Register now for the Indiana Clinical and Translational Science Institute

The Indiana Clinical and Translational Sciences Institute is hosting its 7th annual meeting on September 11, 2015. Young researchers will be recognized and a major highlight of the event will be the awarding of the second Watanabe Prize in Translational Research to the keynote speaker, Carl H. June M.D. To find out more about the event, go to Indiana Clinical and Translation Science Institutes website.

When: September 11thnew-ctsi-logo

Time: 8am-3pm

Where: Hine Hall on IUPUI’s campus in Indianapolis

Registeration is occurring now, to register click here!

Pearl announces 5 years of business

Pearl will be hosting a celebration for its 5 fantastic years of being in business. Pearl opened in 2010 to help fast-track therapeutics and diagnostics for patients in the life science industry. Refreshments and appetizers will be served.

When: August 6th, 2015Photo of 29 E. McCarty Pearl Pathways office

Time: 4:30-7:00pm

Where: 29 E McCarty Street, Indianapolis, IN

RSVP to sjancin@pearlpathways.com by July 31st.

We look forward to seeing you!

openFDA’s one year anniversary

It has been one year since FDA launched its initiative called ‘openFDA’. OpenFDA was an order brought by the White House to help others have access to the agency’s public data. One type of information users now have access to is FDA’s long list of application programming interfaces (APIs) such as medical device reports, approved drug labeling and many more.

FDA is hoping to spur more innovation not only throughout the agency but through the surrounding communities. Communities are the main reason that openFDA has been so successful, and FDA hopes to continue its success by involving them more through prioritizing which data the community is interested in.

To read more on Michael Mezher’s article in RAPS, click here.

FDA and Google joining forces?

The US Food and Drug Administration (FDA) and Google met last month to talk about a new ‘adverse event trending’ system.

FDA currently tracks adverse events in their FDA Adverse Event Report System (FAERS). However there are concerns that this system underreports since patient and doctor reporting to this system is voluntary. While it is mandatory for drug makers to report via FAERS, patients and doctors can as well; however, because this reporting is voluntary, many fear they are missing important adverse event trends.

Adverse reports are vital for drug safety for patients, as often is the case, not all adverse events are found during a clinical trial. To fix the underreporting problem, FDA has explored social media, search engine, and internet sources for additional information.

As reported by Michael Mezher on www.raps.org, FDA and senior leaders at Google met last month. Perhaps FDA is exploring how to collaborate with Google to develop a new system in drug-safety surveillance.

To read more, check out Michael Mezher’s article in RAPS here.

Congress officially passes the 21st Century Cares Act

On July 10th, the 21st Century Cares Act was passed which will increase the NIH and FDA funding. This increase in funds is to install a new framework for evaluating patience’s experience with drugs and to create a new national pediatrics research network and will be impacting CRO’s.

Those against this bill are worried about how the bill will be paid for and their affects of bring new cures to the market. Although the payment of the bill is not stated, many are looking forward to see how the bill will help the world.

To read more on Zachary Brennan’s article in outsourcing-pharma, click here.

What will happen to the medical device tax?

Earlier this month, efforts were made once again to repeal the medical device tax under the Affordable Care Act (ACA). The medical tax is unpopular for both Republicans and Democrats and in June the US House of Representatives passed a bill called Protect Medical Innovation Act in a 280-140 vote. The original tax (created in 2010) would provide a 2.3% tax on the price of a medical device. Many were hoping that this tax would provide the United States with $30 million in revenue.

Although many are hoping to get rid of this tax, the bill will be facing an up hill battle as the White House has announced that it will veto the bill.

To read more on Michael Mezher’s article in RAPS, click here.

What to know about FDA’s priority review vouchers

Since 2007, FDA has been issuing priority review vouchers for pharmaceutical products. In 2015 the newest priority review vouchers to focus on reducing time and cost of drug development. Developing a new drug takes a lot of time and money. In the United States, about every 1 in 10 drugs that reach the phase 1 clinical stage, get approved. Even if a drug does get approved it can take up to a year or more to receive the funding or find patients for clinical studies.

The reason for these vouchers is to spur drug development. The vouchers give a company the ability to have a drug reviewed under FDA’s priority review system. Ultimately these vouchers could lead to finding new drugs or a cure for many diseases, particularly rare or difficult to treat diseases.

To read more, check out Alexander Gaffney’s priority review vouchers article at www.raps.org and click here.

Efforts to repeal tax on medical devices making way in Congress

The fight continues. Recent efforts have been made (again!) to repeal the tax on medical device companies, which was a provision in the Affordable Care Act. The revenue from this tax is estimated at about $30 billion in the next ten years. Those in favor of the tax are hoping it will help support the expansion of health coverage throughout the United States. Medical device manufacturers are opposed.

To read more about this ongoing saga, check out Joseph Keenan’s recent article in www.fiercemedicaldevices.com.

Should GMP include environmental impacts in their guidelines?

SumofUs, an environmentalist group, wants the good manufacturing practices (GMP) to include environmental impact in their guidelines. Both the environmentalist group and industry believe that the Pharmaceuticals Supply Chain Initiative (PSCI) does not go into enough detail on the environmental criteria.

In a recent report on “Big Pharma driving the rise of killer “superbugs””, it was found that there is an increasing amount of an antibiotic resistance. This could impact the food chain and the health care industry if we don’t find a resolution.

To read more about the recent findings of SumofUs and Gareth MacDonald’s article in in-Pharma, click here.

Efforts to encourage FDA to ease up on social media are being made

A Missouri Congressman has proposed a bill which would allow Pharmaceutical companies place more content online. Rep. Bill Long (R-MO) originally discovered the lack of presence on social media from these companies while working on the 21st Century Cures Act.

One of the main drivers of this Bill is to allow companies to use hyperlinks, linking users to the risks and benefits of search diseases (i.e. cancer). The bill hopes to allow individuals to know what to expect when they or a loved one is diagnosed. Currently the bill still has a way to go before it reaches the floor as it is in the House and Energy Commerce Subcommittee of Health.

Want to know more about why Rep. Long wants to pass this bill? Continue reading here.