To view this email as a web page, click here

Today's Rundown

Featured Story

Greene joins Sage as CEO as Jonas swaps to innovation role

Sage Therapeutics is embarking on a new chapter in its development following its $1.5 billion alliance with Biogen last month, and that challenge will now be met by a new CEO.

read more

Top Stories

Eyeing phase 3, Atsena raises $55M financing for blindness gene therapy

University of Florida spinout Atsena Therapeutics has closed a $55 million financing that will help take its gene therapy for a common cause of blindness in children into pivotal trials.

read more

Neuron23 uncloaks with $113.5M to tackle CNS disorders through genetic mutations

Since October 2018, scientists at Neuron23 have worked quietly to find their place in the world of precision medicine. That place is using artificial intelligence and data science to target neurodegenerative and neuroinflammatory diseases in patients with specific genetic mutations.

read more

Sponsored: Vida Ventures: Powering Breakthroughs in Biopharma

RBC Senior Biotech Analyst Luca Issi interviews Co-Founder of Vida Ventures Arjun Goyal on passion for investing, company purpose, and emerging modalities and investor trends in today’s unique market.

read more

Vivace snares $30M to push Hippo-targeting drugs into the clinic

Three years after coming of out stealth, Vivace Therapeutics has raised another $30 million to pursue drugs targeting the Hippo-YAP pathway. The funding, drawn from Boxer Capital, RA Capital Management and Canaan Partners, will push its lead program into the clinic in the first half of 2021.

read more

Exo Therapeutics snags $25M to handle 'undruggable' enzymes through their exosites

Michael Bruce, Ph.D., has worked for the likes of Pfizer and CRISPR Therapeutics, but now he’s the CEO of what he believes will be the future in medicine: Exo Therapeutics. The company raised $25 million in series A funding to back a pipeline of drugs that bind their enzyme targets at their exosites.

read more

Ellume's COVID-19 test nabs first at-home, over-the-counter emergency use authorization

Ellume has been given an emergency use authorization for its OTC pandemic test you can take at home.

read more

Gilead guts its filgotinib plans, dealing a blow to O'Day's diversification dream

After hitting an FDA roadblock, Gilead Sciences has decided to cut its losses on its Galapagos-partnered rheumatoid arthritis drug Jyseleca, better known as filgotinib. The JAK inhibitor was once a blockbuster hopeful and the poster child of CEO Daniel O'Day's early effort to diversify from its core antiviral portfolio.

read more

Resources

Infographic: 6 Ways Phenotypic Data Improves Decision-Making in Your Drug Development Program

Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline.

Case Study: Aerie fuels new product launches with ZS's REVO analytics platform

Learn how Aerie fueled their product launches with advanced analytics.

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

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

Whitepaper: Enabling Fast And Appropriate Drug Product Supply for Phase 1 Clinical Trials

Lack of resources to move from lab concept to the manufacture/delivery of GMP clinical supplies to patients, key milestones can be missed.

Article: Process development and scale-up of pluripotent stem cell manufacturing

Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand.

Whitepaper: The Future of Pharmacovigilance

Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

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.

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.

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: 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: 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