How Are New Medications Developed?

| January 11, 2016

article image
"A new report published by the Tufts Center for the Study of Drug Development (CSDD) pegs the cost of developing a prescription drug that gains market approval at $2.6 billion, a 145% increase, correcting for inflation, over the estimate the center made in 2003."

Spotlight

Daiichi Sankyo, Inc

Daiichi Sankyo, Inc. headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. and a member of the Daiichi Sankyo Group. Global clinical development and regulatory activities are headquartered at Daiichi Sankyo Pharma Development in Edison, New Jersey. Our team of more than 1,400 U.S. employees is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs. We currently market therapies in hypertension, thrombotic disorders, stroke risk reduction, dyslipidemia, diabetes, acute coronary syndrome, opioid-induced constipation and metastatic melanoma.

OTHER ARTICLES

How Pharma Companies Can Scale Up Their Knowledge Discovery with Semantic Similarity Search

Article | March 6, 2020

Pharma has deep roots in human history with centuries of folk pharmaceutical knowledge offering a hit-and-miss range of natural remedies. But the industry as we know it today actually emerged in the second half of the 19th century when the world’s first factory for the sole production of medicines was found. By the late 19th and early 20th century, some chemical companies had already begun using research labs to explore the medical applications for their products. Fast forward to today and the pharmaceutical sector is a global trillion-dollar industry. However, to ensure the safety and efficacy of drugs, the process of drug discovery and development is under extensive scrutiny and control on both national and global levels.

Read More

Clinical Supply Availability & Speed to Study Start-Up

Article | March 6, 2020

If you’re part of a clinical study team racing a new product to commercialization, you likely live by these two simple rules: time is money, and the first one to market wins. But just because it’s simple doesn’t mean it’s easy. That ticking clock is background noise to the responsibilities of regulations, study protocols, supply chains, and patient recruitment — all the details that must be worked out before a study can even begin. The pressure is always there. The longer it takes for a study to start, the longer it takes to complete.

Read More
PHARMACY MARKET

A pharma outsourcing mission

Article | March 6, 2020

In a way, getting through the initial stages of a complex pharmaceutical project that is being outsourced to a contract development and manufacturing organization is like getting a rocket off the ground. Many drug developers express frustration with the time it often takes during the initial stages of working with a CDMO — from the time they first reach out to a CDMO for help until they receive a proposal. Some have described it as months of silence from when they send a request for proposal (RFP) until they have a proposal in hand. The initial stages of a relationship between drug sponsor and CDMO often do not get the attention it deserves, and valuable time is lost, delaying projects and delaying delivery of therapeutics to patients. The quick scheduling of the ACT meeting with the right attendees can deliver immediate answers to key questions needed by the drug sponsor for effective planning and can help propel projects to a successful launch.

Read More

Pharmacist eCare Plan - the newest disrupter in health data exchange?

Article | March 6, 2020

Every member of the health care team shares a common goal of optimizing patient outcomes. Yet each specialty and position of the healthcare team has a unique workflow facilitated by various tools, from an operative report to a progress note. In this regard the pharmacist plays a pivotal function in medication management and requires documentation specific to that role. The Pharmacist eCare Plan (PeCP) allows for an interoperable note to be used in the pharmacy to assist in the exchange of patient information, including active medication list, laboratory results, and payer information. To allow for this, a new type of clinical document architecture for the PeCP was created and standardized for use across pharmacies.

Read More

Spotlight

Daiichi Sankyo, Inc

Daiichi Sankyo, Inc. headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. and a member of the Daiichi Sankyo Group. Global clinical development and regulatory activities are headquartered at Daiichi Sankyo Pharma Development in Edison, New Jersey. Our team of more than 1,400 U.S. employees is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs. We currently market therapies in hypertension, thrombotic disorders, stroke risk reduction, dyslipidemia, diabetes, acute coronary syndrome, opioid-induced constipation and metastatic melanoma.

Events