Best Practices in Drug Development Modeling and Simulation

| December 5, 2017

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The use of modeling and simulation (M&S) in drug development has evolved from being a research nicety to a regulatory necessity. Today, modeling and simulation are leveraged to some extent, across most development programs to understand and optimize key decisions related to safety, efficacy, dosing, special populations, and others.

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Inovio Pharmaceuticals Inc.

Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio’s proprietary platform technology, ASPIRE, applies next-generation antigen sequencing and DNA delivery to activate potent immune responses to targeted diseases.

OTHER ARTICLES

What to Watch in 2020: Non-Specialty Drugs

Article | March 1, 2020

Pharmaceutical manufacturers are constantly working to develop new and improved medications. Join us as we explore the non-specialty drugs you should be watching in 2020. If you missed last week’s article about the most important upcoming specialty drugs, be sure to check it out here. Approximately 40 new medications are approved by the Food and Drug Administration (FDA) every year.1 (Please note: If you’re curious about what it takes to develop a drug and bring it to market, check out our previous article). Why should you care about these new medications? Because they can affect both your organization’s pharmacy spend and your members’ cost share. For non-specialty drugs, we will focus on medications that may come to market this year, including ones that are currently being reviewed by the FDA, or that are in the last clinical trial (Phase III) stage.

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Merck’s Patient-Centric Clinical Trial Recruiting

Article | March 4, 2020

Everyone in pharma knows that product success depends on the results of clinical trials — but we don’t usually hear from the people who are involved in running them. Recently, four Clinical Research Managers (CRM) from Merck (known as MSD outside the United States and Canada) discussed how Merck is overcoming the barriers to clinical trial recruitment by adopting a patient-centric process — a model that affects their trials top to bottom, from design through implementation. Each of the panel members manages clinical trials, serving as the main point of interaction with the Clinical Research Associates (CRAs) on research requirements, goals, and resources, including recruiting and retention.

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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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Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | February 17, 2020

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

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Spotlight

Inovio Pharmaceuticals Inc.

Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio’s proprietary platform technology, ASPIRE, applies next-generation antigen sequencing and DNA delivery to activate potent immune responses to targeted diseases.

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