Posts tagged ‘Pharma Consulting’
October 26th, 2011
That sounds like a simple question, but can actually be difficult to answer.
As part of a market entry strategy or overview of the commercial landscape, we often have to look at the regulatory framework in a country.
For many products from pharma or biotech it’s obvious that something is a drug, medicinal product, biological product or device. However, for those involving nanotechnology, tissue engineering, biologics, or combinations of drugs/devices, it can be less clear.
Understanding how a product is classified from a regulatory perspective, something that may differ between countries, will impact a path to market strategy.
In the United States, under the Federal, Food Drug and Cosmetic Act (21 U.S.C. 321), the term “drug” includes:
“articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”
Dietary supplements such as vitamins are usually not considered to be drugs.
However, new research is coming out that shows vitamins may be more active than we may have previously thought.
Pieter Droppert on Biotech Strategy Blog has commented on research that showed giving vitamin E supplements to healthy men led to a 17% increased risk of prostate cancer.
In future it is possible that the regulatory classification for vitamins may change if they end up being given as active compounds for the treatment of a disease. What is a drug remains a simple question, but one that is not always easy to answer.
September 2nd, 2011
After all the “excitement” of hurricane Irene last week in the New Jersey/New York metro area, this weekend offers the Labor Day holiday. It is to many the last hurrah of summer.
According to the United States Department of Labor, the public holiday on the first Monday in September pays tribute to the American worker, “creator of so much of the nation’s strength, freedom, and leadership.”
Economic prosperity and access to healthcare are very much linked with employment in the United States, so it is sad to see the recent poor job creation results.
Icarus Consultants will be closed on Monday, September 5 and will reopen for business on Tuesday. We wish all our current and prospective pharma and biotech consulting clients an enjoyable weekend.
August 2nd, 2011
It takes desire, discipline and determination to blog regularly, and as a result many blogs fall by the wayside over time. However, Sally Church has been writing a blog on oncology, hematology, cancer science & biology, clinical trials and new product development for the past five years. It continues to go from strength to strength thanks to Sally’s passion for the area.
Sally recently announced on Pharma Strategy Blog that she had reached the 900 blog post milestone. In recognition of this, Sally took the time to answer the follow questions:
- Why do you blog?
- How do you decide what to write about?
- What makes a good blog post?
- Looking back on 900 posts – which posts are most memorable?
- What are your future goals for Pharma Strategy Blog?
You can find out Sally’s answers in the following video:
July 13th, 2011
Sally Church on Pharma Strategy Blog has written about recent research in triple-negative breast cancer (TNBC).
She discusses a published study from Vanderbilt that identified six different subtypes of the disease; each subtype being sensitive to different drug therapies.
As Sally points out these subtypes could be used as a potential biomarker for patient selection into an appropriate clinical trial – yet another step in the direction of personalized medicine.
July 5th, 2011
Sally Church has written two pieces about ASCO 2011 that have just been published by Christiane Truelove on the R&D Directions Insider blog.
In her first post entitled “ASCO follow up: Patients, Pathways, Progress in Practice” Sally discusses in detail a clinical study on personalized medicine presented at ASCO by Anatolia Tsimberdou MD, PhD, Associate Professor in the Department of Investigational Cancer Therapeutics at M.D. Anderson Cancer Center in Houston.
In this study, investigators performed molecular analyses on the tumors of 1144 patients with advanced cancer and identified one or more molecular aberrations in 460 (40.2 percent of patients).
Sally notes that “While the study concept is very promising, feasible and logical, there were a number of flaws that may have confounded the interpretation of this ambitious study.” You can read more on Sally’s insightful post on R&D Directions.
In her second guest blog post about ASCO 2011 news, Sally discusses “Molecular Targeted Therapy progress with Lung Cancer.” This is a topic that Sally wrote extensively about in a series of posts on Pharma Strategy Blog recently.
Sally’s guest blog post on R&D Directions discusses in detail the ASCO 2011 presentation by Mark G. Kris MD, chief of the Thoracic Oncology Service and The William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan-Kettering Cancer Center in New York.
Dr Kris presented at ASCO on how the 14- member Lung Cancer Mutation Consortium (LCMC) had identified one of 10 key “driver” mutations that appear in nearly two-thirds of lung cancer patients.
Sally’s conclusion is that:
“After years of treating all lung cancer patients similarly with chemotherapy, we can see at this ASCO meeting that, at least in adenocarcinomas, we are now beginning to make substantial progress not only in delineating the driving mutations, but also mechanisms of acquired resistance to erlotinib and potential new molecular targeted therapies for both ends of the spectrum – that’s good news for patients and oncologists alike.”
You can read more on this topic on Sally’s blog post on R&D Directions.
June 23rd, 2011
In the run up to the 2011 BIO international convention next week in Washington DC, Pieter Droppert on Biotech Strategy Blog discusses a recent Nature Reviews Drug Discovery paper on Pharma R&D productivity.
One of the take homes from the analysis of 28,000 pharma R&D compounds investigated since 1990 is that “therapeutic innovation has become more challenging and complex.” At Icarus Consultants we agree with that conclusion.
One only has to look at the increasing complexity surrounding oncology pathways as an example. Choosing the right molecular target and one where there is a market opportunity is key to success. Increasingly, patient selection is also becoming a key part of the paradigm.
New Product professionals need to do a comprehensive landscape analysis around potential target indications. Some of the questions to ask:
- Who are your competitors?
- What stage of development are they in?
- Which sub segment are you competing in?
- What does the clinical science show regarding molecular targets?
- Which patients should be included/excluded from the trials?
- What combinations might be relevant – chemotherapy or targeted therapies?
- Which line of therapy are you going for?
- What is the market opportunity for your new product?
These are things we often help our clients with at Icarus – as we learn more about the increasingly complexity of the underlying biology of disease, so the challenge with clinical trials in terms of tumour types and patient selection increases.
Choosing the right target is key to Pharma & Biotech drug development success.
June 15th, 2011
In case you missed the 16th Congress of the European Hematology Association (EHA) that took place this past weekend in London, Sally Church has produced a video blog with her highlights from the meeting.
It’s tough doing ASCO and EHA back-to-back, but Sally is a seasoned road warrior. In the video we even see her working on the plane!
In her video blog, Sally talks about new data from the Congress in AML, systemic anaplastic large cell lymphoma (sALCL), and how pharma/biotech companies can do more with their drug packaging to help promote patient adherence to drug treatments.
Sally formerly worked at Novartis Oncology on imatinib (Gleevec®) in CML, so has expertise in this field. You can read more about EHA and hematology new products on Pharma Strategy Blog.