FTC Commissioner J. Thomas Rosch will speak about the three main areas of antitrust concern for pharma manufacturers, at ACI’s 5th Annual In-House Counsel Forum on Pharmaceutical Antitrust, to take place at the Helmsley Park Lane Hotel in New York City on February 17th and 18th, 2010.

The three areas he will cover are:

-    Reverse settlement payments
-    Authorized genetics
-    Pharmaceutical mergers

In past months, a consensus position by DOJ and the FTC has been noticed on antitrust matters.  In fact, DOJ took back its previous position on reverse settlement agreements, and currently, both organizations consider these agreements anticompetitive.  There is pending legislation that could define, by itself, a prohibition on these agreements if several circumstances are not present.  This shows that the Congress is supporting the antitrust efforts of both organizations in the pharma industry.  Moreover, the European Commission’s Directorate General’s Pharmaceutical Sector Inquiry report adds a more global scope to this dense field.

The Director of the FTC’s Bureau of Competition, Richard Feinstein, along with FTC attorneys Markus Meier, Assistant Director of the Health Care Division, and Michael Moiseyev, Assistant Director of the Mergers l Division, will speak at this event, which is recognized as the place where the leading antitrust authorities meet every year to discuss their upcoming enforcement plans.  Also participating will be Philip Weiser, Deputy Assistant Attorney General from the DOJ’s Antitrust Division, and Harald Mische, member of the EC’s DG Competition’s Pharmaceutical Task Force.

Sunsieray McCall, ACI’s Senior Conference Producer, recalls that the attendance of antitrust enforcers from both the U.S. and EU will offer this conference’s attendees a deep understanding of antitrust priorities under a new global enforcement system.

If you want to know more about ACI’s 5th Annual In-House Counsel Forum on Pharmaceutical Antitrust, contact your life sciences consulting firm, visit American Conference/ PharmaAntitrust, or contact Sunsieray McCall directly at s.mccall@americanconference.com or at the phone number 212-352-3220, ext. 498.

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The impact of influenza can only be reduced through a vaccine.  Today, the U.S. has only approved the use of inactivated influenza virus vaccines, and to be effective, these have to contain an H1N1, and H3N2, and a B virus component.  In the past, at least one of these components had to be modified due to antigenic drift of the strain circulating the human population.

Vaccines are prepared by growing viral strains in embryonated eggs, and then the virus is purified and turned noninfectious through chemical inactivation.  The influenza vaccines available today are effective depending on the antigenic ‘match’ of the circulating viruses with the strains used for vaccination, the person’s age, and his or her immune status.

Here’s what is expected in the future; ask your pharmaceutical consultant for further details:

1.    Cold-adapted influenza virus vaccine
This type of live vaccine has been used successfully in Russia to protect millions of children.  The U.S. has been trying to develop such a vaccine for over 20 years, but the license has not been approved yet.

There are several important advantages here:

-    Live-virus vaccines can be administered through nasal spray, which is easier and less costly than the intramuscular option.

-    These can induce local neutralizing immunity and cell mediated immune responses, which could result in a longer-lasting and better cross-protective immunity.

-    Overall protection may improve for certain age groups, for example, kids 6 months to 9 years of age, with evidence of a massive reduction in secondary bacterial infections causing otitis media.

The more live influenza virus vaccines are used, the more benefits, risks, and economic consequences of this approach will be known.

2.    Genetically engineered live influenza virus vaccines
The introduction of techniques to engineer site-specific changes in the genomes of negative-strand RNA viruses has allowed the consideration of new vaccine approaches.  It is possible now to create strains with unique properties that lead to reduction.

3.    Live influenza virus vaccine candidates expressing altered NS1 genes
Now it is possible to rescue influenza virus vaccine candidates from cells transfected with plasmids.  This allows for the engineering of deletions in genomes of influenza viruses for better stability.

4.    Use of replication-defective influenza viruses as vaccine candidates
This is a promising approach, the construction of virus particles that undergo only a single cycle of replication.  These induce a protective antibody response and stimulate a strong cell-mediated immune response without allowing the replication of infectious virus.

5.    DNA vaccination
This involves the administration of plasmid DNA encoding one or more of the influenza virus proteins.  Studies have been limited to animal samples with very promising results; however, this type of vaccine may be better for diseases like AIDS.  Further studies may present a universal approach to generating protective humoral and cell-mediated responses to different foreign antigens, resulting in the development of effective vaccines.

