What happens at the biggest and best pharmacy event in the world? Join the best and brightest pharmacy professionals in New Orleans this December for an energizing and riching, enlightening experience like no other. Simply put, there is nothing like it. ASHP's mid-year clinical meeting offers everything you need for your career to blossom, including countless professional development and career advancement opportunities. Just imagine what you can accomplish at an event that brings together 20,000-plus pharmacy professionals from across the globe. Special rates are available when you register and book your hotel before September 27th. Learn more at midyear.ashp.org. That's M-I-D-Y-E-A-R.ashp.org. Welcome to the ASHP official podcast, your guide to issues related to medication use, public health, and the profession of pharmacy. Thank you for joining us for ASHP's Practice Journeys Podcast. This podcast and performance members to share their stories about their professional path, lessons learned, and how their experiences shade to and where they are today. My name is Michaela Myerson. I'm a PGY2 investigational drugs and research resident at Brigham and Women's Hospital, and I will be hosting this podcast. Today, we will be chatting with Mrs. K. Woodson for Morehouse School of Medicine, Dr. Kelsey Shelson from Pfizer, and Dr. Mitchell Chan from the U.S. Drug Administration. We'll have the opportunity to learn about the role of each of these professionals, the training they did before they entered their current role, and the advice they have for students and pharmacists who want to start a career in clinical research. Before we begin, I would want to acknowledge the help of Dr. Norma Ahmed, a fantastic research pharmacist from the Morehouse School of Medicine, and Maria Torres, a PharmD candidate at Mercer University for their help with designing this podcast. Welcome, everybody. Thank you for joining us today. Thank you for having us. Great to see you, Michaela. I'm so happy to be here. Hi, everyone. Now, let's start by learning more about each of your clinical research roles. Tell us about the day-to-day responsibilities of your current role, and what your involvement is in clinical research. Let's start with Mrs. Woodson. Hi, everyone. My name is Kay Woodson. Thank you so much for having me. My primary role is to serve as a pharmacist of record and a research pharmacy, which is also called an investigational drug service or IDS. My main responsibility is to ensure that the integrity of the study protocol is maintained in all respects and that it is compliant with accepted clinical pharmacy practice. My day-to-day responsibilities can be most easily explained in relation to the life of a protocol from the start of a study to its conclusion. A research protocol is the plan for how research will be carried out. They use the protocol as our guideline for how to run a clinical trial. When a new research protocol is considered by the research team, the research pharmacist is involved in determining the study's budget requirements and the feasibility of our site being able to adequately conduct it. This includes determining equipment, personnel, and auxiliary medications are required to conduct the study. I develop any standard operating procedures and forms needed to efficiently keep required records according to the protocol. I communicate with the study coordinator and the principal investigator or PI to inform them of any pharmacy needs to conduct the study according to the requirements of the protocol. Prior to a study being started, research pharmacy is involved in the pre-site initiation visit or PSIV. At the pre-SIV, the study sponsor visits and tours the site the suitability to visit or SIV is then held by the sponsor to familiarize the site with all aspects of the protocol and to clarify any questions the site may have about how to conduct the study. The research pharmacy then receives the investigational product or IAP to be placed in inventory and stored according to the report. Once the study begins and participants enter the study and receive investigational products dispensed by the research pharmacy, accounts for the study participants on the study medication. I make sure they understand the informed consent, how to store their medication, how to take the medication, what possible side effects may occur and of course, answer any questions they may have. I have particular responsibilities when I am involved in blinded studies. Blinded studies, the studies whether staff and or participants are not aware if the study product is an active drug or placebo. I am considered unblinded and I am responsible for ensuring that the team members remain blinded. This means I make sure that no difference in my interactions with participants are first there so that they are unable to differentiate between active or placebo either preparation or the administration of IP. I am also just with keeping all the records concerning the storage conditions, inventory and dispensing of investigational products required according to protocol. To that end, I am required to be available for regular monitor visits by the sponsor that determines all pharmacy records to ensure that the protocol is being filed. Thank you very much, Mrs. Woodson. Listeners, as you can tell, Mrs. Woodson is here to represent the institutional or hospital side of research pharmacy practice. Mrs. Woodson mentioned her various interactions with the study sponsor throughout the life of the clinical trial. The sponsor of the research study is the researcher, institution or company who is ultimately responsible for the design, management, financing and conduct