Eric Gruff, PhD MBA
Principal, E4 Consulting
Member of the Healthcare Council
Council Member Biography
Eric Gruff, PhD, MBA, BS, is Founder of E4 Consulting, which specializes in pharmaceutical development, regulatory affairs, and project and portfolio management. Dr. Gruff has over 17 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.
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.
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Link to Pancreatitis is Bound to Negatively Impact Byetta Sales
August 21, 2008
Eric Gruff, PhD MBA, Principal, E4 Consulting
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...
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Tainted Heparin Will Mean More Scrutiny of Drug Manufacturers
April 21, 2008
Eric Gruff, PhD MBA, Principal, E4 Consulting
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...
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AtheroGenics' AGI-1067 Shows Some Promise, But There Are Still Questions
April 16, 2008
Eric Gruff, PhD MBA, Principal, E4 Consulting
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.
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Cubist's Antibiotic Cubicin is Tainted: A Mess Not of Their Doing? Maybe, Maybe Not.
April 14, 2008
Eric Gruff, PhD MBA, Principal, E4 Consulting
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,...
Leading institutions connect with Eric Gruff, PhD MBA through GLG
GLG Study Groups with Eric Gruff, PhD MBA(?)
| Study Group Name | No. Members |
|---|---|
| Document Management Software Experts | 231 |
| Generic Drug Economic Experts | 767 |
| Generic Pharmaceuticals Regulation Experts: Healthcare Consultants | 45 |
| Charles River Labs Toxicology Services Users | 10 |
GLG Live Meetings with Eric Gruff, PhD MBA(?)
Eric Gruff, PhD MBA has not participated in any GLG Live Meetings.