With the announcement today of the pending retirement of Mickey Flynn, as President of  PA Bio the region is about to experience a significant change . Mickey has been a great advocate of the PA region’s biotechnology industry and Smart Consulting Group’s mission and we would like to acknowledge his contributions.

Congratulations and thank you on both counts and for your continued friendship and encouragement.

Pennsylvania Bio news release

MICKEY FLYNN TO STEP DOWN AS PRESIDENT OF PENNSYLVANIA BIO MID-YEAR, BOARD NAMES CHRIS MOLINEAUX HIS SUCCESSOR

Malvern, PA, February 2, 2010—The Board of Directors of Pennsylvania Bio announced today that Dennis M. “Mickey” Flynn will step down as president of the association on June 30, 2010, and named Christopher Molineaux, senior vice president of Pennsylvania Bio, as Flynn’s successor.

To facilitate a seamless leadership transition, Flynn will continue to serve the association for the remainder of 2010 as vice chairman of the Board of Directors and a member of the Executive Committee.  Molineaux will continue in his role as senior vice president for membership services and begin over the next five months to transition into broader operational responsibilities of the association.

Flynn is a founder of Pennsylvania Bio, the trade association for the bioscience industry in Pennsylvania, and served as a Board member and chairman before assuming the role of president of the association in November 2005. “Mickey Flynn has been a tireless advocate for our industry and an outstanding president of our association.  For more than 30 years, Mickey has been a leader in our community and most recently succeeded in making Pennsylvania Bio one of the largest and most effective trade associations in the country for our industry,” said Steven Nichtberger, M.D., Pennsylvania Bio chairman and president and CEO of Tengion, Inc.

Flynn has grown the organization to more than 375 members in his four years as president of the association, making Pennsylvania Bio one of the largest state-level trade associations for the bioscience industry in America.

“Through growth in programs and group purchasing opportunities for members, as well as extraordinary advocacy efforts in Harrisburg and Washington, DC, Mickey Flynn’s leadership at Pennsylvania Bio has had a tremendous impact on bioscience companies in the Commonwealth of Pennsylvania,” said Julie McHugh, vice chair of Pennsylvania Bio’s Board.  “We are fortunate to have someone of Chris Molineaux’s caliber and experience succeed Mickey as president of Pennsylvania Bio and are confident that he is the right person to lead our association to an even greater level of success in the new decade.”

Molineaux joined Pennsylvania Bio in September 2009 from Johnson & Johnson, where he most recently served as worldwide vice president of pharmaceutical communication & public affairs.  He began his Johnson & Johnson career as vice president of corporate communications at Centocor in Malvern. Molineaux brings to Pennsylvania Bio more than 18 years of experience in health care policy and advocacy, including industry and payor community expertise. He served as vice president of public affairs at the Pharmaceutical Research and Manufacturers Association (PhRMA), and for seven years prior to this, he worked with the Blue Cross and Blue Shield Association in roles of increasing responsibility in communications and policy. Molineaux also worked as a public affairs executive for both the federal Departments of Health and Human Services (HHS) and Agriculture.

“Throughout Pennsylvania, the biosciences are a cornerstone of our commonwealth’s economic future. The industry is responsible for more than 77,000 direct jobs and an economic impact in the tens of billions of dollars, making Pennsylvania a national leader in the development and sales of innovative products to patients in need.  I am proud to support the continued growth of the biosciences in our state and will work to ensure that Pennsylvania Bio continues to provide world-class services and advocacy to assist in the success of our member companies,” said Molineaux. “I look forward to expanding on Mickey’s wonderful legacy.”

“I am honored to have spent my career in an industry that is dedicated to improving the lives of people,” said Mickey Flynn.  “Serving as president of Pennsylvania Bio has in many ways been a wonderful capstone to my time in this industry. I am particularly proud to have worked with so many bioscience companies and dedicated professionals focused on providing new therapies for patients who suffer with health issues for which there is no help, but fortunately through medical advancements made by many of our member companies, there is now hope. Chris Molineaux has the experience and vision necessary to be an outstanding president of Pennsylvania Bio, and I look forward to working with him to ensure a successful transition.”

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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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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Laboratory personnel are exposed to a high risk of injury due to repetitive movements during normal lab procedures like pipetting, microscope use, operating microtomes, using cell counters and video display terminals.  This type of injury develops with time and it happens when the muscles and joints are stressed, tendons are swollen, nerves are pinched, and blood flow is restricted.  Another health risk for lab workers comes with standing and working in uncomfortable positions in lab hoods and biological safety cabinets.

Here we show you several ways to control some of these risk factors and to ensure your personnel is working in a comfortable, productive, and safe lab environment.

1.    Pipetting
This task involves various ergonomic strains like thumb force, repetitive movements, and awkward postures of the wrists, arms, and shoulders.  In order to alleviate these hazards follow these tips:

-    Use pipettes that fit comfortably in the user’s hand and that have triggers that need less force to be activated. Also, aspirate with the pointer finger and dispense with the thumb.

-    Use an electric pipette with mixing function to mix and aliquot, and use multichannel pipettors for big aliquot jobs.

