Q: What is your opinion on innovation/creativity as a key characteristic for life science leaders?
Innovation and creativity are especially important traits of life science leaders. To advance scientific breakthroughs, it is critical to think not just “out of the box” but “out of the building,” thereby tearing down mental boundaries and challenging what is known technically, scientifically, clinically, and strategically. Life science leaders must also think globally. The life sciences are advancing at an accelerated rate, yet the more we know, the more we realize what we don’t know. Life science leaders must focus on practical translation of the science while being mindful of the convergence of multiple disciplines like ethics, information technology, and economics. This demands creativity and innovative thinking.
Leslie Williams is president, CEO, and founder of ImmusanT, Inc.,an early-stage company focused on peptide treatments for autoimmune diseases. She has more than 20 years of industry experience.
Q: What are some key components which often get overlooked when developing a value-driven clinical program?
One is the development of a robust definition of “value” for the drug from internal and external stakeholders, including payors, leading to an evolving target product profile that has strategically taken into account the market and current/future competitors. From this foundation, study designs need to be developed with key opinion leaders that minimize/contain cost and risk and maximize/maintain value. Relationships with the payors need to be developed early on in your clinical development program so that organizations can get a better understanding about expectations in reimbursement upon drug approval. There needs to be regularly occurring, disciplined evaluations of the development cost, risk, and ROI of the clinical program due to changing variables such as the competitive landscape, other competing clinical programs, and new regulatory hurdles.
Dr. Mitchell Katz has 26 years’ experience in the pharma and biotech industries, including preclinical research, pharmaceutical operations, and regulatory affairs. In his position at Purdue Pharma L.P., he is the executive director of medical research operations.
Q: What do you see as being the next big game-changing technology in cold chain shipping?
The new trend is to migrate from cold chain to temperature-controlled shipping to include frozen, refrigerated, and controlled room temperature (CRT) products. Temperature monitoring has been the main focus for a long time. However, regulators are asking about humidity monitoring and the effect of light. In addition, the need for all technology to demonstrate the supply chain integrity (SCI) should be utilized. Progress in the application of RFID, real-time monitoring, enhancing security measures in overt and covert solutions, and track and trace should help in avoiding the illicit activities of the counterfeiters. Allocating a stability budget for transportation should assure the quality, integrity, and efficacy of the
temperature-controlled product when it reaches the patient.
Rafik Bishara, Ph.D. is the chair of the Pharmaceutical Cold Chain Interest Group (PCCIG) within the Parenteral Drug Association (PDA). He had a distinguished 35-year career with Eli Lilly & Co. as director, quality knowledge management and technical support.