December 20, 2013

Ear Creation from Living Cells – Scientific Progress Reignites Ethical Questions

Scientists at Cornell University, led by Associate Professor of Biomedical Engineering Lawrence Bonassar, have created an artificial ear using 3D Printing Technology. Their research goal is to be able to regenerate cartilage anywhere in the human body.

The science is fascinating. A camera takes a 3D image of a patient’s head, then ink containing living cells is used to formulate a custom ear that looks and acts like a natural ear.

The living cells used in the ink can be taken from the patients themselves, which is a longer and more painful process, or, as in this study, cells can be derived from collagen from rat tails combined with cartilage from cows’ ears.

The researchers, however, are looking at “ways to expand populations of human ear cartilage cells in the laboratory so that these cells can be used in the mold, instead of cow cartilage.” Could this create ethical complications, as seen in the HeLa cells used in cancer research?

Henrietta Lacks was an African-American woman who was the unwitting source of cells which were cultured by George Otto Gey to create the first known human immortal cell line for medical research. This is now known as the HeLa cell line. Her family members’ cells were also used in research without their consent and Henriettta’s medical records were published without consent, sparking a debate about the ethics of scientific research using human tissue.

According to the author of “The Immortal Life of Hentrietta Laks”, Rebecca Skloot:”A lot of the ethical questions raised by Henrietta’s story still haven’t been addressed today: Should people have a right to control what’s done with their tissues once they’re removed from their bodies? And who, if anyone, should profit from those tissues? Henrietta’s story is unusual in that her identity was eventually attached to her cells, so we know who she was. But there are human beings behind each of the billions of samples currently stored in tissue banks and research labs around the world. The majority of Americans have tissues on file being used in research somewhere, and most don’t realize it. Those samples come from routine medical procedures, fetal genetic-disease screening, circumcisions, and much more, and they’re very important for science—we rely on them for our most significant medical advances. No one wants that research to stop, but it’s pretty clear that many people want to know when their tissues are being used in research, and when there’s a potential for the results of such research to be used commercially. The story of Henrietta, her family, and the scientists involved put human faces on all of those issues, which can otherwise be pretty abstract.”

Bioethicist Ruth Faden wrote an op-ed piece for The Baltimore Sun several years ago in which she stated: “Happily, today, consent is regularly obtained to take tissue or other body components for research purposes. But Mrs. Lacks' story has brought new focus to many tough bioethical and public policy questions that persist. Chief among these are: What, exactly, should patients be asked to consent to if the fruits of the research are unpredictable? Should they be compensated if, years or decades later, institutions, scientists or drug companies benefit financially? Should each and every subsequent or conceivable use of human tissue require a separate consent from patients or their families? How do we protect patient privacy in such situations?”

As research continues to explode in areas such as the 3D printing of ears, will these ethical issues continue to be debated?

Learn more about this scientific breakthrough in The Cornell Chronicle or in this video.

 
This article was posted by The CECON Group, a science and engineering consulting firm providing experts in such fields as biomedical consulting, pharmaceutical consulting, and chemistry consulting.

 

 

December 16, 2013

PA Attorneys Now Required to be Tech Savvy


The Pennsylvania Supreme Court joined other states, such as Massachusetts, and amended its rules of professional conduct effective November 21st to include requirements that attorneys keep abreast of changes in relevant technology and take reasonable care to prevent inadvertent or unauthorized access to client information.

This change is in alignment with the ABA’s Rule 1.1, which charges attorneys with monitoring “the benefits and risks associated with relevant technology.” Will other states follow in MA and PA’s footsteps and add similar state guidelines?

Some suggestions to help busy attorneys meet this standard:

1. Discuss data security with staff members, experts, and consultants and have a written document security policy. Be sure to include security guidelines for portable devices (smartphones, tablets, thumb drives).

2. Be careful about using devices on public Wi-Fi networks.

3. Delete your Google history or cookies regularly to avoid targeted ads inadvertently appearing on your computer screen that could disclose your case strategy to someone looking over your shoulder.

