LSL Web-Exclusive Content

  1. Communication For Leaders: How To Share The Good And The Bad

    What do you do when the reality of a commercial launch is finally within reach? The fact is, there’s no one-size-fits-all approach.

  2. Me-Too Drug Sales Return Via Competitive Pricing Or Marketing

    Three non-oncology and three oncology examples since 2014 point to higher rates of successful me-too drugs versus a handful of drugs from 2005 to 2012.

  3. Best Practices In FDA Orphan Drug Submissions

    Since 1983, pharmaceutical developers have been incentivized by the FDA via an Orphan Drug Designation (ODD) program to develop products to treat rare diseases and/or conditions. The program awards orphan status to drugs that show likelihood of benefitting an afflicted population that might not otherwise be the focus of targeted development efforts. To meet the FDA’s specific requirements, sponsors have found specificity matters. Though other steps in a drug’s life cycle require a wider scope, when it comes to defining the orphan population and making a case for the drug’s potential efficacy in that population, a razor-focused effort is key.

  4. Do We Need Competency Standards For Clinical Researchers?

    For clinical researchers, patient-centricity is not a buzzword. It reflects a commitment to patients. They should always be at the center of everything we do.

  5. What’s the best approach for effective use of Real World Data – Functional Focus or Enterprise Strategy?

    The 21st Century Cures Act encourages the use of Real-World Evidence (RWE). But what’s the best approach for this relatively new arena of Big Data and analytics?

  6. Orphan Drugs And The Case For Standardization

    Would a standardized approach to orphan drug development result in more and better therapies being made available to patients? We think so.

  7. The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections to help determine whether statutory and regulatory requirements of the respective authorities have been met.

  8. Bioprocessing Trends To Watch In 2018

    The current situation in biopharma is exciting, with new technologies, biosimilars, cellular and gene therapies, and opportunities in emerging markets.  And these innovative platforms are going to continue to need improved manufacturing technologies in the future.

  9. How The U.K. Became A Destination For Biosimilar Clinical Trials

    The biosimilars market is going to heat up considerably over the next three years, but is the NHS ready for the biosimilars boom?

  10. 10 Ways to Speed Up in 2018

    As a leader, your job is to make decisions that help your team navigate the endless demands on their time – and to protect energy and resources for the actions that matter most. Here are some suggestions on how to do that.