From Idea to IPO: CRO in Drug Discovery and Development Process
Dr. Christian Grant ( LinkedIn)is a Scientific Director in Biomere. He joined Biomere after completing his Ph.D. from Penn State College of Medicine and postdoc from NIH (NIDDK). With over 18 years of extensive preclinical and project management experience he is currently leading a team of pre-clinical researchers at Biomere in Worcester. In his seminar at UMass Chan on 26th March 2019, he shared his experience of working at CRO (Contract Research Organization) and discussed the role of CROs in drug discovery and development process. Highlights of his talk are: -
What are CROs?
CROs are independent organizations that partner with many big and small pharmaceutical companies to speed up the drug development process. Once the new molecule with therapeutic potential has been identified, the company can outsource services to a CRO for organizing and conducting clinical trials, data analyses as well as developing and submitting regulatory filings to FDA. In recent years, CROs are also actively involved in R&D and have started providing services for pre-clinical animal studies and conducting various ex-vivo/ in-vitrobiochemical assays and in-silico experiments. They can also help industries to develop various medical and healthcare devices. CROs are well-equipped and well-versed with Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and Good Manufacturing Practices (GMPs).
In what capacity do they function?
CROs can range from large, international organizations to small specialty groups. In Massachusetts, there are more than 900 CROs, which are currently functional in different capacities, and providing services to clients at different stages of drug discovery and development pipeline, ranging from conception of a new drug to its FDA approval. CROs can collaborate with various government, non-profit organizations and academic institutions to receive sponsorships or funding for conducting R&D and advancing healthcare. However, once the contract is finished with sponsoring agency and study is concluded, CRO will not continue this research independently.
What are the possible career options at a CRO?
There can be many career options and job opportunities for PhDs, postdocs, and aspiring scientists in CROs. This encompasses pre-clinical and clinical research areas. People who are not interested in bench work can find opportunities to be consultants, project managers or regulatory affair managers. Dr. Grant also discussed about Pros and Cons of working at CROs vs. big pharmaceutical companies. He mentioned that, “as an employee in a CRO you get to wear many hats compared to a big pharma company, where your hat will be bigger in size”. Since CROs work with multiple clients, employees at CROs get exposed to variety of technologies and work responsibilities in their early career, which help them to enrich their experiences rapidly and climb the ladder at a faster rate.
