Outsourcing in Clinical Trials Pacific Northwest 2019

Biography:

Session Details: Exploring how Small Trial Sponsors can Engage their CRO to Gain Access to Valuable Resources 16-10-2019, 10:00 am View In Agenda

Biography: Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. Mr. Luciano earned a B.A. in Psychology and Biology from the University of California at Santa Cruz.

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Session Details: Q&A Panel: FDA Meeting Advice and Lessons Learned 16-10-2019, 11:30 am Speaker Hosted Roundtables 17-10-2019, 9:00 am View In Agenda

Biography: Dr. Alexandre is President and CEO of Life Science Washington, an independent, non-profit 501(c)(6) trade association whose mission is to stimulate life science innovation, job creation and ecosystem vibrancy across Washington state through engagement, collaboration, promotion, and advocacy. She is a 30-year veteran of the life science and health care industries. Her background includes leadership roles in companies ranging in size from startup to Fortune 500, the National Institutes of Health and prominent research institutions. As President and CEO of the internationally renowned North Carolina Biotechnology Center from 2002-2007, Dr. Alexandre led the development and execution of an extremely successful strategic plan for growing the economy statewide through biotechnology. Dr. Alexandre previously served as Assistant Director of Industrial Relations for the National Cancer Institute, led corporate affairs for Oncormed, served in senior health policy positions for two U.S. senators, and was the primary liaison between EDS and the Washington, DC health policy community. Dr. Alexandre is the recipient of numerous business awards and other honors, and has extensive experience serving on corporate, academic and non-profit boards.

Session Details: Keeping Pace with Washington State’s Fast Growing Life Science Industry: Opportunities and Challenges 16-10-2019, 9:00 am View In Agenda

Biography: Patrick Martin is Vice President of Clinical and Regulatory Affairs of Mirabilis Medica, Inc.  He has over 30 years experience in the medical device and biotech industry, mainly with startup companies.  He has helped numerous companies bring diagnostic and therapeutic medical devices to the market in the US and OUS jurisdictions.  He is a published medical author, has lectured internationally, and serves as a mentor to medical device startup companies in the Seattle area.

Session Details: Q&A Panel: FDA Meeting Advice and Lessons Learned 16-10-2019, 11:30 am Discussing Strategy and Tactics for A Successful Pre-Submission Meeting With the FDA 17-10-2019, 1:45 pm View In Agenda

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Session Details: Present and Discuss: Exploring Various Approaches to Monitoring your Vendor 16-10-2019, 4:00 pm View In Agenda

Biography: Dr. Hanson has founded five companies including Tier Seven, where he is a biomedical and human systems consultant for connecting industry technologies to DoD/Federal Agencies researchers via cooperative R&D agreements (CRADAs) and obtaining non-dilutive funding. He is dual board certified in Preventive Medicine and Aerospace Medicine and has an MPH degree in epidemiology with a genetics concentration from Johns Hopkins. He was a Senior Flight Surgeon with worldwide operational experience and over 750 flying hours in 36 different aircraft. His last US Air Force position was serving as the Division Chief of Science & Technology at the USAF Surgeon General’s office. Dr. Hanson has been awarded over $68M in research grants as a Principal Investigator and assisted in over $200M in RDT&E funding. He has published four books, 24 articles and eight patents. He is an affiliate Associate Professor at OHSU in the Department of Medical Informatics and Clinical Epidemiology and serves on numerous Advisory Boards. LinkedIn profile at www.linkedin.com/in/erichansonmdmph.

Session Details: PANEL DISCUSSION: Working with the Military in Medical Device Development and Clinical Research 17-10-2019, 11:15 am View In Agenda

Biography: Jonathan Monti is an emergency medicine-trained PA, sonologist, educator, author, and U.S. Army veteran with two decades of clinical experience in military/operational & academic medicine, and military research. As President of the Society of Point-of-Care Ultrasound, he dedicates much of his time to the research, training, promotion, and employment of point-of-care ultrasound employment in austere settings. He is currently employed as a scientific advisor and grant writer and Madigan Army Medical Center.

Session Details: PANEL DISCUSSION: Working with the Military in Medical Device Development and Clinical Research 17-10-2019, 11:15 am View In Agenda

Biography: Dr. Schutz is a board certified cardiologist and Fellow of the American College of Cardiology with over 35 years experience in clinical cardiology specializing in cardiac ultrasound. Prior to founding Sonivate Medical he developed cardiac electrical and radio-frequency sensor devices that resulted in successful medical technology start-up ventures. B.S., Phi Beta Kappa, and MD, University of Illinois. Cardiology Fellowship, former Assistant Professor of Medicine and Director of the Adult Echocardiography Laboratory, Oregon Health and Science University.  

