New Drug Delivery Systems and Treatments for Improved Adherence and Better Management of Epilepsy

12 Submissions
132 Views
$50,000 USD
Due:  26th Aug 2024

Challenge overview

OVERVIEW

Angelini Pharma, the Seeker for this Wazoku Crowd Challenge, is looking for innovative Drug Delivery Systems and Treatments to significantly improve the lives of people living with epilepsy (PE).

Angelini Pharma is particularly interested in solutions that take into account a wide range of factors, both related to patients - including but not limited to age, genetics, potential side effects, and the overall medical adherence – and to specific drug-related aspects (efficacy and safety, optimal dosage, pharmaceutical forms).

Despite the presence of about 30 antiseizure medications (ASMs) available in different pharmaceutical forms for epilepsy treatment, patients still face several obstacles.

The goal of this Challenge, therefore, is to identify and describe novel approaches to using available ASMs in PE, especially in elderly and pediatric patients.

This Prize Challenge has a special award structure.

By taking part, you are granting to Angelini Pharma a royalty-free, perpetual, and non-exclusive license to use (but not own unless the Option stated below is exercised) any information included in your proposal, including for promotional purposes. 

However, Angelini Pharma must determine award winners within 60 days from the start of evaluation, otherwise Angelini Pharma loses this right.

A Guaranteed Award of $25,000 will be paid out for this Challenge, with the potential for further awards. Please note that an award of $25,000 will be paid to at least one Solver for a proposal that meets all Solution Requirements, with the possibility of further awards not less than $5,000 for a proposal that partially meets the Solution Requirements.

The Challenge requires a written proposal to be submitted and awards will be contingent upon the theoretical evaluation of the proposal by Angelini Pharma against the Solution Requirements.

The Option: Awarded Solvers further agree to grant Angelini Pharma an exclusive 90 day option to acquire ownership with respect to all intellectual property rights in their proposal with the commitment by Angelini Pharma to pay a consideration for the transfer of the ownership equal to $25,000. This one-time payment is in addition to the aforementioned Guaranteed Award or further awards stated above.

Angelini Pharma can exercise this option within 90 days subsequent to the notification to Solvers that they have been selected as an awarded Solver(s).

Submissions to this Challenge must be received by 11:59 PM (US Eastern Time) on August 26th, 2024.

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ABOUT THE SEEKER & ELIGIBILITY

Angelini Pharma is an international pharmaceutical company and part of the privately owned multi-business Angelini Industries. The Company researches, develops, and commercializes health solutions with a focus on the areas of Brain Health, including Mental Health and Epilepsy, and Consumer Health. Founded in Italy at the beginning of the 20th century, Angelini Pharma operates directly in 20 countries, employing more than 3,000 people. Its products are marketed in over 70 countries through strategic alliances with leading international pharmaceutical groups. For more information about Angelini Pharma please visit https://www.angelinipharma.com.

The challenge is open to Solver as Individual or Solver as Organization.

If the Solver belongs to an Organisation, the Organisation might be: a SME, a startup, a research centre, a university, small or large enterprises directly or indirectly controlled by companies operating in the pharmaceutical business (list not exhaustive).

If the Solver is an individual, he/she must be authorised by the organisation he/she works for, whether this is required by the organisation.

The Solver should not be in any condition of conflict of interest with Angelini Pharma.

Employees of Angelini Pharma as well as of any company that is part of Angelini Industries group are ineligible to participate as Solver and cannot receive an award for this Challenge.

Find out more about participation in Wazoku Crowd Challenges.

 

THE CHALLENGE

Background

Epilepsy is a heterogenous group of brain diseases that affects 50 million people worldwide, almost equally females and males, and is the third leading contributor to the global burden of neurological disorders [1].

The incidence of epilepsy shows a bimodal age-specific distribution, with the highest peak in childhood, followed by a decrease in mid adulthood and a second peak in elderly adults [2].

In addition to periodic seizures—and irrespective of the age of onset—people living with epilepsy (PE) have higher rates of neurodevelopmental, psychiatric, psychological, and emotional disturbances. These disturbances lead to a wide set of secondary conditions, including cognitive impairment, mood disorders (such as depression and anxiety), sleep disorders, and attention-deficit/hyperactivity disorder (ADHD) [3]. All these conditions have a profound negative effect on PE’s overall quality of life.

Currently, about 30 antiseizure medications (ASMs) are available for epilepsy treatment in different pharmaceutical formsmainly oral tablets, capsules, suspensions, and injectionsand several ASMs are approved for nonepileptic conditions, such as neuropathic pain, migraine, bipolar disorder, and generalized anxiety disorder [4].

