The Vault series

Insight on what matters - so you can transform your business.

How to Submit an eCTD to the FDA

11 August 2017

To market a drug or biological product in the United States, you must provide adequate information to the FDA demonstrating that the product is safe and effective for the conditions prescribed,...

Four Ways to Value Your Early Drug Candidate

14 July 2017

Fundamental to a biotech company's success is the degree to which they effectively partner with large pharmaceutical companies to advance their drug candidates and to raise funds. In the process of...

Best Practices for Selecting Medical Device Suppliers

11 July 2017

Maren Nelson has developed multiple medical devices during her career. Her projects have included internal and external resources for both the development and manufacturing of new products and...

Novel FDA Drug Approvals for 2017

15 June 2017

Each year, the US Food and Drug Administration (FDA) approves a wide range of new drugs and biological products. The drugs are classified as either new molecular entities (NMEs) or new biologics...

The Top 5 Reasons to Attend the BIO International Convention

06 June 2017

 The Bio International Convention is the largest and most influencial global event for the biotechnology industry. This year the convention will be held in San Diego from June 19 - 22.  To learn more...

Outsourcing Trends: What CMOs Need to Know

06 June 2017

There’s both good news and bad news for today’s Contract Manufacturing Organizations (CMOs). The good news is that outsourcing is a trend that appears to be remaining strong. Pharmaceutical companies...

WHY DOES HEALTHCARE GET HACKED?

12 May 2017

According to a website maintained by the Department of Health & Human Services Office for Civil Rights, over 100 healthcare providers have suffered security breaches in 2017, and it’s only May. The...

Why Clinical Trials Fail

10 May 2017

GlaxoSmithKline CEO Andrew Witty once commented on the high cost of drug development, saying, “If you stop failing so often, you massively reduce the cost of drug development.” So, why do clinical...

HOW TO CHOOSE A CONTRACT RESEARCH ORGANIZATION

28 April 2017

For the pharmaceutical industry, outsourcing to Contract Research Organizations (CROs) is an integral part in developing drugs. Both large pharma and smaller biotechs, who partner with CROs for...

The 4th Due Diligence Summit for Life Sciences

11 April 2017

  On May 18-19, 2017 ExL Events will host the 4th Due Diligence Summit for Life Sciences at the Hyatt Regency in Boston. This is the only life sciences event that is focused on the needs of...

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