APPLY NOW ! - A Novel Approach for Incentivizing Drug Delivery Innovation

INTRODUCTION

One of the most critical early steps in the development of novel drug delivery systems is to demonstrate convincing proof-of-concept. The dilemma is that while pharma companies can be interested in the technology, the reliance on a few outdated model “old chestnut” compounds often leads to less compelling case examples to show the full potential of the delivery concept. Boehringer Ingelheim aims to change this situation by openly sharing significant amounts of several pharmacologically active novel compounds that are more representative of contemporary chemistries designed against recent/current therapeutic mechanisms. For this purpose, Boehringer Ingelheim will utilize its opnMe.com platform that has been highly successful in supplying novel compounds, at no charge, to stimulate external scientific endeavors relevant to research interests, such as target identification and validation. To incentivize drug delivery research, Boehringer Ingelheim Development has sponsored an opnMe call focused on supporting scientific work and novel technology concepts to overcome challenges due to poor solubility of drug candidates. The call went live early in October and interested parties are highly encouraged to apply for participation prior to Dec 17, 2020. Learn more….

BACKGROUND TO THE DRUG DELIVERY OPNME OPPORTUNITY

Poor solubility of drug candidates is a persistent challenge to discovery and development functions in pharma companies.¹ Medicinal chemistry strategies to eliminate solubility challenges by modification of physicochemical properties can require significant effort, time, etc., and even with extensive efforts, it can be an intractable problem to achieve the desired level of target engagement with compounds with adequate solubility.² Many drug delivery options and various technologies already exist for improving solubility;³ however, their applications can be limited, with numerous gaps in knowledge, and possibilities exist for improvements in the future. Evaluation and rigorous application of more innovative delivery science and technologies compete often times with speed of drug product development in pharma. Pragmatic and empirical approaches to identify potential options enable quick assessment and decisions but limit the scientific understanding and full assessment of potentially valuable opportunities. At the same time, external scientific researchers and technology developers have the frustrating challenge of trying to prove the value of their great ideas using much older model drugs rather than contemporary pharmaceutically relevant drug candidates. The absence of such materials leads to feasibility programs that can be less convincing due to data that have limited relevance to current molecules that have significantly different properties and behavior.

In recognition of these realities, we have created a scientific philanthropic mechanism to supply a collection of novel drug candidates, free-of-charge, to selected participants in our latest call on opnMe.com. The question posed is, “Presented with a set of novel, late-stage molecules, how would you propose to improve their solubility to generate insights into future drug delivery?”  The submission process requires a simple two to three page summary briefly describing the scope and benefits of the proposal. Successful recipients will be provided significant quantities (up to 20g initially) of each drug substance free-of-charge. Physicochemical information for all of the compounds is provided and there is a possibility to receive additional pre-clinical data, and/or direct discussion with Boehringer Ingelheim scientists, depending on the scope and potential of the proposal. Participants in the program will be encouraged to publish results of their work in peer-reviewed journals.

THE OPNME.COM PLATFORM

Boehringer Ingelheim launched its open innovation portal end of 2017 with the release of about 20 molecules which could be ordered completely free of charge with “no IP strings attached” as the opnMe team emphasizes. In addition, since 2017, there are opportunities to submit collaboration proposals for select, unprecedented molecules for collaboration. These are projects fresh from the drug discovery bench and the company is seeking scientists who come forward with a novel hypotheses for the molecules presented. Since its launch, 30 additional molecules to order have been added, and the current Molecule for Collaboration program represents the seventh program since the launch of opnMe.com. Meanwhile, nearly 700 research proposals have been received covering a broad range of novel ideas and approaches.

We hope to be able to interact with scientists from around the world who share the same passion for scientific excellence as we do. We think that scientists who are focused on problem-solving, inspired by new discoveries and technologies and eager to try out something new will find the right molecules or exciting scientific challenges and questions on opnMe.com.

All molecules on this platform have gone through a rigorous internal review process where we looked at quality and disease relevance. We have focused on molecule quality which is characterized through the great level of detail that we provide upfront to allow an independent assessment of their strengths. We belief our molecules are unique and target molecular pathways of relevance to human disease.

We aim to create a new way to help scientists to validate their scientific hypotheses and to publish their data to advance scientific knowledge. Importantly, we are transparent about the rights and obligations of the scientists who approach the portal to submit their exclusive ideas, in particular with regards to intellectual property which will remain with the participant.

It should add an opportunity for scientists to advance science and to interact with Boehringer Ingelheim scientists if they wish. Ultimately, we hope to increase their network and experience.

SUMMARY

Participation in this opnMe.com program will provide the opportunity to work with a unique set of poorly soluble (BCS Class II) novel drug candidates from a world-class company to advance fundamental research and/or delivery technology to address an important challenge in the pharmaceutical industry. The submission process only requires a simple two- to three-page summary briefly describing the scope and benefits of the proposal. Successful recipients will be provided significant quantities (up to 20g initially) of each drug substance free-of-charge. Participants will be encouraged to publish results of their work in peer-reviewed journals and will retain any rights to their intellectual property. The opnMe team will promote the drug delivery call on various social networking platforms with an opportunity to use these channels to highlight any publications resulting from work conducted by participants in the program. We look forward to receiving your proposals and any feedback on the initiative. Get started on opnMe.com today!

REFERENCES

1. Siepmann et al., 2020, Int. J.Pharm., 577, 119055.
2. Yang, W., et al., 2020, The AAPS Journal, 22, Article 21.
3. Williams, H., et al., 2013, Pharmacological Reviews, 65(1), 315-499.

Dr. Keith Horspool is Vice President of External Alternative CMC Development (EACD) at Boehringer Ingelheim Pharmaceuticals, Inc. EACD operates as a “biotech within pharma” using an integrated network of virtual resources to deliver all CMC requirements for projects, applying alternative development approaches for NCEs and NCE‐like new modalities. Prior to joining BI, he worked at Pfizer and Astra Zeneca. He has worked in Pharma for more than 30 years with experience managing preformulation, product development, drug delivery, and materials science. He has diverse experience with a broad range of delivery systems and various routes of delivery, particularly oral, inhalation, and parenteral delivery. He can be reached at keith.horspool@boehringer-ingelheim.com or (203) 482-2896.