10 October 2012

The Royal Swedish Academy of Sciences has decided to award the Nobel Prize in Chemistry for 2012 to Robert J. Lefkowitz Howard Hughes Medical Institute and Duke University Medical Center, Durham, NC, USA and Brian K. Kobilka Stanford University School of Medicine, Stanford, CA, USA "for studies of G-protein–coupled receptors"


Smart receptors on cell surfaces

Your body is a fine-tuned system of interactions between billions of cells. Each cell has tiny receptors that enable it to sense its environment, so it can adapt to new situtations. Robert Lefkowitz and Brian Kobilka are awarded the 2012 Nobel Prize in Chemistry for groundbreaking discoveries that reveal the inner workings of an important family of such receptors: G-protein–coupled receptors.

For a long time, it remained a mystery how cells could sense their environment. Scientists knew that hormones such as adrenalin had powerful effects: increasing blood pressure and making the heart beat faster. They suspected that cell surfaces contained some kind of recipient for hormones. But what these receptors actually consisted of and how they worked remained obscured for most of the 20th Century.

Lefkowitz started to use radioactivity in 1968 in order to trace cells' receptors. He attached an iodine isotope to various hormones, and thanks to the radiation, he managed to unveil several receptors, among those a receptor for adrenalin: β-adrenergic receptor. His team of researchers extracted the receptor from its hiding place in the cell wall and gained an initial understanding of how it works.

The team achieved its next big step during the 1980s. The newly recruited Kobilka accepted the challenge to isolate the gene that codes for the β-adrenergic receptor from the gigantic human genome. His creative approach allowed him to attain his goal. When the researchers analyzed the gene, they discovered that the receptor was similar to one in the eye that captures light. They realized that there is a whole family of receptors that look alike and function in the same manner.

Today this family is referred to as G-protein–coupled receptors. About a thousand genes code for such receptors, for example, for light, flavour, odour, adrenalin, histamine, dopamine and serotonin. About half of all medications achieve their effect through G-protein–coupled receptors.

The studies by Lefkowitz and Kobilka are crucial for understanding how G-protein–coupled receptors function. Furthermore, in 2011, Kobilka achieved another break-through; he and his research team captured an image of the β-adrenergic receptor at the exact moment that it is activated by a hormone and sends a signal into the cell. This image is a molecular masterpiece – the result of decades of research.

Senior Manager, DR/BC, IT QA, and Process Improvement

MindPharm is partnering with a large, diversified BioPharmaceutical company to identify candidates for an exciting opportunity to join the Information Technology Team and to advance new ideas and approaches to DRBC.

Location: MidWest
Department: IT

Position Description:

This key leadership position is responsible for the IT Disaster Recovery/Business Continuity/Crisis Management, IT QA, and for process improvement projects within IT.

Own and implement Disaster Recovery processes and strategies to ensure the security and integrity of data, data systems, and data networks across the organization. This includes re-establishing servers, applications, databases and operating systems in the event of a disruption, whether minor or catastrophic.
Responsible for the Disaster Recovery Plan and overall strategy along with executing the disaster recovery plans and tests for Astellas's applications.
Develop and mature the IT Disaster Recovery planning processes, including the strategy, approach, plans, and resources.
Develop, maintain, and lead Crisis Management planning and execution.
Facilitate the cross-functional activities necessary to conduct Business Impact Assessments for all applications with IT business partners and third-party vendors.
Work with internal IT teams and PMO to ensure that policies, procedures, and tools are integrated into Disaster Recovery processes.
Manage the creation of program status communications to internal management and external stakeholders regarding the status of the IT disaster recovery program, including annual reporting, audit report responses and customer requests.
Provide PMO support with quality assurance of deliverables and overall support.
Drive and own process improvement initiatives utilizing best practice process methodologies.

Requirements:
Bachelors Degree in Computer Science or Business, or equivalent experience required. Masters Degree preferred
10+ years of related experience required, pharmaceutical industry preferred
Must have excellent interpersonal and communications skills in order to effectively relate to internal and external professionals
Vendor management of external Disaster Recovery service providers
At least two years experience in Business Continuity Management, QA, and Process Improvement Methodologies
Experience in defining, implementing and enforcing risk-based standards, processes and procedures for responding to disruptions in business or IT operations
Proven competency in executing large projects, on time and within budget, with business and IT personnel
Proven ability to work under stressful conditions, such as business-related crises

MindPharm is partnering with a large, diversified BioPharmaceutical company to identify leadership for the Biology Department and Oncology portfolio. 

