Call for Projects
Instructions
PIs recruited by OTT should prepare and submit to OTT a one (1) page (MAXIMUM) proposed project description using the one-page “Non-Confidential Application Form.” Please also attach your CV with the completed form.
PLEASE DO NOT INCLUDE ANY CONFIDENTIAL INFORMATION!
Project descriptions are due to BioSP by February 9th, 2018
Questions should be directed to your TTO, or Michele Washko, BioStrategy Partners Program Director, at or 717-514-0436.
Introduction
BioStrategy Partners, Inc. (BioSP) is a 501c3 nonprofit organization whose mission is to advance translational life sciences research and technology transfer within the academic research enterprise.
BioSP is partnering with GlaxoSmithKline (GSK) on the GSK Germinator, an innovative program developed by BioSP that facilitates industry-academic collaborations via a customized sponsored research process. BioSP’s role is to manage and facilitate:
●Sourcing, presentation, selection and review of projects from multiple academic institutions, in disease and platform areas selected by GSK. The review process includes face-to-face discussion between academic and GSK scientists, under confidentiality.
●Grant award administration, including joint development of the experimental plan and facilitation of Material Transfer Agreements.
●Monthly presentations and submission of electronic reports, site visits, final presentations, and any required troubleshooting.
In the current round (Germinator 2018), we anticipate six (6) cash grant awards. Each grant will consist of up to $30,000 from GSK and up to $30,000 in academic match, for a total per award value of up to $60,000, to carry out a six (6) month experimental plan developed in collaboration with GSK associates.
Germinator Program Description
One hallmark of the Germinator program is a simple application process. BioSP releases a Call for Projects to the Office of Technology Transfer (OTT) at participating academic institutions. OTT collects project descriptions and submits to BioSP for review, editing and compilation. BioSP then submits a complete package to GSK, every project is considered and about 12 will be invited to face-to-face review sessions. BioSP schedules and coordinates these presentations and review sessions, which take place under confidentiality to allow robust scientific exchange.
ALL PROJECT SELECTION AND FUNDING DECISIONS ARE MADE BY GSK
After GSK has selected the projects which are to receive funding, BioSP notifies participants of award decisions and facilitates joint development of the experimental plans, final budgets, timelines, milestones, communication schedules, etc., between GSK and the selected projects. Grant monies are awarded upon acceptance of these “Road Maps,” and upon acceptance of the final project report.
Key Program Dates
Proposals and intake form reviewed w Tech Transfer.Distribute to PIs. / January 12, 2018
Concepts Due to BioSP / February 9, 2018
Notification by BioSP of invitation to present and initiation of establishment of CDA / March 9, 2018
Technology presentations / April 6, 2018
Notification of Award / April 20, 2018
Establishment of award contract and confirmation of match / April 30, 2018
Initiation of Project / May 18, 2018
Completion of project / October 15, 2018
Final technical report / November 15, 2018
Final financial report for release of final check / November 30, 2018
Six Calls for Proposals from GSK Platform and Therapeutic Area Teams
1.Drug Delivery Call for Proposals
Background:
Long-Acting Injectables: Novel formulation technologies that extend biological half-life of drugs and enable patient-friendly, infrequent dosing schedules, improved compliance, and lower dose burdens. This is traditionally achieved by physically and chemically associatingdrugs with release rate-controlling polymers, reducing aqueous solubility (e.g. prodrugs) to drive slower in vivo dissolution rates, or delaying clearance and extending circulation time in the blood. Recently, innovative device engineering approaches have also been applied to mechanically sustain drug release over extended periods of time. While several long acting injectable products utilizing many of these approaches have been developed, there is a need for new strategies especially as more patients can benefit from this mode of administration.
In addition, to inform development of long acting injectable formulations, there is a need to develop a much stronger fundamental understanding of the biological dynamics that can influence the performance of these technologies.
Targeted Drug Delivery:Maximizing delivery of drug to the desired site of action while minimizing drug exposure at off-target sites is the ultimate ambition for targeted drug delivery. The ability to bias the distribution of drug to desired cells/tissues would yield enhanced efficacy and improved safety for patients. This has already been demonstrated in clinical practice through local delivery of drugs (e.g., inhaled lung delivery for airway diseases, steroid injection into arthritic joints), and minimizing systemic exposure of drug to non-targeted tissues. For targeted tissues less accessible to localized drug administration, other means of biasing drug distribution are needed.
