The Yakatan Rules for Pharma R&D Efficiency #2

Welcome to The Yakatan Rules blog, which shares the opinions of Dr. Jerry Yakatan, Chairman, CEO and founder of IRISYS. Please see Rule #1 – Establish small discovery teams led by “Drug Finders”

Rule #2 – Assign responsibility & authority to teams

  • Program identification

  • Budget

  • Hiring

  • Funding

  • “Feed & clothe”

Program identification is the first – and possibly the most important – assignment for R&D teams.  It involves a thorough analysis of the objectives, timelines, and other aspects of a new program.  At IRISYS, we work with our clients to create tailored plans for their research and development needs as well as science-based strategic plans for regulatory approvals.

Budget adherence is always critical for R&D teams, whether associated with government agencies, start-up organizations, or mid-tier biotech companies.  Specific team members can be assigned responsibility and oversight for establishing a budget prior to program initiation and having regular assessments to make sure expenditures are consistent with expectations.

Hiring the right leadership and employees ensures that R&D programs will get expert guidance and strategic direction, as well as hands-on technical proficiency.  The best leadership teams cannot do everything themselves.  Similarly, the most skilled technicians will benefit from the experience of a well-rounded management staff.  The administrators responsible for identifying and hiring new personnel are the indispensable start to well-run R&D organizations.

Funding is often a “go-or-no go” determinant for R&D programs.  In August 2017, IRISYS was honored to be awarded a new “CRO Support for Drug Product Development, Manufacture, and Stability Studies” contract for up to $14.4 million by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).

NCATS studies and supports translational science on a system-wide level as a scientific and operational problem, developing and supporting innovative collaborations across traditionally separate scientific disciplines and organizations. Serving as a catalyst for translational science, the Center convenes teams with diverse expertise to reduce, remove or bypass significant bottlenecks across the entire continuum of therapeutic development. Contracted organizations provide manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to NCATS to assist with probe and assay development, lead selection and optimization, and Investigational New Drug – or New Drug Application/Biologic License Application-directed studies.

“Feed & clothe” your R&D team to make sure they have the necessary equipment, supplies, and other materials necessary to perform their functions.  In addition, “feed” their minds with scientific publications, and ongoing continuing education opportunities.  Activities like IRISYS’ Enrichment Seminars are valuable for supporting our employees’ functional responsibilities and their extracurricular pursuits.
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