proposal archive. Review labeling, labeling update(USPI), SmPC

ELAN PHARMACEUTICAL, King of Prussia, PA 10/ 2005 - 3/ 2007

Senior Associate. CMC-Regulatory Affairs, Analytical Operations, Analytical Sciences

Managed drug substance/drug product stability studies’ (including reserve samples) of marketed products and newly formulated drugs through nanotechnology from the transfer or startup throughout the life cycle testing through writing protocols, monitoring status, collecting data from LIMS, reviewing results and submitting study report in accordance with FDA/ICH/EU guidelines in support for the development of DMF.

Provided feedback in documentum on methods development, optimization, validations, master formula records, investigations and related corrective action (CAPA). Overseen the qualifications (IQ, OQ, PQ) of laboratory instruments. Wrote SOPs, protocols and amendments for optimum laboratory efficiency

Managed process of regulatory changes and developed strategies for pharmaceuticals through risk

assessment and mitigations.. Incorporated changes mandated by new regulations, monograph or compendia in testing procedures. Informed project team regarding any regulatory issues

Involved in drug shipment to Investigators for clinical studies (for IND, NDA, ANDA)

Manager/ Consultant (contract),CMC, Quality 5/2004- 9/2005

EXIMIAS PHARMACEUTICAL CORPORATION, Berwyn, PA (3/2005-9/2005))

Managed the review processes of CMC sections including stability studies, method development and method validations of for NDA submission of a new biological Cancer parenteral drug product. Established the specifications of the test methods. Managed the outsourced partners in CMC activities

Developed regulatory strategies of method validations of API and their stability studies in accordance with CMC/FDA/ICH/EU guidelines.

Managed R&D stability testing as outsourced partner and successfully submitted report in accordance with FDA/ICH guidelines. Performed investigations for root cause and set up CAPA

TEVA PHARMACEUTICALS 11/1988- 4/2004

Scientist/Senior Investigator/Supervisor

PLIVA INC., Hanover, NJ

Supervisor/ Manager, CMC-Stability-Quality Dept. ( 7/2003 – 4/2004)

Managed analytical testing support and stability studies for marketed products and newly formulated

drugs from the transfer or startup throughout the life cycle of the process. Supported for

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continuous improvement under GMP/GLP in accordance with /FDA/ICH/EU guidelines and gained success in domestic and global submission (NDA, ANDA and sNDA)

Assigned work to associates for testing through HPLC, GC, FTIR, UV/VIS, RI, spectroscopy, and dissolution Provided expert project guidance/support proactively through project completion. Provided tracking, reporting and presentation through project completion. Wrote investigation report (LIR). Managed and reviewed the documents generated by contract laboratories.

Maintained databases of commitments, deviations, and investigations and related CAPAs. Managed quality review of change controls, validation protocols and maintenance of work orders. Reviewed and overseen equipment calibrations and validations (IQ, OQ and PQ)

Performed the product data including batches manufactured, investigations for laboratory & manufacturing quality, complaints, stability data, product recall/returned data, change controls, specification changes, validation activities, CAPA reports for the preparation of interim and Annual Reports

TEVA PHARMACEUTICALS (formerly Lemmon Pharmaceutical), Sellersville, PA

Scientist/Senior Investigator/Supervisor, Quality Dept. (11/ 1988 – 7/2003)

Supervised Regulatory compliance group. Provided regulatory feedback on CMC documents from concept to submission (old, new product of varying dosage form of solid, liquid and parental) encompassing analytical support, formulation, through validations, and investigational reports for scientific consistency, accuracy and regulatory conformance (ANDA, NDA, global)

Tracked activities, investigations, deviations, CAPA, and provided strategies for FDA responses. Participated in process of regulatory changes, developed strategies, assessed the impact for the

changes, and provided the strategies for mitigation. Incorporated changes mandated by new regulations OTC monograph, compendia in testing procedures

Conducted FDA/GMP compliance audit, evaluated deficiencies through internal gap analysis and provided strategies to be FDA inspection ready.

Reviewed product data for the review period including batches manufactured, investigations for laboratory & manufacturing, quality complaints, stability data, product recall/returned data, change controls, specification changes, and validation activities, and CAPA reports for the preparation of interim and Annual Report. Participated in Project team starting from concept through product development (old or new products of varying dosage forms e.g. solid, liquid and parental including analytical support, formulation, and scale up, pilot studies, validations and aseptic process. Reviewed and audited testing results under FDA/ICH/EU guidelines

Supervised calibration and computer validation (IQ, OQ and PQ) of the instruments used in the Laboratory as well as in Manufacturing Plant to assure the validity of the instruments under GMP, GLP, and 21CFR Part11. Wrote requirement functions, SOP, protocols & executed the protocols and completion of the approved final reports. Maintained life-cycle method

Developed and validated analytical methods for various drug products of varying dosage forms through writing protocols along with the methods for cleaning validations using right swabs following FDA/ ICH guidelines

Supported Manufacturing process. Provided analytical support to the marketed or newly

formulated products. Performed Method transfer. Wrote protocols. Assisted in troubleshooting

Participated in analytical testing for stability and finished product by HPLC, GC, FTIR, UV/VIS, RI, spectroscopy, and dissolution along with finished products under cGMP environment. Generated LIMS report. Resolved issues and assisted in trouble shooting. Conducted investigations (LIR) and reports. Wrote SOPs.