Request:
We are seeking novel drug delivery solutions towards the following areas:
Long-Acting Injectables
- Novel Long acting formulation and device approaches suitable for therapeutic applications which address any of the following 3 properties
- High dose small molecules (≥ 200 mg) with ≥ 1 month duration
- Hydrophilic small molecules with ≥ 1 month drug release, ≥ 50% loading w/w, and ≤ 10% burst release
- Proteins with ≥ 1 week drug release, and ≥ 50% loading w/w
- Predicting foreign body response (e.g., macrophage recruitment) to injected (sub-cutaneous/intramuscular) drug delivery formulations
- Compatibility of formulation excipients and polymers in biological systems –Predictive in vitro assays
- Pharmacokinetic Modeling strategies which incorporate the effects of a foreign body response
- In vitro dissolution methodologies for predictive profiling of in vivo PK behavior of long-acting formulations via implementation of biological membranes and/or ex-vivo tissues to mimic the subcutaneous / intramuscular space
Targeted Drug Delivery
- Drug delivery to specific cell types (e.g., hepatocytes, stellate cells, renal proximal tubule cells, cardiomyocytes)
- Biasing drug delivery to lymphatics
- Characterizing novel mechanisms of viral entry into CNS as potential mechanisms for CNS drug delivery
- Exploiting the EPR effect for NON-oncology indications
- Novel formulations for gene delivery using ultra-sound assisted drug delivery
2.Target Science Call for Proposals
Background:
For most drug discovery programs, selecting a drug target that will result in the desired therapeutic effect in the intended patient population is critical. We have shown that targets with human genetic evidence supporting the indication are twice as likely to succeed as those without. Although there is a growing body of genetic evidence, understanding the causal relationship between a genetic association, the effector gene, and the disease is very challenging and labor intensive. Methods that improve this, both in silico and in vitro, will have a significant impact on both the speed and attrition in drug discovery and development.
Request:
The Target Sciences group is seeking innovative ways to bridge the gap from genetic association to biological insights to select novel drug targets, including improvements in one or more of the following areas:
- Translating from genetic-effect sizes to potential drug effects on disease;
- Experimental methods to test target-disease associations at scale (>100 targets at a time) in relevant disease models (tissues, primary cells, organoids, iPS derived cells);
- Single cell technologies to analyze proteins and metabolites. Novel technologies to analyze RNA at the single cell level;
- In silico methods for:
- Mapping genetically associated variants to effector genes
- Predicting causal variant function and putative therapeutic mechanisms
3.Exploratory Discovery Call for Proposals
Background:
The Exploratory Discovery group combines the early-stage interests of two GSK teams: Discovery Partnerships with Academia (DPAc) and the Target Incubator. Exploratory Discovery focuses on novel targets (i.e., targets not currently leveraged for medicinal purposes), emerging mechanisms of action and critical pathways – in each case seeking a means to modulate (inhibit or activate) biological activity for therapeutic benefit. Specifically, we are interested in targets/mechanisms/pathways that have either a genetic link1 or clear association2 to a disease of high unmet medical need. We will consider most therapeutic areas, although diseases of the developing world (e.g., malaria, schistosomiasis, leishmaniasis) are out of scope. We are particularly interested in therapy areas outside of oncology, immuno-inflammation, respiratory or anti-infectives.
1The genetic link may either be (i) a common event in a rare disease that supports both target intervention in the rare disease and a larger clinical population or (ii) a rare genetic event showing benefit in a (non-rare) disease. Genetic events may include gene amplification, deletion, mutation or an epigenetic alteration.
2An association to disease includes demonstrating a specific target – disease relationship, e.g., robust correlation of the target with poor prognosis.
