pharmaceutical R&D Archives - Medical Design Sourcing

Anticipating IND submission: Ensuring your drug is ready for preclinical toxicology studies

[Image courtesy of Adobe Stock]

Drug development is often a vast and intricate journey. Each phase signifies an advancement in the process, always with an eye toward patient safety and efficacy. But before any therapeutic finds itself on the bedside tables of hopeful patients, it faces a formidable challenge: preclinical toxicology testing. As the gateway to clinical trials, this early testing is more than just a safety assessment. A robust examination establishes a drug’s potential efficacy, possible adverse reactions, and activity within the human body.

Preclinical toxicology is when a drug’s strengths and vulnerabilities are laid bare for all to see. Imagine the invaluable insights drawn from organ-specific tests that reveal hidden adverse reactions or genotoxicity evaluations that shine a light on the risks of cellular mutations.

Such revelations can influence everything from dosing decisi…

Commitment to operational efficiency and partnerships yield dividends for Teva

Teva’s strategy to boost its operational efficiency and tap strategic partnerships seems to be paying off. In its Q3 earnings report, Teva announced that global revenues were up to $3.9 billion, marking a 7% rise from the previous year’s third quarter. Factors fueling the growth include the robust performance of their specialty medications, Austedo and Ajovy, as well as a strong showing from their generics portfolio. However, despite these promising stats, investors appear to be cautious. Teva’s stock is down almost 8% so far this year, currently trading at $8.77.

For Austedo, Sven Dethlefs, the company’s head of North America commercial, noted that the company has seen growth for the extended-release version of the drug. In an earnings call, Dethlefs said the company has seen “a significant number of new prescribers that have never prescribed Austedo before that now start prescribing Austedo XR.” He added that the demand for the …

A-Alpha Bio attracts $51M in total funding to advance machine-learning-driven protein interaction research

3D illustration of an antibody [peterschreiber.media/Adobe Stock]

A central hurdle in computational protein design is the mismatch between proteins designed in silico and their actual behavior after synthesis. “You can design millions of proteins on a computer over the course of a week or a month, but computational approaches are just not good enough,” explained David Younger, co-founder and CEO of A-Alpha Bio, in a recent interview. That is, after synthesis, the proteins often do not behave as desired.

Furthermore, the throughput for manual protein experiments is typically low. “You might be able to design millions of proteins, but you might only be able to test 10,” Younger said. The company thus built a platform designed to mitigate this bottleneck by focusing on protein binding — a crucial aspect of protein function.

Established in 2017 as a spinoff from the Institute for Protein Design at the Univers…

QuantHealth taking a data-driven predictive approach to simulate clinical trials

[Egor/Adobe Stock]

In drug discovery, the process of shooting for regulatory approval can feel less like a sprint and more like a marathon, but with no guarantee of crossing the finish line. Despite the hefty investment of time, effort and resources, the success rate for bringing new drugs to market hasn’t improved in recent decades. The American Council on Science and Health estimates an average success rate from 2000 to 2015 of only 13.8%, with costs reaching hundreds of millions per drug. The situation appears more grim with the average cost of developing a drug surpassing $2 billion, according to Deloitte.

“Despite increased understanding of diseases and technologies for drug discovery, developing new medicines remains an unpredictable endeavor filled with many failures,” said David Dornstreich, chief commercial officer and general manager U.S. at QuantHealth.

eClinical Solutions Q&A: The quest to transform raw data into drug discovery gold

[Artem/Adobe Stock]

Top pharmaceutical companies sponsor over a hundred clinical trials annually, generating vast amounts of data. Harnessing this deluge is a monumental task. eClinical Solutions, led by CEO Raj Indupuri, tackles this through advanced applications of data analytics and machine learning with a strong emphasis on AI in clinical trials optimization.

Specifically, eClinical Solutions taps AI/ML for automated data mapping, classification, review and mining insights. This enhances efficiency, speeds up cycle times and ensures quality as data complexity grows. The company’s Elluminate platform integrates and structures data, supporting advanced analytics.

Powerful techniques like anomaly detection algorithms can automatically flag potential data issues for human review. ML also classifies and categorizes data to focus reviewer time on the most critical areas. Fostering an innovative cultur…

Pharma 2023 half-year review reveals winners and losers

[Zerophoto/Adobe Stock]

In many ways, the economic landscape of 2023 has been turbulent. High inflation? Talent shortages? Rising costs of doing business? Volatile currency markets? New regulatory hurdles? Check, check, check. To navigate the choppy waters, a significant number of companies have turned to strategic M&A to drive growth and strengthen product pipelines. Despite these challenges, a handful of pharma companies have managed to thrive, while others have seen steep drops in sales. Here’s an analysis of the leaders and laggards among top Big Pharma pharma companies in the first half of 2023.

The analysis centers on the companies with the highest overall revenue. We looked at companies with the largest percentage change in stock prices from the start of the year to June 27, 2023. For context, the NASDAQ Composite Index is up about 30% so far this year.

Pharma 2023 half-year review: Top 5 w…