Posts tagged ‘Pharma Strategy Consulting’
The 2013 annual meeting of the American Society of Clinical Oncology (ASCO) is fast approaching, and for many in cancer drug development, it is one of the landmarks of the year.
This year, there’s a lot of interesting data on PD-1 and cancer immunotherapy, something we picked up on before the annual meeting last year. Sally Church, PhD is in the process of finalizing her pre-ASCO video and it will be available soon.
For a meeting that is typically orientated around solid tumors, there is a lot of data at the meeting on Chronic Lymphocytic Leukemia (CLL).
The CLL landscape is set to change, with new treatment options on the horizon. Ibrutinib received FDA Breakthrough designation earlier this year in three different indications, and we will be writing more about this market in a forthcoming Pharma Strategy Report.
For those clients and potential clients interested in learning more about our capabilities or discussing our services, we will be in Chicago for ASCO – please do contact us if you would like to meet up.
Pharma Strategy Report on Chimeric Antigen Receptor Technology CART available to download
May 21st, 2013
Daedalus
To celebrate the launch of Pharma Strategy Reports, we are offering a complimentary executive summary on Chimeric Antigen Receptor Technology (CART), written by Sally Church, PhD.
You can obtain your complimentary copy of this report on the Pharma Strategy Reports website. You will gain insights into:
- The challenges associated with immunotherapy and stimulating the immune system
- How are next generation immunotherapies making waves in cancer research?
- How recent papers in NEJM and Science & Translational Medicine have described this novel approach and what the preliminary data shows
- Some of the potential challenges or hurdles for registration of CTL019, the CART therapy being developed by Novartis.
CART is emerging as potential new exciting leukemia treatment – impressive results have been reported in a small cohort of adults with CLL and children with ALL who received the Novartis CTL019 therapy.
We expect there will be more data available at the 2013 annual meeting of the American Society of Hematology (ASH) later this year in New Orleans.
If you have an interest in understanding the potential of CART technology, then please sign up at Pharma Strategy Reports to download a complimentary executive summary. You will also be the first to know about future reports when they are published, such as what the new FDA Breakthrough designation means?
The challenge of Tumor Lysis Syndrome in Hematology New Product Development
February 20th, 2013
Daedalus
Tumor Lysis Syndrome (TLS) has been in the news recently as a result of two patient deaths in a chronic lymphocytic leukemia (CLL) clinical trial with AbbVie’s ABT-199, a novel BCL-2 inhibitor in early stages of development.
What is TLS and why is this important in cancer research was subsequently analyzed by Icarus Consultants hematology industry expert, Sally Church, PhD on Pharma Strategy Blog.
Sally notes in her post, “we don’t yet know whether the effect in ABT-199 is a dose-schedule issue or a compound structure issue (especially given the reformulation from the original navitoclax issue).”
It’s a major setback to AbbVie ($ABBV) when the company was poised to start a phase 3 clinical trial with ABT-199 in CLL.
AbbVie will have to convince doctors that careful dose scheduling can solve the problem of a drug that may be too potent for the body to handle. Further deaths due to TLS could easily stop the development of this compound.
The setback to ABT-199 is, however, good news for ibrutinib that along with ABT-199 is in a race to market in CLL.
On February 12, 2013, ibrutinib received “breakthrough designation” from the FDA for the treatment of mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia.
Breakthrough designation means that a drug can be approved on the basis of early clinical data. Depending on when filing takes place, FDA approval of ibrutinib in MCL could be forthcoming later this year.
We expect to be producing a report on the CLL new products in development soon. This will cover some of the challenges and issues companies are facing. If you haven’t already done so, please sign up below if you would like to receive news alerts and be the first to know when reports are available.
Celgene Corporation’s nab-paclitaxel (Abraxane) will be a new treatment for advanced pancreatic cancer. That was the news from the 2013 American Society of Clinical Oncology Gastrointestinal Cancers symposium (ASCO GI) that took place in San Francisco last month.
At the 2012 European Society of Medical Oncology (ESMO) meeting in Vienna, Sally Church, PhD noted on Pharma Strategy Blog that pancreatic cancer experts such as Margaret Tempero, MD were excited about the prospect of nab-paclitaxel in pancreatic cancer
The data presented at ASCO GI showed that for patients with metastatic adenocarcinoma of the pancreas, the addition of nab-paclitaxel to the chemotherapy gemcitabine led to an increase in median overall survival of 1.8 months compared to receiving gemcitabine alone (8.5 months versus 6.7 months, Hazard Ratio: 0.72, P=0.000015). While this may seem a small amount of time, there are few effective treatments for advanced pancreatic cancer.
