December 2009

Medical education to fill the credibility gap
David H. Recht of North State Resources Inc. and Kelli Soare and Ed Leon of S+R Medical Communications discuss how credible, needs-based branded S+medical education can help to make the pharmaceutical industry a trusted resource for physicians once again.

Ad agencies decode behavior in women's health
Healthcare ad agencies are using behavioral science to push the right buttons when it comes to marketing women's health brands.

November 2009

HC&B’s tech picks
Joe Doyle of HC&B Digital and Kerry Hilton of HC&B Healthcare Communications offer their personal picks of technology tools that can help make any pharma sales force more efficient and effective.

Six surprising outcomes of FDA’s draft REMS guidance
Dr. Gary Slatko of risk-management support provider ParagonRx outlines six interesting developments to arise out of FDA’s first draft guidance for industry on Risk Evaluation and Mitigation Strategies.

Q&A: Patent landscape faces change
Charlie Van Horn, a patent attorney with the law firm of Finnegan, Henderson, Farabow, Garrett & Dunner LLP, spoke with R&D Directions managing editor Michael Christel about the inherited hurdles facing new leadership at the United States Patent and Trademark Office. The former agency executive addressed other related topics as well, including the unique challenges patent examiners encounter when reviewing pharmaceutical and biotechnology applications; the push for long-awaited reform to U.S. patent law; and recent proposals made by the patent office to change the examiner count system.

Q&A: Sanofi transforms R&D approach as patent cliff looms
Paul Chew, M.D., senior VP, U.S. chief science officer/chief medical officer, Sanofi-Aventis U.S., answered questions from R&D Directions managing editor Michael Christel about tactics the drugmaker is using in R&D to help overcome present economic challenges and how the company is preparing for the approaching “patent cliff”, where several top-selling branded drugs will lose market exclusivity.

October 2009

The creation of transformative leaders
To find out what it takes to be a leader who can recognize a need and then take an organization in a new direction, Med Ad News spoke with Kim Palmisano and Karen Addison of the Center for Creative Leadership (ccl.org).

Agency focus on pain management
To zero in on the branding perspective in the area of pain management, Med Ad News interviewed Jeff Kozloff, CEO and co-founder, Verilogue; Dan Bobear, executive VP, managing director, client service, Palio; Uwe Tigor, senior VP, director of medical services, Palio; Joe Gattuso, executive VP, chief strategic officer, Commonhealth; Barry Schmader, executive VP and creative director, and Frank Powers, executive VP and management supervisor at Dudnyk.

Doing more with less in clinical development: How to enhance efficiency through better organizational planning
Plagued by slowing growth in mature markets, increased risk from patent expirations, and increasingly sluggish FDA approvals, the pharmaceutical industry is facing an unprecedented level of uncertainty. Liquidity issues, job cuts, and potential healthcare reform are also contributing to the volatility. Mike Menta, senior practice executive, Campbell Alliance, addresses how pharmaceutical companies can build an effective organizational plan as a companion to clinical development strategies.

Stem cell efforts forge ahead
Buoyed by a renewed emphasis on medical science in Washington, activity in the stem cell research space has picked up significantly in recent months, with strong interest from the biotechnology industry.

New cell 'reprogramming' techniques hold promise
Induced pluripotent stem cells are considered to be the best means to create personalized cells for regenerative medicine, since they can be made from any adult cell and can be made into any cell type. Fate Therapeutics Inc. is one company using this technology in the treatment of degenerative diseases such as diabetes, Parkinson's and Alzheimer's disease, amyotrophic lateral sclerosis, heart failure, stroke and paralysis, and metastatic cancers.

Lymphoma candidates could boost options
The availability of more potent and effective therapies for lymphoma, a disease which accounts for about 5% of all cancer cases in the United States, is a high priority for drugmakers and FDA alike, recent clinical development activity shows. In just the last two months, a pair of investigational agents targeting lymphoma were granted orphan-drug status from FDA, while three late-stage candidates reported favorable strides in their quests for approval.

Q&A: CROs adjust to changing pipeline priorities
Stephanie Wells, corporate senior VP, Charles River Laboratories, talked with R&D Directions managing editor Michael Christel about the trend in big pharma of companies reprioritizing and consolidating their R&D portfolios, and how those changes are affecting decisions by contract research organizations to invest in certain therapeutic areas.

