The Insights Lab - J Janiak Consulting

The Insight Lab

Venture Funding Rebounds for Platform Biotech

Despite market volatility, platform biotechnology, especially in modalities like mRNA, gene editing, and targeted protein degradation has seen renewed investor confidence.

Biopharma Talent Gaps Shifting To Data & Digital Skills

Insight

The 2025 talent reports clearly communicate that the shortage of digital, AI and data-science skills in life sciences is no longer a peripheral issue; it’s central to operational effectiveness.

Regulatory and Commercial Readiness – More Intertwined Than Ever for Advanced Therapies

Insight

With more than 140 advanced therapies approved or in development, the business models of commercialization, manufacturing scale, and regulatory strategy must align.

FDA Establishes ISTAND as a Permanent Qualification Program

Insight

The FDA’s ISTAND Pilot Program has been elevated as a permanent qualification program to be qualified as Drug Development Tools (DDTs).

NAMs are Gaining Real Regulatory Traction

Insight

The FDA’s “Roadmap to Reducing Animal Testing” signals a shift.

The Insight Lab

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