Be sure to send your team to take advantage of both tracks at the conference – Business Development and Clinical Trials. Speakers include industry experts who have been there and done it.
Business Development:AM Session: The Reimbursement “Top Ten” Checklist
What Companies should know and investors should ask when developing or evaluating a new medical technology.
There is often a stark contrast in the perception of what investors want to know and what companies understand pertaining to the reimbursement of a new technology. This session will offer insights from investors, a reimbursement consultant with over 20+ years in the medical device industry as well as senior executives from the medical device and biotech industry. Attendees will develop an understanding of the key drivers of reimbursement, identify the critical elements to incorporate into a reimbursement strategy to secure funding for a new technology, understand the importance of well-designed clinical studies to support reimbursement and will walk away with a working checklist of the key reimbursement elements to incorporate into the strategic plan.
PM Session: Creating Value in Your Technology
Often good ideas and technologies with great promise never realize their full commercial potential. This panel discussion will focus on strategies that build value in technologies by positioning them for success to overcome the many hurdles they face in the areas of intellectual property, finance and regulatory. Utilizing these strategies will help position your assets to be most attractive to investors.
Moderator: Gary Connell, Shareholder, Sheridan Ross
Joe Kovarik, Partner, Sheridan Ross
Kyle Lefkoff, Founder and General Partner, Boulder Ventures
Gail McIntyre, Ph.D., Senior Vice President, Research, Furiex Pharmaceuticals
Clinical Trials:AM Session: Non-Clinical Safety Assessment Methods for IND filings
This session will provide an overview of IND-enabling pre-clinical approaches and recent case studies of novel approaches to support IND submissions. You will learn the critical nonclinical pieces for an IND filing, how to structure your non-clinical work to answer key questions while saving time and money, and how regulatory considerations in pre-clinical development may support your future clinical development.
Alfred Botchway, Ph.D., Founder and President, Xenometrics
Catherine McCall, Clinipace Worldwide
Moderator: Dave Trollinger, Director, Clinical and Translational Research Division, NextGen Pharma
David Mitchell, Ph.D., President & Owner, Mitchell Pharmaceutical Consulting, LLC
Juuso Salmu, PhoenixBio
PM Session: Biomarkers in Clinical Development
Biomarkers can have an important role in product development decision-making, and are increasingly used in clinical trial design. Experts in the development, application and use of biomarkers will share their experience in this interactive session.
Mark Duncan, Ph.D., Professor, University of Colorado
Rosalynn Gill, Ph.D., Vice President, Clinical Affairs, Boston Heart Diagnostics
Gilad Gordon, M.D., President, ORRA Group, LLC
Frank Richardson, Ph.D., President, FC Richardson Consulting LTD