High-Fidelity PCR Reagents Continue to Propel DNA Research with Unparalleled Accuracy and Speed

New proprietary tracking dyes within high-fidelity DNA polymerase and qPCR master mixes facilitate easier, more accurate PCR set-up for researchers.  The Thermo Scientific Phusion Green High-Fidelity DNA Polymerase and Luminaris Color qPCR master mixes utilize proprietary tracking dyes to speed up the pipetting process. By providing a visual confirmation, the mixes are designed to vastly reduce the chance of human error, while also decreasing the number of procedural steps required. Most importantly, the dyes have been engineered not to interfere with the reaction or any downstream applications.

These new Phusion and Luminaris products form the latest additions to the renowned Thermo Scientific Phusion High-Fidelity DNA Polymerase family. First launched a decade ago, the Phusion High-Fidelity DNA Polymerase was the first DNA polymerase, developed using fusion protein technology to provide a combination of accuracy and speed previously unattainable using conventional enzymes.  Known for performance with all major PCR applications, the Phusion technology has played a central role in helping researchers accomplish an array of key scientific achievements, including the creation of the first functional synthetic genome.

“Phusion Polymerase technology has dramatically increased the productivity of labs running PCR,” says Margarita Leckiene, Director of Nucleic Acid Detection & Molecular Tools for Thermo Fisher Scientific. “Our philosophy is to simplify customer workflows further and increase the reproducibility of results. We are constantly working to further advance the accuracy and robustness of Phusion polymerase including the most recent innovation of special enzyme formulations that are optimized for NGS applications, offering equal amplification efficiency across entire genomes.”

This technology, coupled with Thermo Scientific PCR instruments and accessories such as theThermo Scientific Arktik Thermal Cycler and Thermo Scientific Piko Plate Illuminator, provides an efficient integrated solution that delivers

• DNA amplification with extreme accuracy
• Enhanced visual control
• Significantly shorter protocol times.

To recognize the impact of the original Phusion polymerase and a subsequent decade of innovation in this area, Thermo Fisher has launched Phusion Fest, an interactive campaign celebrating the importance of PCR in the laboratory. Phusion Fest encompasses a fun, scientific trivia game, special offers across a variety of molecular biology products and free samples of selected Phusion products.  More information on Phusion Polymerases and the Phusion Fest can be found by visitingwww.thermoscientific.com/phusion.

HIV/AIDS and Biotechnology

When the HIV/AIDS epidemic became widely known in the early 1980s I lived in San Francisco. I lost many dear friends during those years. That made working on “HIV/AIDS and Biotechnology” very personal to me.

Thirty years later and despite an all-too-common public perception that this terrible disease has been solved, the research to find a vaccine is actually more important than ever. The sad truth is that the cost in both human lives and economic treasure remains astronomical.

Producing this short film for BIO about the role of biotechnology in the on-going fight to save lives and dollars brought me face-to-face with three awesome individuals: a researcher, a patient, and an advocate. The researcher is Dr. David Asmuth, one of the world’s leading HIV experts. The patient, Brian Brown, received VACC-4X, a biotech vaccine produced by Bionor Pharma, in a clinical trial and went a full 18 months without anti-retroviral treatments. The advocate is Stephen Bailous, executive vice president of the National Association of People with AIDS (NAPWA) — he’s also an HIV survivor.

Together, these three men send a compelling message to all of us: If we are to conquer HIV/AIDS the necessity to fund sustained biotechnology research has never been more vital and more hopeful.

I wish to thank our entire team, especially our director Emily Deckelman, for their commitment to producing this important video.

Drugs Need Friends Too

At the BIO CEO & Investor Conference, industry leaders will address how new technologies fit into the biotech business model.

Drugs approved with companion diagnostic tests represent the next wave of personalized medicine and have the potential to significantly improve patient outcomes.

Companion diagnostics are changing the face of drug discovery and development and clinicians and investors alike are coming together for partnerships focused on the development of therapies for specific patient populations.

