Archives: Speakers

Over 20 years of R&D experience in Biotech and Big Pharma, with focus on the development of biotherapeutics and novel therapeutic platforms in oncology. Core expertise in oncology and immune-oncology research and development, spanning from target identification and validation, selection of therapeutic modalities and lead compounds, development of companion diagnostics, translational support for early clinical development and regulatory filings. As CSO and SVP of 3 T Biosciences, Hanspeter is overseeing platform- and therapeutic program development of novel classes of TCR based therapies to enable differentiated, innovative and transformational, cancer therapeutics that impact patients’ lives significantly.

Leadership of the Global Analytical Harmonization and Modernization organization within Global Quality reponsible for driving robustness, harmonization and modernization strategies and programs across GSK Vaccines with the intent to improve quality and timely QC testing

Dr. Diaz-Mitoma is a renowned medical scientist and professor who most recently served as a professor of the Northern Ontario School of Medicine (“NOSM”). While in this position, Dr. Diaz-Mitoma was Vice President of Research at Health Sciences North and founder of the Advanced Medical Research Institute of Canada (“AMRIC”) and served as its Chief Executive Officer and Chief Scientist. AMRIC is focused on translational medical and vaccine development research. Prior to joining the faculty at the NOSM, Dr. Diaz-Mitoma was a professor of Pediatrics, Pathology, Laboratory Medicine, and Microbiology at the University of Ottawa. While in this position, he founded the Vaccine and Infectious Disease Centre at the Children’s Hospital of Eastern Ontario (“CHEO”), a pediatric health and research center. Dr. Diaz-Mitoma received his medical degree from the University of Guadalajara, completed fellowship training in Infectious Diseases at the University of Manitoba, and earned a Ph.D. in Virology from the University of Alberta

Raj is the founder of the Gastric Vest Technology System (GVS), which was acquired in 2017.  The GVS has several issued patents involving weight loss technologies, including – gastric restriction, intra-gastric technology, bio-electronics for type II diabetes, and spine surgery.

• 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.