 

Job Description

The Department Head will lead several biology teams in support of small-molecule drug discovery and will set strategy to achieve biology goals for multiple candidate-directed programs. The individual will be a member of the therapeutic area leadership team which is primarily responsible for portfolio advancement. 

Department leadership responsibilities will include;

• coordinating resources across programs, 
• identifying and filling gaps in technology and/or capacity, 
• sourcing and overseeing external resources, and 
• identifying and applying new technologies. 

The Department Head will line-manage leaders and their teams and foster scientific and professional development of staff. The individual will ensure scientific excellence and the use of best practices across teams. A scientific leader and therapeutic area biology expert with a proven track record of delivering high-value clinical candidates, the individual will share responsibility for the overall therapeutic area strategy, the delivery of clinical candidates and other top-level goals. 

 

Scope and Responsibilities: 

As the department you are leading is responsible for:

• Portfolio advancement including
• Development of quantitative molecular and cellular assays for compound characterization, and advising project teams on the interpretation of quantitative in vitro data in the context of Hit to Lead and Lead Optimization to enable project advancement into clinical development
• Adaptation of in vitro target engagement assays to in vivo settings in order to permit target validation with intervention studies
• Developing and implementing translational medicine strategies including patient stratification and selection of optimal drug combinations
• Setting therapeutic area strategy as a member of the leadership team
• Directing and coordinating biology resources across programs
• Identifying and reducing gaps in technology and capabilities to accelerate lead optimization and mechanism of action studies
• Identifying, establishing and maintaining external resources to supplement internal resource activities
• Establishing innovative research concepts and proposals to management
• Implementing productive interactions with consultants and collaborators
• Working closely with the Early Lead Discovery organization to coordinate the transition of new target programs to Late Discovery
• Representing Therapeutic Area and working with Early Lead Discovery on new targets committee to ensure successful transition of new targets to HtL and LO
• Vetting target opportunities and aligning them with the areas of focus
• Reallocating biology resources to ensure streamlined transition to Project Directors for HtL / LO activities 

Leadership Responsibilities:

• Typically manages several groups (directly or indirectly) comprising 15-30 scientists which include PhDs and research professionals.
• Manages leaders and their teams by fostering scientific excellence and best practices. Appropriately delegates and prioritizes strategy and tactics with direct reports
• Identifies, recruits and develops key talent. Acts as a mentor to direct reports and other high potential employees. Creates a stimulating and innovative work environment that attracts, retains and develops top talent. Ensures that employees are developed to their full potential and assists them in identifying appropriate development opportunities within the organization.
• Able to address a variety of challenging employee relations situations, including but not limited to performance problems, integrity issues, teamwork difficulties, etc.
• Ensures that personal and employee skills are continuously updated and modified to address business developments and opportunities and ensures that an appropriate succession plan exists for critical positions in his/her organization.
• Represents function internally and externally (scientific meetings, advisory boards, expert panels etc.)
• Responsible for Departmental Budget 

 

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

 

 

MindPharm is partnering with an established BioPharmaceutical company to identify candidates for  the in vitro Biology Cancer Research group to augment  the discovery and development of innovative treatments to help patients in the fight against cancer.

We are currently seeking a highly motivated cell biologist to join our Cancer Biology group within the Cancer Research Division. The incumbent will be expected to identify and validate novel cancer targets as well as develop biochemical and cellular assays to support lead discovery and optimization. The individual must be able to prioritize and manage multiple research activities. Experience in DNA metabolism (repair/replication), apoptosis, cell cycle and/or other signal transduction pathways related to oncogenesis is essential.
The grade level will be commensurate of the individual's experience.

Major responsibilities:
Independently guide the development of novel target candidates; develop and maintain appropriate in vitro assays to guide SAR studies; interact with cross-functional teams to facilitate lead advancement; critically evaluate relevant scientific data and apply this knowledge to research efforts; contribute substantially to the overall research strategies; continually implement and validate novel research approaches to advance project goals; communicate results to multi-disciplinary teams; publish project-related research in peer-reviewed journals.Skills/Experience
 
RequirementsSkills/Experience:

• Ph.D. in Cell Biology or related discipline with 3 years post-graduate experience in the area of cancer is required.

• Demonstrated scientific achievements, i.e., strong publication and/or patent record.
• Proficiency in standard biochemical, cellular and molecular techniques are highly preferred.
• Strong communication and teamwork skills are essential.
•  

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

 MindPharm is partnering with a large, diversified BioPharmaceutical company to identify candidates for an exciting opportunity to join the Quality Assurance team and to lead vendor compliance fro Global R&D.

