pharmaceutical research Archives - Medical Design Sourcing

Pfizer veteran pays it forward through AAPS mentorship

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When Cindy Oksanen started out at Pfizer’s Groton, Connecticut research headquarters in 1992, she entered an environment where female Ph.D.s in leadership positions were rare. Starting out as a lab scientist, she developed formulations for new drugs including oral dosage forms like tablets and capsules. “We would develop the dosage forms and then transfer the manufacturing technology to sites around the world,” she recalled. At the time, there were roughly 10 men to every female Ph.D., Oksanen recalled. “It’s changed now, but back then, there weren’t many female role models in leadership roles,” she added.

Oksanen quickly assumed supervisory and leadership roles in analytical and manufacturing departments. Over time, she led development of more than 20 drugs from scratch through to regulatory approval. “I learned a lot about how to develop a drug product,&#…

Zepbound helps people lose 25% of body weight on average 88 weeks, but weight regain is a concern

Lilly’s hot weight loss drug Zepbound (tirzepatide) may be one of the most effective drug therapies for weight loss. In an open-label 36-week study, participants lost an average of 20.9% of their body weight in 36 weeks. With an average weight of 107.3 kg (236.5 lbs), that equates to about 22.4 kg (49.4 lbs) on average.

Weight regain a risk for those going off Zepbound

The catch, however, is that participants needed to keep taking the drug to keep losing weight. Those who stopped taking it saw a rebound, regaining about half of what was lost in the 52-week period after the initial 36-week study. But those who kept taking tirzepatide continued losing weight — an additional 5.5% reduction from week 36 to week 88.

In general, significant weight loss followed be regain can be more than an inconvenience. A Journal of Clinical Endocrinology and Metabolism 16-year prospective cohort study looking at patients with type 2 diabetes found such fluctuations to be linked to…

Pfizer Ignite: Kathy Fernando’s vision for accelerating biotech innovation

Kathy Fernando, the senior vice president, head of Pfizer Ignite and Pfizer CentreOne, has had a professional trajectory marked by pivotal serendipities. One occurred when attending a seminar at the University of Pennsylvania, where she met Dr. Drew Weissman, a prominent immunologist and RNA vaccine researcher. Weissman, along with Katalin Karikó, recently received the Nobel Prize in medicine for discoveries that led to the development of mRNA vaccines against COVID-19.

Hearing Weissman first speak, Fernando recalls being “just blown away” by his scientific creativity. “He just took things to the next level,” she said. She would go on to study under his tutelage, eventually co-authoring a paper with him on HIV that was published in the journal Blood in 2007. The paper explored the potential of mRNA in an HIV vaccine, and the challenges associated with triggering an unintended immune response from the approach. “When you gave mRNA, the bod…

Novo Nordisk stops once-weekly semaglutide kidney outcomes trial early following interim analysis

Novo Nordisk will halt the phase 3b FLOW trial, which investigated the effects of once-weekly injectable semaglutide on kidney outcomes in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD).

The company reached the decision following the recommendation of the independent Data Monitoring Committee (DMC), following an interim analysis that met pre-specified criteria for stopping the trial early for efficacy. The company noted that it would maintain the integrity of the trial data, blinding to the results until the trial’s completion. It plans on announcing results in the first half of 2024.

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New HHS initiatives put spotlight on long COVID

The U.S. Department of Health and Human Services (HHS) recently announced two major initiatives to shed light on long COVID, a condition affecting millions. First, the agency plans to establish the Office of Long COVID Research and Practice. HHS is also set to launch new long COVID-19 clinical trials through its RECOVER initiative. Jointly, the long COVID drug development efforts highlight the need for therapies and create openings for pharmaceutical companies to drive research and drug development related to the condition.

HHS has earmarked $1.15 billion for the RECOVER Initiative to explore novel therapies for the condition estimated to have affected between 7.7 and 23 million Americans. To date, the RECOVER Initiative has enrolled more than 24,000 participants in observational studies on long COVID. New clinical trials, beginning enrollment in summer 2023, will test experimental therapies across five focus areas to identify therapies that can alleviate symptoms and…

Decoding Bayer’s digital health leap and its implications on drug discovery and personalized medicine

The German multinational pharma and biotech colossus Bayer is taking further steps to ramp up its focus on digital health by launching a new business unit. In 2022, Bayer invested $9.5 million in Woebot Health, an AI-powered behavioral health platform company. In 2020, it launched a venture known as G4A Digital Health Partnership Program to drive digital collaboration in cardiometabolic and renal disease, oncology and women’s health.

This new unit, the Bayer Precision Health group, plans to focus on identifying digital and digital-supported consumer healthcare opportunities. The group seeks to create new precision health products based on real-world evidence and digital technologies.

Bayer’s new digital health unit has a priority mission. It seeks to cultivate pioneering digital technologies. The goal? Empower individuals to make more informed health choices. It aims to accomplish that objective by uncovering novel delivery mechanisms, as our sister…

Emory and Pfizer partner to develop new COVID-19 treatments

Emory University has partnered with Pfizer (NYSE:PFE) to create new drugs and therapies aimed at stopping serious disease from COVID-19. The Emory and Pfizer collaboration will take place in Emory University’s Schinazi Laboratory, led by scientist Raymond Schinazi, with the goal of producing novel antiviral compounds to combat COVID, according to The Atlanta Journal-Constitution.

Although the threat of COVID has waned over the past year, the virus remains a leading cause of death. CDC data shows 1,862 COVID-related deaths in the U.S.

Pfizer, the developer of Paxlovid and collaborator with BioNTech (Nasdaq:BNTX) on the Comirnaty COVID-19 vaccine, is arguably the most visible COVID drug developer.

For Pfizer, this partnership represents an opportunity to maintain its leadership position in the COVID-19 drug market and potentially increase revenue. The company, however, expects its revenue to slide by as much as one-third this year as a result of ebbi…

The data to solve many pharmaceutical research problems already exists. We just need to harness it.

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In searching for new therapies, pharmaceutical research teams worldwide are conducting experiments daily and generating knowledge. Thanks to this constantly expanding pool of scientific data, we are starting projects with access to more information than ever before.

Data is good. The right data is better. But finding the right data is no easy task. Inaccessible data sources, the growing complexity of search terms required to attain appropriate results, and the multitude of databases available means that finding data – and then applying it to inform research – is taking up more and more valuable researcher hours. As a result, 80% of researcher time is dedicated to acquiring and reformatting data; time that could be much better spent on analysis and developing scientific insights.

It is, however, essential. What’s needed are methods to accelerate the search …