Teaming with the US Government to Develop New Vaccines and Therapeuticsproposal development through program management

Webinar Overview• US Government (USG) as a Customer• Capturing USG Business

– Selling to the USG– Building winning proposals

• USG as a Teaming Partner• USG Culture and Business Practices• Building Customer Satisfaction and Repeat

Business• Summary and action items

USG as a Customer

• One of the worlds largest purchasers of goods and services

• Employs standardized acquisition processes designed for purchase of everything from pencils to spacecraft

• As a governmental body, has unusual rights, privileges, legal remedies, and susceptibility to external pressure– can circumvent intellectual property rights depending on

circumstances– can confer unusual rights to contractors (“acting as an agent of

the US government”)– partisan alignment and legislative lobbying by interested parties

(including competitors) can influence program emphasis, funding levels, management decisions

USG as a CustomerAcquisition Policy

• USG operates under standardized acquisition rules and policies which are available for review and use by contractors

• Global acquisition policy is found in the Federal Acquisition Regulations (FAR)– http://www.arnet.gov/far/

• Department of Defense has developed supplements which are often used by other agencies– Defense Federal Acquisition Regulation Supplement (DFARS) and

Procedures, Guidance, and Information (PGI)• Provides details of DoD implementation and supplementation of the FAR• http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html

– DoD Instruction 5000.2-R (The Defense Acquisition System Guidebook) • reference resource for acquisition professionals• https://akss.dau.mil/dag/DoD5000.asp?view=document&doc=2

• What is a USG Grant?– Financial assistance award for peer reviewed research. The grantee is

responsible for the research with little or no direct government involvement. Grants are generally awarded to institutions, which must comply with all terms and conditions of award.

• What is a USG Contract?– A wide selection of contract types is available to the US Government

and it’s contractors in order to provide needed flexibility in acquiring the large variety and volume of supplies and services required by agencies.

– Contract specialists work with project officers to select a contract type. Selecting a contract type significantly affects acquisition planning and contract administration and must be done carefully, beginning with a precise definition of the work. Contract type is stated in a solicitation; however, it may change before award based on negotiations with offerors.

USG as a CustomerGrants and Contracts

• General DHHS/NIH grant categories (see http://grants.nih.gov/grants/funding/ac.pdf for details)

– F – fellowships– K -- career development awards– N -- research contracts – P -- program project and research center grants– R -- research project grants– S -- research-related programs– T -- training grants– U -- cooperative agreements

• A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

– Y -- interagency agreements

• Web portals for identifying grant and contract opportunities– http://www07.grants.gov/ (Grants.gov)– https://www.fbo.gov/ (FedBizOpps.gov)– http://www.hhs.gov/aspr/barda/index.html (BARDA: Bioshield, Pandemic)

USG as a CustomerGrants and Contracts: Types of Grants

• Small Business Grants http://grants.nih.gov/grants/funding/sbir.htm#sol – SBIR (R43, R44)

• All NIH institutes set aside 2.5 percent of their research budget for Small Business Innovation Research (SBIR)

• http://grants.nih.gov/grants/guide/pa-files/PA-08-050.html

– STTR (R41, R42) • All NIH institutes set aside 0.3 percent for Small Business Technology Transfer (STTR)

awards.• http://grants.nih.gov/grants/guide/pa-files/PA-08-051.html

USG as a CustomerGrants and Contracts: Types of Grants

Requirements SBIR STTRTime Phase I -- six months to

one yearPhase I -- one year

Usual maximum award Phase I -- $300,000Phase II -- $1 million

Phase I -- $300,000Phase II -- $1 million

Performance site Grant funds must be used entirely in U.S.; part of research must take place in company-controlled research space.

Grant funds must be used entirely in U.S.; part of research must take place in company-controlled research space and part in that of academic partner.

• Contracts can be grouped into two broad categories: fixed-price (see FAR 16.2) and cost-reimbursement (see FAR 16.3).

– Fixed price contracts: Used to acquire commercial items, supplies, or services based on reasonably definite specifications. They give contractors the greatest incentive to control costs and perform effectively, while imposing the smallest administrative burden on both parties.

– Cost reimbursement contracts: Used when uncertainties about performance do not allow us to accurately estimate costs. Contractors have less risk for performance and little incentive to control costs, and the government must ensure contractors are using efficient methods and controlling costs.

