Legal

Pharma companies should review their commission-based compensation arrangements with independent contractors to address enforcement risk under the Anti-Kickback Statute, in light of recent Department of Justice enforcement.

Instead, incorporate ESG into your long-term business planning.

Role drift and clinical trials among many areas for compliance professionals to keep an eye on in 2022.

Cross-sector businesses are banding together to protect their intellectual property, but there’s a better way to do it.

Pharma and legal experts weigh in on the rush to secure intellectual property around psychedelic medicines, the value imperative that should govern pricing strategies, and the likely long-haul battle for more widespread decriminalization of these drugs.

New technology serves as reminder for the appropriate uses of CRISPR.

As the pressure on teams reviewing promotional content has increases, both in terms of volumes of content and complexity, Sameer Lal discusses the need for a near-term strategies using artificial intelligence (AI) and machine learning (ML) to decongest bottlenecks of the manual review process.

The Identification of Medicinal Products (IDMP) software industry has talked up the broader potential of data-driven processes. Pharma companies and their software providers have an important role to play in realizing these processes. Frits Stulp discusses the foundations that need to be laid for lasting transformation of pharma information access in the real world.

Understanding of recent legal developments can help companies avoid infringement.

The eight key areas biopharma manufacturers must stay on top of when planning and executing alliance agreements with prospective digital health partners.

In an unpredictable world, international life sciences collaborations can lead to misunderstandings and enforcement challenges, making an effective dispute resolution mechanism an essential risk management tool.

Assessing the implications for the pharma industry of the America Rescue Plan Act of 2021, which provides nearly two trillion dollars in funding for various government programs, including many related to public health.

Mitigating potential risk for stakeholders in light of latest Sunshine Act developments.

Treat patents as strategic business assets and build an IP portfolio.

Disputes over mRNA-related patents are poised to persist.

Fighting the pandemic with joint projects and IP sharing.

Exploring practical points to further understand and strengthen quality culture.

Cybersecurity vulnerabilities embedded in AI and machine learning pose significant litigation risks as life sciences companies move to digital technologies.

Pharma manufacturers may need to upgrade their coupon programs to accommodate for the emergence of copay accumulators and related benefit mechanisms.

How the unfolding of notable infringement claim could alter commercial approaches for players in wider CBD treatment field.

How PREP Act protections will apply to potential COVID-19 vaccine-related claims.

Whether your company already has a data-driven compliance program in place or is contemplating building one, Michael O'Connor and Isha Arora outline four things the DOJ is now focused on that your compliance team needs to know.

How pharma leaders can convert data collected for compliance purposes from a cost center into a critical success factor.

Amid the limitations of traditional compliance programs that emphasize control measures, here are steps biopharma companies can implement in their own cultures to ensure they’re behaving and performing with integrity.

Case study illustrates how compliance teams, in today’s climate, can foster innovation across an organization to help achieve corporate goals.

Xavier Duburcq describes how pharma leaders can convert compliance from a cost center to a critical success factor.

It is vital to begin asking questions about your company’s DSCSA readiness and compliance, as well as that of your strategic partners, writes Rob Besse.

Is Congress harming pharmaceutical research by limiting enforcement of improvement patents?

Op-Ed: The best way to capitalize on the potential revenue influx from enterprise-level drug adherence programs is to create room at the executive table for a Chief Adherence Officer.

James Clark addresses one of the key questions data protection and compliance officers are asking following the implementation of the General Data Protection Regulation -"What role am I playing under the GDPR?"