IRVINE, CA, May 12, 2010 (MARKETWIRE via COMTEX) — BioMedGPS, LLC, the developer of the SmartTRAK Online Business Intelligence system, has announced two back-to-back educational workshops, “The New Golden Rules of Clinical Trial Planning and Implementation,” at its JointVentures All Orthopedics and Spine Strategic Partnering and Investment conference. The event is being held June 14th and 15th at the Crowne Plaza Chicago O’Hare in Rosemont, IL, prior to OrthoWorld’s OMTEC 2010 conference.
The clinical trial and product launch-focused workshops, presented by JointVentures sponsors Musculoskeletal Clinical Regulatory Advisers (MCRA) and Medmarc and The Hartford Financial Services Group, have been thoughtfully designed as complementary, fast-paced and interactive discussions to help start-up companies manage their resources and investment capital in a more efficient manner and improve the likelihood of meeting milestones and achieving benchmarks. The educational sessions will take place Monday morning, June 14th.
Session One, presented by industry experts at MCRA, will cover the following timely topics: clinical data similarities and differences affecting reimbursement and regulatory planning; integrating reimbursement activities for future coding and health economics; value creation through reimbursement integration; management of surgeon and hospital selection and compensation for clinical trials; investigator/investors: financial disclosure and conflict of interest; and responding to increased costs of compliance with new/proposed regulation.
“There has never been such a period of sweeping change at the FDA in the way orthopedic and spinal device companies must plan and prepare for the development and marketing of innovative products,” says Glenn Stiegman, VP Regulatory Affairs at MCRA. “These workshops will offer an important primer on how best to adapt to change and achieve the level of success their products surely deserve.”
Session Two, presented by medical device liability experts from Medmarc and The Hartford Financial Services Group, will cover: the relationship between regulatory/compliance controls and clinical trial/products liability risk; the U.S. Tort System; Tort System impact on the medtech and life sciences industry; best practices for mitigating clinical trial/product liability risk; duties and responsibilities of corporate directors and officers; and illustrations of private company directors and officers litigation.
“Organizations developing and marketing orthopedic and spine innovations bring the promise of significant improvement to the quality of life and present third-party liability risks, such as products and directors’ and officers’ liability,” says Tom Konopka, Senior Vice President, Medmarc, and Joe Coray, Vice President, The Hartford Financial Services Group. “Our workshop will help executives understand these risks and provide actionable recommendations for managing them throughout the life cycles of their companies.”
The JointVentures 2010 event will showcase presentations by approximately 30 musculoskeletal start-ups seeking funding or strategic partnership, as well as timely venture capital and regulatory/reimbursement panel discussions, and a keynote address by Dane Miller, PhD, Co-Founder and former President/CEO of Biomet, along with other guest speakers. Presenting companies confirmed to date include Accelalox, Anulex Technologies, Articular Engineering, Bone Biologics, CoreSpine Technologies, Echometrix, Innovative Medical Device Solutions, Life Spine, LifeModeler, LRS Ortho, MTF Sports Medicine, NociMed, ORTEQ Bioengineering, OrthoCor Medical, OrthoPediatrics, OrthoX, ProChon Biotech, Small Bone Innovations, Soft Tissue Regeneration, SpineAlign Medical, SpineFrontier, and TissueGene, with more being added to the program regularly.
Event sponsors include Medmarc and The Hartford Financial Services Group, Musculoskeletal Clinical Regulatory Advisers (MCRA), P&M Corporate Finance, OrthoWorld and their upcoming OMTEC 2010 conference, the Medical Device Manufacturers Association (MDMA), and Marketwire.
To attend, sponsor or become a presenter at JointVentures 2010, contact BioMedGPS or visit www.jointventuresconference.com.
About BioMedGPS, LLC Founded by Sharon O’Reilly, Founder and former CEO of Medtech Insight and the In3 conference series, BioMedGPS provides online business intelligence and dynamic decision-making tools specifically designed for life science executives. Visit the BioMedGPS website for an online tour of the Company’s new SmartTRAK Online Business Intelligence platform, or call to schedule a live demo.
CONTACT: Sharon O'Reilly or Tracy Neilssien 949-559-5511 Email Contact www.biomedgps.com