By showing a significant increase in overall survival, Abraxane met the primary endpoint of the phase 3 MPACT clinical trial, and is likely to be approved by the FDA in the future.
Abraxane will provide a new treatment option in pancreatic cancer
The Abraxane data presented at ASCO GI was good, but it was not great. Sally Church interviewed Dr Hedy Lee Kindler, Associate Professor of Medicine at the University of Chicago about the significance of the data.
In her “Making a difference in Pancreatic Cancer Interview“, Dr Kindler says that for most of her patients she would still use FOLFIRINOX. This is a chemotherapy combination (5-fluorouracil, irinotecan, and oxaliplatin) that has side effects that need to be carefully managed.
It is only suitable for those patients who are well enough to take it, but offers a superior survival advantage in advanced pancreatic cancer. Data from the PRODIGE 4/ACCORD 11 study presented at the 2010 meeting of the American Society of Clinical Oncology (ASCO) showed the median overall survival time for patients receiving the FOLFIRINOX regimen to be 11.1 months.
Where we expect Abraxane to receive most pancreatic cancer use in the United States is from community oncologists who don’t wish to manage the side effects associated with FOLFIRINOX
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If you would like to learn more about the pancreatic cancer market and evolving treatment landscape, we will be publishing an in-depth report in the next few weeks.
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Making sense of data is what we do. We live in a world where, thanks to the internet, the sheer volume of available data is increasing at an enormous rate.
Too often we see staff at client companies focus their energy on gathering data as cheaply as possible, instead of asking or seeking to understand what does all the data mean from a competitive stand point?
Data is now commoditized. Anyone can gain access to past ASCO Virtual Meetings, for example, and watch a rerun of conference presentations. While obtaining data is relatively easy, insights are a lot more expensive and difficult to generate.
Why?
Well, they require the application of knowledge, deep understanding and expertise of the topic to analyze, conceptualize and visualize data, and then extrapolate what it means to a company or product.
Here’s a fun video that shows how a picture tells a thousand words. Professor Hans Rosling, in this excerpt from a BBC documentary, shows the public health history of 200 countries in 4 minutes…
Turning data into a powerful illustration requires the expenditure of intellectual effort.
Making sense of data is what we do at Icarus Consultants.
We are delighted to announce the public launch of our annual “New Products MBA” program that involves custom monthly case studies and 1:1 coaching. Previously by private request only, this program is designed for senior executives with responsibility for new product development or those involved with strategic decision making in this area.
How does the coaching program work?
This is an individual program and lasts for one year during which 10 monthly case studies are undertaken on topics selected by the participant. These could be on a tumor type, pathway, indication or topic related to drug development e.g. the science and commercial challenges around chimeric antigen receptors. Case study topics are typically focused around the sponsoring company portfolio to enable learnings to be applied.
Each case study includes a 10-15 page written paper with background, analysis, insights and key strategic questions. Additional material in the form of scientific papers to read and videos to watch is also provided. The commitment required is equivalent to undertaking an Executive MBA.
Following review of the case study and accompanying material, a 1 to 1.5 hour 1:1 coaching session takes place by telephone with Sally Church, PhD in which key learnings are discussed.
Importantly, the program does not discuss confidential or proprietary information, it is focused on helping participants ask the right questions, not making a key decision for them.
Why is a new products coaching program necessary?
In recent years, oncology has become a fast changing environment where it is increasingly important to be able to see the scientific connections between pathways and tumor types, understand the emerging impact of new competitors with novel mechanisms of action, as well as biomarkers and companion diagnostics, and be aware of the evolving landscape for next generation immunotherapies.
What do participants gain from this program?
The result of this coaching program will be an increased scientific understanding that enhances the ability to ask the right strategic questions of New Product Development and Brand Marketing teams and enable more in-depth strategic collaboration at the both the senior and middle management level.
What level of staff is this program aimed at?
This program was originally developed for a board level senior executive at a global pharmaceutical company. Based on its success we are making it publicly available in 2013 to a limited number of participants. We anticipate that it would benefit those at the Senior Director to Executive VP level who are involved with a range of oncology new products.
How much does this coaching program cost?
The program is comparable in cost to attending an Executive MBA, please contact us if you would like to learn more.
Multiple Myeloma (MM) is forecast to be a hot topic at the forthcoming annual meeting of the American Society of Hematology (ASH) that starts in Atlanta next week.
