Pfizer director defends virtual trial after recruitment struggle
By Nick Taylor+
06-Mar-2012
Related topics: Clinical evolution, Clinical Development, Phase III-IV
The head of Pfizer's virtual clinical trial has defended the project after its initial failure to recruit patients raised questions about its viability.
Approval of the trial, which allows patients to take part remotely, was hailed as a big step in the evolution of clinical research. However, since gaining approval the study has met problems.
“It didn't recruit”, Miguel Orri, senior director of clinical sciences at Pfizer, said at Partnerships in Clinical Trials in Orlando, Florida. After working towards approval for two years the setback was dispiriting for the Pfizer team.
Orri said problems stemmed from a failure, possibly caused by the team's regulatory focus, to appreciate what patients need. Aspects of the process were “quite complicated and tedious”, Orri said, and Pfizer has learned that patients are still wary putting lots of their health information online.
In response to these realisations Pfizer has revamped the model. A call centre now helps patients through the initial steps and Pfizer is receiving feedback from participants to help shape its plans for the virtual trial model.
Since making the changes Pfizer has seen an “immense inflow of subjects”, Orri said, but the delay means it is behind on its goal of recruiting 600 patients in the US. Despite the setback Pfizer is implementing plans to expand the trial into Europe.
The European trial, REMOTE 2.0, will learn from the mistakes of the US study. Pfizer wants to contract a recruitment vendor to help patients through the initial setup process to end the obstacles experienced in the US.
In a sign that Pfizer is considering the specific needs of the patient population, all participants in the European trial will receive a communication device. The device is like a simplified iPad and the idea is to help patients, particularly older woman from Southern Europe, who spend little time online.
“I don't think we've failed”
In the two years the Pfizer team spent working towards approval it faced internal skepticism, with Orri often being told the project was unfeasible. The struggle to recruit patients could give credence to these views but Orri was quick to defend the trial.
“I don't think we've failed. We have created a new online informed consent process I think we can use in many studies in the future”, Orri said. By taking a modular approach to the methods and tools used in REMOTE trial Pfizer can add effective virtual elements to its other clinical research projects.
The US Food and Drug Administration (FDA encouraged this approach by telling Pfizer to validate all tools used in the trial, Orri said. After talking about the trial FDA officials told Pfizer to “milk the study”, Orri said, and validate techniques for future use.
Job-Oriented Training Programs at Azyme Biosciences
1. Diploma in Pharma
Biotechnology
Overview:
Our Diploma program prepares graduates and post graduates to excel in their technical fields, and to design, develop & implement strategies for dealing with challenges associated with those fields. The program’s primary focus is to prepare students to take up practical work in laboratories of food, biopharma, phytochemical, CROs and Govt. Laboratories.
Modules Covered:
1.Pharmaceutical
Microbiology
2. Recombinant DNA Technology
3.Immunological Techniques
4.Instrumentation- HPLC,GC,AAS & PCR
Duration: 3 months
2. Azyme Certified Quality Analyst (ACQA
Azyme Biosciences offers a unique and advanced training program on quality control. The ACQA program is an excellent program suitable for chemists, chemical engineers, microbiologists & biotechnologists, who plan to work in a quality control lab or upgrade their knowledge in the quality control sector.
Modules Covered:
1.Basic Techniques of Quality Analysis
2. Instrumentation-HPLC,GC & AAS
Duration– 45 days
Extensive Research Programs:
Objective:
The objective of the program is to familiarize students with the most modern techniques with a strong emphasis on understanding of basics. To imbibe fearless confidence in students to handle any experimental protocol.
Training Takeaways:
- Individual handling of all experimental protocols
- An understanding on the use & prepation of reagents and solutions
- Sample preparation and methods of analysis
- Result interpretation
- Troubleshooting techniques
Duration: 30-45 working days
Dissertation Projects
Project Topics Included but not limited to :
1.Molecular & Recombinant DNA technology
eg: DNA finger printing work , use of RAPD,RFLP,AFLP markers
2. Enzyme
Biotechnology
Eg; work currently being carried out industrially useful enzymes, enzymes with anti cancer activity
3. Phytochemical studies for antimicrobial activity
Eg: use of various plant parts for investigating their antimicrobial and antioxidant property.