4. Research the best software to organize and protect your paperless files.

5. Install security software on all your devices and do semi-annual checks to insure you and your staff are adequately protected from viruses and hackers.

6. Subscribe to e-alert services such as Technolawyer or USCERT to receive updates on new developments in technology.

Previous CECON posts have addressed issues in expert management related to technology and confidentiality (Do You Disclose Case Docs to Potential Experts? And ESI Management- Another Criteria for Expert Witness Selection).

A variety of other tips and resources for staying on top of technology can be found at Americanbar.org and Law.com.  

 
 
The CECON Group has been providing technical experts to attorneys since 1985. Full service expert searches by seasoned industry professionals are CECON’s focus.

 

 

December 4, 2013

Researchers Develop Wearable Battery

Wearable mobile electronic devices are a step closer to becoming a reality following the development of textile-based foldable batteries by a research team from the Korea Advanced Institute of Science and Technology. The batteries are designed to be rechargeable via lightweight solar cells.

The battery utilizes a current collector, binder and separators that incorporate a nickel and polyurethane-coated polyester yarn. The composition allows the battery to be folded several thousand times without losing any of its functionality.

According to the researchers involved in the project, previous attempts at the technology have failed due to the batteries being too inflexible. More durable electrodes made by dipping cloth in nanoparticle solutions have been stronger but have an electrical resistance that is too high to allow them to store adequate amounts of energy.

The research team of Jang Wook Choi, Take-Soo Kim and Jung-Yong Lee, all of the Korea Advanced Institute of Science and Technology, redesigned the electrodes utilizing nickel, which is highly conductive, and using it to coat the fabric. By using polyurethane fabric they were able to eliminate binding problems and allow the battery to maintain its integrity. Anodes and cathodes were made using conventional battery materials.

The product has been tested extensively and was found to be capable of being folded and unfolded ten thousand times. To date it has been utilized in a sweatshirt and a sweatband, but future applications may include other types of clothing, watches and backpacks. The units are sealed so that the fabric can be washed without concern of damaging the battery.

The batteries will be recharged using flexible solar cells that are also integrated into the fabric. Further development plans are to improve the batteries storage capabilities.  The researchers anticipate that the new technology can be produced in already-established facilities. 

For pictures and more details on this technology, click here.
 
The CECON Group has 26 battery experts who consult on legal cases and short term projects for businesses. The CECON Group has over 1200 technical experts in over 200 technical specialties in its network.

 

November 21, 2013

Upgrading Laboratory Safety Procedures

Many colleges and universities need to upgrade their laboratory safety practices in order to protect their students and researchers and to ensure public safety.  Recent experience poignantly shows that chemical fires, explosions, and theft cause personal tragedy and consume inordinate administrative time. (See articles on explosions at Texas Tech and University of Florida).  However, disaster usually leads to improved practices by the facility’s teaching and research staff.


What are some of the first improvements that can be made?
§  Overall review of current practices, including mock inspections, looking for gaps and early opportunities to mitigate potential problems.

§  Inventory assessment , for example, excess and old chemical inventories need to be monitored or discarded.

§  Proper selection and use of PPE, personal protective equipment.

§  Written and understood SOP’s, standard operating procedures, for each type of experiment, special chemicals and process equipment.

§  ERP, emergency response procedures, for potential or past situations.

Such knowledge and practices are well established in the chemical, biotech, energy and pharmaceutical industries.  Specialty technical search firms can often help.  They can individually advise researchers on specialty situations (chemical formulations, chemical processes) or they can be critical team members to assist with management issues (regulatory compliance, security/surety, forensic investigations, expert witness).

University of California recently underwent an extensive safety procedures overall. Read about their experience here.

Additionally, OSHA has just released new resources to help businesses protect workers from hazardous chemicals. These resources can be found here.
 


