Skip To The Main Content
Committee & Speaker Biographies

Committee & Speaker Biographies

2021 PDA/FDA Joint Regulatory Conference

27-29 September 2021

  • Kevin ODonnell

    Kevin J. O'Donnell, PhD

    Health Products Regulatory Authority
    Kevin O'Donnell is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the Irish Medicines Board), in Dublin, Ireland. He has been with the HPRA/IMB since 2001 and is a Senior GMP Inspector. He is also responsible for a number of compliance-related programmes at the HPRA, including the Quality Defect and Recall programme, the Sampling and Analysis programme, and the Advertising Compliance programme. He obtained his PhD in the field of Quality Risk Management (QRM) from the Dublin Institute of Technology in 2008. He is currently Chair of the PIC/S Expert Circle on QRM and is also Rapporteur for the ongoing revision of ICH Q9.
  • Pat OSullivan

    Pat C. O'Sullivan, MBA

    Sanofi

    Pat OSullivan first joined Genzyme (subsequently acquired by Sanofi) in 2001 as Head of Manufacturing for the start-up of the Waterford drug product site and progressed to the role of General Manager in 2008. Pat oversaw the start-up and ramp up of operations including the establishment of oral dose and injectable manufacturing technology platforms employing over 600 people. In 2013 Pat moved to the US to take on the General Manager position at the Allston Landing site in Boston Mass. He led the organisation through the transformation of the site including the full remediation of the facility in accordance with the FDA Consent Decree workplan requirements. In 2016 Pat took on his present role and has successfully deployed the planning and execution processes and associated organisation to support the E2E Demand and Supply management for a growing portfolio of products focused on immunology, neurology, oncology, rare diseases and rare blood disorders.This includes the successful launches of global products such as Dupixent, and other immuno therapies.

    Pat has more than 30 years of experience in the biopharmaceutical industry and holds an MBA from the Open University and a BSc in Chemical Engineering from the Munster Institute of Technology.

  • Erika Pfeiler

    Erika A. Pfeiler, PhD

    U.S. FDA
    Dr. Erika Pfeiler is a microbiologist and Branch Chief in the FDA/CDER Division of Microbiology Assessment, where she performs and oversees microbiology reviews of ANDAs, NDAs, and INDs. She joined CDER in 2012. Her areas of particular interest in pharmaceutical microbiology include rapid microbiological testing methods, pharmacy compounding, and the microbiological aspects of nonsterile products. Dr. Pfeiler has an educational background in food microbiology, and received a B.S. from the University of Tennessee and a Ph.D. from North Carolina State University.
  • blank-profile

    Michele H. Piepoli

    Johnson & Johnson
    Recognized as an expert in Quality and Compliance, Michele has over 45 years’ technical experience in the pharmaceutical industry, including 35 years in management. Michele has led domestic and international projects ensuring completion of regulatory commitments. With deep technical knowledge and experience in the global pharmaceutical industry including Quality, Compliance and Regulatory, areas of expertise include Quality Systems, Laboratory Operations and Excellence, Inspection Readiness, Process Improvement, management of Health Authority inspections, as well as responsible for Inspection Readiness programs, and major contributor to HA response activities. A facilitator of change and learning, Michele has demonstrated the knowledge, passion, and ability to develop and conduct effective training workshops. Core experience includes conducting facility audits and playing a key role in the development, implementation and oversight of Quality Systems, and completion of large-scale, consent-decree-driven projects ensuring compliance to Health Authority commitments. Long term assignments have included: VP Quality (QA/QC); Site QA Head and Site Compliance Head at a major major Vaccine international company, CDMO and Biotech international company. Michele was responsible for the regulatory and quality oversight of all operations performed within two international regional sites.
  • Simone Pitts

    Simone E. Pitts, Ms

    U.S. FDA

    Simone Pitts is a National Expert, Pharmaceutical, in FDA’s Office of Regulatory Affairs. Her +20 years of regulatory experience at FDA spans working as a Microbiologist, Domestic Investigator, Foreign Drug Cadre Investigator, and Team Biologics Investigator to her current position as a National Expert, Pharmaceutical. Ms. Pitts is recognized as a global Subject Matter Expert in Biologics, Pharmaceutical, and Active Pharmaceutical Ingredients (API) inspections; and a global industry thought leader in inspectional areas including Process Validation and Data Integrity.

