Tomorrow’s drugs: Improving lives through clinical trials

Abstract

For Sam Abdelghany, PharmD, BCOP, practicing pharmacy is an Indiana Jones-style adventure, following clues and unraveling the mysteries of disease. As the coordinator of the Investigational Drug Service at Yale-New Haven Hospital, he is called upon to manage both small clinical trials for rare exotic diseases and large international studies with thousands of patients for the most common conditions on earth. “Not many people have the opportunity to get a sneak peek at the newest and latest treatments for so many disease states,” said Abdelghany.According to Abdelghany, coordinating the pharmacy component for hundreds of clinical trials is extremely satisfying because it all boils down to helping patients. “We’re here to find something that slows down Alzheimer’s disease or prevents cancer,” he said. “Being on the leading edge of what’s coming tomorrow is very exciting, and improving lives through the use of investigational drugs is what we’re here to do.”The Investigational Drug Service at Yale-New Haven was established in 1983, and Abdelghany is one of two pharmacists who coordinate the pharmacy services for around 250 trials. His primary role is to ensure high-quality pharmaceutical care to all patients enrolled in clinical studies. “I do that by making sure that each protocol is conducted in a safe, effective, and efficient manner in compliance with professional standards and all the applicable laws and regulations,” said Abdelghany in an interview with Pharmacy Today.■Sam Abdelghany, PharmD, BCOP, is involved with the clinical trial process from developing protocols to creating drugs.■Abdelghany and a colleague coordinate the pharmacy services for around 250 trials.Clinical trialsPharmacists play an important role in the clinical trial process. Abdelghany is often involved with the design of the protocol and determining how a drug will be dispensed, stored, and even manufactured. “You feel like you are part of a group that enhances patient care and moves science forward,” said Abdelghany. “Trying to find a cure for a disease, improve what we know, or enhance the knowledge we have in disease states is very rewarding.”In addition to the daily activities that include dispensing research drugs, randomization, record keeping, and inventory management, Abdelghany regularly meets with investigators, site coordinators, study monitors, and sponsors’ representatives to coordinate study logistics. Clinical trial sponsors include drug manufacturers, federal entities such as the National Institutes of Health (NIH), foundations, or cooperative groups.Abdelghany is a voting member of the Yale University Institutional Review Board (IRB) and participates in several scientific review committees. By serving on these committees, Abdelghany ensures patient safety and helps investigators accomplish research goals.Following the rulesAs with most complex processes, the devil is in the details—especially when it comes to clinical trial protocols. “I develop a specific procedure for every study that outlines who can order the drug, where the drug can be dispensed, what the requirements are for each patient, and how the information be communicated to us by the investigators,” said Abdelghany. For example, if a patient is located in the hospital, then an investigator will inform the research pharmacy staff when a patient is enrolled in a particular trial. “We make sure consent has been obtained, the patient meets the eligibility criteria, and coordinate the dispensing of the drug,” Abdelghany explained.Sponsors typically want to ensure that the study is being done according to the protocol, so Abdelghany often hosts monitoring visits and inspections from study sponsors. Because of the large number of studies conducted through the Investigational Drug Service, it is not unusual for Abdelghany to host multiple sponsor visits every day. The most nerve-wracking auditor is FDA. “It doesn’t get any bigger than FDA in my world,” said Abdelghany. “The pharmacy world in general is very heavily regulated, and the investigational drug world is even more regulated than the pharmacy world. It’s taking a highly regulated profession and making it even more so.”Creating drugsIn addition to coordinating pharmacy services for clinical trials, Abdelghany is often called upon to manufacture a certain formulation or develop an agent from scratch. Sometimes an investigator will come in with a great idea, but the agent they want to study doesn’t exist or is not commercially available. “I’m helping an investigator right now with writing an Investigational New Drug application to study crack cocaine,” said Abdelghany. “That’s not something that you can look up in a pharmacy book.”To manufacture a batch of smoked (crack) cocaine for the clinical trial, Abdelghany turned to YouTube. “I told the investigator that if the drug users can make it, then of course we can make it here. It can’t be that hard,” said Abdelghany.He has also created an oxytocin nasal spray for use in an autism study and a long-acting parathyroid hormone