adbc newsletter september/october 2011

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Head of U.S. MDA Visits Weibel in Denmark U.S. Navy to Support Advanced Biofuels Greening the Army: New Energy Strategy International Project Contracts IFC Involvement in Maritime Projects Danish Energy Delegation at RETECH 2011 The Embassy Strengthens Relationship with FDA Membership Update & Upcoming Events

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Keeping with traditions, ADBC presents its members and other stakeholders with the latest news from selected industries.

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Page 1: ADBC Newsletter September/October 2011

Head of U.S. MDA Visits Weibel in Denmark

U.S. Navy to Support Advanced Biofuels

Greening the Army: New Energy Strategy

International Project Contracts

IFC Involvement in Maritime Projects

Danish Energy Delegation at RETECH 2011

The Embassy Strengthens Relationship with FDA

Membership Update & Upcoming Events

Page 2: ADBC Newsletter September/October 2011

Front page, from left: Gitte Lillelund Bech, Minister of Defense, Denmark and Leon Panette, Secretary of Defense, U.S. Copyright, R. D. Ward, Department of Defense.

This page, from left: BG. Jørgen Jacobsen, Embassy of Denmark, Gitte Lillelund Bech, Minister of Defense, Denmark and Peter Taksøe-Jensen, Ambassador. Copyright, Embassy of Denmark

Page 3: ADBC Newsletter September/October 2011

On the 17th of August, I had the honor of welcoming the Danish Minister for Defense, Ms. Gitte Lillelund Bech,

to the Danish Embassy in Washington. The Defense Minister traveled to Washington to meet with her Ameri-

can colleague, Mr. Leon Panetta, who took office as Secretary of Defense on July 1st this year.

Not only was this visit a timely opportunity to discuss the future for Danish and American defense collabora-

tion, but indeed also a clear indication of the importance that the United States attaches to its relationship with

Denmark. On that note, I would like to emphasize the fact that Ms. Lillelund Bech was only the second Euro-

pean Defense Ministers to meet with Mr. Panetta since his July inauguration.

Considering the close ties between Denmark and the United States on defense cooperation, we have focused

this edition of the American-Danish Business Council newsletter on the possibilities that exist within the Ameri-

can defense sector for both Danish and American companies alike.

With energy consumption within the Department of Defense equal to that of Portugal and continued efforts to

improve military health services, it is fair to say that the American defense sector is more than just a market

place for military products and services in the traditional sense. Certainly, companies within, especially, the

energy and health sector should focus on the growing potential within the Department of Defense.

That brings me to the Renewable Energy Technology Conference & Exhibition (RETECH) that took place on Sep-

tember 20-22 here in Washington, with Invest in Denmark as a proud sponsor. From Denmark, a delegation of

seven companies lead by the Confederation of Danish Industry participated at RETECH, among them three

members of ADBC, Cowi, Danfoss and Vestas, respectively. In relation to RETECH, the Embassy organized a

seminar on greening the U.S. military and I had the pleasure of hosting a reception. Guests included the Ameri-

can Ambassador to Denmark, Ms. Laurie S. Fulton, and high ranking members of the Department of U.S. De-

fense.

In the time passed since our latest newsletter, a new Danish Government has been elected. As our first ever

female Prime Minister, Ms. Helle Thorning-Schmidt will lead a coalition of center-left parties, hereby marking a

political shift from the former two-term liberal Government. We look forward to welcoming Ms. Thorning-

Schmidt and the newly appointed Ministers to Washington. It is our ambition to ensure that these visits at Min-

isterial level will be used to the benefit of your businesses as members of ADBC.

On the membership side, I am pleased to welcome Mil-tek A/S as our newest member to the ADBC network.

Finally, I encourage you to look ahead to this year’s Christmas reception at the Embassy on the 6th of Decem-

ber. I hope to see as many of you as possible.

// Peter Taksøe-Jensen

Newsletter Sept/Oct 2011

Page 4: ADBC Newsletter September/October 2011

Copyright, Weibel Scientific

Page 5: ADBC Newsletter September/October 2011

Unmatched Technological Potential

When the Director of the U.S. Missile Defense Agency

(MDA) Lieutenant General Patrick J. O’Reilly’s visited

Denmark in connection with international missile de-

fense conference in early September, his busy sched-

ule allowed him to visit the company Weibel Scientific.

A company whose radars could become essential to

the European missile defense system.

It was with great pleasure that Defense Industrial Atta-

ché Lieutenant Colonel Per Lyse Rasmussen was able

to accompany the general to Weibel following the em-

bassy’s successful effort to facilitate the visit.

Lt. Gen. O’Reilly showed great interest in Weibel’s

multi-frequency Doppler radar systems.

“During my visit I got a new understanding of

the advantages of the multi-frequency Doppler

radars and I will definitely investigate the possi-

bilities for closer collaboration between Weibel

Scientific in Allerød and the MDA in USA fur-

ther. Weibel Scientific has demonstrated that its

multi-frequency Doppler radar has an un-

matched technological potential and we should

in the MDA definitely take advantage of what

has already been developed here in Denmark.”

