Mind the Gap: Pharma Chasing Biotech Assets

Validation with big pharma – is it still necessary? Depends on who you talk to. This was one of several questions posed to panelists at today’s business roundtable session. Arguments can be made on both sides, but one thing is for certain, the life sciences financing community has become much more sophisticated in recent years. And biotech and pharma companies have become more sophisticated in doing deals because they have a lot more experience to draw from. That’s definitely a win-win for everyone involved.

From the Hill to the Street: Examining Policy Issues in Biotech

Without a supportive legislative and regulatory environment, biotech companies cannot raise the funds necessary to get a product to market.  The panelists explored the pressing policy issues which could have a significant impact on the industry, from the creation of a pathway for the approval of follow-on biologics, patent reform, comparative effectiveness and the implementation of the Food and Drug Administration Amendments Act (FDAAA) which was signed into law last year.  The panelists also discussed health care reform in the Presidential campaigns, and the importance of selecting the right person as FDA Commissioner in the next Administration.

Elusive Cancer Endpoints: How to Survive the Uncertainty

The debate surrounding cancer endpoints has focused on the issue of quality of life and progression. Panelists shared some of the challenges in assessing quality of life, since it can be a fickle and subjective process. The data can be hard to nail down since patients don’t always fill out the forms. The critical issues include survival rates, improved quality of life and progression of disease. Everything must be taken into consideration to determine endpoints, which is why the issue is hotly debated.

Diabetes: New Mechanisms, New Opportunities

Panelists in the diabetes panel stressed the importance of the growing prevalence of the disease – it’s expected to more than double by 2030. Those are big numbers, particularly because diabetes is the number one cause of preventable blindness. There is a light on the horizon – several new treatments for both Type 1 and Type 2 diabetes:

• XOMA – two current trials for Type 2 diabetes. XOMA’s drug could be administered once a month versus once a day, making compliance more manageable.
• Biodel, Inc. – new treatment for Type 1 diabetes that is currently in Phase 3 trials and showing strong results. VIAject is designed to absorb more rapidly in the body. In addition, it disperses more quickly from the body.
• Tolerx, Inc. also has a new mechanism for treating Type 1 diabetes, the company is in Phase 2 trials of an anti CD3 therapy. Tolerx’s work focuses on preserving the Beta cells that are remaining at the time of diagnosis.

Pain “A Pain Free” Guide

The CEO & Investor Conference started out strong with several therapeutic workshops.

The Pain “A Pain Free“ Guide to Current Therapies panel shared efforts to develop drugs with greater efficiency and fewer side-effects, including a patch for the site of pain (NeurogesX, Inc.), the use of Morphine products for acute to moderate pain (Javelin Pharmaceuticals, Inc.), and low dosage steroids (CombinatoRX).  Pain is the most common reasons patients seek medical attention and is one of the hardest to decipher and heal.  Pain is a good place to invest because there are many different types of pain and it is a prevalent problem, so there is a constant need for drug discovery.