Some of these ASMs may be more effective or better tolerated in certain age groups or subpopulations of PE based on their genetic profile. For example, older patients may be more susceptible to certain adverse effects of ASMs and may require lower doses or more careful monitoring. Similarly, some ASMs may be less effective in certain genetic subpopulations of PE or may have a higher risk of causing adverse effects or drug interactions in patients with certain genetic variants.

It's therefore important to consider patient-specific factors, such as age and genetics, when making treatment choices for seizures.

Additionally, safety concerns, such as potential drug interactions or adverse effects, may need to be taken into account when selecting an appropriate ASM [5].

However, equally, if not even more, important is the strict adherence of EP to the treatment regime, both with respect to dosage and dosage regimens.

Unfortunately, ASM non-adherence among adult EP range from 29 to 39% and is even lower in elderly and pediatric EP [6], [7],

The problem is that non-adherence to ASM regimens can result in several negative consequences, including increased risk of seizures, decreased effectiveness of treatment, and reduced quality of life.

References

  1. https://www.ilae.org/guidelines/definition-and-classification
  2. Kotsopoulos IA, van Merode T, Kessels FG, de Krom MC, Knottnerus JA. Systematic review and meta-analysis of incidence studies of epilepsy and unprovoked seizures. Epilepsia, 2002, 43(11): 1402-9.
  3. Beghi, E. (2017). Addressing the burden of epilepsy: Many unmet needs. Pharmacological research, 116, 11-19. doi: 10.1016/j.phrs.2016.12.019;
  4. Löscher W, Klein P. CNS Drugs. 2021 Sep;35(9):935-963. PMID: 34145528.
  5. Löscher, W., & Schmidt, D. (2015). Modern antiepileptic drug development has failed to deliver: Ways out of the current dilemma. Epilepsia, 56(4), 649-658. doi: 10.1111/epi.12955.
  6. Modi AC, Rausch JR, Glauser TA. Patterns of nonadherence to antiepileptic drug therapy in children with newly diagnosed epilepsy. JAMA. 2011;305(16):1669-1676. doi:10.1001/jama.2011.506
  7. Sajatovic M, Colon-Zimmermann K, Kahriman M, et al. Treatment adherence in older patients with epilepsy. Epilepsy Behav. 2017;70(Pt A):141-145. doi: 10.1016/j.yebeh.2016.12.031

 

The Challenge

The goal of this Challenge, therefore, is to identify and describe in sufficient detail, novel approaches to using available ASMs in patients with epilepsy (PE), especially in elderly and pediatric patients.

Two general drug delivery approaches can be considered.

Firstly, we are seeking improved and advanced drug delivery systems (DDS) and treatment approaches that can enhance the effectiveness, safety, and the overall adherence of ASMs. In particular, we’re interested in DDS that can improve precision in drug administration and offer dosing flexibility.

Two important considerations need to be outlined:

  • DDS are the specific interface that facilitates delivery by controlling the interactions between the drug and its microenvironment.
  • "Improved and advanced drug delivery systems and treatments" refers to a more effective delivery and management of ASMs that are already available.

Currently used ASMs are available in different pharmaceutical forms, mainly oral medications (tablets, capsules, and suspensions), and injections.

However, they suffer from certain shortcomings:

  • Oral medications may be associated with problems related to adherence and appropriate dose-management.
  • Injectable medications can be associated with pain, discomfort, and bruising at the injection site.

Secondly, we are seeking new drug delivery systems (DDS) and treatment approaches that utilize novel technologies. For instance, specific nanotechnologies have the potential to improve drug bioavailability (drug absorption into systemic circulation) and to increase efficacy; indeed, by crossing the Blood-Brain-Barrier (BBB), they have the potential to improve drug permeation into the brain while decreasing side effects.

In conclusion, the solutions we are seekingboth through improved and novel technologiesshould be designed to solve some of the most common unmet needs, associated with:

  • Age: children and elderly patients with epilepsy may have difficulty swallowing pills or using complicated medication regimens. Additionally, young children may require specific formulations, including liquid formulations of ASMs, which may not be available for all medications.
  • Comorbidity: elderly patients with epilepsy may have other health conditions that need to be managed properly.
  • Safety: subgroups of patients, regardless of their age, may have different metabolic pathways that are linked to specific safety profiles. This may necessitate a lower dosage, while maintaining high efficacy levels.

