‘Breakthrough’ drugs speed path to cures and the NBA

By Katie Kerwin McCrimmon

Hovering at just over 4 feet 5 inches, the Broomfield second-grader is a smidge short for the NBA.

But thats not stopping Caleb Nolan from planning his career as a basketball star and neither is his cystic fibrosis (CF).

Diagnosed at birth with the rare disease, Caleb receives regular care at Childrens Hospital Colorado and happily plays basketball, soccer, baseball and football. Aside from licking salt on the sidelines to thwart dehydration, hes like any of the other boys on his team.

And thanks to a new medication called Kalydeco that has been fast-tracked to market, Calebs lungs are in excellent shape and his future is very bright.

Just decades ago, children born with CF had a bleak outlook and could hope to live only into their teens. Doctors could do little to help them except to treat the frequent infections that attacked and damaged their lungs. Now the official life expectancy for Caleb and kids like him is 37 and Calebs doctor expects that number to keep going up.

On Friday, Caleb got the chance to meet Sen. Michael Bennet, the Colorado Democrat who supported the legislation in Congress that is helping drugs like Kalydeco get to patients faster.

Kalydeco received approval last year and has now been designated as a breakthrough therapy. This faster pathway for drugs to make it to market is based on a provision that Bennet wrote and that Congress approved last July as part of the FDA Safety and Innovation Act.

Its been making a big difference. Its been helping me a lot by clearing out my lungs, Caleb said of Kalydeco, one of about 25 pills he takes each day. I get sick less with Kalydeco. I sometimes dont even notice I have CF.

Nolan chatted and joked with Bennet, giving the Senator a hard time when he said that he believes kids should have to go to summer school all summer long.

But I cant get anybody else to agree with me, Bennet confided.

Yeah, I dont agree with you either, Nolan said.

Neither do my daughters, said Bennet, the former superintendent of the Denver Public Schools.

Charmed by Nolans candor, Bennet said the trip to Childrens Hospital Colorado was a refreshing change from the gridlock on Capitol Hill. Seeing the results of the new legislation and meeting Nolan marked one of his favorite days since joining the Senate in 2009.

This is easily one of the highlights of the last four years, Bennet said as the 7-year-old schooled him on CF treatments, hoops and his dislike for spelling and vocabulary tests.

Bennet said that speeding safe and successful drugs to market makes sense for both patients and drug developers.

Essentially what this legislation did was say that if you are finding drugs and they show exceptional results for patients, for heavens sake, we should get them to market (faster). There ought to be a priority for those kinds of drugs, Bennet said.

He said Colorado is home to about 600 bioscience firms and that hes trying to do all he can to speed the approval of promising drugs. He said its getting harder and harder for bioscience firms to attract venture capital since drug approval can take as long as 15 years. In the case of drugs that receive breakthrough designation, approval can come in as few as three to five years.

Most importantly, it makes a huge difference for patients, Bennet said. The rollout has been faster than I expected.

Kalydeco has been shown to be effective for a small percentage of CF patients who, like Caleb, have a specific gene mutation. But theres great hope that in the future, the drug can be paired with other new drugs to help a much higher percentage of people with CF.

Childrens Hospital Colorado houses the largest CF clinical care center in the U.S., with more than 500 young patients. Caleb was originally diagnosed with CF as a newborn because Dr. Frank Accurso, Calebs doctor, spearheaded legislation to make CF screenings standard at birth. Thats now the case across the country.

CF affects about 70,000 people worldwide and about 30,000 in the U.S. Known as an orphan disease because its so rare, advocates for people with CF have had to create an entirely new system for drug development known as venture philanthropy. (Read more: Venture philanthropy new cure for deadly diseases.)

In essence, theyve had to raise money and drive the drug development process themselves.

Even though the number of patients is small, the impact is significant, said Accurso who helped lead the clinical trials for Kalydeco.

We all believe it is life-extending and in some cases life-saving. It certainly improves the quality of life, Accurso said.

Calebs dad is a UPS driver and he personally delivered his sons first treatments of Kalydeco.

Now Calebs mom has given herself permission to imagine her son years from now.

Weve always held on to hope and faith, Melissa Nolan said. Now we can see the future.