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  FOURTH QUARTER 2011

Ken_headshot_2011

On September 15th, we held the third quarterly roundtable of our 2011 Tufts CSDD Executive Forum series. The topic was Creating and Maintaining Successful Partnerships. The roundtable featured informative presentations by large and mid-sized pharma firms, a multi-company collaborative, and a Massachusetts organization that facilitates alliances. Discussion, which included the perspectives of several CROs and academic research centers, was highly energetic and productive.

 

I couldn't help but think as I listened to the excellent presentations and lively discussion how much the industry has changed over the past decade. Gone are the days when companies refused to share strategy, internal benchmarks, or operational initiatives with competitor firms. In today's enormously challenging R&D environment, there's a new openness across industry, to share ideas, discuss strategy, and consider different approaches to improving efficiency.

 

Moreover, Tufts CSDD, as an independent and neutral academic research group, is the ideal organization for bringing these participants together and hosting forums such as this. The Tufts CSDD Executive Forum is one example of the Center's commitment to helping all stakeholders improve the efficiency and productivity of pharmaceutical R&D.

 

As a final note, this past summer, I had the pleasure of participating, along with Clayton Christensen, professor at Harvard Business School and author of The Innovator's Dilemma and other highly acclaimed books, in an interview hosted by the Economist Intelligence Unit, entitled The Innovation Imperative in Biopharma. Here is the link: http://www.businessresearch.eiu.com/innovation-imperative-biopharma.html (click on Multimedia button). Over the course of the 30 minute piece, I offer my views on current challenges in pharma innovation, academic-industry partnerships, outsourcing strategies, and the emerging role of payers in the drug development process. I hope you enjoy the interview.

 

I'm pleased to share with you our fourth Tufts CSDD Quarterly Update of 2011. Please feel free to contact me with any comments or questions. And as always, I thank you for your support.


Sincerely,
 KenKsignature
Kenneth I Kaitin, Ph.D.
Director and Research Professor

REGISTER TODAY: The 39th Annual Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation

PGC 2012 Brochure thumb February 6-10, 2012

TAJ Boston Hotel, Boston, MA

For the past 39 years, Tufts CSDD has assembled top speakers from industry, government, and academia to bring you our highly acclaimed, five-day Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation. This CME-accredited course provides advanced instruction in practical and technical problem-solving in the areas of clinical pharmacology, drug development & clinical trial strategies, biopharmaceutical development, drug safety, and new drug regulation. Thousands of drug development professionals are alumni of this prestigious program.

Seats are filling fast, so visit our website to
find out more and register. For a look at this year's brochure, click on the image above. 

Tufts CSDD Publications and Reports 

SeptOctImpactReportNearly 60% of all protocols require amendments; one-third are avoidable, Vol. 13, Issue 5 

Nearly 60 percent of all protocols used in clinical trials for new drugs are amended during the trial. Moreover, one-third of those changes could have been avoided, according to the first-ever analysis, conducted by the Tufts Center for the Study of Drug Development, quantifying the impact of protocol changes on clinical trials. [View press release]   


Tufts CSDD Impact Reports is our premier bi-monthly publication, presenting the latest CSDD research findings in a concise and easy-to-read format. With key data, analyses, and insights on critical drug development and regulatory issues, it's an industry "must-read." Visit our website for current Tufts CSDD Impact Reports and become a subscriber today.

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Tufts CSDD R&D Management Report: October 2011  

 

R&DMngmntReport#4_2011 Designing and Maintaining Successful Innovation Partnerships, Vol. 6, Issue 4 

Responding to strong and growing pressure to reduce development times and increase the output of new medicines, drug companies are engaging in innovative partnerships that are leading to, among other things, more molecular entities entering Phase I trials and shorter study times. [View press release]  


Tufts CSDD R&D Management Reports
summarize speaker presentations and main discussion points from our quarterly Tufts CSDD Executive Forum roundtable series. At each roundtable, senior executives from large pharma, small and mid-tier companies, and contract service providers join the CSDD research staff in a lively discussion on current drug development challenges and strategic initiatives within the research-based industry.


Click here
to subscribe or purchase recent
Tufts CSDD R&D Management Reports
. To participate in our next Tufts CSDD Executive Forum roundtable, contact us.

