In this article, we shine the spotlight on Dr Laurie Smaldone Alsup our Chief Medical & Scientific Officer. Laurie is an expert in clinical development and regulatory strategy, she is a challenger and problem solver and her passion is to support companies build effective global development strategies to bring innovative new medicines to patients who need them.
To live is to keep moving
“There is nothing easy about it”, says Laurie Smaldone Alsup, MD, NDAs Chief Medical and Scientific Officer. We were talking about the critical factors for a successful first meeting with a regulatory agency, such as FDA or CHMP to get input into one’s program. Done right these interactions could help to reduce your time to market, done wrong it could add years to your program. It takes the right skills, planning, and experience to get it right the first time. If Laurie makes it look easy, it’s because of her long-standing experience of being in the front lines of bringing new medicines to those who need them.
Opportunity and flexibility
Laurie has always been captivated by science. It started by running experiments with her father in grade school. At a young age she saw herself working in science in some way but as she grew, so did her interests and she got involved in a wide variety of activities. At the Bronx High School of Science, a competitive NYC high school she participated in modern dance, drama, stage design and writing as well as routine course work. Later in college she continued along this path exploring many artistic and scientific disciplines.
“I danced, I edited the university magazine while working hard as a pre-med student and a biology major and I absolutely loved it”, she says.
Her pursuits led her to the Yale School of Medicine where she realized that she really enjoyed the application of medicine to patient care. She discovered that she ‘just had a knack’ for interacting with patients and deciphering their illness and realized that this was what she wanted to do.
“When meeting a sick patient for the first time you need to pay attention”, she explains. “Taking a proper clinical history can be sometimes frustrating. You need to translate what the patients are saying into signs and symptoms of disease. If you can get a good dialogue going, you might be able to save time and not have to run so many tests”.
Thrive in the face of challenge
After nine years of medical training, including a fellowship in oncology followed by a couple of years as an attending physician, Laurie was recruited to Bristol Myers Squibb. She wanted to learn more about the industry side of running clinical studies and thought she would try it out for a couple of years and then return to academic medicine. At BMS, she was thrown into the deep end right from the start, working on a phase III oncology program requiring her to quickly get up to speed. Her responsibility was to partner with many scientific disciplines internally and externally, communicate with the FDA, European and Canadian health authorities and manage oncology opinion leaders and collaborative groups globally.
“That experience changed my mind completely about the path I’d planned for myself, and I saw an opportunity to make a much greater impact to patient care globally. Those early days were instrumental in my flipping the switch and saying, I want to stay in the pharmaceutical industry”.
Being on the innovation side of things rather that delivering direct health care really excited Laurie. She decided to stay in the industry and go wherever the road would take her, and it took her everywhere. She got every ounce out of what big pharma had to offer. Over the next 20 years she moved around within the BMS, met new challenges, and learned new therapeutic areas and brought multiple drugs to market globally. Starting out in oncology clinical development, followed by HIV eventually leading the infectious disease clinical therapeutic area. She spent 10 years on the front lines in clinical development talking to regulators, negotiating product labels, and preparing teams for all sorts of agency meetings including advisory committee meetings and oral explanations. Experiences that led Laurie to head the global regulatory function for BMS and gradually morphed her into the expert in regulatory science she is today.
“It made me realise that the regulatory function has tremendous power to turning innovation into reality” she says.
Before Laurie left big pharma, she was needed on the corporate side creating and building a Business Risk Management function for the corporation. She then became CEO for a small biotech focused on inflammatory disorders before finding her home in consulting. Here she uses her extensive bank of drug development and regulatory knowledge and business experience every day.
Hearing more than what is said
Laurie is naturally curious and believes the best way to learn and to grow is by forcing herself outside her comfort zone. When faced with client problems she takes time to untangle them. The key to solving these problems, according to Laurie, is to understand the details, break it down and find the root cause. To do this in the best way, she leverages the team of remarkable people, where chances are that whatever the problem is, somebody in the team has come across something similar at some point in their career. Even if Laurie has worked in every conceivable therapeutic area, she is humble about her qualifications:
“No one can possibly manage difficult client or business situations on their own”, she says. “Having a network of colleagues to tap into is incredibly valuable”.
The most important lesson Laurie learned over the years is the importance of listening. Listening is a path to new, sometimes hidden information and a way to build trustworthy relationships. In complex projects where there is less than a full understanding of all the risks, listening carefully allows Laurie to ask the right questions which often reveal subtle issues, preventing rushed and often incorrect decisions.
To be able to give proper support to a drug program, every stone and every pebble needs to be turned. When Laurie advises companies directly, she gets invested in the projects and appreciates the frustration that can occur for client teams when things are not moving forward as planned.
“But when a client’s product gets approved, we know exactly how much work the whole team has put into it, and it is an incredible joy to celebrate with them”.
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