Their unmatched technological potential is what

makes Weibel’s multi-frequency Doppler radars stand

out: According to Weibel Scientific, they are “mobile,

highly accurate and have extremely long ranges. This

means that a Weibel radar can accurately track enemy

missiles across very long distances.”

Emphasizing the potential usefulness of their radars to

the US-led effort to establish a missile defense system

in Europe, Weibel Scientific’s CEO, Peder R. Pedersen,

says: “NASA uses our technology and so does a large

part of Europe’s and U.S. defense organizations. For

us, being part of the future missile defense system is a

natural development of our multi-frequency Doppler

technology.”

Unlike many other Danish companies, Weibel Scientific

is not outsourcing, but actually doing the opposite.

Identifying this as a key reason for the company’s suc-

cess, CEO Peder R. Pedersen says that it would not be

possible to produce such advanced technology at such

a low cost if it was outsourcing parts of the production

line to the same degree that it once used to: “It is core

to our business to develop and own the most impor-

tant components ourselves, this is the only way to se-

cure our position as the technology leader – at ex-

tremely competitive prices.”

Weibel was recently awarded two contracts with the

U.S. military, worth USD 47 million combined for the

delivery of well over 2,000 radars. Additionally, Weibel

has won contracts throughout most of the world with

other customers.

For further information, please contact:

Lt. Col. Per Lyse Rasmussen, Assistant Defense, Military, Naval and

Air Attaché / [email protected]

Newsletter Sept/Oct 2011

From left: Lt. Gen. Patrick J. O’Reilly, Director MDA, Peder R. Pedersen, President and

CEO of Weibel and Lt. Col. Per Lyse Rasmussen, Assistant Defense Attaché at the

Embassy of Denmark, Washington. Copyright, Weibel Scientific.

Page 6: ADBC Newsletter September/October 2011

Copyright, Department of Navy.

Page 7: ADBC Newsletter September/October 2011

Agricultural Industry

Last month during his trip to the mid west states,

President Obama, along with Secretary of Agriculture

Tom Vilsack, took the opportunity to focus on the on-

going biofuels debate. From the American depart-

ments for Agriculture, Energy and Navy, respectively,

came an initiative to further the development of ad-

vanced biofuels. This came in the shape of an “Request

for Information (RFI)” calling on private companies to

draw up a rapports on the conditions needed to estab-

lish the production and development of advanced hy-

dro-carbon biofuel with “drop in” potential. Drop in

potential indicates that this new fuel should be able to

replace the current fossil fuels, without changes to the

machinery that is the Navy’s large quantity of aircraft.

The purpose of this RFI is for the government to estab-

lish programs that helps private companies break

through some of the barriers preventing them from

establishing an American market for advanced biofu-

els.

On the 16th of August the three departments decided

to earmark USD 510 million to promote private R&D

and infrastructure within the advanced biofuels area.

This is only legislatively possible because of “The De-

fense Production Act” from 1950, which allows the

president to intervene in private business if there is a

military impetus, even if it means direct government

investment in private initiatives.

There seems to be two main political reasons for this

federal involvement.

First off, security concerns. The U.S. is dependent on

fossil fuels from abroad and self-sufficiency in regard

to energy is a significant military concern.

Secondly, and perhaps most politically poignant, is job

creation. The high rate of unemployment is one of the

biggest concerns for both the President and Congress

alike, especially with the election coming up.

This sort of initiative would create jobs in some of

America’s rural states; states where the crisis has hit

hard and where jobs for returning army veterans are

sorely needed. The Department of Energy has already

supplied grants to states like Illinois, North Carolina

and Wisconsin, so that new biofuel plants could be

established. These plants were also supported finan-

cially by the respective states.

It is interesting to note that nowhere do environ-

mental concerns pose as a reason for the establish-

ment of this program.

Focus on Energy Independence

It seems that a long term effort for the production of

advanced biofuels with military application is due. Nei-

ther the fuel nor the production facilities to create it

are yet in existence, but federal funding is to make it

so. Navy secretary Mabus states that:

“Energy independence is critical to the military

and critical to national security. That is why the

Department of Navy is partnered in the effort to

create a biofuels market.”

It is emphasized at several points in the bioenergy dis-

cussion that the establishment of a competitive and

efficient market for bioenergy is never to contribute to

raising the already record high commodity prices, and

this condition also appears in the present RFI. How-

ever, nowhere is it stated how this is to be accom-

plished.

For further information, please contact:

Steen Steensen, Minister Counselor, Food and Agriculture /

[email protected]

Newsletter Sept/Oct 2011

Page 8: ADBC Newsletter September/October 2011

Copyright, Department of Defense.

Page 9: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

New Energy Strategy

The Department of Defense recently released a strat-

egy to meet its ambitious energy targets for the entire

US Army. To the Department this strategy is a matter

of savings, energy security and enhancing tactical secu-

rity. As one of the largest single-consumers of energy,

DoD has a potential to lead the way and be a central

driver in the energy market.

The Department of Defense, as an institution, is one of

the single largest consumers of fuel in the world. In

2010, the Department consumed nearly 5 billion gal-

lons of petroleum in military operations, costing USD

13.2 billion. This is a 255 percent increase over 1997

prices. Costs that cannot be priced are the lives lost

protecting and moving fuel across the battlefield.

