Weekly News Roundup For Pharma CROs, CMOs — August 19, 2014
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
Making Sense Of Serialization After DQSA
An article on Packaging Digest entitled “What You Need To Know About Prescription Traceability” discusses serialization following the release of the Drug Quality and Security Act of 2013. The article goes into detail about the change of ownership and transaction details (“transaction statement” and “transaction document”), as well as packaging requirements and evolving EPCIS standards. Packaging Today also featured a recent article about the impact of Europe’s Falsified Medicines Directive and the way some pharma companies are keeping up with traceability requirements.
CDSCO Outlines Practices To Improve Drug Manufacturing
According to the Wall Street Journal blog, India’s CDSCO has released a list of practices to ensure that companies tighten inspection procedures, issue reports more quickly, and improve the process for qualifying inspectors, among others. This move was made following a rash of recent FDA inspections that turned up quality issues and tarnished India’s manufacturing representation. The CDSCO’s letter outlining proper manufacturing practices aims to serve as a step towards ensuring India’s reputation in the global pharma supply chain.
Trends Affecting Pharma Manufacturing Investments
The Pharm Exec blog highlights several trends in the pharma and biopharma industry that are promoting the need for smaller-capacity production facilities, and in turn affecting manufacturers’ investments. These trends include the shift to biologic-based drugs and the shift to emerging markets for production. As single-use technologies continue to take root, facilities are more able to scale-down and change portfolios quickly to meet industry needs.
Global Asthma Market To Hit $2.4B By 2021
According to Datamonitor Healthcare, the global asthma market is poised to grow at a rate of 1.4 percent by 2021. There are currently 6 treatments forecasted to be launched in this period, including GSK’s Breo, which is expected to top sales of Advair and Symbicort. Biologics will also generate approximately $2.7 billion in sales by 2021. It is expected however that the high target population and the high cost of manufacturing the drug could restrict commercial opportunities and impact pricing/reimbursement of asthma biologics.
Data Sharing Requires 3D Approach, Says EFPIA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) released an article arguing in favor of a 3D approach to responsible clinical data sharing. The 3 D’s that must be assessed include, Diligent ongoing industry efforts; Developments of external regulatory and legislative; and the need to align Divergent approaches.
Pharma Moves “Beyond The Pill” With The IoT
An article in Forbes discusses the trend of Big Pharma’s investments in The Internet of Things (IoT), including wearables, ingestables, and implantables. As the industry sees fewer blockbuster drugs, pharma companies are seeking new ways to provide value outside of the drug. According to Forbes, pharma companies are looking into “beyond the pill” value-added services, a majority of which are digital, that can ultimately help improve patient outcomes and make the companies more competitive in the market.
Pharma Talking points
The Indian Government has extended the deadline for pharma barcodes, The Economic Times reports. The deadline to place barcodes on mono-cartons has been extended to April 2015.
Amidst all the industry hype and public concern over the emergence of Ebola, the FDA issued a warning last week about the emergence of fraudulent products being sold online that claim to prevent or treat the Ebola virus.
According to Henry Miller for Forbes, clinical trial design needs to become more innovative in order to lower development costs and bring more drugs out into the market. In his article, Miller touches on the FDA’s proposed “adaptive design clinical study” and a “large, simple, randomized trial,” stating that the industry will need to “think outside the box” in order to ensure sub-populations have a place in clinical trial design.
The Partnerships In Clinical Trials blog discusses the recent decline in the Indian CRO industry following heightening regulatory pressures and an increasing lack of attention from the global life sciences and CRO industries.