Biotechnology sector irrespective of its boon and bane always secures a space in the news section. With many biotechnology firms operating globally, everyday either one or few of these companies makes in the news for its new innovations, novel therapeutics and its approval, shares, growth and expansion and so on. Here’s some collective news on happenings in different biotechnology firms this month.

Can-Fite, an Israeli public company found in the year 2000 which is into the development of oral bioavailable drugs of small molecules for the treatment of various inflammatory diseases and cancer has recently carried out agreements with 10 well progressed Pharma and biotech companies with regard to the commercialization of its product CF 101 developed to treat autoimmune inflammation disease and is looking forward to the result from its phase IIb clinical study in treating rheumatoid arthritis. The global market of therapeutics of rheumatoid arthritis is expected to rise from 12 billion dollars to 20 billion dollars in 2020 which will be significant for the growth of the can-Fite. Elseiver Business Intelligence has ranked the study of the drug CF 101 as the top autoimmune and anti inflammation project.

Piper Jaffery, a leading investment bank and asset management firm head quartered in Minneapolis is looking forward to diversify its biotechnology research area following the absorption of Mr. Josh Schimmer into the organization as Managing Director and senior research analyst who will concentrate on small and mid scale biotechnology firms dealing with therapeutics, its marketing and partnership strategies.

Plandai Biotech a research firm dealing with live plant extracts for a decade is stepping into the medical marijuana field with a new technology in hand to derive cannabis plant extracts with a focus to increase the bioavailability and purity of the extract. Plandia Biotech formed its subsidiary Cannabis Biosciences Inc exclusively to test and study the extract from the plant cannabis. The firm also claims that they could be able to obtain the psychoactive molecule from Cannabis which substantiates the medicinal property of the plant. Already the medicinal value of the plant triggered the idea of legalizing the use of the plant. In another 3 years the medical marijuana industries are likely to touch 9 billion dollars from the existing value of 1.3 billion dollars.

Natick biotech karyopharm therapeutics dealing with the drugs that boosts proteins (natural tumor suppressors), in a public offering raised $109 million.

Biotechnology market is as competitive as its innovations and there is no stop for research works and new innovations in this field.

3rd Biotechnology World Congress

Organisers: Eureka Science Ltd. and Higher Colleges of Technology

Dates: February 10th-12th, 2014

Location: Dubai Women’s College, Dubai, UAE

Website: http://biotechworldcongress.com/index.php

The website gives all the necessary information on abstract submission, fees, registration, conference agenda, hotel, exhibitions and other important facts.

Purpose of the conference
The conference aims to clarify the translational nature of biotechnological research. There will be emphasis on both the basic science as well as its applications in industry and academia. Latest researches, business development, strategic alliances, partnering trends, product opportunities, growth business models and strategies, licensing and pharmaceutical biotechnology (e.g. vaccines, CNS, cancer, antibodies), medical biotechnology, industrial biotechnology, bioprocess engineering, protein engineering, plant and environmental technologies, transgenic plant and crops, bioremediation, and microbial diversity research will be the subjects of discussion.

Important dates
Early Bird Registration: 30th September, 2013
Last date for accommodation request: 25th December, 2013
Last date of abstract submission for Lecture and Poster Presentation: 31st December, 2013
Last date of article submission for the Conference Proceedings: 12th February, 2014
Final Deadline for Registration: Registration forms received after 30th December 2013 will be processed as on-site and confirmations may not be sent.

Speakers

Plenary speakers
Ferid Murad (USA): NOBEL LAUREATE
Edmond Fischer (USA): NOBEL LAUREATE
Robert Huber (Germany): NOBEL LAUREATE

Invited speakers
Business Development: Su-Fen Yang (Taiwan)
Medical Biotechnology: Maher S. Amer (USA); Sherif M. Karam (United Arab Emirates); Tai-Horng Young (Taiwan)
Other Areas: Paolo Benanti (Italy); William H. Redd (Italy)
Pharmaceutical Biotechnology: Takeshi Imai (Japan); Mariusz Skwarczynski (Australia)
Plant and Environment: Chinnaiya Namasivayam (India)

Session speakers
Joachim Venus (Germany); Y.L. Gong (China); Mahmoud Ali Halablab (Lebanon); Laszlo Pusztai (Hungary); Ewa M Cukrowska (South Africa); K. Strzalka (Poland)

Topics:

Pharmaceutical Biotechnology: biopharmaceuticals discovery (CNS, cancer, cardiovascular, endocrine, immune); vaccines; antibodies; protein engineering.

Plant and Environment: transgenic plants and crops; bioremediation; microbial diversity; bio-monitoring; photosynthetic microorganisms, cyanobacteria and microalgae; translational genomics and Genomics-assisted Breeding

Industrial and Manufacturing: bio-fuels; energy crops (cellulosic ethanol industry); industrial enzymes; bioprocess engineering and optimization.

Medical Biotechnology: biopharmaceutical manufacturing; diagnostics; imaging; pharmacogenomics (personalized medicine); microarray technology; biomarkers.

Business Development: strategic alliances; partnering trends; product opportunities; growth; business models and strategies; licensing; merger and acquisitions; outsourcing; venture capital and financing; intellectual property.

Regenerative Medicine: stem cells, gene therapy; tissue engineering; cell based therapy; cell cultivation.

Marine Biotechnology: Environment applications of Marine Biotechnology; Marine Natural Products; Bioproducts and Bioactive Compounds; Marine Microbiology and Biodiversity; Marine-based Drug Discovery & development; Genomics and Proteomics of Marine Organisms; Aquatic Microbial Ecology.

Other areas: Food; Bio-safety; Systems Biology, Clinical Research/clinical trials; bioethics; nanobiotechnology.

Clustered Regularly Interspaced Short Palindromic Repeat Sequences (CRISPR) discovered in the year 1987 by Japanese scientists is no more a junk DNA. Yes, CRISPR is identified as an apt tool to cut and edit DNA which is a significant breakthrough in the field of genetic engineering, exciting gene scientists.

CRISPR when initially identified by scientists did not get its importance and was just left out as a junk DNA. Later the fact that CRISPR acting as a bacterial (prokaryotic) immune system fascinated the researchers which led to the detailed study. CRISPR being present as short direct repeats in bacteria and archaea was found to play the role of immune system enabling the prokaryotes to exhibit acquired immunity towards the foreign bodies like phages and plasmids. A part of the foreign DNA coined as spacers is embedded between the regions of CRISPR and stored as memory region which enabled the resistance of bacteria towards future attack by the foreign body.

