Speaker Biographies - SBIA Events

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Speaker BiographiesIn Order of Workshop PresentationsDay 1Lawrence Yu, PhDDirectorOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDALawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food andDrug Administration. Dr. Yu created the Question-based Review, defined thePharmaceutical Quality by Design (QbD), inaugurated the FDA modern review system - IntegratedQuality Assessment (IQA), developed the FDA historic concept of operations agreement to integratereview and inspection, and originated the Knowledge-aided Assessment and Structured Applications(KASA) initiative. Dr. Yu is also an adjunct Professor at the University of Michigan. His compartmentalabsorption and transit (CAT) model has laid the foundation for the commercial software,GastroPLUSTM and Simcyp , which are being widely used in the pharmaceutical industry. Dr. Yu is afellow and the past section Chair of the American Association of Pharmaceutical Scientists and anAssociate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 150 papers and given over300 invited presentations. He is a co-editor of the books entitled “Biopharmaceutics Applications inDrug Development”, “FDA Bioequivalence Standards”, and “Developing Solid Oral Dosage Forms:Pharmaceutical Theory and Practice, 2nd Ed.”Erin Skoda, PhDBranch Chief (Acting)Division of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAErin Skoda is currently an Acting Branch Chief in the Division of Lifecycle API in theOffice of New Drug Products within OPQ. She has worked on CMC quality assessment, divisioninitiatives and policies, and collaborations with several divisions and offices within the Agency. Sheholds a Ph.D. in organic chemistry from the University of Pennsylvania. Prior to joining the FDA in2014, Erin worked as a medicinal chemist.1

Vathsala SelvamTechnical Information SpecialistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAVathsala Selvam is a Technical Information Specialist in the Division of Life cycleAPI (DLAPI), where she manages administrative aspects of DMF submissions. Vathsala is an essentialmember of the DLAPI staff and has taken the lead on various projects and assignments. She acts as aliaison between DMF data entry staff, FDA reviewers, and industry on inquiries related toadministrative portion of DMF submissions. She performs administrative review on varioussubmissions, drafts correspondence letters to DMF holders and their responsible agents, as well asverifies that DMF submissions are administratively complete prior to quality review. Prior to herposition in DLAPI, she was a Conflict-of-Interest Specialist in the division that cleared specialgovernment employees for their participation in advisory committee meetings.Before joining FDA in 2004, Vathsala worked as a Computer Programmer/Analyst for a reputedcompany. Vathsala is married to Mouna Selvam, who is a chemist in the FDA for over 30 years and theyare blessed with two children. Vathsala enjoys her work and to be a part of public health service.Jonathan ResnickProject Management OfficerCloud Collaboration Capability TeamDivision of Data Management Services & SolutionsOffice of Business Informatics (OBI)CDER US FDAJonathan Resnick is a member of CDER’s Division of Data Management Servicesand Solutions. His focus is on electronic submissions and has been with FDA since 2011. Prior to joiningFDA, Jonathan spent 18 years working in IT project management supporting federal and private sectorclients.2

Hanah PhamCommander, USPHSDivision of User Fee Management and Budget Formulation (DUFMBF)Office of Management (OM)CDER US FDACDR Hanah Pham currently serves as a Facilities Team Lead in the GenericsBranch, Division of User Fee Management and Budget Formulation, Office ofManagement at FDA’s Center of Drug Evaluation and Research. Her primary responsibility is to leadher team to timely and accurately execute GDUFA user fee requirements on generic drugmanufacturers. She joined her Division in the early phase of GDUFA I implementation in 2012. Shereceived a Doctor of Pharmacy degree from Hampton University and a Master of Science degree fromUniversity of Florida.Evelyn Hong, MS, PharmDLieutenant Commander, USPHSDivision of User Fee Management and Budget Formulation (DUFMBF)Office of Management (OM)CDER US FDALCDR Evelyn Hong currently serves as a Senior Program Manager, Team Lead inthe Applications team of the Generics Branch, Division of User Fee Managementand Budget Formulation, Office of Management in FDA’s Center for Drug Evaluation and Research. Inher position, she is responsible for designing and implementing the Office’s policies and businessprocesses necessary in assessing and collecting generic user fees; assessing and evaluating the user feeobligations for all submitted generic drug submissions. She joined the Division in the early phase ofGDUFA implementation in 2012. She received a Doctor of Pharmacy degree from University ofNebraska – Medical Center and a Master of Science degree from University of Florida.Jayani Perera, PhDReview ChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical Quality (OPQ)CDER US FDAJayani Perera joined the FDA in 2014 as a review chemist in the Office of Pharmaceutical Science. Withthe stand of Office of Pharmaceutical Quality in 2015, she remained with the Division of Life Cycle API.She has assisted in the design, optimization, and management of the GDUFA CompletenessAssessment (CA) process and the Timely Consult and Early Information Request (TCIR) Process for DrugMaster Files. In addition to her role as a primary reviewer in the chemistry, manufacturing and controls(CMC) of generic API, Jayani also serves as the secondary reviewer for CAs. Jayani holds a Ph.D. degreein Inorganic/Organometallic Chemistry from Wayne State University in Detroit, Michigan.3

