Michael Christel is the group managing editor of Pharmaceutical Executive, Pharmaceutical Commerce, and Applied Clinical Trials and can be reached at mchristel@mjhlifesciences.com.
Behind the Push and Pull of Copay Accumulator Programs
March 11th 2024In this Pharmaceutical Executive video interview, Chris Dowd, senior vice president of market development, ConnectiveRx, discusses the evolution of drug copay adjustment programs and the circumstances that fueled their controversy across industry, political, and healthcare community circles.
2023 Pharm Exec Top 50 Companies
June 10th 2023With the sales boom from COVID-19 products now in the rear-view, a resetting is underway for those in Pharm Exec’s listing of the top biopharma producers—shifting attention to new Rx roads ahead and the steady strategies needed to navigate a bumpy business terrain.
2022 Pharm Exec Top 50 Companies
June 9th 2022The windfall from COVID-19 vaccines and treatments has shaken up Pharm Exec’s latest listing of the top global biopharma sales producers in record-breaking fashion, but a likely leveling off—along with challenging patent and global climates—should shift some of the spotlight to anticipated non-COVID risers and perhaps more definitive maneuvering ahead.
2021 Pharm Exec Top 50 Companies
June 9th 2021Pharm Exec’s latest listing of the top global biopharma sales producers captures the critical business and public health balancing act that was required in the Year of COVID—reinforcing the staying power of building brand value while championing medical innovation.
The Patient-Engagement Quest: A Conversation with DIA’s Barbara Lopez Kunz
August 9th 2018DIA’s global chief executive talks with Pharm Exec about the current trajectory of patient-centric product development and the need to establish common pathways and metrics to best harness its benefits in everyday practice.
Latest Developments in Alzheimer’s R&D
September 10th 2014With drug-development efforts in Alzheimer’s disease continuing to produce underwhelming results-as clinicians have long battled the inherent diagnosis and translational research challenges associated with the disorder-it’s no secret that there is increased clinical focus now on the prevention and early detection of Alzheimer’s. Those were two areas of emphasis at the recent Alzheimer’s Association International Conference (AAIC) in Denmark. In fact, data presented at the event that reported a decline in incidence of dementia in the U.S. and Europe seems to indicate that reducing the risk of Alzheimer’s and even preventing the disease may be possible. Critical to those pursuits, however, will be future learnings generated from the growing recognition that treatment approaches in Alzheimer’s should target multiple pathologies. Joyce Suhy, Ph.D., VP of neuroscience at BioClinica Inc., a provider of medical imaging solutions for clinical trials, says that people who get dementia usually have mixed pathologies, whether it’s Alzheimer’s, Lewy body dementia, for example, or other similar neurodegenerative conditions. As evidence that researchers are focusing more on multiple pathologies, Suhy cites the recent collaboration struck between the Michael J. Fox Foundation for Parkinson’s Research and the Alzheimer’s Association and the W. Garfield Weston Foundation around studying the links between the Parkinson’s and Alzheimer’s patient populations, with the hopes of reshaping future treatment targets. For Alzheimer’s, specifically, Suhy and her team at BioClinica are focused on helping drugmakers determine whether patients in clinical trials targeting the build-up of amyloid plaque in the brain-considered a crucial factor in the onset of disease-actually have that pathological feature. Most of the notable prevention trials underway are testing drugs that target amyloid. In addition, Novartis recently partnered with Banner Alzheimer’s Institute (BAI) on a clinical study that will determine whether two Novartis experimental anti-amyloid drugs can prevent or delay the emergence of Alzheimer’s symptoms. Advanced molecular imaging techniques can aid in these efforts by ensuring a patient’s pathology is matched appropriately. Further, they provide clinical investigators with sophisticated tools to monitor Alzheimer’s in their studies. Suhy chaired a session on neuroimaging at AAIC, where BioClinica team members presented recent clinical trial progress using amyloid PET screening for enrichment of patient recruitment for early-stage Alzheimer’s. She notes that advances over the past decade in amyloid phenotyping, whether through PET scans or imaging of cerebrospinal fluid (CSF) flow, have helped to better target enrollment in Alzheimer’s trials, particularly as researchers are increasingly studying subjects with more prodromal and milder cognitive impairment. In its presentation, BioClinica reported higher amyloid-negative rates due to the inclusion of earlier-stage patients, when compared to historical trials, which focused more predominately on the mild-to-moderate Alzheimer’s population. “As we’re moving towards earlier screening for enrolling patients into Alzheimer’s disease trials, we find an increasing rate of patients that are amyloid-negative,” says Suhy. “Many of these patients may never advance to mild-to-moderate Alzheimer’s.” Uncovering these earlier clues can be valuable for drug developers when recruiting patients for Alzheimer’s treatment trials targeting amyloid. In past studies, otherwise qualified individuals-who turns out didn’t have amyloid clusters in their brains-were often enrolled, adding significant noise to those trials. The challenge, Suhy says, is that these subjects typically meet the various clinical criteria for the study protocol, such as memory or cognitive decline, and, therefore, are considered good candidates for enrollment. They often progress smoothly through the screening process, and only when getting a PET scan at the end is it discovered they are amyloid-negative. “If a patient doesn’t present with amyloid in the brain, then a drug targeting amyloid will not be effective,” says Suhy. “In other words, the drug target must be present in order for a drug to work. Hence, the current and important initiatives for screening clinical trial patients using molecular imaging like PET or CSF analysis to verify the presence of pathology and enroll appropriate patients for a trial.” Suhy points out that there are several ways to enrich Alzheimer’s patient populations to increase the chances of a successful trial. Besides PET or CSF imaging, some studies are looking at genotype ApoE 2, for example. “By identifying patients earlier in the course of disease, clinicians can maximize their ability to treat and ultimately help patients,” she says. “A key aspect to this is the identification and selection of the right patients.” Key takeaways AAIC, held in Copenhagen, Denmark’s capital city, featured more than 150 data unveilings in Alzheimer’s R&D. One particular notable development, according to Suhy, is the continued promise of tau PET tracers. Tau neurofibrillary tangles, like amyloid, represent one of the hallmark pathologic signs of Alzheimer’s. Though still early in testing, it is thought that tau is more closely linked to memory decline than amyloid, and, therefore, tau imaging-and the development of ligands for early detection of Alzheimer’s risk-may eventually be a better tool for determining cognitive impairment than amyloid imaging. Another takeaway for Suhy was the release of Phase II results for Genentech drug crenezumab, a monoclonal antibody that target all forms of amyloid beta. Though crenezumab did not meet its primary endpoints for cognition and function, a secondary analysis showed promising cognition effects in the milder Alzheimer’s patient cohort when taken at a higher dose. Suhy believes this data further reinforces the importance of early screening of disease risk.
Emerging Pharma Leaders: Susanne Heinzinger
August 14th 2014To say that Susanne Heinzinger’s career trajectory has taken her from one spectrum of the healthcare arena to another may be an understatement. Before entering the pharmaceutical industry as a sales person, Heinzinger, who earned a Bachelor of Business Administration degree in accounting, worked as an auditor; she picked the job of auditing hospitals and home healthcare companies, mainly because she had always had an interest in the healthcare industry.