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Today's Rundown

Featured Story

Ex-AstraZeneca executive launches D3 Bio with $200M

D3 Bio has emerged with $200 million from a syndicate of heavy hitters and an ex-AstraZeneca leader in the CEO role. George Chen, M.D., set up D3 Bio after seven years at AstraZeneca and persuaded investors including Sequoia Capital China and Temasek to bankroll his plans. 

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Top Stories

Retrophin sheds Shkreli connection with new name: Travere Therapeutics

Retrophin may have ousted Martin Shkreli back in 2014, but he kept reappearing, last year suing—and settling with—the management of his former company, all from a prison cell. Now, the rare disease biotech is turning the page for good with a new identity: Travere Therapeutics.

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CymaBay tees up new phase 3 study for resurrected liver drug as truncated trial shows promise

CymaBay Therapeutics is getting its liver disease drug back on track. The treatment beat placebo at lowering a liver enzyme in patients with primary biliary cholangitis (PBC), a rare, progressive disease that can lead to inflammation and scarring in the liver.

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Sponsored: It’s never too early to think about automation for your bioprocessing facility

The right automation design can meet your initial needs and be expanded for your future growth. Planning for success takes a little effort upfront but can pay huge dividends in the long run.

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AHA: Bayer's finerenone helps kidney, heart disease patients regardless of medical history

Following an upbeat release of top-line data earlier this year that showed its finerenone treatment helped stave off kidney and heart disease, Bayer is now providing more details on the drug’s ability to improve the health of chronic patients regardless of their past history of cardiovascular conditions.

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Avrobio tracks improvements in first patient treated with Gaucher gene therapy

Avrobio has shared data on the first Gaucher disease patient to receive its gene therapy AVR-RD-02. The patient, who was stable on enzyme replacement therapy at baseline, experienced a 22% drop in a toxic metabolite after receiving AVR-RD-02 and stopping taking the standard of care.

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Deep Genomics hits the partnering ground running with BioMarin deal

Deep Genomics is wasting no time. Two weeks after hiring a new chief business officer to ramp up its partnering game, it’s unveiling its first biopharma tie-up: BioMarin. The duo will use the Toronto biotech’s artificial-intelligence-based drug discovery platform to discover new drugs for rare diseases.

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Glympse Bio clears first-in-human safety study of its injectable biosensors

Glympse’s open-label phase 1 study also confirmed signal detection in samples and helped identify the optimum time to collect urine following the sensors' injection.

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Worms solve mystery of key inflammatory molecule implicated in asthma, eczema and more

IL-33 is a cytokine that’s known to be a key player in inflammatory diseases such as asthma. Now, with the help of worms, University of Pennsylvania scientists have discovered that IL-33’s activity is governed by the type of cell that produces it—a finding that could boost the development of drugs targeting the cytokine.

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Resources

Research Report: 2020 North America Customer Reference Data Survey

New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress.

Whitepaper: Survey Reveals Demand for Clinical Trial Innovation in the Wake of COVID-19

The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement.

Whitepaper: How sites can navigate the COVID bandwidth crunch

Need additional site resources for your current or upcoming clinical trial?

eBook: Mass Spectrometry-based Host Cell Protein Analysis in Biologics Development

Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics.

Webinar: Using SPOT™ & CHO-BC® During Cell Line Development for Titers up to 9 g/L

Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards.

Research: Premier Research Resource Hub

Browse the latest learnings and insights from our clinical development professionals.

eBook: THE NEED FOR TRIAL VIRTUALIZATION

Responding to site challenges. Approaching virtualization. Leveraging real-time data. Medidata shares 8 parameters to implement your virtualization strategy during COVID-19 and beyond. Download Now.

Infographic: Reducing Time to Clinic for Your Biomedical Applications

This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments.

Whitepaper: Liquid-Filled Capsules for Highly Potent Drug Compounds

Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives.

Whitepaper: 6 API Challenges That Could Slow Your Development & How to Avoid Them

One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline.

Whitepaper: Rapid BYOD Build Timelines

This white paper covers a Phase III case study; BYOD advantages and misconceptions; and regulatory, copyright, and equivalency considerations.

Whitepaper: Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation

Anticipate early development challenges to avoid rework and costs.

Article: Strategies to address the viral vector manufacturing shortage

Accelerating the production of viral-vector based therapy requires both understanding of strategies to address viral vector manufacturing and how to select the most cost-effective solution for your therapeutic. Read more in this article.

Whitepaper: How to Leverage IDN Data – Everything You Need to Know

Get insights into healthcare decision-makers networks.

Whitepaper: Gene and Cell Therapy: Planning for Manufacturing Success Early

Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience.

Whitepaper: Companies Need An Effective Remote Workforce Cloud Strategy To Survive

A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Q&A: Planning Successful Launches

Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools.

eBook: CMC Considerations for Successful Early Drug Development

This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success.

Webinar: Phase Appropriate Expertise and Technologies to Accelerate Product Development to Commercialization

In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site.

Whitepaper: How to Achieve Time and Cost Reductions in Clinical Trial Design and Build

Learn how to save time and reduce costs and complexity by streamlining the clinical trial process.

Whitepaper: Why Your Business Needs a Ransomware Strategy To Avoid Being Hacked!

Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now!

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Executive Summary: Keys to a Successful Rapid Commercial Launch

Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

Case Study: Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

Fact Sheet: Forecasting to Optimize Clinical Trial Supply Management

Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study.

eBook: Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study.

Events