of the study. Pfizer Incorporated is an American multinational pharmaceutical company that acts as a study sponsor. Dr. Shaulson is here to tell us about the sponsor side of the clinical pharmacy practice from her work advisor. Dr. Shaulson, what are the day-to-day responsibilities of your current role in what is your involvement in clinical research? The clinical research pharmacist at Pfizer are the experts in the investigational products used in our clinical trials. We review study documents such as the clinical study protocol and the investigator brochure. An investigator brochure is a thorough document that accompanies the study protocol and contains detailed clinical and non-clinical data about the investigational product such as prior research that has been done with the investigational product drug information and real-world evidence when applicable. Our team also creates patient dosing tools like dosing diaries used for research participants to track their medication adherence, dosing instructions and dosing videos to show participants how to take their dose. Working with our formulation scientists, we author the instructions for the pharmacist preparation and administration of these products and sometimes create videos for the site staff to demonstrate the preparation procedures. Once all of these materials are finalized, our team also trains the clinical site staff participating in our studies before the study starts and during the study. We're also the resource for questions that come up from sites and clinical study team during the study. Ultimately, we represent the site and the patient in the development of our investigational products. Thank you very much, Dr. Shaulson. As we could see, the pharmacist has an important role when they are working on the sponsor side. Now, we have Dr. Chan here from the US Food and Drug Administration or FDA. The majority of research studies are pursuing FDA approval for their drug, whether it be for a new drug or a new indication, dose or formulation of a drug that is already approved. Pharmacists play many roles at the FDA from serving on the groups that decide on approvals to developing the regulations that affect how research studies conduct it. Dr. Chan plays a very unique role at the FDA. Dr. Chan, can you tell us about the day-to-day responsibilities of your current role in your involvement in clinical research? Absolutely. Thanks, Michaela. I work on a specific project in the FDA's Oncology Center of Excellence called Project Facilitate. Our day-to-day responsibilities in Project Facilitate include staffing our National Call Center, monitoring our Project Facilitate inbox, and answering inquiries and reviewing applications that come in. We receive inquiries in Oncology single-patient expanded access applications through both email and phone, and the single-patient applications, also known as expanded access or more familiarly compassionate use applications, are a pathway for people to gain access to investigational drugs when there is no adequate standard of care therapy for them to use, and there is no clinical trial that would suit their needs. Most of our time is spent performing the clinical review of each application and evaluating the safety and potential effectiveness of the investigational treatment in that respective patient. In addition to these duties, we're also involved in research and other initiatives around the FDA and Oncology Center of Excellence. Since our work in Project Facilitate requires reporting to senior leadership and often the White House, I have to make sure we are capable of reporting accurate data. This is where some of my time is spent performing data analytics to gather the data, process, and clean it, and then run analytics and visualizations with the data. Additionally, sometimes we get very complex applications or situations that require a lot of coordination with other FDA centers and offices. For example, recently I had to coordinate with a shipping broker due to issues with an investigational drug coming from overseas. This is often a surprise when I get a phone call either from the shipping company or the FDA investigator at the port of entry. And this isn't something I usually deal with on a daily basis, but really goes to show that anything can happen and to always be open to learning new things. And recently, I also had to coordinate with our Center for Devices and Radiological Health to get their input regarding a complex expanded access request that involved both a drug and a device for delivery. And I'm not going to lie, I know very, very little regarding drug devices, but by ensuring the CDRH medical officers assist in reviewing the device component, I was able to make a final determination whether this expanded access request was safe to proceed. And to go a little further into what my review process looks like, you have to think of my review in two parts, regulatory and clinical. Regulatorily, I make sure the required documents are present, the legal definition of expanded access is upheld. And whether the request meets the definition of extended access under the code of federal regulations. And clinically, I look at the patient's prior medical history and see what kind of chemo, radiation and surgery they've had. What is their prognosis and do they have established or possibly curative options available still? I also have access to data that is not accessible to the public since they're trade secrets. And I'm able to cross reference this data from drug companies to determine whether this treatment plan is safe and reasonable given the patient's condition. It's a lot of reading and thinking, but I really