meet maria

Just thinking about this next intro could make me tear up. Everybody please welcome, Dr Maria Bertoni. I’m truly so proud of all your accomplishments and watching all of your hard work pay off. I know the journey has been long but it’s all finally paying off. I just want to thank you again for taking the time out of your busy schedule to join in on this very special segment of conversations with. So let’s begin shall we? 

Hi Maria! How’s everything going? How’re the dogs? 

The dogs are great. 9 months and counting. They grow so fast! 

So, where do you get your determination and drive from?

  The work ethic modeled by my parents has been a guiding force, influencing my determination and drive throughout my life. Adopting the work ethic I saw in my parents during my childhood became a reality for me when I began pursuing my passion in my professional life.

With having such a busy schedule, do you use any apps to keep organized? What’s the tricks? 

 The only app that i use is a fitness app. I exclusively rely on the 1st Transformation fitness app as my primary fitness tool. Given my incredibly busy schedule, adhering to a structured workout plan alleviates additional stress. I consistently follow the same workout split for months, meticulously logging all my data. This approach allows me to track and assess my progress systematically over the course of the year. 

For those reading, Maria’s work involves a comprehensive journey from preclinical stages to making medications available for human use. Considering the significant time and effort invested in this process, i am interested in understanding the emotional toll. When a drug doesn't succeed, does it feel like a significant setback, or do you view it as an opportunity to find a way forward? 

While the process of developing drugs is indeed demanding and time-consuming, facing the failure of a drug doesn't feel like the end of the world for me. The dedication and effort invested in building medications are substantial, and setbacks are undoubtedly disheartening. However, rather than viewing a failure as a conclusion, I see it as a pivotal moment in the journey. It serves as an opportunity for reflection, learning, and adaptation. In the complex realm of drug development, challenges are inherent, and each obstacle propels us to find innovative solutions. The ultimate goal of contributing to advancements in healthcare remains a driving force, maintaining our resilience and optimism, even when faced with setbacks.

I am intrigued by the intricacies of a dosing regimen. Could you elaborate on the testing process involved in determining the appropriate dosage?

 Wow, putting me on the spot! This is tough to answer in a few sentences so bare with me.The determination of a dose in a clinical trial is a meticulous process designed to safeguard the safety and efficacy of the investigational drug. In Phase 1 clinical trials, the primary goal is to assess the drug's safety and initial effectiveness. This involves administering varying doses to small groups of healthy volunteers, employing a dose-escalation design that starts with a low dose and incrementally increases it in subsequent cohorts. Moving to Phase 2, the focus shifts to evaluating the drug's effectiveness in treating the targeted condition or disease. Dose determination in this phase is based on data from Phase 1, where researchers select a dose or range that demonstrated acceptable safety and potential efficacy. Larger groups of patients with the specific condition are then treated with the selected dose(s). In Phase 3, the objective is to confirm and expand on the findings from Phase 2, with dose confirmation involving validation in a larger and more diverse patient population through randomized, controlled trials. Considerations for individualized factors, such as patient characteristics and safety, play a crucial role in dose selection. Throughout the trial, adjustments may be made based on observed effects, and post-trial, if the drug advances to market approval, dose refinement may occur with additional data from post-marketing surveillance. This comprehensive approach ensures a balanced and informed determination of the optimal drug dosage. 

Do you have a particular disease state that you are more enthusiastic to work on? Perhaps a drug in demand globally or the prospect of improving a medication that is already on the market? 

My dedication lies within the realm of rare diseases, and my journey into pharmacy was catalyzed by my participation in a post-baccalaureate program centered on rare and undiagnosed diseases at the National Institutes of Health (NIH). Witnessing patients with the most uncommon ailments coming from various places to seek assistance was incredibly intriguing to me. However, what struck me even more was the absence of effective treatments for these rare conditions. Motivated by this realization, I chose to pursue a career in pharmacy. Fortunately, the pharmaceutical company I am currently employed at shares my passion for tackling challenging projects, particularly those associated with rare diseases. This alignment allows me to contribute to the development of treatments for conditions that often go unnoticed in the broader medical landscape.

Could you provide more information on the lab testing process that occurs from the initial stages involving animals to the eventual availability of products on the market? 

The progression of pharmaceuticals from initial lab testing with animals to their eventual availability on store shelves involves a stringent process. This journey begins with preclinical testing, where the safety and efficacy of a new drug are assessed using cell cultures and animal models, providing critical insights into potential effects, toxicity, and optimal dosage. Subsequently, the Investigational New Drug (IND) application is submitted upon positive preclinical results, paving the way for human clinical trials upon approval. These trials, conducted in phases, aim to evaluate the drug's safety, dosage, and effectiveness in humans under strict regulatory oversight to ensure ethical practices and data integrity. Positive clinical trial outcomes lead to the submission of a New Drug Application (NDA), followed by a thorough review by regulatory agencies before granting approval. The manufacturing process is then scaled up with stringent quality control measures in place to guarantee consistency and purity of each batch. Post-marketing surveillance involves continuous monitoring for safety and efficacy, with any adverse events or unexpected side effects promptly reported and investigated. Finally, through careful packaging and distribution channels, the drug reaches retail availability, ready for purchase on store shelves and use by patients under the guidance of healthcare professionals. Throughout this comprehensive process, unwavering adherence to ethical standards, regulatory compliance, and vigilant monitoring collectively contribute to the safe and effective transition of pharmaceuticals from initial lab testing to consumer access.

How long does it take to develop a drug before it is ready to be made available on the market?

 A new drug can take an average of 10 to 15 years, a duration subject to considerable variation influenced by multiple factors. Timelines can be influenced by diverse factors, such as disease complexity, trial success, regulatory processes, and unforeseen challenges. There are shorter pathways with drugs already on the market seeking approval for new indications, but we can leave that topic for another time.

You have such a complex and fascinating, yet scary job. What helps you wind down at the end of a long week?

 To unwind at the end of a demanding week, I've cultivated a multifaceted approach that encompasses fitness, quality time with friends and family, the joy of spending time with my puppies, and of course pickleball.

 Thanks for including me in this segment!

Wow! I truly can’t thank you enough for joining in on this segment. The knowledge you have and the focus is truly a goal. I can’t wait to see you in the new year!