The Institute of Psychiatry and Neurology (IPIN) (hereinafter also referred to as the "Leader") announces an open recruitment of a consortium member, i.e. a scientific society, for the joint development and implementation of a project as part of the competition announced by the Medical Research Agency (hereinafter referred to as "ABM" or the "Agency") no. ABM/2024/1, for non-commercial clinical trials and research experiments.

Competition description

The main goals of the competition include:

• development of new standards of treatment, diagnostics or rehabilitation as part of non-commercial clinical trials or research experiments;
• increasing knowledge about the most clinically optimal therapies for a wide spectrum of diseases with particular emphasis on cardiology and hypertension, neurology and psychiatry, infectious diseases - infections and immunity, rare diseases, pediatrics, reproductive health, telemedicine solutions and digital health;
• increasing the number of non-commercial clinical trials and research experiments in the pediatric population (including the infancy, neonatal and prenatal periods).

1. The competition announcement together with the Regulations and full competition documentation are available at: https://www.abm.gov.pl/pl/konkursy/aktualne-nabory-1/2315,Otwarty-konkurs-na-niekomercyjne-badania-kliniczne -i-experiments-research-ABM20.html

Purpose of recruitment

The leader announces open recruitment for a Consortium Member, i.e. a scientific society for the joint preparation and implementation of the project entitled: "Multicenter, randomized study comparing the effectiveness of two doses [IMP - confidential information] in drug-resistant depression versus standard therapy. A study using innovative neuroimaging methods to assess the effectiveness of treatment.” (hereinafter referred to as the Project").

Consortium goals

1. The aim of the consortium is to jointly prepare and, if funding is granted, joint implementation of the Project.
2. The main tasks planned to achieve the consortium's goal include:

• participation in the preparation of the assumptions of the application for co-financing of the Project submitted as part of the ABM competition;
• cooperation in the preparation of the research protocol;
• cooperation in the field of study registration;
• cooperation in preparing the necessary documentation;
• additional cooperation in the field of:

1. analysis of data resulting from a clinical trial,
2. disseminating knowledge about the research.
3. The project will be implemented on the basis of a consortium agreement concluded between the Leader and the selected consortium member selected in the recruitment procedure to which this announcement applies.
4. The consortium member should have a team, infrastructure and experience in working to treat or improve the health of patients. The Consortium Leader and the Consortium Members jointly implement the Project in terms of content, i.e. they participate in the creation of the study design, in particular in the preparation of the assumptions of the Application, in the design of the Protocol, in the process of registration of the study, and also in the analysis of data resulting from the Clinical Trial/Experiment. research and conduct a common financial policy (participate in bearing the costs related to the implementation of the Project) covered by the Consortium Agreement, and are also, on the same basis, mutually obliged to jointly strive to achieve the objective of the Project and bear joint and several liability towards the Agency for the proper implementation of the Project covered by co-financing . In this respect, they are also obliged to act in a coordinated manner.

