Q: What are some best business practices for selecting a supply chain vendor so as to maintain quality?
A: First, look for suppliers that understand, respect, and accommodate your internal values and expectations. Such suppliers share a common commitment to behave ethically, with integrity, and compliantly. They incorporate quality, safety, and sustainability into their operations, and they place patients and customers at the center of what they do.
Remember, it’s not just about cost; it’s about total value. We evaluate suppliers on such things as quality, reliability, innovation, speed to market, business continuity, sustainability, growth, flexibility, and cost. Quality is a more heavily weighted criterion.
Lastly, we perform technical and quality assessments jointly, via cross-functional teams. This helps assure that all business partner concerns are addressed and weighed appropriately, before deciding to engage a new supplier. This also allows the potential identification of technical issues that could develop into future quality problems.
is the VP and chief procurement officer, enterprise supply chain at Johnson & Johnson. She also serves as a board member for DCAT.
Q: What are the regulatory roadblocks ahead for personalized medicine, and how can these be overcome?
A: The industry needs greater clarity on a global basis for the support of codevelopment programs. Although companion diagnostics and their targeted therapies are available in markets outside of the U.S., regulatory bodies outside of the U.S. are woefully behind in providing clear regulatory guidance for codevelopment programs. Newer technologies (e.g., next generation sequencing [NGS]) have gained rapid and broad use in research, clinical investigations, and assignment of drug therapy. However, NGS does not yet have a defined regulatory pathway for approval. A regulatory-approved pathway is needed to ensure accurate test results for patients. Companion diagnostic tests developed by diagnostic manufacturers face higher regulatory hurdles than laboratory developed tests (LDTs). As there has yet to be a regulatory review of LDTs used as a companion diagnostic, manufacturers are disadvantaged and disincentivized thus discouraging innovation.
DR. TIM GARNETT
is the chief medical officer and senior VP of Medicines Development Unit (MDU) for Lilly and is responsible for medical, regulatory, global product safety, and global health outcomes.
Q: How does the interpretation of Hippocrates’ statement, “Declare the past, diagnose the present, foretell the future” apply to antibiotic development?
A: The Gain Act and the Obama administrator's executive order are acknowledgements of the need for action to tackle resistance and stimulate development of treatments. FDA efforts have focused on streamlining the antibiotic regulatory pathway, yet there is a need for more guidance on how to convey a drug’s possible effectiveness against resistant pathogens on the label. In the absence of rapid diagnostics, physicians receive causative pathogen and susceptibility information after a patient has started therapy. The antibiotic label is the best source for useful information about performance of an antibiotic in the context of resistance patterns. It is imperative to juxtapose what we know from the past — that is — how the antibiotic has performed against known mechanisms both in vitro and in the clinic — with what is unknown because the only certainty is that pathogens will adapt and evolve.
BARRY EISENSTEIN, MD, FACP, FIDSA, FAAM
is senior VP of scientific affairs at Cubist Pharmaceuticals.