Manufacturing

Regulatory response to the COVID-19 pandemic: Fast tracking therapeutics

The efforts to end the COVID-19 pandemic have been multifaceted: epidemiological data for understanding, vaccines and non-pharmaceutical interventions for prevention, and new or repurposed drugs for treatment.  In this blog post, Monia Tumminello, Manager, Cortellis Regulatory Intelligence™, and Jaime Polychrones, Medical Writer, Cortellis Regulatory Intelligence, discuss the regulatory response to therapeutic development, from issuing new […]

Regulatory response to the COVID-19 pandemic: Prevention via non-pharmaceutical intervention

Preventive strategies for COVID-19 include a variety of non-pharmaceutical interventions (NPIs) such as social distancing and the use of personal protective equipment (PPE). Reliable case identification and contact tracing guide the distribution of supplies and implementation of NPIs. In this blog post, we discuss how regulatory agencies have addressed the ongoing need for NPI, PPE, […]

Regulatory response to the COVID-19 pandemic: Careful planning to minimize disruptions

Beyond the need to address the ongoing pandemic itself, regulators also must address the impacts to clinical trials as well as essential supplies of treatments and medicines for other diseases and conditions. In this final blog post of our series, we describe strategies to minimize disruption to ongoing clinical trials, drug manufacturing and essential supplies […]

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 […]