Current CSDD Multi-Company Working Groups 

  • Quantifying the Cost of Unused Protocol Data
  • Benchmarking the Study Initiation Process
  • Biologics for Cancer 
  • Global Landscape for Study Monitoring
  • Patient Recruitment and Retention Practices
  • Assessing the Impact of New Outsourcing Strategies
  • Evaluating Factors Driving Clinical Trial Costs
  • Evaluating Completeness and Accuracy of Adverse Event Reporting 
Tufts CSDD's research spans a broad range of critical issues facing the industry. If you would like to commission a Tufts CSDD project or participate in one of our Multi-Company Working Groups, contact Robert Chung for more information.
Upcoming Programs and Events   

Tufts CSDD Forum on the Impact of Comparative Effectiveness Research on Biopharmaceutical Innovation and Patient Access
January 12, 2012 
Tufts University School of Medicine, Boston, MA

The forum will be an opportunity to explore the impact of Comparative Effectiveness Research (CER) - research evaluating and comparing health outcomes, specifically the clinical effectiveness, risks, and benefits of two or more medical treatments, services, and items - on patient access and biopharmaceutical innovation in the post health reform environment. At the event, we will hear from health care providers as well as representatives from the R&D-based biopharmaceutical industry, the insurance industry, government, and academia. Speakers will share their unique perspectives on CER and how they believe this tool will impact biopharmaceutical innovation, reimbursement decisions, and prescribing behavior.

 

For more information or to register, visit our website or contact Ashley Malins by email or by phone at 617-636-2927. 

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Tufts CSDD Executive Forum Roundtables:  

Managing the Transition from Nonclinical to Early Clinical Development 

February 25, 2012

Boston, MA   

 

Many companies are focusing on the transition from nonclinical to clinical drug development as an area where improvements in R&D efficiency and productivity can be achieved. To kick-off this roundtable, Tufts CSDD will present data from its recent multi-company benchmarking project on the topic. Companies will then discuss specific strategies for bridging the gap between nonclinical and clinical development. 

 

The Tufts CSDD Executive Forum is a unique program of highly interactive, one-day roundtables for senior R&D leaders. Hosted by Tufts CSDD, the Executive Forum was developed in response to industry concerns that there were few opportunities for pharma leaders to meet in a neutral venue to exchange information, discuss industry trends, and network with colleagues. After each roundtable, members receive the Tufts CSDD R&D Management Report, which provides highlights of the roundtable presentations and discussion.

For more information or to register for upcoming roundtables, visit our website or contact Stella Stergiopoulos by email or by phone at 617-636-0322.
Tufts CSDD Recent Publications   

 

Cohen J. Dearth of Clinically Useful Diagnostics Limits Growth of Personalized Medicine. Expert Review of Clinical Pharmacology 2011;4(5): 527-529.

 

Cohen J, Christensen K, Feldman L. Disease Management and Medication Compliance. Population Health Management 2011;15:1-9. 

 

Milne, CP, Zuckerman R. Biopharm Perspectives on Business Prospects for Personalized Medicine. Personalized Medicine September 2011.

 

Wilson A, Cohen J. Patient Access to New Cancer Drugs in the United States and Australia. Value in Health 2011;14(6):944-52. 

  

Faculty Presentations
Selected presentations given or scheduled to be given by Tufts CSDD staff:

Joshua Cohen: 7th Annual Burrill Personalized Medicine Meeting, Oct. 3-4, 2011, San Francisco, CA  

 

Christopher Milne: NORD Rare Disease and Orphan Product Summit, Oct. 11-13, 2011 (Panelist on Oct. 12), Washington, DC 

 

Kenneth Kaitin: Clinical Operations Retreat for Executives (CORE), Oct. 14, 2011, Chatham, MA 

 

Mary Jo Lamberti, Stella Stergiopoulos: 4th Annual Drug Discovery Partnership: Filling the Pipeline, Oct. 17-18, 2011, Boston, MA

 

Christopher Milne: RAPS Annual Conference, Oct. 24, 2011, Indianapolis, IN

 

Christopher Milne: NIH Workshop on Pediatric Drug Formulation, Nov. 1-2, 2011, Potomac, MD

Kenneth Getz: ACRP Fall Symposium, Nov. 4, 2011, Waltham, MA  

 

Kenneth Getz: ISPE Plenary, Nov. 8-9, 2011, Dallas, TX

 

Christopher Milne: World Theranostics Conference, Nov. 15-16, 2011, San Diego, CA

 

Kenneth Kaitin: Informa's Partnerships in Clinical Trials Conference, Nov. 16, 2011, Lyon, France 

 

Janice Reichert: European Antibody Congress, Nov. 30, 2011, Geneva, Switzerland 

 

Janice Reichert: Antibody Engineering and Antibody Therapeutics, Dec. 6, 2011, San Diego, CA 

 

I N   T H I S   I S S U E
Upcoming Programs and Events
Tufts CSDD Publications and Reports
Current CSDD Multi-Company Studies
Tufts CSDD Recent Publications
Faculty Presentations
FYI. . .
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 Tufts CSDD in the News
Selected excerpts from recent articles

Boston Globe
October 23, 2011
Mid-size Biotechs Making Their Way: Flurry of Drug Applications Creates New Tier of Players

"You're seeing a maturation of the local life sciences industry," said Kenneth I Kaitin, director of [Tufts CSDD], a nonprofit research group. "There are new companies being formed all the time. But this is the first wave of this new generation of companies that have gotten far enough to see their products reaching the marketplace."

