OutsourcedPharma.com, CRO, CMO, Pharmaceutical Drug Development Services

Biosimilars: A Brief Manifesto of Morality And Markets
As best I can describe it, here's an ideology for biosimilars in the U.S. healthcare system, from Sumant Ramachandra, executive and scientist at Hospira, Inc.

More From the Editor

Vetter Continues To Expand Capacity
Following 16 months of construction, the first phase of a modern, multi-functional building at Vetter’s Ravensburg Schuetzenstrasse site has been completed.

AstraZeneca Announces Collaborations To Use CRISPR Technology For Genome Editing Across Its Drug Discovery Platform
Scoring Progress Against Cancer
Ash Stevens To Manufacture Amotosalen Active Pharmaceutical Ingredient For Cerus’ INTERCEPT Blood System
Microneedles Breakthrough Brings 3M One Step Closer To Introducing New Alternative Drug Delivery Method

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From Cold To Controlled
World Courier Ground Europe reveals impressive test results for new fleet of temperature-controlled vehicles.
Drug Developments’ PR Problem
We went into this business to save lives. So why does it feel we’re always portrayed as the guys in the black hats?
Profiling Metal Content In Parenteral Grade Protein Stabilizers
As the demand for parenteral excipients continues to rise, the biopharma industry is considering guidance that would require more extensive analysis of a variety of minor constituents, including metals.
The Impact Of The Surging Biotech Market On New Startups And CMO Outsourcing
The biotechnology market sector has experienced stellar performance in recent years, outperforming the S&P 500 and most other market segments. In just under three years, the NASDAQ Biotechnology Index (BMI) has risen over 180 percent, climbing 32 percent, 65 percent, and 34 percent (as of Dec 1, 2014) in 2012, 2013, and 2014 respectively. First quarter 2014 kicked off with 23 Biotech IPOs, the strongest first quarter performance since 2000. With such strong market demand for new biotech companies with innovative assets, most analysts believe the outlook for the sector remains quite promising. This would potentially seem like good news for contract manufacturing organizations (CMOs) as market enthusiasm and gains would be expected to stimulate investment in new biotechnology startup companies.
A New Approach To Laboratory Efficiency: On-site Instrument Concierge Service
Scientists are spending an enormous amount of their time and effort simply getting instrumentation to the point that it can be used,” the NRC reports. “This wasted time can be used more productively when a well-functioning repair and maintenance system is in place.
Keeping The Right Chemistry In Compound Procurement
What happens when virtual screening libraries meet the real world?

Virtual screening libraries can be brilliantly designed to deliver the best range of chemistry for your wet screen, but when the virtual meets the real, things get more complicated. Including computational chemistry in the procurement process means that you can move from virtual screening to plated compounds and still keep the best of both worlds.

Delivering a plated library of screening compounds is a more complex process than first meets the eye and involves a series of sometimes conflicting requirements. First and foremost, the compounds must include the right chemistry. Virtual screening is an excellent way to design an optimum set of compounds, but the complexities of the procurement process often means that the best compounds cannot be obtained on time and within budget. Offsetting pricing, availability and shipping overheads from multiple vendors is a major logistical challenge and often leads to compromises in the chemical diversity of the final purchased set.

More Insights

Is A Customer-Centric Strategy A Fit For Pharmaceutical Manufacturing?
In an industry such as pharmaceutical manufacturing, which typically focuses on improving operational excellence or coming up with the next big drug, is a business strategy with a customer-first focus the right fit?
Lilly Moves From Patent Expirations To New Product Growth
Eli Lilly and Company has announced its 2015 financial guidance and outlined growth plans for the remainder of the decade. The company’s refined strategy places an emphasis on growing revenue and expanding margins by providing a greater focus on research and commercial activities, while maintaining a sustainable flow of innovative medicines.

"We are successfully moving from a challenging period of patent expirations to a period of resumed growth, led by diabetes, oncology and animal health," says John C. Lechleiter, Ph.D., Lilly's chairman, president, and CEO. "We are launching new products and competing more effectively. We also retain one of the strongest pipelines in our history. Our refined strategic direction gives us a blueprint that will provide greater focus for our research and commercial activities and help Lilly respond to an ever more challenging environment. In these ways and more, we'll continue to create value for all our stakeholders while improving the lives of patients."
Will More Capitalism Save Pharma?
Capitalism for some people is equated with greed. Whether this notion is born from increasing consumer resentment towards corporate profits, or perhaps that iconic Gordon Gekko speech in the 1987 movie Wall Street still resonates, capitalism seems to be under greater attack with each passing year. Unfortunately, along with greater resentment of capitalism comes ever increased oversight by government agencies seeking to correct perceived wrongs caused by free markets.

In the December 29^th, 2014 issue of Forbes magazine, editor-in-chief Steve Forbes makes the case for capitalism, specifically from the perspective of the pharmaceutical industry. Forbes gives two examples to back up his stance.
Bayer Change Notification Process For Raw Material Supply Encourages Supplier Collaboration And Transparency
When it comes to raw material supply, increased regulatory focus on the raw material supply chain is creating a transformational change in the industry. Because of this, quality agreements create a responsibility among suppliers to notify their partners with advanced notice any time a change is made to the raw materials those partners are receiving. To ensure change notifications are handled properly and evaluated thoroughly, Bayer Healthcare utilizes an internal process that allows notifications to be filtered to the appropriate stakeholder and reviewed thoroughly before action is taken. Albert Obrero, Jr., Senior Project Specialist at Bayer HealthCare, recently presented the Bayer process to an audience at Bioprocess International 2014, where he outlined how it works as well as its benefits.
The Impact Of The Surging Biotech Market On New Startups And CMO Outsourcing
The biotechnology market sector has experienced stellar performance in recent years, outperforming the S&P 500 and most other market segments. In just under three years, the NASDAQ Biotechnology Index (BMI) has risen over 180 percent, climbing 32 percent, 65 percent, and 34 percent (as of Dec 1, 2014) in 2012, 2013, and 2014 respectively. First quarter 2014 kicked off with 23 Biotech IPOs, the strongest first quarter performance since 2000. With such strong market demand for new biotech companies with innovative assets, most analysts believe the outlook for the sector remains quite promising. This would potentially seem like good news for contract manufacturing organizations (CMOs) as market enthusiasm and gains would be expected to stimulate investment in new biotechnology startup companies.