Newsletter | February 11, 2019

02.11.19 -- Measuring The Financial Impact Of Remote Clinical Trials

Featured Editorial
Measuring The Financial Impact Of Remote (Digital) Clinical Trials
By Débora S. Araujo

In 2014, The Tufts Center for the Study of Drug Development estimated the cost of bringing a drug to market to be $2.6 billion. With such escalating costs, and drug pricing discussions at an all-time high, many companies are exploring ways to continue to innovate and bring novel drugs to patients while reducing the overall costs of drug development processes. Enter remote clinical trials.

Industry Insights
Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs
White Paper | By Luke Gill, Peter Larson, MD, and George Hemsworth, Ph.D., Premier Research

Explore the many aspects a company must consider in planning and executing an early-phase oncology trial of this hypothetical compound, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints.

Addressing eCTDs And New Regulatory Standards For Pharmaceutical Advertising And Promotional Materials
White Paper | By Thomas Christensen, Synteract

The requirement to submit promotional material in eCTD will add complexity and more room for error, making it all the more important to prepare for potential challenges.

Study Change Requests: A Test Of Agility, Efficiency, And Experience
Article | By Christopher Gent, Cenduit LLC

With study protocols becoming more complex, with changes that require amendments, it is crucial to find a partner that can define, build, test, confirm, and deploy quality studies.

Ingenuity In Clinical Manufacturing Reduces Duration And Complexity For Phase 3 Trial
Case Study | Sharp Clinical Services

Sharp Clinical Services provided a solution for a pharma client that needed a new oral formulation of their product. Multiple active ingredients created a complex manufacturing process with a requirement of eight different batches, requiring the expertise of the Sharp analytical and formulation development teams.

FDA Leadership On Future Biologics And EMA/FDA Cooperation
Podcast | DIA

In the following podcast from the DIA 2018 Global Annual Meeting, Sudip Parikh, senior vice president and managing director, DIA Americas, is joined by Dr. Sandra Kweder, deputy director and liaison to the EMA, Office of International Programs, FDA, and by Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, to discuss EMA/FDA bilateral cooperation and related regulatory issues.

New Drug Application
Webinar | Rho

Marketing application submissions, including NDAs, biologics license applications (BLAs), and premarket approvals (PMAs) in the U.S., are the culmination of years of research and the final hurdle before a product makes it to market. During this webinar experts David Shoemaker, Ph.D, senior vice president, research and development, and Rob Woolson, J.D., M.S., chief strategist, biostatistics and data standards for regulatory submissions at Rho, will help you navigate submissions in the most efficient and effective way.


The 7th annual Chief Medical Officer Summit attracts the largest gathering of physicians in biotech and will take place on April 4 and 5, 2019 in Boston. Although the program is primarily designed for CMOs of emerging biotech companies, large pharma CMOs and other R&D decision makers also attend to exchange best practices in drug development and business management.

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