It was found that CRISPR uses an enzyme called CRISPR associated enzyme (CAS) to chop of the genome of the phage molecule invading the bacteria and this unique property brought CRISPR into the lime light enabling various studies on this interesting piece. Finally, the collaborated work on CRISPR by research team from university of California, Berkeley headed by prof. Jennifer Doudna and the research team from Umea university Sweden headed by prof. Emmanuelle Charpentier ended up with a fascinating outcome that “CRISPR along with CAS9 enzyme can be employed to edit precisely any part of a genome”.

The whole act of editing a genome requires a CRISPR, a programmed RNA molecule and CAS9. With the help of the programmed RNA, CRISPR identifies the target region on the genome and CAS9 cuts the two strands of the DNA enabling the deletion of the sequences from the target region and allowing the insertion of the copied DNA into the target region. This method of gene editing is appreciated by all the gene scientists for its accuracy and flawlessness and is considered to revolutionize the field of genetic engineering.

Following the discovery by Prof. Doudna and team many other scientists tried gene editing using CRISPR in other species in a hierarchy from yeast to mice involving worms, flies and fish. The findings from the application of CRISPR system of gene editing in human cells by the researcher George Church from Harvard University inferred the positive outcomes in human medicine development.

The CRISPR-CAS9 gene editing system is very precise which enables even nucleotide level correction and hence it is outstanding from the existing methods of DNA cutting like the Zinc fingers, Talens and the use of restriction enzymes. Scientists are looking forward to develop gene therapies for various disorders like cancer, Down syndrome, Huntington’s disease and sickle cell anemia and are also discussing the possibility to treat HIV infection using this type of gene editing. They are also focusing on germ cell level gene correction and embryo level gene correction which may bring up some controversy.

From now, DNA scientists can rely on CRISPR-CAS9 tool to edit any region of human genome precisely.

A study published this week in the journal Veterinary Record from a research group in the Norwegian School of Veterinary Science suggests that the prevalence of respiratory diseases in cattle could be controlled. The study examined incidence of infection of cattle herds in Norway with the bovine respiratory synctial virus (BRSV), which is a major cause of respiratory infection in cattle.

BRSV is an enveloped, negative sense, single-stranded RNA virus of the pneumovirus genus and Paramyxoviridae family. Alone, this virus causes severe disease in calves. It also predisposes calves to secondary infections with bacteria including Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, resulting in bovine respiratory disease complex. This is the major cause of feed-lot cattle morbidity and mortality. It is reckoned it can cause losses to the cattle industry approaching $1 billion annually, with deaths to cattle along with reduced feeding efficiency, reproductive impact and milk production loss, as well as costs of vaccinations and treatments. On an immunological level, BRSV infection inhibits the CD8 T cytotoxic cell response and promotes a Th2 response, which can in turn further dampen the Th1 response. There have been some promising developments in terms of safe, stable, attenuated virus vaccine candidates. However, the epidemiology and evolution of the virus and the mechanisms by which it establishes infection are not fully understood.

The current Norwegian study looked at 134 herds. The herds were tested twice at intervals of six months and were classified as BRSV-positive if at least one animal between 150 and 365 days old tested positive for antibodies against BRSV. While the prevalence of positive herds at both samplings was high, at 34 per cent and 41 per cent, respectively, there was variation between regions. Importantly, negative herds were found in close proximity to positive herds and some of these remained negative even when new infections arose nearby, implying that it is possible to avoid herd infection even in proximity to infected herds nearby. In addition, one third of the herds that originally tested positive managed to get rid of the virus and tested negative on the next test.

The authors of the study suggest that prevalence and impact of BRSV could be reduced by employing effective surveillance of herds and putting a high biosecurity focus on the negative herds. Research on mechanisms of BRSV infection are therefore even more imperative.

Sources

GERSHWIN, L.J., 2012. Immunology of bovine respiratory syncytial virus infection of cattle. Comparative immunology, microbiology and infectious diseases, 35(3), pp. 253-257

KLEM, T.B., GULLIKSEN, S.M., LIE, K.- I. , LOKEN, T.,OSTERAS, O., and STOKSTAD, M., 2013. Bovine respiratory syncytial virus: infection dynamics within and between herds. Veterinary Record, 2013; DOI: 10.1136/vr.101936

SACCO, R.E. et al., 2013. Respiratory Syncytial Virus Infection in Cattle. Veterinary pathology, 2013

SARMIENTO-SILVA, R., NAKAMURA-LOPEZ, Y. and VAUGHAN, G., 2012. Epidemiology, molecular epidemiology and evolution of bovine respiratory syncytial virus. Viruses, 4(12), pp. 3452-3467

Norwegian School of Veterinary Science. "The prevalence of colds and pneumonia in cows can be controlled." ScienceDaily, 5 Nov. 2013. [Accessed 7 Nov. 2013]

Shares in the company Keryx Biopharmaceuticals' received a 20% boost this week following further positive results for its (CKD) drug Zerenex. Zerenex passed a Phase II trial on non-dialysis-dependent patients, opening up the possibly of broader indications for the drug when the FDA make a final decision on it in June of next year.

Zerenex is designed to treat hyperphosphatemia. This is a common problem among patients with CKD as one of the functions of the kidneys is to excrete excess dietary phosphate; therefore patients with CKD can suffer from phosphate overload and hyperphosphatemia. Hyperphosphatemia is a risk factor for vascular calcification, cardiovascular mortality, left ventricular hypertrophy, and CKD progression in CKD patients.

Zerenex passed phase III trials measuring reduction in serum phosphorous in end-stage renal disease patients on dialysis versus placebo earlier this year, leading to a boost in share prices. However, concerns had been growing that emerging generic competitors for Zerenex in dialysis patients, including Renvela (Sanofi) and Fosrenol (Shire), could erode its value. The latest Phase II results are on a less critically ill cohort of 149 anaemic, non-dialysis-dependent CKD patients. Significant reductions in their serum phosphorous and increases in their iron were observed over 12 weeks. Keryx are hopeful that these results will prompt the FDA to give the drug a labelled indication to treat a broader population of less critical CKD patients with iron-deficiency anaemia. Zerenex has tertiary benefits that Keryx are anxious to emphasise, including reduced need for intravenous iron and erythropoiesis-stimulating agents, which could help to distinguish it from its emerging generic competitors. However, Zerenex may still fact problems in being given New Chemical Entity status from the FDA as its active ingredient is very similar to that in Ferriseltz (Otsuka). Thus generic competition issues may become a problem for Keryx sooner than they would like.

