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January 18, 2018

Today's Rundown

Featured Story

Gilead/Kite team up with Pfizer for CAR-T-mAb combination

Gilead and its shiny new $12 billion biotech buy Kite Pharma have teamed up with Big Pharma Pfizer to work on a Yescarta-utomilumab combination test in certain blood cancers.

Top Stories

Pandion Therapeutics launches with $58M series A

Pandion Therapeutics is working on localized treatments for autoimmune and inflammatory disease as a more effective and durable alternative to current systemic immunosuppressive therapies.

U.K. seeks to help startups by easing access to samples, data and disease models

The Medicines Discovery Catapult has detailed how it plans to help biotechs in the United Kingdom address their current pain points. Officials at the government-backed unit identified efforts to make informatics tools, preclinical models, data and samples available to startups as the best uses of its resources.

[Sponsored] Contract Execution Timelines: An Important Factor in Site Selection

The impact of protracted contracting timelines can be felt throughout the study start-up process. Coupling predictive enrollment analytics with contract execution timelines of a site decreases time to Last Patient First Visit by up to 25%.

Forma’s John Hohneker takes the reins at Anokion

After shepherding Forma Therapeutics from its discovery stage to clinical trials as its R&D chief, John Hohneker is joining Anokion Therapeutics as president and CEO, effective Jan. 22.

Inositec names ex-Roche, Novartis staffer as CMO

Inositec has named former Roche and Novartis staffer Frits van Alphen, M.D., as its CMO. Van Alphen joins Inositec as the biotech gears up to move its lead vascular calcification candidate into the clinic next year.

PPD, Quotient Sciences pen pact to speed up therapies aimed at kids

Major CRO PPD and U.K.-based drug development company Quotient have signed up to a new partnership aimed at shortening timelines, reducing costs and cutting down on paperwork when it comes to making new drugs for children.

Chinese buyers mull bids for Johnson & Johnson’s $4B diabetes unit: report

Multiple Chinese organizations are considering buying some or all of Johnson & Johnson’s diabetes care unit, Reuters reports. J&J began assessing whether to sell subsidiaries that make glucose meters, insulin pumps and other pieces of diabetes equipment last year.

Novartis and Biocon partner on ‘next wave’ of biosimilars

Novartis and Biocon, which have each had success developing biosimilars on their own, will now see what they can do together. The two have formed a partnership to produce “next generation” biosimilars.

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] Streamline your mAb Intact Protein Characterization: Download App Note

This Agilent intact protein analysis includes:

[Marketplace] Asia-Pacific Compliance Training for Life Sciences Professionals

Don’t miss this educational program trusted by multi-national companies as part of their employee’s compliance training. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating in the Asia-Pacific region. Visit event page for session topics.

[Whitepaper] Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?

Download Patheon’s whitepaper to discover two main areas where a drug developer can face significant obstacles during biologics development and how by evaluating these capabilities, it can answer the critical question of whether its in-house strategy is ready for these uncertainties.

[Webinar] How to Prevent, Identify, and Implement a Clinical Trial Rescue

What do you do when timelines are missed, data is dirty, and everyone is pointing fingers? Join this webinar to learn how to prevent, identify, and implement a successful clinical trial rescue.

[Whitepaper] Key to regulatory transformation is unified RIM

Expanding into new markets places a spotlight on inefficient processes.

[Whitepaper] Best Practices for Managing Regulatory Processes 

Regulatory leaders share challenges and best practices from a lack of standardization, manual processes, and fragmented systems.

[Whitepaper] Choosing the Right Solution: Improving the Site Feasibility Process

Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals.

[Whitepaper] 5 Steps to Managing Quality Globally

Read this guide if you’re a global life sciences company - conducting clinical trials across several countries, or manufacturing and distributing products in multiple regions - to learn five steps to align and improve quality oversight, as well as avoid common mistakes in harmonization initiatives.

[Whitepaper] How Do Sponsors Ensure Quality in Global Clinical Trials?

Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives.

[Webinar] Validating a 7 Day Membrane Filtration Sterility Test using Celsis®

Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols.

[Infographic] Evolution of Flexible Commercial Biologics Manufacturing

Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility.

[eBook] Developing Site-specifically Modified ADCs: Using a Chemoenzymatic Approach

Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology.

[Article] Optimizing titer and use of a specific enzyme for generating a fully processed antibody

Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing.

[Webinar] Within-Subject Clinical Trials: Intro to New Methods & Stat. Models

In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods.

Events

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