Newsletter | December 14, 2020

12.14.20 -- Considerations For Biologic Drug Development

Can Your In-House Strategy Handle Uncertainties Of Biologics Development?

To avoid costly mistakes and wasted efforts, a company must prepare for any surprises along the drug development pathway. One way to accomplish this is to diversify its strategies rather than develop only a single-pronged attack for launching a product. But is it possible to achieve efficiency and flexibility within a drug developer’s own walls, or is outsourcing pharma’s best not-so-secret weapon against today’s development uncertainties?

The Right Biomanufacturing Partner Can Mitigate Forecasting Risks
While forecasts can never be 100 percent accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible. To reduce the impact of inaccurate forecasting over the life cycle of a product, companies need to focus on those variables that they have the most control over.
Process Characterization And Validation For Biologic Processes
Even during the early drug discovery process, there are valuable opportunities to simplify the path to commercialization. Using a risk-based approach to generate an appropriate control strategy will help ensure your product meets regulatory requirements, enabling timely approval and launch to market.
Choosing The Right CDMO For Late Phase Clinical Trials
For many pharmaceutical companies that do not have their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical consideration in the management of parenteral products. This webinar reviews the importance of finding a partner with extensive experience in the parenteral arena as products move through clinical phases and toward commercialization.