In its new strategy, DoD emphasizes the importance of

assessing all risks and costs when making decisions on

its energy and equipment procurements. An example

of this is the great risks associated with transporting

fuels supplies for vehicles and generators through the

battle field in large convoys. This calls for a reduction

of the energy demand and ambitious efficiency meas-

ures in its operations, but also for exploring alternative

fuels and sources of energy in the battle field.

Growing Interest in Public-Private-Partnerships

In the report, DoD clearly signals an interest in learning

from and working with other agencies and the private

sector to diversify and secure fuel and energy supplies.

The areas mostly prone to commercial interests have

recently been summarized by the Washington-based

think tank, the Pew Charitable Trust. The report

(“From Barracks to the Battlefield: Clean Energy Inno-

vation and Americas armed forces”) highlights the fol-

lowing three areas: vehicle efficiency (aircrafts, electric

ground vehicles, ships), advanced biofuels; and energy

efficiency, renewable energy technology for buildings

and energy storage.

Danish companies in the energy industry have a lot of

relevant solutions to bring to the table. But competi-

tion is fierce: Major defence contractors like Boeing,

Lockheed Martin and Raytheon are also pursuing this

as a new and emerging market. Surely, Danish compa-

nies have the advantage of many decades of experi-

ence in developing and improving smart, energy effi-

cient solutions so they will have a lot to offer in re-

gards to the integration of improved and secure en-

ergy supplies.

With these policies, the US Defense is moving forward

in becoming the driver of alternative energy and en-

ergy efficiency within the rest of the US society. Hence,

clear advantages arise for Danish companies, ready to

be part of the US Defense solutions. These solutions

are likely to create a “spill over” effect on the rest of

the emerging U.S. energy market, likely to create a

windfall for the companies involved.

For further information, please contact:

Anders Østervang, First Secretary, [email protected]

Page 10: ADBC Newsletter September/October 2011

- A Bureacratic Headache or an Attractive Business Opportunity?

Copyright, World Bank Group.

Page 11: ADBC Newsletter September/October 2011

370 million US dollars

In the past five years, Danish companies have won a

total of 236 contracts with the World Bank for a com-

bined value of USD 370 million. Within the European

Union, this positions Denmark at a respectable 9th

place alongside countries such as Austria and the

Netherlands. Yet, among the Nordic countries, Den-

mark continues to hold a clear lead ahead of Sweden

and Finland respectively.

Thomas Djurhuus, Minister Counselor at the Danish

Embassy and head of the department for develop-

ment, is not surprised by the success of Danish compa-

nies:

“The World Bank shares several priorities with

Denmark, among other things, our continued

focus on sustainable development, health and

education. Hence, Danish companies offer a

variety of goods and services that match spe-

cific project demands as set forth by the Bank in

order to deliver and implement the best possi-

ble solutions to support the countries’ contin-

ued growth and development and to reach the

Millennium Development Goals for 2015.”

A majority of the USD 370 million stems from projects

on clean energy, delivery of medicine, especially to

African countries, and consultant services, which are

needed by the World Bank during preparation and im-

plementation of new projects.

Unmet Potential and New Initiatives

Although Public-Private Partnerships with international

organizations such as the World Bank seldom rank

high, when looking at priorities for most companies,

there are still a number of reasons why companies

could benefit from the opportunities offered by the

World Bank.

Perhaps the Bank’s best kept secret is the fact that it is

one of the few international financial institutions

where lending has remained unaffected by economic

booms and recessions. Thus, as the financial crisis con-

tinued to affect markets during 2010, the World Bank

paid nearly USD 60 billion in loans and direct financing

to projects in developing countries – to date a new

record high.

Throughout 2011, the Danish Embassy has had a num-

ber of meetings with interested companies, who wish

to learn about the possibilities of doing project work

for the World Bank. And even though, Danish compa-

nies have performed well up until now, recent infor-

mation from the Bank shows that there is still consid-

erable unmet potential for Danish companies.

For that reason, the Danish Embassy in Washington

and the American-Danish Business Council has decided

to initiate a series of new activities to promote the po-

tential for procurement at the World Bank. A closer

collaboration with the Confederation of Danish Indus-

try is intended to coordinate domestic and interna-

tional activities that focus specifically on international

project contracts with the World Bank.

For members interested in learning more about the

possibilities for procurement at the World Bank, the

American-Danish Business Council offers to assist with

further inquiries and to facilitate contact to relevant

representatives within the World Bank organization.

For further information, please contact:

Ulrik Eversbusch, Executive Secretary / [email protected]

Kasper Meldgaard Nielsen, Assistant Secretary / [email protected]

Newsletter Sept/Oct 2011

Page 12: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

World Bank Annual Meeting 2011

On 22-25 September 2011, Danish delegations from

the Ministry of Development Cooperation, the Ministry

of Finance and Denmark’s Central Bank, visited Wash-

ington, D.C. in order to participate in the Annual Meet-

ings of the World Bank and the IMF. Focus was on the

international economic outlook and on the Bank’s em-

phasis on jobs and growth, gender equality, and recent

reforms that have made the Bank more open and

transparent.

