Pharmaceutical Marketing Cutbacks, Doctors Getting Squeezed

Posted by Chris Burns on Mon,Apr 29, 2013 @ 10:00 AM

Two of the biggest pharmaceutical companies, Pfizer Inc. and GlaxoSmithKline, are significantly reducing spending with doctors for events at which doctors make presentations to their peers. Combined with cutbacks in spending on meals during lunchtime presentations by drug makers, doctors are feeling the financial impact. 

Increased Scrutiny of Pharmaceutical Marketing Practices - Will it Affect Drug Development?

Pharmaceutical Marketing Changes - Payments to Doctors Down SignificantlyPfizer and GlaxoSmithKline have cut spending on dinners and other events where expert doctors are paid to give presentations to peers about drugs and diseases as part of the pharma companies' drug development and marketing efforts. An increase of layoffs of pharmaceutical sales representatives and patent expirations for big-selling drugs are resulting in fewer sales calls and fewer free lunches provided to physicians’ offices.

There is increased scrutiny on the relationship between the pharmaceutical companies and the doctors who prescribe their drugs over concerns the perks may affect doctors’ prescribing patterns. The Sunshine Act included in the 2010 US healthcare overhaul requires drug companies and medical device makers to report doctor payments to the federal government for later posting of the information online.

Reported Cutbacks in 2012

The cutbacks listed below are difficult to accurately compare among companies as some use different criteria for reporting and many have changed their criteria in 2011 thereby making year-over-year comparisons difficult to assess.

    • Pfizer: 40% reduction on doctor meals- due to an increase in “virtual meetings” many meals can be avoided (Spokeswoman Sharon Castillo) 
       
    • Pfizer: total payments reduced from $173.2 million, down 11% from 2011. Most payments were related mainly to clinical research, which stayed flat.
       
    • Eli Lilly & Company: 30% reduction in US sales force while facing the loss of patent protection on two top-selling drugs. 
       
    • GlaxoSmithKline: 20% reduction in payments to US physicians (skewed partially due to a change in reporting criteria) to 97.1 million, reflecting a reduction in the need to fund speaker programs in recent years found through yearly re-evaluation. 
       
    • Teva Pharmaceutical Industries Ltd.'s TEVA-0.69% Cephalon unit reduced payments to health care professionals in 2012 by nearly 11% to $28.1 million.
       

Pfizer’s Cuts Based On Loss of Exclusivity

Pfizer cut more than 60% of its spending on expert-led forums including events where company-paid doctors discuss Pfizer drugs or certain diseases.  Cut from 1,539 health-care professionals speaking to peers 3,569 in 2011, average payments declined to $5380 from $6110. This drop was partially related to loss of exclusivity for drugs like Lipitor triggering low-cost generation generic competition. Pfizer also attributes the decline in spending on speaker programs to “more efficient ways to deliver educational materials and evolving approaches to meet physicians’ information needs.”

The Drive for Transparency in Pharma Company Payments to Doctors

According to Allan Coukell, deputy direction of medical programs for the Pew Charitable Trusts, “It is possible the trend we’ve seen for a few years toward increasing focus on payments will continue, and both providers and companies” will re-examine some of these financial relationships.

Drug makers claim payments are needed to compensate doctors who advise, assist in research and clinical trials, and educate other doctors about drugs and diseases. However, proponents of transparency are concerned with the patients’ knowledge of money doctors receive for prescriptions from the makers of drugs they provide.

Major changes in doctor compensation from pharmaceutical companies include:

    • 44 medical schools ban/restrict faculty participation in speaker’s bureaus (AMSA reports)
    • Commercial support for continuing medical education –needed for doctors to maintain licenses- has trended downwards
    • Industry influence is waning due partly to limitations on what medical school faculty and students can accept from companies
       

Doctors Concerned Over Payment Disclosures

Some doctors fear inaccurate or misleading data to will be posted online by the Federal government.  Of 1,000 doctors surveyed by MMIS Inc. and Healthcare Data Solutions, 63% showed concern regarding public disclosure and 21% said they would sever relationships with manufacturers reporting inaccurate information.

