The ideals of reliability and quality (which I have come to learn is a metaphysical concept) are two distinct topics that have been top of mind lately. Perhaps it’s due to the fact that as I am getting older, my expectations for dependability have increased dramatically. Or perhaps it’s the fact that I just left my mechanic in a vapid attempt to solve a car problem that seems to defy all mechanical logic and human comprehension. So in embracing these two themes, it’s probably high time to evaluate recent manufacturing news and diagnose what is happening, or quite simply, what is not happening.
(more…)
Posts Tagged ‘Business Strategy’
Biopharmaceutical Manufacturing Gaffes in 2010: Why It’s Time To Learn From Failure
Monday, August 2nd, 2010Buying into a new model – Lilly’s Alnara Acquisition
Monday, July 12th, 2010One hallmark of our industry is the incredible risks faced in bringing a new product to market. New technologies bring risks of not performing the way we’d like. Clinical and regulatory risks can delay or prevent approval. Commercial and market risks may limit success with physicians, patients and customers. All of this leads to huge financial risks for investors along the way, and we have seen this scenario play out repeatedly here in the local area in disappointing results for companies like Therion, Vion, and Acusphere.
(more…)
The Balance of Extremes in the Decision Making Process May Be the Optimal Way
Monday, June 7th, 2010“In any moment of decision the best thing you can do is the right thing, the next best thing is the wrong thing, and the worst thing you can do is nothing.” Theodore Roosevelt
An action is usually preceded by a decision to execute that action. These can be simple decisions, such as the choice to act to prevent a thrown ball from hitting you in the face. Or these can be much more complex decisions, such as the choice to initiate a series of actions, for example the decision to bring a therapeutic to market. While each activity is fraught with differing levels of uncertainty, the point of choosing how to deal with that uncertainty occurs prior to the action, and consequently this point can become the source of much angst. President Roosevelt’s observation offers a convenient framework for exploring the decision point.
“You can’t get there from here” – A case for creating a Targeted Product Profile (TPP)
Monday, May 24th, 2010In today’s drug development world it still amazes me to find companies that don’t have an overall drug develop life cycle plan in place, especially when there is a baseline tool endorsed by FDA that could be used. In March 2007, the FDA released a draft guidance entitled, “Guidance for Industry and Review Staff Target Product Profile – A Strategic Development Process Tool”. The Target Product Profile (TPP) template format described in the guidance is a summary of a drug development program presented in terms of labeling concepts. The guidance describes the purpose of a TPP, its advantages, and its optimal use. It also provides guidance on how to complete a TPP and relates case studies that demonstrate its usefulness.
Zen and the Art of Innovation: Big Pharma Shifts Its R&D Focus
Tuesday, April 20th, 2010Here in Massachusetts, we hold a firm belief that springtime is a time of renewal. The days grow longer and brighter as the resident’s moods begin to elevate for the season to come. This “renewal” is certainly analogus to a seismic shift over the past few months within the pharmaceutical industry, for which Big Pharma is beginning to evaluate their future R&D strategies. Major industry headlines are broadcasting drastic billion dollar cuts in internal R&D spending due to the lack of substantial drug development productivity over the past decade. In response, multinational pharmaceutical companies are beginning to search for external opportunities to nurture the innovation process, namely through collaboration and alliances with external research organizations, academia, and emerging biotechnology companies. The overarching concept is it that these distinct groups posses the necessary resources and IP to develop disruptive biopharmaceutical technologies that have the potential to treat major unmet medical needs that will revolutionize the industry.
3PL Strategies in Life Sciences – Important Points from Supply Chain Working Group Meeting
Monday, April 12th, 2010Almost all (if not all) life sciences companies outsource some portion of their Supply Chain. Among those capabilities most commonly outsourced are those associated with the downstream activities of shipping and distribution. Many companies come to the understanding very early on that to have these activities in-house is not something they want to invest in and, in doing so, turn to 3PL providers to be their partners (more…)
Utilizing a REMS Program as a Competitive Advantage?
Monday, March 1st, 2010Under the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85), the FDA has the authority to require manufacturers submitting drug approval applications to submit a proposed Risk Evaluation and Mitigation Strategy (REMS) program as part of the application.
There are varying degrees of a REMS program; it can be as simple as a medication guide included in each product package for patients and physicians, which outlines the risks and side effects of the medicine. Since going into effect in 2007, a majority of all approved REMS programs fall into this category.
(more…)
Virtual Workforce is a Growing Trend at Emerging Life Science Companies
Tuesday, February 2nd, 2010There is a growing trend at emerging life science companies to adopt a ‘Virtual Workforce’ model in order to keep head count and capital burn rate down, and flexibility up. Instead of hiring full time employees to fill department roles, companies are bringing on the appropriate level of talent via consulting firms, resource companies, or hiring contractors directly. Even some manager level roles are being filled this way. Some companies run virtually by design, while others do so because experienced FTE resources were simply impossible to find when they needed them.
(more…)
