Bridging The Policy-Practice Divide In Genome-Editing For Agriculture

| March 18, 2019

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Regulation of emerging technology such as genome editing has mainly focused on responding to the consequences of innovation. The classical regulatory model of “identification-quantification-assessment-safety management” takes a risk-oriented approach to regulation of emerging technology and focuses on constraining the practice of science based on ethics, and administrative and risk management procedures.

Spotlight

Guide Healthcare

We are dedicated to improving the provision of allied heath services in aged care homes. Residents now expect and deserve access to expert clinicians and evidence based treatment programs. The challenge for providers, is to adapt to these changing demands. To remain innovative and competitive, organisation are beginning to shift services towards home environments, modified consumer directed models and the introduction of reablement programs.

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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The Future of Pharma Beyond Blockbusters

Article | March 17, 2020

We’ve all heard the saying “treat the patient, not the disease”, and this couldn’t be truer in today’s ever-changing pharmaceutical landscape. We are living in a time of revolution – advancements in genomics and technology are improving our ability to develop precise drugs and targeted therapies, rather than focusing on a one size fits all approach. Each individual’s genetic makeup is slightly different from everyone else’s,

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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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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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Spotlight

Guide Healthcare

We are dedicated to improving the provision of allied heath services in aged care homes. Residents now expect and deserve access to expert clinicians and evidence based treatment programs. The challenge for providers, is to adapt to these changing demands. To remain innovative and competitive, organisation are beginning to shift services towards home environments, modified consumer directed models and the introduction of reablement programs.

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