Coronavirus (COVID-19) and Its Effect on Pharmaceutical Marketing and Sales

| March 16, 2020

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With the rapid onset of coronavirus in the United States, many pharma companies are being forced to prepare for a scenario in which their reps cannot visit providers and patients are limited in their ability to visit their healthcare professionals (HCP). The CDC has gone as far as recommending the use of telemedicine and patient portals as primary channels for HCPs and patients to interact.

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Gador

Gador is a national capital pharmaceutical company that started its activities in 1940. As a result of sustained growth, Gador is today one of the leading companies in the Argentine market in a wide range of medical specialties, manufacturing its products in its own plants equipped with More high technology and counting on a staff of 850 employees in the country and 120 in the region.

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New Dimensions of Clinical Trial Optimization

Article | April 20, 2021

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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What do you have to lose taking hydroxychloroquine for coronavirus? Potentially your life

Article | April 10, 2020

The president and some of his close advisors — desperate for a COVID-19 cure — are asking “What do you have to lose?” by taking hydroxychloroquine (HCQ), a strong medication never adequately tested for efficacy or safety in COVID-19 patients. The correct answer to the president’s question, which he doesn’t seem to want to hear, is that we have our lives to lose. The president acknowledges “I’m not a doctor” but this raises the question “What do doctors know about the drug recommended by the president? Most doctors are aware that HCQ can be effective for patients with malaria, arthritis or lupus. If they were to follow the president’s suggestion and prescribe it for COVID-19 patients, they would also like to know that it will benefit some of those patients, at least.

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Decentralized Clinical Trials: Imperative for Pharma Sector to fight COVID19

Article | April 3, 2020

These are unprecedented times. The world is mobbed by a contagion virus, putting people’s health at risk, threatening to destabilize economies. It has already put global healthcare systems under tremendous pressures, and managed to resist efforts to contain it. Even though coronaviruses are not new, this COVID-19 strain has created panic and forced us to be locked down in our homes sans any movement for weeks, if not months. Organizations are fighting an intense battle to keep their workforce safe, minimize risk, and ensure business continuity. For the Life Sciences industry, however, the challenge is even more significant. The whole world is looking at them to come up with a vaccine and a cure. But that is easier said than done. Bringing a new drug to market is an uphill battle and requires rigorous clinical trials. This process already has regulatory challenges. With the current lockdown situation, the Pharma community is grappled with the challenge of continuing some of the critical and time-sensitive in-flight trials so that their regulatory submission, registration, and market entry are not impacted. But all may not be lost. With the right technology solution, it is possible to turn the situation around rapidly.

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Coronavirus Pandemic Brings Hundreds Of U.S. Clinical Trials To A Halt

Article | April 11, 2020

Rene Roach fired off a quick email in late March for an update on a colorectal cancer clinical trial for which she hoped to qualify. Worried about the coronavirus, she asked, almost as an afterthought, whether the study had been put on hold because of the pandemic.The answer crushed her: It had been. "That's when COVID-19 shut down everything," says Roach, 50, of Germantown, Md. Roach assumed that there would be workarounds for patients like her, who have stage IV cancer. These patients often depend on clinical trials as their best chance to knock cancer out when other therapies have failed. For now, she's being treated with traditional chemotherapy, but she was counting on the drug cocktail from the clinical trial. She figures if chemo was going to rid her body of cancer for good, it would have done so already.

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Spotlight

Gador

Gador is a national capital pharmaceutical company that started its activities in 1940. As a result of sustained growth, Gador is today one of the leading companies in the Argentine market in a wide range of medical specialties, manufacturing its products in its own plants equipped with More high technology and counting on a staff of 850 employees in the country and 120 in the region.

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