The CECON Group has been providing science and engineering consultants to businesses, universities, and attorneys since 1985. Our technically trained project managers are skilled at helping locate the right expert or team of experts for projects of varying scopes and sizes.

November 7, 2013

GMO Food Labeling Defeated in Washington State

Voters in Washington State rejected a proposal on Tuesday, November 5th, to  require special labeling for genetically engineered/modified foods. Initiative 522 received a great deal of publicity, primarily as a result of corporate advertising.
 
Is the defeat of this initiative a good thing or a bad thing?
 
What is genetically engineered food?
 According to the World Health Organization: “Genetically modified organisms (GMOs) can be defined as organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally. The technology is often called “modern biotechnology” or “gene technology”, sometimes also “recombinant DNA technology” or “genetic engineering”. It allows selected individual genes to be transferred from one organism into another, also between non-related species."

Why would anyone genetically engineer food? Reasons include: for an innovative taste, higher nutritional benefit, or increased resistance to pesticides or plant diseases.  As of 2011, the U.S. leads a list of multiple countries in the production of GMO crops, and 25 GM crops had received regulatory approval to be grown commercially. As of 2013, roughly 85% of corn, 91% of soybeans, and 88% of cotton produced in the United States are genetically modified.”

The FDA and WHO both consider the genetically engineered foods in the current food supply to be safe. Examples of foods modified by traditional methods include nectarines (genetically altered peaches) and  tangelos (hybrid of tangerine and grapefruit).  Genetically engineered foods common in the US food supply include soybeans, sugar beets, zucchini, corn, and papaya.

Modern genetic engineering differs from traditional methods in the technologies used (recombinant DNA and cell fusion vs cross pollination), but offer greater predictability and precision in the new breed of plants produced. Scientists are able to isolate genes and introduce new traits into foods without introducing undesirable traits, as would occur with traditional techniques.

Proponents of mandatory GMO food labeling seek revised labeling in the name of transparency, with concerns that consumers need to know what chemicals and allergens may be present in their foods.

Opponents to the revised labeling standards note that GMO labeling would raise food prices (as seen in Europe), intensify misconceptions about GMO  foods being dangerous, remove GMO foods from market, and slow growth in 3rd world nutrition advances, which use GMOs.

The Food and Drug Administration oversees food safety in the US, including genetically engineered foods. According to the FDA website:  “Under the FD&C Act, food labeling that is false or misleading is generally prohibited. Food labeling is misleading if it fails to reveal "material" facts—information that is material in light of statements made or suggested on the label, or material with respect to consequences that may result from the use of the food."

The FDA currently supports voluntary food labeling, as long as it is not misleading.

 

The CECON Group  has been providing science and engineering consultants to companies and law firms since 1985. Consultants include experts in the areas of Biotechnology, FDA Regulations, Regulatory Compliance, Labeling, and Food Safety.

October 23, 2013

Drug vs Cosmetic: Does the FDA Regulate all the products you think they do?


Do you ever wonder if your skin cream or make-up is safe? Most of us assume that if we are buying a cosmetic product at our local drugstore or mall, that the ingredients have been approved and tested by the FDA.
 
According to Dr. Stanley Tocker, an expert in chemicals used in cosmetics for The CECON Group, with the exception of color additives, only products that are labeled as food or drugs are regulated by the FDA.  If a product is NOT an approved drug, its ingredients have not been tested, reviewed, or approved by a government agency.

So, your cosmetics can contain any ingredient the manufacturer selects as active or inert components. It is certainly in the legal interest of the manufacturer and marketer of a product to do sufficient product safety testing.

What steps should consumers take to research the products they use? Obviously read labels and reviews of products (one summary of possible toxins can be found here). Check the FDA’s page for product recalls (click here to see a warning about mercury poisoning linked to certain skin products).