Generated CAPA and updated pertinent SOPs

Provided strategies in implementing API qualification program, reviewing the master formulae, and executed batch records.

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Trained personnel in laboratory audit and data review. Reviewed Performance of personnel

ADJUNCT CONSULTANT (FACULTY)

DEPARTMENT OF MEDICINE, SUNY, Stony Brook, NY 5/1996- 6/2006

Adjunct Consultant (Molecular Biology-Part time faculty),

Provided strategies on lung (& ARDS) injury and attenuation by neuropeptides and biological stability studies. Restriction enzyme analysis-gene expression-RT-PCR- SDS-PAGE-CE-HPLC hybridization- Western blot – monoclonal antibody- conjugation- immunoassay (ELISA & RIA)- immune disease-Protein purification & characterization Aseptic process- Data analysis, evaluation and validation

Provided strategies for IND submission

DEPARTMENT OF MEDICINE, THOMAS JEFFERSON UNIVERSITY, Philadelphia, PA, 5/1991- 8/1997

Adjunct Consultant (Molecular Biology, Part time faculty),

Provided strategies on Molecular Biology of neuropeptides – develop methods for CNS receptor and validate-cloning of CNS neuropeptide receptor cDNA – Ligand binding- transcription of neuropeptide receptor cDNA- gene expression of neuropeptides and different NOS -Mammalian expression system- Regulation of neuropeptides, and cytokine type I gene expression.- inflammation-Restriction enzyme analyses- RNA/ DNA purity-restriction analysis SDS-PAGE- - Protein or peptide purification- LC-MS, GC-MS- Antibody production & conjugation-ELISA and Radioimmunoassay –-Protein Chemistry

EDUCATION

B.S., Chemistry, University of Calcutta, India

Ph.D., Chemistry, University of Calcutta, India,

(Indiana University Medical Center, Indianapolis, Indiana)

M.S., Computer Science, Villanova University, Villanova, PA

US regulations on Pharmaceutical from RAPS; US regulations on Medical device from RAPS

RAC certification

PROFESSIONAL ORGANIZATIONS

American Chemical Society, biological, chemical and computer sections;

American Association of Pharmaceutical Scientists;

Regulatory Affairs Professional Society; Drug Information Association

TECHNICAL EXPERTISE

Regulatory writing, submission & compliance: Project management: set up project meeting – developed project plan - project discussion – regulatory strategies – liaised with department – regulatory feedback for scientific content, consistency, and accuracy – regulatory writing- selected vendor for publishing- submitted INDs and NDA-participated in the preparation of package insert and provided regulatory feedback

Laboratory Analytical Instruments: Chromatography (HPLC, FPLC, column, GC, TLC) and Data Acquisition by Millennium or Turbochrome, sample management by Sample Manager, Spectroscopy,

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DNA sequencer,

Maintained laboratory safety following FDA, DEA, and OSHA rules

Computer Programming & Validations: UNIX, Windows, Microsoft Word, Access, Excel, PowerPoint, PhotoShop, SAS, Multivariate analysis, Statographics, C++, C, Java, Visual Basic 5.0, Visual C, SQL and various other databases including Oracle and TCP/IP Laboratory Information System (LIMS).and electronic data Management (EDMS) system, Computer validations of Manufacturing equipment’s and Laboratory Instruments (IQ,OQ,PQ).Familiarity and knowledgeable in 21 CFR Part 11.

Techniques: Method validation and Method development for active ingredients, excipients, degradation products, trace materials, cleaning validations (CIP/SIP), Troubleshooting and Method transfer. Validated and qualified USP and other compendia methods

Preformulation, Formulation, Reformulation of Pharmaceutical and Biological products. Strong knowledge in

Organic, Physical and Biochemistry. Proficient in GMP, GLP. Analysis of raw materials, bulk pharmaceuticals, finished products using HPLC, GC, dissolution, UV/VIS, GC, FTIR, DSC, Karl-Fisher, LOD, water analysis.

