BioDefense Solutions

Mr. James Viscardi
VP of Sales & Business Development
Security Systems
www.SmithsDetection.com

SecuritySolutionsWatch.com: Thank you for joining us today, Jim.  Before discussing Smiths Detection solutions in greater detail and the upcoming ASIS 2014 please tell us about your background.

James Viscardi:  I have been with Smiths Detection for ten years and currently serve as the Vice President of Sales and Business Development, Security Systems.  I joined Smiths Detection in 2004 as a Sales Manager.  Prior to Smiths Detection I was employed at Safe Passage International.  I am a graduate of Indiana University Bloomington, where I received my BA degree, and the University of Rochester, where I earned my MBA.

SecuritySolutionsWatch.com: Smiths Detection customers seems to be facing an extremely challenging environment. Budget cuts on the hand and unprecedented security challenges on the other. Your thoughts?

James Viscardi:  While the government has cut back on its defense spending, it has not eliminated it.  Homeland security remains a high priority. There is no question that our customers who had relied on grants from the government in the past to purchase defense and security products have faced challenges in receiving funding lately, but what I believe is happening now is they are reshuffling their spending priorities so that security does not fall by the wayside.  Security and defense spending is cyclical and has historically been reactive, however I believe we are becoming more proactive in nature.  This mindset will take time to change, but spending will follow.  As terrorist plots grow more sophisticated and criminals become more elusive, we have no choice but to respond with increased security.  At Smiths Detection we strive to offer our customers value.  By providing them with a quality product that is reliable, customers can justify their purchase, because they will serve a long life with minimal maintenance.   

SecuritySolutionsWatch.com: What is the value proposition Smiths Detection brings to the table in this environment.

James Viscardi:  Smiths Detection products are designed with the customer in mind.  Our customers trust us to deliver innovated solutions that not only increase safety, but also efficiency.  By manufacturing products that solve several problems, customers find value.  Take for example the ACE-ID, our newest handheld explosives identifier.  Bomb squads face the difficult challenge of investigating and mediating high risk situations quickly while keeping themselves and the public safe.  As a result, Smiths Detection created ACE-ID, an ultra-portable, handheld device that can identify suspected explosives in less than a minute without making contact with them.  By not having to physically touch the substance to take a sample for testing, the value is potential lives saved.  By not having to carry several, heavier devices to do the same job, the value is efficiency.  And by receiving identification results in less than a minute, the value is deescalating an emergency situation faster and restoring resources to their normal state.

SecuritySolutionsWatch.com: Any new products or solutions you’d like to discuss?

James Viscardi:  I previously discussed ACE-ID which is a new product, but I also wanted to tell you about Target-ID.  This new Fourier Transform Infrared Spectroscopy (FTIR) illicit drug identifier is a handheld unit that rapidly and accurately identifies up to 2,500 narcotics, precursors and chemicals, including emerging designer drugs.  Target-ID delivers lab quality results and court admissible evidence to its customers in the field.  This product is particularly useful to corrections personnel, law enforcement, and ports and borders security.

SecuritySolutionsWatch.com: Congratulations on the “win” with Leidos which will involve 400 US airports. Please tell us more.

Mr. John M. Clerici
Principal
Tiber Creek Partners, LLC
www.tibercreekpartners.com

John Clerici is a founding Principal of Tiber Creek Partners, LLC and a Partner in the government contracts practice at McKenna Long & Aldridge LLP. For over 13 years, John has been at the forefront in the creation of the public health preparedness sector, including helping large pharmaceutical and emerging biotechnology companies develop creative approaches to access non-dilutive capital to fund the development of biotechnology for emerging disease and engineered threats. Since 1999, John has assisted over three dozen companies in obtaining nearly $4 billion in funding for research, development and procurement of public health countermeasures to the Federal government, including the majority of the awards made under Project Bioshield, the U.S. Government's initiative for preparing the Nation against a bioterrorist attack.

In 2005, John played a substantial role in the drafting and passage of the Public Readiness and Emergency Preparedness Act (PREP Act), landmark legislation that provides substantial liability protections for makers and distributors of pandemic, epidemic, and bioterrorism countermeasures. John testified as an expert in support of this legislation on four occasions before the United States Senate Appropriations Committee, HELP Committee, and Judiciary Committee.

In 2006, John was instrumental in the passage of legislation creating the Biomedical Advanced Research and Development Authority (BARDA), which builds upon and improves Project BioShield. John's expertise in the area of public health preparedness has been recognized by leading news outlets such as the Wall Street Journal, Business Week, the Associated Press, the Boston Globe, and The Hill. He has also appeared live on the Fox News Channel as a bioterrorism expert.

