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January 16, 2020___

Today's Rundown

Featured Story

Analysts tip Biogen to file for aducanumab approval within weeks

Analysts at Jefferies expect Biogen to file for approval of aducanumab in Alzheimer’s disease within weeks. Biogen, for its part, is keeping mum about its plans, stating only that it is preparing modules of the common technical document for submission to the FDA.

Thank you to Rho for sponsoring this year's JPM 2020 coverage.

Top Stories

Pfizer teams up with Insilico to mine data for drug targets

Pfizer has entered into a research collaboration with Insilico Medicine. The partners will use Insilico’s technology to identify real-world evidence for drug targets in multiple therapeutic areas.

After IPO, BioNTech nabs cell therapy startup Neon Therapeutics

There’s been a deal at the annual J.P. Morgan Healthcare Conference in San Francisco, but probably not with the largest names and certainly not big bucks.

JPM: In conversation with Steve Paul, CEO of Karuna Therapeutics

SAN FRANCISCO—Having worked on drugs like Zyprexa and Cymbalta over his 17 years at Eli Lilly, Steven Paul, M.D., left in 2010 to “do something a bit more entrepreneurial”—he founded a pair of central nervous system-focused biotech companies and stepped up to lead a third.

JPM: Concerto HealthAI unveils $150M raise, 2 pharma data collaborations

SAN FRANCISCO—Concerto HealthAI unveiled a steady drum beat of announcements at this year’s J.P. Morgan Healthcare Conference, including a $150 million funding round and separate real-world data partnerships with Big Pharma companies.

Cancer-killing virus boosts immuno-oncology responses in mice in Astellas-led study

A team of Japanese researchers led by Astellas Pharma’s drug discovery unit engineered a piece of the vaccinia virus to carry two cytokines that stimulate anti-cancer responses from immune cells. When they injected it directly into tumors in mice, the cancers regressed. Combining the treatment with drugs that inhibit the immune checkpoints PD-1 and CTLA-4 was even more effective.

Enrollment Showcase

Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career.  Learn more.

Resources

[Whitepaper] Assessing the Financial Impact of Translational Pharmaceutics®

Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.

[Whitepaper] Simplify 21 CFR Compliance Documentation

A digital transformation is taking place in the life sciences industry, from research laboratories to manufacturing facilities. But there has always been a gap in these technologies. Download the whitepaper to learn how this challenge was addressed.

[Whitepaper] Consent and the GDPR: An Essential Guide

This paper discusses some of the challenges that the GDPR will introduce, with a particular focus on its requirements for obtaining verifiable, unambiguous consent.

[Whitepaper] Solutions Overview: 10 Digital Prescriptions for Life Sciences

Download this paper to learn how you can fully digitize all paper processes. By doing so, you will see shorter cycle times, reduced development costs, and greater customer satisfaction.

[Whitepaper] What to Look for in an Informatics Platform for Large Molecule R&D

As emerging modalities transform the needs of life science R&D, how can biotech and pharma companies use modern software approaches to increase productivity and reach breakthroughs faster?

[Presentation] Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

[Executive Summary] Overcoming Manufacturing Challenges for Accelerated Drug Development

Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project.

[Whitepaper] Digital Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D

The beginning of this digital transformation is well underway and is likely to accelerate. Read our white paper, “Digital Disruption in Biopharma: How Digital Transformation can reverse declining ROI on R&D,” to learn more.

[Whitepaper] Telemedicine: Facilitating Clinical Trial Participation

Download this white paper and read the expert feedback that snapIoT has gathered from industry thought leaders on the evolution, evaluation, and use of telemedicine solutions in clinical trials.

[Whitepaper] Are We Transforming in the Right Way? Why Launches Can’t Be Distracted By Empty Promises.

How are your launch strategies can convert “innovation” into value for patients?

[Whitepaper] Modernizing clinical trials with Amazon Web Services (AWS)

From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks

[Whitepaper] Why Partner with CSP’s to Validate Mission Critical Apps in the Cloud?

Why companies leverage the expertize of industry focused cloud service providers to design and build quality systems and facilitate the FDA Validation of Mission Critical Apps in the Cloud.

[Whitepaper] How to Protect your Supply Chain from Security and Compliance Threats Utilizing On-Dose Authentication Technologies

Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication.

[Whitepaper] The Unexpected Key to Building Value in Drug Discovery and Development

Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor.

[Executive Summary] Clinical Supplies - Made to Order

Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric.

[Whitepaper] Digital Twins: Creating Digital Operations Today to Deliver Business Value Tomorrow

This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future.

[Q&A] Embarking Upon the Commercial Manufacturing Journey for a Biologic

In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

Events