Q: For a start-up, what are some initial approaches to raise money?
If the company is spun out of an academic laboratory, the university may provide a small amount of money to get started. If the founder is independent of a research institution, then oftentimes the founder’s own resources are used (this may include money raised from friends and family, such as through a convertible debt offering). Many states offer “greenhouse” grants or loans to small businesses through programs financed through the federal government, such as the Small Business Administration (SBA). The federal Small Business Innovation Research (SBIR) grant program is another way to obtain funding. Private foundations can be a source of funding if the topic agrees with the foundation’s goals. Once the project is ready to move towards the clinic or commercialization, angel investors and venture capitalists can provide larger amounts of funding in return for an equity stake in the company.
Laura Hales, Ph.D.
Dr. Laura Hales has more than a decade of experience in biologics discovery research and is currently a founder of Extend Biosciences and The Isis Group.
Q: What is the biggest factor for a sponsor when selecting a CRO?
The team the CRO provides is the biggest factor. As a sponsor, you are going to work with these individuals. Do you want to? Is the CRO providing a team that will execute? The successful conduct of a clinical trial is a complex orchestration of people, skills, knowledge, good clinical practice, and risk mitigation over time. Teamwork is the most underrated factor in success, and by outsourcing, your challenge is to form a well-functioning team across two companies, two cultures, and teammates with multiple agendas. That desired team is one that is execution-driven and will put the team goals ahead of their own. Will you be able to create a team that proactively mitigates risk because, despite your careful planning, the clinical trial will not go as planned? Will your team still execute in the face of obstacles? If not, therapeutic expertise, geographic reach, costs, and any other factors you might consider will not be relevant.
Tim Krupa is president of TSK Clinical Development, LLC, a consulting firm providing leadership and solutions in clinical planning, project management, clinical operations, and outsourcing. He began his career with Eli Lilly and most recently served as executive director, project management with Quintiles.
Q: How can you ensure the safety and integrity of products during cold chain transportation?
You must first understand your product and the environment through which that product must pass. The more comprehensive your understanding of the metrics of a distribution or transportation system, the more precise your communication to your service providers can be. Communications, particularly for products requiring special handling, should always be in the form of a quality agreement or service contract between and among supply chain stakeholders and followed through with regular, healthy, and open dialog.
For the unaware, quality agreements are negotiated, documented processes between the customer and service provider that define common understandings about materials or services, quality specifications, responsibilities, guarantees, and communication mechanisms. Their scope often outlines minimum requirements, performance monitoring and reporting, problem management, escalation procedures, compensation information, and remedial action.
Kevin O’Donnell is senior partner at Exelsius Cold Chain Management Consultancy US, an international provider of consultative, research, and training services to manufacturers, airlines, forwarders, and other stakeholders in the life sciences logistics sector.
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