StratAcuity

On January 12th I presented in front of the FDA Advisory Committee relating to the pending approval of Liprotamase from Alnara Pharmaceuticals (a wholly owned subsidiary of Eli Lilly) on behalf of CF parents/caregivers. It was a valuable learning experience for sure, but one with an unfortunate outcome.

Liprotamase is a pancreatic enzyme capsule that would largely benefit Cystic Fibrosis patients (30,000 people in U.S.) of which 90% suffer from pancreatic insufficiency. CF patients are required to swallow enzymes (presently only derived from ground up pig pancreases coated in plastic) with every meal and snack so that they can absorb fat and nutrients. It’s an exhausting, unpredictable and unfortunately necessary regiment.

My argument for FDA approval of Liprotamase boiled down to three points.

1. Babies with CF could greatly benefit from an enzyme that could easily dissolve in liquid to ease the current parental/caregiver burden.
2. The new drug could be a lifesaver in the event of a devastating viral outbreak in the world’s pig population. In short: No pigs means no enzymes for CF patients who would potentially starve to death.
3. The new enzyme capsule could greatly improve CF patient’s quality of life. Today, my 11 year old daughter Kate takes about 20 porcine-based enzymes each day, while the approval of Liprotamase would result in her only having to take 1-2 pills per meal!

Based on Liprotamase receiving their NDA from the FDA in 2010 and having read the glowing reports from Alnara’s clinical trials, I was expecting this meeting to basically be a “slam dunk” approval. You can imagine the shock I was in after the FDA voted 7-4 to not grant the approval.

The next step is for the Alnara/Lilly/CFF team to meet with the FDA to see what exactly that panel needs to feel more comfortable about approving Liprotamase and also to continue educating them about those living with CF.

And while the meeting’s outcome wasn’t what I expected, I left with a much better understanding of the incredible effort that goes into the clinical process of developing a pharmaceutical and getting FDA approval.

I have an intensified admiration for the MD’s, Clinical Operations, Regulatory Affairs, and everyone else whose lives involve clinical trials and FDA approval. The Alnara clinical team that I saw in action on January 12th was the most organized group of warriors I could imagine.

One has to wonder about the decision-making process of a 12-member FDA advisory panel that has no CF-specific expertise. Are they really hearing and understanding the concerns of the thousands of parents and patients pleading for this product?

Clinical trials proved Liprotomase to be a very safe and effective product that could be of huge benefit to CF patients.

I just hope FDA scrutiny like this doesn’t unnecessarily burden the type of cutting-edge biotech and pharmaceutical development leaders that we at StratAcuity help move forward by making sure they are staffed with the most talented scientists.

I’m keeping my fingers crossed that the FDA will make the right decision by approving this groundbreaking capsule sooner than later.

Excitement over advancements in cystic fibrosis research/care is always palpable when you step into one of the most historic operating rooms in the world to gather with top medical minds in the field.

Massachusetts General Hospital’s circa-1821 “Ether Dome” played host to the Richard C. Talamo Memorial Lecture on November 19 and it was only fitting that StratAcuity was a sponsor for the third year running.

As a top biotechnology/pharmaceutical recruitment firm, StratAcuity is intimately familiar with the type of scientific talent needed to tackle complex diseases and genetic disorders like CF – a life-threatening genetic disorder that impacts the lungs and digestive system.

StratAcuity was born in part by its founders desire to make sure top scientists are plugged into cutting-edge companies working to extend and improve the lives of those living with CF and other illnesses.

It’s for this reason that our recruiting firm has been sponsoring a Talamo Memorial Lecture that honors the memory of Richard Talamo – an outstanding pediatric pulmonologist who practiced in Boston and cared for many individuals diagnosed with CF.

On Nov. 19 professionals from around the country gathered in the historic amphitheater to share advancements in CF science and honor those leading the charge whether it be in the laboratory or bedside.

Attendees heard from Bonnie Ramsey – the head of the Cystic Fibrosis Foundation’s clinical arm – and got the chance to marvel at the talent filling an Ether Dome that’s an experience in an of itself.

We at StratAcuity continue to be amazed by the dedication of those tackling CF and other complex diseases, but our staff is no stranger to the talented scientist and companies working in a Boston area rife with opportunity.

Our biotech recruiting firm works only with top scientists and is always looking to find the perfect career for the types of people recognized annually by the Richard C. Talamo awards.

The annual Talamo Lecture only makes us strive harder as we see the types of results that can be achieved when the right people are working on a cure.