Manufacturing

Q&A: Five simple strategies to ensure regulatory compliance when globalizing your development program

Industry expert Lawrence Liberti shares his tips for tackling the complexity and diversity of regulatory requirements in divergent markets While expansion into new markets potentially introduces tremendous opportunities to scale your business, globalizing your development program doesn’t come without risks. Whether you’re a pharma or biotech from an established region looking to expand into an […]

Regulatory considerations, strategy and best practices for choosing a quality CMO

Historically, the relationship between a sponsor and a CMO has been mostly transactional – one side manages items like regulatory filings and the other simply manufactures a specific product for a fee.  Today, however, said Bryan Coleman of the EAS Consulting Group, the market and regulatory environment require a much higher degree of collaboration and […]

Partnering to innovate creates ‘window of opportunity’ in biopharma sourcing and procurement

Partnership strategies are essential in driving value and performance in sourcing, procurement and supply management. Executives from Johnson & Johnson, Bristol-Myers Squibb and McKinsey & Company shared their experiences during the “Innovation in Sourcing and Procurement” educational session at DCAT Week ’18 in New York in March. Supplier collaboration is the next horizon with potential […]

Changing product mix, shifting geography drive sourcing and manufacturing outlook

Manufacturing (supply) and sourcing (demand) are very much intertwined. In an industry where scaling up manufacturing or getting approvals to use a new supplier can take several months, if not years, it is critical to anticipate future needs. It is clear that one area to watch in biopharma sourcing and manufacturing is the changing product […]