David Skanchy (CDR), PhDDirectorDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDACDR David Skanchy has been at the FDA for 18 years as a review chemist andmanager in the generic drug program. He is currently the director of the Division ofLifecycle API in the Office of Pharmaceutical Quality and has served in this position for the last 8 years.Benjamin Y. Danso, PharmDRegulatory Business Process ManagerOffice of Program & Regulatory Operations (OPRO)Office of Pharmaceutical Quality (OPQ)CDER US FDABenjamin Danso joined the FDA in 2004 as a Regulatory Project Manager withthe Office of Generic Drugs. During the reorganization in 2012, he was assigned to the transitionalteam in the Office of Pharmaceutical Science. With the standup of Office of Pharmaceutical Quality, heremained with the Office of Program and Regulatory Operations. He assisted in multiple roles inregulatory and business processes to aid in the standup of the Office of Pharmaceutical Quality. Heserved as the Post-Marketing Branch Chief, leading the design, optimization, and management of postapproval submissions for New and Generic drug applications. In 2019, he was transferred to serve asthe program manager with the Division of Life Cycle API. Benjamin holds a Doctor of Pharmacy Degreefrom Temple University in Philadelphia, Pennsylvania.Wei Liu, PhDSenior Pharmaceutical Quality AssessorDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAWei Liu joined the FDA in 2012 and currently is a senior pharmaceutical qualityassessor in the Division of Life Cycle API, Office of New Drug Products within the Office ofPharmaceutical Quality (OPQ). She focuses on the assessment of chemistry, manufacturing andcontrols (CMC) information for drug substances. She has a M.S. from Chinese Academy of Sciences andPh.D. from University of Florida.4

Cassandra AbellardQuality Assessor/Consumer Safety OfficerDivision of Pharmaceutical ManufacturingOffice of Pharmaceutical Manufacturing Assessment (OPMA)Office of Pharmaceutical QualityCDER US FDACassandra Abellard is currently a reviewer in DPM IV Branch 11, Office ofPharmaceutical Manufacturing Assessment (OPMA). She started her career withthe Agency in 2014 as a Consumer Safety Officer (Investigator) in ORA and moved to OPMA as aProcess/Facility Assessor in 2015.Prior to her experience at the FDA, she worked in the Pharmaceutical and Food Industries for over 17years in various roles from Production Management to Quality Management. Within OPMA, she servesas a process and facility reviewer for generic and new drug applications.She has an AAS in Veterinary Science and a B.Sc. in Cellular Biochemistry from Plattsburgh StateUniversity.Anita Tiwari, PhDSenior Pharmaceutical Quality AssessorDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAAnita obtained her Ph.D. in Organic Chemistry from Lucknow University, India.She worked as a research scientist at Southern Research Institute for 23 years inthe area of drug discovery and development of anticancer and antiviral drugs. She joined FDA, Office ofGeneric Drugs in 2013 as a CMC review chemist, focusing on quality assessment of drug master files(DMFs) in the DMF team. She became an Acting Quality Assessment Lead in 2017 in the Division ofLifecycle API (DLAPI) in the Office of New Drug Products (ONDP). Currently she is Senior PharmaceuticalQuality Assessor.Xinghua Wu, PhDChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAXinghua is currently working with Division of Lifecycle API as a chemist reviewingDrug Master Files submissions. He received his M.S. in Quality Assurance and Regulatory Affairs fromTemple University, Philadelphia, and Ph.D. in Medicinal Chemistry from Rutgers University, NewBrunswick. Prior to joining the FDA in 2014, he worked for Idenix and Celgene, and gained his expertisein process chemistry and analytical chemistry.5