Some Companies Showed Increased Spending

    • AstraZeneca PLC- showed increases of about 2% to $30.6 mission million including consulting fees, speaker fees and meals but not clinical research
    • Johnson & Johnson- Some pharmaceutical divisions report increases by 15% to $27 million attributed to J&J’s scientific educational activities

The above post is a condensed and edited summary of an article appearing in the Wall Street Journal online on April 12, 2013.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Developers, Drug Development, Pharmaceutical Marketing

Will Oncology and Pathology Unite on Molecular Testing?

Posted by Judi Space on Wed,Mar 27, 2013 @ 07:00 PM

For more than a decade, we have been listening to the leaders in cancer research tell us that in order for targeted therapy to work, we must be able to identify who will benefit from it through the use of predictive biomarkers. This is the essence of personalized medicine.

Is molecular testing the key to targeted therapies and a solution to a one-size-fits-all approach?Molecular testing (MT) is becoming the new paradigm for determining an individual cancer patient's course of treatment. Although it is fairly widespread in large academic cancer centers, community hospitals and cancer clinics, where most cancer patients are treated, are often completely out of the loop.

Recently the Association of Community Cancer Centers has sought to better understand the scope of this problem through a survey of its members (1). This survey polled the member institutions' administrators, oncologists, pathologists nurses, and pharmacists (N=52 institutions) about policy, practices, and proceedure related to MT as well as reimbursement issues.

Implementing Molecular Testing: Education of Stakeholders is Key

There are many challenges to the implimentation of MT in the community oncology setting(1).  Chief among them is unwillingness of various stakeholders to work together to make MT a routine proceedure for all newly diagnosed cancer patients. The reality is that testing is already being done on a very limited basis for breast cancer patients (HER2, and ER/PR), but the cancer centers appear to balk at the expansion of similar testing in other cancer indications.(2)

It also represents a great new opportunity to improve the coordination between pathologists and oncologists.

In order to implement MT, The ACCC survey indicated that there should be "champions" that drive the institution toward a coordinated testing program. Most often these champions come from the ranks of the oncologists. They must educate their peers and the institution's administration about the necessity for having a MT policy/proceedure to decide how and when specific tests will be implemented.

Will Oncology & Pathology Come Together Over MT?

Can oncology and pathology unite over molecular testing?The lack of collaboration between pathologists and oncologists is one of the things that's holding molecular testing programs back. Many physicians can't seem to agree on whether MT is necessary, and when. Some don't see the value in personalized medicine, while cancer center administrators see it as simply a line in the budget and are unwilling to spend the time and money in an environment of competing interests.

However, there is safety in numbers. By uniting on the molecular testing issue, oncologists and pathologists will have a greater chance of convincing administrators its necessity.

Is Molecular Testing Costly or Cost Effective?

One of the drawbacks to molecular testing programs is the cost of testing. The decision for doing MT may lie with the payer, rather than the patient's specific needs.  Each assay can run as much as $7,000, which can make insurance companies unwilling to cover the cost in many cases.

However, most oncologists and pathologists agree that molecular testing can actually save money in the long run. The detailed, personal information that it provides can guide an otherwise uncertain treatment plan. A negative test result can save a lot of money on expensive, targeted therapies.

In order for progress to take place, continuing education is essential. This is true of both the medical oncologists and the pathologists. In the rapidly evolving world of cancer drug development, new molecular tests will emerge on a regular basis which will help choose new options for treatment where there were none before.  Pathologists and oncologists must work together to use the test results to guide treatment by identifying who will benefit from specific targeted therapy regimens. 

References

(1)http://accc-cancer.org/education/molecularTesting-Overview.asp

(2) http://obroncology.com/obrgreen/article/Molecular-Testing-Preparing-for-the-New-Normal-in-Community-Oncology


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Oncology, Predictive Biomarkers, Targeted Therapy, Drug Development, Molecular Testing, Personalized Medicine

Orphan Diseases Open Opportunity for Pharma, Biotech Drug Developers

Posted by Shannon Flynn on Sat,Feb 23, 2013 @ 09:00 AM

Orphan Diseases Attract Increasing Attention Across the Board

The lack of FDA-approved orphan drugs represents a significant economic opportunity for pharma and biotech drug development firmsAs patents expire and generic competition increases, more drug companies are investing in the development of therapeutics for orphan diseases. Although the pool of patients for an orphan disease is small, the economic potential of an expensive biologic administered over the lifetime of a limited number of patients presents an attractive commercial opportunity that is a savvy alternative to the en mass selling of lower-priced small molecule compounds which are the mainstay of the industry.