that is not commercially available. “I have to think back to all my pharmacy education and use some of the skills I learned that most people don’t use today in terms of pharmaceutical compounding and pharmaceutical calculations,” Abdelghany explained. “You have to think outside the box and become a problem solver.”IRIS trialIn addition to coordinating the pharmacy aspects for studies conducted at Yale-New Haven, Abdelghany also works on large international multicenter trials. He is currently managing all of the medication needs for the Insulin Resistance Intervention After Stroke (IRIS) trial, with more than 3,800 patients and 176 sites all over the world in countries like Italy, Germany, United Kingdom, Canada, Israel, and Australia. In the IRIS trial, patients newly diagnosed with stroke are treated with either pioglitazone or placebo and followed for a total of 5 years. The IRIS trial is now in its 9th year and is the largest NIH stroke trial.Abdelghany discusses the preparation and dispensing of an investigational drug for a hospitalized patient with clinical pharmacist Abraham Tharakan, PharmD.View Large Image Figure ViewerDownload (PPT)“[Pioglitazone] is delivered to my pharmacy, where we handle blinding the medication and shipping to the participating sites,” said Abdelghany. “With that comes a lot of work in terms of meeting the regulations in every country, including meeting the labeling/language requirements, customs regulations, and the demands of local IRBs. It’s almost a mini-manufacturing operation, and as far as I know, not many hospital pharmacies do anything at this scale.”To handle such a large project, Abdelghany had to transform his small pharmacy into a major center capable of coordinating and controlling the pharmacy shipments to all the different countries. “You can imagine the number of meetings we had and the communication with all the foreign investigators about the rules and regulations,” said Abdelghany. “Every country has its own challenges—Israel requires labels to be printed in four languages; Canada needs labels in English and French.”Studying rare diseasesAbdelghany also provides pharmacy services for a multitude of smaller studies focused on rare disorders. “We see everything here,” said Abdelghany. “At Yale-New Haven Hospital, we have experts in many disease states, and we treat diseases that many people don’t see.”Abdelghany answers drug-related questions from Catherine Parmelee, RN, before the first infusion at the research unit.View Large Image Figure ViewerDownload (PPT)L—R: Kenneth Lupi Jr., PharmD, BCPS; Nilesh Amin, PharmD; Abdelghany; Rupangi Datta, PharmD, BCPS; and Martha Stutsky, PharmD, BCPS, review the pharmacy procedure for a new clinical trial initiated at Yale-New Haven Hospital.View Large Image Figure ViewerDownload (PPT)Yale-New Haven is a referral center for patients with idiopathic pulmonary fibrosis, a condition where scarring or thickening of the lungs occurs without a known cause. Abdelghany also works on a trial focused on ichthyosis, a family of genetic skin disorders. Researchers at Yale-New Haven also study urea cycle disorders, a genetic disorder that typically shows symptoms in new-borns within the first 24 hours of life, and X-linked hypophosphatemia, the most common form of heritable rickets.Future of trialsOver the years, Abdelghany has observed an ebb and flow to the diseases studied in trials. In the late 1990s, there were many studies focused on HIV, he noted. “Today, we’re seeing a dramatic increase in the number of oncology clinical trials,” said Abdelghany. Alzheimer disease and hepatitis are also active areas of research, with several exciting new therapies under investigation.The clinical trial process is also evolving. When the Investigational Drug Service was first launched, the drug was most likely dispensed to a patient in the hospital. Today, Yale-New Haven has several satellite campuses all over the state. Many of the trials are multicenter and few are multinational.“It’s a very exciting time for pharmacists to be involved with investigational drugs and emerging research,” said Abdelghany. “As the medication expert, pharmacists are critical to the clinical trial process from start to finish.” For Sam Abdelghany, PharmD, BCOP, practicing pharmacy is an Indiana Jones-style adventure, following clues and unraveling the mysteries of disease. As the coordinator of the Investigational Drug Service at Yale-New Haven Hospital, he is called upon to manage both small clinical trials for rare exotic diseases and large international studies with thousands of patients for the most common conditions on earth. “Not many people have the opportunity to get a sneak peek at the newest and latest treatments for so many disease states,” said Abdelghany. According to Abdelghany, coordinating the pharmacy component for hundreds of clinical trials is extremely satisfying because it all boils down to helping patients. “We’re here to find something that slows down Alzheimer’s disease or prevents cancer,” he said. “Being on the leading edge of what’s coming tomorrow is very exciting, and improving lives through the use of investigational drugs is what we’re here to do.” The Investigational Drug Service at Yale-New Haven was established in 1983, and Abdelghany is one of two pharmacists who coordinate the pharmacy services for around 250 trials. His primary role is to ensure high-quality pharmaceutical care to all patients enrolled in clinical studies. “I do that by making sure that each protocol is conducted in a safe, effective, and efficient manner in compliance with professional standards and all the applicable laws and regulations,” said Abdelghany in an interview with Pharmacy Today.