Focus on Gender Equality and Development

At the Annual Meetings the World Development Re-

port 2012 on Gender Equality and Development was

presented at a well-attended seminar, where the Dan-

ish State Secretary, Mr. Ib Petersen, had the privilege

of participating as a key-note speaker. Along with Mr.

Petersen, Ministers and senior government represen-

tatives from around the world gave their perspective

on gender and development issues relating to – among

others – women in the Middle East and North Africa in

the aftermath of the Arab Spring, Rwanda’s impressive

success on gender equality performance, specific gen-

der equality challenges in a large and heterogeneous

country like India, and lastly the view of the donor –

represented by Denmark.

The Danish delegation met throughout the weekend

with key senior staff of the World Bank as well as with

bilateral and multilateral development partners. Apart

from gender, focus was on the current global financial

crisis and its potential impact on developing countries,

as well as the critical issue of rising food prices. More-

over, important discussions where held on how to as-

sist fragile states, including how to create jobs in North

Africa and elsewhere. Finally, the Danish delegation

had the opportunity to address the humanitarian crisis

on the Horn of Africa.

For further information, please contact:

Thomas Djurhuus, Minister Counselor, [email protected]

From left: Nalia Chowdhury, CEO Grameen Solutions, Bangladesh, John Rwangombwa, Minister of Finance, Rwanda, Ib Petersen, State Secretary of Development Coor-

peration, Denmark. Copyright, World Bank Group

Page 13: ADBC Newsletter September/October 2011

Copyright, World Bank Group.

Page 14: ADBC Newsletter September/October 2011

IFC Involvement in Maritime Projects

The Danish embassy in Washington has initiated a dia-

logue with the private sector window under the World

Bank Group, the International Finance Corporation

(IFC). Leading officials from the Global Infrastructure

Department of the IFC express clear interest in team-

ing up with Danish companies within the transporta-

tion sector.

In a number of projects, the IFC has co-financed the

building of new ships. This includes projects for off

shore supply vessels, Ro-Ro vessels, handymax tankers,

and barges to be used for internal waterways.

The IFC is also looking at infrastructure projects in rela-

tion to dredging and sea ports. And earlier this year,

the IFC signed on to provide long-term project financ-

ing to develop a new container terminal within the

Port of Santos to serve Sao Paulo and surrounding ar-

eas in the Brazilian metropolis. APM Terminals is a ma-

jor shareholder in the project company.

The financing for the Sao Paulo project will be pro-

vided at a maturity necessary for the project's comple-

tion, but unavailable in the commercial market. It will

help the project company better manage the startup

risk inherent in a greenfield project. The proposed IFC

financing is expected to include an investment of up to

USD 140 million from IFC’s own account and up to USD

535 million in the form of a B Loan. IFC's involvement

will also help raise additional financing.

The Sao Paulo – APM project illustrates how the IFC

sees its role in creating venues for the private sector to

engage in projects with a development prospect. The

anticipated development impact is a strengthening of

the port sector in Brazil by increasing container han-

dling capacity, which again will help ease the existing

congestion at the Port of Santos. The accompanied

remediation of a site formerly used for waste disposal

will benefit the Santos community and avoid further

contamination of the soil and water. The Project will

also create direct and indirect employment opportuni-

ties and increase revenues for the Government of Bra-

zil through increased economic activity.

Looking to Partner with Danish Companies

For most projects in the maritime sector, the bank’s

involvement will make up around USD 30-40 million.

The process for evaluation of potential projects and

negotiating terms and conditions on average runs for a

period of 6 months, although this of course depends

on the concrete case. The IFC’s Infrastructure Depart-

ment last year signed on to about 20 projects making

up a total sum of close to USD 700 million. The bank

typically requires 20%. ownership of a project.

The IFC wishes to engage with Danish companies inter-

ested in maritime infrastructure projects in Asia, Africa

and Latin America. The Danish embassy in Washington

is in a key position to facilitate dialogues.

For further information, please contact:

Henrik Juhl Madsen, Maritime Advisor / [email protected]

Newsletter Sept/Oct 2011

Page 15: ADBC Newsletter September/October 2011

Copyright, Renewable Energy Law Blog.

Page 16: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

Danish Energy Delegation meets with key U.S.

Stakeholders and Leaders

On September 20-22, 2011 the annual Renewable En-

ergy Technology Conference & Exhibition, RETECH,

took place in Washington, D.C. RETECH 2011 gathered

government, utility, technology and finance profes-

sionals from over 50 countries, and it covered all of the

cleantech industry’s key technologies, such as wind,

solar, biomass, biofuels and waste energy.

In conjunction with RETECH, the Danish Green Partner-

ships delegation visited Washington from September

19-23. The visit was organized by the Confederation of

Danish Industry and the American Embassy in Copen-

hagen, both of which had representatives in the dele-

gation. Members of the delegation also included lead-

ing Danish companies and American-Danish Business

Council members Cowi, Danfoss, and Vestas along with

the companies ABB, Grundfos, Solardrive, TK Energy,

and Invest in the Faroes.

As part of the visit, the Danish Embassy in Washington

hosted a well-attended reception on September 20.

