R&D Archives - Medical Design Sourcing

Harnessing the untapped potential of legacy data in pharma R&D

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Clinical trials for a new therapy cost a median of $41,117 per patient. Costs like this are no surprise to pharma leaders. But during an age of increasing budgetary pressures, drug developers are under pressure to do more with less money and staff. While there are no “simple” answers to this challenge, there is one strategy that offers research and development (R&D) teams a very powerful approach: better leveraging existing legacy data.

Pharmaceutical companies own petabytes of imaging data, generated by in-house research, investigator-initiated studies or clinical trials. This data is valuable and can yield insights that can help researchers better understand disease mechanisms and inform therapeutic approaches. But in many cases, researchers cannot access this important data, as it remains in silos with CROs, investigator labs, or within a specific research group…

Inflation may slow, but R&D still hot, in this week’s R&D Power Index

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The R&D World Index (RDWI) for the week ending June 17, 2022, closed at 4,413.63 for the 25 companies in the RDWI. The Index was down -.3.44% (or -157.22 basis points) from the week ending June 10, 2022. Two of the 25 RDWI members gained value from 0.86% (Oracle) to 6.67% (Cisco). Twenty-three of the 25 RDWI members lost value last week from -0.86% (IBM) to -11.92% (Ford Motor Co.).

Drug companies on the list include Johnson & Johnson, Roche, Merck, Novartis and Pfizer.

Get the full story from our sister site, R&D World.

J&J’s CSO to retire by the end of 2021

Dr. Paul Stoffels, who serves as Johnson & Johnson’s chief scientific officer, will end his tenure on December 31.

Stoffels, who is also vice-chairman of J&J’s executive committee, was responsible for reinvigorating J&J’s Janssen pharmaceutical pipeline and was instrumental in developing a COVID-19 vaccine.

The company’s CEO and executive chairman, Alex Gorsky, is also retiring from the company, effective January 3, 2022.

Dr. Paul Stoffels

Stoffels, a Belgian, intends to spend more time with his family in Europe.

Earlier in his career, Stoffels focused on tropical-disease research and antiviral drugs.

He co-founded the antiviral firm Tibotec-Virco, which Janssen acquired in 2002, paving the way to the company’s focus on HIV drugs.

Stoffels also had a passion for tackling tuberculosis and Ebola and pushed Janssen to develop treatments for them.

In 2020, St…

VectorBuilder and Landau join forces to create primate gene therapy research center

Recombinant vector specialist VectorBuilder and Landau Biotechnology, which develops nonhuman primate models for clinical research, have entered into a strategic partnership. The two companies will collaborate on establishing a primate gene therapy R&D center.

VectorBuilder is based in Chicago and has facilities in Germany, Japan and China. Landau Biotechnology is headquartered in China.

The center will focus on the development of platforms for vector screening and optimization and offer a range of contract research organization–based services for cell- and gene-therapy companies. It will also offer in vivo screening of nonhuman primate to identify potential gene delivery vectors for human clinical use.

Nonhuman primate vectors have received attention during the COVID-19 pandemic given the use of such technology in the Oxford–AstraZeneca COVID-19 vaccine. Specifically, the vaccine uses a modified chimpanzee adenovirus ChAdOx1 vector developed at the …

Biden and Pelosi pursuing plans to cap drug prices

Joe Biden and Nancy Pelosi images from Wikipedia

President Biden has instructed FDA to develop a plan to import prescription drugs from Canada while asking federal officials to create a “comprehensive plan” to cut drug prices within 45 days.

Biden has also recommended that FTC block “pay for delay” agreements from pharma companies paying generic drug makers to hold off on introducing competitive products.

The proposals are included in a far-reaching executive order with several healthcare provisions. The main thrust of the order, however, is stimulating competition in the economy.

Earlier this year, Biden asked Congress to allow Medicare to negotiate drug prices, which was also a goal spelled out in the 2019 House Bill H.R. 3 that Democrats reintroduced in April.

Biden included the recent effort to give Medicare drug negotiation powers in an executive order intended to spur economic comp…

Q&A: Keys to unlock data science potential for drug discovery

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For all of its promise in healthcare and elsewhere, deploying artificial intelligence is frequently a challenging endeavor. “Close collaboration between data science teams, other project team members and stakeholders is essential,” said Jennifer Bradford, director of data science at Phastar, the London-headquartered contract research organization. While input from computational, statistical or medical experts could be essential to inform data science models, all stakeholders understand the requirements and are working “in sync with the project,” Branford said.

