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April 29, 2020___

Today's Rundown

Featured Story

New Gilead remdesivir data likely enough for speedy FDA approval: Jefferies

As investors and much of the world await any glimmer of hope for treating the ongoing pandemic, it shouldn’t be much of a surprise that Gilead Sciences' shares rocketed up on word that one key trial was positive and details were out in another for severe patients.

Top Stories

AstraZeneca downplays risk of COVID-19 to late-stage timelines

AstraZeneca has downplayed the risk COVID-19 poses to its clinical trial timelines, telling investors it “does not expect material delays to anticipated dates of late-stage and lifecycle-management news flow in 2020 and 2021.”

Pfizer, BioNTech finish dosing in COVID-19 vax test; emergency use could start in the fall

Pfizer and partner BioNTech are keeping pace with the speed of the sweeping pandemic as they finish dosing in the first cohort of their COVID-19 inoculation test.

[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.

Radius CEO Høiland hands reins to ex-Elan boss Martin

Radius Health CEO Jesper Høiland is stepping down after nearly three years in the post. Taking his place will be Kelly Martin, the banker-turned-biopharma-chief who led Elan Pharmaceuticals for more than 12 years. Høiland will return to his native Denmark after 25 years abroad, as Radius chief and in various roles at Novo Nordisk.

One IPO attempt pulled, a drug on partial hold and a pandemic, but ADC tries again

One of the more surprising elements of the pandemic is how well biotech IPOs have managed, and now Swiss startup ADC Therapeutics is hoping for a second-time lucky attempt despite COVID-19.

Taysha Gene Therapies hits the ground running with $30M, 15 programs

The team that developed Zolgensma is back for round two. A group of former AveXis executives and investors unveiled a new gene therapy company, and they’re wasting no time. With 15 programs, $30 million in seed funding and an “unrivaled” partnership with UT Southwestern Medical Center, Taysha Gene Therapies plans to be in the clinic by the end of the year.

Merck taps Almac in neurodegenerative disease drug discovery deal

Merck has weathered some neuroscience setbacks in recent years, but it’s picked up new programs through licensing and M&A. Its latest deal? An R&D pact with Almac Discovery centered on deubiquitinases, a family of enzymes that play many roles in cellular regulatory processes.

AACR: Thrive's early blood test doubles real-world cancer screening rates

Thrive found its blood test more than doubled the number of cases detected by traditional diagnostics, from 25% to 52% when added to a routine workup—and also revealed several cancers that have no standard screening methods, like mammograms or colonoscopies.

IQVIA: 80% of our trial sites are 'inaccessible' due to pandemic, eyes Q4 for turnaround

As IQVIA released its first-quarter financials Tuesday morning, the CRO-analytics firm outlined just how hard its R&D business had been hit by the COVID-19 pandemic.

Resources

[Whitepaper] New Lonza Whitepaper on Modulating lgG Effector Function

This whitepaper summarises approaches for modulating antibody effector functions and pharmacokinetics, and provides examples of antibodies in clinical studies.

[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