GLG News by Biopharmaceuticals Manufacturers (US)

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.

Hany SalamaVice President, Worldwide OperationsNEOSTRATA COMPANY, INC.

CROs - Beyond Cost Savings

May 6, 2010

The concept of utilizing Contract Research Organizations (CROs) is not foreign to many large and small pharma and biotech organizations. However, in today's competitive markets, pharma and biotech organizations are looking beyond the costs savings and focusing on how they will be leveraging CROs to advance drug discovery and development. Organizations are now viewing CROs as a strategic asset and a key contributor to the drug development process.

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.

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.

Hany SalamaVice President, Worldwide OperationsNEOSTRATA COMPANY, INC.

Sterile Injectables Contract Manufacturing Market Outlook

February 28, 2008

Analysis of:Jubilant News for Hollister-Stier | www.contractpharma.com

As demand of the sterile injectables products grows, more and more contract manufacturers are evaluating this landscape as a potential opportunity for growth.  The major concerns in this market outlook are how complex is the technology, how much capacity is needed and will this technology be the future for the pharmaceutical and biotech companies and are contract manufacturers ready/capable of the challenges. 

Hany SalamaVice President, Worldwide OperationsNEOSTRATA COMPANY, INC.

Sustainable Cost Cutting Efforts Through Strategic Partnerships

January 25, 2008

Analysis of:Pfizer, Novartis, Amgen: cutting costs could boost short-term profits | www.pharmaceutical-business-review.com

In today's ever changing pharmaceutical/biotech landscape, manufacturers need to take an aggressive approach to reduce cost while developing their robust pipelines.  To do this successfully, manufacturers need to focus on their core competencies as strategically determined by the senior management of the organization.  Companies now need to focus on: 1.  Outsourcing of none strategic activities such as manufacturing/packaging, some development activities and clinical operations 2.  Look at strategic licensing partnerships to drive more enhanced pipelines 3.  Continue to look at the global landscape to leverage effective operational opportunities

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