Research & Development Solution Center

  1. Technology Considerations To Increasing Clinical Trial Efficiencies With Risk-Based Monitoring 1/31/2014

    When it comes to site monitoring, pharmaceutical companies have traditionally taken a conservative approach, performing frequent on-site monitoring and 100 percent verification of all data. This practice goes beyond what’s required, says the FDA in its Guidance for Industry: Oversight of Clinical Investigations — Risk-Based Approach to Monitoring, issued in August 2013. The agency asserts that sponsors adopted current practices based on a “perception” that 100 percent source data verification (SDV) was the FDA’s preferred way to meet monitoring obligations.

  2. Mission TransCelerate: Transforming The Drug Development Terrain 1/8/2014

    During the ill-fated 1970 Apollo 13 mission to the moon, it was astronaut Jack Swigert who alerted ground control that something had gone terribly wrong when he uttered the phrase, “Houston, we’ve had a problem here.” Those same words seem very fitting to the current state of affairs around the skyrocketing costs of drug discovery. Recent estimates place the expense of successfully bringing just one drug to market at between $350 million and $1.2 billion. However, in the last decade, companies having brought 4 to 13 drugs to market have watched the price tag reach stratospheric heights — orbiting $5 billion+. “I think the pain point has reached a threshold that’s no longer bearable,” states Dalvir Gill, Ph.D., CEO of TransCelerate BioPharma.

  3. Prevent Drug Development Costs With The KISS Principle 1/7/2014

    Ever heard of the KISS (keep it simple, stupid) principle? The general idea behind it is that systems perform best when the design is simple, not complex. My favorite example demonstrating the application of KISS, as well as the impact of failing to do so, is captured in a scene in the 1995 movie Apollo 13. An incident necessitates three astronauts use the lunar module (LM), a ship built just for landing on the moon, as a lifeboat to survive.

  4. Despite Challenging Economic Environment, Biotechs Are Booming 1/6/2014

    The U.S. economy has been unstable for many years now, and this year, the U.S. experienced the first government shutdown since late 1995, causing many investors to become wary of the market. In spite of economic uncertainty over the budget deficit, biotechs remained a “safe haven,” according to CNBC.

  5. The Next Emerging Markets After BRIC 12/9/2013

    According to the Business Perspectives on Emerging Markets 2012-2017 Report by Global Intelligence Alliance (GIA), Brazil, Russia, India and China (BRIC) will retain their leading positions as the worlds’ top emerging markets for 2012-2017. In a ranking of the top 30 emerging markets international companies plan to target in 2012-2017, most of the non-BRIC emerging markets are in Asia or Latin America, with Indonesia, South Africa, Vietnam, Mexico, Turkey and Argentina ranking highest amongst secondary emerging markets.

  6. Real/Future Information Risk of R&D – CROs 12/9/2013

    The jury is still out on the ultimate impact of healthcare reform in general, and perhaps this impact is even murkier in the life sciences  space. Certainly there will be very dramatic changes to the providers and payers, but it is more difficult to see exactly how the changes will manifest themselves for the remaining entities in the health sciences arena.

  7. Biotech R&D Spending Jumps 5% 12/9/2013

    “With revenues growing, it is no surprise that biotech firms are again investing substantial dollars in research and development,” said Ryan Starkes, partner and leader of the Life Sciences Practice at BDO.  “However, broader economic challenges persist. Smaller companies are struggling to generate returns on their past investments, and continue to target innovative medicines in hopes of greater revenues down the road.”

  8. Executive Insights From A Successful Entrepreneur: Creating Companies And Looking At Problems In A Different Way 12/6/2013

    Daphne Zohar is the founder and managing partner of PureTech Ventures, a Boston-based venture creation firm specializing in translating breakthrough research from top tier academic institutions into therapies that will impact human health and well-being. A successful entrepreneur, starting her first company at the age of 16, Zohar has been recognized as an influential and innovative force in biotech. She recently sat down with me to share some of her life science industry insights, and PureTech’s approach to creating companies and looking at problems in a different way

  9. Companies To Watch: Vivaldi Biosciences 11/1/2013

    Vivaldi biosciences is aiming to parlay its new vaccine target a live-cell approach to accomplish an unprecedented level of protection against the flu, using live attenuated influenza vaccines (LAIVs) to stimulate multiple arms of the immune systems: antibodies, T-cells, and interferon.

  10. NeoStem's CEO Spearheads Stem Cell Research Collaboration With The Roman Catholic Church 10/31/2013

    Robin Smith, M.D., CEO of NeoStem, strikes up a conversation about stem cell research benefits with one of the largest, wealthiest organizations that are very publicly against embryonic stem cell research – the Roman Catholic Church.