Submitting offers

1. Offers should be sent by May 8, 2024 via e-mail to the e-mail address: ajanuszkiewicz@ipin.edu.pl, entering in the subject of the message and in the file name: "Consortium member recruitment for the ABM Project 2024/1".
2. A bidder may submit one offer.
3. The bidder bears the costs of preparing and submitting the offer.
4. The leader does not provide for reimbursement of the costs of preparing and submitting the offer.
5. The offer must be prepared in Polish.
6. The content of the offer must correspond to the content of this announcement and be submitted on the form specified in Annex 1 to this announcement.
7. The offer must include all required documents and attachments, i.e. the organization's statute, an extract from the National Court Register or another document that confirms the status of a non-governmental organization acting on behalf of patients.
8. Offers submitted after the deadline will not be considered (the date of receipt is decisive).
9. The number of entities selected in the recruitment for a Consortium Member will not exceed three (3).
10. Any questions related to the recruitment process should be sent electronically to the e-mail address: ajanuszkiewicz@ipin.edu.pl, no later than May 8, 2024 at 12:00. Failure to submit any of the documents listed in this announcement and the deadline for submitting offers will result in rejection of the offer.
11. The documents constituting the offer must be signed by the person(s) authorized to represent the Bidder in accordance with the information contained in the Bidder's registration documents or by the person(s) with an appropriate power of attorney to perform legal transactions, granted by the person(s) authorized to represent the Bidder. . Signatures should be submitted in a way that allows identification of the signatory. If the documents are signed by a proxy, a copy of the power of attorney must be attached to the offer.
12. Submitting an offer is tantamount to the Bidder's declaration that he or she has read it
    with all the conditions of this announcement and the competition announcement along with the Regulations and full competition documentation available at: https://www.abm.gov.pl/pl/konkursy/aktualne-nabory-1/2315,Otwarty-konkurs-na- non-commercial-clinical-research-and-research-experiments-ABM20.html and does not raise any objections to them.
13. Submitting an offer is tantamount to the Bidder's declaration that it accepts the template of the consortium agreement indicated by ABM and, if its offer is selected, undertakes to conclude an agreement on the terms specified in the template agreement and within the deadline indicated by the Leader. Failure by the Bidder to conclude the contract on the terms specified in this announcement within the time limit set by the Leader authorizes the Leader to select another offer from among the offers that cannot be rejected or to invalidate this recruitment.
14. The offer validity period is 45 days from the date of the offer submission deadline, with the first day of the offer validity period being the day on which the offer submission deadline expires.
15. All activities related to the recruitment on behalf of the Leader are carried out by a committee appointed by the Director of the Institute of Psychiatry and Neurology (IPIN).

Conditions of participation in the recruitment and criteria for evaluating offers

1. Offers in the recruitment process may be submitted by entities that demonstrate that they have technical or professional abilities, i.e. they have the status of a scientific society (confirmed by the statute or another document confirming the status of a scientific society).
2. When selecting a consortium member, the following criteria will be taken into account:

• compliance of the Bidder's activities with the purpose of the consortium (30 points);
• the Bidder's declared contribution to achieving the consortium's goal (45 points), i.e.:

1. having human resources with appropriate qualifications necessary to implement the Project in the scope related to the Bidder's declaration (15 points),
2. possession or access to infrastructure necessary for the implementation of the Project in the scope related to the Bidder's declaration (15 points),
3. having experience in conducting research and/or disseminating knowledge on the treatment of treatment-resistant depression (15 points);

• The Bidder's experience in implementing or disseminating and promoting modern methods of diagnosis and/or treatment of drug-resistant depression (25 points).

1. In the event that the Bidders obtain the same number of points, the Leader may call for descriptions of other activities undertaken by the Bidder for patients, e.g. preventive and information campaigns carried out on the implementation or dissemination and promotion of modern methods of diagnosis and/or treatment of drug-resistant depression or other activities not listed, which serve/have served to support and help patients in the last 2 years.
2. Regardless of the cases specified above, the offer is subject to rejection

• submitted after the bid submission deadline;
• submitted by an entity that does not meet the conditions specified by ABM in competition No. ABM/2024/1;
• inconsistent with the conditions specified by the Leader in this announcement.

Method of evaluating offers

1. After the deadline for submitting offers, the Competition Committee will open them and then examine and evaluate the submitted offers in order to select the most advantageous offer. Based on the submitted Offers, the Commission will prepare a ranking list based on the sum of points from the criteria listed above.
2. The Evaluator reserves the right to select a maximum of 3 Consortium Members for the Project, and the entities with the highest number of points will be selected successively.

Final provisions

1. In justified cases, the Leader may, before the deadline for submitting offers, change the content of this announcement. The change made is made available by the Leader on the website.
2. The Leader reserves the right to call on Bidders to complete their offers or provide explanations. The above right does not constitute an obligation for the Leader.
3. The leader reserves the right to cancel this recruitment at any stage without giving a reason.
4. In the event of invalidation of the Competition, the Leader shall not be liable for any damage incurred by the entity interested in submitting an offer or the Bidder.
5. After the announcement of the recruitment results, a Consortium Agreement will be signed with the selected consortium member with a qualified electronic signature, regulating the detailed conditions of cooperation between the consortium members in the preparation and implementation of the Project, no later than April 30, 2024.
6. The recruitment results will be announced on the website: https://ipin.edu.pl/
7. There is no appeal against the announced recruitment result.