Sources

http://www.fiercebiotech.com/story/keryx...2013-11-05 [Accessed 7 November 2013].

http://www.fiercebiotech.com/story/keryx...2013-01-28 [Accessed 7 November 2013].

GONZALEZ-PARRA, E., TUÑÓN, J., EGIDO, J. and ORTIZ, A., 2012. Phosphate: a stealthier killer than previously thought? Cardiovascular Pathology: The Official Journal Of The Society For Cardiovascular Pathology [Cardiovasc Pathol], 21(5), pp. 372-81.

Myriad Genetics, pioneer in molecular diagnostics lost its long fought battle to retain its patent protection on the gene BRCA1 and BRCA2 in June 2013 following the Supreme Court’s judgment stating that the isolated gene or gene sequences are not patentable for they are all naturally occurring. The verdict also stated that the synthetic DNA/ manmade DNA like cDNA and genetically engineered gene sequences are patentable.

The link between breast cancer and the genes BRCA 1 and BRCA2 was established in early 90’s by Myriad genetics and the company got its patent protection over these two genes from US patent and Trade Office. This triggered a legal battle between Myriad genetics, US Patent and Trade office, University of Utah Research Foundation on the one side and many associations like American Civil Liberties Union, Public patent foundation, Association for Molecular Pathology, ACMG, Breast cancer Action and Women’s Health Collective groups as opponents with the later groups appealing to the court to remove the patent protection of Myriad genetics over the BRCA1 and BRCA2 genes claiming that genes cannot be patented.

Starting in May 2009 over several appeals in Court of Appeals for Federal Circuit and hearings in the following years the verdict of Supreme Court in June 2013 “Naturally present human gene or gene sequences cannot be patented just because it is identified and isolated”, proves to have severe impact on industries and organizations involved in the development of innovative medicine, science and technology, biotechnology community and its principles of patenting. Though denied US patent protection on BRCA1 and BRCA 2 genes, Myriad genetics still possess the patents of the genes approved by Canadian IPO.

A similar verdict appeared in the district court of California on 3rd November 2013, in a case filed by Ariosa diagnostics against Sequenom diagnostics for its patent over its gene testing facility for Down’s syndrome. The verdict “natural phenomenon are not patentable” is not in favor of Sequenom diagnostics impacting the stocks held by the firm initiating the company to appeal in Court of Appeals for Federal Circuit.

The ultimate verdict that human genes cannot be patented will definitely be a game changer in the future prospects of biotechnology.

Hi! my supervisor wants me to use exosomes in our model and I am trying to follow the method of Nat. Protocols El-Andaloussi et al 2012 and Alvarez-Erviti Nat Biotech 2011 but I am not getting any silencing in the brain and I have just seen these comments in you tube and in this blog talking about fraud and saying that this papers should be retracted! who should I trust? does anybody know other protocol for brain delivery of siRNAs using exosomes? I am quite desperate! any advice would be greatly appreciated!

http://www.youtube.com/watch?v=Ry9kL-R-7E8
http://metamodern.com/2011/03/22/across-...-exosomes/

Cheers
Ana

2014 5th International Conference on Food Engineering and Biotechnology – ICFEB 2014

Organisers: Asia-Pacific Chemical, Biological & Environmental Engineering Society

Dates: 12th-14th March, 2014

Location: The Gurney Resort Hotel & Residences Penang, Malaysia

Website: http://www.icfeb.org/index.html
The website gives all the necessary information on fees, registration, conference agenda, hotel, exhibitions and other important facts. Registration is currently open.

Important dates:
Paper Submission (Full Paper): Before 20th November 2013
Notification of Acceptance: 10th December 2013
Final Paper Submission: Before 30th December, 2013
Authors' Registration: Before 30th December, 2013
Academic Official Visit (Half Day): 14th March 2014

Purpose of the conference
To promote research and developmental activities in Food Engineering and Biotechnology and promote scientific information interchange between researchers, developers, engineers, students, and practitioners working in Malaysia and abroad.

Topics to be covered in conference sessions:

Topics of interest for submission include, but are not limited to:

Microbiology
Microorganism technology
Bioremediation of polluted sites
Agricultural Biotechnology
Food Biotechnology
Environmental Biotechnology
Pharmaceutical Biotechnology
Industrial Biotechnology
Medical Biotechnology
Nano Biotechnology
Marine Biotechnology
Animal biotechnology
Plant biotechnology
Bioinformatics
Enzyme Engineering
RNA and DNA structure and sequencing
Gene regulation
Gene expression databases
Biomedical Computational drug discovery
Protein and gene delivery systems
Cell and tissue engineering
Artificial organs and implants
Bio-MEMS and micro bioreactors
Medical and biological devices
Biosensors and molecular diagnostics
Drug screening and pharmaceutical synthesis
Biocatalysis, organocatalysis and nanobiotechnology
Biological and biomedical imaging
Biomimetic and self-assembled materials
Nanoparticles, nanocomposites, and nanoporous materials for bio-applications
Nanoparticle sequestration in biomolecules
Heat, mass transfer and fluid flow in food processing
Plant design using conceptual design techniques
Food properties including thermal, chemical and mechanical properties
Food microstructure development and characterization
Food biotechnology
Electronics and instrumentation in food industry
Food engineering education
Control and system engineering for food industry
Heat, mass transfer and fluid flow in food processing
Food microstructure development and characterization
Mathematical modelling and software development for food processing purposes
Application of artificial intelligence in food engineering research and in industry
Food biotechnology
Thermal processing
Non-thermal food processing
Separation and purification processes for food production
Food engineering education
Plant design using conceptual design techniques
Mathematical modeling and software development for food processing purposes

Publication opportunity:
All ICABT 2013 papers will be published in the journal IPCBEE, ISSN: 2010-4618), and included in the Engineering & Technology Digital Library, and indexed by Ei Geobase(Elsevier), Ulrich's Periodicals Directory, EBSCO, CABI, CNKI (中国知网), WorldCat, Google Scholar,Cross ref, and sent for review by Compendex and ISI Proceedings.

