Posts Tagged ‘Contract research organization’

Reporter: Aviva Lev-Ari, PhD, RN


Cambridge Healthtech Institute’s Inaugural

Next-Generation Sequencing in Medicine
Part of the Fifth Annual ADAPT: Accelerating Development & Advancing Personalized Therapy
November 4-6, 2013 | Boston Cambridge Marriott Hotel | Cambridge, MA

The latest developments in NGS technologies provide opportunities for clinicians and drug developers to guide patient care, improve clinical development, and advance personalized medicine.  But adoption of NGS tests in the clinic requires assay development, clinical and analytical validation, CLIA certification, quality control, and standards development. Cambridge Healthtech Institute’s Inaugural Next-Generation Sequencing in Medicine meeting will address assay development and validation, case studies in using NGS in clinical care, utility of sequencing in clinical drug development, regulatory and reimbursement issues, as well as potential of NGS as companion diagnostics.

Topics Include:

  • NGS as a clinical test: assay development, validation and quality control
  • Clinical utility of sequencing in guiding patient care
  • Interpretation of clinical NGS data
  • Utility of NGS in drug development and clinical trials
  • Diagnostic potential of whole genome sequencing
  • Role of NGS in advancing personalized medicine

Scientists who wish to present their knowledge and expertise to their colleagues are asked to submit an abstract.  Remember to specify the conference that you are interested in and please provide your full contact information.

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program.

If you are interested in presenting, please click here to submit your proposal.

Deadline for submission is Friday, April 26, 2013

For more information, please contact:Julia Boguslavsky
Executive Director, Conferences
E-mail: juliab@healthtech.com

For sponsorship information, please contact:Ilana Quigley
Manager, Business Development
E-mail: iquigley@healthtech.com
Phone: 781-972-5457

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A collaborative effort in reaching the set targets in a stipulated time frame is inevitable in every walk of life and the pharmaceutical industry seems to be in no exception. New products identification and their evaluation in terms of their safety and efficacy towards the targeted disease condition and finally bringing them to the needy as quickly as possible is a continuous and tedious process.

In order to minimize the time lines across the drug development process thru the market one may (have to) seek for external collaboration while safely and strategically harnessing the in-house resources to break new grounds in the field.

External collaboration will bring-in new talent into the existing system of Science and Business of the firm, whether small, mid-sized, or big company, that could lead to great innovations and investments on a win-win basis.

It is anticipated that Oncology therapeutic area will reach approximately $75 billion in global spending by 2015. OncoProducts continue to dominate the global therapeutics market and it is the leading research therapeutic, with 672 oncology drugs in development.

Conducting clincal trails is very challenging because:

  • clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.
  • Cost incur in a full series of clinical trials is enormous.
  • of the burden of paying for all the necessary people and services is usually borne by the sponsor.

Clinical trails can take place only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted in the country where the trial is taking place.

Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies as and when positive safety and efficacy data are gathered.

Such a rigorous evaluation in clinical trials that assess effcacy and safety in appropriate patient populations are critical to the continued development of the highly sensitive targeted therapies. The challenges to such studies, especially in phase I, are particularly great in oncology and cannot be met solely by most small- to mid-size oncology companies’.

Thus, though many companies have a range of talent and tools to apply to trials, often a clinical trial is managed by an outsourced partner, such as a Contract Research Organization or a Clinical Trials Unit. Moreover partnering with external organizations can bolster expertise and experience to ensure successful trial outcomes in terms of quality, data and time.

One such organization to partner with to successfully conduct and complete especially optimizing early phase, which is most challenging, oncology clinical trails is “NOVELLA Clinical”.

Novella is a specialty clinical research organization (CRO), that offers a range of services ranging from protocol development thru data analysis, that can be tailored to and mesh seamlessly with a sponsor’s specific needs.

When selecting a sponsor one must consider the following:

  • Expert scientific staff availability
  • Synergistic clinical trail models (e.g., PM/CTM clubbing or effective coordination where possible)
  • Clinical site selection expertise
  • Clinical trail efficiency through Operation Excellence that uses eClinical technologies (e.g., EDC, CTM)
  • Effective Cohort Management
  • Quality Data Documentation, and last but not least
  • ‘Trust’.

Therefore selecting a specialty oncology CRO especially for early stage oncology trials is important and moreover partners bring sponsors ‘results that lay the foundation’ for advanced efficacy trials in the most appropriate oncology patients, particularly when acquired in a time- and cost-effective manner.

Sponsors interested, especially the small- to mid-size pharmaceutical and biotechnology companies who may be planning early stage oncology clinical trials, in taking advantages offered by “NOVELLA Clinical” can visit the source for further details.

 For further reading:

Website: “NOVELLA Clinical”



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