Attachments:

1. Formularz zgłoszenia ofertowego
2. Regulamin konkursu Agencji Badań Medycznych 2024/1
3. Umowa Konsorcjum – wzór ABM

The Institute of Psychiatry and Neurology (IPIN) (hereinafter also referred to as the "Leader") announces an open recruitment for a Consortium Member, i.e. a non-governmental organization acting on behalf of patients, for the joint development and implementation of a project as part of a competition announced by the Medical Research Agency (hereinafter referred to as "ABM" or “Agency”) No. ABM/2024/1, for non-commercial clinical trials and research experiments.

Competition description

1. The main goals of the competition include:

• development of new standards of treatment, diagnostics or rehabilitation as part of non-commercial clinical trials or research experiments;
• increasing knowledge about the most clinically optimal therapies for a wide spectrum of diseases with particular emphasis on cardiology and hypertension, neurology and psychiatry, infectious diseases - infections and immunity, rare diseases, pediatrics, reproductive health, telemedicine solutions and digital health;
• increasing the number of non-commercial clinical trials and research experiments in the pediatric population (including the infancy, neonatal and prenatal periods).

1. The competition announcement together with the Regulations and full competition documentation are available at: https://www.abm.gov.pl/pl/konkursy/aktualne-nabory-1/2315,Otwarty-konkurs-na-niekomercyjne-badania-kliniczne -i-experiments-research-ABM20.html

Purpose of recruitment

The leader announces an open recruitment for a Consortium Member, i.e. a non-governmental organization acting on behalf of patients in order to jointly prepare and implement the project entitled: "Multicenter, randomized study comparing the effectiveness of two doses [IMP - confidential information] in drug-resistant depression versus standard therapy. A study using innovative neuroimaging methods to assess the effectiveness of treatment.” (hereinafter referred to as the Project").

Consortium goals

1. The aim of the consortium is to jointly prepare and, if funding is granted, joint implementation of the Project.
2. The main tasks planned to achieve the consortium's goal include:

• participation in the preparation of the assumptions of the application for co-financing of the Project submitted as part of the
• ABM competition;
• cooperation in the preparation of the research protocol;
• cooperation in the field of study registration;
• cooperation in preparing the necessary documentation;
• additional cooperation in the field of:

1. analysis of data resulting from a clinical trial,
   disseminating knowledge about the research.
2. The project will be implemented on the basis of a consortium agreement concluded between the Leader and the selected consortium member selected in the recruitment procedure to which this announcement applies.
3. The consortium member should have a team, infrastructure and experience in working to treat or improve the health of patients. The Consortium Leader and the Consortium Members jointly implement the Project in terms of content, i.e. they participate in the creation of the study design, in particular in the preparation of the assumptions of the Application, in the design of the Protocol, in the process of registration of the study, and also in the analysis of data resulting from the Clinical
4. Trial/Experiment. research and conduct a common financial policy (participate in bearing the costs related to the implementation of the Project) covered by the Consortium Agreement, and are also, on the same basis, mutually obliged to jointly strive to achieve the objective of the Project and bear joint and several liability towards the Agency for the proper implementation of the Project covered by co-financing . In this respect, they are also obliged to act in a coordinated manner.

