PharmExec Blog

Industry Seeks Clearer Track-and-Trace Standards

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain, writes Jill Wechsler.

Beginning Jan. 1, 2015, manufacturers and distributors will need to have in place systems able to transmit information on prescription drug movement in the United States from plant, to packagers and various wholesalers and distributors, and ultimately to dispensers. FDA is charged by the Drug Supply Chain Security Act (DSCSA), a key component of the Drug Quality and Security Act (DQSA) of 2013, to issue guidance and rules for establishing such a process and is consulting with all stakeholders on viable approaches and policies (1).

FDA held a public workshop in May 2014 (2) to gain input from manufacturers and other supply-chain parties on developing standards for what eventually will be an interoperable tracking system for prescription drugs. FDA officials and industry leaders further reviewed DSCSA requirements, along with broader supply-chain security issues, at a June conference in Washington, D.C. sponsored by the Parenteral Drug Association (PDA). Read More »

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CMOs Take a Hit as Payers Refuse to Cover New Drugs

By Jim Miller.

The value of the customer relationship to a CMO is a function of two variables: unit volume and price per unit. Both variables are contentious issues: bio/pharmaceutical companies are putting enormous pressure on their CMOs for lower prices, while their inability to deliver forecasted volumes often means lost revenues for CMOs as reserved capacity goes unutilized. The resulting low margins depress CMO profitability and threaten their ability to raise capital and invest in replacement equipment and new facilities. Read More »

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Pharma Report Predicts Trillion Dollar Global Industry by 2020

By Colin McMahon.

EvalutePharma’s seventh edition of its World Preview documents that worldwide prescription drug sales forecast will exceed the one trillion dollar mark by 2020. The company bases this estimate on the growing compound annual growth rate (CAGR) that the pharmaceutical industry is currently enjoying. It predicts that CAGR will continue to grow through 2020, ultimately reaching a peak at 5.1%, up sharply from the increase from 3.8% to 4.4% over the past year.  Read More »

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The Technologies Set to Transform Healthcare

By G. Steven Burrill, CEO, Burrill & Company.

The promise of precision medicine is beginning to bear fruit as deadly diseases are made treatable, doctors use genetic information to guide treatment decisions, and the convergence of information, communications, and biological technology reinvents the practice of medicine.

The arrival of this new age of medicine has captured the imagination of investors, who are pouring record investments into these emerging areas. Privately held life-sciences companies have raised $7 billion through the first five months of 2014, representing a 36.2% increase compared to the same period last year. Investment in early-stage companies drove the increase as seed, series A and series B investment jumped 182% during the period to $2.9 billion. The surge in funding is going into innovative areas such as gene therapy, immune-oncology, and digital healthcare technologies that promise to move the needle on the delivery of care and improve outcomes for patients with once-intractable diseases.

As Big Pharma shifts its resources away from internal R&D to externalizing innovation, investors see opportunities in backing companies with cutting-edge technologies. And venture investors, boosted by liquidity from the robust capital markets, are backing startups up with adequate funding to allow them to validate their technologies rather than needing to constantly seek new capital.

Over the past year, investors have pumped more than $2 billion into gene therapy, immunotherapies, and digital-health companies, including more than $1.3 billion invested in startups and $819 million raised by nine companies through initial public offerings . Almost every big pharmaceutical company with an oncology program is developing cancer immunotherapies, while companies focused on genetically inherited diseases are exploring gene-therapy solutions.

For the rest of this article by G. Steven Burrill, click on BioPharm International’s website here.

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What Drives Patient Interest in Clinical Trials?

By Fred Gebhart.

Recruiting patients remains one of the most difficult challenges clinical trial sponsors face. Recognizing that fewer than five percent of eligible adult patients enroll in therapeutic trials, many sponsors have turned to supplemental recruitment, the practice of pre-qualifying community-based patients for referral to clinical trial sites for screening.

“The primary reason that patients do not participate is that they are unaware of opportunities to do so,” said Elisa Cascade, MBA, Vice President of Corporate Development at DrugDev.org, an online network designed to link trial sponsors and investigators. “Physician investigator sites and other researches are actively seeking opportunities to make community-based patients aware of clinical trials. There was little information in the literature on patient-level interest in studies and patient characteristics associated with study interest.” Read More »

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