Tissue culture, Aseptic and sterile techniques. Gene expression. Signal transduction pathways, and Cytotoxicity. Microbiological techniques. Purification and characterization studies of biological substances and lyophilization. Restriction enzyme analysis-gene expression-RT-PCR- SDS-PAGE-CE-HPLC-- hybridization -Western blot - antibody preparation- conjugation- immunoassay (ELISA & RIA)- immune disease-Protein purification & characterization Aseptic process- Data acquisition, data processing, data analysis, validation

and data evaluation. LC-MS, GC-MS- Antibody production & conjugation-ELISA and Radioimmunoassay –Peptide mapping-Protein Chemistry. Clinical trial under GCP

ADDENDUM 1 Alok Bandyopadhyay, Ph.D.RAC

PUBLICATIONS

about 80 publications & abstracts, relevant publications are listed) :

1.Bandyopadhyay, A Changes in FDA inspections RAPS, July, 2011 issue

2.Bandyopadhyay, A Issues on the proposed regulatory pathways for biosimilars. RAPS

August, 2011 issue

3.Bandyopadhyay, A Complexities of Biological Molecules Journal of Bioanalysis and

Biomedicine, 2013

4.Bandyopadhyay, A Development Safety Update Report (DSUR) and ICH guidance RAPS

May,2013 issue

5.Bandyopadhyay, A Periodic Benefit-Risk evaluation report (PBRER) and recent guidance

Int. J. Pharm Practice and Drug Research 5(1), 29-33 (2015)

6.Bandyopadhyay, A Complexities of Protein therapeutics and immunogenicity Journal

of Bioanalysis and Biomedicine 7(3). 70-74 (2015)

7.Said,S.I., Dickman,K.,Bandyopadhyay,A., DeStefanis,P., Raza,S., Pakbaz,H., and Berisha,H.I.,

Glutamate toxicity in the Lung and Neuronal Cells: Prevention or Attenuation by VIP and PACAP,

Proc. to New York Acad. Sci. 865,226-237 (1998)

8.K Dickman, A. Bandyopadhyay, S.Mathew, S.I.Said NF-kB activation as a common denominator in

acute lung injury Am.J. Respiratory & Crit. Care Med. (1999)

9.K.Dickman, A.Bandyopadhyay, and S.I.Said Oxidative glutamate toxicity in PC-12 cells.

Mechanism of prevention by VIP Proc. Soc. For Neuroscience, (1999)

10.Bandyopadhyay, A., Chakdar, S., Lynn, R.B., and Rattan, S., Vasoactive intestinal polypeptide

gene expression is characteristically higher in opossum gastrointestinal sphincters. Gastroenterology

106, 1467-1473 (1994).

11.Bandyopadhyay, A., Chakdar, S., Lynn, R.B., and Rattan, S., Vasoactive intestinal polypeptide

gene expression is characteristically higher in opossum gastrointestinal sphincters.

Gastroenterology. 107, 485 (1995).

12.Bandyopadhyay A., Chakdar S., and Rattan .S., Regulation of inducible and Neuronal Nitric Oxide

Synthase Gene Expression by Gamma Interferon and VIP Am. Physiol. Soc.272(Cell Physiol

41)C1790, 1997

13. Chakdar,S., Bandyopadhyay, A., and Rattan,S., Neuronal Nitric Oxide Synthase Gene

Expression in the Gastrointestinal Myenteric Neurons and Smooth Muscle Cells Am Physiol.

Soc. Am. Physiol.Soc. 273(Cell Physiol 42) C1868-C1875, 1997

14.Said S.I., Dickman, K., Dey, R.D., Bandyopadhyay,A., and Berisha, H.I.

PROTECTION BY VIP AND PACAP AGAINST EXCITOTOXICITY3rd Int. Symp.

On VIP, PACAP, and related Peptides, 202,55-68(1997)

15.Bandyopadhyay A., Chakdar S., and Rattan .S., Regulation of inducible and Neuronal Nitric Oxide

Synthase Gene Expression by Gamma Interferon and VIP Ann

meeting of Am. Gateroenterol. Assoc. May 1997

16.Said, S.I., Dickman,K., Dey,R.D., Bandyopadhyay,A, DeStefanis, P, Raza.S.,Pakbaz,H., and

Berisha, H.I., Protection by VIP and PACAP Against Excitotoxicity 3rd Intern Symp. On VIP, PACAP

and Related peptides 1997

17.Chakdar,S., Bandyopadhyay, A., and Rattan,S., Neuronal Nitric Oxide Synthase Gene Expression

in the Gastrointestinal Myenteric Neurons and Smooth Muscle Cells Ann. Meeting of Am. Gastroenterol

. May 1995

18.Bandyopadhyay, A., Rattan, S., and Said, S.I., Activation of neuronal Nitric Oxide Synthase :

A likely mechanism of paraquat-induced lung injury. Ann meeting of Society of Neuroscience,

Nov. 1996

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