As biomarkers are discovered, using a companion test to predict if a specific drug or therapy will work in individual patients, and determining the appropriate dosage, can improve health care safety and drug efficacy.

The Personalized Medicine Coalition, a nonprofit advocacy group, reports that there were 72 prominent examples of personalized medicine drugs, treatments, and diagnostics products available last year.

Last year, there were two significant drug approvals in companion diagnostics:

• Pfizer’s Xalkori: Approved to treat patients with late-stage lung cancer who have an abnormal ALK gene in August.  Comes with a companion diagnostic test to screen potential patients for the ALK mutation.
• Daiichi Sankyo (Acquired when the company bought U.S. based biotech Plexxikon last year ) and Roche’s Zelboraf:  Approved in August for BRAF V600E-mutation positive melanoma.  Also comes with a companion diagnostic test to screen patients for the mutation.

Regulatory challenges associated with an unclear oversight process have slowed timelines and thwarted progress. Obviously, the FDA must address the complexity of personalized medicine as it is not a one-size-fits-all approach to drug discovery and development.

Delivering new and improved treatments and cures to patients should be the primary focus of companion diagnostic R&D, without question. Partnerships hold the key to advancing drug development and delivering on the potential of companion diagnostics.

At next month’s BIO CEO & Investor Conference, industry leaders will address how these new technologies fit into the biotech business model and how companies can best leverage companion diagnostics to enrich products and expand therapeutic opportunities.

The session, Drugs Need Friends Too – Companion Diagnostics and Drug Development, will be moderated byPatrick J. Mahaffy, President and CEO of Clovis Oncology.  Boulder, CO-based Clovis Oncology is a biopharmaceutical company focused on companion diagnostics that direct their product candidates to the patients most likely to potentially benefit.  The company has three product candidates in the pipeline.

Japan Action on GE Papaya

The U.S. Department of Agriculture has announced that the Government of Japan approved Hawaii’s Rainbow papaya for commercial shipment to Japan. The Rainbow papaya is genetically engineered to be resistant to the papaya ringspot virus. This announcement marks the beginning of a new chapter for Hawaiian papaya growers.

“The market opening in Japan is great news for Hawaii’s papaya producers and even better news for American agricultural exports,” said Michael Scuse, Acting Under Secretary for Farm and Foreign Agricultural Services.

In the 1990s, an outbreak of the papaya ringspot virus decimated Hawaii’s papaya crop.  Scientists from Cornell University, the University of Hawaii, The Upjohn Company and USDA’s Agricultural Research Service used biotechnology to develop the Rainbow papaya, which is resistant to the virus.  After receiving full clearance from the U.S. government, the Rainbow papaya was commercialized in 1998.  Now, the majority of Hawaii’s papaya crop is resistant to ringspot virus through genetic engineering.

“The story of the genetically engineered Rainbow papaya is a prime example of how biotechnology can help farmers and consumers by literally saving the Hawaiian papaya industry from extinction,” says BIO’s President and CEO Jim Greenwood.  “This announcement ensures that Hawaii’s papaya producers will continue to help grow our nation’s agricultural sector by expanding exports, creating jobs, and strengthening our nation’s eceonomy.”

Japan was once the major market for Hawaiian papayas, with annual sales reaching $15 million in 1996. These sales dropped to $1 million by 2010 while U.S. exporters awaited Japan’s approval of Rainbow papaya.  With Japan’s approval for import of Rainbow papaya, U.S. papaya producers are set to regain access to this important market, supporting jobs through increased exports.

Brazilian Innovation: A Patent Success

The story of Acheflan highlights the role of patents in homegrown innovation in developing countries.  Professor Michael Ryan of Georgetown reviewed several case studies (including Acheflan) in Brazil that highlight the differences in biomedical innovation both pre- and post-intellectual property reforms.