• Contracts in these categories range from firm-fixed-price in which contractors have full responsibility for costs and profit or loss, to cost-plus-fixed-fee where they have minimal responsibility for costs, and the negotiated fee is fixed. In between are various incentive contracts (see FAR 16.4), that tailor performance costs and profit or fee to the level of uncertainty of the work.

USG as a CustomerGrants and Contracts: Types of Contracts

• Requests for Proposal (RFP)– The DHHS solicits proposals for grants or contracts to procure products or services it

requires. These solicitations are called request for proposals (RFPs). RFPs are initiatives, which are developed and approved within the Institute or DHHS branch and with its advisory Council.

– RFP do not necessarily have specifically designated allocated funding.

• Requests for Application (RFA)– An RFA is used to solicit grant applications in narrowly defined, high-priority, and

high-opportunity areas of science.

– RFA always have set aside funds and a targeted number of awards.

• Program Announcement (PA)– A PA communicates the interest of a HHS institute or center in receiving

applications in the stated scientific areas. – Generally, money is not reserved for awards in these areas outside the payline. – For current NIH program announcements, see

http://grants.nih.gov/grants/guide/search_results.htm?year=active&scope=pa

• See http://niaid.nih.gov/ncn/sop/concept.htm for an explanation of how RFP, RFA, and PA are developed.

USG as a CustomerGrants and Contracts: Types of Solicitations

• Broad Agency Announcements (BAA)– Typically employed by DoD and related agencies rather than HHS.– The Broad Agency Announcement (BAA) is a competitive solicitation procedure used

to obtain proposals for basic and applied research and that part of development not related to the development of a specific system or hardware procurement. The BAA is described in FAR 6.102, “ Use of Competitive Procedures,” and FAR 35.016, “ Broad Agency Announcements.”

– The type of research solicited under a BAA attempts to increase knowledge in science and/or to advance the state of the art as compared to practical application of knowledge. 

– Basically, within DoD and related organizations, the BAA is built around a statement of objectives, the RFP around a statement of work.

– See http://www.darpa.mil/cmo/baa.html for comparison between BAA and RFP

• BAA resource links– http://www.arl.army.mil/www/default.cfm?Action=6&Page=8– http://www.onr.navy.mil/02/BAA/– http://www.jpeocbd.osd.mil/page_manager.asp?pg=3

USG as a CustomerGrants and Contracts: Types of Solicitations

• General Services Administration (GSA) Schedule– A GSA schedule is an unfunded, five-year renewable contract listing the prices

the federal government has agreed to pay for a vendor's commercial products and services.

– Funding occurs when an order is signed by a federal agency. – There are 62 categories of commercial products and services that vendors may

apply for under a GSA contract. Known as schedules, these categories cover everything from industrial products, vehicles, computers and office products, to most categories of professional services.

– GSA schedules are the favored purchasing mechanism for most federal buyers and an ideal sales and closing vehicle for vendors. Large federal contractors can have GSA schedule sales exceeding $ 100 million annually.

– To be an approved supplier under a GSA schedule, the vendor must go through an arduous application process. Negotiating fair and reasonable prices for the products or services to be delivered is the most important aspect of that application process.

– Competition for an individual GSA order is reduced significantly because the prices contained in a schedule are pre-determined at the time of contract award. However, direct sales efforts are usually required to generate an order. GSA Schedule-based sales typically require focused, agency-based sales efforts.

USG as a CustomerGrants and Contracts: GSA Schedule

• Cooperative Research and Development Agreement (CRADA)– Any agreement between one or more Federal laboratories and one or more non-

Federal parties under which the USG, through its laboratories, provides personnel, services, facilities, equipment, or other resources with or without reimbursement (but not funds to non-Federal parties) and the non-Federal parties provide funds, personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts which are consistent with the missions of the laboratory.