Prior to joining the firm, John was a judge advocate with the U.S. Air Force where, among other assignments, he advised the Air Force Research Laboratory on the procurement of technology from research institutions throughout the United States, Europe and Asia. John has appeared as a military law analyst for the Fox News Channel and MSNBC before national audiences.

John earned his Juris Doctor from the University of North Carolina at Chapel Hill. He did his undergraduate work at the Catholic University of America, graduating summa cum laude.

SecuritySolutionsWatch.com: Thank you for joining us today, John. It’s an honor to speak with the Chairperson of the upcoming 11th Emerging Infectious Diseases & Biodefense Vaccines, Therapeutics & Diagnostics Conference. Please tell us about your background and give us a brief company history of Tiber Creek Partners.

John M. Clerici:  Although I am government contracts lawyer by training, I have worked over the last decade helping biotech and pharma companies understand how to work with the US government on a substantive level to further their commercial goals.  Prior to entering private practice, I was a US Air Force Judge Advocate.  In my last assignment, I supported the Air Force’s basic and applied research mission and got my first taste of the US government’s role in furthering science.  Even prior to 9/11, I helped companies in the biotech space understand how to work with the government to address threats such as smallpox.  Following 9/11, I worked with Congress and the Administration to help incentivize private-sector participation in the biodefense and pandemic flu space.  This resulted in the passage of the Project BioShield Act of 2004 and the Pandemic and All Hazards Preparedness Act of 2006, as well as the PREP Act in 2005.  In 2010, Tiber Creek Partners spun out of our law firm, although we maintain an affiliation.

Tiber Creek Partners, LLC provides subject matter expertise, including scientific and business counseling, to biotechnology and pharmaceutical companies that seek to use non-dilutive capital from the U.S. Government, foreign governments, and non-governmental organizations as part of their commercialization objectives. We help communicate the advantages and the state of development of our clients' technology so that it resonates most effectively with funding and purchasing decision-makers. Private equity and venture capital firms are increasingly aware of the fact that legislation and policies established in the US and the EU directly influence the value of their investments.  We help these investors in identifying and analyzing global government procurement trends as well as assessing the risks associated with investing in companies that receive U.S. federal and state funding and government contracts.  Thus, for the investment community, we are able to forecast government priorities and needs – as well as identify federal and state funding available to the biodefense, pharmaceutical, vaccine, diagnostics and industrial biotechnology industries.  Our Principals includes a Ph.D. in molecular biology and a Master’s degree in statistics, in addition to Master’s in Public Policy, that are successfully used to assist clients with a wide range of projects and inquiries.  Thus, Tiber Creek Partners possesses the ability to translate the underlying science of our clients’ technologies and marry it to the appropriate government programs, requirements, priorities and funding opportunities.  In short, we assist clients in navigating the intersection between business objectives, public policy and scientific advancement.

SecuritySolutionsWatch.com:  Infectious diseases and vaccines threats are certainly a major category within biodefense threats. Before drilling down into this specific area, what is your perspective please regarding the  2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy (http://www.phe.gov/Preparedness/mcm/phemce/Documents/2012-PHEMCE-Strategy.pdf)?

John M. Clerici:  The PHEMCE Strategy provides the framework for how the US government, through the Department of Health and Human Services (HHS), carries out the Nation’s research, development and procurement of Medical Countermeasures.  While the document is top-level, it is an essential guide for organizations such the Biomedical Advanced Research and Development Authority (BARDA) to establish priorities and goals to ensure a broad based of products are available to protect us.  Since its inception in 2006, BARDA has proved itself to be an effective organization that has strong track record of bringing products from the bench through to FDA approval.  Without BARDA, we would be far less prepared for smallpox, anthrax, pandemic flu and radiation events.  They deserve a great deal of credit for what they have accomplished, as do the legislators who led the way for its creation (Sen. Richard Burr (R-NC) and Tom Harkin (D-IA) in the Senate and Rep. Mike Rogers (R-MI) and Anna Eshoo (D-CA) in the House).

While the PHEMCE Strategy is helpful, it is just a framework – the complexity between the various US government participants in the process such as the Department of Defense, the National Institutes of Health, the Centers for Disease Control and the Food and Drug Administration, requires a deep understanding of the process and ins and outs of the various programs – that is where Tiber Creek Partners comes in.

SecuritySolutionsWatch.com: As Chairperson of the upcoming 11th Emerging Infectious Diseases & Biodefense Vaccines, Therapeutics & Diagnostics Conference may we have a preview of the key issues and subjects you will be discussing?