 

SOLUTION REQUIREMENTS

The proposed solution should meet the following requirements:

  • Be focused on the advancement of already available DDS and treatments or radically new technologies that enhance the effectiveness, safety, and overall adherence of ASMs.
  • Offer ways to improve efficacy (dosage), while reducing side effects.
  • Address some of the most common unmet needs in epilepsy patients, related to age (for instance difficulty swallowing pills), comorbid conditions (management of multiple diseases in a single solution), and safety concerns.

On the type of solutions, we are expecting to receive advanced ideas that could be fully developed and scaled-up in a pharmaceutical industrial setting.

Important! Angelini Pharma are not interested in proposed solutions that:

  • are not targeting specifically epileptic patients;
  • develop devices for management and monitoring of patients with epilepsy but not drugs themselves (DDS/treatments);
  • are just brainstorming ideas, validation of which will require extensive R&D; we are looking for advanced ideas that could be fully developed and scaled-up in a pharmaceutical industrial setting.

For this reason, we expect Solvers to present sufficient supporting information, technical details and rationale, such as references and precedents, that will help us evaluate and validate the feasibility of the submission.

Please, consider that we are open to solutions with a minimum TRL 3 (close to or with achieved Proof of Concept):

This Prize Challenge, has the following special features:

  • By taking part, you are granting to Angelini Pharma a royalty-free, perpetual, and non-exclusive license to use (but not own unless the Option stated below is exercised) any information included in your proposal, including for promotional purposes. However, Angelini Pharma must determine award winners within 60 days from the start of evaluation, otherwise Angelini Pharma loses this right. You will receive notification.
  • A Guaranteed Award of $25,000 will be paid out, with the potential for further awards.
    An award of $25,000 will be paid to at least one Solver for a proposal that meets all Solution Requirements, with the possibility of further awards not less than $5,000 for a proposal that partially meets the Solution Requirements.
  • The award distribution will be determined after theoretical evaluation of the proposals by Angelini Pharma.
  • Awarded Solvers further agree to grant Angelini Pharma an exclusive 90 day option to acquire ownership with respect to all intellectual property rights in their proposal with the commitment by Angelini Pharma to pay a consideration for the transfer of the ownership equal to $25,000. This one-time payment is in addition to the aforementioned Guaranteed Award or further awards stated above.
  • Angelini Pharma can exercise this option within 90 days subsequent to the notification to Solvers that they have been selected as an awarded Solver(s).
  • Angelini Pharma may also issue “Honourable Mention” recognitions for notable submissions that are not selected for monetary awards.

Angelini Pharma may wish to partner with the Solver at the conclusion of the Challenge. Please indicate your interest in partnering. 

 

YOUR SUBMISSION

Please login and register your interest, to complete the submission form.

The submitted proposals must be written in English and can include:

  1. Participation type – you will first be asked to inform us how you are participating in this challenge, as a Solver (Individual) or Solver (Organization).
  2. Solution Level - the Technology Readiness Level (TRL) of your solution should be minimum TRL 3 or higher.
  3. Partnering - there may be an opportunity to partner at the conclusion of this Challenge. Please indicate if partnering is of interest to you.
  4. Problem & Opportunity - highlight the innovation in your approach to the Problem, its point of difference, and the specific advantages/benefits this brings (up to 500 words).
  5. Solution Overview - detail the features of your solution and how they address the SOLUTION REQUIREMENTS (500 words, there is space to add more in the summary field, and attach supporting data, diagrams, etc.).
  6. Solution Feasibility – Supporting Information and Rationale, such as references and precedents, that will help Angelini Pharma evaluate and validate the feasibility of the solution (up to 500 words).
  7. Experience - Expertise, use cases and skills you or your organization have in relation to your proposed solution (up to 500 words).
  8. Solution Risks - any risks you see with your solution and how you would plan for this (up to 500 words).
  9. Timeline, capability, and costs - describe what you think is required to deliver the solution, estimated time and cost (up to 500 words).
  10. Online References - provide links to any publications, articles or press releases of relevance (up to 500 words).

Wazoku encourages the use by Solvers of AI approaches to help develop their submissions, though any produced solely with generative AI are not of interest.

Find out more about participation in Wazoku Crowd Challenges.

Submissions to this Challenge must be received by 11:59 PM (US Eastern Time) on August 26th, 2024.

Late submissions will not be considered.

Your submission will be evaluated by the evaluation team first reviewing the information and content you have submitted at the submission form, with attachments used as additional context to your form submission. Submissions relying solely on attachments will receive less attention from the evaluation team.

After the Challenge submission due date, Angelini Pharma will complete the review process and make a decision with regards to the winning solution(s) according to the timeline in the Challenge header. All Solvers who submit a proposal will be notified about the status of their submissions.

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