For clarity, the genetic association can be any genetic association such as loss or gain of function to a SNP in GWAS study to a link in a gene in the pathway. It would be better if there were some information on directionality but that, too, is not absolutely needed
Request:
We seek proposals for novel targets that have a human genetic link or clear association to a disease of high unmet medical need. For example:
- Genetic association to a rare disease resulting in a phenotype that supports target intervention in a more common clinical population with high unmet need.(Targets that apply only to a rare disease setting do not fit this criterion.)
- Genetic association in a more common clinical population (or subset of larger clinical population) with high unmet need. Genetic association may include germline or somatic mutations, gene amplification or deletion, or epigenetic alteration.
- Human evidence of target – disease association such as robust correlation of target with poor prognosis.
4.Immuno-Oncology Discovery Performance Unit (IOC DPU) Call for Proposals
Background:
Epigenetic modification has the potential to alter tumor immunogenicity via cell intrinsic mechanisms (e.g. tumor antigen expression/presentation) as well as effects on the immune system (e.g. memory T cell development). Multidisciplinary research has the potential to explore novel combinations at the intersection between epigenetics and immuno-oncology with the goal of improving the effectiveness of cancer therapy.
An emerging area of focus within the field of immuno-oncology (IOC) is the targeting of immunosuppressive populations within the tumor microenvironment. Myeloid infiltrates in tumors can negatively regulate adaptive immune responses; thereby, limiting the clinical efficacy of existing checkpoint blockade therapies.
Request:
The Immuno-Oncology Discovery Performance Unit (IOC DPU) within GSK Oncology seeks proposals to advance the field of oncology in one of two areas:
- Intersection between cancer epigenetics and IO: Identifying epigenetic agents that modulate innate/adaptive immunity and/or tumor immunogenicity.
- Targeting myeloid-induced immune suppression in tumors: Selective depletion of MDSCs, repolarization of TAMs or targeting immunosuppressive networks in the TME.
5.Biopharm Molecular Discovery Call for Proposals
Background:
Antibodies are well established as highly efficacious drugs, which are used to treat a wide range of diseases. In contrast to small molecules, their use can be constrained by their relatively large sizes, which reduce target accessibility. This results in therapeutic mAbs typically administered via injection (intravenously or subcutaneously) and once in-vivo; they are best suited for targeting and binding to circulating soluble factors or cell surface proteins in order to elicit their therapeutic effect.
GSK Biopharm Molecular Discovery seeks to collaborate with research groups that are both interested in, and are developing platform technologies that will result in mechanisms to circumvent the inherent limitations found in the use of antibody therapies. Such technologies will significantly expand the target classes as well as routes of administration applicable to the use of therapeutic mAb.
Request:
Projects are sought that have the potential to enable mAbs to be used to treat a wider range of diseases than currently are tractable, specifically:
- Innovations that facilitate administration and effective delivery by alternate dose routes (e.g., oral, inhaled)
- Enable access to intracellular targets
- Enable effective transport across BBB (Blood Brain Barrier) and the achievement of efficacious dosing to the CNS following systemic delivery
Viral delivery would also be of interest.
6.Synthetic Immunology Call for Proposals
Background:
Heterobivalent molecules are being developed as therapeutic agents in both academia and industry. Two such examples are Antibody Recruiting Molecules (PMID: 22758917) and ProTacs (PMID: 28648379). In the case of antibody recruiting molecules, one end of the heterobivalent molecule binds to circulating antibodies and the other end binds to a target protein displayed on the surface of a cell. In the case of ProTacs, one end of the heterobivalent molecule binds to a target protein and the other end binds to an E3 ligase. The heterobivalent molecule thus drives the ubiquitylation and subsequent degradation of the target protein. Using heterobivalent molecules to drive co-localization of two proteins has the potential to drive numerous physiological outcomes not possible with simple agonists or antagonists.
Request:
We seek proposals around novel ways to utilize heterobivalent molecules to develop therapeutic agents. These could be new targets for published approaches (not limited to the above) or an entirely new way to employ a heterobivalent molecule as a therapy such as altering phosphorylation, subcellular localization, dimerization, etc. We are not interested in chemical methods for synthesizing heterobivalent molecules at this time.
Questions should be directed to your TTO, or Michele Washko, BioStrategy Partners Program Director, at or 717-514-0436.