Beyond the Science - by Gary K Zammit (Hardcover)

About the Book

Beyond the Science offers a behind-the-scenes look at what makes clinical drug and device development succeed--or flop.

Book Synopsis

In Beyond the Science: How People, Process, and Systems Transform the Business of Life Sciences, Gary Zammit, PhD, delivers an insightful guide for professionals working in pharmaceutical and medical device development. Drawing from his twenty-five years of experience leading Clinilabs, a specialty contract research organization focused on central nervous system (CNS) therapeutics, Zammit provides behind-the-scenes insights into the often-overlooked human elements that drive scientific breakthroughs. The book's actionable and practical advice is focused on two core parts, first examining the people and culture needed for research and development (R&D) to thrive, and then elaborating on the systems and processes required to empower those individuals to deliver the kind of R&D capable of changing patient lives--and starting medical revolutions.

In part one, Zammit provides actionable strategies for creating a corporate culture that inspires innovation while maintaining unwavering ethical standards, revealing tips for:

• building a team of A-players,
• defining and setting goals,
• optimizing team function,
• ensuring consistent communication, and
• creating an environment where people aspire to greatness.

Part two delves into the processes and systems that enable these teams to excel. Breaking down the granularities of clinical research processes, Zammit covers best practices for:

• creating clinical trial protocols,
• developing project plans,
• implementing risk mitigation,
• ensuring quality and compliance, and
• integrating technological advances.

Zammit's practical guidance is set against the backdrop of his personal journey, as he shares how he founded a company with scientific expertise but limited business acumen--and nearly lost everything in the Great Recession. With candor and humor, he shares how this crisis forced him to recognize that successful drug development depends on more than scientific expertise--it also requires exceptional people working with effective processes and within well-structured systems.

Throughout the book, insightful contributions from industry leaders provide diverse perspectives on what it takes to succeed in the challenging world of life sciences research. Beyond the Science is essential reading for pharmaceutical executives, clinical research professionals, and entrepreneurs in life sciences who understand that "good enough" is never sufficient when patients are waiting for better treatments.