LEO Pharma Open Innovation

FAQs from partners in the USA

What is LEO Pharma Open Innovation?  LEO Pharma Open Innovation is a collaborative space created to explore partnerships and the latest research using disease-relevant in vitro assays as an initial stepping stone towards finding the next generation of treatments for skin disease together. The open innovation platform allows insight and access to some of LEO Pharma's unique research tools in order to test external molecules for disease-relevant effects, but without the obligation to disclose confidential information (such as the structure of your molecule) or to relinquish intellectual property. By openly disclosing the assays we offer and some of our corporate interests, we hope that someone out there will have a resource, piece of information or an idea that we didn’t know about before, to provide a solution for people with skin diseases.

Does 'open' mean that everything will be revealed to everyone? No, it does not. 'Open' in this context refers to the open disclosure and availability of our disease-relevant assays. Participation in LEO Pharma Open Innovation is an agreement between LEO Pharma and you, the partner. Your decision, compounds, results and conclusion will not be kept confidential by us, and not communicated to anyone outside of LEO Pharma, unless specifically agreed.

What is the Agreement or MTA? The document which you can download here is an agreement between LEO Pharma and you (the partner) which specifies the details, including securing confidentiality and what we do in the collaboration. It covers what sometimes is referred to as a Material Transfer Agreement (MTA). It also states that LEO Pharma will not use the compounds in any other way than agreed upon and that you consider some points when agreeing to nominate compounds for testing in the LEO Pharma Open Innovation platform. One of the main points of the contract is to ensure that your assets (molecules) are safe and protected.

Can anyone participate in LEO Pharma Open Innovation? As long as you are a recognised company or institution and provide the necessary registration information– yes! We also work with individuals.
However, LEO Pharma can choose not to allow access if the registration criteria are not met, or if there is a potential issues with LEO Pharma code of conduct or business otherwise.

Will you test absolutely anything? LEO Pharma Open Innovation invites you to test compounds you believe will have an effect in the disclosed in vitro assays, and to explore science with the intention of further collaboration. We will not filter or select what we test, but by giving you the details of the assays we hope that you can make a sensible judgement on whether your molecule has the potential to produce an interesting result. However, if we for any reason suspect a hazard issue we will of course not test or handle such a molecule.

Can you test an antibody we've developed? Currently our assays are designed to test compounds dissolved in DMSO*. However, we're working on optimising some changes to the protocols which will allow us to test water-based compounds so please reach out to us and we'll explain what we can already offer you. As of today we have tested large molecules dissolved in water-based liquids (such as PBS) in the keratinocyte (CCL2 and IL-8 release assays). We will discuss on an case-by-case level when non-DMSO is required (*DMSO is a solvent that is very common when working with small molecules)

What’s the process of participating? Once we’ve both signed the agreement, we will ship you empty, barcoded vials. You need to put 200 µL of approximately 1-10 mM solution into those vials and send them back to us. When they arrive, we carefully store them and enter them in our internal handling system. The assays are run as quickly as they can be, bearing in mind that we coordinate assays for many different research opportunities, and strive to optimise the number of plates we can fill in each repeat. Finally, we evaluate the results and compile them into a report which we send back to you.

How long does it take? Once we receive the vials from you it can take up to a month for the assays to be ordered. This is because we coordinate assays for many different research opportunities, and strive to optimise the number of plates we can fill in each repeat. Once ordered, it will take up to three months for the assays to be completed. These complex assays which use primary human cells can experience unforeseen complications or delays in rare cases. Nevertheless, the vast majority of molecules will be tested within three months of arriving here at LEO Pharma HQ.

Why do you need 200 µL of my molecule? To minimise cost and maximise efficiency, there are a number of steps in the preparation of the samples for testing which are handled by robots. For example, initially your molecules are titrated into a 96-well plate, and later they’re transferred to a 384-well plate, which is used for the assay. For the titration plate, we take 70 µL of your molecule from the vial, and make a series of dilutions from that, creating ten different concentrations. In order to obtain that 70 µL, there needs to be a ‘dead volume’ of at least 30 µL in the vial. The assays are complex and use primary human cells, so sometimes we need to repeat the experiments, and therefore require an additional 70 µL to re-create the titration plate. Since we’re blinded to the details of these molecules, we also use 10 µL to run a confirmatory LC-MS profile, which tells us whether the molecule matches the molecular weight you reported, and therefore gives us confidence that we’re handling the correct molecule and the molecule hasn’t degraded. That all adds up to a total volume of 180 µL so we have rounded up for simplicity.

