Navigation Links
Project Zero Delay Accelerates Drug's Path to Clinical Trial
Date:8/3/2009

HOUSTON and WILMINGTON, Del., Aug. 3 /PRNewswire-FirstCall/ -- A phase I clinical trial enrolled its first patient only two days after U.S. Food and Drug Administration clearance of the experimental drug for a first-in-human cancer trial, a milestone that normally takes three to six months. Investigators from The University of Texas M. D. Anderson Cancer Center and pharmaceutical company AstraZeneca have reported their work in the Journal of Clinical Oncology published online on August 3(rd).

The joint effort, dubbed Project Zero Delay, is part of a strategic collaboration between the two organizations designed to safely accelerate development of new cancer drugs. In many cases that process takes about 12 years and the cost of bringing a new drug to patients has been estimated at around $1.3 billion. [Ref: J. A. DiMasi and H. G. Grabowski, "The Cost of Biopharmaceutical R&D: Is Biotech Different?" Managerial and Decision Economics 28 (2007): 469-479.]

"Project Zero Delay demonstrates how we can shrink the time it takes to bring new drugs to cancer patients," said Robert C. Bast Jr., M.D., vice president for translational research at M. D. Anderson and the paper's senior author. "We need to find out as promptly as possible whether new therapies will help. Zero Delay is a significant step in that direction. Close cooperation allowed us to eliminate unnecessary delays while fully meeting regulatory requirements for scientific and human safety review."

The key to Zero Delay was performing most tasks in parallel instead of sequentially, said lead author Razelle Kurzrock, M.D., professor and chair of M. D. Anderson's Department of Investigational Therapeutics. In addition, tasks usually done after FDA clearance of an Investigational New Drug (IND) application were instead done in advance. No administrative steps were skipped.

This approach can be applied in other areas of drug development and by other institutions willing to cooperate closely, the authors note. "Zero Delay addressed one aspect of drug development -- clinical trial start-up time," Kurzrock said. "Substantial time could be cut from other steps by applying the same principles."

The time between having a complete written protocol and enrollment of the first patient is typically 135 days in M. D. Anderson's Phase I Clinical Trial Program when processing of the protocol starts after IND approval. Zero Delay went from having a complete written protocol to first patient in 46 days, with FDA clearance of the IND on day 44. Research elsewhere cited in the Zero Delay paper indicates enrollment of the first patient after having a final protocol typically takes 3-6 months.

Administrative tasks accomplished before the FDA's ruling included budget and contract negotiations, site visits and preparation, training and a series of mandatory institutional reviews at M. D. Anderson.

"M.D. Anderson and AstraZeneca share a common goal of using leading edge science to deliver medicines that will benefit patients now and in the future, while speeding up the process and making it more cost efficient," said Alan Barge, vice president and Head of Oncology at AstraZeneca. "AZ is always looking to improve our processes and to optimize value along our pipeline. This achievement is a great example of what can be accomplished when we pair our first class internal capabilities with the strengths of one of our key alliance partners in the U.S."

In 2005, M. D. Anderson and AstraZeneca established a strategic alliance that includes a master agreement for clinical and translational/preclinical research specifying terms for standard items that can cause lengthy negotiations. The master agreement ensures that new research projects and clinical trials are initiated without delays caused by contracting issues. New clinical trials can simply be appended to an existing master agreement, often as quickly as in a day.

"Zero Delay demonstrates what can be accomplished in an atmosphere of trust and collaboration that we've cultivated through our strategic alliance," Bast said. The alliance agreement also includes a commitment to regular meetings, a point of contact to remove obstacles, support of collaborative projects and a commitment to accelerate drug development.

"The next challenge," said Barge, "will be to do this consistently in order to develop truly innovative therapies that will someday offer new benefits to cancer patients."

