QLD BioBriefing / BioCheers - September Medical Countermeasures. Overview and Funding opportunities. Felicia Pradera - PLMCM

Transcription

1 QLD BioBriefing / BioCheers - September 2018 Medical Countermeasures Overview and Funding opportunities Capability through collaboration Felicia Pradera - PLMCM

2 DMTC Overview 2

3 Vision: DMTC Operational Context To provide technology solutions enabling industry to enhance Australian Defence and national security capability. Mission: DMTC creates and enhances Australian industrial capability by leading, facilitating and managing collaborative research and development and innovation activities in the defence and related sectors in manufacturing, engineering and applied science. The Defence and national security customers, industry and research sectors are key stakeholders. Strategic Intent: CAPABILITY THROUGH COLLABORATION Corporate Structure: Public Company. Not for Profit. Limited by Guarantee 3

4 Working with the Defence Innovation Framework

5 DMTC Programs Key Ingredients Addressing articulated and prioritised Defence and National Security needs In-country industrial capability demonstrated, or able to be developed to provide a pathway to market Deployment of research expertise through a single point of engagement Co-investment model that delivers maximum value for all partners 5

6 Medical Countermeasures 6

7 Medical Countermeasures Vaccines Provide acquired immunity against a specific disease. Vaccines are highly effective, however they are expensive to produce, difficult to stabilise and can require multiple injected doses. Therapeutics Can stop the progression of a disease or aid in the recovery from exposure to a toxic agent. They vary widely in complexity and cost, and can vary in their effectiveness depending on the individual. Diagnostics Help understand if an individual has been exposed to a CBR threat and can provide rapid guidance on the best course of treatment. Diagnostics can be developed rapidly and are critical tools. R&D process: Highly complex R&D process: Difficult R&D process: Variable Development time: years Development time: years Development time: 3-6 years Development cost: $350M - $2.5bn Development cost: $350M - $1bn Development cost: $30M - $150M Manufacturing: Highly complex Manufacturing: Difficult Manufacturing: Difficult Vaccine and therapeutic products are most effective if deployed with a corresponding diagnostic product.

8 What is the Global Health Threat? 8

9 DMTC MCMi Strategic Intent and Program Structure 9

10 MCM Program Governance #3 Endorse & Review Program; Advise & Guide relevance & priority. Buy-in and commitment to program Strategic development and recommendations Oversight and communication to Departments Industrial Advisers External Stakeholders + DMTC MCM Program Stakeholder Group (customer view) Sur.Gen, CMO, CDS, CEO CSIRO, CEO MT&P Growth Centre, DFAT. #2 Technical Advisory Committee (TAC) Formulate priority targets. Assess technical worthiness Consult technical expertise Communicate with home organisations #1 Negotiate and manage projects Industry, Research sector participants 10

11 MCM Introduction Objective: To deliver MCM product solutions and strategies benefitting civilian and military health for Australia and globally. Impact: Encourage investment in Australian technologies Enhanced MCM capacity Increase market potential Grow industrial capability On-shore ability to deliver MCM products Jobs, training & manufacturing Ensuring a robust and sustainable product pipeline for MCM that emphasizes multi-functional capabilities rather than stand-alone outcomes. Investment to date: $5M CSIRO & $4M* DST Group (estimated leverage to $27M) * Additional $2M committed in FY18/19 11

12 National Focus on Product Development Technology Readiness Level (TRL): Used to estimate the maturity of a technology TRL1 TRL2 TRL3 TRL4 TRL5 TRL6 TRL7 TRL8 TRL9 Focus on assets at TRL4 and higher Basic research Pre-clinical development Clinical development Manufacturing Market Access Australia does this part well: Strong discovery work Translation of MCM related technology is poor Cross-functional teams lacking for translation 6

13 National Priority, Global Outlook UK CA USA International MCM Consortium under the CBR MOU AU Federal Government MCM Stakeholders International MCM Stakeholders Official Relationships Collaborative Relationships Relationships being developed PFRA Industry Academic Research Institutes

14 DMTC MCMi Program Themes and Cycle Activities 14

15 Themes 1. Point of Care Diagnostics Task within the MCMC CBR MOU 2. Antimicrobial Resistance Task within the MCMC CBR MOU 3. Security Sensitive Biological Agents Dept. Health public list November 2017, other areas of consideration (JHC): Alpha viruses, Orthopox, Malaria, Dengue, MCMs against chemical threats 15

16 Program Development Cycle Phase 1 Briefings Phase 2 Expressions of interest Phase 3 White Paper Proposal Phase 4 Establishing the Project Life sciences (medical technology and biotechnology) networks Universities & Small to medium sized enterprises Industry partner/s Quad chart (single page) - March submission Reviewed and down selected. - April notification Full proposal (no more than 15 pages) June submission Reviewed and down selected August notification Establishing project milestones Negotiation of contracts Beginning of the program December start FEBRUARY MARCH --- APRIL JUNE --- AUGUST DECEMBER (start) 16

17 Program Statistics Quads Received Total Number Number of Partners (Unique) (44) 61 (40) Median Starting TRL Median Duration (months) Resubmitted Unique Partners have submitted collaborative proposals to be a part of the DMTC MCM Program White Paper Proposal Down Selected 11 (9) 14 (9) 10 (7) Resubmitted (SP) 2 1 (2) Total Number of Partners Industry Research International

18 Current Portfolio D D D T D D T V P10.41 P10.42 P10.43 P10.44 P10.50 P10.59 P10.65 P-JEV High sensitivity Point-Of-Care (POC) diagnostic Pathology Lab on A Chip Smart Petri Dish Anti-virulence compounds against BW pathogens Filmarray Warrior Panel Rapid diagnosis of Microbial Infection without culture Biotin Protein Ligase Target Phase 1 Clinical trial JEV Advax - TBC Program Projects Scoping Projects Closed 18

19 International Opportunities Defence and Health Agencies 19

20 Broad Agency Announcements A BAA is a technique for United States government agencies to solicit proposals from outside groups for certain research and development. Broad in their subject matter and focus on advancing science. Pertains to basic and applied research. Usually three staged application process Quad, WPP, Full Proposal 20

21 MCM related exemplars BAA Number Agency Title Closing Date BAA SOL BARDA Biodefense Medical Countermeasure Development 31 October 2019 HR001118S0041 DARPA Biological Technologies 25 April 2019 PAR NIH CounterACT Developmental projects in Translational research PAR FDA Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies 25 May April

22 Conclusions Further Rounds of DMTC MCMi Program Potential opportunity for education program to train the next generation of MCM product developers. Growth of the Program Recommendation If you are interested in working with national or international agencies on medical countermeasures come and have a chat or send me an felicia.pradera@dmtc.com.au 22

23 Capability through collaboration DMTC Ltd Level 2, 24 Wakefield St Hawthorn VIC 3122, Australia Ph +61 (3)