Location: MidWest
Department: QA

Job Description:

• Assure that GPRD remains in compliance with Corporate and Divisional policies and procedures and all applicable worldwide regulations
• Provide consultation and assistance to GPRD personnel on compliance issues.
• Provide GPRD personnel with training on applicable worldwide regulations.
  Lead cross-functional project teams to help identify potential issues and resolve current issues.
• Manage compliance issues in Global Project Team/Functional Area programs, escalating issues to GPRD QA management as appropriate
• Responsible for GCP vendor management activities including vendor qualification, performance and ongoing performance monitoring through onsite auditing, metrics and KPI assessments.
  

Major Responsibilities:

• Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures
• Plan, organize, and lead multiple audits of R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally
• Evaluate the potential risk of compliance deficiencies across protocols and/or compounds within assigned Therapeutic Area/Program, utilizing tools such as metrics and trending of audit findings, and communicate compliance risks to GPRD QA management
• Identify services, maintain audit schedule, plan, organize and lead audits of external contract facilities (specialty testing laboratories, central laboratories, clinical sites, central Institutions, Review Boards (IRBs), Contract Research Organizations (CRO) and distributors as applicable) both within the US and globally
• Communicate Contract Research Organization (CRO) status to GPRD QA management, follow up on ongoing Corrective Action Plans with Suppliers and participate in strategic initiatives involving CROs
• Maintain effective communication of program related information
• Review corrective action plans/audit responses for adequacy and approve if adequate
• Review policies and procedures and suggest improvements
• Create quality/compliance training programs for the GPRD organization
• Identify, initiate, manage, and/or participate in quality improvement projects
• Work independently as well as a team
• Mentor, coach and train QA auditing staff
• Prepare and present multiple project progress reports to update management and keep the team(s) informed
• Maintain project oversight to include assessments for the development program, allocation of QA resources and awareness of project timelines
• Supervise Quality team members for project specific activities as required.
  Directly coordinate GPRD GCP Compliance auditing programs
• Assist with the definition of GPRD Quality Goals.
  
  
  Accoutability and Scope:
  This position is accountable to the Director of GCP Compliance, GPRD QA. The decisions and recommendations made by the individual will directly impact compliance to applicable regulations, and thereby promote the continued success of GPRD. These activities such as auditing and associated functions can have a great impact on the quality of the data, which can, ultimately, lead to delay, or inability of company to market new products.

Skills/Experience Requirements:
The job requires knowledge of quality principles, research, and the development of pharmaceuticals and an understanding of the effect of his/her decisions on it.

The individual must be able to:

• Work independently, in a team environment, and with all levels of personnel within the organization
• Effectively handle multiple assignments simultaneously
• Anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall program
• Demonstrate a thorough knowledge of the applicable regulations and be able to apply them to a wide variety of situations
• Successfully interact with all levels of personnel within the division
• Show initiative to identify and implement new approaches to resolve problems (i.e., risk assessments, CAPA plans)
• Proactively identify issues across protocols and/or compounds;
  · Utilize innovation in solving problems.
  
  Must be able to make decisions with limited supervision, but decisions may be discussed with GPRD QA Management prior to implementation of action plan.

Education Requirements:
Bachelor’s Degree in a physical science, life science, nursing, pharmacy or equivalent experience required.

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

A cure for the common cold may finally be achieved as a result of a remarkable discovery in a Cambridge laboratory

By Steve Connor, Science Editor

Tuesday, 2 November 2010

Finding ways to enhance the activity of specific bacteria in the colon is the tricky part of the puzzle, but the discovery is an interesting one.

Discovery May Help Scientists Boost Broccoli's Cancer-Fighting Power - FierceBiotech

ScienceDaily (Oct. 22, 2010) - A University of Illinois study has shown for the first time that sulforaphane, the powerful cancer-fighting agent in broccoli, can be released from its parent compound by bacteria in the lower gut and absorbed into the body.

"This discovery raises the possibility that we will be able to enhance the activity of these bacteria in the colon, increasing broccoli's cancer-preventive power," said Elizabeth Jeffery, a U of I professor of human nutrition.

Sea snail venom has been previously used to make an injection for pain, but this formulation has a much wider range of potential applications, including peripheral neuropathy.  