Pharma / Biotech Economics: 7,000 Orphan Diseases, 200 Treatments

Thomson Reuters reports that in the U.S. alone, rare diseases afflict an estimated 25 million people, representing approximately 8% of the total population[i]. According to the National Organization for Rare Disorders (NORD) nearly 7,000 orphan diseases have been categorized already and that number continues to grow year by year as new discoveries are made. Nevertheless, only about 200 of these have FDA approved treatments, leaving the market wide-open to newcomers.

In 2011, orphan drugs represented one third of NMEs approved by the FDA. The same year the orphan drug market was estimated at over $50 billion, accounting for roughly 6% of all pharmaceutical sales. In 2012, approximately one quarter of the 39 new drugs approved by the FDA had orphan status. This pattern continues, as a recent analysis reports that nearly 1,800 of the 5,400 drugs currently in development have received orphan status[ii].

In addition to tantalizing premium prices, which can range from $100,000 to over $400,000 per patient annually, growth is driven by government incentives including tax credits, grants, and regulatory fee waivers as well as shortened approval times and higher probability of approval. Faster uptake, lower marketing costs and longer market exclusivity are also key drivers of growth. In addition, patient organizations often raise funds for research, lowering R&D spend.

Hurdles to Drug Development

Though the lucrative profit potential of these drugs is alluring, success in the orphan market is not without its own set of challenges. Lack of education and awareness among patients and providers alike, along with sometimes poor diagnostic methods hinders identification of the target patient population. Rare disorders are often cryptic, leaving patients misdiagnosed or undiagnosed for long periods of time which can span many years. For example, it is not uncommon for patients suffering with Hereditary Angioedema (HAE) to wait up to 10 years before receiving an accurate diagnosis[iii].

Locating and recruiting patients poses logistical problems to organizing and carrying out clinical trials, resulting in increased costs. Nevertheless, companies have proven successful in overcoming these obstacles and expanding the patient population through utilizing social media, engaging patient advocacy groups and spearheading awareness campaigns and educational programs.

While the economic burden of leaving the population untreated typically outweighs the costs of treatment due to improved patient outcomes, as interest in high-priced, specialty drugs continues to grow, so does the potential for payer pushback. At present, the jaw-dropping costs are largely covered by government programs, health plans and company-sponsored payment assistance programs in order to ensure access to affordable care for patients.

Nevertheless, as patient phenotyping and personalized medicine further characterize more common diseases into specific indications, the number of diseases that meet the criteria for orphan status will continue to expand, placing even greater burden on the healthcare system.

Worthwhile Opportunity for Pharma and Biotech Drug Developers for the Foreseeable Future

For the moment however, it appears the benefits of orphan drug development far outweigh the cost for industry and payers alike, creating a stable and growing market ripe with opportunity.

 


[i] “The Economic Power of Orphan Drugs” Thomson Reuters Report, Aug 2012

[ii] “Innovation in the Biopharmaceutical Pipeline: A multi-dimensional view” Analysis Group, Jan 2013

[iii]  Lunn, M. L., C. B. Santos, and T. J. Craig. "Is There a Need for Clinical Guidelines in the United States for the Diagnosis of Hereditary Angioedema and the Screening of Family Members of Affected Patients?" Annals of Allergy Asthma & Immunology 104.3 (2010): 211-14.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Development, Pharma Consulting, Biotech Consulting, Orphan Drug Development

ASCO GU: Heads-Up for Biotech Drug Development in Kidney Cancer

Posted by Marne Wessner on Mon,Feb 11, 2013 @ 11:50 PM

Interesting Data for Pharma and Biotech Drug Developers

ASCO GU2 2013 Genitourinary Cancers Symposium for Pharma and Biotech Drug DevelopmentASCO’s second meeting of the year, ASCO GU, is coming up next week, and here is our list of anticipated data releases for renal cell carcinoma.  (Note that full abstracts won’t be available until February 12, so it is impossible to comment on the significance of these results until then.) It looks to be a quiet meeting this year for RCC, according to key opinion leaders, but there are some presentations on the schedule with the potential for interesting data for Pharma and Biotech drug developers.

Additional Data from TIVO-1 Trial of Aveo/Astellas’ Tivozanib

There are several abstracts reporting aspects of the TIVO-1 trial data at this year’s meeting. OS, subgroup analyses, and quality of life data are of high interest, and two additional poster presentations will also address biomarker research and tivozanib efficacy in patients previously treated with Bayer’s Nexavar (sorafenib).

