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Today's Rundown

Featured Story

Tapping GSK tech, Medicago kickstarts later-stage COVID vax tests

After signing up to use GlaxoSmithKline’s adjuvant vaccine technology back in the summer, Canadian biotech Medicago has already finished off a phase1, and is now kicking on with several phase 2/3 trials.

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Top Stories

UCB inks Handl buyout to boost nascent gene therapy unit

UCB has struck a deal to buy gene therapy startup Handl Therapeutics. The takeover, which was disclosed alongside a separate gene therapy collaboration, positions UCB to accelerate its push into genetic medicines. 

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Silverback tees up $100M IPO to push ADCs for cancer, Hep B

Silverback Therapeutics is on a roll. After banking more than $160 million in venture capital this year, the immuno-oncology biotech filed on Tuesday to raise up to $100 million in its Wall Street debut. The funds will bankroll early-phase trials for its lead antibody-drug conjugate and preclinical work for its other programs.

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Best Practices for Research Sites: Effectively Using Patient Recruitment Advertising Dollars

Are you looking to optimize your site’s patient recruitment advertising dollars? WCG’s experienced team of patient recruitment experts can help your site efficiently use your advertising funds by creating customized recruitment campaigns for any of your studies, and we’ve also curated a list of best practices to ensure your spend sees the best ROI.

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Bayer powers gene-editing startup Metagenomi to $65M A round

Metagenomi has raised $65 million to apply its suite of CRISPR-based systems to the treatment of genetic diseases. Leaps by Bayer co-led the series A round, continuing the German conglomerate’s multi-front push into cell and gene therapies. 

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Kira Pharma launches with $46M to bring complement drugs to more diseases

Targeting the body’s complement system could be a solution for many diseases, including those of the skin and nervous system. But “inherent problems” with this pathway have made it historically difficult to drug. Enter Kira Pharmaceuticals, which launched with $46 million and technology out of the University of Pennsylvania to surmount those hurdles.

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Qiagen joins with T-cell biotech TScan to develop immune system test for COVID-19

Qiagen has begun working with a biotech startup focused on cell therapies to develop a COVID-19 diagnostic test capable of comprehensively profiling a person’s immune response to the disease.

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Arming the rabbit pox virus to fight cancer

Arizona State University spinout OncoMyx Therapeutics is designing anti-cancer therapies out of a type of rabbit pox virus called myxoma. The company has early data showing that the virus, when armed with relevant transgenes, can suppress different types of cancer in mice.

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COVID-19 tracker: Moderna hits phase 3 case count for vaccine review; AstraZeneca's Calquence misses in COVID trial

Right on the heels of Pfizer's mRNA vaccine data reveal, Moderna's phase 3 trial racked up enough infections for an interim review. AstraZeneca's cancer drug Calquence flopped in a COVID trial. Amgen and Eisai joined an AI-powered study to assess potential COVID treatments. And MSF pushed for transparency on vaccine licensing agreements.

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Resources

Whitepaper: How sites can navigate the COVID bandwidth crunch

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

Research Report: 2020 North America Customer Reference Data Survey

One sentence that will be displayed in the newsletter and should be written to grab the interest of your audience to want to read more.

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.

Webinar: Elevate Your Digital Events Strategy

Learn how to plan immersive digital event experiences

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: COVID-19 Vaccine Clinical Trials in Children: Challenges on the Horizon

Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper

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.

Whitepaper: Go from Process R&D to Clinical APIs Quickly and Effectively

Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success.

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