■Sam Abdelghany, PharmD, BCOP, is involved with the clinical trial process from developing protocols to creating drugs.■Abdelghany and a colleague coordinate the pharmacy services for around 250 trials. ■Sam Abdelghany, PharmD, BCOP, is involved with the clinical trial process from developing protocols to creating drugs.■Abdelghany and a colleague coordinate the pharmacy services for around 250 trials. ■Sam Abdelghany, PharmD, BCOP, is involved with the clinical trial process from developing protocols to creating drugs.■Abdelghany and a colleague coordinate the pharmacy services for around 250 trials. Clinical trialsPharmacists play an important role in the clinical trial process. Abdelghany is often involved with the design of the protocol and determining how a drug will be dispensed, stored, and even manufactured. “You feel like you are part of a group that enhances patient care and moves science forward,” said Abdelghany. “Trying to find a cure for a disease, improve what we know, or enhance the knowledge we have in disease states is very rewarding.”In addition to the daily activities that include dispensing research drugs, randomization, record keeping, and inventory management, Abdelghany regularly meets with investigators, site coordinators, study monitors, and sponsors’ representatives to coordinate study logistics. Clinical trial sponsors include drug manufacturers, federal entities such as the National Institutes of Health (NIH), foundations, or cooperative groups.Abdelghany is a voting member of the Yale University Institutional Review Board (IRB) and participates in several scientific review committees. By serving on these committees, Abdelghany ensures patient safety and helps investigators accomplish research goals. Pharmacists play an important role in the clinical trial process. Abdelghany is often involved with the design of the protocol and determining how a drug will be dispensed, stored, and even manufactured. “You feel like you are part of a group that enhances patient care and moves science forward,” said Abdelghany. “Trying to find a cure for a disease, improve what we know, or enhance the knowledge we have in disease states is very rewarding.” In addition to the daily activities that include dispensing research drugs, randomization, record keeping, and inventory management, Abdelghany regularly meets with investigators, site coordinators, study monitors, and sponsors’ representatives to coordinate study logistics. Clinical trial sponsors include drug manufacturers, federal entities such as the National Institutes of Health (NIH), foundations, or cooperative groups. Abdelghany is a voting member of the Yale University Institutional Review Board (IRB) and participates in several scientific review committees. By serving on these committees, Abdelghany ensures patient safety and helps investigators accomplish research goals. Following the rulesAs with most complex processes, the devil is in the details—especially when it comes to clinical trial protocols. “I develop a specific procedure for every study that outlines who can order the drug, where the drug can be dispensed, what the requirements are for each patient, and how the information be communicated to us by the investigators,” said Abdelghany. For example, if a patient is located in the hospital, then an investigator will inform the research pharmacy staff when a patient is enrolled in a particular trial. “We make sure consent has been obtained, the patient meets the eligibility criteria, and coordinate the dispensing of the drug,” Abdelghany explained.Sponsors typically want to ensure that the study is being done according to the protocol, so Abdelghany often hosts monitoring visits and inspections from study sponsors. Because of the large number of studies conducted through the Investigational Drug Service, it is not unusual for Abdelghany to host multiple sponsor visits every day. The most nerve-wracking auditor is FDA. “It doesn’t get any bigger than FDA in my world,” said Abdelghany. “The pharmacy world in general is very heavily regulated, and the investigational drug world is even more regulated than the pharmacy world. It’s taking a highly regulated profession and making it even more so.” As with most complex processes, the devil is in the details—especially when it comes to clinical trial protocols. “I develop a specific procedure for every study that outlines who can order the drug, where the drug can be dispensed, what the requirements are for each