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OK, let’s pick up our discussion where we left off last week, at feasibility. You did it. You successfully convinced a room full of vice presidents and directors, or maybe even the CEO that they should take your fabulous product idea to the next level. You’ve got marketing on board, excited to promote it and now it’s time for the work to begin.
You are the lead scientist so this will be your baby. You most likely are working on other projects too so you have to divide your time wisely. An R&D scientist always has multiple projects as various stages of the development process. You don’t get to spend full time on one thing. You know what your deadlines are and the target dates for giving updates to the committee and you make it a point to meet them.
I think to fully explain how a product is developed it would be helpful to have an example. Let’s use an example of something that no one has ever figured out how to do yet but almost everyone wishes they had a solution for. How about:
A novel method that allows for any protein of any size or sequence or species to fold correctly when recombinantly expressed in E.coli cells.
No inclusion bodies, no toxic protein issues, and no solubility issues. How is such a thing possible? Well, you tried Takara’s method using chaperone proteins on a previous project but it didn’t work on mammalian proteins. But, what you discovered, serendipitously, is that when the protein contains a specific sequence on the N-terminus, a novel undiscovered chaperone protein binds to the expressing protein and folds it during synthesis. As long as you have this tag, you can express any protein active and soluble.
During feasibility testing, you did some minimal testing. You tried it on some small protein fragments known to be very hydrophobic and it worked. How did you discover this sequence? While working on another project where you were making antibodies to different fragments of a hydrophobic protein, one of your polyclonals recognized a 42 kDa protein that, upon sequencing, had homology to several chaperone proteins but this one had never been characterized before.
You, being brilliant and knowing when to take initiative, made several tags based on the protein sequence and cloned them in frame next to sequences of the gene that were not expressed as soluble protein, and presto! They worked. So now you have a system that looks like it makes it possible to express soluble folded protein for very difficult species.
What’s next? So it worked on a few smaller proteins but how good is this system? You need to start trying it for multiple difficult proteins from human, mouse, maybe even plant, but you need to flesh out what your new product can and can’t do.
By this time you will have spoken to scientists who struggle with protein expression and asked them about the kind of proteins they work with to get an idea of what the biggest market is for this area. Is it human proteins? What kind of proteins? Receptors? Nuclear proteins? G-proteins? What do the majority of people work on? Some of these people will be your beta testers later on.
At this point you can use the literature and get some ideas for very difficult proteins to express and also see if the customers will give you their clones to work with. Now is the time to get to work, cloning sequences with your magic tag. By the way, you’ll need to ask all the outside labs working with you to sign non-disclosure agreements (NDAs) in order to protect the invention. If your invention is patentable, usually the legal department will help you get that submitted before you talk to anyone. You cannot talk to anyone about your invention without an NDA. It could prevent you from getting a patent.
For the next few months, your work will involve expressing various proteins, showing that they are insoluble without the tag and soluble with it. You’ll want to devise a method for removing the tag so you may need to engineer a protease cleavage site. And then maybe you’ll want an antibody for the tag itself so you can separate it from the untagged protein using an affinity column. This will all be part of your new kit. The idea is to make a product that has everything a scientist would want.
As a scientist who does this work day in and day out, you already know what people want to do next with their protein. So you have to cover all those requirements as well. Could you sell a product that is just a tag and a vector? Yes. But with the antibody for doing Westerns and an enzyme for tag removal and a way to purify the cleaved protein, your product is a home run.
During this R&D development stage, you work out all the issues. If your product doesn’t work on all the proteins tested, maybe gets only 50% soluble for proteins >100kDa, you figure out why and try to get it to work. Or, you don’t and you sell something that will at least get people 50% soluble protein from something they previously got nothing. It’s a trade off. And time is ticking so the time comes when you have to decide if 50% is good enough or if you should delay the launch to figure it out.
Marketing helps you with this. Based on surveys of the customers, they will tell you, well, only 10% of customers want to express a protein >100 kDa, so let’s ask them how happy would they be with 50% soluble protein. Or >50% of customers want to express large proteins with at least 75% soluble so we need to keep working on it or we can’t sell it. R&D and marketing should always be working together.
Towards the end of the development phase is when you start giving your kit to select customers who agree to try it in a specified period of time. Most scientists do not have time to test something so it can be very difficult to get enough willing participants. But this data and feedback is critical. If the feedback is negative, you take the time to make the changes they request. And if it is positive, it gives you a much needed boost. The closer it gets to launch, the more your anxiety increases as your worry about how the beta test labs will like it and if it works as well for everyone else as it does for you.
R&D development overlaps with marketing's part of this process and goes until just about launch. The last tasks involved in product development are writing the protocol so that a technical writer can put it into a company template, and deciding how to QC the product. The QC protocol has to be something that a much less trained scientist can do and needs to catch any problems that may have occurred during the scale up in manufacturing. Often times, when the QC scientist has a problem, the R&D scientist is called in to help, even years after it has been launched.
I think that pretty much covers the R&D development phase of product development. It’s really fun and you become very attached to your product. Even when the product launches, you never really cut the apron strings.
Next week I'll cover all the things marketing is doing to make sure your invention gets all the love and attention it deserves.
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I have to admit this does sound fun. Its a big puzzle piece and you get people involved and then find the niche. You are a real part of research making the road much more drivable. Plus with this sort of project there is a deadline and you have definite goals and some sort of predicted outcome and plan of attcack for each. The hardest part is inding a feasible idea it looks like. Great Job! This is great insight into Biotech, like I said before wicked curious on what Biotech does, what the process is.
I think you hit it right on the head when you said the hardest part is having the ideas.
Once you are immersed in a field, the ideas come to you. You have to do the work to know what pain people have and then you can figure out how to overcome it. The rest is a big puzzle - you are starting with a end result you want and work your way backwards- from the outside to the last piece.
Some people are inventive by nature and always have ideas. If that describes you, you would enjoy being in biotech.
Really liked this post. At what point in the process do you set a hypothetical price point to determine ROI?
re: patents ... where I work, if we can't get both US and International patent rights*, we just publish the idea instead. I am assuming that industry is the same (or may just scrap the idea without publishing altogether)?
*usually because someone shot their mouth off and publically made mention of the idea, which instantly scuttles most international patent opportunities.
@GR- It can depend on whether it is a totally novel product or you are going to try to take market share from someone who makes something similar. Also, sometimes we will ask the beta testers or ask in a survey "What would you pay for this?" to get an idea of what the value is to the scientist.
If this is something that competes with an existing product, you already know your price has to be the same or 5-10% lower than the competition. So if you already know what your price is, you already know what you can spend to build it (the cost each) and then you can determine how much time should be spent on it.
I would say that you need to have an idea of the price point fairly early in order to plan the amount of resources and marketing dollars you want to invest in it.
Most people will file for patents in the US if they are from Europe so I think it would be rare to find a EU patent that is not at least applied for in the US. I have seen ideas patented only in Japan or Korea. The problem is, you won't get your patent in the US or anywhere else if something similar is patented in another country. It now becomes "obvious". Your will be rejected based on the prior art.
In this case we would keep something a trade secret and not patent. When you patent, it means that everyone has your formula. The alternative is to contact the patent holder and try to negotiate a license to use their technology. But if they are an Asian country, we probably wouldn't do that because their invention is not protected in the US so anyone can copy their invention.
I wouldn't scrap the idea necessarily. There may be ways to still apply for a patent and prove that your invention was not obvious. You just may not get broad claims.
In industry you never talk about any of your work so that you can never risk your ability to apply for a patent. You would be in pretty big trouble for doing that.