David Amspacher, MBAChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDADavid Amspacher is a Drug master file reviewer in the Division of Lifecycle API at the FDA and has 25years of experience in API manufacturing and IND, NDA, and ANDA regulatory activities. Dave startedhis journey in the Marine Corps and afterward received his bachelor’s degree in chemistry at YorkCollege of Pennsylvania. He did his graduate work at Louisiana State University under Rob Strongin andworked as a process chemist at Pfizer for over a decade where he earned his MBA at the University ofRhode Island. Dave joined the FDA in 2014 and lives with his lovely wife Nicole in southernPennsylvania where they used to enjoy international travel and scuba diving before the world came toa screeching halt.Bapu R. Gaddam, PhDChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDABapu R. Gaddam is a quality reviewer in the division of lifecycle API and joinedFDA about seven years ago. He has review experience of several complex drug substances andparticipated in facility inspections. Before joining FDA, Dr. Gaddam has worked as project leader forsmall molecule drug discovery programs for thirteen years in several therapeutic areas. As a projectleader, Dr. Gaddam was responsible for moving the program forward and involved in selecting thecandidates for the advancement based on their profile generated from in vitro and in vivo studies.Bapu R. Gaddam was also responsible for the initial formulations for the toxicology studies and cGMPmanufacturing of drug substance for phase-I and Phase-II studies.6

Day 2Ramnarayan (Ram) Randad, PhDBranch ChiefDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDARamnarayan (Ram) Randad Ph.D. is a Branch chief in the Division of Lifecycle API.He joined FDA in 2002 as a review chemist. He has served on a number of working groups such as Postapproval drug substance guidance, Complex Drug Substance, Risk-Based Review, QbR, DMFCompleteness assessment team, and US Pharmacopeia monograph development committees. He hasfrequently represented Agency on CMC and regulatory science issues at various conferences. He haspublished 28 research papers and has 14 patents and has authored chapter on “FDA Drug Review andRegulation” in the “Burger's Medicinal Chemistry, Drug Discovery and Development”. Prior to joiningFDA he worked in a various research positions for National Cancer Institute, Tibotec, and Neogenesis.Hongbiao LiaoChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAHongbiao Liao graduated from State University of New York at Albany andreceived MS in organic chemistry in 1999. Prior to joining FDA, he has worked as asenior chemist in Merck & Co for fifteen years. His expertise is in process development and GMPmanufacturing of active pharmaceutical ingredient. Currently he is a primary reviewer in the Division oflife cycle API, ONDP/OPQ/CDER.Barbara ScottChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAMs. Barbara O. Scott is a chemist and CMC Senior Assessor in the Division of LifeCycle API, Office of New Drug Product, Office of Pharmaceutical Quality at the FDA Center for DrugEvaluation and Research. Ms. Scott has been with the Agency for over 17 years and came to theAgency with over ten years of pharmaceutical and biotechnology experience. Ms. Scott received herM.S. in Chemistry from the University of California at Berkeley, and a B.S. in Chemistry from IthacaCollege in Ithaca, New York.7

Ms. Scott joined the FDA in 2004, as a generic drug chemistry reviewer in the Center for DrugEvaluation and Research. In her current position as CMC Senior Assessor with the FDA’s Office ofPharmaceutical Quality, she focuses on the chemistry, manufacturing and controls (CMC) of activepharmaceutical ingredients. Her current professional interests include the scientific and regulatoryaspects of drug substance manufacture and quality control.Naomi L. Kruhlak, PhDScientific LeadDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDADr. Naomi Kruhlak has worked for US FDA’s Center for Drug Evaluation andResearch (CDER) as a computational toxicologist for 19 years, developing and applying (quantitative)structure-activity relationship ((Q)SAR) models to support the regulatory review of pharmaceuticals.She is the Scientific Lead for CDER’s Computational Toxicology Consultation Service and is the PrincipalInvestigator on three FDA/CDER Research Collaboration Agreements with commercial (Q)SAR softwaredevelopers, as well as an Inter-Agency Agreement with NIH generating in silico-based drug safetypredictions. Dr. Kruhlak has published 43 peer-reviewed articles describing data standardization,transformation, and classification for modeling purposes, and the creation and regulatory applicationof (Q)SAR models with chemical interpretability. Dr. Kruhlak holds B.Sc. and Ph.D. degrees in chemistryfrom the University of Salford, England, and the University of Calgary, Canada, respectively.Chanchal GuptaPharmacology/Toxicology ReviewerDivision of Clinical Review (DCR)Office of Bioequivalence (OB)Office of Generic Drugs (OGD)CDER US FDAChanchal Gupta is a Pharmacology/Toxicology reviewer in the Division of ClinicalReview (DCR) within the Office of Generic Drugs (OGD) at the Food and Drug Administration (FDA).Chanchal joined DCR in 2017 where she conducts safety assessment of impurities, residual solvents,excipients, and extractables/leachables in generic drug products.Chanchal completed Bachelor of Science in Pharmacy from the University of Delhi, India. She earnedMaster of Science and Doctor of Philosophy in Pharmacology and Toxicology from the NationalInstitute of Pharmaceutical Education and Research, Mohali, India. Her doctoral research focused onthe role of high glucose and insulin-induced epigenetic changes in breast cancer using in vitro models.Prior to joining the FDA, she worked as a Research Scientist in private sector for two years.8