enjoy what I do. Lastly, I mentioned before that I started doing some data analytics, and this quickly became somewhat of a daily thing I'm involved in, and have over time become entrusted with this. Early on in Project Facilitate, I realized that the way we were collecting, storing and managing our data was not conducive to reporting. It was really hard to get accurate information from our databases since we were getting non standardized and unclean data. And this meant that drug names were misspelled either lowercase or all uppercase, or some drug names included the generic name or even the internal code name at the FDA. Without standardized and clean data, it was near impossible to accurately determine how many requests we were getting for a specific drug or disease. And this is where I come in and write code to automatically clean and standardized this data from our databases. Because of this, we're able to report out as accurately as possible and provide quick and effective actionable insights. And additionally, I've helped revolutionize the way our leadership interacts with data. I use Power BI and Tableau to provide data dashboards and reports based off of my process data. And this helps both leadership and staff interact the data in real time in a way that provides an effective bottom line up front. For the past four years of doing this, I've seen the positive impact a cross train pharmacist can have when they understand regulatory terms and know how it impacts the analysis of information. I call this sort of cross training data stewardship and I really think data stewards can have an incredible impact in any setting by understanding the core principles of your data and how to analyze it. And it's sometimes really hard to pinpoint what a normal day looks like in project facilitate, but we've always got to be prepared for anything. Thank you, Dr. Chan. As we can see, pharmacists are involved in every part of the drug development and research process from the design of clinical studies to conducting them at the study site and working at the federal level. Students and pharmacists alike often don't but the different roles that pharmacists play in this field. Consequently, one of the most frequent questions I hear and maybe you all hear as well is how do I get into clinical research? I'd love for you all the type of education and training you did to get to the role that you are in today. Mrs. Woodson, I'll start with you. In 1979, when I graduated from the Auburn University School of Pharmacy, research pharmacy was definitely not on my radar as a career path. At that time, your choices were mainly hospital or retail pharmacy. I chose hospital pharmacy at a hospital that had both the inpatient and outpatient pharmacy. I started out in the inpatient pharmacy where I gained experience in all aspects of inpatient pharmacy practice, which included preparing and dispensing topical oral and injectable medications. As an inpatient pharmacist, I was also a resource for drug information for the medical staff. I was involved in a very basic way in some physician-initiated studies. That is, the pharmacy role was solely to dispense their study product for inpatient use. Since I like new experiences, I eventually transferred to the outpatient pharmacy prior to the development of a standalone HIV clinic with its own pharmacy during the infancy of the HIV epidemic. Initially, I was a staff pharmacist in this HIV clinic. Emory University had his ACTG, which stands for AIDS Clinical Trial Group, unit based in this HIV clinic. Their focus was on studying the various resumes being developed to determine the best way to treat HIV. I became involved in research upon becoming the backup to the research pharmacists. In addition to conducting ACTG trials, we also conducted industry-initiated studies and physician-initiated studies. Being the backup research pharmacist was how I learned what research pharmacy is all about. It was exciting to be involved in the groundbreaking development of HIV therapies from AZT monotherapy to the advent of protease inhibitors. As my mentor moved on, I became the research pharmacist. As the research pharmacist for 15 years, I also had the opportunity to mentor other pharmacists to become research pharmacists. Thank you, Mrs. Woodson. That's fantastic. Dr. Sharlson, you had a different path than Mrs. Woodson. Can you tell us about that? Sure. Thanks, Vikila. When I was in pharmacy school, I decided to pursue the Fellowship Pathway. So I completed a two-year post-PharmD Fellowship in clinical research at Genzyme, which is now part of Sanofi. During this fellowship, I was the lead pharmacist in clinical studies managing the investigational product needs for the studies and creating the preparation and handling procedures for the products used in our studies and also training clinical sites on these procedures. I also coordinated a pharmaceutical industry elective course for PharmD students at MCPHS University and obtained a teaching certificate as part of the academic component of my fellowship. After completing the fellowship, I helped to start a similar role at Pfizer called the Clinical Research Pharmacist. And after spending five years in that position, I spent another five years in different medical affairs roles at smaller companies. One was called flexion therapeutics and the other GASE pharmaceuticals. And most recently returned back to Pfizer in a leadership position in clinical research pharmacy and have been in that position for the past two years. Thank you, Dr. Sharlson. Dr. Chan, you had a different path than both Mrs. Woodson and Dr. Sharlson. Tell us about the education and