2013 International Conference on Agriculture and Biotechnology (ICABT 2013)

Organisers:
Asia-Pacific Chemical, Biological & Environmental Engineering Society

Dates: 29th-30th December 2013

Location: Coronade Hotel, Kuala Lumpur, Malaysia

Website: http://www.icabt.org/

The website gives all the necessary information on fees, registration, conference agenda, hotel, exhibitions and other important facts. Registration is currently open.

Important dates:
Notification of acceptance of submitted papers: 30thOctober 30, 2013
Authors' Registration: Before 20th November, 2013
Final paper submission: Before 20th November, 2013

Purpose of the conference:
To provide a platform for researchers, engineers, academics and industrial professionals from all over the world to present their research results and development activities in Agriculture and Biotechnology

Topics to be covered in conference sessions:
Topics of interest for submission include, but are not limited to:
Advanced Machine Systems
Agricultural Biotechnology
Agricultural Ergonomics
Agricultural Production and Food Safety
Agricultural systems
Agricultural waste management
Agro-industry
Animal Agriculture in the Globe
Animal Health & Welfare
Animal Protein and fibre products
Aquaculture and Biosystems Research
Biological natural resource engineering
Bio-machine systems
Bioprocess and Biosystems
Biotechnology for Livestock, Pests and Aquaculture
Biochemical Engineering
Biotechnology
Product Engineering in the Bio Industries
Self-organisation in the Bio-sciences and elsewhere
Delivery of the final product
Biotechnology applied to production of new and better quality food
Physical chemistry and thermodynamics for life sciences and biotechnology
Improvement of environmental remediation processes
Food process technology and engineering
The impact of bio-based polymeric materials
Biochemical and bio-molecular engineering
Bioengineering and biomedical engineering
Biological and Medicinal Chemistry
Energy and environment
Forest product processing
Milk product processing

Publication opportunity:
All ICABT 2013 papers will be published in the journal IPCBEE, ISSN: 2010-4618), and included in the Engineering & Technology Digital Library, and indexed by Ei Geobase(Elsevier), Ulrich's Periodicals Directory, EBSCO, CABI, CNKI (中国知网), WorldCat, Google Scholar,Cross ref, and sent for review by Compendex and ISI Proceedings.

A variant of the fungal plant disease Fursarium wilt or Panama disease, which has been causing serious damage to banana crops in South-East Asia, has been found to have spread to Jordan, according to a new study in the journal Plant Disease. Panama disease is caused by the fungus Fusarium oxysporum f. sp. cubense (Foc). This development increases concerns that banana crops worldwide could be under threat, with the potential for devastating economic and human cost in areas including Latin America and Africa.

In the previous century, Foc ravaged banana plantations in Latin America, which were based on the ‘Gros Michel’ cultivar. This cultivar was replaced by Cavendish cultivars, which were resistant to Foc. However, in 1992 a new Foc variant termed tropical race 4 (TR4) was identified in South-East Asia which affects the Cavendish clones. TR4 has spread throughout the region and concern has grown that it may spread to other regions including Latin America and Africa. In Africa, bananas represent a vital dietary component and any threat to bananas would have huge consequences in terms of food security in the region.

The outbreak in Jordan was confirmed to be TR4 by the research group of Dr. Gert Kema of Plant Research International B.V/ Wageningen University in the Netherlands in collaboration with the University of Florida and centres in Jordan including Plant Protection (NCARE) and the University of Jordan. Selective culturing techniques followed by total DNA extraction and polymerase chain reaction (PCR) were employed by the Dutch group on the Jordanian samples and the disease-causing agent was confirmed as TR4 after comparison to control samples. The researchers point out that this is the first confirmed outbreak of TR4 affecting Cavendish cultivars outside South-East Asia and is the most northerly outbreak. Some 80% of Jordanian banana plantations are now affected by Panama disease. Dr Kema is concerned at what this spread represents in terms of international banana cultivation and has stated that "A concerted international approach is now needed to prevent the spread of Panama disease and, in the worst-case scenario, contain it."

Sources

GARCIA, F.A., ORDONEZ, N., KONKOL, J., ALQASEM, M., NASER, Z., ABDELWALI, M., SALEM, N.M., WAALWIJK, C., PLOETZ, R.C. and KEMA, G., 2013. First Report of Fusarium oxysporumf. sp.cubenseTropical Race 4 associated with Panama Disease of banana outside Southeast Asia. Plant Disease, 2013: DOI: 10.1094/PDIS-09-13-0954-PDN

Wageningen University and Research Centre. "Banana disease spreading: Panama disease spreads among bananas again." ScienceDaily, 4 Nov. 2013. [Accessed 4 Nov. 2013].

Organisers: Biotechnology Industry Organization (BIO)

Dates: June 23rd -26th, 2014

Location: San Diego Convention Centre, San Diego, California, USA

Website: http://convention.bio.org/

The very detailed website gives all the necessary information on abstract submission, fees, registration, conference agenda, hotel, exhibitions and other important facts.

Purpose of the conference

The key elements of the event are listed as education, networking and BIO Business Forum partnering. 1,600 companies will be showcasing technologies, products and services in the BIO Exhibition. One third of BIO attendees come from outside the U.S.A, offering a truly international perspective and bringing together life science leaders and policy makers from around the globe. Many networking events are scheduled, facilitating the forging of new connections.
The BIO International Convention is the largest global event for the biotechnology industry, with 16500 attendees in 2012. It features keynotes and sessions from key policymakers, scientists, CEOs, and celebrities. Past speakers include President George W. Bush, President Bill Clinton, Former Prime Minister of Great Britain and Northern Ireland Tony Blair, Michael J. Fox, Sir Elton John, Her Majesty Queen Noor of Jordan, and General Colin Powell. The Convention also features the BIO Business Forum (One-on-One Partnering), hundreds of sessions covering biotech trends, policy issues and technological innovations, and the world's largest biotechnology exhibition - the BIO Exhibition.
In 2012, attendees came from thousands of organisations ranging from leading biotech companies, top 25 pharma companies, top 20 CROs and CMOs, more than 300 academic institutions including the major research labs and government agencies and the leading consultants and service companies.

