1

LEIDOS LIFE SCIENCES

ID/IQ Contract Vehicles: Teaming and Winning Task Orders

20 November 2015

Presented by:

Harold E. Modrow, Ph.D.Senior Life Sciences Program Manager

2

Leidos Life Sciences Succeeds in Three Markets

► USAID Malaria Vaccine Development Program► DoD Congressionally Directed Medical Research Programs► NIH Vaccine Research Center► Biotech clients working in cancer, infectious, and genetic diseases

Global Health► U.S. Army Medical Research and Materiel Command – Headquarters

(PART, PAA, SPO, PPA&E, ORP, PAO) and supporting laboratories► Military Infectious Diseases Research Program► Clinical and Rehabilitative Medicine Research Program► USAMRMC Enterprise-IT Program Management Office► Hantaan/Puumala Vaccine Integrated Product Team► Defense Healthcare Management System Modernization (DHMSM)► Traumatic brain injury and post-traumatic stress disorder research► Substance abuse counseling for OCONUS active duty Soldiers and

their families stationed overseas

Defense Medical

► NIAID/DMID Regulatory Affairs and Biopharm Translational Research ► Plum Island Animal Disease Research Center► Defense Threat Reduction Agency (J9-CB)► Biomedical Advanced Research and Development Authority

Leidos is a unique research management and product development organization that bridges government mission and commercial biotech/pharma

► Leidos Life Science’s 2015 USAMRMC portfolio is just a fraction of our 30+ year performance history and includes:• USAMRMC task orders for PART, MIDRP, CRMRP, eIT-PMO, and SPO• CDMRP contract that includes 36 active task orders• DTRA-WMD (CB/J9) and JPEO-CBD (OPETS IDIQ medical) contracts

► Other contract/subcontract efforts support NIAID/DMID, NIAID/VRC, NIAID/DAIDS, and BARDA► Current commercial contracts focus on the development of 5 novel cancer therapeutics► Additional contracts with 9 non-profit foundations support medical research program execution, peer review, and market analysis

Threat Reduction

Our diverse client base and broad scope of contracts demonstrates deep experience and understanding of medical product development

as well as portfolio management expertise

3

► Contract awarded 3 December 2013► Total of 7 prime teams► Total of 43 RFPs since contract award

– 27 task orders awarded– 16 task orders not yet awarded– Leidos has won 8 task orders

► Of the above, 11 RFIs for medical product research and development – Two RFPs issued– One award made

► Remaining RFP was submitted on 2 February– No award yet

DTRA Combating Weapons of Mass Destruction ID/IQ

4

Utilizing Small Business Vendors

4

► DTRA ID/IQ small business requirement – 25% revenue at the ID/IQ.

– Current status is ~18%► Additions to team must be approved by DTRA Contracting Officer.

– Must show unique capability► Steps/requirements for small business subcontracting:

– Do not sole source if at all possible! When we are limiting competition to small businesses, we should take extra care to avoid a misperception of skirting the competitive process altogether

– Must demonstrate capability to perform work proposed (Past Performance)

5

Leidos is a Prime Contractor for the USAMMDA MPRD ID/IQ

1. Awarded 30 July 2015 – Proposals submitted October 2014.► Four prime teams

2. Task order RFP expected to be released in January 2016.3. Total ceiling value of $500 million (M) for 5-year base period with $100 M for

each of an additional 5 option years. Total value is $900 M.

4. No staffing for government organizations (no SETA).

5. Covers medical product research and development. Purpose is to develop and bring medical products from the technology base through licensure and fielding.► Total of 9 task areas► Approximately 30 members on team to cover all requirements

6

Leidos’ MPRD ID/IQ Small Business Commitment

Selection of ID/IQ teammates was based on ability to provide R&D capability in one or more of the 9 Functional Areas identified by USAMMDA

► University Strategy: Leverage laboratories and research capabilities► Meet Socio-Economic Goals: 60% of all subcontracted dollars for

small businesses► All Additions to Teams Must Be Approved by USAMRAA Contracting

Officer Before Task Order Release► Minimum for Each Category of Small Business:

Disadvantaged Small Business – 8% Woman-Owned Small Business – 5.5% Historically Underutilized Business Zone (HUB Zone) Small Business – 1% Veteran-Owned Small Business – 6% Service Disabled Veteran-Owned Small Business – 3%

7

Complete Spectrum of Medical Product Development Services

Product Development Services at Leidos

5.2 Non-Clinical Development

► Proof of Concept► Mechanism of

action► GLP safety studies► PK/PD testing► GLP ADME studies► Animal rule

efficacy studies

5.1 Clinical Development

► Protocol development

► Site assessment► Clinical monitoring► CRF development► CSRs for products► Secure data

management

5.5 Translation Services

► Consent forms► Supporting clinical

information► Production records

5.6 DoD Acquisition Documentation

► Product development planning

► Analysis of alternatives/ cost benefit analyses

► Integrated logistics support plan

► Acquisition/milestone decision package

5.7 Sustainment Planning & Support

► Inventory storage of biological materials

► Product life cycle support

► Product distribution, permitting & disposition

5.8 Maintenance Development

► Configuration management

► Device service & repair

5.9 Admin & Tech Support

► Stakeholder meeting support► Decision support► IPT support► GXP & other training support► Partner Agreement support► IT support

5.3 Investigational Medical Product Manufacturing & Testing

► Feasibility Assessment & Audits• Pilot production• Expression platform evaluation• CMC characterization• Animal studies• Cell banking

► Assay Development• Assay design, development &

validation• Stability-indicating assays: design,

development & qualification

► Process Development• Manufacturing & purification

development• Formulation studies• Release, analytics & stability assays• Technology transfer

► GMP Manufacturing• Characterization of FDP• Product stability program• Finish & fill• cGMP drug product, vialing & labeling

5.4 Regulatory Support

► Pre-IND meeting► IND/CTD prep &

submission to FDA► Electronic

submission► Monitoring support

during clinical life cycle

► In-house QA & QC

► All tasks under one umbrella► Cost effective► No IP issue► IT infrastructure and data security► Complete services from bench to bedside

8

Suggestions for Partnering

1. Understand the DoD Acquisition/Contracting System is neither a rapid nor responsive system.► There will be a significant delay between submission and award

2. Create a specialty. Identify your niche and work to become recognized as “Best in Class.”

3. Contact local prime contractors to sit down and exchange information. Ask them, “What do you know and offer?” — and listen to what they tell you.

4. Join local professional organizations, and attend meetings such as SMART PROC.

5. Read FedBizOps on a daily basis.6. Understand the environment has changed. DoD, and Army especially,

has started downsizing. Less money means less work.