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"The session will deal with novel emerging therapeutic modalities to address medical needs that cannot be met by existing therapeutic approaches. The opportunities to
complement some established modalities and the challenges
in building business around new therapeutic strategies will be discu...
"When developing new approaches or options to treat disease, it is key that the industry establish and nurture its relationships with target patient organizations, their leaders and members. Exchanging information and providing education about disease
intervention and program development pave ...
Recent alliances for late-stage compounds have broken through traditional barriers. These include deal economics, joint responsibility for development and concurrent funding of multiple indications. This session will review several of the breakthrough deals of 2007.
Objective1: Prepare for the ma...
"FDA and the pharma/biotech industry are being compelled by Congress, healthcare payors and patients to be more transparent with respect to the conduct and outcomes of clinical trials, including through the new clinical trial registry requirements of the Food and Drug Administration
Amendments...
"Next-generation molecular diagnostics represent a rapidly growing field with transformative potential for cancer management and medical practice. Possible clinical
applications range from screening of asymptomatic individuals to predicting the risk of recurrence or response to therapy to surv...
Where are companies in this industry investing in growth, and why? How are industry clusters developing, and what critical issues or benefits are driving these location decisions by the executives as they choose where to invest? What are the U.S. states and cities doing to compete with other countri...
"The pharmaceutical industry is facing a continued decline in the productivity of new drug approvals—especially evident in new molecules designed to modulate "unprecedented" targets. Participants in this panel will discuss the factors contributing to clinical stage attrition and...
"Companies filing their first NDA or BLA have a significantly lower likelihood of receiving first-cycle approval. Some factors contributing to this fact were discussed in an independent evaluation of FDA's first-cycle review performance, conducted by Booz Allen and currently being updated. This...
Whether private or public, early or late stage, management teams and shareholders are turning to debt more often to lower their cost of capital and extend cash runways. Panel members representing equipment and growth lending, royalty financing, receivables financing and venture capital will offer pe...
The panel discussion will start with the tech providers' progress on implementation of the Excellence in Stewardship Programs and how it has brought in the grain handlers, food processors and regulators.
Objective1:Raise awareness of progress in implementing stewardship processes.
Objective2:D...
"Many disease areas have high incidence and great unmet medical needs in developing countries. From a company's perspective, there is a balance to be struck between developing a drug to help alleviate the disease burden in these countries and return on investment to ensure the business can surv...
"The adverse financial impact of workplace injuries and resulting loss of key talent and diminished morale can be more devastating than the failure of an investigational product. Yet workplace safety issues tend to suffer from a relative lack of attention until injuries manifest themselves. Thi...