In the early 1980’s, Ache Laboratorios Farmaceuticos (a Brazilian generics manufacturer) became aware of a plant that grew near coastal cities that local fishermen would mash into an oil rub to serve as an anti-inflammatory and anti-scarring medicine.  Ache wanted to develop the plant into a product they could bring to the Brazilian and worldwide markets.  Ache realized that to develop the product they would need to isolate the active ingredient and then take it through toxicology studies, animal testing, and human clinical trials to demonstrate the safety and efficacy of the product.  However, Brazilian patent law at the time prohibited patenting of pharmaceutical patents.  While Brazilian patent law allowed for process patents, Ache quickly realized that competitors could easily reverse engineer the product and make their own version.  Ache did not pursue the project.

When Brazil reformed its patent law in 1996 to allow patents on pharmaceutical products, Ache resumed work on the shelved project.  Now they could finally invest in the project with a promise of a return guaranteed by a patent.  Not having the capacity to conduct research, Ache established research partnerships with Brazilian professors.  From 1998-2004, some 100 university agronomists, biochemists, pharmacologists, and medical doctors were involved in taking the product through isolation and toxicology studies.

The company launched the product, Acheflan, in 2005 and the years of hard work paid off.  Acheflan is the first medicine innovated and introduced in the marketplace by Brazilians and within a year the product received a 30 percent share of the anti-inflammatory market.  By the end of 2007, its market share exceeded 40 percent (beating out competitors among established global pharmaceutical companies).  The company is in the process of launching the product worldwide.

While Brazilian patent laws still require much improvement to lay the foundation for its future as a developed country, this case study is one of many suggesting that even incremental positive changes to the IP environment can catalyze commercialization of Brazilian innovation

Let’s Get PDUFA V Approved, Fast

At this time of the year, it can be helpful to reflect on the past to guide us in the future. I was recently reading an editorial about the National Health Council (NHC) printed in January 1957 – 37 years after the organization’s creation. It spoke about the need for action with “an unprecedented degree of cooperation among health agencies and the people they serve.” Well, that time is now and the issue is reauthorization of the Prescription Drug User Fee Act (PDFUA).

I want to thank the FDA and the pharmaceutical industry for again hearing the concerns of patients and for addressing our issues in a meaningful way. Today, we have a forward-thinking reauthorization agreement – PDUFA V.About a year and a half ago, at a Food and Drug Administration (FDA) meeting with patient advocacy organizations, we talked about how it was patients, two decades earlier, who chained themselves to the gates outside the FDA and the National Institutes of Health demanding access to treatments that were still in clinical trials and under review. Patients were told that they couldn’t have access to those treatments because researchers didn’t know if the compounds were safe or effective. But the patient community pushed back; many were going to be dead in a year. Their actions resulted in the creation of the early access program and a new environment that led to the first PDUFA.

Since the authorization of the first PDUFA, we have seen tremendous progress in the development of medicines for people with chronic diseases and disabilities. The time it took for the FDA to approve new drugs got shorter. However, there is now an emerging frustration among many people with chronic conditions who feel they still are not getting access to treatments as quickly as they would like. For many, such as patients with degenerative diseases like Alzheimer’s, clinical development moves slower than the progression of the disease.

For the past year and a half, the patient advocacy community has worked with the FDA and industry to get its three key priorities included in the proposed reauthorization agreement.

First, we need a qualitative, objective, framework for assessing the benefit-risk of new drugs. Benefit-risk is an important part of the FDA review process, but there is no consistently used framework or agreement among all stakeholders. How do we account for known and unknown risk or variation among subpopulations? Are benefits and risks appropriately placed in the therapeutic context?

No country in the world has articulated such a process, and there is increasing anxiety among patients who are denied access to new drugs based on a benefit/risk assessment they simply don’t understand.

The FDA and industry have agreed to include in PDUFA V the creation of a qualitative framework that would assess the level of certainty and variability of the benefits and risks, and that would provide for flexible scoring in the context of the therapeutic indication.

This benefit-risk framework will work for both patients and consumers. Both are stakeholders in this issue, but depending on where you fall on the health care needs spectrum, your perspective of benefit-risk can shift dramatically. For healthy consumers, the tolerance for risk, variability, and uncertainty for a new medicine to treat a condition such as hay fever is virtually zero. But if you are diagnosed with ALS (Lou Gehrig’s disease) and you have only two years to live, your tolerance for a risky new drug is dramatically different.