Dr. Tocker recommends checking the safety of suspicious ingredients online. Some chemicals to avoid include parabens, glycolic acid, some sunscreen agents (see EWG website), and strong detergents/exfoliants. Consumers should also test a small amount of any new cosmetic on an obscure body part (such as an arm) prior to applying to the more sensitive skin on the face.

Generalized safety guidelines are difficult because each person reacts differently. Judging safety in some ingredients is a matter of quantity used, individual sensitivities, care taken in use, and frequency of use. Some chemicals react with other products used by the consumer to cause a reaction not anticipated by reading label ingredients.

For more information, see the FDA’s Cosmetics Page.
 

October 7, 2013

Adult Stem Cell Therapy Status: Summary and FDA Issues


 
Embryonic stem cells are often discussed in the media, but adult stem cell technology gets less coverage.  The article below is a primer on adult stem cell technology and therapy, with comments on a recent FDA ruling. Attorneys, pharma consultants and investors may be interested in the potential impact of adult stem cell technology and applications for future cases and opportunities.
 
 
  
Adult stem cells exist in all people and are naturally used by our bodies to repair and regenerate injured issue.  The generation and use of naturally occurring stem cells generally diminishes with age.   Adult stem cells differ from embryonic stem cells in that they are based on embryo or placenta materials, which have a much larger ability to adapt to specific body tissue and organs. There are many types of adult stem cells, but mesenchymal stem cells are considered the most useful.  Mesenchymal stem cells (MSC) can be harvested from tissue in the body rich in MSC, such as bone marrow or adipose tissue.

Typically in adult stem cell therapy, stem cells are harvested from the bone marrow, often from a patient’s hip, by aspiration.  They are then concentrated by centrifugation and mixed with blood platelets extracted from the patient’s blood; blood platelets are rich in natural growth factors and aid in the stem cell’s effectiveness.  The concentrated stem cells and blood platelets are combined and then precisely injected back into the damaged part of the body in need of regeneration.  Such procedures are usually done the in one day at an outpatient clinic with little discomfort to the patient.

The claims of positive results from adult stem cell therapy are huge, in areas such as:  Repairing meniscus tears in the knee; repairing shoulder joint injuries; healing diabetic wounds; regenerating back tissue; regenerating heart tissue and valves; and reducing back pain.  There are also experimental reports of in vitro organ growth using adult stem cells, where a “constructed” organ is placed in the body to carry on normal functions.  The literature is replete with examples of marvelous outcomes with adult stem cells therapies that, while not nearly effective as embryonic stem cells therapies, sidestep the ethical and supply issues associated with embryonic cells. 

Adult stem cell therapy has FDA problems, however. For extensive coverage, click here.  In July of 2012, litigation involving Regenerative Sciences, LLC  as the defendant and the FDA, the United States District Court for the District of Columbia ruled in favor of the FDA.  The ruling essentially said the “Regenexx” procedure is a drug under the Federal Food, Drug, and Cosmetic Act and must comply with New Drug Application (NDA) regulations for current Good Manufacturing Practices (cGMP).  This issue has not been resolved, but Regenerative Science continues to practice the procedure on the “surgery exemptions “ of  CFR 21 Part 1271.15(b).  One basis of Regenerative’ s position is that “…patient’s cells are harvested in the morning, isolated and processed, then re-injected into the patient’s injured area – all within a period of a few hours.”  More elaborate adult stem cell procedures are practiced outside the United States to avoid FDA issues.  Many doctors believe the FDA is inhibiting successful client therapies and the science and medical breakthroughs of adult cell technology.  Some medical specialists imagine that medical device manufactures, such as those supplying spine, knee and hip replacement parts, lobby against adult stem therapy, seeing it as a disruptive technology.

 It is important to note that Dr. Shinya Yamanaka, a Japanese physician and researcher, won the Nobel Prize in Physiology (Medicine) in 2012 (along with Dr. John Gurdon) for the discovery that certain cells can be converted to cells closely resembling embryonic stem cells.  Recently, the Spanish National Cancer Research Centre (CNIO) reported that it has successfully treated adult stem cells in such a way as “…to recover the characteristics of embryonic stem cells.”  The research in stem cell medicine and science that circumvents the embryonic approach is intense. 

