February 15, 2008 (Vol. 28, No. 4)

Research Collaborations Often Assist with Candidate Selection and Enhance Future Revenue

Research collaborations are a valuable tool that your company can use to explore scientific arenas that lay beyond your core areas of biological expertise. In an ideal world, your organization would have all of the internal resources needed to research and develop all the discoveries that your talented scientists make. Unfortunately, financial constraints, market considerations, and manufacturing concerns will force you to focus your efforts on only the top candidates. How will you be able to choose among them?

One of the best approaches is to use research collaborations to help you finalize your selection of a lead drug candidate for development. If well chosen and productive, these collaborations will lead to increased revenues in the years to come. Other benefits will accrue as well; the top ten are highlighted in this article.

What are the top 10 benefits of research collaborations?

1. Collaborations provide “free” data. New animal disease models, fundamental biology experiments, and cutting-edge reagents such as knock-out mice can all come out of collaborations. Academic scientists will often be interested in working with the compounds that you have discovered. Take advantage of their special skills to learn more about the biological properties of your molecule in a timely, useful manner.

2. Collaborations can speed development decisions. The faster you learn about the biological activities of your molecules, the easier it is to decide which ones to take into clinical trials and to move into manufacturing. Patents on your molecules have a limited lifetime, so rapid decisions on clinical utility have a clear economic benefit. Good collaborations accelerate the acquisition of key data, so decisions come sooner and time-to-market shrinks. These decisions can be based on positive data or negative data suggesting possible problems that may arise during clinical trials.

3. Collaborations may reveal new indications. The diversity of experimental models available through collaborations enhances the probability of discovering new molecular functions, or conversely, revealing potential development, dosage, or safety problems.

Broader understanding of a molecule’s biology brings better understanding of development options. But, one of the greatest benefits is that collaborations outside your area of biological expertise may reveal new indications. With clinical trial success so difficult to achieve, having a second or third indication tremendously increases chances of eventual regulatory approval.

Consider Enbrel®, which failed during the mid 1990s in Immunex’ trials for sepsis. Rheumatoid arthritis, which made Enbrel a multibillion-dollar drug in the past few years, was originally only an alternate indication with key data provided by academic collaborators.

4. Collaborations can increase intellectual property. Collaborations may frequently contribute to your research group’s patent filings. Effective collaboration management can identify discoveries made by your research partners, allowing you to notify your patent attorneys before patentability is lost by public disclosure.

5. Collaborations can lower your cost of goods. Imagine that you already have the good fortune to have an excellent protein drug on the market. This particular protein is manufactured using mammalian cells, an expensive and laborious process. You would like to test out some other manufacturing methods, but your staff lacks both the expertise and equipment to make this happen.

Find collaborators who can make your protein in yeast, in bacteria, or in plants. You can then test their products in your bioassays and determine if these will yield a less expensive way to make your drug. Patent extensions via a new manufacturing process may also result from this approach.

6. Publishing with collaborators enhances your scientific reputation. Manuscripts published with collaborators demonstrate your scientific leadership and heighten awareness of your pipeline molecules progressing through development. Venture capitalists and investment bankers highly regard publications as evidence of scientific credibility. These publications can help build goodwill with the academic community as well.

7. Collaborations can attract scientific talent. Ambitious young scientists always try to attach themselves to scientific leaders. Publications with collaborators as well as talks that your staff are invited to give at meetings will raise your scientific profile and make recruiting top-notch talent easier. In addition, your collaborators will often recommend your company to their younger colleagues searching for positions.

8. Collaborations build relationships that speed clinical progress. Collaborations with thought leaders establish relationships that often lead to clinical studies conducted by these same experts. Progress from preclinical to clinical research accelerates through the influence of their reputations, their greater resources, and the quality of their work. Moreover, the need to educate different investigators about your molecule decreases. A strong collaboration program can establish productive and long-lasting relationships with investigators and institutions worldwide.

9. Multiple collaborations help when time is critical. When it is essential to obtain data without delay, it may be advisable to have multiple collaborations involving similar but qualitatively different experimental models. Many companies hesitate to set up such collaborations, for there is a danger of losing collaborators’ goodwill when they (in effect) compete to deliver data. But imagine what would happen if a key collaborator that you are counting on fails to generate the data that you need to make a go/no go decision.

When the need is critical, multiple collaborations can be established in an ethical manner. The key is honesty about what you are doing and why. Treat your collaborators with respect and they will understand.

10. Collaborations attract new opportunities. As a leader in your field, outside investigators may approach your company about helping them in new projects. It is not only your scientific reputation that attracts them, however. Very likely they checked with some of your collaborators and heard you have a reputation for fairness in addition to scientific excellence.

There are compelling benefits to extending research capabilities through collaborations. As partnerships increase, however, dozens of questions, large and small, arise. Effectively answering these questions is the basis for good management. Therefore, putting in place efficient practices to keep the benefits of collaborations from slipping away is necessary for all companies.

Stewart Lyman, Ph.D., can be reached at Lyman BioPharma Consulting. Phone: (206) 931-6403. Web: www.lymanbiopharma.net. E-mail: [email protected].

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