Second, we need greater use of patient-reported outcomes and biomarkers. Patients want more of a say in the drug review process, and they want the approval process to go faster than the progression of their disease. The patient community saw the reauthorization of PDUFA as an opportunity to develop metrics and tools to make the review process more effective, more efficient, and allow for the delivery of safe and effective medicines to people who need them.

Under PDUFA V, resources for patient-reported outcomes (PROs) will be increased, resulting in the patient perspective being incorporated earlier in the review process, dramatically reshaping drug research. It was psoriasis patients who taught us that it is not necessarily the size of their lesions that matters, but where the lesions are located on their body, such as on their faces or joints. This realization greatly altered the focus of psoriasis drug research.

PDUFA V would also increase resources to help the FDA speed up the approval of biomarkers in clinical trials. The use of these surrogate endpoints or clinical markers is greatly needed for people with chronic conditions. Polycystic kidney disease (PKD) is a genetic disorder of the kidneys. With PKD, fluid-filled cysts develop in the kidneys, which then can increase in both size and weight, sometimes weighing many pounds each. Currently, the recognized end point for PKD is kidney failure, which can occur as late as 40 years after diagnosis. No company would undertake a 40-year clinical trial, so qualifying a biomarker for a PKD drug is imperative. It is conceivable that if a new compound prevents a PKD patient’s kidney from getting larger, then something positive is happening.

Third, for the millions of people with rare diseases, we need new resources and greater flexibility in the regulatory review process. As proposed by FDA and industry, PDUFA V will utilize new regulatory science to speed the development of and access to new medicines for people who desperately need them.

The opportunity to engage in the PDUFA reauthorization process has been tremendously beneficial for the patient advocacy community, and I hope for the FDA and industry.

I say to those reading this column and to members of Congress, let’s get PDUFA V approved. Let’s get it done fast.

15 Keys to Success from Fierce Biotech’s Top 15 Women in Biotech

This week, Fierce Biotech recognized 15 women who are leading the way in biotech. Each of them represents the drive and determination that it takes to succeed in the industry, but what do they recommend beyond these inherent qualities? We pulled together the list below based on their profiles so that others can learn from their experience (yes, that made the list). In no particular order:

1. Take risks

2. Have an entrepreneurial spirit

3. Encourage teamwork

4. Be creative

5. Mentor others

6. Balance personal and professional life

7. Shatter stereotypes

8. Cultivate your business acumen

9. Be technically savvy

10. Seek knowledge and information

11. Stay curious

12. Exemplify leadership

13. Cultivate your career

14. Plant seeds

15. Buck the trends

Bioinformatic

Bioinformatics - it sounds like something from a science fiction story, but in reality it is a fast-growing scientific field in which biology, computer science, and information technology merge to form a single discipline, according to the National Center for Biotechnology Information. 

“The National Science Foundation says that Bioinformatics is an area of “national skill need.’”  Kettering’s program will have a heavy focus on storage and algorithmic searching of biological information, particularly genomic information” said Dr. Robert Simpson, Kettering provost.

“The Kettering Bioinformatics program will use existing faculty and it is an excellent example of how two academic departments working together can foster collaboration,” said Simpson. “The early goal for the program would be 20 students a year,” he added.

 

The Kettering Bioinformatics program will be one of only 23 undergraduate degree-granting programs in the U.S., according to Dr. John Geske, department head for Computer Science. Only one other university in Michigan offers an undergraduate Bioinformatics degree program; Michigan Technological University.

Geske worked with Dr. Stacy Seeley, department head for Chemistry/Biochemistry to develop the curriculum.

The Bioinformatics degree will originate from the Computer Science department in collaboration with the Chemistry/Biochemistry department. Its goal is to provide students with a strong foundation in computational methods used to analyze biological systems. 