This gave the participating companies an opportunity

to meet and connect with relevant U.S. business lead-

ers and decision makers, such as Bob Simon, the De-

mocratic Staff Director on the Senate Energy and Natu-

ral Resources Committee, and Katherine Hammack,

Assistant Secretary of the Army for Installations, En-

ergy, & the Environment.

From left: Peter Taksøe-Jensen, Danish Ambassador to the U.S and Laurie S. Fulton,

American Ambassador to Denmark. Copyright, Embassy of Denmark.

From left: Lt. Col. Per Lyse Rasmussen, Assistant Defense Attaché, Embassy of Den-

mark, Washington, Katrine Hammack, Assistant Secretary of the Army for Installa-

tions, Energy, & the Environment, BG. Jørgen Jacobsen, Embassy of Denmark and

Kristine Kingery, Acting Director, Army Sustainability Policy. Copyright, Embassy of

Denmark.

From Left: Anne Mette Vester, Minister, Deputy Chief of Mission, Embassy of Den-

mark, Bob Simon, Democratic Staff Director on the Senate Energy and Natural Re-

sources Committee and Ulrik Eversbusch, First Secretary, Embassy. Copyright,

Embassy of Denmark.

Page 17: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

Green Partnerships Delegation Attends Energy

& Defense Seminar at the Danish Embassy in

Washington

On the occasion of the visit of the Green Partnerships

delegation in Washington, the Danish Embassy held a

seminar on energy efficiency in a defense context on

September 22. Within the U.S. Department of Defense

(DoD) there is increasing focus on the energy issue

and, in particular, on solutions that can help reduce

energy consumption. The DoD thus has a stated goal

that 25 percent of all energy consumed by 2025 must

be supplied from renewable sources. The potential for

energy savings is enormous, considering that the DoD

is America’s largest energy consumer, representing

about 80% of federal sector energy consumption.

The seminar included networking opportunities as well

as presentations by relevant representatives from the

public and private sector. The first speaker was Tarak

Shah, Special Assistant to the Assistant Secretary of

Defense for Operational Energy, who outlined the

DoD’s newly released Operational Energy Strategy and

provided insight into how the DoD aims to lower its

energy consumption.

Next, the participating Danish companies learned how

the U.S. Army, the U.S. Navy, and the General Services

Administration (GSA) plan to implement this strategy

and what role Danish energy companies may have in

this regard. Rick Ballard, Director for Energy Strategy &

Policy at the Office of the Deputy Assistant Secretary

of the Army (Energy & Sustainability), represented the

Army, while Captain (select) James Goudreau, Director

at the Navy Energy Coordination Office at the Office of

the Chief of Naval Operations, spoke on behalf of the

Navy.

Bryan Steverson, Sustainability and Green Buildings

Program Advisor at GSA, then explained how his or-

ganization implements energy efficiency, before Wes

Stith and Marston Smith from Clark Construction

Group concluded the seminar, providing first-hand ex-

perience on how a major U.S. building contractor

works with the DoD.

For further information, please contact:

Ulrik Eversbusch, Executive Secretary / [email protected]

James Goudreau, Captain (select), Director at the Navy Energy Coordination Office at the Office of the Chief of Naval Operations. Copyright, Embassy of Denmark.

Page 18: ADBC Newsletter September/October 2011

Copyright, Jacob Ehrbahn.

Page 19: ADBC Newsletter September/October 2011

Life Sciences & Healthcare Update

The U.S. and Danish regulatory policies are not only in

place to ensure safe and efficacious medical products.

They are more than ever important components of the

larger framework conditions needed to retain and bol-

ster a medical industry, capitalize on product develop-

ment, ensure economic growth and job creation.

The FDA Commissioner Margaret Hamburg has lately

intensified public outreach promoting FDA as an inno-

vation agency. This is an important component of the

current politics and advocacy between sponsors and

FDA user-fee negotiations, surely to affect revenue,

research and regulatory oversight.

In recent articles, for example in the Wall Street Jour-

nal Aug. 1st titled “America’s Innovation Agency: The

FDA, “Hamburg reiterated points made at a Senate

HELP Committee hearing. Noting FDA approved 21

new drugs so far in 2011, equaling the total for all

2010, Hamburg further wrote “we hope this signals a

larger trend in industry and at the FDA.” She added

that “when presented with high-quality applications

that are based on strong science, we work quickly and

efficiently.”

According to FDA the review stage is the fastest

and most predictable part of drug develop-

ment. Referring to FDA’s failure rate analysis,

Phase I has a 38% failure rate, Phase II has a

68% failure rate, and Phase III has a 45% failure

rate all related to scientific issues. Regarding

the FDA review there is a failure rate of 22%

related to regulatory issues.

However, Hamburg also acknowledges that medical

devices raise problems, but blamed approval delays on

poor quality applications that require FDA reviewers to

ask manufacturers for additional data not found in the

original filing.

These are important arguments for a commissioner to

be making at this time. The negotiation between FDA

and the drug and device industry over PDUFA and

MDUFA reauthorization is ongoing, and much critique

has been said about the agency’s ability to communi-

cate, meet deadlines, and basically stay on course.