training you did to get to the school you are in today. This is a great question and a complex one to answer. I just want to preface this with some clarification that I never thought I'd be doing what I do now. And I never thought that what I'd be doing would become my passion. I would say my training and experience started back in my undergraduate degree at Oregon State University. And I got involved in starting a student chapter of an HIV/AIDS awareness organization, which led me to Rwanda, where I got to travel around the country with global health superstars and see the impact we had alongside partners in health. I was also involved in other student-centric non-government organizations that gave me vital insights into public and global health in Honduras. And this was also an incredible experience since we were creating fresh water lines to remote villages and providing sustainable health care to rural communities that we were partnering with. And this really sparked the why, which I continued to figure out in grad school. I graduated with my doctor pharmacy degree from the University of New England College of Pharmacy, where I continued my global and public health experience through our school's partnership in Ghana, where we provided sustainable and comprehensive medical support for rural communities. And subsequently, I completed a PG by one pharmacy practice residency at a critical access community hospital at South County Health in Rhode Island. And I started to really get into emergency medicine and critical care. And luckily, my program director allowed me to shift my general residency to focus on my interests by being in the ER and ICU daily, in addition to my regular duties, such as in the oncology clinic. I've always had a poll towards uniform service since I was a kid. And since at that time, all armed forces branches were not taking any additional pharmacists. I put my package in for commissioning into the US public health service, which is one of the eight uniform services. I also thought this to be very fitting, given my public health background. And then after residency, I started at my first duty station at the federal hospital at Northern Navajo Medical Center in Shiprock, New Mexico. I received my advanced pharmacist clinician training from the University of New Mexico when started to practice as a family medicine provider in the hospital, as well as an acute care provider in our urgent care. And this was a ton of work, but it was an incredible experience working at the top of my license with the prescriptive authority. I then made a big shift away from bedside and transitioned to my new duty station at the Food and Drug Administration as a regulatory project manager. As an RPM, you're responsible as the quarterback for FDA's drug review team. And the sheer amount of knowledge you gain in this position still amazes me today. During my time with the division of oncology products one, we managed drug applications for breast, gynecologic, genetic urinary, and supportive care. I felt like I was really making an impact as a pharmacist in this regulatory role. I was able to provide my own clinical suggestions and insights, but it was also learning an incredible amount of information for my teammates who are some of our nation's brightest oncologists, toxicologists, pharmacologists, labeling, and safety staff. Then in 2019, I went on TDY or temporary duty to the oncology center of excellence and was part of a multidisciplinary team that launched Project Facilitate. And this is an incredible and novel program that even today is unmatched by any other country's regulatory agency. The goal of the program is to make oncology expanded access more accessible and efficient to the American public. We initially started as a call center where healthcare and regulatory professionals can call or email us to ask questions or submit their single patient expanded access applications. Then in 2020, we expanded the program to be more than a call center. We started performing clinical reviews of all oncology single patient applications within our center, which over time reduced the average time between submission and FDA decision by over 90%. So this means that if you submit your oncology single patient expanded access application, you'll receive a determination within 24 hours. And most times, this is even within one to two hours the same day in comparison to an average of five days or more before Project Facilitate took over the review process. And to clarify, the clinical review process involves evaluating the safety and potential effectiveness of the investigational treatment in the respective patient. I know that was a little long-winded, but I feel that although I don't often fully know where I'm going in life sometimes, I seem to have a theme of service in public health. Thank you so much, Dr. Chan. As we could see, each of our have pursued different training paths with this woods and transferred from clinical practice. Dr. Stoss in pursuit of fellowship and Dr. Chen completed the residency. Michaela, your residency program is a unique opportunity to train directly in clinical research practice. Do you want to share a bit about your experience? Sure, Dr. Chen, thank you. As I mentioned in the introduction, I am a P2I2 resident in investigational drugs and research at Brigham and Women's Hospital. My program is one of 12 current programs of this type. I can only speak to my program, but being a P2I2IDR resident offers an incredible opportunity to train in all three major areas of research pharmacy practice, institutional, industry, and federal. To elaborate, I've had the opportunity to work with research teams