Getting started with federal contracting
Feature: Getting Started with Government Contracting
You don’t know what you don’t know. This is particularly true in government contracting. The Federal market is large, but entry can be daunting due to the seemingly endless string of requirements and documentation.
So, where can you start? A variety of resources on government contracting are available online. Regional organizations, like the Fort Detrick Business Development Office (FDBO) and Tech Council of Maryland, and the U.S. General Services Administration (GSA) itself offer inexpensive introductory courses periodically. Procurement fairs are useful to connect with larger companies that hold prime contracts. Prime contractors often work with subcontractors to complete various pieces of the work, and they can help you learn the lingo. Plus, many of them are required to work with small or otherwise disadvantaged businesses to meet government requirements.
Before you start your government contracting journey, you’ll need to register with SAM, request a D-U-N-S number, and take care of some other paperwork. You’ll also need to know where to find opportunities: FedBizOpps. A search of this central repository can give you an idea of the government’s needs in your specialty area, and what might be required for a successful bid.
However you proceed, be advised that patience is key; expect to wait months before contract winners are notified. Start slowly, and find a mentor or business partner who can help you along the way.
A version of this article was originally published on the Sisarina blog.
Learn more:
System for Award Management (SAM)
Keep up with ever-evolving federal guidelines with Washington Business Journal’s FedBizDaily, available online and via email
More government contracting resources
Team with us:
DynPort is actively looking for teaming partners with novel nerve agent countermeasures and broad-spectrum host-directed therapeutics for potential government contract work. Please contact Mike McGinnis or call 301-607-5245 if you are interested in discussing these opportunities.
TechWatch: Science News Tidbits
DARPA explores using pollen grains to deliver oral vaccines
“Pollen is normally just a frustration for those of us with hay fever, but it could actually turn out to be a lifesaver. A research project at the U.S. Defense Advanced Research Projects Agency (DARPA) is looking at turning pollen grains into a delivery system for oral vaccines. Harvinder Gill, an assistant professor of chemical engineering at Texas Tech University who is sponsored through DARPA's Young Faculty Awards (YFA) program, is developing a pollen-based oral vaccination platform in order to create a vaccine that is easy to transport and easy to take, needing no specialist medical training. This is particularly important for troops deployed in remote areas and for people living in areas where medical support is hard to come by.” (Source: Suzanne Elvidge, FierceDrugDelivery)
Image: Tiny pollen spores can be crushed, cleaned and then filled with vaccine as future vaccine pills in a U.S. military-funded project. Credit: DARPA/Dr. Harvinder Gill
Firefly chemistry used to evaluate tuberculosis vaccines
“The results of a study by Food and Drug Administration (FDA) scientists suggest that a laboratory test based on firefly chemistry could accurately and rapidly evaluate the potency of tuberculosis vaccines in triggering immune responses. The findings are important because the new test might be able to replace the existing one, which is time-consuming, labor intensive, and often does not yield reproducible results. Additional studies are underway to further evaluate the findings to determine the adoptability of this test. This test has the potential to facilitate the production process of current tuberculosis vaccines while enabling development of newer vaccines now being studied in the laboratory.” (Source: FDA)
Journal article, from the Journal of Microbiological Methods (full text requires a subscription): Characterization of an intracellular ATP assay for evaluating the viability of live attenuated mycobacterial vaccine preparations
Self-boosting vaccine could give single-shot immunity
"A self-boosting vaccine would, with a single dose, give people regular re-exposure to the proteins of dangerous infectious agents possibly handling several risks with a single dose. The downside? The method would involve giving the vaccine's recipients a lifelong viral infection. Of course, many people already have these infections. Herpes viruses and cytomegalovirus often set up shop in human cells without causing any symptoms for years. But they also sporadically come out of hiding (rather famously in the case of the herpes family) and start a brief flare up. Although the immune system can clear the active infection, it never manages to eliminate the reservoir of quiescent virus hiding out in some cells.” (Source: ARS Technica)
Journal article, from Proceedings of the National Academy of Sciences (PNAS) of the United States (full text requires a subscription): Self-boosting vaccines and their implications for herd immunity
Industry and Government Contracting News
Biopharma and Biodefense
For less painful shots, scientists look to... porcupines?
Journal abstract, from PNAS: Microstructured barbs on the North American porcupine quill enable easy tissue penetration and difficult removal
FDA has approved raxibacumab injection to treat inhalational anthrax; it was the first monoclonal antibody to be licensed under the FDA Animal Efficacy Rule, and the first licensed drug produced by the BioShield program.
