BioPharma Strategy

Conferences & Courses
Pharmaceutical R&D Informatics Pharmaceutical R&D Informatics
April 29 - May 1, 2014 | Boston, MA

Executive Summit: Companion Diagnostics Executive Summit: Companion Diagnostics
April 30 - May 2, 2014 | Philadelphia, PA
Track 4: Executive Summit: Companion Diagnostics The signature event/conference in Cambridge Healthtech Institute' s Biomarker Series, The Biomarker World Congress/conference 2013 is dedicated to all areas of biomarker research spanning the pharmaceuti

Strategic Alliance Management Congress Strategic Alliance Management Congress
May 5-7, 2014 | Philadelphia, PA
The Strategic Alliance Management Congress is the most prominent alliance management event in North America.




Life Science Media Library
Clinical Trial Monitoring and Compliance Clinical Trial Monitoring and Compliance
February 4, 2013 |
In this DVD, we will discuss the ever-changing role of the CRA and explore ways in which this relationship can be leveraged to maximize productivity with study sites. Key topics to be addressed: How to build and maintain the relationship between sponsor and site Ways to partner with your sites during different phases of clinical trials How to have an enrollment discussion with your site; define mutual goals and expectations How to ensure ROI on territory development activities
Impact of Affordable Care Act and the Sunshine Act on Industry Impact of Affordable Care Act and the Sunshine Act on Industry
February 4, 2013 |
In this DVD, we will discuss the new "sunshine provisions" in the Patient Protection and Affordable Health Care Act ("PPACA") and its implications and effects on clinical trial operations. Key topics to be addressed: Insurance coverage and strategies to improve clinical trial enrollment What is the Sunshine Act and what are the company’s legal requirements? Opportunities in the Biosimilars FDA rules and changes in operations What are first steps and strategies to become compliant with state and federal laws? How can companies maintain flexibility in dealing with evolving legislation? What business processes and systems are involved? Implementation struggles: Centralization of all payments; FMV process and standardization and the effect Change Management with Study teams: The balance of compliance and challenges of patient recruitment, site shortage
EMR/EHRs: Utilization of Electronic Health Record Data EMR/EHRs: Utilization of Electronic Health Record Data
February 6, 2012 |
In this DVD, we will discuss the potential benefits and risks involved in mining information outside of controlled trials to create insights on diseases, drugs, and patient populations and to optimize the conduct of clinical trials. Key topics to be addressed: •Using EHRs to support clinical protocol design, feasibility determination and optimization •Mining large EHR databases to support site identification through regional geographic heat maps •Leveraging EHRs for data-driven patient identification and recruitment: learning from the experience from a clinical research site •Understanding the limitations of current systems, including data quality issues •Recognizing the benefits and complexities of EHR–EDC integration •Navigating rules, regulations and policy: a US, EU and healthcare institution's perspective




Publications, Reports, & Whitepapers
Vaccines: The End of Illness
This report analyzes recent trends in medicinal chemistry and evaluates their significance for advancing R&D productivity. We consider technological modalities and market dynamics, with an emphasis on outsourcing and user views on the implications of current practices.
Digital Pathology Insights: Imaging Technologies, Expert Perspectives, Standardization, and Current Outlooks
This report analyzes recent trends in medicinal chemistry and evaluates their significance for advancing R&D productivity. We consider technological modalities and market dynamics, with an emphasis on outsourcing and user views on the implications of current practices.