Important dates

Registration opens January 2014.
Housing opened on October 16, 2013
2014 BIO International Convention Call for Sessions was opened September 5 and closed October 14, 2013; grading process for submissions closes in late 2013
International Market Briefings Call for Sessions is taking place from October 14 through November 4, 2013.

Attendee Key Technologies and Product Categories:
 Plant & Animal Made Pharmaceuticals
 Gene/Cell Therapy
 Bioinformatics
 Genomics/Genetics
 Biomanufacturing
 Medical Devices
 Cell Biology
 Nanotechnology
 Clinical Research & Lab Services
 Platform Technologies
 Chemistry
 Stem Cell Research
 Drug Delivery
 Tech Transfer
 Drug Discovery & Development

Roche and their partner Biogen Idec have just achieved the FDA ‘breakthrough’ designation for their cancer drug GA101, now named Gazyva, a month ahead of the FDA’s stated decision date of December 20th. Gazyva, which was developed by the Roche-owned Genentech, is a successor to Roche’s multi-billion dollar selling drug Rituxan (rituximab) and is designed to treat patients with chronic lymphocytic leukaemia (CLL). Both of these drugs are CD20 monoclonal antibodies but Phase III clinical data shows that, in combination with the chemotherapeutic drug chlorambucil, Gazyva was more effective than Rituxan in extending survival of CLL patients without any worsening of their cancer and Gazyva plus chlorambucil was more than twice as effective as chlorambucil alone in effecting progression-free survival. The news is all the more welcome to Roche as biosimilars from other companies are likely to begin to eat into sales of Rituxan. Industry analysts estimate that Gazyva will be worth $1.5 billion to $2.5 billion a year to Roche at peak sales.

As anti-CD20 antibodies, GA101 and rituximab target cancer cells. However, pre-clinical data already indicated that GA101 was more effective than rituximab in harnessing the immune system in fighting tumour progression in in vitro assays, particularly in terms of antibody-dependent cell-mediated cytotoxicity (ADCC). This enhanced ADCC activity has been linked to the decreased ability of GA101 to fix complement relative to rituximab. In serum, complement blocks rituximab-induced natural killer (NK) cell activation but not GA101-induced ADCC. In SU-DHL4 and RL xenografts in vivo models, GA101 was strongly anti-tumourigenic and effected complete tumour remission in the SU-DHL4 model. Its overall efficacy was superior to both rituximab and ofatumumab, another approved anti-CD20 antibody, and it remained able to control tumour progression in animals that had been pre-treated with rituximab whereas the tumours were resistant to second-line treatment rituximab treatment. Meanwhile, Phase II data on GA101 was positive in terms of both efficacy and safety of the drug.

The Phase III data on cancer-free survival has ensured the drug’s breakthrough designation for CLL, but Roche and Genentech are confident it will have applicability in other blood cancers. Medical chief Hal Barron stated: "We have spent 20 years researching blood cancer medicines, and we will continue to study Gazyva to assess its efficacy in other types of blood cancers."

Sources
HERTER, S. et al., 2013. Preclinical Activity of the Type II CD20 Antibody GA101 (Obinutuzumab) Compared with Rituximab and Ofatumumab In Vitro and in Xenograft Models. Molecular Cancer Therapeutics, 12(10), pp. 2031-2042

KERN, D.J. et al., 2013. GA101 induces NK-cell activation and antibody-dependent cellular cytotoxicity more effectively than rituximab when complement is present. Leukemia & lymphoma, 54(11), pp. 2500-2505

MORSCHHAUSER, F.A. et al., 2013. Obinutuzumab (GA101) monotherapy in relapsed/refractory diffuse large b-cell lymphoma or mantle-cell lymphoma: results from the phase II GAUGUIN study. Journal Of Clinical Oncology: Official Journal Of The American Society Of Clinical Oncology, 31(23), pp. 2912-2919

RADFORD, J. et al., 2013. Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000). Blood, 122(7), pp. 1137-1143

http://www.fiercebiotech.com/story/roche...2013-11-01 [Accessed 3 November 2013].

http://www.fiercebiotech.com/story/roche...2013-07-24 [Accessed 3 November 2013].

Public health care is an emerging market. This is being recognized globally and particularly in India. India is becoming patient destination from all parts of the world because of its health infrastructure and technical skill in health sector. Recent development in the sequencing technology leads to the drastic reduction in the cost and time in sequencing the human genome. This led to the surge in the investment to tap the promising market associated with genomics. One of the applications of this area of genomics is in the clinical field. It is expected to bring a revolutionary shift in the treatment and management of many diseases. The prime question is how realistic this expectation is. What are the promises and challenges for this technology in the application in public health care system? Are we addressing these issues?

The recent case of Angelina Jolie, a celebrity in US, has bought the public attention for the application of genomics for the clinical genomics. She had undergone surgery to remove her breast to avoid the risk for breast cancer. The scientific basis for this decision was a genetic test which showed a mutation in BRCA1 and BRCA2. This mutation has been shown to increase the risk for breast cancer. Such incidence will definitely push the efforts to implement this technology for clinical need in society.
The efforts to tap this market have already been started. There has been increase in the investment both in the opening of new laboratory to provide the gene sequencing service and to propose new tests for the clinical purpose. It is therefore important to explore the potential benefits and limitation of this technique.

The clinical practice to use the genetic test for the diagnostic purpose is not new. One of the successful uses of genetic test is the identification of Huntington disease (previously referred to as Huntington’s chorea). Huntington disease (HD) is a neurodegenerative disorder characterized by nervous and motor degeneration. The affected person eventually succumbs to the disease later in life. The genetic cause of the disease was identified. The gene responsible for the disease contain the trinucleotide CAG repeat 10 to 35 times in normal individual which increases (>100) in the affected person. So genetic test identifies the disease well before it manifests which enable the person and the family to take appropriate decision. The current advancement in the technology promises a new hope to manage and treat diseases. This technology has a potential application in the personalized treatment by the drug. It is a general observation that some individual responds well to a particular therapy but the other persons do not respond well to the same therapy. If we know the genetic basis for the behavior, we could treat a patient based on their genetic makeup. This will definitely bring a paradigm shift in the therapy of disease. Unfortunately there are not many successful cases as the Huntington disease (HD).So the natural question is to develop a framework to identify and validate the genetic tests so these can be used for the clinical intervention.