6.    New adjuvant approaches
Current influenza virus vaccines are administered by intramuscular injection.  To improve their immunogenicity, liposome-like preparations have been developed, which contain cholesterol and viral particles that are very effective in mice when delivered subcutaneously or in intranasal form.  More tests are needed to confirm how it will work in humans.

7.    Universal vaccine
This has been the focus of increased attention due to the current necessity to develop a new vaccine every year given the influenza virus’ continuous antigenic change.  Even though some virus components are more conserved than others, a good approach to a universal vaccine based on these conserved elements is still pending, because these are minor antigens, and thus, are less immunogenic and less likely to create a protective response.

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A group of top researchers is focusing on understanding how an embryo’s developing pancreas recognize which cells produce insulin and which ones have other functions.  This understanding is crucial in the use of stem cells, developed into beta cells that produce insulin, to treat type-1 diabetes.

Today, Lund University scientists have new discoveries to announce in this regard, and they will do it in the journal Cell, which is one of the top biomedical journals.

Diabetes researcher Henrik Semb’s team has been analyzing two vital scientific questions:

1.    How are tubes formed in organs where they fulfill vital functions?  For example, the tubes that filter urine in the kidneys, the tubes that carry blood in the blood vessels, and the tubes that carry air in the lungs.

2.    How is the differentiation of cells, the development of immature cells into various mature ones, related to the formation of tubes?

These two processes are known to happen simultaneously in an embryo, but it was not known if they were related, until now.  Henrik Semb’s research team can explain step by step how certain cells in the developing pancreas form miniature cavities that join together to create a system of tubes, and how cells that end up in different parts of this tube system are exposed to different environments, thus they develop in separate ways.  Some produce insulin, others, enzymes that digest food in the intestines, and yet others take part in the tube’s construction.

This research team also discovered that there is a critical gene related to these processes, it is called Cdc42.  They found this out through knock-out mice that had this gene removed.  The lack of Cdc42 blocks the formation of tubes in the pancreas, thus, the dominant environment is like the one around enzyme-producing cells instead of the most important insulin-producing beta cells one.

These discoveries provide knowledge that is critical for the future of medical treatments.  A new door has opened for the research on stem cell treatment for type-1 diabetes, given the new understanding of how immature cells grow into beta cells.  This knowledge will also be valuable for diseases where cyst formation in the tubes produces organ failure, for example, in kidneys and liver.

Every important article published in Cell requires committed and lengthy research, and this is exactly what the Lund scientists have done.  They have devoted years to studying tube formation, cell differentiation, and the role of Cdc42 in the mentioned processes.

Their secret resides in the team itself, formed by amazing scientists capable of keeping their passion alive and energy focused even when they were tempted to publish several partial findings in other journals.  They definitely knew better.

If you wish to know more about stem cell research and their future medical potential, talk to your pharmaceutical consultants; they should be on top of the latest developments and market opportunities.

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It has been proven through an FDA-approved clinical trial that treating heart attack patients with adult stem cells is safe and seems to repair damaged heart tissue.  The results of this study, which was conducted by Joshua M. Hare, M.D. and director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine, and sponsored by Osiris Therapeutics of Columbia, Maryland, were published in the December 8th issue of the Journal of the American College of Cardiology.

The first phase of the trial intended to prove the safety and efficacy of injecting a formulation of adult mesenchymal stem cells, Prochymal, in patients right after they suffered a heart attack, to diminish the damage to the heart muscle.  The sample consisted of 53 patients who had suffered a heart attack between one to ten days before.  They were randomized to one of three doses of stem cells, each dose compared with placebo.  After six months, researchers analyzed the serious side effects that were related to the treatment and used echocardiography to measure the efficacy.

The study discovered that the patients treated with stem cells presented fewer side effects like cardiac arrhythmias and showed important improvements in their heart, lung, and global functions.  According to Dr. Hare, the echocardiography showed better heart function, especially in patients with lots of cardiac damage.  Up to date, damaged cardiac tissue cannot be repaired through any known scientific method, and close to a million United States’ citizens suffer heart attacks each year.

These results will put to rest some of the discussions in regards to clinical stem cell research for heart disease.  Although many think that it is too soon to test stem cells in patients, this study has proven the value of exact and controlled clinical trials. In doing so, it also establishes the basis for the development of novel cell heart therapies.

Many believe that this trial acts as a key point of reference for the advancement of these types of approaches. There are several advantages to mesenchymal stem cells as cell-based therapy; among these are:

-    Can be taken from donors that are genetically different
-    Are easy to prepare
-    Tend to gather around injured spots

It is certainly exciting to imagine what is ahead.  Each study will provide new information, new teachings, and new possibilities for the use of adult stem cell therapies to treat cardiac patients.