Q&A: Progress, hurdles mark cardiovascular disease research
Michele F. Mercuri, M.D., VP, global clinical development and acting head of cardiovascular development, Daiichi Sankyo Pharma Development, spoke with R&D Directions managing editor Michael Christel about the current state of cardiovascular disease research, the evolving risk factors for disease, the likely market drivers moving forward, and the progress and challenges of applying personalized medicine to research endeavors in heart disease.

Q&A: New guidelines challenge diabetes field
Almost a year has passed since FDA introduced heightened testing standards for new diabetes drug, now requiring companies to screen such candidates for heart risks before they can be approved. Kevin Koch, Ph.D., president and chief scientific officer for Array BioPharma Inc., talked with R&D Directions managing editor Michael Christel about the ramifications of FDA’s new safety guidelines as well as emerging protein targets being explored in diabetes research.

September 2009

Drug safety burden a plus for CROs
Drug safety and risk management is fast emerging as an intriguing market for the contract research industry. Despite business slowdowns in others areas of clinical development, CROs are experiencing a surge in demand for drug safety services as their customers in pharma deal with increased regulatory pressure to further prove the safety and efficacy of their medicines, while also mitigating risk.

Q&A: Pharma-CRO bond tightens
Glenn Gormley, Ph.D., president, Daiichi Sankyo Pharma Development, a U.S. division of Daiichi Sankyo Co., spoke with R&D Directions managing editor Michael Christel about the evolving relationship dynamics between pharmaceutical companies and contract research organizations and what factors sponsors consider the most when evaluating and ultimately selecting a CRO partner.

August 2009

Poll results reflect shifts in physician decision making
MDOUTLOOK's Quick Poll was developed to measure the pulse in the global thoracic oncology community, as well as assess adoption rate of the different maintenance regimens into clinical practice.

Top 10 launch challenges and how to manage them
As a majority of product managers will take part in only one or two major launches during their careers, many do not have a wealth of personal launch experience to draw upon when preparing for the daunting job at hand. Brand managers will face 10 major challenges during the course of planning and executing a product launch. Some challenges are external, while others are internal to the organization. By becoming familiar with the critical challenges, product managers can take necessary steps to plan accordingly and be better equipped to prevent or manage issues effectively, thereby increasing the prospects of a successful launch.

Opportunities in oncology: An agency perspective
Med Ad News spoke with Michael Parisi, president, Altum, about marketing challenges and opportunities within the oncology space. Altum is a CommonHealth professional advertising and promotion agency, which maintains a focus on biotechnology and specialty brands with about 90% of the agency’s work in oncology.

Four trends drive the future of sampling
In its October 2007 issue, Med Ad News profiled Pharmagistics as one of four Pharmaceutical Marketing Ventures to Watch. Part of Publicis Strategic Solutions Group, Pharmagistics (pharmagistics.com) offers pharmaceutical companies a single-source solution for direct marketing, PDMA compliance, and distribution and warehousing services. Keeping track of drug samples is Pharmagistics’ specialty. Two years later, Med Ad News senior editor Joshua Slatko caught up with Rick Keefer, president and CEO of Publicis Strategic Solutions Group (psellingsolutions.com), to get his insight into what the future holds for drug sampling.

July 2009

Extreme measures: New tactics required in drug value differentiation
Charlie Gombar, VP, R&D strategy and business improvement, Wyeth Research, talks with R&D Directions about ramped up standards in medical valuable differentiation and Wyeth’s new drug comparison tool.

Clinical data game plan
Imogene Grimes, Ph.D.,VP, biostatistics & data sciences strategic services, Parexel International, outlines the best industry practices for organizing trial data for research and new drug applications.

FTC sees benefits in biogenerics
The Federal Trade Commission has weighed in on the ongoing debate over follow-on biologics with a report examining how follow-on biologics could enter the market and what competition between follow-on biologics and pioneer biologic drugs would look like.

Interchangeability key cog in biosimilars debate
The debate over what should be considered an adequate market exclusivity period for original biotechnology drugs has gained the most attention in securing a regulatory pathway for biosimilars in the United States, but the issue of interchangeability may take on equal importance.