Deborah F. Johnson, PhDBranch ChiefDivision of Lifecycle API ONDP OPQ CDERDeborah has a Ph.D. in Organic Chemistry from Brigham Young University. Sheworked as a pre-formulation chemist for Wyeth Pharmaceuticals for 4 yearsand then joined the US FDA in Aug 2010 as an CMC assessor for AbbreviatedNew Drug Applications (ANDAs). In 2012 she joined the newly formed DrugMasterfile Review team. After the Office of Pharmaceutical reorganization this group became knownas the Division of Lifecycle API (DLAPI) and is now located in the Office of New Drug Products. In 2014Deborah became a branch chief and is still serving in that position.Sruthi King, PhDAssociate Director of Pharmacology/ToxicologyDivision of Clinical Review (DCR)Office of Bioequivalence (OB)Office of Pharmaceutical QualityCDER US FDASruthi King earned her Ph.D. in pharmacology from Georgetown University andcompleted postdoctoral training at Stanford University in the Department ofDermatology. Sruthi joined FDA in 2008 as a Pharmacologist in the Division of Gastroenterology andInborn Error Products within the Office of New Drugs and later moved to the Office of Generic Drugs asteam leader in 2015. Sruthi now serves as an Associate Director of Pharmacology and Toxicology inDivision of Clinical Review within the Office of Generic Drugs (OGD) at the Food and DrugAdministration (FDA). Sruthi has been a member of the CDER nitrosamine task force for the past 2. 5years and also serves on several working groups with international regulators to harmonize approachesrelated to nitrosamine safety assessments.9

Jay JariwalaTeam LeaderDivision of Drug QualityOffice of Manufacturing QualityOffice of ComplianceCDER US FDAJay Jariwala is a Team Leader with the Office of Manufacturing Quality (OMQ),Office of Compliance, CDER, where he provides leadership and operational oversight of complianceofficers assessing violative establishment inspections and resulting regulatory actions. During histenure he spearheaded numerous regulatory actions such as warning letters, regulatory meetings, andimport alerts. He also participates in inspections as a Subject Matter Expert. He was instrumental indeveloping various risk-based assessment processes including Warning Letter review procedurecurrently being utilized. He also represented CDER in Mutual Reliance Agreement Initiative in assessingvarious EU drug inspectorates’ capabilities.He also served as an Assistant Country Director with FDA’s India Office from 2017 to 2019. His primaryrole is to advise FDA leadership on drug policy issues as it concerns India and collaborate with variousgovernmental, internal, and industry stakeholders to advance FDA’s strategic priorities in India. Healso acted as Supervisory Consumer Safety Officer managing all inspections conducted by the IndiaOffice.He began his FDA career in CDRH, where he spent 7 years in CDRH Office of Compliance and heldpositions of increasing responsibilities starting as a compliance officer to a quality system specialist.While at CDRH, he was part of Medical Device Single Audit Program (MDSAP) team which is acollaborative inspection effort between US FDA, Health Canada, Therapeutic Goods Administration ofAustralia, and ANVISA Brazil. Due to his multi-commodity and multi-center background, he wasmember of a core group instrumental in developing CGMPs for Combination Products, resulting FDAguidance, and investigator training. He was selected and successfully completed CDER’s EmergingLeader Program (ELP.) He has regularly spoken at various conferences and taught various CGMPrelated courses on behalf of the Agency.Brian Connell, PhDSenior Pharmaceutical Quality AssessorDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDABrian Connell holds a Ph.D. in organic chemistry and has been involved in the review of Drug MasterFiles and drug substances at the FDA since 2013. As a member of the Division of Lifecycle API, Brian hasinterests in strategies for impurity control, including mutagenic and elemental impurity control, toensure the safety and quality of APIs available in the U.S. market.10