4. Fermentation & downstream Processing / Industrial
Biotechnology
Eg : production of antibiotics, amino acids & enzymes
Duration: 45 days to 6 months
z7x2x3.initialize({
'userName':'jnuinterestforma',
'formHash':'z7x2x3',
'autoResize':true,
'height':'825',
'header':'show',
'ssl':true} ;
z7x2x3.display( ;
NATIONAL SEMINAR
“CHALLENGES IN COMBATING DISEASES: CAUSE TO CURE”
March 23, 2012
ORGANIZED BY
DEPARTMENT OF
Zoology
, M.D.UNIVERSITY, ROHTAK
ABOUT SEMINAR :
Ever since man took his first steps in civilization diseases and illness have plagued him continuously. To combat these, man has evolved various methods of treatment, some of which are preventive and some of which are reactive. Diseases and medicines have been co-existing and dramatic medical advancements over the past century found out cures for many ailments, which were incurable and put a check on mortality on a large scale. One such example of the advancement of medical science coming to the rescue of mankind is the eradication of small pox from the face of this earth. However, there are certain diseases like cancer, AIDS, Malaria, cardiovascular diseases which are still a cause of challenge to physicians, scientists and researchers who are doing best to combat diseases. Certain pharmaceutical companies are taking leads and working for vaccines and drugs development as synthetic and from herbal plants. The governmental institutions like
CSIR
, ICMR, Ayurvedic traditional system, pharmaceutical organizations,
Biotechnology
/ Industrial sector etc are doing leading role in drug development and linkage of the Government and Industrial/Private sector. This is another milestone for furtherance of research to accept challenges to combat diseases. Drugs are often invaluable in overcoming disease and with the right diagnosis and treatment, bring rapid results. However, nutrients work on the body in a different way, strengthening it in order to prevent and combat disease and therefore the response is much slower, but longer lasting. Though doctors, research scientists have been doing a great job and so that newer and newer discoveries will happen in the field of medicine. The earlier it happens the better it will be for mankind in general and the needy in particular.
THEMES OF SEMINAR :
1.
molecular biology
and diseases
2. Genes/genetic diseases
3. Clinical and experimental medicines
4. Bimolecular diseases
5. Drug target discovery and development
6.
Bioinformatics
and diseases
7. Medical
Biotechnology
8. Plant products and diseases
9. Epidemiological diseases
10.Animal/plant parasitology
11.Pharmacology and pharmacognosy
12. Toxicology and xenobiotics
13. Hormonal diseases
14. Environmental Impact Assessment
15. Any other
Life Sciences
themes
REGISTRATION : ON SPOT
1. Faculty Scientist : Rs 1000/-
2. Research Scholar : Rs 800/-
3. Accompanying person : Rs 400/-
ABSTRACT :
Abstract (not exceeding 300 words of original work are invited for oral/poster presentations. The name of presenting author should be underlined. The abstract could be submitted upto 20.3.2012 by email to:
zoomdu.sem@gmail.com
Deadline : 23.03.12
Applications are invited on plain paper for the vacant post of
Junior Research Fellow
in the
DBT
-funded project entitled "Evaluation of the potential of prebiotics (Lactobacillus SPP for the prevention and treatment of intestinal and vaginal parasitic infection" under Dr Rakesh Sehgal, Professor, Department of Parasitology, PGIMER, Chandigarh
- Post :
Junior Research Fellow
- No of Post : One
- Essential Qualification : 1st class
M.Sc
degree in
Life Sciences
or any related discipline from a recognized University/Institute. Preference will be given ot those who have cleared
NET
/GATE
- Pay Scale : Rs 12000 + 20% HRA
The above appointment will be purely on temporary basis till the project is continued. Interested candidates fulfilling the above conditions are required to submit their bio-data and necessary testimonials by 21.03.12 in the office of Dr Bikash Medhi, Additional Professor, Room no : 403, Department of Pharmacology, Research Block-B, PGIMER, Chandigarh
Deadline : 21.03.12
Prospective students interested in attending Gloucester County College will have the opportunity to gain more information about its academic, athletic and cultural programs during the 2012 open house Thursday from 5 to 8 p.m. in the College Center.
