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Tufts report cites complexities of clinical trials as source of delays and costs

Complex Clinical Trials

A recently completed analysis by the Tufts Center for the Study of Drug Development cites rising protocol complexity as a key factors that negatively impacts clinical trial performance and efficiency, while driving up the cost of developing new pharmaceuticals, reported Melissa Fassbender in Outsourcing Pharma. The situation could get even worse.

Gottlieb proposes plan to simplify FDA structure

Reorganizing FDA

Dr. Scott Gottlieb, who became the 23rd Commissioner of the Food and Drug Agency (FDA) on May 11, 2017, is proposing “to flatten out FDA’s structure by having the Center directors report directly to him, instead of through a level of “directorates” between the commissioner and Center staff,” as reported by Jill Wechsle of Pharmaceutical Executive. The objective is “to give more authority to the agency’s six product regulatory Centers and to the Office of Regulatory Affairs (ORA) and will ensure that the commissioner remains in close contact with the Center leadership,” according to Gottlieb in an email to FDA staff this week.


Market surge creates opportunities and challenges

Biopharma in China

The sophistication of drug production in China has come a long way in a short time, offering both opportunities and challenges for Chinese and Western pharma and biotech companies, according to an article by Peter Young in Pharmaceutical Executive. In recent memory, China was “principally a low cost, low quality producer of pharmaceutical intermediates and fine chemicals,” according to Young, but the country cleaned up its manufacturing practices, developed more sophisticated medicines, conducted clinical trials, improved its regulatory system and developed “a more diversified, modern system of providing patient care.”

Sen. Patty Murray reprimands BIO and PhRMA about gender diversity

Silent on Sexism?

Sen. Patty Murray, D-Wash., the top Democrat on the Senate Health, Education, Labor and Pensions Committee, is furious. After an industry party that objectified women, Murray sent letters to the Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) about their efforts to combat workplace harassment at their member companies, according to an article by Amirah Al Idrus in Fierce Biotech.

Google, Amazon, Facebook, and Apple Spur Life Science Growth

Leading the Way with Strategic Partnerships

Frost & Sullivan, which analyzes markets to help investors, corporate leaders and governments navigate economic changes and identify disruptive technologies and companies, as well as Mega Trends and new business models, predicts that data monetization, direct-to-consumer and eCommerce business models will create growth opportunities in life sciences.

FDA's Gottlieb urges more clinical trial participation by women

Female Factor

In a speech acknowledging National Women’s Health Week, Food and Drug Commissioner Scott Gottlieb reiterated the “importance of making sure women are appropriately represented in clinical trials,” according to a blog by Michael Causey on the Association of Clinical Research Professionals (ACRP) website. He commended the U.S. Food and Drug Administration’s (FDA’s) Office of Women’s Health (OWH) and acknowledged that it provided more than $40 million for 371 projects to “inform the FDA’s work about issues specific to women’s health and sex differences” at an agency event May 16 on “The Great Debate: What is Enough…Women in Clinical Trials?”

FDA goes after sales of e-cigs to minors

Crackdown on Juul Labs

Juul Labs, a San Francisco-based maker of e-cigarettes since 2015, has become a focus of Food and Drug Administration (FDA) enforcement efforts after dozens of undercover illegal sales to supposed minors were made by retailers caught in “compliance checks,” according to Kate Zernike and Sheila Kaplan on the website www.mobilenytimes.com.

Clinical trials can be fake – and dangerous – too

Worse than Fake News

From 2013 to 2016, more than two dozen people who thought they were participating in a clinical trial to obtain a vaccine for herpes. The participants, from the Caribbean island of St. Kitts and in the state of Illinois, had no idea that the Southern Illinois University (SIU) professor had never gotten approval for the so-called clinical trials from the U.S. Food and Drug Administration (FDA), a safety panel or the government of St. Kitts and Nevis. Participants had side effects such as dizziness, aches and ringing in the ears, although nobody had life-threatening issues.

Lilly invests in Sigilon diabetes cell therapies

“Living Therapeutics”

Eli Lilly - a global healthcare leader founded more than a century ago – is paying $63 million up front to license islet cell encapsulation technology from Sigilon Therapeutics, a Cambridge, Massachusetts-based, privately-held biopharmaceutical company focused on discovering and developing "living therapeutics" with its Afibromer™ technology product platform. Sigilon, which is using the technology for Type 1 diabetes, could garner an additional $410 million in milestones and royalties, according to an article by Amirah Al Idrus in Fierce Biotech.

New funding helps company to bring clinical studies to more doctors

Inclusiveness with Elligo

A new round of funding will go a long way to enable Elligo Health Research to fulfill its stated mission of providing “physicians and their patients the opportunity to participate in clinical trials using advanced health care informatics.” According to the company’s website, “Improved access to physicians and patients means sponsors reach trial enrollment goals faster, and new products are accelerated to market, benefiting patients everywhere…We accomplish this by being the preeminent provider of clinical research infrastructure (CRI) services and technologies. As a CRI provider, we bring together and empower sponsors, clinicians, patients and CROs to improve clinical trial access and efficiency.”

GSK buys Novartis out of joint venture

$13 Billion Deal

GlaxoSmithKline (GSK) is buying Novartis out of the consumer healthcare joint venture the two companies had. The $13 billion buyout will give GSK full control of products such as Sensodyne toothpaste, Panadol headache tablets, muscle gel Voltaren, and Nicotinell anti-smoking patches. Under the terms of the 2014 deal to pool their consumer assets, Novartis had the right so sell its 36.5 percent stake to Glaxo. The transaction should be complete in the second quarter of 2018, subject to necessary approvals.

Clinical Trial Registries Show Many Mistakes

Tracking Trials

A review of 10,492 clinical trials that are registered on both the United States government’s ClinicalTrials.gov registry and the European Union’s Clinical Trials Register (EUCTR) found that 16.2 percent had differing statuses on the two sites, and 33.9 percent of trials shown as “completed” on ClinicalTrials.gov were only “ongoing” on EUCTR, reported Melissa Fassbender in OutsourcingPharma.com.