Finally, there is the equipment side of adult stem technology, whose growth is important to consider. One equipment leader is Harvest Technology Corp. located in Massachusetts but operating globally and owned the Japanese company Terumo  that specializes in blood management system and cardiac and vascular therapeutics.  Harvest provides point-of-care equipment for marrow aspiration, centrifuges to separate adult stem cells, and growth factors and disposables that are used in clinics.

Medical researchers and scientists, medical device specialists, and investors should keep a close eye on the progress, successes and acceptance, particularly by the FDA, of future adult stem cell technology and applications.

Additional information on this topic can be found in the videos below:
http://www.youtube.com/watch?v=OkS8ShmW7GQ or http://www.youtube.com/watch?v=L_8tmSw3UU8 ) 


What do you think the next innovation will be using stem cell technology?
 

The author, Boyd Sorenson, is a Vice President with The CECON Group, Inc. He holds a B.S. in Chemistry, and an  MBA, from Brigham Young University. Boyd is a technical marketing and business expert and executive with over 40 years' experience in defining, launching and operating high-technology new business. Boyd worked 25 years for the Du Pont Company, followed by 5 years at W. L. Gore, 4 years importing titanium dioxide from China for North America markets, and 9 years as the President of The CECON Group, Inc.

 

 

September 23, 2013

International Business Perspectives: How Different Countries View Contracts


Doing business internationally means becoming aware of cultural differences. One cultural paradigm not often touted is different countries’ attitudes towards negotiation and the sanctity of the contract.

Obviously, not all individuals and companies will share these general attitudes, but an understanding of a general perspective can help maintain goodwill and decrease frustration during negotiations.
 
 
         
Country Perspective on Contracts Negotiating Style Value Helpful Practices
         
US/Canada Terms viewed as final and binding. Directness and efficiency Brevity and integrity.  
         
India Seen as flexible, to be further negotiated. Idealistic standards can lead to prolonged negotiations. Fairness Document interactions as terms may be questioned throughout term of contract.
         
China Tendency to re-open negotiations to get the best deal; collective mindset. Trust is slowly earned. Hierarchy and formality. Status conscious. Prefer one on one relationships and discussions. Contracts can be difficult to enforce, so prepayment clauses can be beneficial.
         
Europe Varies by country and sub-culture; can be prolonged negotiation. Diplomatic, guarded, self deprecating.   Discuss how VAT will be handled and consider necessary pricing adjustments to cover this tax.
         
Japan Take time to consider various fine points. Sense of honor leads to adhere to and seek to surpass agreed upon points. Prolonged, attention to detail, customer service. Honor and respect of hierarchy. Remember to spend time on social interaction before getting to the heart of business discussions.
         
Russia/Mid East Careful negotiators Thoughtful, reserved. Verbal Communications, long term relationships Discuss how foreign taxes will be handled and consider necessary pricing adjustments to cover this tax.
         
Latin America Focus on spirit of the contract rather than letter of the contract. Use of humor is not usually appropriate. Verbal communication stressed over written communication. Expressive styles are common. Eye contact, physical touch. Follow up on written documents with a phone call or visit.
 
Do you agree with these cultural paradigms? Do you have any perspectives to offer other readers?

Useful perspectives on world business cultures can be found at the websites below:


 
The CECON Group, Inc. has over 1300 technical consultants, located in 21 countries and has done business in 22 different countries. Specializing in science and engineering technical support, CECON has 28 years’ experience placing consultants for technical due diligence, expert witness services, regulatory & compliance audits, interdisciplinary preliminary design, and materials properties and processing.

 

August 29, 2013

Pharmaceutical Dilemma: New Antibiotics Needed to Fight Superbugs


CECON posted an article for Health-line.com titled: "Should there be a TARP for Public Health Superbug Issues?"