Larisa Wu, PhDSenior Pharmaceutical Quality AssessorDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDALarisa Wu, Ph.D., is the ONDP Associate Director for Science and Communication(acting). Prior to ONDP, she was in OPQ Immediate Office where she served as Special Assistant to OPQDeputy Director since OPQ stood up in 2015. Since she joined FDA in 2011, Larisa contributedsignificantly to various initiatives that became pivotal to the launch of OPQ, including integrated teambased quality assessment, risk-based review, and ANDA backlog review and management. In her mostrecent roles, Larisa worked extensively on several FDA, CDER, and OPQ initiatives including:Knowledge-aided Assessment and Structured Application (KASA), Concept of Operations (ConOps) forInspection of Human Drugs, Process and Facility Integration, OPQ Secondary Assessment, and BARDAFDA Drug Shortage Program. Her contributions have been recognized in award ceremonies at theagency, center, and office level. Larisa received her Ph.D. degree in Bioengineering from University ofUtah, followed by a postdoctoral fellowship in Pharmaceutical Sciences at University of Maryland,School of Pharmacy. She also holds an M.S. degree in Chemistry and a B.S. degree in BiomedicalEngineering.11

Poster Presenter BiographiesIn order of poster presentation.Wei Song, Ph.D.Review ChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical Quality (OPQ)CDER US FDAWei Song currently is Quality Assessor of Division of Life Cycle API (DLAPI) in FDA Office ofPharmaceutical quality (OPQ). She has more than 15 years of combined experiences in the areas ofdrug development and regulatory review and approval. Before joining the FDA, Wei was an analyticalscientist working at a contract research organization (CRO). She has been with the Center for drugevaluation and research (CDER) since 2012. As Drug Substance Quality Assessor, she is responsible forthe evaluation of drug substance chemistry development, manufacturing, specifications, analyticalmethods, container closure systems, stability.Yingzi Wang, Ph.D.ChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDADr. Wang is a Chemist working in the Division of Lifecycle API, Office of NewDrug Products, Office of Pharmaceutical Quality in FDA’s Center for Drug Evaluation and Research. Herprimary job function is to support GDUFA by reviewing drug master files (DMFs) for drug substances(DSs)/active pharmaceutical ingredients (APIs). She also contributes to several relatedregulatory/consulting workflows, such as providing controlled correspondences to sponsors’ questionsto FDA during the drug product development stage and reviewing new USP PF monograph proposals.Before she joined FDA in 2017, Dr. Wang worked as a research investigator in the pharmaceuticalresearch and development field. She received her PhD in Physical Chemistry from Clark University.12

Steve Kinsley, Ph.D.ChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDASteve Kinsley completed a BS in Chemistry at Saint Louis University. Aftercompleting a Ph.D. in Organic Chemistry under Andrew Streitwieser at University of California,Berkeley, and a Post-Doctorate under Tobin Marks at Northwestern, Steve worked for seven years,attaining the rank of Senior Scientist at Rohm and Haas in Philadelphia. After a few years helping hisfather in a family business, Steve taught Organic and Inorganic Chemistry at Washington University inSt. Louis from 2003 to 2016, where he received multiple Teaching Awards and was often selected tospeak to incoming freshmen regarding majoring in Chemistry. Steve joined the FDA in 2016 as aRegulatory Business Process Manager and transferred to the Division of Lifecycle API in 2018 as anAssessor.Weiqin Jiang, MS, Ph.D.ChemistDivision of Lifecycle APIOffice of Pharmaceutical QualityOffice of New Drug ProductOPQ CDER US FDADr. Weiqin Jiang finished her PhD at the University of Chicago’s Organometallic Chemistry program. Her dissertation focused on the synthetic studies of Taxol andasymmetric Diels-Alder reaction using Chromium Fischer carbene complexes. Weiqin then joined Dr.Dale Boger group in The Scripps Research Institute, CA as a postdoctoral fellow and worked on thehigher order iminodiacetic acid libraries for probing protein-protein interactions in order to discoversmall peptide mimic targeting Erythropoietin protein. Weiqin worked in drug discovery group inPharmaceutical Research Institute in Johnson & Johnson at Raritan, NJ for a decade, where shepublished patents on pyrroloquinoline as novel phosphodiesterase type 5 inhibitor for male erectiledysfunction and pyridine-imidazoles and aza-indoles as selective progesterone receptor modulators. InJ&J she also worked on liver-selective glucocorticoid antagonist for the treatment of Type II diabetesand PET (positron emission tomography) Tracer Design & Synthesis of TRPV1 Antagonist using [3H]Ligand. In 2008, she started in OGD (Office of Generic Drug) as Drug Product Quality Assessor,evaluating drug substance chemistry, drug product composition, development, specifications,analytical methods, container closure systems, stability, quality aspects of labeling and environmentalimpact in abbreviated new drug applications (ANDAs). In 2013, she joined the Division of Lifecycle APIas drug substance reviewer. During her tenure in FDA, she regularly reviewed USP-PF monographs.Weiqin earned her BS degree in Fudan University in polymer chemistry and MS degree in RutgersUniversity in medicinal chemistry.13

