In the News: Advances in Manufacturing Key to Biosimilar Approval Fast Track

Late last week the FDA issued its long-anticipated draft guidance documents governing the development of biosimilars. As reported in FiercePharma Manufacturing the documents contain numerous references to how technological and manufacturing advances will help pave the way to abbreviated approvals. 

The FDA said “[g]reater knowledge due to advances in science and technology, and improvements in manufacturing processes, process controls, materials and product testing, as well as characterization tests and studies, facilitate the use of an abbreviated pathway for the approval of a protein product.”

The article goes on to detail more about the manufacturing process found in the FDA’s “Quality Considerations” document:  “A comprehensive understanding of all steps in the manufacturing process for the proposed biosimilar product should be established during product development. Characterization tests, process controls, and specifications that will emerge from information gained during process development must be specific for the proposed biosimilar product and manufacturing process. The use of Quality-by-Design approaches to pharmaceutical development, along with quality risk management and effective quality systems, will facilitate the consistent manufacturing of a high-quality product.”

 -- Joe Rothman

Use of CMOs in Europe Forecasted to Sharply Increase

Conditions are ripe for an expanded use of CMOs in Europe, according to a Frost & Sullivan report recently highlighted in Pharmaceutical Technology. As blockbuster drugs come off patent manufacturing plant utilization rates are expected to decrease by half. Frost & Sullivan predicts that pharma and biotech companies will focus on strengthening core competencies, which leads to more outsourcing and the increased use of CMOs in the manufacturing mix.

The report forecasts “The European pharmaceutical contract manufacturing market could earn revenues of up to $20.75 billion in 2018, almost double that of 2011’s revenue when the market earned $10.02 billion. Over the same period, the European market for biotechnology outsourcing is forecast to grow from $1.21 billion to $2.67 billion.”

Interestingly the article notes that CMOs themselves run the risk of overbuilding manufacturing capacity as they grow to meet new demand. 

-- Geri Studebaker

How Adaptable Is Your Supply Chain?

A recent article in FiercePharma Manufacturing highlights the importance of adaptability and planning in the supply chain as effective success strategies for pharma companies in 2012. It references a report, Tompkins International's Strategies to Transform Your Supply Chains in 2012, which describes the situation and remedies as follows:

“Risk, instability and rapid change are here to stay,” according to the report, “making all supply chain planning a risky, albeit a necessary, endeavor. That's where adaptability comes in: Being adaptive is not about having a great plan, but being able to move and change very quickly to stay ahead of the market…In order to increase efficiency and meet all track & trace regulations, as well as security challenges, the requirement to implement the appropriate systems and equipment is mandatory.”

Process intelligence systems are critical throughout the “adaptable supply chain” -- not only to help pharma manufacturers learn what happens, but also why it happens. By utilizing data analysis and technology for better process understanding, companies can adapt quickly when deviations occur -- helping to bring products to market faster, prevent product shortages and reduce overall costs in the supply chain.

-- Joe Rothman

On the Road: San Francisco J.P. Morgan Healthcare Conference

A few weeks ago I attended the healthcare industry’s largest financial conference.  Emerging drug companies and global leaders discussed their 2011 financial results, pipeline and prospects with analysts, venture capitalists, fund managers and life science executives. 

Chemical & Engineering News reported that, “The atmosphere in San Francisco was charged with enthusiasm in the wake of deals indicating that drug companies are prepared to invest in innovative science.”

Life Technologies introduced their genome sequencing machine which some experts believe might be used to routinely guide prevention and treatment on an individual basis.

Other genome-related conference news included funding from Sanofi, Third Rock Ventures and Greylock Partners for the launch of startup Warp Drive Bio.  According to Fierce Biotech, “With a brand new approach for discovering drugs from nature, Warp Drive aims to search the genomes of microbes for molecules that have the potential to target disease pathways that have eluded all other attempts to do so. It's the brainchild of Greg Verdine, a chemical biologist at Harvard and venture partner at Third Rock.”

It seemed that there were more global companies talking about collaborations with emerging companies than the past few years (Chris Viehbacher, CEO of Sanofi, spent a lot of time on this in his Q&A session).

The pace of commercialization can be very slow in a heavily-regulated industry, but after a wave of M&A activity, a few years of evaluating the new US healthcare regulations and key C-level management changes, there were many positive forecasts presented at this year’s Conference.

-          Bob Di Scipio

CMO Relationships – Making Progress But Still Work to Do

In the recent Pharmaceutical Commerce article, “Brand Owner-CMO Collaboration Is Growing – But Is Far From Mature, I joined other industry colleagues who shared thoughts on the state of sponsor-CMO relationships. Organizations are beginning to realize the many benefits they receive in working with CMOs — flexibility, improved time to market, alleviating capital and capacity constraints, specialized manufacturing — to name a few. Yet the article cites a report that indicates sponsor-CMO relationships are far from ideal, because both parties fall short in seeing the others’ perspectives.

So how do companies engage in “integrated collaboration” which can lead to more successful --and profitable -- relationships? 

I wanted to highlight the key takeaways from the article that aid in better CMO-sponsor relationships and ultimately yield greater process understanding in manufacturing, including:

• Integrate CMOs into the planning process.
• Share data across all phases of development and manufacturing.
• Use data sharing and process understanding for Process Intelligence that provides a competitive advantage and financial benefits.

-- Geri Studebaker