Contact your pharmaceutical consultancy firm for more information on stem cell research and the promising future it presents.

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The vaccine manufacturer MedImmune announced at the end of last year that the H1N1 vaccine had lost effectiveness since it first appeared.  Nevertheless, according to U.S. officials, this does not imply a safety issue.

The mentioned manufacturer withdrew thirteen lots of the vaccine against the H1N1 influenza out of its own free will because these had lost part of its effectiveness since they were first manufactured.

In response, Norman Baylor, the director of the Office of Vaccines Research and Review at the Food and Drug Administration, stated that this situation does not create a safety issue because every lot had passed the pre-release testing required to ensure safety, purity, and effectiveness.  He maintained that the loss of effectiveness was a slight one.

The thirteen lots that were withdrawn were a part of 4.7 million doses of the intranasal vaccine, whose origin is a live weakened virus; however, officials think that the majority of these were administered during October and November of 2009, when the vaccine was still performing at its maximum effectiveness.  At the moment of the announcement, the manufacturer still had in its possession 3000 doses affected by the withdrawal, but it is not clear how many are scattered around the country.

This is not the first time lots of the H1N1 vaccine have been withdrawn.  Some weeks after MedImmune’s incident, Sanofi-Aventis withdrew 800,000 doses of the vaccine for children for the same reason; their effectiveness had decreased.

Baylor accepted that this pattern is not normal, having two withdrawals of a seasonal flu vaccine in the same season; however he explained that these are biologicals created from living organisms and thus, it is normal for the vaccine to lose effectiveness over time.

It is for this reason that the vaccine has an authorized shelf life of 18 weeks and that the FDA demands that companies measure its effectiveness regularly.  MedImmune tests its products on a weekly basis, and it was on one of these occasions that the loss of effectiveness was accounted for.

Baylor noted that the withdrawal was a measure of precaution.  He added that those who received vaccines from these lots are fully protected and don’t need to get another shot.  According to him, there is no negative impact whatsoever on the vaccine’s safety and effectiveness.

Contact your pharmaceutical consulting firm, because it should have a lot to say on this respect and lots of important recommendations.

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Seven of the leading consumer groups in the United States, the American Antitrust Institute, Consumers Union, Families USA, The National Legislative Association on Prescription Drug Prices, Consumer Federation of America, US PIRG and Community Catalyst wrote to Speaker Pelosi and Majority Leader Reid asking Congress to include a per se ban on reverse payments in the revised healthcare reform legislation.
Here is the official press release from AAI

AAI, CONSUMER GROUPS ENCOURAGE CONGRESS TO BAN PATENT SETTLEMENTS AND RESTORE COMPETITION IN MARKET FOR GENERIC DRUGS

FOR IMMEDIATE RELEASE

CONTACT:    Bert Foer, 202-276-6002
bfoer@antitrustinstitute.org

(WASHINGTON, DC)  The American Antitrust Institute (AAI), along with Consumers Union, Families USA, The National Legislative Association on Prescription Drug Prices, Consumer Federation of America, US PIRG and Community Catalyst, sent a letter to Speaker Pelosi and Majority Leader Reid today urging Congress to include a ban on exclusion payments in pharmaceutical patent settlements in the final health reform legislation that both the House and Senate will consider soon.

During the past decade, some branded and generic pharmaceutical firms have entered into settlements in which the branded firm pays the generic firm not to enter the market.  These arrangements, known as exclusion payments or pay-for-delay settlements, can significantly impede the entry of generic drugs.  The Federal Trade Commission estimates that these settlements cost consumers $3.5 billion each year.  Efforts to stop these exclusion payments through antitrust litigation have had mixed results, making legislative action necessary to restore marketplace competition to benefit consumers.

“Attacking the exclusion payment problem is a critical element of health care reform,” said Albert Foer, AAI president “Because of these exclusion payments, consumers have paid billions more for drugs, and have been denied the competition and low prices they deserve.”

The letter was delivered as Congressional leadership prepares to finalize a bill for consideration by both the Senate and the House.  The question of patent settlements, in particular, has gained some attention as of late by those unsatisfied with the lack of a ban in the Senate health care bill.  Just a few weeks ago, Senators Kohl, Klobuchar, Shaheen, Franken, Dorgan, Johnson, Brown, Feingold and Begich wrote to Senate leadership with the same message:  exclusion payments in pharmaceutical patent settlements should be banned.

