- Focusing on key role of participants in clinical studies with opportunities for healthcare access and contributions to diversity in clinical trials
- Current and former role as VP, Clinical Operations (SiteBridge Research, Takeda, Revance); VP Clinical Development (Meitheal/Xentria, AnaptysBio) and Head of Strategic Operations/Clinical Research Operations (Pfizer, Avexis, Astellas) leveraging early and late stage Drug Development and global clinical trials experience toward creating a high-performance teams and outsourcing plans for clinical trials
- Experience in Global Development, Clinical Operations, Scientific Strategy and Clinical Affairs over the last 20+ years from bench to commercial; mergers, licensing and acquisitions and organizational evolution
- Global experience including reports both within NA and outside US (including Canada, Eu, Jpn)
- Former Astella’s Board member on AVOCA, Operations Committee member with Transcelerate, scientific development liaison for IFPMA/WHO Clinical Fellowship program.
- Key driver — business case as part of Takeda strategy for Asia development operations in Singapore
- Therapy areas of experience: Women’s Health, Musculo-skeletal Disorders, Oncology, Immunology/Inflammation, InfDiseases, Urology/Nephrology, CKD, Metabolic Diseases, CNS/Pain/Movement Disorders
Notable career achievements:
- Contributions to development, regulatory submissions and/or approval of DaxibotulinumtoxinA, ZolgenSMA, Myrbetriq, Xtandi, Rozerem, Cresemba, ACTOS, Lipitor, Lyrica, Actonel; numerous INDs/ODAs including mabs for rare diseases, pivotal trials for dermatologic and respiratory diseases
- Developing global strategy for Astellas’ Global Operating Model/Global Project Team, including implementation in US, EU and Jpn ; this model remains in place for some 2000+ colleagues in Astellas Medical/Development.
- Globalizing Clinical Operations at Takeda, establishing ‘business units’ with Clinical Program Managers/Study Manager in alignment with key TAs for which Takeda was developing compounds and having high stds/global processes to run projects from Phase I – IV, including internal processes and those for overseeing outsourced study management activities.
- Recognized leader and mentor Pfizer, Takeda and Astellas as a leader and mentor.
A fountain of business knowledge and an accomplished technology innovator, James has led strategy and operations, software engineering and business development functions in a wide variety of industries.
An experienced entrepreneur and prolific investor, he has co-founded and exited a number of highly successful and disruptive tech companies over the last 20 years. His portfolio includes work with both Global 250 and Global 500 organisations, as well as servicing state departments both domestic and international, such as the Ministry of Defence (MoD) and the US Department of Defense (DoD).
As co-founder and CEO of Rainbird Technologies, James combines his deep business intelligence, strategic vision and extensive knowledge of multiple industries and markets to identify unique opportunities for growth.
A man with his finger on the pulse of an ever-evolving marketplace, James is always looking ahead to the next “game-changing” advancement in artificial intelligence. His mission: to demystify the world of “Applied AI”, for both organisations and users alike.
With a history in innovation and service design – having led an artificial intelligence consultancy firm that helped companies develop AI tools to fit their business needs – he possesses an in-depth understanding of the possibilities of the technology and the key part it will play in the future of industry.
In his role as Chief Operations Officer, James is responsible for the daily business operations of the company. A knowledge management graduate from Loughborough University, James has written chapters for numerous Ark Group publications on the subject.
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.