The Embassy of Denmark is aware of the unease with

the agency and work closely with the International Of-

fice of FDA to facilitate international collaboration on

innovative technologies, aiming at enhancing transpar-

ency, clearer approval paths and generally enhance

communication between the agency and sponsor.

Manage Expectations and Meet Requirements

Following years of heated debate over the risk-benefit

balance for drug approvals, many arguing the FDA had

become too conservative and stifled innovation, pre-

sent scrutiny falls within approval of medical devices.

Recent statistics suggests that the average clearance

and approval process for 510(k) products and PMAs

has risen by 45 and 75 percent, respectively, since

2007 (3-6 months and 12-24 months).

This is further complicated by the user-fee negotia-

tions for medical devices and in vitro diagnostics, as

FDA is under review and evaluation of the agency’s

device approval pathway called 510(k) for lower risk

devices, which cause much industry anxiety. This fol-

lows a recent Institute of Medicine report advising the

agency to explore better ways to assess the safety and

efficacy of medical devices, potentially ending with a

sub-classification of the approval pathway.

The Embassy of Denmark follows the U.S. and Danish

medical industry close, including policy and framework

conditions. Regular meetings between the U.S. Depart-

ment of Health and Human Services (HHS), the Danish

Ministry of Health and embassy staff ensure close dia-

logue and exchange of ideas and best practices, ac-

knowledging the importance of the medical industry

ensuring new innovative solutions to health and medi-

cal problems, as well as a broader societal and eco-

nomic value creator.

U.S. an Important Science and Trade Partner for

Denmark – And Vice Versa

Danish exports to the United States increased to 35.6

billion DKK in 2010 which was an increase of 15% com-

pared with 2009, and the largest industry was the

medical device and pharmaceutical industry, contribut-

ing with 29% of the total export to the U.S. The export

of medical device and pharmaceutical products to the

US was 10.3 billion DKK in 2010, an increase of 36%

Newsletter Sept/Oct 2011

Page 20: ADBC Newsletter September/October 2011

Newsletter

compared with 2009.

The U.S. market for medical devices is the biggest in

the world, and it is a key export market for Danish

medical device companies as approximately 20% of the

Danish exports go to the U.S., exceeding 3 billion DKK

in 2010.

FDA CDRH Seminar in Copenhagen

November 15-16, 2011

To facilitate current knowledge about regulations,

health policies and agency guidance the Embassy of

Denmark has teamed up with the FDA Center for De-

vices and Radiological Health (CDRH) and a regulatory

consultancy group, Beaufort, to host a unique FDA

CDRH Seminar focusing on International Regulatory

IVD/Medical Device regulations.

The initiative follows from increased collaboration be-

tween the FDA and the Embassy of Denmark, and the

need to update Danish industry on current regulatory

requirements. This is a win-win, as the seminar aims at

facilitating sponsors submitting complete submissions,

enabling FDA to clear or approve devices within ex-

pected deadlines.

Further, U.S. FDA regulations are different to European

(EMA) regulations in so far the U.S. FDA issues legisla-

tion on both safety and efficacy, whereas the Euro-

pean medical authorities only legislate on the safety of

medical device. This constitutes an important differ-

ence for Danish medical device companies entering

the U.S., as they need to consider another dimension

of legislation.

The FDA Seminar provides four leading official

FDA CDRH staff and several advisory and indus-

try experts, leading the industry to navigate

step-by-step through the regulatory guidelines,

practical steps, and strategic considerations for

determining a product’s regulatory route to

market in the most cost and time efficient way.

Further the seminar will address key insights on new

guidelines, innovation regulations, clinical develop-

ment strategies, compliance and submission priorities,

best practices, agency policy discussions and includes

real life cases and examples followed by plenary de-

bate with the experts. Most important the seminar

offers a rare opportunity for individual face-to-face

consultations with the FDA regulators and regulatory

executives.

The FDA Seminar is supported by Medicoindustrien,

Medico Innovation, Danish-American Business Forum,

The Trade Council of Denmark, and the American-

Danish Business Council.

For information on the seminar, please contact:

Joakim Steen Mikkelsen, Life Sciences & Helathcare Attaché /

[email protected]

Sept/Oct 2011

FDA Seminar 2011

Supported By

Page 21: ADBC Newsletter September/October 2011

Following a successful visit by His Royal Highness

(H.R.H.) The Prince Consort of Denmark in June this

year, organized by American-Danish Business Council

and the Royal Danish Embassy at the company’s

American headquarters in Virgina, Mil-tek has decided

to join our expanding network as the company con-

tinue to promote their activities throughout the US.

Founder of Mil-tek, Mr. Kristian Skannerup and CEO,

Mr. Bryan Wingflied, both praised the participation by

H.R.H. The Prince Consort of Denmark, which they be-

lieved has had a considerable impact on the way they

are now perceived by their American business net-

work.

Progressive and impressive is probably the best way to

describe how Mil-tek has grown from a small start-up

company in Denmark, with a bright idea, to a global

venture with operations in 27 countries.

Mil-tek is one the world’s leading suppliers on waste

disposal solutions. The company offers a varied selec-

tion of air-operated waste balers and compacters for

recycling cardboard, plastic and paper.

