Weekly News Roundup For Pharma CROs, CMOs — July 22, 2014

By Anna Rose Welch

FDA Elaborates On PASs For Generic Manufacturing

The FDA has issued a new guidance explaining how the agency handles Prior Approval Supplements (PAS) under the generic user fee amendments (GDUFA) program, Regulatory Affairs Professionals Society (RAPS) says. FDA approval of the PAS is a key step in ensuring a change in a drug’s manufacturing process can be implemented. The FDA has specified that a decision for PASs will be announced within 6 months following submission or 10 months if a facility inspection is required. In 2015, the FDA hopes to meet these standards in 60 percent of cases, followed by 75 percent in 2016, and 90 percent in 2017.

API Manufacturing Moving Overseas

PMT Magazine features an article highlighting the current regulations and developments in GMP and API supply chain integrity. Currently, the cost of a drug depends heavily on its API component. China currently serves as a leader in the world’s generic API production, accounting for 70 percent, while India is responsible for 19 percent of generic APIs. Companies in the U.S. and EU have begun turning overseas for API manufacturing — indeed nearly 80 percent of U.S. and EU APIs are from foreign countries. The article also presents information on the differences in GMP standards and their impact on API quality; harmonization of GMP standards for APIs; and implementation of supply chain pedigree.

How Will Big Data Affect Big Pharma?

The Health Affairs Blog sets out to define the differences between Big Data, Real World Data (RWD), and Clinical Trial Data (CTD). The article discusses RWD’s and Big Data’s impact on drug discovery and development, health benefit designs, and where ownership of all this data lies. While there is a lot of debate over the ownership of this data, the blog’s authors argue that patient advocacy and the creation of a public-private consortium could be the answer. Only through the creation of a “public good” data repository and the development of incentives promoting collaboration will scientific progress be accelerated.

Adopting Aseptic Techniques Key For Manufacturing Safe Products

According to Pharmabiz.com, a recent workshop in India on aseptic techniques and practices called to attention the need for pharma manufacturers to keep up with the adoption of aseptic technological procedures. In continuing to adopt and update these techniques, companies will minimize contamination by micro-organisms and ensure the safety of patients. The Indian Pharmaceutical Association held this workshop in a greater effort to educate manufacturers about the need to create a micro-organism-free environment for drug production.

New Indian Budget Gives A Little, Takes A Lot

The India Times reports that India’s new budget from the BJP-government aims to boost “Health for All,” in particular “Free Drug Service” and “Free Diagnosis Service.” The government plans to open a new AIIMS-like institution, several drug testing laboratories, and rural health centers. The budget will also be used to bolster 5 research centers. However, the budget still leaves much to be desired, especially in sight of the government’s levy of service tax on clinical trials. As The Business Standard reported, this levy could lead more domestic, research-oriented pharma companies’ trials overseas, damaging the domestic CRO industry.

Biosimilars Markets To Hit $35B

A new Allied Market Research Report suggests that the global biosimilars market is pegged to reach $35 billion by 2020. This would be a drastic uptick from the $1.3 billion the market was worth in 2013. Improving regulatory pathways, more strategic collaborations, and blockbuster drug patent expirations are all supporting this growth.

Pharma Talking Points

In a recent communication to the EU and European Parliament, the European Commission said that the EU needed to pick up the pace in its adoption of Big Data.  According to Out-Law.com, the communication said that EU countries have been “slow to embrace” big data’s potential in various industries in comparison to other countries. The EC has proposed a new public-private partnership (PPP) to promote the use of Big Data and to fund projects aimed towards developing personalized medicines. 

Boston Children’s Hospital Researchers have found that ADHD drug trials have not been focused on determining the long-term safety of these drugs, the Boston Globe says. While these approved ADHD drugs aren’t necessarily dangerous, the study found that many of the initial approval trials did not focus on potential safety issues. Only 5 of the 32 clinical trials carried out on 20 FDA-approved ADHD drugs focused on the safety of the drug. Researchers are now calling for more emphasis to be placed on long-term drug safety in the approval process of ADHD drugs. 

According to the Daily Mail, leading stem cell scientist Robin Lovell-Badge says that genetically modified farm animals could be used in research aimed at tackling drug resistance. Genetically altered animals, Lovell-Badge says, “Allow us to design hopefully cleverer experiments to get to the bottom of a particular genetic disease and to create better models for other types of human disease". While rodents and fish are still popular test animals, sheep and pigs are also increasingly being used more in research—boasting usgae increases of 7 and 10 percent respectively.