Emerging Immunotherapies

Immunotherapy is an exciting field in RCC. The latest generation of immunomodulating agents includes nivolumab, an anti-PD1 from BMS; and AGS-003, a dentritic cell therapy from Argos—both in Ph III for RCC. These agents each have poster presentations, which will hopefully give early indications about their potential in RCC.

Sequencing and Combinations of Approved Therapies for Kidney Cancer

The hottest issue in RCC therapeutics is the sequencing of the many approved agents on the market, and the positioning of any new ones about to be approved. This is a conundrum for oncologists as well as drug developers seeking to leverage the data to gain market share.

  • Votrient: Additional quality of data from the COMPARZ trial of GSK’s Votrient (pazopanib) vs. Pfizer’s Sutent (sunitinib) in first line RCC will report, likely an update of what was reported at ESMO 2012 last fall.
     
  • Inlyta:  Pfizer announced that the AGILE 1051 trial of Inlyta (axitinib) in first line RCC did not meet its primary endpoint in October 2012, and it looks like we will finally see data from that trial as well as the Ph II dosing trial in first line RCC.
     
  • Avastin combos: The Ph II BEST trial, which compared Roche/Genentech’s Avastin alone and combinations of Avastin, Nexavar, and Torisel, will also report data. In RCC, combinations of currently-approved targeted agents have been unsuccessful historically, so expectations are low for this trial.
     
  • mTOR inhibitors: Finally, a new safety analysis of mTOR inhibitors will be presented, which will hopefully provide oncologists with more information on dealing with the side effects of this class of drugs, which are very different from the tyrosine kinase inhibitors that are commonly used in RCC.

 

Key Presentations of Interest at ASCO GU

  1. Overall survival results from a phase III study of tivozanib hydrochloride versus sorafenib in patients with RCC (Motzer, et al, abstract 350)
     
  2. Subgroup analyses of a phase III trial comparing tivozanib hydrochloride versus sorafenib as initial targeted therapy for patients with mRCC (Hutson, et al, abstract 354)
     
  3. Treatment benefit of tivozanib hydrochloride versus sorafenib on health-related quality of life among patients with advanced/mRCC: Tivo-1 study results (Cella, et al, abstract 355)
     
  4. Axitinib vs. sorafenib as first‑line therapy in patients with mRCC (Hutson, et al, abstract LBA348)
     
  5. Quality of life among patients with RCC treated with pazopanib versus sunitinib in the COMPARZ study (Cella, et al, abstract 346)
     
  6. Axitinib with or without dose titration for first-line mRCC: Unblinded results from a randomized phase II study (Rini et al, abstract LBA349)
     
  7. The BEST trial (E2804): A randomized Ph II study of VEGF, RAF kinase, and mTOR combination targeted therapy with bevacizumab, sorafenib, and temsirolimus in advanced RCC (McDermott et al, abstract 345)
     
  8. Incidence and risk of treatment-related mortality in patients with RCC and non-RCC treated with mTOR inhibitors (Choueiri, et al, abstract 347)
     
  9. Clinical activity and safety of antiPD-1 (BMS-936558) in patients with previously treated mRCC: An updated analysis (McDermott, et al, abstract 351)
     
  10. Prolonged survival with personalized immunotherapy (AGS-003) in combination with sunitinib in unfavorable risk mRCC (Amin, et al, abstract 357)


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Developers, Targeted Therapy, Drug Development, Kidney Cancer, Biotech Consulting, Pharma Launch Planning

FDA-Mixed Response to Proposed Faster Drug Development Pathway

Posted by Tom Penrice on Thu,Feb 07, 2013 @ 04:00 PM

Does the US Need Another Expedited Drug Development Pathway?

The FDA’s meeting to discuss a proposed new pathway aimed at expediting the development of “medicines intended to treat serious or life-threatening conditions with unmet medical needs”, met with a mixed response on February 4th.  The proposal was prompted by a report last fall from the US President’s Council of Advisors on Science and Technology(PCAST), which said a “special medical use”(SMU) pathway could improve drug evaluation in the US.

FDA receives mixed results on proposal for faster drug development pathwayThe Public Weighs In

Participants weighing in on the issue included representatives from Cubist Pharmaceuticals, Trius Therapeutics, Biotechnology Industry Organization, The National Research Center for Women & Families, and Antibiotics Working Group (AWG).