American-Danish Business Council will continue to as-

sist Mil-tek in their ambitions to expand into the

American market.

American-Danish Business Council would like to welcome Mil-tek A/S as our newest member to the

organization.

Newsletter Sept/Oct 2011

This page and next: copyright, David Galen.

Page 22: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

Page 23: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

The Crown Prince Couple of Denmark

visits New York from October 20 – 24

From October 20 – 24, the Crown Prince and Crown

Princess of Denmark will present the official promo-

tional project “Creative and Healthy for Life” in New

York. The Crown Prince Couple will participate in sev-

eral activities, promoting a healthy and active lifestyle

as well as sustainability in the areas of design, architec-

ture and gastronomy.

Denmark - Frontrunner in Digital Care

HRH the Crown Prince will give a key note at the Con-

nected Health Symposium in Boston, where the top

tier of Danish Health IT competences and solutions will

be presented. As one of the leading countries in

healthcare technology, Denmark offers a wide range of

solutions within health-IT, incl. electronic health re-

cords, telemedicine, data handling, devices etc.. Stud-

ies have shown that the US healthcare system could

save more than $81 bn. annually, better utilize health-

care resources and improve the quality of patient care,

if it were to widely adopt digital healthcare solutions.

Denmark currently spends approx. 9 pct. of its annual

GDP on the national healthcare sector. The US spends

approx. 17 pct.

Visit to Ground Zero and the UN

In New York, the Crown Prince Couple will visit the Na-

tional September 11 Memorial and pay their respects

by participating in a memorial ceremony together with

the heads of state from the other Nordic coun-

tries. Furthermore, HRH the Crown Princess will meet

with the Deputy Executive Director of the United Na-

tions Population Fund, UNFPA. The Crown Princess is a

patron for the UNFPA that works to promote maternal

health and safe motherhood in more than 150 devel-

oping nations. In these developing countries, 1 out of 7

women risk maternal death, compared to 1 in 17,800

in Denmark.

Design, Architecture and Gastronomy

The renowned Danish furniture manufacturer ‘Carl

Hansen & Son’ is to officially open a new showroom in

Soho with the event “Danish Fusion” that will be at-

tended by the Danish Crown Prince Couple. At the

event, Danish interiors, jewellery, music and food will

Copyright, Steen Evald.

Page 24: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

merge into an American context. Original craftsman-

ship of classics and masterpieces will be showcased as

part of an educational program for architects and inte-

rior designers.

Good health begins with good food! Lead by René

Redzepi, head chef of the world’s best restaurant,

Noma, three Danish chefs will present the best of New

Nordic Cuisine at the Union Sq. Greenmarket in New

York. “New Nordic Cookout” focuses on local, sustain-

able ingredients, the heart of New Nordic Cuisine. The

Danish chefs will present dishes created with green-

market ingredients.

BIG opening!

TRH the Crown Prince and Princess of Denmark will

participate in the official opening of BIG New York

(Bjarke Ingels Group) on October 21. The office is es-

tablished in order to oversee the development and

upcoming construction of West 57th on Manhat-

tan and better service the growing work in North-,

South-, and Latin-America. At the event, the Danish

musical wonder duo the Raveonettes will perform.

Danish open-faced sandwiches coming to

New York

The Danish chef Adam Aamann-Christensen, owner of

the Copenhagen lunch restaurant Aamann's, is well-

reputed among food critics both nationally and inter-

nationally. This October, he is creating a piece of Co-

penhagen in Manhattan with the opening

of Aamanns/Copenhagen - the city’s first Danish res-

taurant and cultural center located in the TriBeCa Film

Center building. The opening will be attended by the

Royal Couple and Consul General Jarl Frijs-Madsen.

The restaurant will offer an authentically Danish ex-

perience with a culinary focus on ‘smørrebrød’, the

traditional Danish dish of select ingredients atop a slice

of fresh rye bread, year-round cultural events and dis-

tinct Danish design.

To find out more about the visit, go to www.royalvisitnyc.com

Copyright, BIG.

Page 25: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

Invitation and Sponsorship Opportunity The Embassy is – for the sixth year running – hosting its annual Public Diplomacy event: Creative Christmas. The

event draws 700+ of the most influential decisions makers in Washington and the US in general and is an ideal

opportunity for an unforgettable evening of networking at the Embassy of Denmark hosted by the Ambassador

in his residence.

This year the event takes place on the 6th of December from 7:00pm – 9:00pm

The Creative Christmas concept aims to present the best Denmark has to offer within the fields of business, art,

gastronomy and culture. Over the past years we have been able to strengthen the Creative Christmas brand to

such an extent that the event is mentioned in national and Danish media.

Companies wishing to sponsor the Creative Christmas and join an ever growing group of partners may contact

Pernille Florin Elbech at [email protected] or at 202 320 0098 to discuss the sponsorship package or a personalized

package for your company. For sponsoring companies this is an perfect occasion to invite your own valuable

customers to the event.

This year’s standard sponsorship package looks as follows:

Sponsor Fee: USD 3,000

4 invitations to the event (2 guests pr. invitation)

Company name on Embassy website

Company name of electronic invitation

Company name in printed program

Company name in electronic newsletter to American Danish Business Council

Copyright, Embassy of Denmark.