-    Use shorter pipettes that decrease hand elevation.

-    Use low profile waste containers for used tips.

-    Take 3-5 minute breaks for every 20-30 minutes of pipetting, exercise and stretch your hands and arms while resting.

-    Clean pipetters regularly.

-    Adjust the workstation so that the employee can work with arms close to the body.

-    Rotate pipetting with other lab tasks and people.

-    Use thin wall pipette tips that fit correctly and eject easily, and use minimal force when applying them.

-    Maintain samples and instruments within easy reach.

-    Use an adjustable chair when sitting at a lab bench.

-    Use anti-fatigue mats when you need to stand for an extended period while pipetting.

2.    Computer workstation
Some researchers spend long hours entering data with a keyboard and mouse over a very high bench, making the person elevate the arms excessively.  This is what you need to do:

-    Install adjustable keyboard trays under the benches, and monitors at viewing distance between 18 and 30″ and with top of screen at eye level.

-    Locate computers away from doors, entrances, and passageways.

-    Use adjustable seating.

-    Hold documents adjacent to and in the same plane as the screen.

-    Install foot rests.

-    Offer different keyboards and mouse attachments for personnel with muscle problems.

-    Order 2-5 minute breaks for every 20-30 minutes of computer use.

-    Do not go from keyboarding to pipetting or vice versa without resting at least 15 minutes.

3.    Microscopy
Microscopy workstations must be adjustable to fit every size of person:

-    Don’t use a microscope for more than 5 hours per day.

-    Locate the microscope on the edge of the table to achieve an upright position.

-    Use a cut-out work table.

-    Elevate the microscope and place it at an angle at which you can look directly into the eyepiece.

-    Keep neutral spine.

-    Give arm rests for while using the adjustment knobs.

-    Use an ergonomic chair with good back support.

-    Ensure there is enough room under the table so that the person can pull the chair up to the ocular.

-    Install footrests and avoid foot rings on stools.

-    Provide sit-stand seats for areas with little leg room.

-    Order regular breaks.

-    Use television systems instead of binocular eyepieces.

4.    Overhead Lifting
Lack of space can force you to store equipment and supplies on overhead shelves, if this is so, follow these tips:

-    Store heavy objects on lower shelves.

-    Use a stable stool or ladder to reach overhead shelves.

-    Do not twist while you lift.

-    Use rotating carrousels to store materials close to the worker.

The well being of personnel is vital for the good functioning of any laboratory.  Any pharmaceutical consultant will agree that people are a pharmaceutical company’s strongest asset; by caring for their health you are taking your company far ahead in the market.

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Now is the time to establish a global vision in the path to a harmonious approach to product security that provides close-term benefits for patient safety.  While the US centers on how to achieve an e-pedigree system and the pharma industry in Europe incorporates a 2D datamatrix-based “bookend” system, patient safety is in possible danger due to the split approaches and expensive implementation strategies.

The drugs supply chain is becoming more and more complex due to the increase in the globalization of the pharma trade.  Manufacturers, distributors, re-packagers, and retailers may be all located in different countries or even continents.  Given the complexity of the supply process, drugs have become a profitable target for illegal distribution and forgery.

Many methods have been proposed to protect patients, however, the answer may be very simple: an approach in phases, which initially focuses on the point of dispensing and avoids the significant difficulties and costs that a full supply chain pedigree system encompasses.

Currently there are two main initiatives that are fragmenting the resources of the industry: The European Federation of Pharmaceutical Industries and Associations (EFPIA) initiative, and the California ePedigree network.  Not long ago, the pharma industry overcame many years of irrational enthusiasm in regards to the near-term potential of RFID technology.  It is time to learn from mistakes and select an approach that leads to improvements in patient safety that are achievable instead of considering a large-scale solution focused on the supply chain.  In this regard, the European initiative is better.

Key organizations and agencies have to become aligned in regards to a global approach that can be launched in any region and using the available technologies.  This global approach should have a main goal: checking drugs at the most critical transaction in the supply chain, when they are delivered to patients.  The EFPIA follows this route, however it requires two important and costly developments: all products must be serialized at the unit level, and an industry wide data routing and data management system has to be established.  These developments will allow for significant short-term improvements to patient safety through point-of-dispensing verification, will offer important knowledge, and will enable other developments of supply chain pedigree programs that can build on this foundation.

Like bank ATM’s and credit cards, this system would permit global use with universal results: the approval or denial to sell a drug.  Along with serialization as an aspect of an authentication program, authentication technologies are also needed.  Explicit and secret product authentication characteristics used by the manufacturer in the product’s packaging or in the product itself, give the manufacturer the capacity to detect abnormalities fast.

In order to make this a reality, the EFPIA, EMEA, FDA, PhRMA, and WHO will have to join forces to define an industry standard with a data exchange infrastructure that could strengthen the broad implementation of unit-level serialization.  Eventually, this system will evolve into a more extensive track and trace system, forming the supreme supply chain management tool.

It is everyone’s responsibility to work towards a solution for patient safety in view of the growing global danger of distribution of illegal and forged drugs.  As pharmaceutical consultants will agree, global problems beg for global solutions.

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