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Eric Gruff, PhD MBA

Eric Gruff, PhD MBA, Principal, E4 ConsultingPrincipal
E4 Consulting
Member of the Healthcare Council

Eric Gruff, PhD, MBA, BS, is the Founder of E4 Consulting, which specializes in pharmaceutical development, regulatory affairs, and project and portfolio management. Dr. Gruff has over 16 years of experience in the pharmaceutical and biotech sector, including leadership roles at Pfizer, Agouron Pharmaceuticals, and Molecular Biosystems. He has served as a regulatory CMC consultant and has been a key player in several drug and device approvals. Dr. Gruff serves on the Board of Directors for two public nonprofit agencies. He is a member of DIA, PDA, PMI, ACS, and AAPS. (This is me - Update Profile)


Employment History
2007 - present Principal
E4 Consulting
1996 - 2007 Senior Director and Research Team Leader
Pfizer Inc

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GLG NewsSM Analyses by Eric Gruff, PhD MBA(?)

Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.
Tainted Heparin Will Mean More Scrutiny of Drug Manufacturers | 04-21-2008
Analysis of: UPDATE: FDA Head Sees Economic Fraud Behind Tainted Heparin | www.reuters.com
Author: Eric Gruff, PhD MBA, Principal, E4 Consulting

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...

AtheroGenics' AGI-1067 Shows Some Promise, But There Are Still Questions | 04-16-2008
Analysis of: AtheroGenics Announces Encouraging Interim Results From Phase 3 Clinical Trial of AGI-1067 in Type 2 Diabetes | www.fiercebiotech.com
Author: Eric Gruff, PhD MBA, Principal, E4 Consulting

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. | 04-14-2008
Analysis of: Cubist Finds Its Antibiotic Cubicin Is Tainted | online.wsj.com
Author: Eric Gruff, PhD MBA, Principal, E4 Consulting

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,...

Insurers Should be the First Line of Defense Against Vytorin | 04-08-2008
Analysis of: Will Insurers Reduce Coverage For Vytorin? | www.pharmalot.com
Author: Eric Gruff, PhD MBA, Principal, E4 Consulting

The pharmaceutical industry continues to lay its collective head on the chopping block by pushing drugs like Vytorin that demonstrate at best marginal activity. Insurers have a fiduciary duty to push back against the poor judgement of drugmakers who take advantage of confusion and DTC advertising to...

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