Co-authors with Kurzrock and Bast are: Susan Pilat, Marcel Bartolazzi, and Dwana Sanders, all of M. D. Anderson's Department of Investigational Therapeutics; Stanley Tucker, Ph.D., Office of Translational Research. From AstraZeneca: Jill Hood, Ph.D., Kevin Webster, Michael Mallamaci, Steven Strand and Eileen Babcock.

About M. D. Anderson

The University of Texas M. D. Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. M. D. Anderson is one of only 40 comprehensive cancer centers designated by the National Cancer Institute. For six of the past eight years, including 2009, M. D. Anderson has ranked No. 1 in cancer care in "America's Best Hospitals," a survey published annually in U.S. News & World Report.

Get M. D. Anderson News Via RSS

Follow M. D. Anderson News on Twitter

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com


'/>"/>
SOURCE AstraZeneca
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. The Female Health Company Receives USAID DELIVER PROJECT Order for 5 Million Units
2. Uncontrolled Blood Pressure Highest Among Hispanics, Prompting New Hypertension Project in Miami
3. The Well Project Web Portal Receives Stevie(R) Website of the Year, InfoWorld 100 Award
4. Hospital Launches Landmark Emergency Medicine Project
5. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
6. DATATRAK and COResearch to Collaborate on Six Cardiac Safety Projects
7. ACORNs Oncology-focused Contract Research Organization Exceeds Projections
8. Dutch Top Institute Allocates 150 Million Euro to R&D Projects Targeting Early Diagnosis and Treatment of Disease
9. QMed, Inc. Receives 2-Year Extension of Medicare Coordinated Care Demonstration Project by CMS
10. TriLink Awarded a Phase II Grant for a Second Hot Start PCR Project
11. Debiopharm and EPFL Sign Research Project Agreement to Identify Inhibitors of Signalling Pathways Controlling Cell Fate for Cancer Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... Feb. 4, 2016 Mettler-Toledo International Inc. (NYSE: ... 2015.  Provided below are the highlights: , ... compared with the prior year.  Reported sales decreased 3% ... quarter. , Net earnings per diluted share as ... prior- year period.  Adjusted EPS was $4.65, an increase ...
(Date:2/4/2016)... ALBANY, N.Y. , Feb. 4, 2016  AMRI (NASDAQ: ... Vice President of Pfizer Inc. and President of Pfizer Global ... effective as of February 4, 2016. In addition, the Company ... member of the audit committee since 2010, has retired from ... time and attention to his other business ventures.  ...
(Date:2/4/2016)... SIOUX FALLS, S.D. , Feb. 4, 2016 ... patient and guest technology solutions, today announced that ... SONIFI Health Senior Living Engagement System. The system ... information tool that residents access through a tablet ... --> The resident engagement system provides access ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... The Muscular Dystrophy Association and ... launched the 14th annual “Appetite for a Cure” campaign on Feb. 1 to ... and related diseases that severely limit strength and mobility. , Now through ...
(Date:2/5/2016)... , ... February 05, 2016 , ... ... President George H. Van Allen have signed a joint enrollment and degree completion ... seamless pathway toward associate and baccalaureate degrees at FHU|Dickson. , The agreement ...
(Date:2/5/2016)... , ... February 05, 2016 , ... US Sports ... Studio in Dover, NH to direct high-performance kids yoga training. ChildLight Yoga Studio is ... just one hour from Boston. , ChildLight Yoga Studio founder Lisa Flynn expresses her ...
(Date:2/5/2016)... New York (PRWEB) , ... February 05, 2016 , ... ... use and find themselves having to wait longer to access the treadmills. It’s a ... New Year’s resolutions to lose weight and get in shape by joining gyms, starting ...
(Date:2/5/2016)... ... February 05, 2016 , ... Pivot ... 2015 Best in KLAS: Software & Services for HIT Implementation Support & Staffing ... report independently ranks vendor performance by healthcare executives, managers and clinicians representing over ...
Breaking Medicine News(10 mins):