patient, and how the information be communicated to us by the investigators,” said Abdelghany. For example, if a patient is located in the hospital, then an investigator will inform the research pharmacy staff when a patient is enrolled in a particular trial. “We make sure consent has been obtained, the patient meets the eligibility criteria, and coordinate the dispensing of the drug,” Abdelghany explained. Sponsors typically want to ensure that the study is being done according to the protocol, so Abdelghany often hosts monitoring visits and inspections from study sponsors. Because of the large number of studies conducted through the Investigational Drug Service, it is not unusual for Abdelghany to host multiple sponsor visits every day. The most nerve-wracking auditor is FDA. “It doesn’t get any bigger than FDA in my world,” said Abdelghany. “The pharmacy world in general is very heavily regulated, and the investigational drug world is even more regulated than the pharmacy world. It’s taking a highly regulated profession and making it even more so.” Creating drugsIn addition to coordinating pharmacy services for clinical trials, Abdelghany is often called upon to manufacture a certain formulation or develop an agent from scratch. Sometimes an investigator will come in with a great idea, but the agent they want to study doesn’t exist or is not commercially available. “I’m helping an investigator right now with writing an Investigational New Drug application to study crack cocaine,” said Abdelghany. “That’s not something that you can look up in a pharmacy book.”To manufacture a batch of smoked (crack) cocaine for the clinical trial, Abdelghany turned to YouTube. “I told the investigator that if the drug users can make it, then of course we can make it here. It can’t be that hard,” said Abdelghany.He has also created an oxytocin nasal spray for use in an autism study and a long-acting parathyroid hormone that is not commercially available. “I have to think back to all my pharmacy education and use some of the skills I learned that most people don’t use today in terms of pharmaceutical compounding and pharmaceutical calculations,” Abdelghany explained. “You have to think outside the box and become a problem solver.” In addition to coordinating pharmacy services for clinical trials, Abdelghany is often called upon to manufacture a certain formulation or develop an agent from scratch. Sometimes an investigator will come in with a great idea, but the agent they want to study doesn’t exist or is not commercially available. “I’m helping an investigator right now with writing an Investigational New Drug application to study crack cocaine,” said Abdelghany. “That’s not something that you can look up in a pharmacy book.” To manufacture a batch of smoked (crack) cocaine for the clinical trial, Abdelghany turned to YouTube. “I told the investigator that if the drug users can make it, then of course we can make it here. It can’t be that hard,” said Abdelghany. He has also created an oxytocin nasal spray for use in an autism study and a long-acting parathyroid hormone that is not commercially available. “I have to think back to all my pharmacy education and use some of the skills I learned that most people don’t use today in terms of pharmaceutical compounding and pharmaceutical calculations,” Abdelghany explained. “You have to think outside the box and become a problem solver.” IRIS trialIn addition to coordinating the pharmacy aspects for studies conducted at Yale-New Haven, Abdelghany also works on large international multicenter trials. He is currently managing all of the medication needs for the Insulin Resistance Intervention After Stroke (IRIS) trial, with more than 3,800 patients and 176 sites all over the world in countries like Italy, Germany, United Kingdom, Canada, Israel, and Australia. In the IRIS trial, patients newly diagnosed with stroke are treated with either pioglitazone or placebo and followed for a total of 5 years. The IRIS trial is now in its 9th year and is the largest NIH stroke trial.“[Pioglitazone] is delivered to my pharmacy, where we handle blinding the medication and shipping to the participating sites,” said Abdelghany. “With that comes a lot of work in terms of meeting the regulations in every country, including meeting the labeling/language requirements, customs regulations, and the demands of local IRBs. It’s almost a mini-manufacturing operation, and as far as I know, not many hospital pharmacies do anything at this scale.”To handle such a large project, Abdelghany had to transform his small pharmacy into a major center capable of coordinating and controlling the pharmacy shipments to all the different countries. “You can imagine the number of meetings we had and the communication with all the foreign investigators about the rules and regulations,” said Abdelghany. “Every country has its own challenges—Israel requires labels to be printed in four languages; Canada needs labels in English and French.” In addition to coordinating the pharmacy aspects for studies conducted at Yale-New Haven, Abdelghany also works on