A genetic test can be only validated if the proper research has been conducted across ethnicity, race and geographical boundaries. This requires the development of an institution which inspect and regulates the entire processes. The conclusion drawn by few centers and publication must not be sufficient to design a new genetic test. Since genetic tests are expensive, these should only be suggested to patient if these are required and provide a necessary therapeutic advantage.

There is also need to examine the state of medical institution that plays very critical role in the implementation of genetic tests to the patients. There is a need to see whether the present curriculum is sufficient to make the new medical graduates aware of the genetic issues. So far the genetics has not been a focus area in the medical curriculum. Without the proper technical expertise, any clinical intervention will not be successful.

In US ,the Federal Food and Drug Administration Federal Food and Drug Administration (FDA) regulates the development of new tests.US congress has passed a bill in 1988 which regulates the development and the implementation of the genetic test. In India CDSCO (Central Drug Standard Control organization ) is the organization to regulates the development of new genetic test in India. It is required that these institution should take the proper initiative so that the issues involved in the development and implementation of genetics tests should be recognized and necessary regulation should be in place.

One can not deny the fact that the clinical genomics promises a new opportunity to bring a new hope for many diseases and patients. This will definitely improves the quality of the patient if implemented properly. At the same time there are many concerns which needs to be recognized. It will be important for the people to see how the country and society take the new challenges associated with clinical genomics.

A study published on October 31st in the Journal Advanced Functional Materials describes a Vitamin E-based hydrogel that facilitates sustained delivery of the Roche breast cancer drug Herceptin. The hydrogel was developed by a team from the IBM Almaden Research Center, San Jose, in the USA and in the Institute of Bioengineering and Nanotechnology in Singapore, who consider that it has potential for more general applicability in subcutaneous, sustained delivery of antibodies.

Herceptin (trastuzumab) is an anti-HER2 (ErbB2) receptor monoclonal antibody. HER2 is a member of the epidermal growth factor receptor (ErbB; EGFR) family, which is the pathway most explored as a next-generation breast cancer therapy target. HER2 is overexpressed in 20% to 25% of breast cancer cases and is associated with poor prognosis. Herceptin treatment has been shown to dramatically reduce relapse rates in these patients, although a subset of patients display primary drug resistance while many patients who initially respond to Herceptin ultimately suffer disease progression. The FDA has approved use of Herceptin in combination with other anti-HER2 agents such as pertuzumab, and docetaxel.

The current study in Advanced Functional Materials addressed the issue of patient compliance by potentially reducing the number and duration of the Herceptin antibody injections from the currently required weekly regime to a possible monthly schedule. ‘ABA’-type triblock copolymers composed of vitamin E-functionalized polycarbonate and poly(ethylene glycol), i.e., VitEm-PEG-VitEm, were used to make the injectable hydrogels. In vitro, the Herceptin-loaded hydrogels were shown to target HER2-overexpressing cancer cell lines as opposed to normal or other breast cancer cell lines. Cytotoxicity was comparable to that of Herceptin solution. In vivo, in BT474 HER2-loaded tumour-bearing mice, a single subcutaneous injection of Herceptin-loaded hydrogel near the tumour enhanced Herceptin retention and resulted in an anti-tumour effect which was superior to that of intravenous or subcutaneous Herceptin solution delivery. Even if the hydrogel was delivered distal to the tumour, the anti-tumour effect was comparable to that of weekly Herceptin intravenous injections over four weeks.

Thus this research offers a potential breakthrough in drug delivery and patient compliance not only in relation to Herceptin but also in delivery of antibody-based therapies in other diseases. The IBM research leader Yi Yan Yang stated "… our approach may help to improve patient compliance, offering a better alternative to existing breast cancer treatments. This technology can also be used to deliver other types of antibodies or proteins to treat different diseases." Currently, the researchers have filed a patent for their hydrogel technology and are seeking pharmaceutical partners in order to further the development of the hydrogel for clinical use.

Sources

BLUMENTHAL, G.M. et al., 2013. First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer. Clinical Cancer Research: An Official Journal Of The American Association For Cancer Research, 19(18), pp. 4911-4916

CHUNG, A. et al., 2013. Current status of anti-human epidermal growth factor receptor 2 therapies: predicting and overcoming herceptin resistance. Clinical Breast Cancer, 13(4), pp. 223-232

JELOVAC, D. and EMENS, L.A., 2013. HER2-directed therapy for metastatic breast cancer. Oncology (Williston Park, N.Y.), 27(3), pp. 166-175

LEE, A.L.Z. et al., 2013. Injectable Hydrogels from Triblock Copolymers of Vitamin E-Functionalized Polycarbonate and Poly(ethylene glycol) for Subcutaneous Delivery of Antibodies for Cancer Therapy. Advanced Functional Materials, , pp. n/a-n/a

NAHTA, R., 2012. Pharmacological strategies to overcome HER2 cross-talk and Trastuzumab resistance. Current medicinal chemistry, 19(7), pp. 1065-1075

http://www.fiercedrugdelivery.com/story/...2013-10-31 [Accessed 31 October 2013].

Merrimack Pharmaceuticals, a Cambridge Massachusetts biomedical company has announced that its drug MM-121, an ErbB3 antibody, did not meet the meet the primary endpoint in a recent Phase II trial. This has had a negative effect on Merrimack share prices. The open-label, randomised trial was carried out to test the effectiveness of MM-121 (SAR256212) in combination with paclitaxel in patients with platinum-resistant or refractory advanced ovarian cancers. The primary end-point was progression free survival (PFS) in the overall population. However, the company announced that in a sub-population of patients who were positive for a combination of two biomarkers, the use of MM-121 may be of benefit. These biomarkers are linked to ErbB3 signalling. Merrimack entered into an exclusive global license and collaboration agreement for MM-121 with Sanofi in 2009.

