Ed Price
Strong Growth, Speedier Approvals and Practical Innovation Dominate, Yet Shortages of Qualified Chemists and Raw Materials Continue to Raise Concern
Lorraine M. Rusch, PhD
We all love technology…right? Some of us will camp outside the Apple store for the next iPhone or rapidly adapt to the next gaming device or streaming capability. It is exciting to embrace new technology, be current in the field and incorporate new capabilities rapidly into your life and work. It is easy to forget that with evolving technologies there are winners and losers (for anyone old enough to recall the Beta and VHS wars, or MySpace versus FaceBook, and others).
Kieran Crowley, PhD
The pharmaceutical research and development (R&D) industry has changed significantly over the last decade. In particular, big pharma is transitioning to a leaner business model that relies heavily on external partners. Since 2007, the explosion of biotech has resulted in a sharp increase in the number of companies actively engaged in research, more than doubling the number of drug candidates under development (Figure 1).
Jerilin Kenney
In an age of precision medicine and big data, we have more opportunities to see, identify and treat disease than ever before. New direct-to-consumer testing solutions, such as 23AndMe and Ancestory.com, have made us acutely aware of our susceptibility to disease and given us renewed vigor to tackle it through new techniques and treatment pathways. However, the ability for patients to benefit from these cutting-edge new treatments – be they drugs, medical devices or biological solutions such as vaccines or gene therapies – rests solely on the success of clinical trials.
Megan Berkowitz
In 2017, Merck was one of many companies targeted by a ransomware attack, known as “WannaCry.” Reuters reported that this attack “disrupted production of some Merck medicines and vaccines,” at a high cost for the company. In addition, work was disrupted for a huge number of the company’s employees, many of whom rely on computers for the vast majority of their work.
If current trends hold, it is expected that new parenteral products will be increasingly complex, requiring nonstandard manufacturing technologies subjected to higher standards of regulatory scrutiny and market expectations.
Tea Rajic
Now more than ever, ensuring the safety, quality, and timely delivery of pharmaceutical products to their final destination is a challenging and costly endeavor. With the tight regulation of supply chain systems, and the U.S. pharmaceutical market expected to grow to a value of $550 billion by 2020, pharmaceutical companies have little room for error when it comes to balancing careful cargo monitoring with reasonable cost output.
Luke Gill
Advances in our understanding of the genetic drivers of cancer and the immune system’s complex response to cancer have led to significant breakthroughs in the treatment of hematological malignancies. While gene therapy technologies are addressing unmet needs in hemato-oncology, the design and execution of clinical trials of these therapies can be challenging.
Amitkumar Lad, PhD, Sunny Christian, MS, Anvit Vasavada, M.S., Hemant N. Joshi, Ph.D., MBA
This quarterly review on new drug applications contains data for applications approved for the first time during the fourth quarter of 2018 which includes New Molecular Entities (NMEs) and new biologics. A total of 46 applications were approved by the FDA during these three months.