We are happy to welcome guest expert bylines sharing:

• Best practices
• Pitfalls to avoid
• Lessons learned
• Recommendations for how to overcome/mitigate certain common challenges
• Regulatory compliance tips, trends, and insights
• Emerging trends
• And other actionable intel on the topics you see listed below.

Please remember that our audience consists of professionals at life sciences companies who are developing their own pipeline of drugs or therapies (and who work with outsource partners such as CDMOs). Any articles would need to “speak to” and provide practical information for this audience.

Ideally, authors of these guest expert bylines are employed at:

• Pharma or biotech companies developing their own pipeline
• Consultancies (or be independent consultants)
• Academia
• Non-profit orgs
• Industry consortia

We cannot accept content from companies that are vendors, suppliers, or outsource partners to our pharma/biotech readers. Content from those types of companies would need to go through our paid media program.

Word count and other details can be found on our Guest Expert Article Submission Guidelines page.

Current Target Topics

Please note that we use the term "contract development and manufacturing organizations" (CDMOs) as inclusive of contract manufacturing organizations (CMOs).

• What are the reasons leading to your decision about building vs. outsourcing?
• What activity or activities do you outsource to CDMOs or other outsource partners, and what are your tips or best practices for doing so?
• What activities/traits do you wish CDMOs were better at, and why?
• Are there any emerging trends that you are seeing as you look for (or work with) CDMOs or other outsourcing partners?
• Some outsourcing decisions are dictated by the specific disease targets that sponsors are pursuing. How were your outsourcing decisions influenced by your needs?
• Tips or best practices for outsourcing strategy: Use a “one-stop-shop” or work with several outsource partners for different needs?
• The role of emerging advanced technologies (AI/ML, automation, etc.) in outsourcing
• Consultants continue to increase in importance. How is your sponsor company using consultants effectively?
• How are CDMOs emerging to fill unmet needs of new drug/therapy developers?
• New/expanding relationships between providers and drug sponsors, for example, flexible contracting
• Is the current worker shortage driving your building vs outsourcing decisions? If so, how?
• Mitigating the supply chain capacity crunch
• Increasing advantages for biopharma or CDMO clusters/hubs
• Offshore, reshore, or domestic manufacturing – and if offshore, where (e.g., China/India) and why?
• How has location become a seminal services and supply chain de-risking strategy?
• Supply chain security
• Sourcing materials
• Tips or strategies for outsourcing specific types of services (for example, fill/finish, sterile services, analytical services)
• Navigating good manufacturing practices (GMP) or quality/risk management and ensuring compliance while working with CDMOs

Regulatory Insights From Major Economies Around The World          

• FDA
• EMA
• PMDA
• NMPA
• Audits and inspections
• How to avoid Form 483s
• Warning letter trends / how to avoid warning letters
• New regulations affecting the industry
• New guidances affecting the industry
• Overseeing CDMO regulatory compliance regionally or globally