ErbB3 (HER3) is a member of the epidermal growth factor receptor (ErbB; EGFR) family. Its expression has been linked to decreased survival in ovarian cancer. It is an activator of phosphoinositide 3-kinase (PI3K) signalling in ErbB1 (EGFR), ErbB2 (HER2) and [hepatocyte growth factor receptor (MET)] addicted cancers. ErbB3 reactivation has been identified as a mechanism by which cancers become resistant to ErbB inhibitors. While targeting of the EGFR family generally had shown limited clinical efficacy in ovarian cancer, studies supported the hypothesis that ErbB3 supports ovarian cancer cell growth and proliferation. RNA interference studies on primary ovarian cancers and ovarian cancer cell line suggested that in a subset of cells, ErbB3 participates in an autocrine signal-transducing loop involving neuregulin 1 (NRG1). Interference with this loop results in decreased cell growth in a three-dimensional cell culture model in vitro and a decrease in disease progression and increased survival in vivo in a xenograft mouse model of ovarian cancer. Use of MM-121 in this in vivo model resulted in a significant inhibition of tumour growth. MM-121 in cancer cell lines blocked ErbB3 ligand-dependent activation induced by ERbB1, ErbB2 or MET. It was most effective both in vitro in the cell lines characterised by ligand-dependent activation of ErbB3 and also in vivo against xenografts in which there was evidence of ligand-dependent ErbB3. A lung cancer mouse model which had become resistant to cetuximab, along with increased heregulin expression and ErbB3 activation, remained sensitive if cetuximab treatment was accompanied by MM-121 treatment. In this case, ErbB3 reactivation was blocked. Therefore, the finding in the Phase II trial of MM-121 with paclitaxel that a sub-population of ovarian cancer patients with biomarkers mechanistically linked to ErbB3 signalling may benefit from the drug despite the failure to hit the primary end-point target for the whole cohort was somewhat consistent with pre-clinical studies. The goal of using MM-121 is to inhibit ErbB3 signalling, thereby restoring sensitivity, delaying resistance and enhancing the anti-tumour effect of a therapeutic partner such as paclitaxel.

The failure on the primary end-point in the ovarian cancer Phase II trial followed a previous failure in another Phase II trial to hit a primary end-point of 40% progression-free survival rate at four months in 50 patients with non-small cell lung cancer patients whose disease had "progressed on an anti-EGFR tyrosine kinase inhibitor." However, Gavin MacBeath, the co-founder and Vice-President of translational research at Merrimack is “encouraged by the biomarker findings in this trial, which are consistent with our preclinical hypotheses.” Evaluation of the drug, in partnership with Sanofi, continues on second line ER/PR+ metastatic breast cancer, ER/PR+ neoadjuvant breast cancer, triple-negative neoadjuvant breast cancer and on other non-small cell lung cancer cohorts.

Sources

SCHOEBERL, B. et al., 2010. An ErbB3 antibody, MM-121, is active in cancers with ligand-dependent activation. Cancer research, 70(6), pp. 2485-2494

SHENG, Q. and LIU, J., 2011. The therapeutic potential of targeting the EGFR family in epithelial ovarian cancer. British journal of cancer, 104(8), pp. 1241-1245

SHENG, Q. et al., 2010. An activated ErbB3/NRG1 autocrine loop supports in vivo proliferation in ovarian cancer cells. Cancer Cell, 17(3), pp. 298-310

TANNER, B. et al., 2006. ErbB-3 predicts survival in ovarian cancer. Journal Of Clinical Oncology: Official Journal Of The American Society Of Clinical Oncology, 24(26), pp. 4317-4323

http://www.fiercebiotech.com/story/sanof...2013-10-30 [Accessed 30 October 2013].

http://www.fiercebiotech.com/press-relea...-sar256212 [Accessed 30 October 2013].

The pain killer Zohydro ER (Hydrocodone bitartrate), the extended release capsules by Zogenix got approval from the Food and Drug Administration on 25th October 2013 leaving behind many criticisms. The reason is that the hydrocodone, the main ingredient of the pain killer Zohydro ER is classified under opiate/opiod group of drugs for its structural resemblance to the opium and also recognized as the abused pain killer by Drug Enforcement Administration (DEA).

Though a hydrocodone combination of painkillers already exists in the market, Zohydro ER gets the status of the first drug with pure hydrocodone, ultimately being the cause of reluctance in acceptance of its approval by many individual bodies like patient safety advocates, pain specialist panel and community groups functioning towards protecting youths from pain killer addiction. Even there was a negative feedback on drug review from FDA’s own advisory panel previous year.

Taking all these into account FDA has taken steps to ensure the safe use of the drug. A day before the approval, FDA suggested enlisting the hydrocodone in schedule II drugs and accordingly FDA stated that the sale of the drug Zohydro ER will stick to schedule II drugs regulations. FDA has also instructed Zogenix, to keep a continuous check on the usage of the drug in the market.

Being the manufacturer of the drug Zohydro ER, the need and responsibility of Zogenix to ensure the safe use of the drug is high. As a result Zogenix has implemented several programs like Risk evaluation and Mitigation Strategy and integrated educational resources (on the drug) exclusively for patients, doctors and pharmacists and a drug surveillance program. Zogenix is also committed to carry out post market studies on the drug Zohydro ER and also into the process of making abuse deterrent formulation for the drug.

With all the controversies and compliments the hydrocodone drug designed in six different dosages to relieve patients from the long term severe pain has influenced a raise in the company’s shares following its approval. However the dignity of the drug in the market should be ensured by sticking to the guidelines framed by FDA and the commitment made by Zogenix .

Traditional medicine or alternate medicine, as known today, can be defined as the knowledge acquired for treatment of various mental and physical health, through many generations and from different societies. Since time immemorial man and animals have relied on Mother Nature for remedies to various ailments. Nature seem to have provided the requirements in its bountiful diversity that makes this world sustainable. There are written texts or knowledge about the use of plants as medicine. Ancient Indian and Chinese texts have listed a number of species of plants and animals that in some capacity, has medicinal properties. Chinese have a strong knowledge for use of biological products for different diseases. As a matter of fact, people all over the world depend upon traditional medicine in some capacity today.

Pharmaceutical products derived from plants occupies a major share in the medicine market today. More than 25% of the medicines are derivatives of plant products either directly or indirectly. In case of certain sections of drugs such as antitumor or antimicrobial medicine, the percentage may be as high as 60%. A number of developed countries such as Germany, USA, Canada, France and Australia as well as developing countries like Ethiopia, Myanmar, Mali, India etc. has a large chunk of the population who rely on herbal medicine for cure to common ailments. According to WHO estimate, the global market for traditional medicine grew from $706 million in 1999 to a staggering $1006 million within a span of two years. The growth of the market in traditional medicine reflects a view that the general population still believes that this alternate form of medicine works.

