Bringing a new drug to life Regulatory Sciences

| June 8, 2017

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For patients with severe neuropsychiatric conditions, the right drug was available—but there was a problem. The drug was in hard-tablet form, which often caused an issue with patient adherence. Patients would “cheek the pill,” instead of actually swallowing it. As a result, the patients remained at risk and physicians were frustrated. How would physicians get their patients to take their meds.

Spotlight

Maine Medical Center

Maine Medical Center is a complete healthcare resource for the people of greater Portland, the entire state of Maine and Northern New England. With a history dating back to 1864, Maine Medical Center is the state’s largest medical center and the flagship facility of MaineHealth, with 637 beds and more than 7,000 employees. In addition, we have achieved Magnet™ status in recognition of our commitment to the highest standards of nursing excellence. Maine Medical Center’s unique role as both a community hospital and a referral center requires an unparalleled depth and breadth of services, including the state’s only medical school, through a partnership with Tufts University School of Medicine, and a world-class biomedical research center, the Maine Medical Center Research Institute Maine Medical Center Research Institute.

OTHER ARTICLES

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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Enabling Active Pharma Ingredients for Batch Balancing and Integration to SAP EWM

Article | April 6, 2020

Batch and its Classification system are two most potent weapons used in Chemical, Pharma or Medical life science industry to record the potency of a batch or technically called as Active Pharma Ingredients(API). These material consist of one or more active ingredients, concentrates, carrier materials, or impurities, and so on. The potency of the active ingredients varies from batch to batch. The active ingredient is the substance of greatest interest in the bill of materials, the proportion of which may vary from batch to batch. Therefore, during creation of a process order, the system must be able to select and adjust the batches needed to obtain the required amount of active ingredient. Take an example of a drug hydroxychloroquine which is used as potent weapon to fight COVID-19. This drug is manufactured by using API, however, the Potency of this API material vary from batch to batch. To map this kind of requirement in SAP ERP, SAP calls it as Material Quantity Calculation.

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WANT LESS “LIABILITY” AND MORE “RELIABILITY” FROM YOUR CLINICAL MOBILITY SOLUTION?

Article | March 2, 2020

I recently discussed the different ways that consumer-grade smartphones can compromise patients’ health, safety and overall care. However, some clinicians and healthcare administrators have indicated in recent months that they need help selecting the right enterprise-grade mobility solutions for their unique operating models and workflows. There are many different hardware and software options, and a single rugged device can come in multiple configurations. So, how do you know if you’re picking the right communication tools for your clinicians? The key is to first set performance expectations for the total mobility solution rather than the device alone.

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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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Spotlight

Maine Medical Center

Maine Medical Center is a complete healthcare resource for the people of greater Portland, the entire state of Maine and Northern New England. With a history dating back to 1864, Maine Medical Center is the state’s largest medical center and the flagship facility of MaineHealth, with 637 beds and more than 7,000 employees. In addition, we have achieved Magnet™ status in recognition of our commitment to the highest standards of nursing excellence. Maine Medical Center’s unique role as both a community hospital and a referral center requires an unparalleled depth and breadth of services, including the state’s only medical school, through a partnership with Tufts University School of Medicine, and a world-class biomedical research center, the Maine Medical Center Research Institute Maine Medical Center Research Institute.

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