Submitting offers

1. Offers should be sent by May 8, 2024 via e-mail to the e-mail address: ajanuszkiewicz@ipin.edu.pl, entering in the subject of the message and in the file name: "Consortium member recruitment for the ABM Project 2024/1".
2. A bidder may submit one offer.
3. The bidder bears the costs of preparing and submitting the offer.
4. The leader does not provide for reimbursement of the costs of preparing and submitting the offer.
5. The offer must be prepared in Polish.
6. The content of the offer must correspond to the content of this announcement and be submitted on the form specified in Annex 1 to this announcement.
7. The offer must include all required documents and attachments, i.e. the organization's statute, an extract from the National
8. Court Register or another document that confirms the status of a non-governmental organization acting on behalf of patients.
   Offers submitted after the deadline will not be considered (the date of receipt is decisive).
9. The number of entities selected in the recruitment for a Consortium Member will not exceed three (3).
10. Any questions related to the recruitment process should be sent electronically to the following e-mail address: ajanuszkiewicz@ipin.edu.pl, by May 8, 2024 at 12:00. Failure to submit any of the documents listed in this announcement and the deadline for submitting offers will result in rejection of the offer.
11. The documents constituting the offer must be signed by the person(s) authorized to represent the Bidder in accordance with the information contained in the Bidder's registration documents or by the person(s) with an appropriate power of attorney to perform legal transactions, granted by the person(s) authorized to represent the Bidder. . Signatures should be submitted in a way that allows identification of the signatory. If the documents are signed by a proxy, a copy of the power of attorney must be attached to the offer.
12. Submitting an offer is tantamount to the Bidder's declaration that he or she has read it
    with all the conditions of this announcement and the competition announcement along with the Regulations and full competition documentation available at: https://www.abm.gov.pl/pl/konkursy/aktualne-nabory-1/2315,Otwarty-konkurs-na- non-commercial-clinical-research-and-research-experiments-ABM20.html and does not raise any objections to them.
13. Submitting an offer is tantamount to the Bidder's declaration that it accepts the template of the consortium agreement indicated by ABM and, if its offer is selected, undertakes to conclude an agreement on the terms specified in the template agreement and within the deadline indicated by the Leader. Failure by the Bidder to conclude the contract on the terms specified in this announcement within the time limit set by the Leader authorizes the Leader to select another offer from among the offers that cannot be rejected or to invalidate this recruitment.
14. The offer validity period is 45 days from the date of the offer submission deadline, with the first day of the offer validity period being the day on which the offer submission deadline expires.
15. All activities related to the recruitment on behalf of the Leader are carried out by a committee appointed by the Director of the Institute of Psychiatry and Neurology (IPIN).

Conditions of participation in the recruitment and criteria for evaluating offers

1. Offers in the recruitment process may be submitted by entities that prove that they have technical or professional abilities, i.e.: they have the status of a non-governmental organization acting for patients (confirmed by a statute or another document confirming the status of a non-governmental organization acting for patients).
2. When selecting a consortium member, the following criteria will be taken into account:

• compliance of the Bidder's activities with the purpose of the consortium (30 points);
• the Bidder's declared contribution to achieving the consortium's goal (45 points), i.e.:

1. having human resources with appropriate qualifications necessary to implement the Project in the scope related to the Bidder's declaration (15 points),
2. possession or access to infrastructure necessary for the implementation of the Project in the scope related to the Bidder's declaration (15 points),
3. having experience in conducting research and/or disseminating knowledge on the treatment of treatment-resistant depression (15 points);

• The Bidder's experience in implementing or disseminating and promoting modern methods of diagnosis and/or treatment of drug-resistant depression (25 points).

1. In the event that the Bidders obtain the same number of points, the Leader may call for descriptions of other activities undertaken by the Bidder for patients, e.g. preventive and information campaigns carried out on the implementation or dissemination and promotion of modern methods of diagnosis and/or treatment of drug-resistant depression or other activities not listed, which serve/have served to support and help patients in the last 2 years.
2. Regardless of the cases specified above, the offer is subject to rejection

• submitted after the bid submission deadline;
• submitted by an entity that does not meet the conditions specified by ABM in competition No. ABM/2024/1;
• inconsistent with the conditions specified by the Leader in this announcement.

Method of evaluating offers

1. After the deadline for submitting offers, the Competition Committee will open them and then examine and evaluate the submitted offers in order to select the most advantageous offer. Based on the submitted Offers, the Commission will prepare a ranking list based on the sum of points from the criteria listed above.
2. The Evaluator reserves the right to select a maximum of 3 Consortium Members for the Project, and the entities with the highest number of points will be selected successively.

Final provisions

1. In justified cases, the Leader may, before the deadline for submitting offers, change the content of this announcement. The change made is made available by the Leader on the website.
2. The Leader reserves the right to call on Bidders to complete their offers
   or provide explanations. The above right does not constitute an obligation
   for the Leader.
3. The leader reserves the right to cancel this recruitment at any stage without giving a reason.
   In the event of invalidation of the Competition, the Leader shall not be liable for any damage incurred by the entity interested in submitting an offer or the Bidder.
4. After the announcement of the recruitment results, a Consortium Agreement will be signed with the selected consortium member with a qualified electronic signature, regulating the detailed conditions of cooperation between the consortium members in the preparation and implementation of the Project, no later than April 30, 2024.
5. The recruitment results will be announced on the website: https://ipin.edu.pl/
6. There is no appeal against the announced recruitment result.

