To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

April 27, 2020___

Today's Rundown

Featured Story

Gilead's COVID-19 hopeful remdesivir may get swift Japanese approval: report

Japanese Prime Minister Shinzo Abe is set to grant Gilead’s experimental COVID-19 drug remdesivir a special, speedy approval, despite it failing to show any definitive clinical signs that it works.

Top Stories

AACR: A look at next-gen CAR-T therapies for blood cancers

CAR-T therapies have been a game changer for certain blood cancers, but there's still room for improvement. Some patients may relapse, while others may not have the time or the T cells for a bespoke treatment. Early data presented at the American Association for Cancer Research virtual sessions sketch out some solutions to those problems.

AACR: Early Trovagene data offer hope for KRAS-mutant colon cancer

Amgen may be leading the race to develop a KRAS inhibitor, but its candidate hasn’t logged the same success in colon cancer as it has in lung cancer. Early data out of AACR suggest a different route to treating patients with KRAS-mutated colon cancer—including those with mutations thought to be undruggable.

[Sponsored] Connecting biotech, pharma and life sciences ecosystem to ramp up COVID-19 capabilities

The life sciences industry is moving in record time to beat COVID-19, but it must connect with partners across the entire ecosystem to ramp up capabilities and deliver the billions of vaccines doses and treatments needed.

AACR: Compugen's checkpoint inhibitor keeps cancer in check

Compugen’s anti-PVRIG antibody showed early promise in a small phase 1 study, curbing tumor growth in more than two-thirds of patients with various solid tumors who had exhausted all other treatment options. The treatment did similarly in tandem with Bristol Myers Squibb’s PD-1 blocker Opdivo, stopping tumor growth in three-quarters of patients.

Compass raises $80M to take magic mushroom drug toward phase 3

Compass Pathways has raised $80 million to prepare its psilocybin therapy for phase 3 development. The London-based biotech is advancing the drug, the active ingredient in magic mushrooms, for use in people with treatment-resistant depression.

European leaders, WHO team up on $8B pandemic vaccine response

The leaders of Germany and France and a host of other EU countries and groups have come together with the World Health Organization for an $8 billion push for a new vaccine against COVID-19.

Rome Therapeutics debuts with $50M and Rosana Kapeller at the helm

In 2018, Rosana Kapeller left Nimbus Therapeutics, the company she built from the ground up, “to do something different.” Two years and a stint at GV later, she’s unveiling that something: Rome Therapeutics, a new biotech startup looking to drug parts of the human genome previously spurned as “junk DNA.”

AACR: Grail substudy shows its cancer blood test could help focus oncologists' diagnostic workups

At the virtual annual meeting of the American Association for Cancer Research, Grail presented a new sub-analysis on its test’s performance, and specifically on how it would fit into everyday clinical practice.

AACR: Adding Roche's Tecentriq to Gilead's Yescarta doesn't help clear lymphoma, early study says

With a study of its Yescarta therapy in tandem with Roche’s Tecentriq, Gilead Sciences was aiming to find out whether adding a PD-1/L1 immuno-oncology drug to CAR-T treatment could improve outcomes for lymphoma patients. But after a small, early study, there’s still no evidence it can.

Resources

[Magazine] Perspective: the patient edition

Report: Think you’re patient-centric? Think again. Find out how patients really feel about patient-centricity. Learn what they would like to experience along with tools and tips for maximising patient engagement across the product life cycle¬ – from clinical trials to service design and creative campaigns.

[GUIDE] Managing Clinical Trial Patient & Site Engagement During COVID-19

Leverage strategic solutions to respond to immediate challenges to patient and site engagement from COVID-19, and learn to maximize the FDA guidance on the conduct of clinical trials during a pandemic.

[Whitepaper] Navigating the Changing Clinical Trial Landscape

The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need.

[Whitepaper] Successful BYOD in Any Phase

This white paper includes a Phase III case study and discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations.

[Whitepaper] A Fast Way to Curb Your R&D Spend: Make Failure a Strategy

Turn your drug failures into competitive advantage.

[Whitepaper] Payers’ Perspectives on Digital Therapeutics In-Depth Interviews Reveal What Manufacturers Can Expect

How will US payers evaluate and manage digital therapeutics? Get insights and recommendations on successful market access considerations.

[Whitepaper] Data Integration and the R&D Organization

Despite advances in content aggregation and search, silos still limit the free flow of data and analytics. So, what can be done, and how can you get more value from the data you already have?

[Webinar] Model-Based Approach to Design Bispecific Modalities in Early Discovery

Learn how we used a tiered model-based approach of a bispecific antibody to appropriately cover multiple antigen pairs to help teams with informed antibody design, prioritization of experiments, and triaging of challenging antigen pairs

[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.

[Guide] Pandemic Survival Guide --- IT Solutions for Business Continuity

To survive in these challenging conditions, companies need to promptly address business continuity issues - especially the remote delivery of data and voice solutions. See how Outer Edge can help.

[Whitepaper] Ensuring the Greatest Return From Your Poorly Soluble Molecule

Poorly soluble molecules hindering your workflow?

[On Demand] Tufts-eClinical Solutions Data & Analytics Survey Results

Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor.

[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.

[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.

[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.

[Executive Summary] Strategies for Flexible Manufacturing

This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market.

[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.

[Case Study] Precision Analytics for Product Launch and Growth

Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights. 

Events