    Over the course of her career, Ms. Pitts developed specialized expertise to conduct and direct highly technical, complex, multi-faceted and in-depth domestic and international inspections and investigations of active pharmaceutical ingredients and finished drug products with extensive experience in areas including but not limited to vaccines, allergenic extract products, antivenins, plasma derived products (and their recombinant analogues), licensed IVD products, gene/cellular therapy products and human cells, tissues and cellular and tissue based products. She holds a bachelor’s degree in Biology and a master’s degree in Microbiology. Ms. Pitts also serves as a training resource for FDA./p>

  • Quallyna Porte

    Quallyna N. Porte, MBA

    U.S. FDA

    Quallyna Porte is a Branch Chief in the Office of Manufacturing Quality in CDER’s Office of Compliance leading a team responsible for regulatory oversight of the human drug manufacturing industry.

    Prior to joining the FDA, Quallyna worked in the pharmaceutical and biotech industries for 18 years. She worked at Baxter Healthcare Corporation (Bioscience Division – Vaccines) in various roles of increasing responsibilities starting with Quality Control up to Facility Quality Management Representative. In the latter role, Quallyna oversaw the commercial manufacturing and release of vaccine products to various geographies, and finally the transfer of technology overseas. She also led the Quality Assurance organization at Emergent BioSolutions in the establishment of Quality Systems at a new facility, qualification of said facility, and subsequent cGMP manufacturing of Phase I to III clinical products.

    Quallyna is a Six Sigma Green belt who received her BS in Biology from Saint Paul’s College, completed graduate coursework at Fisk University, and received an MBA from the University of Maryland, University College.

  • Commander Mahesh R. Ramanadham, PharmD, MBA

    U.S. FDA
    Commander (CDR) Ramanadham is currently the Associate Director for Scientific Operations for the Office of Pharmaceutical Manufacturing Assessment, within the Office of Pharmaceutical Quality. He joined the Agency in November 2009 after graduating with his Doctor of Pharmacy degree from the University of Maryland and his M.B.A. from the University of Baltimore. Prior to joining FDA, CDR Ramanadham had experience in solid oral dosage manufacturing ranging from OTC products to schedule II narcotics. Outside of FDA, CDR Ramanadham continues to practice pharmacy in the community setting to maintain perspective on the clinical relevancy and impact of our efforts in pharmaceutical quality.
  • Emma Ramnarine

    Emma Ramnarine, MS

    Genentech/Roche

    Emma Ramnarine is Executive Director, Global Head of External Development Collaborations at Genentech/ Roche. She leads outsourcing strategies and manages the external clinical development, manufacturing, and clinical collaborations network for Roche’s Biologics and Small Molecules development portfolio.

    Emma has 20+ years of experience in the pharmaceutical, biotechnology and medical device industry in Analytical Science & Technology, Quality Control, Risk Management and Quality System Management. She is a worldwide-recognized expert on Quality Risk Management (QRM), providing QRM training to regulatory authorities and at industry forums. She is currently Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes, an initiative sponsored by Chief Quality Officers of 25+ global pharma companies.

    Emma has served on the PDA Board of Directors for 6 years and is currently the Secretary on the Board Executive Committee. She has additionally served on PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB) and led several other PDA Task Forces and Technical Reports, and also .

  • Sabrina Restrepo

    Sabrina Restrepo, PhD

    Merck & Co., Inc.
    Her expertise includes deployment of single-use systems in vaccine manufacturing, process improvements for vaccines manufacturing, subject matter expertise in extractables and leachables, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. In addition, she is the co-lead of the PDA Vaccines Interest Group.
  • Bethany Rexing

    Bethany B. Rexing, MS

    Eli Lilly and Company

    Bethany Rexing graduated from Case Western Reserve University with a BS and MS in Chemical Engineering in 2003. Bethany joined Eli Lilly in Analytical Sciences Research and Development in 2004 to support manufacturing investigations in the Surface Science Lab, transitioning to the Forensics lab team leader which included additional analytical instrumentation for manufacturing support.

    Bethany took a role as a TSMS representative supporting an API manufacturing site and spent 6 years in both individual contributor and management roles in the API network. She developed a passion for data, process monitoring and control strategies. She represented Lilly externally at the ISPE Process Validation conference in 2017 to share an applied approach to OPV in an API facility.

    Bethany moved to a Parenteral site as a TSMS Director with accountability for primary packaging components, annual product reports and day to day production. Bethany championed the use of data for decision making and has built and mentors others on how to use visualization tools like Power BI and Tableau.