Session Details: PANEL DISCUSSION: Working with the Military in Medical Device Development and Clinical Research 17-10-2019, 11:15 am View In Agenda

Biography: Lawrence Romel has over 25 years of drug development experience in clinical operations and project management for multiple therapeutic indications. Mr. Romel is currently Sr. Vice President of Clinical Operations for Brickell Biotech and was previously Vice President of Clinical Operations at Cascadian Therapeutics. He was Chief Science Advisor and Vice President of Product Development for TranSenda International, a clinical operations software company where he was the main architect of their CTMS System. Prior to TranSenda, Mr. Romel served as Vice President of Clinical Operations and Project Management of Xcyte Therapies Inc., Supergen and Onyx Pharmaceuticals. His breadth of experience includes the clinical development of dermatologic drugs, biologics (GVAX), viral therapies (ONYX-015), toxin-sourced therapies (Ziconotide™), small molecule-based therapies (Tucatinib, Orathecin™, Decitabine), liposome encapsulated drug therapies (DOXIL™, Amphotec™), drug delivery devices and hospital/medical devices. He has managed Phase III development programs in both North America and Europe. Mr. Romel holds a Master of Science degree in Chemistry from the University of Illinois, Chicago and is certified in Project Management through U.C. Berkeley.

Session Details: The Power of Social Media to Support Patient Recruitment and Retention 16-10-2019, 12:30 pm View In Agenda

Biography: JD William Mitchell College of Law, Masters of Business Management Hamline University, Undergrad Bemidji State University Over 12 years in Healthcare Compliance. Most of that experience in house at Medical device and Pharma companies. Around 6 years of data privacy experience, including building out privacy programs, and leading a global GDPR readiness project.

Session Details: Maintaining Data Privacy to Stay Ahead of Regulations and Ensure Worldwide Compliance 17-10-2019, 2:15 pm View In Agenda

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Session Details: Deep Diving into Patient Centric Trial Design to Improve Retention Rates 17-10-2019, 12:00 pm View In Agenda

Biography: Darrell J. Panich, M.Sc. PMP, CPM: An experienced clinical trial management specialist with over two decades experience in the industry, Mr. Panich has managed multinational clinical research studies in 21 different countries for over 20 different pharmaceutical and biotechnology companies. As President of Ceros Management and Advisory, he provides clinical operations and project management solutions to CROs, biotech, pharmaceutical companies. He has a passion for learning and has obtained a Master of Science in Psychiatry, two bachelors degrees, two project management certifications and an Honours Automotive Mechanic Certificate.

Session Details: Chair Opening Remarks 16-10-2019, 8:50 am Present and Discuss: Exploring Various Approaches to Monitoring your Vendor 16-10-2019, 4:00 pm Chair Opening Remarks 17-10-2019, 8:50 am Speaker Hosted Roundtables 17-10-2019, 9:00 am View In Agenda

Biography:

Session Details: Q&A Panel: FDA Meeting Advice and Lessons Learned 16-10-2019, 11:30 am View In Agenda

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Session Details: CASE STUDY: Controlled Human Malaria Infection (CHMI) Clinical Trial Design 16-10-2019, 2:00 pm View In Agenda

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Session Details: Personalized Medicine - Current Status and Impact on CROs 17-10-2019, 2:45 pm View In Agenda

Biography: Dr. Marotta is assisting AmoyDx in expanding their operations in Canada. Dr. Marotta also serves as a consultant to a number of companies, and is an Adjunct Professor in the Faculty of Medicine at the University of British Columbia. Prior to working with AmoyDx, Dr. Marotta served as the Chief Scientific Officer at Augurex Life Sciences Corp. At Augurex, Dr. Marotta led the development of the company's biomarker programs and supported the commercialization of the company's lead asset, JOINTstat™. During his tenure, Dr. Marotta co-authored 90 scientific publications and assisted the company in receiving significant non-dilutive funding. Dr. Marotta has also held positions in Corporate Development with companies like SignalChem and Stressgen. Dr. Marotta bridges his strong scientific/clinical accumen with business expertise to bring strong value to the companies he works with. Dr. Marotta holds a Ph.D. in Experimental Medicine at the University of British Columbia.

Session Details: How Biomarkers Can Improve Your Clinical Trial Success: NSCLC As a Case Study 16-10-2019, 3:00 pm View In Agenda

Biography:

Session Details: Present and Discuss: Exploring Various Approaches to Monitoring your Vendor 16-10-2019, 4:00 pm View In Agenda

Biography:

Session Details: Present and Discuss: Exploring Various Approaches to Monitoring your Vendor 16-10-2019, 4:00 pm View In Agenda