Students in the Bioinformatics program will study software development, data storage, information retrieval, and statistical search techniques and gain a solid background in biological chemistry by taking courses and laboratories in organic chemistry, inorganic chemistry and biochemistry. 

Additional special emphasis in the biological area will be achieved through courses and laboratories in biology.  All Bioinformatics students at Kettering will also have several terms of cooperative work experience, so that concepts learned in the classroom can be applied to real world problems. 

“A Bioinformatics degree provides an excellent foundation for careers in biotechnology, medicine, pharmacology, environmental fields, technical management, education, business, software engineering, and information systems,” said Seeley.

Additionally, Graduates of the Bioinformatics Degree Program will be able to pursue an advanced degree in Bioinformatics, Computer Science, Chemistry, Biochemistry, Molecular Biology, or Medicine, Geske indicated.

 

The field of Bioinformatics will enable the discovery of new biological insights as well as to create a global perspective from which unifying principles in biology can be discerned. At the beginning of the "genomic revolution,” a bioinformatics concern was the creation and maintenance of a database to store biological information,  especially large-scale nucleotide and amino acid sequences such as those related to DNA sequencing.

 

Bioinformatics now entails the creation and advancement of databases, algorithms, computational and statistical techniques and theory to solve formal and practical problems arising from the management and analysis of biological data.

What is Biotechnology? - An Introduction to Modern Biotechnology

Biotechnology is most briefly defined as the art of utilizing living organisms and their products for the production of food, drink, medicine or for other benefits to the human race, or other animal species.

Agricultural Biotechnology

Technically speaking, humans have been making use of biotechnology since they discovered farming, with the planting of seeds to control plant growth and crop production. Animal breeding is also a form of biotechnology. More recently, cross-pollination of plants and cross-breeding of animals were macro-biological techniques in biotechnology, used to enhance product quality and/or meet specific requirements or standards.

Biotech in Everyday Life

The discovery of microorganisms and the subsequent burst of knowledge related to the causes of infectious diseases, antibiotics and immunizations could probably be counted among man’s most significant, life-altering discoveries. However, the most modern techniques in biotechnology owe their existence to the discovery of DNA and the protein products of genes, most importantly, enzymes. The discovery of the techniques essential for gene cloning allowed scientists to manipulate enzyme structure and function for specific purposes. Current scientific methods are more specific than historical techniques, as scientists now directly alter genetic material with atomic precision, using techniques otherwise known as recombinant DNA technology.

Industrial Biotechnology

As technology advances, the many roles biotech plays in our lives increases. Since George Washington Carver, scientists have been learning how to use biochemicals isolated from plants, to produce chemical products for everyday use around the house, the first "green biotech products". Since then, biotechnological advances can be found in nearly all sectors of industry. There are, of course, the obvious medical, pharmaceutical and food industries. Biotechnology is being used to determine cause and effect of various diseases and are used in the production of drugs.

Food Biotechnology

The production of foods is enhanced by biotechnological advances that improve crop yields, introduce in-situ insect resistance and provide new ways of food preservation. Other advances include packaging consisting of biomass plastics, or bioplastics, and built-in bioindicators for detecting contamination.

Environmental Biotechnology

In the environmental sector, biotech has played a role in remediation of contaminated land, water and air, pest control, treatment of industrial effluents and emissions, and acid mine drainage. Bioremediation and phytoremediation are used to restore brownfields for redevelopment.

Biotechnology in Space

Biotechnology has been a powerful tool for studying how organisms respond to low gravity and other environmental conditions found in outer space. Scientists have found that microorganisms exhibit genetic changes in orbit. Biotech is also being applied to develop horticultural techniques that might someday be used on the space station or on another planet.

Molecular Biology

Molecular biology is the study of biology at a molecular level. The field overlaps with other areas of biology and chemistry, particularly genetics and biochemistry.

Molecular biology chiefly concerns itself with understanding the interactions between the various systems of a cell, including the interrelationship of DNA, RNA and protein synthesis and learning how these interactions are regulated. Researchers in molecular biology use specific techniques native to molecular biology, but increasingly combine these with techniques and ideas from genetics and biochemistry. There is not a hard-line between these disciplines as there once was.