Gloucester County College Center
DEPTFORD TWP. — Prospective students interested in attending Gloucester County College will have the opportunity to gain more information about its academic, athletic and cultural programs during the
2012 open house Thursday from 5 to 8 p.m. in the College Center.
This informational event brings students together with faculty members, admissions personnel, activity representatives, coaches and current athletes to provide advice on how to make preparing for college a positive experience.
Those who attend will learn about the new
dual advantage enrollment partnerships between GCC and
area universities and may discuss transfer options with representatives from various
four-year institutions.
Visitors can explore the college’s seven academic divisions that comprise its 70 degree programs and certification offerings — Allied Health and Nursing; Business Studies; Health, Physical Education and Recreation; Liberal Arts; Law and Justice; Science, Technology, Engineering and Mathematics and Continuing Education.
In addition, multiple information sessions are scheduled. They include “Career and Academic Planning Center — A Bridge to Your Future,” “NJSTARS,” “Inspire, Motivate and Support: The EOF Experience at GCC,” and both Thomas Jefferson University’s “Pathways to Pharmacy” and “Bridges to Bioscience Technologies.”
Representatives from financial aid and admissions departments will be on hand to answer questions and guide students through the application process. Campus tours and technology-based classroom demonstrations will give individuals a glimpse of GCC’s facilities.
Members of the athletic department will also be available during the open house. GCC has received honors as the best overall two-year college athletic program in New Jersey and is a two-time winner of the CAANJ Cup. The college fields 13 teams responsible for the more than 20 NJCAA National Team Championships, 50 NJCAA National Individual Champion and 275 All-American Athlete honors.
For more information, call 856-415-2232 or visit
www.gccnj.edu. No registration is required.
Contact Jessica Driscoll at 856-686-3682 or
jdriscoll@sjnewsco.com.
Project fellows in national medicinal plants board project at Department of Genetics, M.D.University, Rohtak
Post : Project Fellows
- No of Post : Two
- Project title : "Studying the impact of climate change on quality and quantity of secondary metabolites in some commercial medicinal plants"
- Sanctioned by : National Medicinal Plants Board
- PI : J.P.Yadav
- Qualification :
M.Sc
Genetics /
Biotechnology
/
Botany
/
Life Science
/M.Pharmacy with 55% marks
- Duration of the project : 3 years
- Fellowship : Rs 12000/- per month
Interested candidates may reach the office of the Head/PI for Walk in Interview at 12.00 noon on 20.03.12 with their original documents. The candidates can also sent their CV through email upto 19.03.12
Deadline : 19.03.12
Now, researchers at UCLA's Jonsson Comprehensive Cancer Center have uncovered how an advanced form of melanoma gets around an inhibitor called Zelboraf, which targets the mutated BRAF gene.
By examining the part of the melanoma genome that encodes proteins, called the exome, Jonsson Cancer Center scientists discovered that in some patients with BRAF-mutated metastatic melanoma, the mutated BRAF gene driving the cancer becomes amplified as the cancer develops resistance to an inhibitor.
Quite simply, by increasing the copies of the mutated BRAF gene, the melanoma is trying to over-produce the protein targeted by the drug, essentially outnumbering the inhibitor. The study findings may lead to alternative ways of preventing or treating resistant melanomas.
"Understanding and solving the problem of how cancer gets around targeted drugs is arguably one of the highest priorities in modern-day cancer medicine," said the study's senior author Dr. Roger Lo, an assistant professor of dermatology and of molecular and medical pharmacology and a Jonsson Cancer Center scientist. "In this study, we found that in some patients, the cancer simply makes more of the target, the mutated BRAF gene, so that the drug dose becomes too weak to fight the cancer.
"If you think of the mutation as a right hand and the BRAF inhibitor as a left hand and the two clasp to be effective, there's clearly an optimal ratio to ensure the mutated gene is fully inhibited. Here, we get more of the drug target, which has the same effect as dropping the drug level."
The one-year study is published March 6 in the peer-reviewed journal Nature Communications.
