Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet Shauna Burns, Expert Consultant, Regulatory Sciences
What do you do at ProPharma? How does your role support ProPharma's mission and higher purpose of improving the health and safety of patients?
I serve as a consultant focusing on Market Access for therapeutics. As pharmaceutical manufacturers become increasingly aware of the imperative to develop market access strategies long before approval, the need to have the right market access and reimbursement expertise is more important than ever in our rapidly evolving market landscape. That's where consultants can play a pivotal role in ensuring clients are positioned for success by removing complex barriers to access for patients.
What is one lesson you've learned in industry that has most helped you?
After 23 years in the industry, I continue to learn many valuable lessons along the way. One of the most important lessons I learned early in my career is to keep the patient at the forefront of my business decisions. Whether it be clinicians, payers or manufacturers, keeping the patient front and center during the decision-making process is the right thing to do for all stakeholders.
What is a current trend you're seeing in the industry and how does it impact our clients and patients?
Without a doubt, one of the most significant trends I'm seeing in our industry today is the increased involvement of the federal government in drug pricing. As an example, the Inflation Reduction Act (IRA) is already having an impact on the way manufacturers forecast and strategize for both their short and long-term business plans. It will be prudent for our industry to pay close attention and continue to work diligently on developing innovative medicines for patients in an even more scrutinized and regulated environment.
What should clients consider when developing market access and reimbursement strategy?
There are many factors to consider when clients are developing a market access and reimbursement strategy. I believe one of the most critical considerations is to first clearly define and determine the product's value. Although this may seem straightforward, there are a multitude of factors at play to not only determine its value, but for the clients to fully understand its value. This is the foundation necessary to develop the right strategy and effectively communicate the product's value proposition. Our consultants have the expertise to help clients develop a strong market access and reimbursement strategy to achieve success.
What value does a client gain by working with ProPharma's Regulatory Sciences experts?
Our experienced consultants are some of the most well-known and well-respected industry, academic, and regulatory professionals in the world. Using our deep scientific knowledge, our regulatory team can provide the full spectrum of functional expertise needed to conduct complete product development programs from bench to marketing authorization. Our experts can provide development and regulatory strategy, expert scientific and technical advice, operational planning and oversight, full program planning and management, regulatory submission and meeting support, to help clients achieve their development objectives. Our track record of success in both the US and Europe is unmatched. By utilizing the best talent available anywhere in the world, we deliver extraordinary value to our clients.