Today’s letter encourages Congress to go a step farther than simply banning the exclusion payments, calling on lawmakers to address the root cause of the problem:  the 180-day exclusivity period awarded to the first-to-file generic manufacturer.  This highly profitable period serves as the main incentive for a branded manufacturer to enter into an arrangement with the generic challenger.  By allowing other generic manufacturers to share in this 180-day exclusivity period when they successfully challenge a patent, Congress has the opportunity to encourage more robust competition in the market for generic drugs.
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About the American Antitrust Institute
The American Antitrust Institute is an independent non-profit education, research and advocacy organization. Since its formation in 1998, the AAI’s mission has been to increase the role of competition, assure that competition works in the interests of consumers, and challenge abuses of concentrated economic power in the American and world economy. To learn more about the AAI, please visit www.antitrustinstitute.org

Contact Information

2919 Ellicott Street, NW
Washington, DC 20008
P: 202-276-6002
F: 202-966-8711
www.antitrustinstitute.org

Researchers from the Hebrew University of Jerusalem have developed a new stem cell technology to aid in the better and faster healing of complicated bone fractures.

This technology, which involves the isolation of stem cells from the bone marrow, has been already used successfully in the treatment of severe fractures in seven patients at the Hadassah University Hospital in Jerusalem.

Up to today, the standard treatment in clinical orthopedics for serious bone loss has encompassed basically two options: amputation or long periods of disability.  Equally, prosthetic implants have proven inefficient in the long term.  When there is too much loss of bone, the fracture may not heal, and this is the case of more than a million people per year, just in the United States.

In the last years, there have been promising advances for biological therapy to treat complicated fractures and skeleton disorders, specifically by using mesenchymal or multipotent stem cells (MSC’s), which can differentiate between various cell types.  These cells are unique adult stem cells that can be rapidly isolated from various places in the body, mainly bone marrow and fat tissues, and used to repair different injured tissues like bone, cartilage, tendons, intervertebral discs, and even heart muscle.

The way in which MSC isolation is normally conducted is lengthy, expensive, and also harmful to the healing quality of the cells, because it requires long periods of growth inside incubators.  It was urgent to find a way that would allow for the immediate use of stem cells; the regenerative medicine field was begging for one, and the Hebrew University heard them.

The technology this group developed is called immuno-isolation.  Basically, MSC’s are sorted out in a bone marrow sample by using a specific antibody.  It was proven that this technique made it possible to immediately use the cells to create new bone tissue in lab animals.  After this discovery, several scientists from different interested parties joined forces to establish a clinical-grade protocol for the use of immuno-isolated MSC’s.

The head of orthopedics at Hadassah University Hospital, the Good Manufacturing Practice facility at Hadassah, and the Gazit group at the Faculty of Dental Medicine, conducted a clinical trial in order to establish the foundation for the use of immuno-isolated MSC’s in orthopedic surgery.

Seven patients have benefited so far from the treatment of combining their own immuno-isolated MSC’s and blood products.  The procedure lasted a few hours and didn’t require the growing of cells in a lab.

This success is expected to touch other skeleton injuries, like degenerated intervertebral disks and torn tendons.  It is expected that this treatment will help tackle morbidity in patients with skeletal fractures and diseases, and will help re-establish function and quality of life for many people.

In hopes of making this technology available to many more, the university has licensed the immuno-isolation technology to TheraCell Inc. in California since July 2009.  This organization will develop and commercialize this technology thoroughly for advanced regenerative medical purposes, like spinal fusion.

The mission of life sciences consulting firms is to help pharmaceutical companies land opportunities like this one, where they are able to change lives for the better, showing care and respect for patients in need, while staying at the head of innovation.

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A leader in vaccine design, development, and distribution, Inovio Biomedical Corporation, informed that its SynCon™ Chikungunya virus DNA vaccine generated protective neutralizing antibody responses in a monkey model.

The Chikungunya virus is a new alpha virus carried by mosquitoes that originated in tropical Africa and Asia.  It has been known to have an infection rate of up to 45%.  Although not life threatening, this virus causes acute human morbidity, presenting serious fever and weakening joint pain, and it could take over a year to cure.

It has been discovered that different mosquitoes normally found in developed countries, including Europe and the United States, can transmit the Chikungunya virus, making it a threat for people in other geographies outside its territories of origin.  The virus is already prevalent in several world regions and clearly has epidemic potential.

