Newsletter | September 16, 2020

09.16.20 -- COVID Pandemic Hastens Search For New Technology And CRO Partner

 
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Digital Health Innovation: The Predictive Impact Of Curated Real-World Data In Times Of Change

The projected costs of healthcare in the United States due to the novel coronavirus, or Sars-COV-19 (COVID-19), are eye-opening. One critical question is the extent to which digital technologies can be useful in informing our understanding of what works in healthcare delivery and what does not. Access to more complete data is crucial to empower a diverse range of stakeholders with the knowledge and ammunition needed to make informed choices about expenditures and the use of scarce healthcare resources.

5 Must-Haves In A Contract Packaging Partner

A contract packaging partner should function as an extension of the pharma’s organization, so careful consideration should be devoted to initiating this relationship. 

Virtual Clinical Trials Best Practices

In recent years, alongside the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials. This paper examines the nature of virtual clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.

The State Of Cell Therapies In Dermatology

Of the many types of skin stem cells that have been identified, epidermal stem cells — primarily keratinocyte stem cells — are recognized to play a key role in tissue repair and skin regeneration. These cells have been characterized as rare, infrequently dividing, and capable of generating the short-lived, rapidly dividing cells involved in regenerating the epidermis and repairing skin injury. This article discusses the challenges of developing cell-based therapies in dermatology.

Three Considerations For Successful Global Sample Processing With A Central Laboratory

Sample preparation and processing are often crucial components in immuno-oncology and cell and gene therapy studies. Obtaining timely and high-quality processing services is an industrywide challenge, particularly within the context of global trials. This paper reviews three of the keys to success for global sample processing.

Three Reasons Why Oncology Trials Need Clear Estimands

Unlike many therapeutic areas, oncology benefits from having standardized endpoints such as overall survival and progression-free survival, as well as standardized methods of measuring such endpoints. While oncology might have the advantage of certain standard endpoints, there are still challenges that suggest estimands can clarify the research plan.

Importing Clinical Supplies Into China

Rich Nelson, senior manager of global logistics at PCI Pharma Services, recently discussed the different aspects of importing clinical supplies into China including the unique import requirements that China has, the benefits of running clinical trials in China, and moving clinical supply between Hong Kong and China.

Regulators Promote Reliance As 21st Century Best Practice

“How do you do the process of regulation? Not the science of regulation, but how do you do the process of regulation more flexibly and agilely?,” asks Murray Lumpkin, deputy director of integrated development and lead for global regulatory systems initiatives at the Bill & Melinda Gates Foundation.

How Sponsors Turn Disclosure As A Service Into A Strategic Advantage

In this panel discussion, Teva and Lung Biotechnology disclosure experts discuss why they opted for disclosure as a service. They will detail how it helps them safeguard regulatory compliance and mitigate risk.

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