Molecular biology is the study of molecular underpinnings of the process of replication, transcription and translation of the genetic material. The central dogma of molecular biology where genetic material is transcribed into RNA and then translated into protein, despite being an oversimplified picture of molecular biology, still provides a good starting point for understanding the field.

Much of the work in molecular biology is quantitative, and recently much work has been done at the interface of molecular biology and computer science in bioinformatics and computational biology.

As of the early 2000s, the study of gene structure and function, molecular genetics, has been amongst the most prominent sub-field of molecular biology.

Introduction to Biotechnology

Biotechnology is technology based on biology, especially when used in agriculture, food science, and medicine. The UN  Convention on Biological Diversity has come up with one of many definitions of biotechnology: "Biotechnology means any  technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products  or processes for specific use."

Traditional pharmaceutical drugs are small chemicals molecules that treat the symptoms of a disease or illness - one molecule  directed at a single target. Biopharmaceuticals are large biological molecules known as proteins and these target the  underlying mechanisms and pathways of a malady; it is a relatively young industry. They can deal with targets in humans that  are not accessible with traditional medicines. A patient typically is dosed with a small molecule via a tablet while a large  molecule is typically injected. Small molecules are manufactured by chemistry but large molecules are created by living cells: for example, - bacteria cells,  yeast cell,animal cells.

Modern biotechnology is often associated with the use of genetically altered microorganisms such as E. coli or yeast for the  production of substances like insulin or antibiotics. It can also refer to transgenic animals or transgenic plants, such as  Bt corn. Genetically altered mammalian cells, such as Chinese Hamster Ovary (CHO) cells, are also widely used to manufacture  pharmaceuticals. Another promising new biotechnology application is the development of plant-made pharmaceuticals.

Biotechnology is also commonly associated with landmark breakthroughs in new medical therapies to treat diabetes, Hepatitis  B, Hepatitis C, Cancers, Arthritis, Haemophilia, Bone Fractures, Multiple Sclerosis, Cardiovascular as well as molecular  diagnostic devices than can be used to define the patient population. Herceptin, is the first drug approved for use with a  matching diagnostic test and is used to treat breast cancer in women whose cancer cells express the protein HER2.

Biotechnology in one form or another has flourished since prehistoric times. When the first human beings realized that they could plant their own crops and breed their own animals, they learned to use biotechnology. The discovery that fruit juices fermented into wine, or that milk could be converted into cheese or yogurt, or that beer could be made by fermenting solutions of malt and hops began the study of biotechnology. When the first bakers found that they could make a soft, spongy bread rather than a firm, thin cracker, they were acting as fledgling biotechnologists. The first animal breeders, realizing that different physical traits could be either magnified or lost by mating appropriate pairs of animals, engaged in the manipulations of biotechnology.

What then is biotechnology? The term brings to mind many different things. Some think of developing new types of animals. Others dream of almost unlimited sources of human therapeutic drugs. Still others envision the possibility of growing crops that are more nutritious and naturally pest-resistant to feed a rapidly growing world population. This question elicits almost as many first-thought responses as there are people to whom the question can be posed.

In its purest form, the term "biotechnology" refers to the use of living organisms or their products to modify human health and the human environment. Prehistoric biotechnologists did this as they used yeast cells to raise bread dough and to ferment alcoholic beverages, and bacterial cells to make cheeses and yogurts and as they bred their strong, productive animals to make even stronger and more productive offspring.

Throughout human history, we have learned a great deal about the different organisms that our ancestors used so effectively. The marked increase in our understanding of these organisms and their cell products gains us the ability to control the many functions of various cells and organisms. Using the techniques of gene splicing and recombinant DNA technology, we can now actually combine the genetic elements of two or more living cells. Functioning lengths of DNA can be taken from one organism and placed into the cells of another organism. As a result, for example, we can cause bacterial cells to produce human molecules. Cows can produce more milk for the same amount of feed. And we can synthesize therapeutic molecules that have never before existed.