John M. Clerici: This is our 10th year of participating in this outstanding meeting.  It will again provide a terrific overview of the current state of affairs, including what the future holds.  Areas such as the emergence of novel viruses like the H7 flu virus and antibiotic resistant bugs such as CRE highlight how things can change on a moment’s notice.  The meeting will show how our government and the industry is prepared to react.   Also, we will discuss on the newly formed Centers for Innovation and Advanced Development and Manufacturing (CIADMS) launched by BARDA that will have a positive impact upon the Nation’s ability to respond in the future.  There have been a lot of positive developments in the last year to discuss.

SecuritySolutionsWatch.com: September 11, 2001 is well behind us but what are the most significant biodefense threats we are facing today?

John M. Clerici: The same threats we have been watching for the last decade – anthrax and smallpox – remain front and center.  While we have a made tremendous progress, particularly in securing a stockpile of both anthrax and smallpox vaccines, as well as seeing the FDA approval of a new therapeutic for anthrax, there is still work to do.  Also, the nuclear threat is still very real as the recent events in North Korea tell us.  BARDA is about to make some key investments in that area that will make a meaningful impact upon our preparedness for such an event.   And of course we must continue to be vigilant and prepared for emerging threats such as the H7 flu virus and the novel coronavirus in the Mideast.

SecuritySolutionsWatch.com: Is Government funding keeping up with the need?

John M. Clerici: Government funding has certainly helped us prepare, but we have reached a critical juncture.  After September 30th of this year, there are no additional funds for HHS’ biodefense mission.  Thus, Congress must act to ensure that this effort continues uninterrupted. That includes appropriating the full $2.8 billion authorized on a bi-partisan, bi-cameral basis by Congress for Project BioShield.  I am very disappointed the President’s FY 2014 budget only funds Project BioShield at less than 10% of that amount – leadership is needed to make sure the progress we have made is not lost and I hope Congress acts responsibly to make this happen.

SecuritySolutionsWatch.com: Government can’t do it alone and a strong, vibrant, responsive private sector, in partnership with the Government, is crucial. Care to give honorable mention and a brief description of the 5 or 10 companies leading the pack?

John M. Clerici: Happy to.  BARDA’s long-time partner Sanofi is certainly an important player in this area.  In the past, they have been there for HHS in supplying flu vaccine, but now Sanofi is also stepping up to offer its FDA approved product, Leukine, for Acute Radiation Syndrome at a critical time.  Likewise, both Bavarian Nordic and Achaogen are continuing their positive relationship with BARDA, most recently with Bavarian Nordic’s extension of its BioShield contract for its next-generation smallpox vaccine, IMVAMUNE.  Emergent BioSolutions has proven to be HHS’ standard bearer by securing the Nation’s supply of FDA-approved anthrax vaccine, AVA, while also participating in BARDA’s CIADM efforts.  And Texas A&M – as a new partner to the government – also has a terrific program underway in its CIADM efforts in College Station, TX.  In the flu space, VaxInnate is building upon BARDA’s multi-phase approach with its recombinant influenza vaccine.  Also, keep an eye on Aeolus in the rad/nuc space.  All in all , BARDA has very strong partners all contributing to making us safer.

SecuritySolutionsWatch.com:  What are some your favorite resources for staying on top of all that is happening in this dynamic space?

John M. Clerici: I’m a big fan of the daily updates put out by the University of Minnesota’s CIDRAP folks.  Beyond that, FierceBiotech and other sector news sources are always great, as are the normal daily news papers, especially the Wall Street Journal, Washington Post, and LA Times.

SecuritySolutionsWatch.com:  What impact is likely to come from the attacks in Boston and the Ricin mailing to Congress?

John M. Clerici: There are several lessons to be learned from Boston.  First and foremost is not matter how well prepared we are, we remain vulnerable.  Second, while there has been proper focus on biological, chemical and nuclear preparedness, we continue to be attacked with traditional explosives – from 9/11, to Madrid, to London to Bali, to Times Square, each time, the terrorists have used explosives to maximum impact.  Through the leadership of former Senator Joe Lieberman raising awareness of this point, BARDA has proactively initiated efforts to address thermal burns and we should see procurements for skin replacement products in the near future to help mitigate impact of these events.  With regard to Ricin, while Ricin is an unlikely weapon of mass destruction, the potential for bio-weapons to appear any time and be delivered through the mail just as they were in 2001 is very real.  This is yet another reason why Congress must act to fully fund Project BioShield and ensure the tremendous work of BARDA/HHS over the last 11 years is not lost.

SecuritySolutionsWatch.com: Thanks again for joining us today, John.