Archives: Speakers

Over 19 years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Device, Digital Medicine and Combination Product areas. In addition, an adjunct assistant professor at USC – School of Pharmacy – Regulatory and Quality Sciences.

Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system arena and regulatory affairs regarding:

• CMC Global Dossiers and Global Device Regulatory Strategy Registrations
• EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)
• 21 CFR Part 3 and Part 4 – Combination Products
• CE Marking
• ISO 13485:2016/MDSAP
• Product Development – Design Controls
• Risk Management
• Human Factors Engineering
• Acquisitions/Divestitures
• Import/Export – U.S. Agent
• Production Controls
• Regulatory Inspection Management
• Materiovigilance
• Health-Care Related Laws and International Regulations

Rupesh Kanchi Ravi is the Lab Head in the Pfizer Oncology Clinical Research Laboratory (POCRL), a clinical genomics GCLP lab overseeing Pfizer Oncology custom genomics clinical sample testing and new platform evaluations for genomics biomarker strategy and clinical utility working with CROs. Previously, Rupesh held the role of Biomarker Assay Specialist as clinical genomics and NGS expertise managing clinical NGS testing for Translational Oncology Phase 1 study programs and working with cross-functional teams that included GPD Oncology, ECD, and Computational Biology.

Prior to joining Pfizer Oncology, Rupesh held senior scientist positions at Genoptix, UCSD’s Genomics Center, TGen in which he developed, validated, and launched novel NGS assays (cfDNA, targeted DNA, targeted RNA, exosomal RNA, miRNA) for GCLP and CAP/CLIA lab environments, and developed novel NGS library generation techniques for numerous nucleic acid sample types. Rupesh earned his PhD in Biotechnology at Pondicherry University where he studied the anti-inflammatory and anti-cancer properties of marine natural products. He received his first postdoctoral training at the French National Center for Scientific Research (CNRS) in the Extreme Environments Microbiology Lab where he characterized the DNA replication/repair machinery of hyperthermophiles. He received his second postdoctoral training at University of Arizona where he identified novel alternate DNA repair pathway Base Excision Repair pathway inHSV-1 and developed a High Thorough put assay for identifying single strand DNA-protein inhibitors.

PeterStiegler earned his PhD in Molecular Biology at the University of Vienna Biocenter and performed a post doc at Thomas Jefferson University in Philadelphia PA. He since held positions in various operational functions in the Clinical Research arena with a focus in oncology early drug development at companies including EMD, Novartis Oncology Translational Medicine and Novartis Molecular Diagnostics.

After working at the Duke Clinical Research Institute focusing on biomarker development he worked as the Director of Clinical Operations at diagnostic development companies Prometheus Laboratories and Progenit

Dr. Roberta Alexander is the Director of Clinical Research at Biological Dynamics, a diagnostics company in San Diego that focuses on early cancer detection. She has been at Biological Dynamics for approximately 7 months. Before then, she was leading the clinical research activities in a rheumatology-focused diagnostic company. Overall, she has worked in clinical research in the diagnostic space for approximately 9 years. Previously, Dr. Alexander was a scientist and worked in preclinical research and drug discovery in the pharma industry. She has a PharmD and a PhD and did her postdoctoral fellowship at the University of Pennsylvania in Philadelphia.

Tanja Obradovic

Dr. Obradovic has over 25 years of experience in clinical pharmaceutical development in Oncology. After holding academic appointment of Research Assistant Professor at Temple University of Pharmacology leading Immunooncology laboratory she joined pharmaceutical industry. She was holding senior positions at Merck within Oncology Clinical Research, Regulatory and Medical Affairs where during her 13 year tenure she was leading over 30 novel drug entities across tumor indications including acting as Strategy lead for Keytruda clinical development and life cycle management across tumor types including melanoma, lung, women’s cancers and many other indications across lines of therapy including neoadjuvant/adjuvant strategies. Her background includes Keytruda development, regulatory approvals and launches in more than 20 solid malignancies and lines of therapy in over 50 countries in the US, EU,  Asia (Japan, China, other East Asia regions) and Latin America. Dr Obradovic held numerous leadership positions on Pharma Collaboration Programs, partnerships with major Oncology Guidance and Consortia Organizations.  Most recently she was leading development of cell-based and novel drug therapies in hemes and solid tumors at Takeda Oncology Clinical Sciences as a Senior Director of Cell Therapy and Redirected Immunity prior to joining ICON in January 2022 as VP of Scientific Affairs leading Oncology medical development strategy.

David brings over 35 years of diverse business and scientific expertise to Xeno Biosciences where he is Chief Scientific Officer. He joined Abbott Laboratories in drug discovery and development and then then transitioned to business development and new venture roles including working with startups for the Nutrition division.  David held academic appointments in GI/Nutrition at U of Chicago and then in Neonatology at Rush Medical Center following his microbiology degree. He has 100+ peer-reviewed publications with 2000+ citations and numerous successful government filings.