Dr. Eric Gruff PhD MBA

GLG News^SM Analyses by Eric Gruff

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The Benefits of R&D Outsourcing in Pharma and Biotech

October 1, 2010

Outsourcing of R&D activities can be a major competitive advantage for medium to large pharma/biotech companies if done correctly. While the general assumption is that outsourcing is cheaper than insourcing (also known as "do it yourself"), the total cost of outsourcing is much greater than the amount paid to the CRO for the work. There are many benefits to outsourcing, however, and when conducted in a strategic context, can provide a significant competitive advantage.

Link to Pancreatitis is Bound to Negatively Impact Byetta Sales

August 21, 2008

Analysis of:FDA Alert: Hemorrhagic or Necrotizing Pancreatitis in Patients Taking Byetta | www.fda.gov

The recent publication of new cases of pancreatitis that are occurring in patients taking Byetta (exenatide) can't be good for Amylin/Lilly. While Byetta and investigational GLP-1 analogs are still very viable therapeutics for Type 2 Diabetes, prescribers will have to reassess the risk-benefit ratio for many patients given the new information. The long-acting form of Byetta (LAR) may suffer the most since its long half-life will make reversal of pancreatitis that much more difficult and may lead to additional damage.

Tainted Heparin Will Mean More Scrutiny of Drug Manufacturers

April 21, 2008

Analysis of:UPDATE: FDA Head Sees Economic Fraud Behind Tainted Heparin | www.reuters.com

Regardless of the reason (greed, carelessness, incompetence, etc.) that Chinese heparin became tainted, the end result will be increased scrutiny on imported raw materials and other ingredients, not only from China, but from all 3rd World suppliers. How the FDA and other regulatory agencies actually intend to step up the scrutiny is still open to debate, but the ultimate responsibility lies with the license holder.

AtheroGenics' AGI-1067 Shows Some Promise, But There Are Still Questions

April 16, 2008

Analysis of:AtheroGenics Announces Encouraging Interim Results From Phase 3 Clinical Trial of AGI-1067 in Type 2 Diabetes | www.fiercebiotech.com

The 3-month reduction in HbA1c demonstrated by AGI-1067 is promising, but I still have many questions regarding the design and outcomes. There are many existing therapies that lower A1c - many have undesireable side effects like weight gain or hepatotoxicity.

Cubist's Antibiotic Cubicin is Tainted: A Mess Not of Their Doing? Maybe, Maybe Not.

April 14, 2008

Analysis of:Cubist Finds Its Antibiotic Cubicin Is Tainted | online.wsj.com

The news that Cubist's Cubicin has been contaminated with 2-mercaptobenzothiazole (MBT) has caused great concern for patients. It appears that the MBT has leeched out of the Cardinal Health ReadyMED drug pumps that are used for delivering Cubicin. Regardless of who is at fault, everyone involved (Cubist, Cardinal, the FDA, doctors, and patients) have good reason to worry.

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