When it comes to outsourcing, I sometimes worry that most of what can be said already has been. How many times do we need to focus on communication issues, which are still an essential element behind successful contract services relationships? As with so many subjects we cover, familiar outsourcing terminology can lead to the false assumption that an industry segment or technical process is pretty much the same as always. After all, speed and efficiency and cost-effectiveness have been goals…
The market for biopharmaceutical contract manufacturing has shown robust growth over the past few years. The continuing growth of biopharmaceuticals and the increase in new and novel drug projects entering clinical pipelines are fueling the market’s double-digit growth rate. Responding to these new demands, contract manufacturing organizations (CMOs) are expanding both their capabilities and capacities. Background Information presented here draws from recent interviews with six executives at biopharmaceutical contract manufacturing organizations, and from HighTech Business Decisions’ latest report, Biopharmaceutical Contract…
In our modern biopharmaceutical industry, the maxim “bigger is always better†no longer applies. The industry’s modest virtual model persists in its popularity, emerging as a contemporary method of workplace efficiency. With an absence of manufacturing, virtual biopharmaceutical companies have found themselves unburdened by the multiple layers of bureaucracy that often plague large companies. With such freedom, they have operated much more efficiently in terms of time, resources, product specialization, and finances. As a result, virtual biopharmaceutical companies are growing…
The biopharmaceutical industry is increasingly interested in a range of emerging therapies. “We’re really starting to get beyond the monoclonal antibody,†said Patricia Seymour (senior consultant with BioProcess Technology Consultants) in her introduction to a lunchtime BPI Theater roundtable at the 2016 Biotechnology Industry Organization annual convention in San Francisco, CA, this past June. The discussion brought together three industry insiders for strategic outsourcing to talk about emerging biotherapies and their manufacturing challenges: Mark Angelino (senior vice president of pharmaceutical…
Partnering with a contract development and manufacturing organization (CDMO) allows drug-product sponsors to turn fixed costs into variable costs. Market forecasting by pharmaceutical companies drives numerous decisions in development programs: sales-force resources, geographic resource distribution, and (of course) manufacturing planning. It is a widely accepted fact in the pharmaceutical industry that accurate forecasting is a challenge, especially for new drug launches. A number of models can be used to develop drug forecasts, but none of these models is perfect. No…
No discussion about the future of the biopharmaceutical industry would be complete without assessing the impact of biosimilars. But such discussions no longer focus on whether biosimilars will enter the market, but rather when and how much market share will they take. The rapid progression of biosimilar candidates in company pipelines and the strong biosimilars research conducted by international organizations are strong indications that if your company is not already working within the biosimilars market, it may already be too…
Outsourcing has become a critical part of the industry in general and will play a larger role as companies continue to seek faster and more cost-effective routes to market. On Wednesday 8 June 2016, Gil Roth (president of the Pharma and Biopharma Outsourcing Association, PBOA) chaired a lunchtime roundtable titled “Making the Correct Outsourcing Decisions.†Roth’s association is a nonprofit trade group that represents CMOs and CDMOs through work with Congress and the FDA, with a focus on intra-industry issues.…
Some issues of BPI more than others emphasize to me the interdisciplinary nature of our audience. One example: I am happy to bring you the latest consensus paper from the CMC Forum series. In its discussion of host-cell protein control strategies, the authors write of their goal to “bring industry, academics, and regulators together for generating integrated perspectives on HCPs and their control.†Those three groups — industry, academics, and regulators (government) — constitute three major categories of our readership…
Women In Bio Launches Executive-Level Certification Program To prepare women in life sciences for roles on boards of directors, the national Women in Bio (WIB) organization has launched a program for executive-level board certification. “Women are significantly underrepresented on the boards of life science companies,†says Kristi Sarno, national president of the group, “and the Boardroom Ready program will ensure that more women are qualified, willing, and proactively seeking board memberships. This new initiative is an important step toward promoting…
Introduction Accelerate activity. Improve predictability. Drive higher process efficiency. Increase quality. Lower cost of goods sold (CoGS). Secure supply. In an era where the biomanufacturing wheels turn faster by the day, where the stakes are higher and the choices seemingly endless, it is easy to become overwhelmed. How can you make good biomanufacturing decisions and develop robust long-term strategies when the environment is constantly changing? Whether a political shift affects your product or market, a natural disaster disrupts your supply…