Attachments:

1. Formularz zgłoszenia ofertowego
2. Regulamin konkursu Agencji Badań Medycznych 2024/1
3. Umowa Konsorcjum – wzór ABM

Co-financed from the state budget

Institute of Psychiatry and Neurology, as a member of the consortium including Stermedia Sp. z o. o. and Affexy Sp. z o. o. is implementing the project entitled “Developing a product innovation in the field of supporting diagnostics and treatment in primary health care, ambulatory specialist care (AOS) and hospital treatment.”

The project is implemented under the contract concluded with the Medical Research Agency No. 2022/ABM/07/00012 - 00 for co-financing of a commercial project under the ABM/2022/7 Competition for the development of innovative medical devices based on artificial intelligence for coordinating diagnosis and treatment in outpatient care specialist and hospital treatment.

The aim of the project is to increase patient access and improve the diagnostic process by developing and implementing the world's first automated system for analyzing the diagnostic session between the patient and the doctor. The proposed diagnostic tool will be independent of factors that may affect the correct diagnosis, such as specialist fatigue or patients' dishonesty.

This goal will be achieved by achieving the following results:

• Quantifying changes in the method of patient-specialist communication over several visits
• Extending the theories and methods of deep learning and complex dynamic systems to two modalities: text and video
• Using natural language processing and machine vision techniques to measure the dynamics of communication and interaction over time, in real conditions.

CO-FUNDING: PLN 6,522,990.48

TOTAL VALUE: PLN 7,811,891.92

Project implementation period: 01/06/2023 – 31/12/2027

The project is financed by the Medical Research Agency from the State Treasury as part of the competition No. ABM/2021/ for non-commercial clinical trials in psychiatry and neurology.

Project title: "Randomized, double-blind, placebo-controlled study assessing the effectiveness and safety of dimethyl fumarate in reducing brain atrophy, improving functional synaptic connections, cognitive functions, functioning and quality of life in patients diagnosed with mild cognitive impairment and dementia in Alzheimer's disease"

Funding agreement number: 2021/ABM/02/00015-00

Project implementation period: 01/12/2021 – 30/11/2026

Project budget: PLN 9,968,771.73

Project implemented in consortium:

Leader: Medical University of Lodz

Consortium members:

Independent Public Health Care Center Central Clinical Hospital of the Medical University of Lodz

Medical University of Silesia in Katowice

Institute of Psychiatry and Neurology in Warsaw

Brief description of the project:

Alzheimer's Disease (AD) is the most common cause of dementia, accounting for 60-75% of all dementia cases. In people with AD, we observe a gradual decline in cognitive abilities, including memory, logical thinking and social skills. Due to the above, patients lose the ability to function independently both at home and outside, in the later stages of dementia we observe behavioral disorders and psychological symptoms accompanying dementia, such as apathy, withdrawal, agitation, anxiety, aggression, sleep disorders, or delirium superimposed on stupor. More than 30 million elderly people around the world suffer from Alzheimer's dementia, which resulted in costs of USD 0.7 trillion in 2018 (USD 23,000 for each patient). The annual incidence of Alzheimer's disease is approximately 3%, resulting in $30 billion in additional costs. Since the greatest risk factor for AD is aging, the outlook for humanity is catastrophic. WHO predicts that the total number of people suffering from dementia (including AD) will be 82 million in 2030 and will increase to 152 million by 2050. The number of people in Poland with Alzheimer's dementia is estimated at 360,000 to 470,000. Such a large medical problem generates huge economic and social costs related to the early loss of independence of patients, institutionalization, social exclusion, and mental and physical burden on caregivers. Starting from a moderate degree of disease severity, people with dementia require constant support and care, therefore the problem burdens not only patients, but entire families both economically and emotionally. This is also a pressing problem for general, psychiatric and neurological hospitals and outpatient clinics, as AD patients often experience neuropsychiatric symptoms such as depression, anxiety, delirium and aggression with the need for urgent care and hospitalization.