Is There a Need for an Alternate Drug Development Pathway?

Creating an alternative approval pathway could "greatly enhance" the prospects for successful clinical development of novel antimicrobials against the ESKAPE pathogens and would complement the GAIN Act's incentives (Generating Antibiotic Incentives Now (GAIN) Act).

However, there are already six other expedited drug development pathways in place and 50% of the medicines approved in 2009 and 2011 were through a priority pathway. Additionally, various other proposals from the anti-infective development community and the Infectious Diseases Society of America (IDSA) are already on the table, with an assortment of names and acronyms, such as "special population limited medical use" (SPLMU) and "limited population antibacterial drugs" (LPAD).

Some Concerns Brought to Light

There were a few concerns expressed during the discussion, including:

  • Could another expedited drug development pathway create potential congressional intervention resulting in added demands on the FDA?
  • If the FDA pursues its new alternative pathway, could the expedited approval pathways in the Food and Drug Administration Safety and Innovation Act, such as the breakthrough therapies designation, get short shrift?

Suggestions to Enhance Potential Advantages:

Suggestions made for enhancing the potential advantages of the proposal included:

  • Adopt a tiered regulatory framework for the new alternative regulatory pathway, which would allow either disease- or pathogen-based label indications, along with labeling that encourages the most appropriate use of the new medicines commensurate with the approved indications.
     
  • Expand the new initiative to include later stage products, and include indications for which there currently is no guidance, such as prosthetic bone and joint infections, osteomyelitis and bacteremia.
     
  • For antibacterials, the FDA's definition of unmet medical need should not only focus on current needs, but also future needs.
     
  • Balance the dual priorities of expediting clinical development through smaller and more targeted studies and use of authorities that promote responsible prescribing for specific sub-populations through appropriate labeling and restrictions of use.
     
  • Provide clarity about mechanisms or processes to expedite the clinical development of limited use products if it is to include postmarket restrictions of use.
     
  • Make any SMU designation available early in drug development so that manufacturer can design appropriate clinical studies for use under the pathway, for example by conducting trials based on only the most severe manifestation of the disease without having to progress through more moderate disease populations first.
     

You Decide

Is there a need for yet another expedited drug development pathway? As mentioned in our prior post, a streamlined clinical trial process for drug development could have significant strategic planning and competitive intelligence implications for pharmaceutical and biotech firms. Please share your thoughts.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: FDA, Drug Development, Competitive Intelligence

FDA to Consider Faster Drug Development via Smaller Clinical Trials

Posted by Tom Penrice on Fri,Feb 01, 2013 @ 12:00 PM

FDA Hearing on Faster Clinical Trial Process

FDA considers faster drug development process. Implications for Pharma and Biotech Drug Development and Competitive Intelligence.In January the FDA announced it will be holding a public hearing on February 4 and 5, 2013 to gather input on what may lead to a faster clinical trial process for drug and biological products development for "serious or life-threatening conditions that would address and unmet medical need". If approved, an expedited drug development process will be permitted for smaller subpopulations of patients with "more serious manifestations" of a condition. Such a process will lead to faster clinical trials vs. typical studies involving a broader group of patients with a wide range of clinical manifestations.

New Labeling Required

Labeling for approved drugs under the proposed process must clearly show that the drug is "narrowly indicated for use in limited, well-defined subpopulations in which the drug's benefits have been shown to outweigh its risks." Labeling requirements may include an appropriate logo to appear on the container.

Obtaining Public Comments

The purpose of the public hearing is to obtain information and comments on the "need for and feasibility of this pathway and its potential advantages and disadvantages".

Other Highlights

The FDA recognizes that the resource-intensive programs required to approve drugs treating a "broad condition with a wide range of clinical manifestations" requires large study populations which can prevent a drugs from becoming available on a timely basis to patients with "important and unmet medical needs".

It is important to explore the benefits and feasibility of a drug development process for smaller sub-populations of patients with serious or life-threatening conditions, including infections caused by antibiotic-resistant bacteria.

The approval of a narrow indication could be broadened if future data demonstrate the effectiveness and safety in treating a "broader condition or patient population".

