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Principal - RAAHA LLC. - Former USFDA
Dr. Aloka Srinivasan till recently was the Vice President and Head of Regulatory Practice at Lachman Consultants. Prior to joining Lachman, Dr. Srinivasan was the Vice President of Regulatory, Lupin Pharmaceutical Inc. Dr. Srinivasan worked in FDA prior to joining industry as a team leader and Acting Director at Office of Generic Drugs and spearheaded the establishment of the DMF review division in CDER based on GDUFA and worked on the regulatory criteria related to complex APIs. Dr. Srinivasan was one of the architects of the QbR-QOS and took part in the QbD initiative of CDER Dr. Srinivasan is also the representative of International Generics and Biosimilar Medicines Association (IGBA) in ICH Q11 Q&A Implementation Working Group (IWG). Prior to joining FDA, Dr. Srinivasan was a senior scientist at National Cancer Institute (NCI) and did her Ph.D. at University of Missouri, Columbia. Her thesis involved studying of intermediates in activation of nitrosamines in cosmetics and drugs. Currently Dr. Srinivasan is an independent consultant, supporting with strategies, submission and life cycle management of generics, NCEs and provide regulatory training on pertinent regulatory topics.
Senior Director - Chemical Medicines - USP
Dr.Edward Gump is currently a Senior Director within the Chemical Medicines Department at the United States Pharmacopeia (USP). His groups support the development of USP documentary standards for medicines including Over-theCounter (OTC) drugs.
Prior to joining USP in 2018, Ed worked for Boehringer Ingelheim Pharmaceuticals for over 20 years primarily in the area of new drug development. During that time he contributed to the development and commercialization of both small chemical and biologic drugs. Ed is an analytical chemist by training and holds a Ph.D. in Analytical Chemistry from the University of California, Riverside and a B.S. in Chemistry from the University of California, Santa Barbara
Professor - Swansea University
Dr. George Johnson is an Associate Professor in the Institute of Life Science at Swansea University, UK. George obtained his PhD degree in Swansea 2006, under supervision of Professor Jim Parry, and since then has developed a great interest in the statistical approaches and underlying mechanisms that support points of departure (PoD) for genetic toxicity. This expertise has lead Dr. Johnson to being a Steering Member of the International Life Science Institute—Health and Environmental Science Institute (ILSI-HESI) Genetic Toxicology Technical Committee (GTTC), as well as being co-Chair of the GTTC ‘Quantitative Workgroup’. His work includes improving the quantitative use of genetic toxicity data for human-health risk-assessment (Johnson et al., 2014, EMM), and he links this to his great interest in replacing, reducing and refining (3Rs) the use of animals in research.Dr. Johnson has experience in teaching Genetic Toxicology at BSc, MSc, PhD and CPD levels, and he has also run workshops on this topic at international conferences, along with running one on the assessment of genetic toxicity data sets at the European Chemicals Agency (ECHA). Recent accolades include becoming a Fellow of the Higher Education Academy (FHEA), a British Registered Toxicologist (BRT) and he won the European Environmental Mutagenesis and Genomics Society (EEMGS) Young Scientist Award 2014. In 2019, Dr. Johnson became President of EEMGS.
Senior Director - Gilead Sciences
Dr. Joel Bercu is an Associate Director in the Drug Substance
Evaluation (DSE) group at Gilead Sciences and has 15 years of
public health/toxicology experience in pharmaceuticals. His
mission while at these positions is to protect the safety of staff,
patients, and the environment. He provides expert toxicological
documentation for Occupational Health Categorization,
Permissible/Acceptable Daily Exposures for cleaning validation,
environmental risk assessments, impurities (including mutagenic/
carcinogenic impurities) and excipients. He has had several
external collaborations to influence regulatory guidances such as
chairing the Risk Assessment sub-section for ICH M7 and
developing its corresponding Addendum. He received his BS from
Texas A&M University, MPH from University of Texas – Houston
School of Public Health, PhD from Indiana University, and is a
Diplomate of the American Board of Toxicology (DABT). He
continues to publish and present at national meetings in the field
of toxicology with a focus on public health and risk assessment.
VP Product Engineering & Production - Leadscope Principal Investigator - USFDA Collaborations
Dr. Kevin P. Cross is the vice-president at Leadscope, Inc. an Instem Company, where he is Principal Investigator of U.S. FDA/Leadscope collaborations. His current responsibilities include the collaborative research and development of QSAR models and database with U.S. FDA Center for Drug Evaluation and Research for prediction of toxicity in support of drug safety, the U.S. FDA Center for Food Safety and Applied Nutrition in support of the Office of Food Safety, and supporting the U.S.FDA Center for Devices and Radiological Health and Center for Veterinary Medicine. He is also responsible for the development of the Leadscope Enterprise product and leads the software development and database production groups at Leadscope.