“In a first for any infectious disease, a vaccine against flu has been made out of messenger RNA (mRNA) – the genetic material that controls the production of proteins. Unlike its predecessors, the new vaccine may work for life, and it may be possible to manufacture it quickly enough to stop a pandemic.” (from New Scientist)
Journal article, from Nature Biotechnology (subscription required for full text): Protective efficacy of in vitro synthesized, specific mRNA vaccines against influenza A virus infection
Ever wonder what goes on at Plum Island?
As more cases of new SARS-like virus are confirmed; authorities are investigating person-to-person spread. The novel coronavirus most closely resembles a strain found in bats. What you need to know about the new novel coronavirus, from WHO.
Belgian company discovers a new class of antibiotics that may offer treatment against multiple drug-resistant infections. Taking a different approach, real-time genetics could squash superbug outbreaks before they spread.
NIAID has launched a new West Nile virus information center on its website, and WHO will change the way it reports H5N1 cases (new WHO page).
Virus found in dogs may fuel new vaccines.
Journal article, from PLOS One: Evaluating a Parainfluenza Virus 5-Based Vaccine in a Host with Pre-Existing Immunity against Parainfluenza Virus 5
Military uniforms of the future will automatically turn into chemical suits in the presence of threats.
Yersinia pestis: new evidence for an old infection, from PLoS One.
DARPA tackles the DNA vaccine, and a new foam to stop internal bleeding.
Research on stricken bats may help in the fight against AIDS.
Journal abstract, from Virulence: Pathology in euthermic bats with white nose syndrome suggests a natural manifestation of immune reconstitution inflammatory syndrome
“About 60 percent of infectious diseases are caused by viruses, bacteria, and other pathogens that make the jump to humans from other species. This includes some of the most devastating disease outbreaks of the past thirty years, including HIV/AIDS, Ebola, and SARS. Despite the huge and rising toll of such diseases, many gaps remain in our understanding of how these “zoonoses” evolve, develop, and spread — gaps that must be filled if we are to succeed in preventing or at least reducing the impact of a next pandemic.” (Source: Homeland Security Newswire)
Journal abstract, from The Lancet: Prediction and prevention of the next pandemic zoonosis
If simian hemorrhagic fever virus jumps species, the fallout could be catastrophic… but if it doesn’t, it could yield clues about how to treat Ebola.
Past pandemics are in our genes: What koalas can teach us about human evolution and disease.
In clinical news, FDA gives the go ahead for a Phase 2 trial using remote monitoring and crowd-sourcing, and people with certain personality traits are more likely to get pain relief from a placebo.
Finally in the "good names for a band category," Antigenic Subversion: A Novel Mechanism of Host Immune Evasion by Ebola Virus (from PLoS Pathogens).
Government Contracting and Business
RWJF Scholar in Health Policy Research Rachel Kahn Best explores the impact of advocacy on federal funding for medical research. “"Increases in the number of nonprofits and lobbying expenditures are both significantly associated with increases in research funding, with each $1,000 spent on lobbying associated with a $25,000 increase in research funds the following year."
The devil in the details: missing a small detail could mean losing a big contract. “Government agencies are held to a high standard and must comply with the strict requirements of procurement law and regulation. Likewise, contractors are held to a high standard of attention to detail, and failure to meet that standard will result in offers being rejected and losing bid protests.” More on forecasting your federal contracting success.
With new biosafety rules, few public health labs will handle the riskiest agents.
Interested in marketing your products down under? New Zealand and Australia regulatory authorities to merge.
In regulatory news, FDA matches the most new drug approvals in years in 2012, while under pressure to relax drug rules to facilitate development of new antibiotics.
Draft guidance: FDA issued this draft guidance in December: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (PDF, 997K)
Silicon Valley Congressman Mike Honda (D-CA) introduced a bill that, among other things, seeks to create an Office of Wireless Health at the FDA, as a company finalizes plans to launch a tricorder-like self-diagnostic device that works with your smartphone.
The U.S. Army Edgewood Chemical Biological Center (ECBC), and the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) opened a new Proteomics Core Facility at Aberdeen Proving Ground, MD.
Join a Tufts Center for the Study of Drug Development study to benchmark clinical contracting and legal processes. Deadline to participate is January 7, 2013.