For further information, go to http://www.gpo.gov/fdsys/pkg/FR-2013-01-15/pdf/2013-00607.pdf

Impact on the Drug Development Industry

If approved, a streamlined clinical trial process for the development of drugs and biological products may have significant implications for pharmaceutical and biotech firms. Strategic planning and competitive intelligence will take on an added dimension. Forward-thinking strategists would do well to thoroughly consider the implications and the potential to gain a competitive advantage should approval be granted for an expedited drug development process.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: FDA, Drug Development, Competitive Intelligence

ASCO GI Preview - Heads Up for GI Cancer Drug Development

Posted by Marne Wessner on Tue,Jan 15, 2013 @ 08:00 AM

ASCO GI Cancer Drug Development

Abstract titles are up for ASCO GI, and here’s a list of the abstracts we are looking forward to seeing next week.  (Note that full abstracts won’t be available until January 22, so it is impossible to comment on the significance of these results until then.)

Abraxane positive in phase III for pancreatic cancer

The Abraxane study in pancreatic cancer (abstract 67) is likely to be the major news from this year’s meeting. At ESMO in October, KOLs were indicating that the results might be positive, and indeed, Celgene announced in November that this trial met its primary endpoint of overall survival with a statistically significant improvement over gemcitabine alone. Now we will finally see the data. There have been so many notable failed trials in this disease (axitinib and ganitumab, for example) that it’s exciting to finally see something positive!

New biomarker and safety data for Stivarga (regorafenib)

Bayer’s Stivarga was just approved for third line CRC in September 2012, and presentations at this meeting include biomarker and safety data (abstracts 318 and 467). Hopefully the new data will shed light on which patients are most suitable for Stivarga and how oncologists can deal with toxicities.

Ramucirumab data notably absent

We also note that the phase III gastric cancer trial of ramucirumab (VEGF inhibitor, Lilly), which was announced as positive a few months ago, will not be presented. The next opportunity to present the data at an important venue will be at the main ASCO meeting in June.

New GI cancer drugs on the horizon at last

KOLs have been complaining that there hasn’t been anything new in CRC for a long time, but it looks like the tide is finally turning with two new approvals in 2012, and some promising new agents on the horizon. All of these developmental agents could eventually make an impact in standards of care for CRC.

In HCC, there are a few developmental agents with early-phase data that will be presented. Of note is the Pfizer CDK inhibitor, PD-0332991, in HCC. Last month at SABCS, this agent reported very promising phase II efficacy data in ER+ breast cancer, as well as a mild toxicity profile. Efficacy combined with good tolerability could make it an attractive compound in HCC.

 

Key presentations of interest for drug development at ASCO GI

  1. Final results of a randomized phase III study of weekly nab-paclitaxel [Abraxane] plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (Von Hoff, et al, abstract LBA148)
  2. Mutational analysis of biomarker samples from the CORRECT study: Correlating mutation status with clinical response to regorafenib (Jeffers et al, abstract 381)
  3. Time course of regorafenib-associated adverse events in the Ph III CORRECT study (Grothey, et al, abstract 467)
  4. Ph II study of PD-0332991 in advanced HCC (Littman, et al, abstract 321)
  5. Patient-reported outcomes from a phase III multicenter, randomized, double-blind, placebo-controlled trial of gefitinib versus placebo in esophageal cancer progressing after chemotherapy: Cancer Oesophagus Gefitinib  (Dutton, et al, abstract 6)
  6. Ph II study of vismodegib, a hedgehog pathway inhibitor, combined with FOLFOX in patients with advanced GaCa and GEJ: A NY cancer consortium led study (Cohen, et al, abstract 67)
  7. A randomized, double-blind, placebo-controlled trial of trametinib in combination with gemcitabine for untreated metastatic PnCa (Infante, et al, abstract 291)
  8. Ph I/II study of golvantinib in combination with sorafenib in patients with advanced HCC: Ph I results (O’Neil, et al, abstract 294)
  9. Long-term efficacy and pharmacodynamic parameter analysis in pretreated KRAS-mutant mCRC patients treated with RG7160 (GA201), an ADCC-enhanced monoclonal anti-EGFR antibody (Delord, et al, abstract 379)
  10. Second-line therapy of KRAS-mutated mCRC with the MEK inhibitor selumetinib in combination with irinotecan: An AGICC study (Hochster, et al, abstract 380)

 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Development, Biotech Consulting, Competitive Intelligence, Gastrointestinal Cancer, GI Drug Development

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