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.
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.
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.
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.
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.
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.
September 22, 2021
Today’s patients benefit from having access to the safest, most advanced pharmaceutical systems around the world. This is because of the work done by the various regulatory bodies who govern the...
July 13, 2023
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...
August 30, 2023
FDA Provides Acceptable Intake Limits for Nitrosamines Drug-Substance Related Impurities (NDSRIs). Can You Comply? The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled;...