Clinical Operations Executive, Genentech / Roche
Archana Sah is a Clinical Operations executive with over 21 years end-to-end experience in pharma / biotechnology drug development. She has held various positions of increasing responsibility and influence including leadership roles in Clinical Affairs and Development Operations. In her current role as Therapeutic Area Leader, Oncology for North America at Genentech / Roche, she is accountable for the strategy and oncology portfolio of clinical trials delivery in North America (US and Canada). She leads a team of 120 members accountable for the operational planning and conduct of over 60 trials. She helps set up the vision for North America Clinical Operations in alignment with organizational goals and sets road maps for its implementation.
She is a strategic advisor to Executive Leadership on emerging topics ranging from therapeutic landscape / healthcare trends expertise to business strategy and operations.
She has led the research and development strategies for multiple FDA and EMEA approved products.
She holds global patents and peer reviewed publications.
Borje Darpo, MD, PhD
Chief Scientific Officer, iCardiac
Borje is board-certified in cardiology and internal medicine. In addition to his role at iCardiac, he is an associate professor of cardiology at the Karolinska Institute in Sweden. Borje has more than 18 years of industry experience, including senior management positions at small, mid-sized and large pharmaceutical firms and at a global contract research organization. He has led or has been responsible for projects in all phases of clinical development, including the filing and approval of a New Drug Application. Borje authored internal QT guidance documents for the design and conduct of clinical QT assessment, such as Thorough QT studies for four sponsors, including Pharmacia and Pfizer. He has advised a large number of clinical trial sponsors on design, conduct, interpretation and regulatory communication on TQT studies for compounds within a wide range of therapeutic areas, including cardiovascular, anticoagulants, antiplatelets, metabolic, oncology, and neurology. When it comes to the cardiovascular safety assessment of drugs, Borje’s broad experience includes participation in the generation of existent regulatory guidance on QT assessment (CPMP and ICH E14). He was former co-chair of the International Life Sciences Institute/Health and Environmental Sciences Institute cardiovascular safety subcommittee and member and co-chair of the scientific oversight committee of the Cardiac Safety Research Consortium, generating internal company-specific guidance on cardiac safety assessment and numerous reviews of programs, both internally and as a consultant. Borje also served as the European Federation of Pharmaceutical Industries and Association deputy topic leader for the ICH E14 Implementation Working Group, which worked on the regional implementation of this guidance and provided support to sponsors through a Q&A process, between 2001 and 2008. More recently, Borje, in collaboration with the industry and the U.S. Food and Drug Administration, led the IQ-CSRC study, which validated the concept of applying exposure-response analysis on data from early stage clinical trials to replace the TQT study. The results from this study paired with the experience from regulators led to the revision of the International Council on Harmonisation’s E14 guideline, which since December 2015 allows this approach to replace the TQT study.
Graham Wood, PhD
Executive Vice President, Phase I Clinical Development, Altasciences Clinical Research
Dr. Wood has a Ph.D. in Neurology and Neurosurgery from McGill University. He joined Altasciences Clinical Research as Executive Vice President, Phase I Clinical Development, in November 2015. Since 1999, his focus has been on clinical pharmacology, managing three new molecular entities from toxicology to Phase IIa, and over twenty from first-in-human to Phase IIa. Dr. Wood has conducted over 400 clinical pharmacology studies with companies such as Phoenix International, MDS Pharma, Allied Research and Cetero. Dr. Wood’s roles have varied from Project Management, Business Development and Clinical Operations. More recently, he was CEO at Manna Research (a late phase clinical CRO) and Chief Scientific Officer at Akesis.
Gregory K. Reid, MSc, MBA
Director, Medical Science Liaison, Altasciences Clinical Research
Gregory Reid has amassed 30 years’ experience in the pharmaceutical industry, chiefly in oncology drug development. He has graduate-level training in immunology and business.
Mr. Reid has acquired substantial operational experience in large pharma and large CROs across multiple therapeutic areas, including late phase Oncology development. Much of Mr. Reid’s experience has been acquired in the small biotech environment, where he most recently guided small teams to successfully bring three novel molecules (two targeted oncology agents and one antifungal drug) from the bench through to IND-enabling studies, initial IND and CTA filings, to Phase I and II clinical development. Mr. Reid was directly involved in the development and execution of clinical strategies for company assets, and was involved in the generation and review of multiple types of regulatory documents. He has over 20 peer-reviewed manuscripts and abstracts to his name. As Director, Medical Science Liaison, Phase I/II, at Altasciences Clinical Research, Mr. Reid assists drug developers in formulating and executing strategies around FIH and NDA-enabling clinical studies.