There are four “Super Friday” satellite symposia and over 700+ MM abstracts that will be presented in multiple oral and poster sessions. If you add in the recent FDA approval for carfilzomib (Kyprolis) and the anticipation that pomalidomide (Actimid) will be approved soon, there’s a lot going on.
We specialize in Thought Leader or Key Opinion Leader (KOL) market research. Often projects are a hybrid where we discuss high-level strategic issues with KOLs and ask community hematology-oncologists or medical oncologists more practice-focused questions.
Based on our experience, multiple myeloma is a challenging topic for pharma market research:
- Treatment regimens can be complex, even some community medical oncologists have told us they are challenged by them.
- Treatment decisions are multifactorial and individualized, so it’s often hard for community based physicians to generalize.
- High prescribing community physicians may be in small towns not near a market research facility, requiring telephone interviews.
- Thought leaders are busy people – you need to focus on a few key questions you want them to answer.
- Access to top-tier thought leaders is difficult, they often will only talk to people they know or have met at medical or scientific meetings.
If you have plans to be in Atlanta for ASH, do contact us. We’d welcome the opportunity to meet up and tell you more about what we do.
Sally Church, PhD has been included in the FierceBiotech Top Voices in Biotech Twittersphere published today.
It is always good to receive recognition of Sally’s expertise in cancer drug development and the way she actively engages in social media (Sally writes as @MaverickNY on Twitter).
The Biotech Twittersphere is a community we are pleased to be part of. It’s where information is shared and discussions take place in real-time about new clinical trial results, and the impact for patients and companies. Sally is widely regarded as an industry expert in oncology/hematology new product development and commercialization.
Thanks FierceBiotech for the recognition!
The 2012 Chemotherapy Foundation Symposium takes place at the Marriott Marquis in Times Square, New York City from November 7 – 10. Fortunately, the timing avoids the disruption expected this week from Hurricane Sandy.
The Greenspan Meeting as it’s also known (in recognition of the late Ezra M. Greenspan MD, the symposium founder) provides the opportunity for oncologists to learn about new developments in cancer therapy.
It is a joint presentation by the Mount Sinai School of Medicine and the non-profit Chemotherapy Foundation.
Sally Church, PhD who frequently attends says she particularly “enjoys the lectures that give a broad strategic overview of a particular topic.”
There’s usually a good turnout from the NJ/NY pharma industry and it’s interesting to talk to local academic and community oncologists about their practice.
You can read more about last year’s prostate cancer session at the 2011 Chemotherapy Foundation Symposium on Biotech Strategy Blog. The informative sessions cover a lot of ground and are well worth attending.
Update November 1, 2012 – Symposium not cancelled after Storm Sandy
Good to see The Chemotherapy Foundation announce on twitter today that the symposium will go on as scheduled. Hopefully the transport network will have some semblance of normality by then otherwise it will remain a challenge for many in the local area to attend.
The Chemotherapy Foundation Symposium will go on as scheduled. You can still register on chemotherapyfoundationsymposium.org
— Chemo Fdtn Symposium (@tcfsymposium) November 1, 2012
For those interested in oncology new product development, and cancer biomarkers in particular, the joint ASCO-EORTC-NCI “Markers in Cancer” meeting in Hollywood, FL (near Fort Lauderdale) from October 11-13, 2012 looks well worth attending:
Markers in Cancer 2012 will stimulate discussion on the use of biomarkers as a tool for screening, diagnosis, and treatment of cancer. This year’s theme is “Bridging the Translational Divides” with a focus on practical aspects of biomarker development, future approaches, and optimal applications in translational research.
In his video preview of the meeting, Dr James Abbruzzese from the MD Anderson Center Center, says that the emphasis of this years meeting is to try and provide a roadmap to take work from the laboratory and translate that into patient care and actual clinical practice.
An area where biomarkers may have an important role to play is in selecting patients for clinical trials, especially where there is the opportunity of misdiagnosis. If inappropriate patients are selected, then not only may they not respond to the treatment, but they could negatively skew or undermine the clinical trial results. Biomarkers can also be important in helping to make differential diagnoses.
Cancer clinical trials such as the “catch-all” ridaforlimus phase III SUCCEED trial in sarcoma, for example, can end up showing favorable responses in some patients and little or no-responses in others, thereby canceling out the responders. More predictive biomarkers are needed to help determine the patient response to a particular treatment or identify those patients who are most likely to respond.
For those unable to make it to Florida, ASCO are offering a “virtual meeting” that will give access to recordings of the main presentations.