ARCHIVE - ISSUE EIGHT - JUNE 2014               COVER   -   FEATURED PICTORIAL   -   TRAINING   -   LIFESTYLE   -   REVIEWS               ARCHIVE - ISSUE EIGHT - JUNE 2014

Spotlight on a Sure Shot

This issue’s spotlight is on Sure Shot co-leader Becca. 

Becca is Vanessa Aguilar's coach.

Becca has been leading our San Antonio chapter since its launch in 2012, while also competing regularly in IDPA and 2-Gun matches. She’s been a huge proponent of the shooting sports, and a great shooter as well! But this beauty’s got brains—Becca spends her days working as a Research Scientist! What does that mean, exactly? Becca explains:

I graduated from college into a broken economy. I had a Bachelor’s Degree of Science in Biology from UTSA and no job prospects. I was taking any job I could get my hands on, ranging from receptionist positions to high-tech DoD contracts that put me in an exotic locations for 2 weeks at a time, only to leave me  broke and jobless at the end. I finally accepted a full-time job in San Antonio at a Rare Earth metals company, working as an administrative assistant  rather than utilizing my hard-earned degree. In 2010 I got a job offer out of seemingly thin air from a small San Antonio based pharmaceutical company. They were in the stages of completing a Phase II clinical trial for a novel chemotherapy treatment with huge potential. When I interviewed, there were only 4 employees, and I was told the future of the company was uncertain and may not be around for more than another 3 months or so. Aside from my hobby as a thrill-seeking gun enthusiast and competitive shooter, I  would not consider myself a risk-taker in my career or personal life. This time, however, I had a feeling that fate was calling my name (also, I got a fortune cookie telling me to take the job!). I had to make a crazy choice between staying in a permanent and relatively secure position which I despised, or accepting an extremely high-risk venture in an area that interested me greatly. I chose the latter, and 3 and a half years later, I can finally say I’ve found a job that suits me perfectly. 

It wasn’t easy at first. We had only 4 other employees at the time I started: three employees with Bachelor’s of Science degrees and minimal experience in the pharmaceutical industry, and an Office Manager. We had no guidance outside of sporadic input from the Board of Directors, and almost no funding. If floors needed cleaned, we cleaned them. If a door needed fixed, we fixed it. My job title for the first two years of employment included everything from purchasing and receiving to general facility maintenance to the development and implementation of complex biopharmaceutical assays and manufacturing protocols. My main duty was to manufacture drug product to support clinical trials for our novel drug, and to perform research and development for our side project, a generic version of one of the most popular new chemotherapy treatments on the market, Doxil®.

Becca coaching Vanessa during the filming for Nightline last year.

We had an extremely rudimentary cleanroom with a manufacturing process that lasted up to 14 straight hours. I felt like I was in a crazy Sci-fi movie when I was all dressed up in my cleanroom gear! The technology behind our products is very high-tech. The major problem with many chemotherapy drugs is that once they are administered they  begin destroying cells all throughout the body, which is responsible for most of the horrible side effects associated with chemotherapy. Nanoencapsulation technology has provided a major breakthrough in many areas of medicine, especially cancer treatment. By developing and perfecting a complex manufacturing process, we are able to take these highly toxic chemotherapeutic compounds and nano-encapsulate them inside delivery vessels called liposomes. These tiny vessels are engineered to target solid tumors. Once the liposomes reach the tumor site they release their toxic compound directly into the tumor, greatly minimizing the exposure to the rest of the body and reducing the amount and severity of side effects experienced by the patient. The manufacturing of liposomal formulations for chemotherapeutic agents is possible in only a few laboratories in the world, due to the highly complex nature of the manufacturing process and the strict regulatory requirements imposed by the FDA and EMA regulatory bodies.  I was pushed to my limits to go from a person with virtually no previous experience in the pharmaceutical sector to an expert in the field of liposomal drug maufacturing and process engineering. While I still find the thought of myself as “a leading expert” to be laughable, that is exactly what my tiny team and I had become, practically overnight! 

Becca in her cleanroom suit.

Not long after I started, the Board hired our current President and CEO to oversee operations and hire more people.  Then, a major development in the pharmaceutical industry changed my job forever. Unsatisfactory conditions in the Johnson & Johnson owned plant that manufactured our competitor drug Doxil® had caused the FDA to shut them down, producing a shortage of this important medicine. The shortage made headlines around the world as thousands of patients were put on a waiting list to receive life-saving treatments. Stories abounded about patients desperately buying black-market versions of Doxil® out of pharmacists’ trunks, traveling the world, paying fortunes and doing the unthinkable to obtain the medicine for themselves and their loved ones suffering and dying from cancer. Soon, Congress began to pressure  Johnson & Johnson for a solution, which they were unable to provide.  We became a headline too, since we were among the 3 companies in the U.S. currently working on a generic version on Doxil®.  We began to feverishly work on an FDA submission that would push for our expedited approval onto the market, but pressures and pay-offs from Big Pharma got our application pushed under the rug. But we didn’t give up, instead, we broke into an all-out effort to steer our tiny company through every unforseen loophole and over every hurdle thrown in front of us to get our drug to market. Suddenly, my job was no longer about going to work every day and getting a paycheck. It was an all-out battle to fight Big Pharma and put out a drug that had the potential to save tens of thousands of lives every year. 

After three and a half years, we are finally close to our goal. With the help of numerous private investors and donations, we have raised millions of dollars in funding to see us through our work. Although we did not gain the expedited approval from the FDA which would have helped us make our drug immediately accessible to the thousands of patients waiting for Doxil®, we have persevered  in our efforts and are now in the final stages of a clinical study that will allow us to commercialize our product by 2015.  I have since moved up in the company from a manufacturing and R&D scientist to a member of the Quality team. We are working towards getting ready for commercialization through process improvement initiatives. We've also been funding my personal efforts to become a Certified Six Sigma Green Belt, which will greatly advance my career in Quality. I take the test in two weeks! 

Becca spending time on the range.

My experience here has been a whirlwind. At first I would lay awake at night worrying about my “crazy” decision to take a high-risk job with an uncertain future. Now I lay awake at night wondering how the results from our clinical trials will turn out, and how we will handle the next roadblock thrown in our path. But through all the chaos, I am at peace knowing that I’ve finally found a purpose in my life after college. When this adventure ends, I hope to find a position at another small, high-risk pharmaceutical start-up, and continue to fight the good fight to help bring effective and affordable treatments to patients in need. 

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