    In 2021, Bethany moved to Lilly’s Global Quality organization to establish a new M&Q Data Management team. Her team has responsibility for establishment of data standards, business processes and governance for the M&Q organizations.

  • Carmelo Rosa, BS, MS, PsyD

    U.S. FDA

    Carmelo Rosa has a B.S., M.S., Psy.D. He started with the FDA in May 1990 as an Investigator for the Los Angeles District. Dr. Rosa later transferred to the San Juan District, where for 13 years he served as a pharmaceutical drug Investigator and 6 years as a Compliance Officer. He is member of the foreign drug inspection cadre. He has conducted many inspections of complex pharmaceutical inspections and other commodities regulated by the FDA that have resulted in significant regulatory actions initiated by the FDA. In August 2008 relocated to Maryland to work for CDER as Compliance Officer. In 2009 he was promoted to Team Leader at CDER/DMPQ/OC/ICB, and then to Branch Chief for the International Compliance Branch. He currently serves as the Director for the Division of International Drug Quality I. Dr. Rosa is one of the FDA officials responsible for the review of non-compliant inspections (domestic and foreign), and is involved in FDA’s decision to initiate an enforcement action against pharmaceutical manufacturing and testing facilities that fail to comply with CGMPs. Dr. Rosa has served as an invited Professor at the University of Puerto Rico, School of Law, where he teaches a course on Federal Regulations Enforced by FDA and a General Overview to the FD&C Act. He works very closely with International Regulatory Authorities in different collaboration initiatives. Dr. Rosa is the former Chair for the PIC/S API Expert Circle.

  • blank-profile

    Abriana Rozentsvayg, MA

    Pfizer
    Anna Rozentsvayg is a Director Component Control, Data Analytics at Pfizer Inc. Anna has over 25 years of Pharmaceutical experience and a diverse background in Bio Operations, Quality Assurance and Technical Leadership. Since the beginning of pandemic, Anna was charged to lead the Pfizer’s CCI Sub-team and develop a Holistic Science based CCI strategy to mitigate the risks posed by ultracold storage and distribution supply chain.
  • Kimberly Schultz

    Kimberly LW Schultz, PhD

    U.S. FDA
    Kimberly Schultz is a Gene Therapy Product Reviewer in the Division of Cellular and Gene Therapies at FDA’s Center for Biologics Evaluation. She is responsible for review of pre-IND, IND, and BLA submissions for gene therapy products. Kim actively participates in inter- and intra-agency working groups, meetings, and conferences focused on advancing cell and gene therapy products and has contributed to regulatory guidance documents for gene therapy products. She was a member of the BLA review team for the first approved CAR T cell therapy product (KYMRIAH). Kim joined the FDA in 2015 as a Commissioner’s Fellow to conduct a cross-study analysis of CAR T cell data. Prior to joining the FDA, she received her PhD from the University of Wisconsin and conducted postdoctoral studies at Johns Hopkins Bloomberg School of Public Health specializing in virology and immunology.
  • Melissa Seymour

    Melissa S. Seymour, MBA

    Biogen

    Melissa Seymour is the Chief Quality Officer for Biogen Inc. In her current role Melissa leads the PO&T organization in setting the quality strategy, implementation of quality processes and systems, and development of talent to ensure the highest level of quality in the pharmaceutical industry. Prior to this, Melissa served as VP of Global Quality Control assuming responsibility for the strategy and implementation of Global QC testing worldwide. Additionally, she spent several years as the VP of Corporate Quality with responsibility for global compliance and quality systems including management of Quality Systems, Internal and External Auditing and Global Affiliate GMP oversight.

    Melissa holds BS degrees in both Biological Sciences and Biochemistry from NC State University and an executive MBA from Duke University. She has over 25 years of experience in the quality arena including quality positions at Novo Nordisk pharmaceuticals and Glaxo Smith Kline.