Read the full text of the article below:
=====================================================================
 TARP Approach for Public Health Superbug Issues?

In March 2013, both the U.S. Centers for Disease Control and Prevention (CDC) and the chief medical officer in England, Sally Davies, sounded the alarm about the current infection dangers that are rapidly growing in severity, stemming from the “nightmare bacteria” such as the E.coli and CRE superbug strands.  At the moment, there are only seven new treatment drugs currently in development and that are being tested on people with infections that are drug resistant and gram-negative.

The CDC made their statement based on the most recent data that has been released by the Infectious Diseases Society of America (IDSA) which showed the results of having monitored the number of bacteria that are capable of remaining resistant to even the strongest antibiotics available in today’s treatment arsenal.

At the very heart of these announcements is the suggestion that the world may be on a rapid path back in time to the days before antibiotics could come to the rescue and keep patients safer from infection following premature birth, surgery, or chemotherapy.  In the words of Dr. David Relman, the president of the IDSA, in a statement he released following the report “Simply put, the antibiotic pipeline is on life support and novel solutions are required to resuscitate it – now”.

According to the author of the IDSA report, Dr. Helen Boucher, a Tufts Medical Center infectious diseases expert and IDSA board member, “We’re all at risk.”.  Boucher explained that she feels this way because health officials are not only failing to move forward, but they are actually losing ground because the drugs simply are not being developed fast enough to keep up with the evolution of these superbugs in building resistance. There is an “alarmingly low” number of antibacterial compounds in the phase 2 or 3 of development trials right now.

Drug resistance isn’t anything new.  Bacteria has been growing resistant to available drugs since shortly after penicillin first made its way into pharmaceutical use in 1940.  This has also been the story with each new generation of antibiotics that has been developed since that time.  The blame for this has been aimed directly at the misuse and overuse of each of these different forms of drug.

It is already known that not all of the antibiotics currently being tested will make it all the way through the development process.  Among the seven that were identified as being in phase 2 or 3 of development, the company behind one of the drugs, Polymedix, has already filed for Chapter 7 bankruptcy.  Another company, AstraZeneca, which is the manufacturer of two of those drugs, has announced that it will be moving forward with a smaller investment into the development of antibiotics. The remaining companies include GlaxoSmithKline, Cubist Pharmaceuticals, Merck, and Achaogen Inc.

The IDSA is now seeking new and innovative economic incentives to help to encourage pharmaceutical companies to turn their attention back to the development of antibiotics.  Could a TARP-like approach (used to strengthen the financial sector) for the pharmaceutical industry be a solution to this public health crisis?
 
 
The author of this article. Mike Fisher, is the President of The CECON Group, Inc..

August 15, 2013

A Better Silica Gel – By Accident?

Researchers in Uppsala, Sweden accidentally left a reaction running over the weekend and ended up resolving a century-old chemistry problem. According to Science Alert: “Their work has led to the development of a new material, dubbed Upsalite, with remarkable water-binding properties.  Upsalite promises to find applications in everything from humidity control at home to chemical manufacturing in industry.”

Currently, silica gel is the most common desiccant (or drying agent) on the market. Silica gel packets can be found in almost everything you purchase including shoes, foods, medicines, and electronics. Silica gel absorbs and holds water and is easily contained in fiber packets due to its large particle size. It does not react chemically with most substances and is safe in proximity to food.

However, the newly formulated Upsalite, or dry Magnesium Carbonite (MgCO3), may be an even more efficient desiccant than silica gel due to its larger surface area. The obstacle to overcome: Upsalite  may not be easily contained in porous packages due to its small particle size.

It will be interesting to see how this discovery is integrated into commercial products and chemical processes.
 

This article was authored by an employee of The CECON Group, Inc., which has been providing chemists, chemical engineers, pharmaceutical consultants, and other scientific and technical experts to businesses and law firms for over 25 years.