More questions on combo components

[mk99]

Taking into account, safety, feasibility and patent/intellectual issues: what could be the next most realistic component to add to a combo therapy? I can't see Bioaxone, Novartis or Boston Life Sciences making their key inhibitors available for combo therapies before they try phase1 trials themselves.

Is my understanding wrong regarding legal/patent issues? How about International Legal issues? Must each inhibitor be tested alone before being combined?

Time is ticking... how to speed up progress?

[Wise Young]

Mike,

Everything depends on people, personalities, opportunities, and money.

• People. Combination therapies require that people with different interests work together. What we need are people in companies who are open-minded and knowledgeable, particularly about spinal cord injury. Once people are in place, they will talk to each other.

• Personalities. Amazing as it may seem, personalities make a difference. Just like people on these forums, certain scientists just don't like each other and will not work together. This is also true of business. Very often, if two people get along together, even from different companies, things happen.

• Opportunities. There are specific times when companies are looking for partners and other times when they are not. A good time often is when support of a given product in the company is low. The company often will welcome attention from the outside, particularly attention in the form of an offer to invest in developing the treatment.

• Money. This is of course essential. A deal can be struck only if it yields profit for both companies. If one is innovative enough, one can always structure a deal that would benefit both parties. But, in order for that deal to go forward, one or both parties must put down some money. It doesn't have to be a lot, say a couple of million. Having watched several of deal go through in the last several years, some cash upfront is essential for the commitment to the deal to go through.

Let us consider the example of chondroitinase. As you know, this is a very hot area of development right now. Sekagaku owns some of the patents on making and purifying the enzyme. Another Japanese company actually has the patent on the main bacterial gene for the enzyme. A use patent has been applied for by the British laboratory group that reported its beneficial effect on spinal cord injury.

Let's say that there is a company that is interested in using chondroitinase with their stem cells. The company would have to go to license the use patent from the scientists but this is only the first step and often the easiest and cheapest step. The company then has to get the material. This is very often quite expensive. Finally, if there is another company that owns a piece of chondroitinase, it is important to try to strike a deal and work out the terms early before one has convincing positive results. Once that happens, the price is much higher. Contrary to other business deals, in biotech, it is often best to strike the deal before the iron gets too hot.

Wise.

[mk99]

Awesome answer. Lots of food for thought. Do you think some of these stakeholders would be more or less open to working with a new non-for profit biotech company? vs. a traditional for profit?

I am thinking about setting up a mini-meeting with some of these key people and maybe some kind of joint venture could result? This seems like a logical and relatively inexpensive first step. (with, of course, a lot of thought and legwork done first)

Can you recommend any good consultants/experts that specialize in this field? (preferably in Toronto area but not necessarily)

[skier]

I agree with all the Wise has said but there is one more over-riding and most critical issue here and that is with each patent and license one must have "freedom to operate" otherwise all of the "good" that is discovered is useless as someone out there has a blocking technology and your discovery cannot be used. Make sure as yu put these players together that there are no sleepers that get ignored.

[Red_1 Canada]

tic-toc

Hey Mike;

Glad everything went well in China.
I guess you are now our resident specialist, after all you're the only one who has had 2 real heros in your back.

Anyways to the point.
As you can see from my FROM:...I am a Canadian.

Well, my Dad is and has been trying to figure out what he can do to help all of us since I was injured.
My Dad is a Finacial Advisor who owns his own firm as well as various other businesses. He was thinking about lobbying our government for support. So I decided to point him in your direction. Please e-mail me so I can put you in touch with him as I'm sure he will be able to help you with what you are trying to do. Also maybe you would be able to help him!

Kevin_Carta@hotmail.com

[bruce]

Wise, what you say is very familiar to me and a wonderfully concise explanation of how business deals in general work, and not just in the biotech and pharmaceutical industries. In a "past life" I was the business development director for a telecom software company and experienced first-hand these forces in structuring deals within that sector.

Here's a concern: It's easier to create deals that allow companies to work together than it is to sustain them. In fact, most of the deals I've seen fall apart after a while for any number of reasons. Perhaps the biggest one is that the people involved change, lose their passion, or often both. Sometimes one company's technology fails to meet its promise. There's certainly more reasons, but the end result is the same.

While this is an issue in the software biz, in biotech, and especially in the area of it so close to our own hearts, the HUGE HUGE HUGE difference is that people's lives are at stake. How are we going to see sustainable trials when there are so many business issues that could tank a combination trial?

I'm thinking that it's going to be doctors and scientists outside the companies involved that have the real chance of making combination trials work. They become customers of the companies involved and work out the therapies there. Having a SCI clinical trial network would go a long way towards helping. Mike, your idea of non-profit entities that do this work is also intriguing.

Maybe a collection of semi-random thoughts, but it seems that combination therapies are going to be hard to do and it's not the science that's going to stand in the way.

- Bruce