– Allows the partners to agree to share intellectual property emerging from the effort or to agree that one partner may retain exclusive license to patentable research. Enables both partners to stretch their research budgets and optimize resources

– Provide a means for sharing technical expertise, ideas, and information in a protected environment. The Federal government can protect from disclosure any proprietary information brought to the CRADA effort by the partner(s)

– Permits Federal and non-Federal scientists to work closely and offer non-Federal partners access to a wide range of expertise in many disciplines within the Federal government

– Permits the Federal government to protect information emerging from the CRADA from disclosure for up to five years, if this is desirable

USG as a CustomerCooperative Agreements

• Traditional grants and contracts pathways can be bypassed by working directly with congressional representatives (Senators, Members of the House of Representatives)

– Typically involves working directly with a local Senator or Representative– Initiative must be timed with legislative cycle

• Often requires cooperation of a federal agency such as NIH, CDC, DoD– Specialty organizations have been established which can help facilitate these types of

arrangements• CDC Foundation http://www.cdcfoundation.org/ • Foundation for the National Institutes of Health http://www.fnih.org/ • Henry M. Jackson Foundation for the Advancement of Military Medicine http://www.hjf.org/ • Uniformed Services University of the Health Sciences http://www.usuhs.mil/

• Examples of successful directed appropriations projects– Windber Research Institute www.wriwindber.org

– Aeras Global TB Foundation/CDC Site Development http://www.aeras.org/about/funders.php

– Ligocyte Norovirus Vaccine program http://www.ligocyte.com/norovirus/norovirus.html

– DoD Prostate Cancer Research Program http://cdmrp.army.mil/pcrp/

– Other Congressionally Directed DoD programs http://cdmrp.army.mil/research.htm

USG as a CustomerDirected Appropriations

• Understand the customer’s needs by reviewing strategic plans– BARDA Strategic plans

• HHS PHEMCE Strategy and HHS PHEMCE Implementation Plan http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html

• BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/bardaplan.html

– NIAID Strategic plans• Global NIAID Strategic plan

http://www3.niaid.nih.gov/about/overview/planningpriorities/strategicplan/strategicplan2000.htm • NIAID Strategic plan for biodefense research

http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/biosp2007.pdf • NIAID list of emerging and re-emerging infectious diseases

http://www3.niaid.nih.gov/research/topics/emerging/list.htm

– DoD Joint Program Executive Office, Chemical and Biological Defense• Global access http://www.jpeocbd.osd.mil/ • JPM Biological Defense http://www.jpeocbd.osd.mil/page_manager.asp?pg=2&sub=6

• Register your interests and monitor web portals for new grant and contract opportunities

– http://www07.grants.gov/ (Grants.gov)

– https://www.fbo.gov/ (FedBizOpps.gov)

– http://www.hhs.gov/aspr/barda/index.html (BARDA: Bioshield, Pandemic)

Capturing USG BusinessSelling to the USG

• Align your business practices to meet customer expectations and requirements (contracts)

• Register in the Central Contractor Registration (CCR) system• http://www.ccr.gov/

• Obtain a “Data Universal Numbering System” (DUNS) number• See http://www.ccr.gov/pdfs/DUNSGuideGovVendors.pdf for instructions• Online registration link

http://fedgov.dnb.com/webform/displayHomePage.do;jsessionid=1C7056C0F138128763516187DA975184

• Complete the On-Line Representations and Certifications Application (ORCA)• https://orca.bpn.gov/login.aspx• You will need your DUNS number first!

• Determine if you are a “Small Business”, and if so what type!• Different agencies and programs may use different definitions, or have

multiple definitions!• http://www.acq.osd.mil/osbp/links/other_federal.htm

• Minority or woman owned?• http://www.osdbu.gov/

• Review and align your accounting practices and structures!

Capturing USG BusinessSelling to the USG

• Communicate your solutions and capabilities• If you are a small business and just starting out, consider subcontracting to an

established prime contractor• See http://web.sba.gov/subnet and

http://www.sba.gov/aboutsba/sbaprograms/gc/contacts/gc_subcontracts_opportunities.html for subcontracting opportunities

• Identify key government opinion leaders in the agency that you wish to target• HHS Organizational directory http://directory.psc.gov/• HHS Employee directory http://directory.psc.gov/employee.htm • Within NIH, contacting program officers can be quite helpful

http://www.niaid.nih.gov/ncn/grants/charts/check_po.htm http://www.ncbiotech.org/services_and_programs/intellectual_exchange/documents/nih_program_four.pdf (tutorial on working with program officers)