Dr. Cross has received his Ph.D. in chemistry from Michigan State University in 1985 and has been developing chemoinformatics tools and products for over 30 years. He is involved in several collaborative efforts to create protocols and procedures for performing in silico assessments for regulatory purposes as well as to assess their performance.
Most recently he is co-leading project on N-Nitrosamine Structure-Activity Relationships involving 41 members from 21 companies and institutions. He has authored over 30 papers and over 40 presentations. Recently he participated in the International Workshop on Genetic Toxicity (2017) where he helped determine Ames tester strain equivalency and identify in silico toxicity prediction issues related to genetic toxicity testing.
Global Risk Assessment Services Lead - Pfizer
Dr. Krista Dobo holds a B.S. in Biology from Indiana University of Pennsylvania and received her Ph. D. in Environmental Toxicology from the University of California, Riverside. During her graduate years she applied various in vitro genotoxicity assays to evaluate mechanisms of clastogenicity and mutagenicity.
Dr. Dobo joined Pfizer in the Genetic Toxicology department, where she contributed to the team as a study director, subject matter expert, supervisor and department head. During her time at Pfizer Krista has also developed expertise related to impurity qualification and risk assessments. She represents Drug Safety on a multidisciplinary council that provides advice to teams regarding impurity qualification matters. Most recently she took on leadership of Drug Safety’s Global Risk Assessment Services Team (GRAS). GRAS collaborates with Pfizer Global Supply manufacturing sites and contributes to the development of risk assessments to address potential safety issues that arise across Pfizer’s global marketed product supplies. External to Pfizer, Krista has served two terms as a member of the Genetic Toxicology Association (GTA) Board of Directors and also acted as Chair of the GTA.
She is also a former Councilor of the Environmental Mutagenesis and Genomics Society (EMGS) and served as Co-Chair of the EMGS Applied Genetic Toxicology special interest group. She has been an active participant in PhRMA LDKIT efforts to revise the ICH Genetic Toxicology Testing Guidance (ICHS2R) and develop the ICH M7 Guideline and Addendum. Dr. Krista Dobo is currently a member of the ICH M7 Expert Working Group, serves on the Board of Trustees for Lhasa Limited and is on the Editorial Board of Environmental and Molecular Mutagenesis.
Vice President Global API R&D - Apotex
Dr. Martin Ehlert obtained a B.Sc. in Applied Chemistry at McMaster University in 1987. He subsequently obtained a Ph.D. in Chemistry at the University of British Columbia in 1992. In 1994, Dr. Ehlert commenced his career in the pharmaceutical industry as an industrial postdoctoral fellow at Phytogen Life Sciences and continued with the company for the next four years working in the areas of API process development, engineering and production operations. In 1998, he joined Apotex Pharmachem Inc., serving in various capacities within API R&D and Operations. In 2015, sDr.Ehlert moved to Apotex Inc. and currently holds the role ofVice President, Global API R&D.
Vice President Sciences and Regulatory Affairs - Association for Accessible Medicines (AAM)
Ms. Lisa Parks holds a BS in Pharmacy from the Massachusetts College of Pharmacy in Boston, MA. In her current role as the Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines (AAM), she assists with the development of scientific affairs initiatives and member communications and training opportunities. She is involved with facilitating discussions and efforts with FDA, law makers and other industry stakeholders on numerous topics that impact the generic and biosimilar industry.
Ms. Parks served as a key member of AAM's negotiating teamfor the Generic Drug User Fee Amendments (GDUFA II) and the Biosimilar User Fee Act (BsUFA II) with FDA. She currently serves in the same capacity for the implementation phase of both user fee programs and is the primary strategist for the upcoming GDUFA III and BsUFA III negotiations.
Prior to joining AAM, she held crucial positions in various offices at the FDA. Lisa’s ability to drive cross-functional teamwork led to her appointment as a key representative for the implementation of GDUFA I for the Office of Generic Drugs. Ms. Lisa Parks moved on to support the implementation of GDUFA Ifor FDA overall and played a pivotal role in the establishment of the Office of Pharmaceutical Quality (OPQ) for the Center for Drug Evaluation and Research (CDER).