    Melissa has been involved in the influencing of regulatory guidance through her participation on non-profit Boards of the PDA as well as Rx-360. She has been an advocate for simplification of PAC processes, participating in industry forums, writing articles and interacting with regulators. Melissa is an ASQ Certified Quality Engineer, Certified Quality Auditor and Certified Quality

  • Derek Smith

    Derek S. Smith, PhD

    U.S. FDA
    Derek Smith is Deputy Director of the Office of Pharmaceutical Manufacturing Assessment in the Office of Pharmaceutical Quality providing leadership of the assessment of the manufacturing process and facilities for biologics and small molecule drug applications with a focus on the integration of application assessment and inspection findings and data reliability assessments. He also serves as the co-chair for FDA's New Inspection Protocol Project (NIPP) initiative for pre-approval inspections and remote assessments. During the COVID-19 pandemic, he has led CDER's efforts on inspection and a key contributor to the utilization of alternatives to inspections. He holds a Ph.D in Chemical and Biochemical Engineering from University of Maryland, Baltimore County.
  • Steven Solomon

    Steven M. Solomon, DVM, MPH

    U.S. FDA

    Dr. Steven Solomon was appointed Director of the Food and Drug Administration’s Center for Veterinary Medicine in January 2017. Dr. Solomon previously served as the Deputy Associate Commissioner for Regulatory Affairs within the Food and Drug Administration’s Office of Regulatory Affairs.

    He joined FDA in 1990 as a Veterinary Medical Officer in the Center for Veterinary Medicine and has served in various policy and leadership positions in the Office of Regulatory Affairs’ Office of Enforcement, Office of Regional Operations, and as the Assistant Commissioner for Compliance Policy.

    He also served in the Office of Global Regulatory Operations and Policy. Dr. Solomon has a Doctor of Veterinary Medicine from The Ohio State University and a Master’s in Public Health from Johns Hopkins University.

  • Emily Thakur

    CDR Emily T. Thakur, RPh

    U.S. FDA

    CDR Emily Thakur, R.Ph., is a Team Leader with the Drug Shortage Staff at the FDA. She joined the FDA in 1999 as a Consumer Safety Officer for the Regulatory Support Branch in the Office of Generic Drugs. She then joined the Office of Regulatory Policy in the Center for Drug Evaluation and Research in 2005. She has been in her current position, with the Drug Shortage Staff since February 2011. Prior to joining the FDA, she held a position as a staff pharmacist with CVS/Pharmacy and held a part-time position until 2014. She received her Bachelor of Science degree from Rutgers College of Pharmacy in 1999.

  • Douglas Throckmorton

    Douglas R. Throckmorton, MD

    U.S. FDA

    As Deputy Director for Regulatory Programs, Dr. Throckmorton shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States. He is committed to ensuring that the benefits of approved drugs outweigh their known risks.

    Dr. Throckmorton received his medical degree from the University of Nebraska Medical School and completed his residency and fellowship at Case Western Reserve University and Yale University, respectively. Prior to coming to the FDA in 1997, he conducted basic science research and practiced medicine at the Medical College of Georgia, Augusta, Georgia and Augusta Veterans Administration Hospital.

  • Weida Tong

    Weida Tong, PhD

    U.S. FDA
    Dr. Tong is the Director of Division of Bioinformatics and Biostatistics at NCTR/FDA. He is Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS) Expert (formally Senior Biomedical Research Service) since 2011 at FDA. He has served Science Advisory Board for several multi-institutional projects in Europe and USA. He also holds adjunct appointment at several universities. He is the founder and board chairperson of international MAQC Society (2017-2020), President of MCBIOS Society (2019-2020), and Chair of SOT Board of Publication (2019-2020). He has published over 300 peer-reviewed papers from his roles in (1) Supervising and leading the FDA-led community wide MicroArray and SEquencing Quality Control (MAQC/SEQC) consortium to assess technical performance and practical utility of emerging genomic technologies with emphasis on regulatory application and precision medicine, (2) addressing the drug safety concerns related to drug-induced liver injury (DILI), (3) developing machine learning and AI for digital health and drug repositioning, and (4) conducting molecular modeling and QSARs on various toxicological endpoints such as carcinogenicity.
  • Nicholas Violand

    Nicholas A. Violand

    U.S. FDA
    Nicholas A. Violand began his career with FDA in 2008 as an Investigator in the New Jersey District, which is now part of the Office of Pharmaceutical Quality Operations, Division I, within ORA. Focusing primarily on drug CGMP and pre-approval inspections both domestically and internationally, as well as inspections of compounding pharmacies in the State of New Jersey, he has experience with a wide variety of sterile and non-sterile dosage forms, and his work has resulted in many significant regulatory actions. He became a Drug Specialist in 2014, training and mentoring newer Investigators, and in 2018, a Drug National Expert within the Pharmaceutical Quality Programs Branch, where he continues inspectional work and a focus on training and inspection-related projects. Mr. Violand received a B.S. in Biotechnology from the School of Environmental and Biological Sciences at Rutgers University.