• Within DoD, each program and base typically maintains a commercial contractor liasion site

• Chem-Bio http://www.jpeocbd.osd.mil • USAMRMC https://mrmc.amedd.army.mil/lamindex.asp• Fort Detrick (Main Biodefense campus) http://www.fdbdo.com/prodn/default.asp • Naval Medical Research Center http://www.nmrc.navy.mil/nmrc_pipi.htm

• Assist the customer to develop specifications and solicitations

Capturing USG BusinessSelling to the USG

Capturing USG BusinessProposal development

What companiesthink it takes to win

What the USGmost often selects

Our products or services

Our management

Our people(resumes)

Our Experience(past performance)

Our Company (corporate capabilities)

Our products or services

Our management

Our people(resumes)

Our Experience(past performance)

Our Company (corporate capabilities)

Good Ideas!

• Use “capture management” processes so that you anticipate or create opportunities instead of reacting to them!

• Best ideas win– What discrimates the winner? Better ideas! – Evaluator’s confidence that you can deliver on the better ideas.– Must meet minimum criteria of clearly addressing all evaluation criteria

• Design a solution that is carefully matched to the customer’s stated needs (not what you think the customer needs, or what you think that you would like to “get funding for”)

– Analyze the customer’s needs and carefully re-state them as your preferred solution– Design the preferred solution independent of your companies pet projects– Clearly describe structure and details of your solution

• Detailed description of products or services• Detailed work breakdown structure tied to contract line items (CLIN) if appropriate• Management plan should include quality assurance aspect

– Adapt your company’s ideas, strengths, and capabilities to the preferred solution– Test the solution to see if it addresses the solicitation requirements (seek independent

review by non-team member)

Capturing USG BusinessProposal development

• Put yourself in the position of the reviewers– Use clear proposal structure based on structure and language of statement or

work, statement of objectives, RFP, RFA, BAA etc.– Use section headings which clearly correspond to evaluation criteria– If it is an unscored criteria, then it is a luxury- focus on scored criteria

• Do not submit subpar proposals! – Reviewers are typically selected from influential senior thought leaders in your

field– The review process is laborious, time consuming, expensive for the USG, and

reviewers are typically performing a “public service”– Whether you win or not, the quality of your proposal will impact on your

reputation as a team, as a company, and/or as a technical solution

• Be aware that reviewers often use the peer review process as a way to “troll” for new ideas

• Reviewer conflict of interest and confidentiality rules are more rigorously enforced for contract review, almost completely ignored for grants

• Appeals process can be effective for contracts in some cases, typically is completely ineffective for grants

Capturing USG BusinessProposal development

• Establish, task and empower a dedicated proposal development team– Small dedicated proposal teams are better than large teams.– Bring in subject matter experts only as needed– Use SOW/SOO/RFP to structure proposal development process– Clearly designate a proposal manager

• Use visuals where appropriate to clarify and underscore key points

• If the reviewers do not see or understand a key aspect of your proposal it is your fault! Your response needs to be explicit and crystal clear.

• Employ “mock review” processes to insure proposal clarity and completeness

• Avoid hype

Capturing USG BusinessProposal development

USG as a Teaming Partner• There is an increasing trend toward active involvement of USG staff and

consultants as “partners” in managing large grants and contracts– NIH language “The administrative and funding instrument used for this program will be the cooperative

agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities”

– BARDA employs classical program management tools and practices (Gantt chart, milestones, go/no go decisions, monthly reports with telecons, quarterly reviews with expert consultants). Programs are typically structured around CLIN (contract line items) with specific milestones, dates, and deliverables.

– BARDA language “The Contractor shall participate in regular meetings to coordinate and oversee the contract effort as directed by the Project Officer. Such meetings may include, but are not limited to, meetings of all Contractors and subcontractors to discuss clinical manufacturing progress, product development, product assay development, scale up manufacturing development, clinical sample assays development, clinical study designs and regulatory issues, meetings with individual contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program; and meetings with technical consultants to discuss technical data provided by the Contractor. Monthly teleconferences with the Contractor and subcontractors with HHS officials will be held at times and dates to be determined to review technical and product development progress, except during clinical lot manufacturing when meetings shall be held on a weekly basis. In addition, the Project Officer may schedule progress reviews, including quarterly progress reviews, on-site at the Contractor’s facilities and other locations.

