Addressing the Challenges of Pharmaceutical Content

| August 29, 2017

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As demographics change, and more and more new pharmaceutical and medical devices come to market, content plays an increasingly important role in regulatory requirements, and physician and patient knowledge and support. Yet content is still created and managed using manual methods requiring enormous amounts of time and human intervention.

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PCI Synthesis

A Leading Supplier to Life Sciences Companies and Users of Advanced Materials PCI Synthesis is a custom chemical manufacturer of new chemical entities (NCEs), generic APIs, and other specialty chemical products. PCI Synthesis operates two sites in the Greater Boston area.

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As Pandemic Continues, Rafael Pharmaceuticals Enrolls Patients in Phase III Pancreatic Cancer Trial

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That simple truth about the severity of the disease is one of the reasons that Rafael Pharmaceuticals is slowly continuing with a Phase III trial in metastatic pancreatic cancer during the COVID-19 pandemic. While many companies have paused enrollment in clinical trials during the outbreak, Cranbury, N.J,-based Rafael opted to continue to enroll patients in its Phase III AVENGER 500 study of its lead compound CPI-613 (devimistat) in combination with modified Folfirinox (mFFX) as first-line therapy for the disease. Sanjeev Luther, president and chief executive officer of Rafael Pharmaceuticals, told BioSpace that the company made the decision to continue to enroll the trial, which was 75% filled, due to the short timeline patients with metastatic pancreatic cancer have. After discussing the matter of the trial with the company’s leadership team, Luther said they felt comfortable leaving the decision of whether or not the trial should continue to the conducting institute.

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3 Big Pharma Stocks Plunging the Most During the Coronavirus Stock Market Crash: Are They Buys?

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Merck’s Patient-Centric Clinical Trial Recruiting

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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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Pricing of drugs – at what cost?

Article | February 27, 2020

We go into a doctor’s office and leave with a diagnosis and a prescription. Next we stop by the pharmacy. In Germany, if your insurance is not private, you mostly don’t even know the price of your drug because it’s paid for directly by your insurance. You only notice the 5-10 Euros copay. But how is a drug priced in Germany? And (how) does data play a role in helping pharma secure an attractive price point? Let’s fast forward directly to the launch of a new drug. At the time of launch, the pharmaceutical company has to present patient level evidence of the drug’s added value compared to existing comparative therapies. In the first year, however, the drug’s price can be defined freely by the company.

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Spotlight

PCI Synthesis

A Leading Supplier to Life Sciences Companies and Users of Advanced Materials PCI Synthesis is a custom chemical manufacturer of new chemical entities (NCEs), generic APIs, and other specialty chemical products. PCI Synthesis operates two sites in the Greater Boston area.

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