Novel Agents Committee for Cancer (NACC)
The Novel Agents Committee for Cancer (NACC) in Singapore aims:
- To bring the clinical and scientific communities together to review proposals of novel agents from ETC/D3, other A*STAR Institutes, local universities (NUS & NTU) and small biotechnological companies;
- To provide clear recommendations on the potential clinical value and the appropriate developmental pathway for the agent;
- To recommend potential projects for funding and development.
Terms of Reference
NACC makes recommendations based on a comprehensive review of novel anti-cancer treatments for early clinical trials. NACC members are experts in early clinical trials of novel agents and other aspects of the drug development process. Proposals and meetings are confidential. NACC recommended novel agents in development include molecularly targeted small molecules, cytotoxic agents, antibodies, vaccines, viral gene therapy, immunotherapy, cell therapy, radioimmunotherapy, diagnostics and imaging agents.
NACC is interested in proposals for scientifically-driven trials of novel unregistered anti-cancer agents and recommends for funding:
- Exploratory/preclinical development prior to a clinical trial
- Phase 1 trials, including First-in-Man and First-in-Class
- Combination trials of unregistered and registered agents
- Early Phase 2 hypothesis-testing trials
How proposals are assessed
Proposals are subject to external peer review and are assessed on the basis of:
- The novelty of the proposed anti-cancer agent
- The scientific rationale for the target and for taking a new agent against this target into man
- The adequacy of the preclinical data package to support clinical development
- The quality and feasibility of the clinical research proposal
- The translational research aspects of the proposal, e.g. pharmacokinetic, pharmacodynamic, immunological, biological and functional imaging endpoints
- The competitive position and patents landscape
Operational Group Members:
Professor Stan Kaye, Royal Marsden NHS Foundation Trust
Dr Alex Matter, ETC/D3
Dr Boon Cher Goh, NUHS
Dr Wee Joo Chng, NUHS
Dr Darren Lim, NCCS
Dr Daniel Tan, NCCS
Dr Kishore Bakoo, SBIC
Dr David Virshup, Duke-NUS
Dr Pauline Yeo, D3
Professor Stan Kaye, Royal Marsden NHS Foundation Trust
Dr. Pauline Yeo, D3 (Drug Discovery & Development)
Frequency of meetings
Three times a year
Procedure for submission of Novel Agent Proposal
The NACC welcomes initial proposals of 2 types, representing earlier and later stages of the drug discovery and development process:
a) those describing a novel target with supporting biological data, where a specific therapeutic agent may not yet have been identified. Here we are looking for targets that are novel but have a degree of target validation, with some understanding of the epidemiology of the target and its drugability, via small molecular weight compounds, antibodies or other modalities
b) those describing a novel agent, with supporting preclinical data. Examples include small molecules, biologics, diagnostics or imaging agents. Here we seek evidence that these drug candidates are close to, or at the stage of entering preclinical development. The entities would preferably be patented or patentable and would plausibly cover a well-defined medical need. The competitive position of these entities should be intact and we would exclude “me-too’s”.
In both cases evaluation is a 2-step process. The initial submission (maximum of two pages) should be submitted for review by the Operational Group (preclinical and clinical experts in Oncology). The proposal will be evaluated based on scientific rationale, feasibility, translational potential, medical need and competitive landscape and it should be framed accordingly. The results of this initial review will be communicated to the researcher within one week after the Operational Group Meeting.
The second stage of the process will involve expansion of the initial proposal for those submissions that have been selected for review in the NACC meeting. The details of the expanded proposal document will be provided during the feedback letter from the NACC Operational Group.
All submissions are strictly confidential. Please send your proposals via email with appropriate security to:
Secretary: Dr Pauline Yeo, D3
Proposals should reach the Secretary by the deadlines provided in the section on “Meeting dates and submission deadlines”.
Meeting dates and submission deadlines
|NACC Meeting date
|22 Nov 2018
||9 Oct 2018
Frequently Asked Questions (FAQs)
- Q: What kind of proposals can be forwarded to NACC?
A: Preferred proposals are those that focus on a novel compound or biological with demonstrated anti-cancer activity in cellular and/or animal systems, and that is effectively ready to enter preclinical development. Compounds can be small molecular weight chemicals, Natural Products, peptides and polynucleotides. Extracts and compound mixtures will not be considered. Biologicals can be antibodies of a defined molecular species including variants thereof, cytokines, soluble receptors and cells of a defined clonal nature. Mixed cell populations will not be considered. Proposals that are focusing on early compounds or biologicals (that are not ready to enter preclinical development) would be triaged to ETC or another RI of A*STAR that is able and willing to take this up. Proposals for medtech applications and diagnostics will not be considered.
- Q: When is a compound or Biological ready for preclinical development?
A: The compound/Biological must be pure, stable as a powder and in solution, stable in animals over a useful window of time, patentable, fully characterised chemically and biologically, with adequate pharmacokinetics (bioavailability) for its intended use, preliminary non-GLP toxicity data and plausible efficacy data to support development addressing one or more specific medical need(s).
- Q: Will NACC fund such projects?
A: No, NACC will make recommendations for D3 to initiate a Due Diligence process which looks comprehensively at the scientific rationale, medical need to be covered, patent position, technical feasibility, competitive position and commercial plausibility. If this Due Diligence of D3 delivers a positive outcome, the project will be presented to the Steering Committee for endorsement. If the Steering Committee of D3 is endorsing the project, preclinical development will start.
- Q: What happens if the opinion of NACC is negative?
A: The project proposal will be returned to the applicants with comments explaining why the opinion of NACC was negative. The proposing party is entitled to a rebuttal which will be taken back to NACC.
- Q: What happens if the proposal is not considered to be mature enough to be presented to NACC?
A: ETC, or another RI of A*STAR may be able to help and adopt the project in the project portfolio, provided the proposing party is agreeable. Alternatively, the proposing party retracts the proposal and comes back at a later stage.
- Q: How does submission to NACC affect my rights to IP?
A: Pre-existing patents and patent rights will be strictly unaffected (= Background IP). IP that has been developed during the collaboration (= Foreground IP) will be handled as follows: authorship on the patent will be determined according to US patent law; ownership will follow, as a rule, authorship but is in most contracts pre-negotiated by the concerned institutions.