Dr. 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 - Unspecified
- Principal, E4 Consulting
- 1996 - 2007
- Senior Director and Research Team Leader, PFIZER INC.
GLG NewsSM Analyses by Eric Gruff(?)
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
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.
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Tainted Heparin Will Mean More Scrutiny of Drug Manufacturers
April 21, 2008
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.
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AtheroGenics' AGI-1067 Shows Some Promise, But There Are Still Questions
April 16, 2008
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
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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Insurers Should be the First Line of Defense Against Vytorin
April 8, 2008
Will Insurers Reduce Coverage For Vytorin? | www.pharmalot.com
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 make money.
Leading institutions connect with Eric Gruff through GLG
GLG Study Groups with Eric Gruff(?)
| Study Group Name | No. Members |
|---|---|
| Experts in the Leisure & Lodging Council | 4887 |
| Experts in the Automotive Council | 3422 |
| Generic Drug Economic Experts | 766 |
| Medical Device Experts | 317 |
| Document Management Software Experts | 231 |
GLG Live Meetings with Eric Gruff(?)
Eric Gruff has not participated in any GLG Live Meetings.