Hiring. Genius. Today.
The StratAcuity Blog.

A Day with the FDA …

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.

Sponsoring what we believe in.

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.

Biotech Recruiting: Staying Ahead of the Employment Curve

Are you looking at the people who aren’t yet looking?

Considering the reality of the current economy it’s not surprising that many recruiting companies and human resources aficionados have no problem finding people looking for work whether it be in biotechnology or any other industry.

And while there are lots of talented people actively seeking opportunities, StratAcuity – a leading biotech/pharmaceutical recruiting firm - has long taken the position that many recruiters ignore a largely untapped resource.

There are millions of talented individuals who have the potential to be an asset to clients, but they aren’t searching for new opportunities … yet.

Reaching out to satisfied workers can generate positive outcomes in the future and essentially involves recruiters letting potential candidates know: “we are here when you are ready.”

Understanding “active” vs. ”passive” recruitment is realizing that an estimated 70 percent of people aren’t seeking a new job, but that doesn’t mean they shouldn’t be on your recruitment radar.

Think of it as reaching out to the satisfied and putting their talents on the shelf until their desire for a career change ripens.

They aren’t yet on the radar for the mega job-searching sites of the world and may never be if recruiters are proactive about reaching out to them.

StratAcuity became a leader in Boston’s biotech recruiting world by developing an ever-expanding cache of qualified candidates that doesn’t rely solely on those currently pushing resumes.

It’s about getting to know the “best of the best” in the biotech and pharmaceutical industry so our clients have the first crack at them if they decide to make a move.

Real Passion: Real Results

It’s the story of how the diagnosis of a rare disease in a newborn lead to the recruitment and placement of over 400 scientists each working towards new therapies and ultimately, cures. It’s our story at StratAcuity.

On a snowy February 18th, 2000 my wife and I learned our first born child, Kate had CF – a genetic life threatening genetic disease that impacts the lungs and digestive system.

It was difficult, but with the help of family, friends and the many people associated with the Cystic Fibrosis Foundation we made it through those first dark days and emerged with a plan to learn everything possible about CF, find ways to make a difference personally and do our part to make a difference.

Researching CF made me recognize that many Boston-based biotech/pharmaceutical companies had a vast number of job vacancies.

In my mind this meant progress was being delayed as long as those positions remained unfilled; a thought that still goes through my mind when accepting new search assignments.

Imagine that every person hired could be the catalyst toward the next successful drug development program. On the other hand, hiring the wrong person could possibly delay a program or even lead to it’s failure.

What if we could place scientists who fit better into those vacancies? An opportunity to create a superior method of recruiting top scientific talent for the Boston-area biotech industry was right in our backyard.

Having spent several years working closely with Rob Patten, Co-Founder, recruiting for the communications industry, we had a healthy admiration for each other professionally and the idea of partnering on this new idea seemed natural.

We set about pioneering this new means of filling biotech and pharmaceutical jobs. While it wasn’t easy our motivation to succeed was huge.

The fact is, Rob and I would be useless in a chemistry laboratory, but we both understood the importance of interpersonal chemistry between candidates and employers. We knew this type of chemistry would play a critical role in linking exceptional scientists to companies working on the frontlines of biotechnology.

We started by conducting an in-depth study to obtain in depth understanding of what makes a scientist tick and in the past 10 years have created relationships that have us working with over 80 companies.

It’s not surprising that our first client was a company working on a drug to treat cystic fibrosis, but nowadays we cover every imaginable therapeutic area.

Our placements throughout the Boston area continue to grow along with the number of individuals realizing we are the only biotech-specific recruitment agency focused more on the long-term success of our clients than our own bottom line.

It’s a focused approach that works on the assumption that even the most talented scientists must truly fit in with an employer to drive exceptional results. Our meticulous interview process ensures results that its clients can trust and in the past 10 years the company has grown from two people to roughly 40 full time and part time employees.

We’ve placed upward of 400 scientific professionals and boast a more than 90 percent offer-to-acceptance ratio.

And when our team isn’t placing people in careers, we’re leading efforts to raise money for the Cystic Fibrosis Foundation.

This past October we celebrated our 10th year as hosts for The Swing for CF Charity that saw 140 people hitting the links and over 300 attending the post golf bash. Through golf outings like this, Great Strides Walkathons, and other fundraisers, StratAcuity has helped to raise over $1,000,000 in the last ten years.

Whether it’s recruiting or charity, our staffers know each dollar raised and each successful hiring represents a step toward a cure for people like Kate.