About 50 percent of patients with metastatic melanoma, roughly 4,000 people a year, have the BRAF mutation and can be treated with Zelboraf, two pills taken twice a day. Zelboraf was approved by the U.S. Food and Drug Administration for use in metastatic melanoma in August of 2011. Many other common human cancers, including cancers of the colon, thyroid and lung, also harbor BRAF-mutated subsets, Lo said.
Oncologists cannot give more Zelboraf to these patients to combat the increased number of mutated BRAF genes because the dose approved by the FDA is the maximum tolerated dose, Lo said. However, Zelboraf could perhaps be given with inhibitors of other cell-signaling pathways in metastatic melanoma to try to stop patients from becoming resistant.
Lo and his team examined samples from 20 patients for this study, taking their normal tissue, their tumor tissue before treatment with Zelboraf, and a tissue sample when the cancer had responded earlier but subsequently became resistant. Using high-throughput DNA sequencing technology, the scientists examined the entire cancer exome to see what changes were occurring that may point to resistant mechanisms.
Lo found that five of the 20 patients showed increased copies of the mutated BRAF gene. Cell lines developed from melanoma patients also showed pathways downstream of the amplified gene that could be blocked with inhibitors to fight resistance.
"For the first time, we were able to see in actual patient tissue samples how the cancer gets around this drug by altering the target," Lo said. "It appears that the drug target is not only mutated and hyper-activated, but it's also massively over-produced in some cases of clinical relapse."
Lo said there's an experimental drug that also inhibits mutated BRAF which may be effective against this form of melanoma at a dose that does not result in substantial side effects. In that case, an oncologist might have room to increase the drug dose once a relapse driven by BRAF amplification is encountered in the clinic.
Scientists so far have discovered five mechanisms of BRAF-inhibitor resistance in melanoma patients, accounting for about 60 to70 percent of patients. However, 30 to 40 percent of patients are relapsing by as-yet uncovered mechanisms.
Going forward, Lo and his team will seek to find out what is happening molecularly in every patient that relapses after therapy so that novel combination drug strategies can be developed to help them.
"If we know what happens in every relapse, we can have a plan in place that will help us avoid or overcome resistance," he said.
About 70,000 new cases of melanoma are diagnosed each year in the United States. Of those, 8,000 people will die of the disease.
The study was funded by a Bud and Sue Selig Innovative Research Grant from Stand Up to Cancer, the Burroughs Wellcome Fund, the Seaver Institute, and the Richard C. Seaver Charitable Trust. Additional support came from the National Cancer Institute, the V Foundation for Cancer Research, the Melanoma Research Foundation, the Melanoma Research Alliance, the American Skin Association, the Caltech–UCLA Joint Center for Translational Medicine, the Sidney Kimmel Foundation for Cancer Research, Wendy and Ken Ruby, and Louis Belley and Richard Schnarr.
UCLA's Jonsson Comprehensive Cancer Center has more than 240 researchers and clinicians engaged in disease research, prevention, detection, control, treatment and education. One of the nation's largest comprehensive cancer centers, the Jonsson Center is dedicated to promoting research and translating basic science into leading-edge clinical studies. In July 2011, the center was named among the top 10 cancer centers nationwide by U.S. News & World Report, a ranking it has held for 11 of the last 12 years.
For more news, visit the UCLA Newsroom and follow us on Twitter.
DESCRIPTION
Chiltern International Spain is looking for a CRA to work for a real good Client in a good enviroment.
An excellent opportunity has arisen to work in one of the fastest growing global Contract Research Organisations.
Chiltern is Europe’s largest privately owned full service (Phase I-IV CRO, with over 1400 employees and 23 offices throughout Europe (both Eastern and Western , North and South America and Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones.
REQUIREMENTS
- A BSc or BA degree in a biomedical or related life science, or nursing qualification.
- Thorough knowledge of ICH GCP
- Computer literacy
- Excellent written and oral communication skills
- Knowledge of regulatory environment
- Fluent in English
- Fluent in Spanish
Please note that we are only able to consider applications from candidates that already hold current authorization to work in Spain
No comments:
Post a Comment