GaBIO Online
October 21, 2011
Clinical Biosimilar Data Should Be Accessible to All

[According to Janice Reichert], "The most critical, 'non-negotiable' issue [for mAb biosimilar manufacturers] is to have substantial data to prove that there are no clinically meaningful differences in terms of safety, purity, and potency to the reference product. Perhaps more importantly, such data, and particularly discussion of the significance of any such differences in the clinical setting, should be presented in the public domain."

Genetic Engineering & Biotechnology News

October 18, 2011
Pfizer Edges Toward Lipitor Patent Cliff as Exclusivity Extensions Near End

"In other words, seven out of 10 products in [a company's] portfolio actually don't earn the cost of developing a new drug. And a lot of the top selling drugs, the ones that sustain the pipelines - the three out of 10 products - are the ones that are going off patent in this five-year window right now," Kenneth I Kaitin, Ph.D., director of [Tufts CSDD], told GEN. 

 

Triangle Business Journal

October 14, 2011

$90M Payday at Duke: University sells rights to lucrative drug

 

"Academic research centers in the United States are increasingly being viewed as essential players - and potential partners - in pharmaceutical innovation," says Kenneth Kaitin, director at [Tufts CSDD].

 

Nature.com

September 29, 2011

Translational Research: 4 ways to fix the clinical trial

 

At least 90% of [clinical] trials are extended by at least 6 weeks because investigators fail to enroll patients on schedule. Only about one-third of the sites engaged in any multicenter study ever manage to enroll the requisite number, says Kenneth Getz, an expert on clinical research at [Tufts CSDD]. The result: longer, more expensive trials - some of which may never be completed.

 

Datatrial
August 29, 2011
Are CROs and Virtual Biotechs Made for Each Other?

 

"It's a very exciting and profound change," [Kenneth Getz, a researcher at Tufts CSDD] told DarcÚ. "We're moving away from the siloed, compartmentalized and insular approach that companies took to develop a (drug) candidate, and moving into an open research and development environment, where you can tap into expertise anywhere in the world."

 
Nature.com

August 22, 2011

Toxic antibodies blitz tumours  

 

Janice Reichert, an analyst at [Tufts CSDD], expects more approvals to follow. Between 2000 and 2005, only six antibody-drug conjugates entered the clinic for the first time, she says. From 2005 to 2009, 15 more joined their ranks. Now, 25 are currently in cancer clinical trials - more than at any other time.

 

USA Today
August 19, 2011

Study: Whites fare better than blacks seeking medical grants

  

The "most troubling" aspect of the findings, says Kenneth Getz of [Tufts CSDD], is on efforts to recruit African Americans to join drug trials. ... "There is a critical need to improve minority patient access to investigational treatments," Getz says. Turning away black researchers from running studies, he adds, will, "ultimately play a major role in driving health disparities among minority patients."

  

Chemical & Engineering News

August 15, 2011

Pfizer Augments Academic Network

  

Kenneth I Kaitin, director of [Tufts CSDD], says Pfizer's partnering strategy is "particularly good" because it calls for industry and academic scientists to work side by side... In the process, he says, Pfizer gains access to cutting-edge science, and academics can tap into the company's development and commercialization expertise.

 

American Medical News

August 15, 2011 

HHS cutting red tape to speed clinical trials   

  

"Using a single IRB would greatly assist sites in dealing with so many of the problems that come from contradictory board assessments," said Kenneth A. Getz, senior research fellow at [Tufts CSDD]. "So many boards have different sets of guidelines they follow, and there is so much inconsistency. And, as a result, there is a lot of bureaucracy and inefficiency."

 

OncLive

August 10, 2011

Industry Testing New Models for Developing Biomarkers  

 

"Early indications show that development of personalized medicines is commanding more resources," said Christopher-Paul Milne, DVM, MPH, JD, associate director at [Tufts CSDD], and author of the November/December Tufts CSDD Impact Report last year.

  

"Scientifically, the process of biomarker discovery and validation in general, and parallel development of drugs and companion diagnostics in particular, has been slow," Joshua P. Cohen, PhD, senior research fellow at Tufts CSDD and author of the study, said in a press release.

TUFTS CSDD FACULTY

Kenneth I Kaitin, PhD
Director and Research Professor


Christopher-Paul Milne, DVM, MPH, JD
Associate Director and Research Assistant Professor


Joseph A. DiMasi, PhD
Director of Economic Analysis

Joshua P. Cohen, PhD
Research Assistant Professor

Kenneth A. Getz, MBA
Research Assistant Professor


Janice M. Reichert, PhD
Research Assistant Professor

Richard I. Shader, MD
Professor Emeritus, Senior Research Fellow & Medical Consultant
 
Tufts CSDD
617.636.2170 | csdd.tufts.edu