Reports and Resources
Report: Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan - full plan (PDF, 521K) and one-page fact sheet (PDF, 102K)
Report: Emerging Infectious Diseases in 2012: 20 Years after the Institute of Medicine Report, by NIAID’s Dr. David M. Morens and Dr. Anthony S. Fauci
Workshop summary: The Social Biology of Microbial Communities (Institute of Medicine)
Editorial round-up:
- Americans depend on a strong CDC (Politico)
- Curing cancer by throwing spaghetti at the wall - increasing innovation in federal research (Skeptical Outsider/Bio-IT World)
- Let’s gang up on killer bugs (New York Times)
- How vaccines save lives, grow economies (GAVI Alliance)
- Lessons from vaccine history (Nature)
Awards: Nominate vaccine industry colleagues and companies in India for the Vaccine Outstanding Achievement Awards. Nominations due by January 14, 2013.
Infographic: FDA drug approval process, from CDER
Blog: A new blog from PLoS: Public Health
Book: Preparing for Bioterrorism: The Alfred P. Sloan Foundation’s Leadership in Biosecurity (free PDF available)
Video (2:35): Herbs And Empires: A Brief, Animated History Of Malaria Drugs
Coloring book: Download a Flu Fighter coloring book (PDF, 4.6MB), produced by the National Foundation for Infectious Diseases (NFID) and National Association of School Nurses
Upcoming Events
January 21-25, 2013, Palm Springs, CA – Pep Talk: The Protein Science Week – now accepting speaker applications
January 22, 2013, Rockville, MD – MdBio Leadership Series: Continuing the Dialog with the FDA – Breakfast with Senior FDA Officials from CDER, CDRH and CBER
January 24-25, 2013, Arlington, VA – 3rd Annual Developing CAPAs in the GCP Environment
January 28-30, 2013, Washington, DC –Phacilitate Vaccine Forum Washington, co-located with the Protein Therapeutics Forum and Cell & Gene Therapy Forum
January 30 - February 2, 2013, Raleigh, NC – Science Online2013: Conversation, Community, & Connections at the Intersection of Science & the Web
February 4-8, 2013, Boston, MA – Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation
February 5, 2013, Somerset, NJ – 3rd Annual Biologics Symposium (complimentary, registration required)
February 5-7, 2013, Miami, FL – 4th Annual Summit for Clinical Ops Executives (SCOPE)
February 6-7, 2013, London, UK – Clinical Outsourcing World Europe
February 11-12, 2013, San Francisco, CA – Genomics in Medicine (part of Molecular Med Tri-Con) - speaker proposals now being accepted
February 20-21, 2013, Washington, DC – Marketing Pharmaceuticals 2013: Workshop for Regulatory/Legal/Communications Professionals and Promotional Review Teams
February 21, 2013, Boston, MA – Tufts CSDD Executive Forum: Managing Protocol Design to Improve Clinical Study Efficiency
March 5-7, 2012, Pune, India – Vaccine World Summit India 2013 – speaker abstracts now being accepted
March 8 -10, 2013, Chicago, IL – NFID 2013 Clinical Vaccinology Course
March 11-13, 2012, Rosslyn, VA – International Society for BioProcess Technology ISBioTech 3rd Annual Meeting, including Baculovirus Expression Technology and Viral Vectors & Vaccines tracks - call for papers and posters now open
March 18-20, 2013, Baltimore, MD – 14th Annual Immunogenicity for Biotherapeutics - register by January 11, 2013 to save $400
April 22-24, 2013, Baltimore, MD – NFID 16th Annual Conference on Vaccine Research
April 22-25, 2013, Chicago, IL – BIO International Convention
April 29-May 3, 2013, Boston, MA – 9th Annual PEGS, the Essential Protein Engineering Summit
May 9-10, 2013, San Diego, CA – 7th Annual Sample Prep 2013 - speaker abstracts accepted until January 4, 2013
May 14-16, 2013, Seattle, WA – Development, Validation and Maintenance of Biological Assays - register by January 18, 2013 to save $500
May 29-31, 2013, Silver Spring, MD – FDA’s Medical Countermeasures initiative (MCMi) 2nd annual Regulatory Science Symposium – now accepting topic suggestions
June 18-19, 2013, Washington, DC area – 21st Biodetection Technologies - speaker abstracts accepted until January 14, 2013
June 23-27, 2013, Boston, MA – DIA 49th Annual Meeting - Advancing Therapeutic Innovation and Regulatory Science - call for posters, due February 28, 2013
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