in multiple Boston specialty hospitals to do a rotation in the division of allergy, immunology, and transplant at the NIH and an industry rotation advisor. I will be going into a clinical research practice position in a hospital setting next year, but my residency has adequately prepared me for any type of clinical research role. I can't recommend it enough to students who are planning to pursue the residency path by and have an interest in clinical research. Thanks for sharing, Michaela. Of course. Now, let's move on to our next question. As pharmacy practice evolves, we see that many specialties are evolving with it. What do you see as the future trends or emerging areas of research pharmacy practice? Mrs. Woodson, I'll start with you. I think that in the future, all research will include pharmacy involvement. Currently, not all research sites have a pharmacist on staff to conduct investigational product dispensing and to maintain storage and inventory records. Some sites may have someone other than a pharmacist dispensing IP under the direction of the principal investigator. I firmly believe that pharmacists, as the medication experts, are professionally equipped to do the best job in managing all pharmaceutical aspects of a study protocol. Thank you, Mrs. Woodson. Dr. Shulsen, what are your thoughts? As our clinical trials and the treatments and development become increasingly more complex, having specialized experts in conducting research from investigational drug service pharmacists, as well as pharmacists on the sponsor side, is critical, as is collaboration between the two. One specific area that is a very hot topic is the updates to handling of hazardous drug products and the implications for pharmacies preparing and handling potentially hazardous investigational products. This is especially important now that we have many cell and gene therapies in development. Thank you. I agree. I've heard a lot of dialogue about hazardous drugs this year. Dr. Chen, what do you think is next? Local research pharmacy. This is a really great question. Since I interface directly with healthcare professionals performing the direct patient care, I've been noticing more pharmacists involved in investigational research, treatment, and regulatory practice. I think this is an incredibly important shift that capitalizes on how dynamic pharmacists are to any professional team. Often these pharmacists call us to discuss how to start the application process and sometimes are even the coordinator for the entire process for their team. This is a lot of work and there's an incredible amount of detail involved when interfacing with the FDA and industry. We have a lot of regulatory vocabulary and processes and sometimes it's very overwhelming even for those of us that make regulatory science their full-time job. When pharmacists often take this burden for their oncology team, I really see a future where research and investigational drug pharmacists all have a duality of clinical and regulatory expertise. Ultimately, I like to see more of an emphasis on regulatory science, even as students. To be honest, I never really understood how regulatory science was important to clinical care as a pharmacist until I started at the FDA. I really got to see how important it was for pharmacists to answer drug information questions, whether in the hospital or in the community, and this really expanded during COVID-19 with basic health information and vaccines. Thanks Dr. Chan. Now, I want to transition the topic to some of our listeners who are students and practicing pharmacists who have been interested in becoming a political research pharmacist. What experiences would you recommend for a student or practicing pharmacist who is interested in joining up in clinical research? Mrs. Woodson, we'll start with you. I would recommend that a student or practicing pharmacist who is interested in clinical research experiences in a wide variety of pharmacy practice. Inpatient, outpatient, IVAD mixture, drug information, and inventory management are all areas that I have worked in. And as I look back over my career, I see those varied experiences have all contributed to my ability to be a successful research pharmacist. Depending on the protocol, any and all of these experiences have positively affected my ability to manage a new protocol presented to me. And every protocol is different. That's great advice, Mrs. Woodson. Thank you. Dr. Johnson, what advice do you want to share? For our role specifically, experience and investigational drug services at hospitals or in carrying out research at sites is very valuable. The ASHP investigational drug service listserv network has a lot of great discussion on IDS practices amongst research pharmacists. I also, of course, can't leave out our post-PharmD Fellowship program at Pfizer and MCPHS University in clinical research pharmacy, where our fellows receive in-depth training on how to be a clinical research pharmacist. They're also part of a network of other fellows through MCPHS University called MFN, where they can connect with their peers and learn about all of the different areas of industry pharmacists can be successful in. Thank you, Dr. Johnson. Dr. Chen, what advice would you like to share? My recommendation to get into regulatory science is to apply for positions where you can learn on the job. This is especially helpful if you don't have a residency or fellowship opportunity that will give you this experience. In the regulatory field, proving you can manage multiple projects, initiatives, or roles simultaneously is a skill highly utilized in regulatory science. And regulatory science is heavy on