Manivannan Ethirajan, Ph.D.ChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAMani Ethirajan is currently a chemist in the Division of Life Cycle API (DLAPI).For the past 7 years, he has been reviewing Drug Master Files specifically dealing with complex APIs.Prior to FDA, he spent 13 years as a Medicinal chemist in academia and pharmaceutical company andreceived NIH-STTR grant. He has co-authored several synthetic/medicinal chemistry articles publishedin peer-reviewed journals and books. Mani holds a PhD degree in synthetic chemistry from IndianInstitute of Technology-Bombay, India.Keduo Qian, Ph.D.ChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAKeduo Qian joined DLAPI/ONDP in 2013 as a drug master file (DMF) reviewer. Previously, she wasResearch Assistant Professor of Medicinal Chemistry and Natural Products at the University of NorthCarolina at Chapel Hill. She received her Ph.D. in Pharmaceutical Sciences from UNC-Chapel Hill. Inaddition to the assessment of chemistry, manufacturing process, controls and stability of drugsubstances associated with DMFs, Keduo specializes in the quality assessment of complex activepharmaceutical ingredients (APIs), such as low molecular weight heparins (LMWHs), polymers,peptides, etc. Keduo was detailed to the Office of Pharmaceutical Manufacturing Assessment (OPMA)during 2018-2019, with emphasis on the assessment of complex API manufacturing as well ascompliance of manufacturing facilities.14

Thomas O’Connor, Ph.D.DirectorDivision of Product Quality ResearchOffice of Testing ResearchOffice of Pharmaceutical QualityCDER US FDADr. O’Connor is the director of the Division of Product Quality Research in theOffice of Testing and Research in the Office of Pharmaceutical Quality and is a member of CDER’sEmerging Technology Team. His responsibilities include managing regulatory science projects tosupport the implementation of emerging technologies in pharmaceutical manufacturing such ascontinuous manufacturing, 3D printing, and the utilization of modeling and simulation for qualityassurance. Tom is a co-author of several papers and book chapters on continuous manufacturing andemerging pharmaceutical technology. He has participated in the review of several regulatoryapplications utilizing continuous manufacturing. He is the co-chair of the OPQ Manufacturing Scienceand Innovation Center of Excellence and is a member of the advanced manufacturing working groupswithin the FDA.Prior to joining the FDA, Tom worked at ExxonMobil Research and Engineering where he held jobfunctions in both process analytical technology and process control. Dr. O’Connor earned a B.S. inchemical engineering from the Cooper Union and a Ph.D. in chemical engineering from PrincetonUniversity.Madhusudhan Gowravaram, Ph.D.ChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAMadhusudhan Gowravaram is a Senior Pharmaceutical Quality Assessor andTeam Leader in the Division of Lifecycle API, Office of New Drug Products/OPQ/CDER/FDA. He has beenat the FDA since 2014. During his career at the FDA, he has been involved in the quality assessment ofActive Pharmaceutical Ingredients (APIs) in support of ANDA and NDA applications. Prior to joining theFDA, he worked as a Medicinal Chemist in Pharmaceutical R&D for 20 years, where he contributed toseveral R&D programs in infectious, cancer, and inflammatory disease areas. His educationalbackground is as a synthetic chemist with a Ph.D. in Organic Chemistry and M.Sc. in Chemistry.15

Yun (Jenny) Wang, Ph.D.ChemistDivision of Lifecycle APIOffice of New Drug ProductsOffice of Pharmaceutical QualityCDER US FDAJenny has been a CMC assessor in the Office of New Drug Product’s Division ofLifecycle API since 2013. Prior to joining the FDA, Jenny worked as an a

Dr. Yu created the Question-based Review, defined the Pharmaceutical Quality by Design (QbD), inaugurated the FDA modern review system - Integrated . Vathsala Selvam is a Technical Information Specialist in the Division of Life cycle API (DLAPI), where she manages administrative aspects of DMF submissions. . Commander, USPHS Division of .