During the long downturn in R&D productivity, a handful of biopharmaceutical companies have consistently bucked the trend. How did they manage it? After all, they have experienced the same industry pressures as their peers - pressures such as lengthier R&D cycle times, higher costs of failure, and sharper regulatory scrutiny.
Analyst Insight: Over the next few years, numerous new regulations are coming into effect worldwide, requiring pharmaceutical manufacturers, distributors, dispensers and others up and down the chain to build serialization, verification, and traceability into their supply chains. While there is tremendous potential ROI and added value from these investments, right now all the focus is on the race to comply before the deadlines hit. Those who get there first will likely have a head start in finding additional value from these newfound capabilities. - Bill McBeath, Chief Research Officer, ChainLink Research
The times they are a changin' for the players across pharmaceutical supply chains, from API suppliers to CMOs, to manufacturers, packagers, distributors, dispensers/pharmacies ... just about everyone across the chain.
In 2011, batches of a cancer medication called Avastin, on their way to U.S. doctors from Canada, were found to contain no active ingredients. They were counterfeit - a rarity on U.S. soil. While no patient ever received the drugs, the fact that a potentially life-threatening counterfeit was able to make it to the U.S. shocked the pharmaceutical industry. It pointed to a growing trend - triggered by the rise of e-commerce and globalization - reaching the United States.
Janssen Supply Chain has furthered its partnership with the Rutgers University School of Engineering by providing more than $6m to expand ongoing research efforts supporting the company's introduction of continuous manufacturing techniques for pharmaceuticals.
Analyst Insight: The pharmaceutical industry is finally sharpening its focus on profitability and efficiency. 2014 saw continued mergers and acquisitions, but more importantly, the acceleration of business focus on core sectors. Now that the impacts of the Affordable Care Act are better understood, the ability to streamline operations into sectors is driving spin-offs, sell-offs and renewed operational pressures. Two key drivers this year involving supply chains will be inventory reduction and control and lean cost reduction. – Brian Hudock, Partner, Tompkins International
Analyst Insight: The pressures faced by the pharmaceutical industry are well known. These include the increasing cost of healthcare, the aging of the population in the developed world, market entry hurdles in many emerging markets, excess manufacturing capacity, reimbursement decisions based on comparative effectiveness research, and the continued adoption of generics and bio-similars. Another well-known about the industry: change occurs at a glacial pace. What role does the supply chain have in helping the industry transition to a solution-oriented approach to healthcare? – Barry Blake, Vice President, Research, SCM World
Analyst Insight: Radically changing market conditions in the global pharmaceuticals industry are creating volatility in supply and demand, as well as affecting customer service levels and costs. Pharma companies are also faced with impending margin pressure from generics. In this environment, pharma executives are looking to improve efficiencies, understand emerging market customers and be better prepared to meet financial objectives. Supply chain analytics provides pharma supply chain executives with powerful tools to maintain a competitive edge. – Jay Welsh, Principal, and Srihari Rangarajan, Manager, Ernst & Young LLP
At the core of supply chain trends in healthcare is a need for quality data so that leaders can make informed, quality decisions. Quality data means accurate data for sourcing and procurement along with normalisation of data for reporting and predictive analytics.
With the Jan. 1 U.S. Drug Supply Chain Security Act (DSCSA) lot-level traceability deadline now behind us, many pharmaceutical companies are turning their attention to full drug serialization. DSCSA requires that manufacturers mark packages with a product identifier, serial number, lot number, and expiration date by 2017. In that period, highly regulated packaging and distribution processes must be changed; physical equipment must be procured and operationalized; enterprise-wide IT must be implemented; and end-to-end serialization testing with supply chain partners must take place well in advance of the deadline to allow time for any necessary adjustments. Given these multi-faceted complexities, three years is an aggressive implementation time frame.