The project was financed by the Medical Research Agency from the State Treasury as a subsidy for conducting scientific research / development work, the final result of which will be a non-commercial clinical trial

Funding amount: PLN 9,290,923.10

Funding agreement number: 2021/ABM/02/00008-00

Project implementation period: 01/10/2021 – 30/09/2026

Task description:

Bipolar disorder (BD) is a mental disorder
affecting 2-3% of the population. This disorder is chronic and recurrent, the risk of recurrence reaches 100%. This disease significantly reduces the quality of life, is associated with an increased risk of suicide and a reduced life expectancy of 8-12 years compared to the general population. The most disruptive quality of life and worsening socio-professional functioning are depressive episodes, which dominate the course of the disease, accounting for 70-81% of the disease duration. They are also associated with an increased risk of suicide - it is even 10-30 times higher than in the general population. According to the current state of medical knowledge, mood stabilizers of the first generation (lithium, valproates and carbamazepine) and second generation (atypical neuroleptics - clozapine, olanzapine, quetiapine, aripiprazole and risperidone) and lamotrigine are used in the prevention of bipolar disorder. In the treatment of depression in the course of bipolar disorder, antidepressants are used, as well as biological treatment methods such as electroconvulsive treatments. Currently available treatment, even when properly prescribed and with satisfactory patient cooperation, is insufficiently effective in up to half of patients. This group of patients is often diagnosed with treatment-resistant depression (30-50%). They experience disease symptoms and impaired psychosocial functioning for approximately half of their lives. Hence the need for new, more effective therapies.

The project was financed by the Medical Research Agency from the State Treasury as a subsidy for conducting scientific research / development work, the final result of which will be a non-commercial clinical trial

Funding amount: PLN 9,704,627.60

Funding agreement number: 2021/ABM/02/00002-00

Project implementation period: 01/11/2021 – 30/10/2027

Project implemented in consortium:

Leader: Institute of Psychiatry and Neurology

Consortium members:

Institute of Biocybernetics and Biomedical Engineering Maciej Nałęcz PAN (IBIB),
Military Institute of Aviation Medicine (WIML)
Institute of Experimental and Clinical Medicine. Mirosław Mossakowski PAN (IMDiK).

Task description:

The project includes a multicenter clinical trial aimed at assessing the effectiveness and safety of cladribine administered subcutaneously in the treatment of secondary progressive multiple sclerosis (SPMS), with active and inactive forms of the disease (in whom no relapses are observed and who do not need to have active changes on magnetic resonance imaging). None of the drugs used so far have proven their effect in inactive SPMS, so the study is particularly important for patients who are not currently under causal treatment.

Project Coordinator at the Institute of Psychiatry and Neurology in Warsaw:

Mrs. prof. Ph.D. Iwona Kurkowska-Jastrzębska
e-mail: ikurkowska@ipin.edu.pl , tel. +48 22 458 25 37
Information contact for study participants: neuro2@ipin.edu.pl, tel. 22-4582601

Project financed by the Medical Research Agency as part of competition No. ABM/2019/1 for research and development activities in the field of non-commercial clinical trials.

Financing agreement number: 2019/ABM/01/00061-00

Project number: 2019/ABM/01/00061

Project implementation period: 01/07/2020 – 30/06/2026

Project budget: PLN 26,349,901.54

Institute of Psychiatry and Neurology in Warsaw:

Task No. 4: Conducting immunological tests in patients undergoing treatment

Project Partners:
Medical University of Lublin – Consortium Leader
Institute of Psychiatry and Neurology in Warsaw
ŁUKASIEWICZ research network – Institute of Industrial Chemistry Prof. Ignacy Mościcki
Institute of Experimental and Clinical Medicine. M. Mossakowski PAN
Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University London

Project Coordinator at the Institute of Psychiatry and Neurology in Warsaw:

Mrs. prof. Ph.D. Iwona Kurkowska-Jastrzębska

e-mail: ikurkowska@ipin.edu.pl, tel. +48 22 458 25 37