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Plus: packaging trends, data integrity, serialization, ADCs and expediting clinical development
June 13, 2019
By: Tim Wright
Editor-in-Chief, Contract Pharma
Welcome to the June issue of Contract Pharma, which features a diverse editorial line-up. We kick things off with the 20th Annual Salary and Job Satisfaction Survey, beginning on page 30. More than 200 respondents from our audience sounded off about employment attitudes, responsibilities, education and their 2018 salaries. Also be sure to visit the online version of the survey at ContractPharma.com where you’ll find more charts, graphs and info. Contract Pharma’s Kristin Brooks tackles Packaging Trends for the issue. She talks with several packaging service providers about the key factors influencing the $70 billion market. While the market is projected to grow somewhere between 6-9% over the next ten years, increasing packaging costs due to regulatory measures and stringent regulations are impacting the full growth potential of the market. As data integrity continues to be a hot topic among regulators and auditors, how are modern CMOs staying ahead of the curve and keeping up with stringent regulatory guidelines in this sector? According to Bob Voelkner, vice president of sales and marketing for LabVantage, and author of, “A Brave New World of Data Integrity,” today’s CMOs must begin by embracing advanced laboratory information systems. He also says in the article that for those unwilling or unable to adapt, prepare for the possibility of severe consequences. On the topic of serialization, Angela Holley, business development director at WDPrx, says nearly half of all pharmaceutical manufacturers were not compliant before the November 2018 DSCSA deadline. In her article, “Serialization and the Rest of Us,” she says its the small to mid-size manufacturers that are being impacted the most as they continue to search for compliance solutions. “For this segment, confusion about DSCSA requirements and lack of financial resources to manage the transformation are exposing them to serious implications for their businesses.” Next, Charlie Johnson, chief executive officer of ADC Bio talks about trends in the antibody drug conjugate (ADC) market. ADCs and checkpoint inhibitors used in combating cancer are having a massive impact on the ADC R&D market. In “The ADC Market is Fast Evolving,” he says, “As the number of ADCs used in drug development and actual healthcare treatment expands, so does pressure to intensify their development, driving advanced manufacturing techniques and supply chain innovation.” Lastly, on the clinical development front, Jamie Weishaar, business development executive, PCI Clinical Services, says sponsor companies are attracted to Asia-Pacific because of the vast availability of trial participants. Within the region, Australia is one of the most mature markets for conducting clinical trials and also has many other advantages. In, “Speed, Quality and Cost,” he talks about leveraging Australia to expedite clinical development. Tim Wright, Editor twright@rodmanmedia.com
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