managing multiple projects and managing regulatory requirements. And having project management skills is greatly beneficial. At the FDA, when looking for candidates to fill RPM or health scientist positions, having a regulatory background helps. However, the most important skill is being able to project manage. Project management is pretty broad and can range from managing multiple outpatient pharmacies, being involved in coordinating initiatives around the hospital or community, and can also include managing multiple patients and floors in the hospital. Basically, the self-management and project management side of the job is important, since the regulatory component is able to be learned and gained through experience over time due to the sheer amount of regulatory information you can learn. Every job is different, so be sure to apply to positions that will help you grow and learn versus needing you to already be a regulatory expert. Thank you so much, Dr. Chen. Before we wrap up, I want to open the floor for anyone who has final thoughts. This is what's in. The two guiding principles I have followed and have served me well in my research pharmacist's career are as follows. Number one, it is important to be very detail oriented when following a protocol. Be willing for the protocol in essence to be your Bible when it comes to conducting a study. And number two, remember the study monitor from the study sponsor is your friend. Any questions you may have that can answer, or get the answer for you, no matter how trivial it may seem. Also, all way, stay inspection ready at all times. If you stay ready for a month to visit, you never have to scramble to get ready. That's great advice, Mrs. Woodson, and I second that. Dr. Shelson? It's exciting to see more focus on the role of the pharmacist in clinical research and in the pharmaceutical industry. When I started my fellowship, there were only three companies in the Boston area that had a fellowship program. Now there are over 28 companies with fellowship programs with each company offering multiple positions. Many of these positions are in medical affairs, but several are in clinical research and clinical supplies. Also, in investigational drug services pharmacy, residency programs and ideas are starting to pick up. Pharmacists have a unique skill set that positions us extremely well for contributing to research that will ultimately improve or prolong the lives of our patients. Completely agree. Thank you, Dr. Shelson. Dr. Chen, what are your final thoughts? My advice for anyone, whether a student or established professional, is to take the opportunities that come. Don't have your mind made up that you're going to be a certain kind of pharmacist, and that's it. Sometimes we do get a little busy in our heads and thinking about how to become the best critical care pharmacist or to become a certain other type of pharmacist. And we completely miss or ignore these other opportunities that may actually become your passion and open up even more doors. A great example is my colleague in Project Facilitate who was a dual board certified critical care pharmacist from the VA. He saw an opportunity open up and he took it. Project Facilitate is very different than what he was used to in clinical care, but it's opening up a chapter of his career to use those skills he learned as a critical care pharmacist towards a novel national program helping patients with cancer. Staying open and flexible is key, but most importantly knowing how to react to failure is one of the most important skills you can have. The field of pharmacy is even more saturated now than when I graduated almost 10 years ago, and the risk of failure becomes exponentially more common with more great candidates to compete against for jobs and opportunities. Failure is inevitable, but I truly believe that using a setback as motivation can ultimately change your trajectory. I've seen so many people go for an opportunity and not get it, and this crushes them and they'd often never reapply or continue forward. I truly believe that those that never give up never actually fail. Not many people know, but I didn't get into pharmacy school the first year I applied after I graduated with my bachelor's. I spent that next year using that sadness and pain to propel me forward into public health, traveling the world to learn global health fundamentals. I also didn't get patched for my residency in the initial phase, but immediately got back on my feet and successfully got offers from multiple sites during the scramble. I also didn't get my military promotion to lieutenant commander the first time, so I spent the following year establishing new skills on deployment as a command and general staff officer. As representative Elijah Cummings said in his commencement speech for Morgan State University in 2019, do not mistake a comma for a period. And that's a great quote under podcast. That's the time we have today, and I want to thank Mrs. Woodson, Dr. Charleston, and Dr. Chan for joining us today and sharing their stories. As we have learned, there are many great opportunities for pharmacists who want to work in clinical research. Join us here at ASHP official in the practice journey podcast as we learn about how our members seek out, grow, and evolve during their careers. Thank you for listening to ASHP official, the voice of pharmacists advancing health care. Be sure to visit ashp.org/podcast to discover more great episodes, access show notes, and download the episode transcript. If you loved the episode and want to hear more, be sure to subscribe, rate, or leave a review. Join us next time on ASHP official. [Music] [BLANK_AUDIO]