• Inclusion of trained program management professionals (certified PMP) with federal grants/contracts experience can greatly enhance competitiveness and “teaming” effectiveness

USG as a Teaming Partner• Transparency and integrity of information communicated is paramount!

• Particularly in issuing subcontracts or purchase agreements, consult with your contracting officer before entering into an agreement when operating with USG grant or contract funds (best is to have internal or consulting FAR-trained contracting officer on your team!)

• Better to view USG as partner and seek assistance and council when problems develop with the contract or deliverables, rather than to “cover up”

• USG has a variety of options available if concerns of non-performance or failure to disclose key events develop

• http://www.arnet.gov/far/current/html/Subpart%2012_4.html • If termination for cause, the USG can readily recover damages including forced

payment of costs by the original awardee to have a third party (your competition!) complete the contracted work

• As a consequence of receipt of federal funds, companies may be required to enter into various agreements having to do with resource and reagent sharing, including public access to data (including genomics data)

– http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm– http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html– http://grants.nih.gov/grants/gwas/

USG Culture and Business Practices• Yes, they work government hours! • Yes, the bureaucracy is cumbersome! • USG staff are typically underpaid relative to commercial peers• There are structural disincentives to decision making and risk taking

by USG staff• Conflict of interest rules and restrictions are becoming increasingly

cumbersome• USG staff are prohibited from lobbying activities, and very wary of

anything that might be interpreted as such. Federal funds received cannot be used for lobbying activities.– http://www.ed.gov/policy/fund/reg/edgarReg/edlite-part82a.html

• An informal communication strategy of “informed empathy” is often effective – USG employees may be wary of putting things in writing- don’t push!

– Look for ways to make their job easier- it will yield dividends!

• Model your proposals and business practices on preferred USG processes and practices– Use management tools that reflect the government’s own objectives for e-

government, that being the use of real-time online tools for collaboration and reporting

– Use documented management processes

– Use USG-recognized management tools like MS Project

– Design and implement quality assurance process and practice consistent with ISO-9001:2000

– Incorporate performance-based work and subcontracting processes and management tools

– Explicitly identify and manage risk, and communicate this activity to the contracting or project officers

– Use accredited project managers

– Focus on government and company managers working as a team, and communicate this perspective at every opportunity

USG Culture and Business Practices

Satisfaction and Repeat Business• Past performance on grants and contracts will impact on future scores and

probability of awards– From the FAR “Past performance information is relevant information, for future

source selection purposes, regarding a contractor’s actions under previously awarded contracts. It includes, for example, the contractor’s record of conforming to contract requirements and to standards of good workmanship; the contractor’s record of forecasting and controlling costs; the contractor’s adherence to contract schedules, including the administrative aspects of performance; the contractor’s history of reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the contractor’s business-like concern for the interest of the customer.”

– BARDA RFP language “Communications will be held with Offerors whose past performance information is the determining factor preventing them from being placed within the competitive range. “

– http://www.acquisition.gov/far/current/html/Subpart%2042_15.html

• Over time, contractors develop a past performance portfolio (often with scores, depending on agency) which must be disclosed

• Absence of past performance can be an obstacle to achieving contract award. Teaming with a successful prime contractor is one way to build a performance history.

Summary and Action Items• Investigate whether your business/business model can benefit from

establishment of a GSA schedule• Develop an understanding of which branches, divisions and programs

within the USG may benefit from your goods and/or services• Understand and align your business and accounting practices with

USG/FAR requirements, agency culture and interests• Attend meetings and conferences where USG KOL discuss current

and upcoming initiatives and strategic plans • Directly cultivate relationships with program staff and KOL within USG

agencies aligned with your business interests- focus on their programmatic needs and communicate how you can provide support

• Look for “sole source” opportunities where you can provide unique goods or services to USG

• General rule of thumb- “if you are beginning your response to an RFA/RFP once it is published, you are too late!”

• Question and answer session• Thanks for participating!• If you wish a copy of this presentation with the

associated web links, please send an email to the following: marketing@biopractice.com

Teaming with the US Government to Develop New Vaccines and Therapeuticsproposal development through program management