There are drugs derived from plant sources which caused a major impact to human health. Artemisia annua, which the Chinese have been using as a traditional medicine for cure against fever, jaundice and headache, was used to isolate a drug Artemisinin. Artemisinin is a major antimalarial drug that is currently in use. Other example is paclitaxel (Taxol) which is a chemotherapeutic drug used against cancer derived from Taxus brevifolia.However, a plant part or plant extract used in traditional medicine is a combination of a plethora of biochemical, which can have detrimental effect on health. Such is the case, when the US FDA warned against invalidated use of such products. The capacity of modern experimentation combined with the traditional herbal medicine can be an answer to this issue. Biotechnology based approach for screening of such medicinal plants and its product can promote a sense of validation and value addition to the already known system of medication. Modern high throughput bioassay guided system of screening can lead to fast discoveries and isolation of bioactive compounds from such sources. Such approaches are currently in progress at different laboratories around the world.

Not only can experimentation with cultured animal cells in the laboratory be used for effect of such plant products on human cells, biotechnology can be applied for enhancement of the biologically active compounds. Plants which are known to have medicinal properties can be propagated in large numbers in a short duration of time using plant tissue culture, which has the capacity to produce millions of genetically and physiologically identical plants from a fragment of tissue. Plant tissue culture bypasses the natural cycle of reproduction which can be detrimental in some way, by mixing of unwanted genes or the long reproduction cycle of plants. Moreover, it can help in conservation of the plant species of interest as human greed can destroy the entire population.

Another application of plant tissue culture is to isolate the drug from suspension culture. It is a type of cell culture in which individual plant cells are grown in a liquid medium for a definite period of time. The conditions of growth are properly monitored and the right environment for maximum production of the compound are provided. The advantage of this technique is that, there will be uniformity in production of the desired products as the condition is standardized by different methods of experimentation, maximum production can be obtained, purification is much simpler as compared from a whole plant, and above all the requirement of growing the plants in fields, harvesting and processing of it is drastically minimized. This causes a considerable reduction in time and manpower with increase in production of the drug.

In a molecular approach, the genes coding for the desired product can be enhanced for maximum productivity. A method called combinatorial biosynthesis in which genes from different organisms are put together for synthesis of a novel plant product of pharmaceutical value. This method can be used for synthesis of new drugs as well as for enhancement of efficacy of existing drugs. With the ongoing rate of development in modern experimentation methods and our rich flora of medicinal value an arsenal of drugs can be rapidly added for fight against various diseases.

Zostavax, Zoster Vaccine Live - the brain child of Merck and co received the Prix Galien USA award for the best biotechnology product of the year 2013.

Zostavax, the drug found by Merck to treat a type of viral disease called Shingles caused by Varicella Zoster Virus got its FDA approval in the year 2006. Initially the drug was approved for the age group of 60 years and above and was recommended for the people in the age group of 50 – 59 years in the year 2011 following FDA’s approval.

Shingles can be called as the second phase of chickenpox. With an episode of chickenpox, the virus remains in the dormant form in the affected individual and becomes active due to factors like poor immune system, age or some type of medication. In such a case the virus will cause the condition shingles, with symptoms like headache and flu followed by appearance of rashes on the skin which turns into blisters over the period. Merck delivered its product Zostavax to treat Shingles with a nod from FDA.

The prix Galien award is given every year as recognition of the excellence in new medicine development to the pharmaceutical industries by the Prix Galien foundation under various categories. Prix Galien was found in the year 1969 by Roland Mehl in the memory of Galen, the father of innovative medicine and science and pharmacology. Merck’s product Zostavax is awarded the best biotechnology product of the year 2013 by Prix Galien.

Merck is pioneer in products like prescription drugs, vaccines, biological therapies, consumer care and veterinary health. This is not the first time Merck is recognized by Prix Galien. Yes, in the past seven years the company has received the awards five times from Prix Galien and this is the 6th award. The earlier awarded Merck’s products and the year of award are,
JANUVIA, a type II diabetes drug – 2007
GARDASIL, a drug against HPV – 2007
ISENTRESS, an antiretroviral drug – 2008
ROTATEQ , vaccine against rota virus -2010
VICTRELIS, HCV protease inhibitor – 2012 and

Now the 2013 award for the ZOSTAVAX vaccine received by Merck is another feather in the cap. The President of Merck Research laboratories Dr. Roger M Perlmutter, acknowledges the work of all the Merck employees who made this award possible.

The long awaited approval by Actelion pharmaceutical for its pulmonary Arterial Hypertension drug (PAH), Opsumit is sanctioned by FDA.

Actelion Pharmaceuticals filed its first application with FDA seeking approval for its drug Opsumit (Macitentan) on 22nd October 2012 and received the FDA’s acceptance of the application in December 2012. Following this sequence of procedures, Actelion got the approval from FDA for Opsumit on 18th October, 2013 which had an impact of 7% rise in its shares. The 14 years of untiring effort by Actelion towards drug discovery for Pulmonary Arterial Hypertension reaped its success by FDA’s approval for Opsumit.

Pulmonary Arterial Hypertension is a condition indicated with a pulmonary arterial pressure increasing above 25 mm Hg when the individual is at rest and above 30 mm Hg with physical activity. The blood flows from the heart to the lungs through pulmonary arteries and in case of pulmonary arterial hypertension, the blood vessels thickens in the lungs restricting the blood flow from heart to the lungs resulting in the increased pressure in the lungs. The severe condition of PAH requires lung transplantation or it could be fatal.

Actelion pharmaceutical proudly presents the endothelin receptor blocker drug Opsumit which reduces the blood pressure in the lungs by relaxing the pulmonary arteries and also claims Opsumit as an effective oral drug to treat people with pulmonary arterial hypertension. The cost of this drug is almost similar to its predecessor drug Tracleer.

Actelion warns the use of this drug in pregnant women as it may affect the fetus and also ensures the safe use of this drug on female patients through a program called Opsumit Risk Evaluation and Mitigation Strategy (REMS). This program demands practitioners prescribing this drugs and pharmacists supplying this drug to be certified through this program thus ensuring the safety of the drug. Some of the side effects of Opsumit are decline in RBC, common cold and flu, bronchitis and UTI.

The entry of Opsumit into the drug market is of greater importance to the patients treated for PAH, as this drug is known to delay the progression of the disease.

Food additive as a clue to the drug discovery against the most dangerous avian flu virus H7N9