05-02-jan1505.qxd

G E N E T I C E N G I N E E R I N G N E W S
F D A N E W S & A N A L Y S I S
Taking a Look at FDA’s Critical Path Initiative Update on Progress roadmap for achieving near- and interactions, especially under the DIA webcast on December 3 have expectation is not being fulfilled.
and the Next Steps the perceived imbalance between Board, and an open docket for for- progress made since March to show that, while there has been an By the time this article When it released its “Challenges cation to applied scientific research
Improving Public
path is becoming increasinglychallenging, inefficient, and cost-ly. To address this concern, FDAlaunched the initiative to identifythe most pressing obstacles inthis path.
tize the steps that provide thegreatest opportunities for rapidimprovement in public health,concentrating on the importantaspects of the product develop-ment (critical) path, i.e., assess-ment of safety and evaluation ofmedical utility.
together with all stakeholders (sci-entists, reviewers in FDA’s medicalproduct centers, and the publicand private sectors through theopen docket, meetings, and work-shops) to identify the most impor-tant challenges and to create theCritical Path Opportunities List asan outline of its strategy to over-come them.
from within and outside theagency, and has worked with itsmedical product centers to priori-tize problem areas, analyze com-ments received through the opendocket, and identify issues seen asbottlenecks and needing attention.
Request for
Recommendations
phase of the initiative were pre-sented to the FDA ScienceAdvisory Board at its November 5meeting along with a request forrecommendations prioritizing theissues and identifying mechanismsto implement solutions.
comments transmitted to FDA viathe docket by industry, societies,and patient advocacy groups, it hasbecome clear that there is over-whelming support and concurrencewith the Critical Path diagnosis.
need for research and science-basedstandards and collaborations, andrecognition of the science infra-structure problem as well as FDA’simportant role as the gatekeeperbetween the research enterpriseand the patient’s bedside.
Biotech News
Updated Daily:
www.genengnews.com
Circle 4 on Reader Service Card
G E N E T I C E N G I N E E R I N G N E W S
Key “Critical Path”
Key Considerations
Weblinks
www.fda.gov/oc/initiatives/
criticalpath
www.connectlive.com/events/
fdacriticalpath
www.fda.gov/ohrms/dockets/
ac/oc04.html
See FDA on page 14
Common Themes
opportunities were identified, FDAreported that certain commonthemes have emerged. The overrid-ing concerns are clinical trials, bio-markers, and surrogate end points.
pleased to introduce anew column, which will appear in each of our mid-monthissues as well as in our singleissues in July, August, andDecember. readers with news and analysis ofFDA activities and initiativesthat directly impact the R&D ofpharmaceuticals and biothera-peutics. We are extremely pleasedthat the authors of the columnhave the “right stuff ” to do the job. Kiki B. Hellman, Ph.D., is the
founder and president of TheHellman Group, a biomedicalconsulting firm that performsstrategic analysis and planning inall areas of product development,from concept to clinic and mar-ket. Dr. Hellman joined theindustry after a 35-year career atthe FDA where she served in anumber of different roles. agency, Dr. Hellman heldresearch and research manage-ment positions at Oak RidgeNational Laboratory, Universityof Michigan Medical School, andM.D. Anderson Hospital andTumor Institute. David Smith, J.D., is founder
and principal of Teregenics,which focuses on helping compa-nies and research centers trans-late tissue engineering andregeneration R&D projects intoproducts. He has been involvedwith the tissue engineering fieldfor over 10 years, with particularemphasis on tissue transfer andregulatory issues. vp and general counsel atTissueInformatics and counsel in the corporate and securitiesgroup of Reed Smith. He is amember of the board and secre-tary/treasurer of the TissueEngineering Society Internationaland secretary of the PittsburghTissue Engineering Initiative. Circle 13 on Reader Service Card
G E N E T I C E N G I N E E R I N G N E W S
FDA Continued from page 13
handling is an important first step.
BIOMARKERS Public discussion
CLINICAL TRIALS Attention to
Next Steps
collection and analysis are essential.
as an example where sponsors candiscuss data outside the reviewprocess, such as genomic data inconcert with development of par-ticular drugs, should be a goal.
include collaboration on specificbiomarker projects, such as safetybiomarkers, data mining projects,imaging as a potential biomarker,and evaluation of consortia inadvancing the study of specificmarkers and surrogate end points(as discussed at the November 3public meeting of the ClinicalPharmacology Subgroup of theFDA’s Pharmaceutical ScienceAdvisory Committee).
the initiative and progress made todate can be found at the key“Critical Path” web links listed inthe Table. The December 3 web-cast also provides insight into theagency’s thinking on related issues,including the importance ofimproved communication withproduct sponsors to ensure theapplication of current best prac-tices and efficient integration ofnew assessment tools as theybecome available.
Kiki B. Hellman, Ph.D., is founder and presidentof The Hellman Group in Clarksburg, MD. Phone:(301) 916-1520. E-mail: kbh@hellmangp.com.
David Smith, J.D., is founder and principal ofTeregenics in Pittsburgh, PA. Phone: (412) 576-2088. E-mail: dss@Teregenics.com.
C O R R E C T I O N S
G E N, the Legal Affairs column onpage 8, entitled “Legal Uses of aPatented Invention in the U.S., shouldhave been titled “Registration of ClinicalTrials.” section of the December 2004 issue of
G E N, it was noted that Rio-North
American concluded a two-year Phase
III clinical trial for rimonabant
(Acomplia™). In fact, the Rio-North
American trial was conducted by
Sanofi-Synthelabo (New York City).
G E N in an article entitled “Drug
Discovery Trends for the Next Decade”
a quote by Christopher Ahlberg of
Spotfire (Somerville, MA) was run
incorrectly.
It should have read: “Today’s methods can feel like speeding down a dark roadin a sports car without headlights, theengine is fast but you don’t know ifyou’ve passed something worthwhile orare about to hit a wall. New instrumenta-tion, tools, and analysis software need tobe developed in parallel, so researchers Circle 9 on Reader Service Card

Source: http://www.pepperlaw.com/pdfs/GEN%20FDA%20Column%20Jan05.pdf