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Today's Rundown

Featured Story

Pfizer, BioNTech see stock, hope soar as they say COVID-19 vax 90% effective, plot November EUA

Pfizer and German mRNA biotech partner BioNTech have released an early look at their experimental pandemic vaccine, and the news is good.

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Top Stories

FDA panel slams Biogen's controversial Alzheimer's med

Biogen shocked the biopharma world last year when it resurrected its once-failed Alzheimer’s drug based on findings from a post hoc analysis. But its hopes for a speedy FDA nod look dashed as a panel of outside experts picked apart the data supporting the new drug application, panning it in multiple votes.

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Sanofi, Alnylam’s hemophilia med fitusiran is on hold—again

Sanofi hit pause on the development program for fitusiran, its Alnylam-partnered RNA-silencing hemophilia treatment, thanks to new side effects seen in clinical trials, a trio of hemophilia organizations announced on Friday.

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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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EIP Pharma tees up phase 3 for ex-Vertex dementia drug

Dementia with Lewy bodies may be among the most common types of dementia, but there aren’t many treatment options for the disease. EIP Pharma is one step closer to changing that, with phase 2 data showing its prospect beat placebo at boosting cognition in 91 patients. It hopes to kick off a phase 3 trial in late 2021.

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Decibel scores $82M to push hearing loss gene therapy into the clinic

Launched in 2015 to tackle hearing loss broadly, Decibel Therapeutics kicked off 2020 with a new CEO and an R&D makeover. Now it’s grabbing $82 million to propel its lead programs, including a gene therapy for children with congenital deafness and a program left over from its early days designed to protect hearing in cancer patients undergoing chemotherapy.

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RemeGen grabs one of the world's largest ever biotech IPOs

RemeGen has raised $515 million on the Hong Kong exchange in one of the largest biotech IPOs ever produced.

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Fierce Pharma Politics—Biden puts COVID-19 transition task force on the job

President-elect Joe Biden unveiled his COVID-19 transition task force Monday, with Vivek Murthy, David Kessler and Marcella Nunez-Smith co-chairing—and some other bold-faced names in the infectious disease world serving on the panel. First order of business: Working with state and local officials to determine conditions around the country as case counts surge.

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Oxford's rapid COVID-19 test acquired by Prenetics to screen airport passengers in London, Hong Kong

A low-cost, rapid coronavirus diagnostic developed by researchers at the University of Oxford is now in place to screen passengers at major international airports in London and Hong Kong.

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Attacking pancreatic cancer with a novel immuno-oncology drug conjugate

Researchers at Boston Children’s Hospital engineered an antibody-drug conjugate to home in on pancreatic tumors and deliver a cancer-killing compound to them. Two doses of the drug shrank tumors and prevented metastasis in mouse models of the disease.

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Resources

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: CRCs Equip Sites to Navigate the New Normal

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

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