In the following interview, Bradford shares advice on how to collaborate effectively on data science projects, the impact of COVID-19 on data science in pharma and the potential for AI to accelerate R&D timelines.

What comes next after alignment between different stakeholders on data science projects is confirmed? <…

Organ-chips could streamline drug development, but hurdles remain

Emulate Bio’s CHIP-S1

While organ-on-a-chip technology has evolved tremendously over the past 15 years, adoption of the technology remains at an early stage. But as organ-chip technology advances and the R&D costs for pharma companies continue to hover near unsustainable levels, organ-on-a-chip technology has the promise to address what cell biologist and bioengineer Donald Ingber called the “broken” drug-development model.

One of the key challenges is the drug industry’s reliance on animal studies in preclinical research, Ingber said in an Emulate Bio virtual event. “There are ethical issues,” said Ingber, a member of the company’s board of directors. “But the real problem is that the results of these animal preclinical models often don’t predict clinical responses,” he added.

Complicating matters further is the rise of biologics, which make up a sizable portion of the drug-development pi…

Why focusing on the quantity of pharma innovation is misleading

Photo by Louis Reed on Unsplash

Since the early 2000s, pundits have lamented that there is an innovation crisis in the pharmaceutical industry. One of the most common reasons given is the challenge of bringing new drugs to market.

The U.S. Government Accounting Office concluded in 20016 that the “productivity of [the pharma industry’s] research and development expenditures has been declining.” The cost of developing a new drug frequently tops $1 billion, and scores of drug candidates never make it to market.

While the COVID-19 pandemic has heightened society’s appreciation for the pharmaceutical industry’s innovation, the concept of an innovation crisis hasn’t gone away.

Many of the arguments purporting such a crisis focus on the quality of pharmaceutical innovation rather than its quantity, said Troy Groetken, a shareholder, board member, and executive committee member at the intellectual prop…

Here’s what molecular shape can tell you about pharma innovation

Photo by Anna Shvets from Pexels

Is it possible that pharmaceutical innovation has accelerated over the past two decades — with the novelty of small molecule and peptide drugs steadily increasing?

That’s the conclusion suggested by a recent study published in ACS Medicinal Chemistry Letters, which found roughly 65% of FDA-approved drugs in 2020 were structurally novel. Last year’s drug approvals even included at least one new molecular entity based on a novel molecular shape.

The finding flies in the face of the talk of an innovation crisis in the pharmaceutical industry. Before COVID-19 struck, pharma industry observers tended to chide the industry’s recent innovation track record. R&D costs per drug have increased significantly, while drug blockbusters have grown more scarce. Despite the pharma’s historically high-profit margins, the sector generally trailed the S&P 500 in the years leading up to the pandemic.

Get the full story …

Here’s what molecular shape can tell you about pharma innovation

Photo by Anna Shvets from Pexels

Is it possible that pharmaceutical innovation has accelerated over the past two decades — with the novelty of small molecule and peptide drugs steadily increasing?

That’s the conclusion suggested by a recent study published in ACS Medicinal Chemistry Letters, which found roughly 65% of FDA-approved drugs in 2020 were structurally novel. Last year’s drug approvals even included at least one new molecular entity based on a novel molecular shape.

The finding flies in the face of the talk of an innovation crisis in the pharmaceutical industry. Before COVID-19 struck, pharma industry observers tended to chide the industry’s recent innovation track record. R&D costs per drug have increased significantly, while drug blockbusters have grown more scarce. Despite the pharma’s historically high-profit margins, the sector generally trailed the S&P 500 in the …

3 notable types of innovative drugs from 2020

Chemical structure of the COVID-19 therapy remdesivir. Image is from Wikipedia.

Last year, FDA approved 53 drugs, leading the industry to describe 2020 as “a strong year for new drug therapy.”

There are several drugs that stand out, according to Todd Wills, the co-author of a study that analyzes how innovative drugs are based on their structure.

The drugs that follow are examples of notable innovative therapies.

[Related: Here’s what molecular shape can tell you about pharma innovation]

1. COVID-19 therapies

One of the prominent drugs that stands out as structurally novel is remdesivir from Gilead Sciences (NSDQ:GILD). The first COVID-19 treatment to win FDA approval, remdesivir (Veklury), was first developed as an Ebola treatment. But the broad-spectrum antiviral also showed promise against the SARS-CoV-2 virus.

Gilead recently announced that sales of remdesivir beat …