Currently, there are no vaccines in the market to treat this virus.  The truth is that very little is known about the disease, including the mechanism of viral clearance based on immunity and why it causes clinical symptoms.  Thinking about the potential the Chikungunya virus has for spreading disease globally, it is crucial to understand its pathogenic mechanism and to develop effective treatment alternatives.

Inovio used its SynCon™ approach to create a Chikungunya virus DNA vaccine that is delivered as a single DNA plasmid construct including harmonious sequences of key surfaces antigens.  Its design is based on the alignment of various primary sequences of key surface antigens and on the selection of the most common amino acid or base pair at each site.

In the study with money models, the entirety of the sample that was vaccinated developed protective neutralizing antibody responses against the original virus, demonstrating the vaccine’s effectiveness in a preclinical model.  This data presents solid evidence highlighting the likelihood of  nearterm future human clinical progress.

Inovio’s new SynCon™ technology allows them to design DNA-based vaccines that can protect against known or unknown pathogen strains.  It can synthetically define antigens and gene sequences that are common between different viral sub types or families of diseases like HIV, HCV, HPV, and influenza.

This company recently disclosed provisional information regarding a Phase I therapeutic HPV/cervical cancer vaccine test that showed important and strong immune responses from T-cells and antibodies, highlighting the possible broad use of its DNA vaccine technology platform and application to various diseases, among which is the Chikungunya virus.

This is a clear example of how pharma companies and pharmaceutical consultants who are on top of things win the race on innovation and market trust.

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Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A’s, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidances, workshop announcements, etc. The following information is being sent to you via the ListServ

1. New Guidance. The Food and Drug Administration announced in a Federal Notice of December 23, 2009, the availability of a guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 5: Disintegration Test General Chapter.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Disintegration Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between thelocal regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region.

http://edocket.access.gpo.gov/2009/pdf/E9-30441.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073427.pdf

2. Amendment of the Informed Consent Regulations. The Food and Drug Administration (FDA) issued a proposed rule in the Federal Register of December 29, 2009, that, if finalized,would amend the informed consent regulations to require that the informed consent documents and processes for applicable drug, biologic, and device clinical investigations include a statement that clinical trial information for such clinical investigations has been or will be submitted to the National Institutes of Health/National Library of Medicine (NIH/NLM) for inclusion in the clinical trial registry databank. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that FDA update its informed consent regulations to require that the informed consent documents and processes for certain clinical investigations include a statement that clinical trial information for such investigations has been or will be submitted for inclusion in the clinical trial registry databank. http://edocket.access.gpo.gov/2009/pdf/E9-30751.pdf

3. New Guidance. The Food and Drug Administration (FDA) announced in the Federal Register of December 17, 2009, the availability of a draft guidance entitled ‘‘Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1).’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides recommendations on nonclinical studies to support the safety of clinical trials and marketing applications for biotechnology-derived pharmaceuticals. http://edocket.access.gpo.gov/2009/pdf/E9-29991.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf

4. FDA Clinical Trial Requirements, Regulations, Compliance and GCP. The Food and Drug Administration (FDA) Florida District, in cosponsorship with The Society of Clinical Research Associates, Inc. (SoCRA), is announced in a Federal Register notice of December 17, 2009, a workshop entitled ‘‘FDA Clinical Trial Requirements, Regulations, Compliance and GCP.’’ This 2-day public workshop is intended to provide information about FDA clinical trial requirements to the regulated industry. The public workshop will be held on Wednesday, March 3, 2010, from 8 a.m. to 5 p.m., and Thursday, March 4, 2010, from 8 a.m. to 4:35 p.m. The public workshop will be held at The Wyndham Orlando Resort, 8001 International Dr., Orlando,FL 32819. http://edocket.access.gpo.gov/2009/pdf/E9-30017.pdf

5. Newly Added Guidance Documents. This website provides newly added guidance documents issued within the last three months. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

6. Orphan Drug Workshops. The FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases. Orphan drugs are either drug or biologic products used to treat conditions affecting fewer than 200,000 people in the United States. Orphan drugs may be already-approved or experimental drugs. The workshops will be held Feb. 25-26, 2010, in Claremont, Calif., and Aug. 3-4, 2010, in Minneapolis. At the workshops, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop. To help participants develop strong applications, FDA staff will provide one-on-one regulatory help. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm195343.htm

7. FDA/DIA 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making, February 2-4, 2010, 5701 Marinelli Road, Bethesda, MD. Meeting Information and registration/

8. DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010, Bethesda, MD. Meeting information and registration

Ron Wilson Director of Small Business Assistance    ronald.wilson@fda.hhs.gov 301-796-3177