GLG News by Charles River Labs Toxicology Services Users

Eric GruffPrincipalE4 Consulting

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.

Evan SiegelAdjunct Professor THE UNIVERSITY OF QUEENSLAND

Risk/Benefit is the Answer, Even More Now

December 22, 2008

Analysis of:Tysabri - Multiple Sclerosis patient with progressive multifocal leukoencephalopathy has died | www.msrc.co.uk

1. In general, the more pharmacologically potent a therapy, the more the possibllity that adverse experiences will be seen. 2. Risk/Beneift is a critical consideration, even for products intented for serious or life-threatening disease. It is incumbent upon both the FDA and the physician community to realistically assess preclnical and clinical data during the review and approval process. 3. Patients must be fully and competently informed of the risks and benefits of such therapies and have the right to decide for themselves whether or not to participate in clinical trials and therapeutic treatment with marketed products. 4. No therapeutic regimen is risk-free and society needs to understand and embrace this fact.

Eric GruffPrincipalE4 Consulting

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.

Evan SiegelAdjunct Professor THE UNIVERSITY OF QUEENSLAND

A Complex Personal and Societal Issue

July 17, 2008

Analysis of:Costly Cancer Drug Offers Hope, but Also a Dilemma | www.nytimes.com

The issues associated with expensive therapeutics are multifaceted and involve personal, professional and societal components. Value related to medical treatment is uniquely assessed by each individual with respect to his/her financial burden, overall lifestyle and quality of life, societal role, and belief structure. Society itself is beset with contrary stakeholders in the insurance, governmental, medical and belief-centered establishments. This article is important in that it lays out some fundamental questions that wealthy countries face with respect to cost vs. benefit for new therapies in an environment relatively little constrained by cost-containment in the medical arena.

Evan SiegelAdjunct Professor THE UNIVERSITY OF QUEENSLAND

A Word to the Wise...

July 8, 2008

Analysis of:Drug Makers Say FDA Safety Focus Is Slowing New-Medicine Pipeline | online.wsj.com

1. Sponsors need to be "squeaky clean" with respect to their assessment of signals of toxicity in drug develpment programs. 2. This assessment should be made at the preclinical and early clinical stages of the process, irrespective of political and financial considerations. 3. The per cent of failures in Phase 2 and 3 will be higher unless programs are honestly and thoroughly assessed according to the above. Even so, there will likely be more failures in late-stage programs as clinical data are generated. The FDA will spend more time and effort on safety assessment to avoid large populations being exposed in the marketing environment to new drugs.

Eric GruffPrincipalE4 Consulting

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.

Eric GruffPrincipalE4 Consulting

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.

Eric GruffPrincipalE4 Consulting

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.

Eric GruffPrincipalE4 Consulting

Insurers Should be the First Line of Defense Against Vytorin

April 8, 2008

Analysis of: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.

Eric GruffPrincipalE4 Consulting

Pfizer's Melanoma Treatment Setback Has Bigger Implications

April 8, 2008

Analysis of:Pfizer Ends Clinical Trial Of Melanoma Treatment | online.wsj.com

While disappointing for patients and caregivers, Pfizer's loss of a late-stage treatment for melanoma casts an even darker shadow on the ability of pharmaceutical and biotech companies to successfully bring new treatments to market. Coupled with other recent Phase 3 failures, this latest outcome points to the need for even more investment in better biomarkers.

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