Sea snail saliva may become new treatment for most severe pain

Scientists have developed a new version of a medication, first isolated from the saliva of sea snails, that could be taken in pill form to relieve the most severe forms of pain as effectively as morphine but without risking addiction. An article on the topic appears in the current issue of Chemical & Engineering News

This article covers the advances being made in individualized (patient-specific) cancer vaccines as well as the science behind them.  Most of this generation of vaccines will be used following radiation and chemotherapy to clear residual cancer cells  from the body, but the potential exists for future vaccines that would replace chemo entirely.

New Cancer Vaccine Kills Lymphoma, Now in Phase III Clinical Trials | Singularity Hub

Accentia Biopharmaceuticals and Biovest International have developed a non-Hodgkin?s lymphoma (NHL) vaccine that teaches the body?s immune system to identify and destroy tumor cells while leaving healthy tissue intact. The vaccine, called BiovaxID, is already in Phase III clinical trials.

Autopsy results have confirmed that scans performed using the dye while the patient was still alive map the distribution of plaques in the brain.  The dye is currently in clinical trials by Pfizer, Eli Lilly, and Bristol-Myers


Squibb,

Brain dye can spot Alzheimer's - FierceBiomarkers

A study has found that researchers can detect Alzheimer's disease with a brain scan using radioactive dye called AV-45 or florbetapir, which was developed by Philadelphia-based Avid Radiopharmaceuticals.

No recommendations are being made until there is independent confirmation, but the results are encouraging.

Fish Oil May Reduce Risk of Breast Cancer

Researchers at the Fred Hutchinson Cancer Research Center in Seattle, Wash., led by Emily White, Ph.D., a member of the public health sciences division, asked 35,016 postmenopausal women who did not have a history of breast cancer to complete a 24-page questionnaire about their use of non-vitamin, non-mineral ?specialty? supplements in the Vitamins and Lifestyle (VITAL) cohort study.

After six years of follow-up, 880 cases of breast cancer were identified using the Surveillance, Epidemiology and End Results registry.

Regular use of fish oil supplements, which contain high levels of the omega-3 fatty acids, EPA and DHA, was linked with a 32 percent reduced risk of breast cancer. The reduction in risk appeared to be restricted to invasive ductal breast cancer, the most common type of the disease.

A research team at Karolinska Institutet has been able to cluture human stem cells on a matrix of a single human protein: laminin-511.

Breakthrough in stem cell culturing

"Now, for the first time, we can produce large quantities of human embryonic stem cells in an environment that is completely chemically defined," says professor Karl Tryggvason, who led the study. "This opens up new opportunities for developing different types of cell which can then be tested for the treatment of disease."

Together with researchers at the Harvard Stem Cell Institute, the researchers have also shown that in the same way they can culture what are known as reprogrammed stem cells, which have been converted "back" from tissue cells to stem cells.

Researchers at the Memorial Sloan-Kettering Cancer Center have developed a new molecule based on migrastatin derived from Streptomyces bacteria.  The study reveals how the new agent works to prevent metastasis, by attacking an actin cytoskeletal protein critical for cell movement.

Anti-Cancer Agent Stops Metastasis In Its Tracks

Mice implanted with cancer cells and treated with the small molecule macroketone lived a full life without any cancer spread, compared with control animals, which all died of metastasis. When macroketone was given a week after cancer cells were introduced, it still blocked greater than 80 percent of cancer metastasis in mice.

A California Institute of Technology (Caltech)-led team of researchers and clinicians has published the first proof that a targeted nanoparticle?used as an experimental therapeutic and injected directly into a patient?s bloodstream?can traffic into tumors, deliver double-stranded small interfering RNAs (siRNAs), and turn off an important cancer gene.


Caltech-led Team Provides Proof in Humans of RNA Interference Using Targeted Nanoparticles - Caltech

These results, published in the March 21 advance online edition of the journal Nature, demonstrate the feasibility of using both nanoparticles and RNAi-based therapeutics in patients, and open the door for future "game-changing" therapeutics that attack cancer and other diseases at the genetic level, says Mark Davis, the Warren and Katharine Schlinger Professor of Chemical Engineering at Caltech, and the research team?s leader.

Researchers at the Wistar Institute in Philadelphia found that mice lacking the p21 gene regain the ability to regenerate lost tissue, more or less like an amphibian.  

Humans could regrow body parts like some amphibians - Telegraph

According to the Wistar researchers, the loss of p21 causes the cells of these mice to behave more like regenerating embryonic stem cells rather than adult mammalian cells. This means they act as if they (are) creating rather than mending the body.

Their findings, published in the Proceedings of the National Academy of Sciences, provide solid evidence to link tissue regeneration to the control of cell division.