Page 26: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

The annual board meeting of the American-Danish Business Council will take place on December 6

2011 at the Embassy of Denmark in Washington, D.C.

All of our Sponsoring members are automatically members of the board as part of their membership and are

thus invited to the meeting for a discussion on the year that has past and the opportunities to come.

A separate invitation will be sent out with specified information and a proposed agenda.

Sponsoring members:

Lockheed Martin Scandinavian Airlines

Bavarian Nordic Torm

Vestas Novo Nordisk

Biogen Idec Raytheon

Novozymes Weibel Scientific

Mil-tek GN

Rupari Terma

Leo Pharma Pratt & Whitney

Systematic

In conjunction with the ADBC board meeting, you are cordially invited to participate in the Embassy’s 6th annual

Christmas event – Creative Christmas – which is expected to gather more than 700 of the most influential deci-

sions makers in Washington and the US in general.

Page 27: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

Houston is the headquarter for newly formed DANISH

AMERICAN CHAMBER OF COMMERCE SOUTHWEST.

The newly formed Chamber of Commerce with the

mission of promoting trade and good-will between

Denmark and U.S. will operate primarily in the South-

western part of the USA .

The Chamber will be a resource and a forum for ex-

change of information and networking for companies

doing business in both Denmark and the US. Houston

is home to a number of companies that are either sub-

sidiaries of large Danish companies or independent

companies with Danish roots. Among the founding

members of the Danish American Chamber Southwest

are such well known names as:

Maersk Oil and Gas, Grundfos, Haldor Topsoe, Hempel

USA, Vestas Technologies, Scandic Foods and Nordana

Line along with Ocean Projects and Danish Inspira-

tions.

The founding Board of Directors are: Anna Thomsen

Holliday, Founding Chair, Robin Ann Johansen, Found-

ing Vice Chair, Founding Secretary Thomas Damsgaard

and Founding Treasurer Sten Svendsen.

Danish Ambassador to join first official event

The first official event of the Danish American Com-

merce Southwest will be a luncheon meeting with Dan-

ish Ambassador to the United States of America, Peter

Taksoe-Jensen as keynote speaker. The luncheon will

be held on Tuesday, October 18th at the Hilton Ameri-

cas Hotel, Skyline Ballroom, 1600 Lamar Street.

For more information including membership, please visit our

website: www.daccsw.org

Copyright, Temporary Housing Blog.

Page 28: ADBC Newsletter September/October 2011

Newsletter Sept/Oct 2011

October 10-12: Association of the United States Army Conference

and Exhibition (AUSA) In connection with the annual Association of the United States

Army Conference and Exhibition (AUSA) during 10-12 October

2011 we will have the pleasure of the company of Major

General Agner Rokos, Commander Army Operational Command,

Denmark. The general will be spending time on the exhibit floor

at AUSA. For the first time at AUSA, Danish companies will

participate with a joint Danish pavilion.

October 18: The Ambassador visits new Chamber of

Commerce in Houston

October 18: Bjarke Ingels from BIG speaks at National Building

Museum in Washington

October 20-24: Royal visit New York TRH the Crown Prince and Crown Princess of Denmark Present

Danish Healthcare, Architecture and Gastronomy in New York.

October 27: Concert at the Danish Embassy The band Suspicious Package will perform at the Danish

embassy. Besides great music, this event will also feature Danish

cooking by the renowned chef, Trine Hahnemann and

sponsored by Danish Crown.

October 27: Upcoming meeting in the maritime network Members of the maritime network will meet at the embassy to

discuss issues of common interest, including a presentation of

the economic outlook and a session on relevant shipping policy

issues.

November 15-16: FDA seminar in Copenhagen

December 6: Board meeting ADBC

December 6: Creative Christmas 700+ of the most influential decisions makers in Washington and

the US in general are expected to participate at the Embassy of

Denmark for our annual Christmas event.

Page 29: ADBC Newsletter September/October 2011

Sponsoring Members

Corporate Members

Associate Members

Beaufort Advisors

AmCham Denmark

Danish-American Chamber of Commerce, Midtwest

Danish-American Chamber of Commerce, Northern Carolina

Danish-American Chamber of Commerce, Southern Carolina-

Northwest Danish Foundation

COWI

Danish-American Business Forum

Danish-American Chamber of Commerce, New York

Danish-American Chamber of Commerce, South East USA

Danish Information Systems Professionals

Page 30: ADBC Newsletter September/October 2011

The American-Danish Business Council promotes Danish companies in the US, and American companies in Denmark. It

is engaged in a range of activities aiming at obtaining an even more thriving American-Danish market place with in-

creased trade and investment. The Council has 40 Danish and American companies and organizations as members.

A number of sector-specific committees are being formed, including on Health & Life Science, Defense, Finance, Mari-

time, Food & Agriculture and Energy. By using the Danish Embassy's contacts and access to American as well as to

Danish Authorities, the committees work to enhance business opportunities and to create network synergies and cor-

poration.

To read about membership benefits, please visit our homepage, www.usadk.org, or contact Kasper Meldgaard Nielsen, [email protected]