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Today's Rundown

Featured Story

Secretive Sana, still a year away from the clinic, files for an IPO after a mammoth raise

Sana Biotechnology is following the Moderna playbook to a tee: Promise a lot based on very early science, be vague, nab a major VC raise, then gun for an IPO.

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Thank you to Catalent for sponsoring this year's JPM 2021 coverage.

Top Stories

Meet Binney Street Capital: Dana-Farber Cancer Institute's first venture fund

The Dana-Farber Cancer Institute is getting into the life science funding biz with the launch of its venture arm Binney Street Capital.

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JPM: Can we take J.P. Morgan out of San Francisco? We're virtually there

This week's virtual J.P. Morgan Healthcare Conference gave us a rest from the behemoth the meeting has evolved into. Could it be the catalyst that gets it out of San Francisco? Reviews are mixed. Some think branding and history will keep it in town, while others thing moving the meeting won't solve its problems.

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NewAmsterdam bags $196M to resurrect Amgen's discarded CETP drug

NewAmsterdam Pharma has raised $196 million to fund late-phase trials of a cardiovascular  disease drug discarded by Amgen. The series A will support the revitalization of obicetrapib, part of the once-hyped CETP class of molecules that was torpedoed by a series of clinical setbacks.

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Knopp’s oral asthma drug hits primary endpoint in phase 2

A phase 2 clinical trial of Knopp Biosciences’ dexpramipexole in patients with moderate-to-severe eosinophilic asthma has met its primary endpoint. Knopp said the data support further development of a drug it is pitching as an oral alternative to antibodies such as Regeneron and Sanofi’s Dupixent. 

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Fierce JPM Week: Koller on what 2021 holds for insitro, machine learning and working virtually

While 2020 has changed the way we live, the pandemic may also deliver lasting changes to how we work—and, as machine learning aims to have a larger impact on the life sciences, they may be changes for the better, according to insitro founder and CEO Daphne Koller.

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Cognito Therapeutics nets FDA breakthrough label for light, sound therapy for Alzheimer's disease

Using specific frequencies of flashing lights and sounds to stimulate the brain’s electrical activity, Cognito Therapeutics believes it can help treat Alzheimer’s disease by energizing neurons and reactivating the immune system.

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Eye stem cell transplant to treat blindness bolsters retinal function in monkeys

Retinal cell transplants are considered to be an attractive approach for treating blindness. Question is, where do you source the cells? An international research team is using a type of stem cell in the eye to grow the pigmented layer of retina that’s essential for vision, and the approach is showing promise in preclinical studies.

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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.

Whitepaper: Success in Rare Diseases: Understanding the Rare Disease Ecosystem

Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.”

Content Hub: Emerging Biotech Resource Center

A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule

Whitepaper: Accelerate innovation and manufacturing to better serve patients

A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields.

Survey: Cell and Gene Clinical Supply Needs Market Research Survey

Cell and gene therapies hold the promise to offer novel therapeutic avenues for individuals facing serious medical conditions, but bringing them through the clinical trial process introduces a level of supply chain risk and complexity.

Whitepaper: Gene and Cell Therapy: A New Age of Medicine

Gene and cell therapy are shifting paradigms for manufacturers, patients, healthcare providers and pharmacies. We invite you to learn more by reading Gene and Cell Therapy: A New Age of Medicine.

Executive Summary: Manufacturing Strategies to Effectively Industrialize Autologous Cell Therapies

Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

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.

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.

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.

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: 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.

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