Tim Wright, Editor06.07.21
Welcome to the June issue of Contract Pharma! This issue features a diverse editorial line-up highlighted by our 22nd Annual Salary and Job Satisfaction Survey, beginning on page 66. More than 200 respondents from our audience sounded off about employment attitudes, responsibilities, education and their 2020 salaries. Also, be sure to visit the online version of the survey at ContractPharma.com where you’ll find more charts, graphs and information.
For this issue’s cover story, Contract Pharma’s Kristin Brooks dives into CRO industry trends beginning on page 30. She talks with several CRO leaders in the space including IQVIA, Syneos Health, IDDI and PPD, about the key factors influencing the market, which is on pace to reach $74 billion valuation by the end of the decade. With a soaring number of drugs in development coupled with growing R&D expenditure, Brooks says the increasing complexities in today’s drug development supply chain will make sponsor organizations more reliant on their CRO partners to help improve efficiency and productivity on their quest to get drugs to the clinic and beyond.
Speaking of getting drugs to clinic, in a separate article beginning on page 36, Mark Walker from the CRO WuXi AppTec offers his expertise to companies prepping for the preclinical phase of the drug development journey. Provided is a preparation checklist companies can use to make sure they are ready for preclinical testing. It is vital, Walker says, that before initiating the preclinical testing phase, developers should start internal conversations to ensure a program is ready to advance on all fronts and the project’s ideal laboratory partnership criteria are unambiguous.
Further along the drug development voyage, Joshua Baker and LaRee Tracy from the CRO PHASTAR, offer a regulatory perspective on the new product review process within CDER/FDA—often a complicated endeavor involving many steps, reviews, and negotiations between regulators and biopharmaceutical developers. In this article (page 44) the authors say the statisticians at CDER/FDA and those working for the product developer/sponsor play a key role in helping move the product development process forward smoothly and efficiently.
These are just a few issue highlights, with many more topics covered including cell and gene therapy trends, CEO interviews, the importance of data integrity risk assessment and, for those in management positions, how to keep your staff motivated. Hope you enjoy!
Tim Wright, Editor
[email protected]
For this issue’s cover story, Contract Pharma’s Kristin Brooks dives into CRO industry trends beginning on page 30. She talks with several CRO leaders in the space including IQVIA, Syneos Health, IDDI and PPD, about the key factors influencing the market, which is on pace to reach $74 billion valuation by the end of the decade. With a soaring number of drugs in development coupled with growing R&D expenditure, Brooks says the increasing complexities in today’s drug development supply chain will make sponsor organizations more reliant on their CRO partners to help improve efficiency and productivity on their quest to get drugs to the clinic and beyond.
Speaking of getting drugs to clinic, in a separate article beginning on page 36, Mark Walker from the CRO WuXi AppTec offers his expertise to companies prepping for the preclinical phase of the drug development journey. Provided is a preparation checklist companies can use to make sure they are ready for preclinical testing. It is vital, Walker says, that before initiating the preclinical testing phase, developers should start internal conversations to ensure a program is ready to advance on all fronts and the project’s ideal laboratory partnership criteria are unambiguous.
Further along the drug development voyage, Joshua Baker and LaRee Tracy from the CRO PHASTAR, offer a regulatory perspective on the new product review process within CDER/FDA—often a complicated endeavor involving many steps, reviews, and negotiations between regulators and biopharmaceutical developers. In this article (page 44) the authors say the statisticians at CDER/FDA and those working for the product developer/sponsor play a key role in helping move the product development process forward smoothly and efficiently.
These are just a few issue highlights, with many more topics covered including cell and gene therapy trends, CEO interviews, the importance of data integrity risk assessment and, for those in management positions, how to keep your staff motivated. Hope you enjoy!
Tim Wright, Editor
[email protected]