Cline Davis & Mann launches Brand Anatomy
Brand Anatomy, based in New York, was founded on the belief that healthcare brands – medicines, medical devices, and healthcare services – face unique challenges and require a unique approach to the development of brand identities.

Connect Tech opts into content partner program
Connect Tech, a division of Draftfcb Healthcare, has become the first Gold Certified Content Partner in Proscape Technologies Inc.’s Content Partner Program.

A new landscape for physician relations
Med Ad News spoke with Jennifer Colapietro of PricewaterhouseCoopers about the potential effect of pending physician gift legislation on medical device and pharmaceutical marketers.

Wyeth readies Prevnar-13 for the global market
Med Ad News spoke with Peter Paradiso, VP, new business and scientific affairs at Wyeth Corp., about Prevnar 13, the company’s anticipated follow-on to the blockbuster 7-valent conjugate vaccine Prevnar.

Physicians drive vaccine dialogue
Recorded patient-physician conversations provide an understanding of how vaccines are discussed at doctor’s visits and identify communication needs.

June 2009

CSOs and the specialty sales transition
Med Ad News spoke with Nancy Lurker, CEO, PDI Inc., about how contract sales organizations can help the pharmaceutical industry to fill its specialty sales force needs.

Behavioral science at work: Purohit Navigation
Ahnal Purohit, Ph.D. gave Med Ad News several examples of her agency’s behavioral science work in patient compliance.

Experimental drug harnesses T-cell’s tumor-killing powers
Christian Itin, Ph.D., president and CEO of Micromet Inc., spoke with R&D Directions about the biotech company’s experimental and potentially revolutionary new class of constructed monoclonal antibodies, drugs designed to direct a patient’s T-cells to attack and kill tumor cells that hide beneath the bone marrow.

ACRO’s Doug Peddicord addresses key issues
Doug Peddicord, Ph.D., executive director with the Association of Clinical Research Organizations, spoke with R&D Directions Managing Editor Michael Christel about several key issues facing CROs and pharmaceutical companies, including comparative effectiveness research and globalization.

May 2009

DTC and dangerous interactions
One scientist makes the case that by driving prescriptions of newly approved drugs with limited clinical experience, DTC advertising may be increasing the risk of dangerous drug-drug interactions.

Compliance certification provides a leg up
When it comes to regulatory compliance, healthcare advertising agencies must avoid being the weak link in the communications chain. Med Ad News spoke with Ilyssa Levins, president, Center for Communication Compliance (communicationcompliance.com) about the advantages agencies might find in compliance training and certification.

Partnerships in diabetes education
Since 2008, several pharmaceutical marketers have sought the assistance of organizations and celebrities for diabetes education campaigns and initiatives.

Navigating patient recruitment on global stage
Motivated further by today’s tenuous economic environment, international drug developers, seeking the benefits of faster patient recruitment and other clinical-trial cost savings, are increasingly migrating oversees to test their products.

Centralized patient recruitment really works
Rick Malcolm, CEO of Acurian Inc., presents three case studies that illustrate the value of centralized patient recruitment

Make or break: Retention tactics key
When it comes to successfully completing clinical studies, keeping patients enrolled is crucial. With a dropout rate in Phase II/III trials still in the 20% to 30% range, adopting more effective patient retention and compliance measures remains a top priority.

Imaging technique looks beneath the surface
The emerging technology of optical coherence tomography, or OCT, is being put to use in the diagnosis of a variety of central nervous system diseases. An optical signal acquisition and processing method, OCT allows researchers to take high-quality, micrometer-resolution, three-dimensional images from within biological tissue.

April 2009

Drug-safety service opens channels between industry and patient
Hugo Stephenson, founder and president of iGuard.org, talks to R&D Directions about the intriguing side benefits his consumer service offers pharmaceutical researchers.

Multiplex biomarkers on the rise
Michael Spain, M.D., chief medical officer at Rules-Based Medicine Inc., an Austin, Texas-based biomarkers testing laboratory, answered questions from R&D Directions about the emergence of multiplex biomarker assays in drug development.

Q&A: CROs and China
Nick Wright, VP and general manager, Asia Pacific, clinical development, Covance, discusses the advantages and challenges for international contract research organizations in conducting work in China.