large international multicenter trials. He is currently managing all of the medication needs for the Insulin Resistance Intervention After Stroke (IRIS) trial, with more than 3,800 patients and 176 sites all over the world in countries like Italy, Germany, United Kingdom, Canada, Israel, and Australia. In the IRIS trial, patients newly diagnosed with stroke are treated with either pioglitazone or placebo and followed for a total of 5 years. The IRIS trial is now in its 9th year and is the largest NIH stroke trial. “[Pioglitazone] is delivered to my pharmacy, where we handle blinding the medication and shipping to the participating sites,” said Abdelghany. “With that comes a lot of work in terms of meeting the regulations in every country, including meeting the labeling/language requirements, customs regulations, and the demands of local IRBs. It’s almost a mini-manufacturing operation, and as far as I know, not many hospital pharmacies do anything at this scale.” To handle such a large project, Abdelghany had to transform his small pharmacy into a major center capable of coordinating and controlling the pharmacy shipments to all the different countries. “You can imagine the number of meetings we had and the communication with all the foreign investigators about the rules and regulations,” said Abdelghany. “Every country has its own challenges—Israel requires labels to be printed in four languages; Canada needs labels in English and French.” Studying rare diseasesAbdelghany also provides pharmacy services for a multitude of smaller studies focused on rare disorders. “We see everything here,” said Abdelghany. “At Yale-New Haven Hospital, we have experts in many disease states, and we treat diseases that many people don’t see.”L—R: Kenneth Lupi Jr., PharmD, BCPS; Nilesh Amin, PharmD; Abdelghany; Rupangi Datta, PharmD, BCPS; and Martha Stutsky, PharmD, BCPS, review the pharmacy procedure for a new clinical trial initiated at Yale-New Haven Hospital.View Large Image Figure ViewerDownload (PPT)Yale-New Haven is a referral center for patients with idiopathic pulmonary fibrosis, a condition where scarring or thickening of the lungs occurs without a known cause. Abdelghany also works on a trial focused on ichthyosis, a family of genetic skin disorders. Researchers at Yale-New Haven also study urea cycle disorders, a genetic disorder that typically shows symptoms in new-borns within the first 24 hours of life, and X-linked hypophosphatemia, the most common form of heritable rickets. Abdelghany also provides pharmacy services for a multitude of smaller studies focused on rare disorders. “We see everything here,” said Abdelghany. “At Yale-New Haven Hospital, we have experts in many disease states, and we treat diseases that many people don’t see.” Yale-New Haven is a referral center for patients with idiopathic pulmonary fibrosis, a condition where scarring or thickening of the lungs occurs without a known cause. Abdelghany also works on a trial focused on ichthyosis, a family of genetic skin disorders. Researchers at Yale-New Haven also study urea cycle disorders, a genetic disorder that typically shows symptoms in new-borns within the first 24 hours of life, and X-linked hypophosphatemia, the most common form of heritable rickets. Future of trialsOver the years, Abdelghany has observed an ebb and flow to the diseases studied in trials. In the late 1990s, there were many studies focused on HIV, he noted. “Today, we’re seeing a dramatic increase in the number of oncology clinical trials,” said Abdelghany. Alzheimer disease and hepatitis are also active areas of research, with several exciting new therapies under investigation.The clinical trial process is also evolving. When the Investigational Drug Service was first launched, the drug was most likely dispensed to a patient in the hospital. Today, Yale-New Haven has several satellite campuses all over the state. Many of the trials are multicenter and few are multinational.“It’s a very exciting time for pharmacists to be involved with investigational drugs and emerging research,” said Abdelghany. “As the medication expert, pharmacists are critical to the clinical trial process from start to finish.” Over the years, Abdelghany has observed an ebb and flow to the diseases studied in trials. In the late 1990s, there were many studies focused on HIV, he noted. “Today, we’re seeing a dramatic increase in the number of oncology clinical trials,” said Abdelghany. Alzheimer disease and hepatitis are also active areas of research, with several exciting new therapies under investigation. The clinical trial process is also evolving. When the Investigational Drug Service was first launched, the drug was most likely dispensed to a patient in the hospital. Today, Yale-New Haven has several satellite campuses all over the state. Many of the trials are multicenter and few are multinational. “It’s a very exciting time for pharmacists to be involved with investigational drugs and emerging research,” said Abdelghany. “As the medication expert, pharmacists are critical to the clinical trial process from start to finish.”