If there are strong needs and reasons whey 200 µL is too much, we can discuss potential options, including running only specific assays or hand pipetting.

What are the key contractual points?­­

  1. You retain all rights to your molecules. No strings attached.
  2. You own all the data we generate in the assays and are free to use those data as you wish.
  3. LEO Pharma will not use your molecules for any purpose, other than to test them in the Open Innovation assays we offer.
  4. We won’t ask for information about your molecule, other than its molecular weight, so that you can be sure it’s completely safe and your rights are not being jeopardized.

What is the potential follow-up scenario? Once we’ve sent you back your results, there isn’t a standard format for how we continue our dialogue, but we will always strive to ensure that everything we do is of mutual benefit. If your data look scientifically interesting we’ll reach out to discuss them with you. Usually we will agree to talk more with the protection of a CDA, so that you can feel comfortable telling us more about your molecule. Often the molecules that are disclosed to us turn out to be chemicals LEO Pharma has already explored, and either has ongoing activities with them or has discounted for a scientific or business reason. If that’s not applicable in the case of your molecule, then generally we will suggest a follow-up study to generate more data and evaluate the opportunity more thoroughly. The evaluation will be conducted with input from colleagues in Research and Business Development, and if we need other experts from within the organisation then we’ll pull them in too.

How do I ship my molecule? Molecules can be shipped at room temperature (if they’re not stable enough for their journey to Denmark at RT, they’re unlikely to remain active throughout the assays which are conducted over several days at RT or in a 37°C incubator). The vials are relatively robust, so a padded envelope is generally sufficient to keep them safe. We can supply brown glass vials if your molecule is light sensitive.

Vial shipment is at your own expense, but you’re very welcome to use standard mail carriers, because there isn’t a short deadline for us to receive the molecules (six months from the contract execution date). LEO Pharma has an import license from the Danish Medicines Authority which permits us to receive chemicals for research purposes, including those derived from biological sources. Please contact us if you’d like a copy of the license. You should check with your carrier if there are any restrictions on what substances they will transport. Here are links to the restricted/prohibited items from some of the most popular shipping services:

FedEx cross-border restricted & prohibited items:

https://crossborder.fedex.com/us/assets/prohibited-restricted/

US Postal Service restricted items:

https://www.usps.com/ship/shipping-restrictions.htm

UPS prohibited items:

https://www.ups.com/us/en/help-center/shipping-support/prohibited-items.page

Vials should be sent to:

LEO Pharma Open Innovation,

Compound Management,

Industriparken 55,

2750 Bellerup,

Denmark

 

If you need to specify a contact person for the shipment, please use Helen Frost. It’s useful (although not essential) for you to let us know when you’ve sent the shipment, however we will always notify you when your shipment arrives here at LEO Pharma Headquarters.

Do you have any success stories? We are proud to say we have lots of success stories. Since 2016 we’ve partnered with over 90 partners and tested over 900 molecules. Approximately 10% of the molecules we test produce data that we would consider ‘interesting’ (show a disease-modifying effect without serious signs of toxicity) and we always reach out to the owners of these molecules to discuss potential next steps which are mutually beneficial.

How can I use the data? The data we generate in our assays using your molecules belong to you. You are free to use them as you wish and there are no restrictions from us on how you may share them. We’d like to know if you publish them in an article, because we’d really like the recognition for our hard work. You might chose to use the data to apply for funding or financing; you might want to publish them; you might even use them to negotiate an in-licensing deal with a competitor of ours. You should consider whether sharing those data would jeopardize a future business deal with LEO Pharma, but really, there are no restrictions.

Can you share the assay protocols? Detailed assay protocols are available here. We can also send out PDF versions if that’s helpful for you.

Is it still relevant if we’re not working with dermatology? YES! In the USA, as an example, the investment in dermatology research is approximately 0.02% of total science/health research funding. We know that there’s so much great research going on out there that isn’t focused on dermatology, and that’s exactly what we’re hoping to connect with. If you’re working outside dermatology, you might have a technology that could help those living with a skin disease, but maybe you haven’t even thought about testing your asset in a dermatological disease. This is your opportunity to see if your molecule has an effect that you didn’t expect! We’re really interested in molecules that have immune-modulating or anti-inflammatory effects, but we’re also looking for those ‘out of the box’ ideas.

What controls do you use? each assay has a positive control (100% effect), a negative control (0% effect) and a reference molecule. For more details, download the protocols here.