Breaking down the Merck-Schering-Plough merger
Merck & Co. agreed to acquire Schering-Plough Corp. last month for $41 billion in a cash and stock transaction expected to close in the fourth quarter of this year. Datamonitor analysts recently broke down the R&D impact of the planned merger by therapeutic area.

March 2009

Cimzia Q&A
To learn more about the marketing efforts behind Cimzia, Med Ad News spoke with David W. Robinson, VP/general manager, U.S. Immunology Business Unit, UCB Inc.

85 New Medicines of 2008
Expanded descriptions of the products catalogued in the March 2009 issue's special report on new drug approvals.

Q&A: Hepatitis C
Robert Kauffman, M.D., senior VP of clinical development at Vertex, discusses the company’s late-stage hepatitis C inhibitor, telaprevir, and the challenges of developing drugs for the virus.

Enrollment musts
Executives at patient recruitment provider Praxis tout the advantages of program-level recruitment in helping sponsors speed up enrollment.

February 2009

Q&A: The making of prasugrel
To learn more about the development process behind prasugrel, Med Ad News spoke with Joseph Pieroni, president and CEO, Daiichi Sankyo Inc. and Francis Plat, M.D., VP of clinical development, cardiovascular medicine, Daiichi Sankyo Pharmaceutical Development.

Eidetics and drug/diagnostic combos
Med Ad News spoke with Robert Pearlstein, VP of Eidetics, about the transformative significance of drug/diagnostic combinations, examples of successfully marketed combos, and the work his company has done in this area.

Imaging partnership boosts trial efficiency
Many challenges face companies who manage and deliver clinical trial imaging data to clients.

Clinical trial checklist
Neil Patel, Pharm.D, pharmaceutical R&D operations, PriceWaterhouseCoopers, shares key factors to consider for any type of clinical study.

Q&A: Personalized medicine
David Sidransky, M.D., chairman of the board of directors at Champions Biotechnology Inc., is one of nine renowned scientists profiled in this month’s R&D Directions. The 20-year oncologist, known for his work in early cancer detection (he was named by Time as one of the top physicians and scientists in 2001), expands on the topic of personalized medicine and the tough challenges researchers still face in developing effective targeted therapies

January 2009

Q&A: Joe Pieroni
For the pharmaceutical manufacturer perspective on the major issues of the coming year, Med Ad News spoke with Joe Pieroni, president and CEO of Daiichi Sankyo Inc.

No perfect strategy
Late last year, Ernst & Young released the sixth issue of Progressions, the organization’s global pharmaceutical report. For insight into the report’s fi ndings, Med Ad News spoke with Carolyn Buck- Luce, global pharmaceutical leader, Ernst & Young.

The sales force agenda
In 2009, pharmaceutical sales forces will continue to shrink while relying more on technology as a means to reach the physician audience.

The agency agenda
With the economy in crisis and political uncertainty in Washington, the agenda for healthcare advertising is intense for 2009. In this online exclusive, a number of top healthcare advertising executives offer their view of the challenges ahead.

Biotechnology funding troubles
Small emerging and biotechnology companies are facing a perfect storm of funding challenges, forcing them to cut costs, prioritize products, and act strategically as they they try to track down capital.

Drug distribution reform in China
The Chinese drug distribution system poses signifi cant challenges to even the largest pharmaceutical company, but the government has been proposing some reforms.

The preemption question
The U.S. Supreme Court’s decision on preemption in the Wyeth v. Levine case could have serious consequences for pharmaceutical marketers.

Report spotlights trial-termination trends
Termination of clinical trials, most common at Phase II, is a natural consequence of drug development.

Q&A: Research and recession
Terri Cooper, principal in Deloitte Consulting Life Sciences practice, answers questions from R&D Directions on the economic tightrope facing the pharmaceutical industry to sustain innovation.

Striving for excellence in China
By Chris Perkin, corporate senior VP and president of Canadian Preclinical Services, Charles River

Management Method Boosts Drug-Development Timelines
As many R&D organizations struggle to meet deadlines and launch products, Procter & Gamble Pharmaceuticals has found a way to revitalize its clinical trials process – Critical Chain Process Management, or CCPM.