A Different Type of Conference

Yesterday I took part in a panel at the ePharma Summit Marketing in a Digital World conference in NYC. The panel organized and led by WEGO Health’s Bob Brooks was titled Social Media for Pharma: A Match made in Heaven or Hell. 

I have attended ASCO annual meetings which were geared toward cancer research results and two Ovarian Cancer Survivors Courses by the Foundation for Women’s Cancer but this was the first time I attended or took part in a conference not geared completely toward ovarian cancer or cancer research but geared toward digital pharmaceutical marketing. My audience  and a majority of the other attendees were not other survivors or researchers but marketing directors, communication executives and marketing and healthcare technology professionals.  

I arrived early to be able to listen to a few of the other speakers. There were talks on how to use real-time data, how to use Big Data ( lots and lots of data) effectively, how to engage patients and how to build a relationship with patients to improve patient compliance in taking their prescription medication. 

Notable lines:

Data beats opinion. 

How have I satisfied my customer?

Engage your customer.

Get more personal.  

I was happy to see that the theme was how companies need to listen to their consumers/patients. 

Then the afternoon rolled around and it was time to walk up on the stage with the other panelists, Michael Weiss, a Crohn’s disease activist( www.hospitalpatient.com), Tiffany Peterson, a Lupus activist (tiffanyandlupus.com) and Casey Quinlan, an author and breast cancer activists( cancerforchristmas.com). They are amazing activitists going above and beyond to raise awareness of their diseases and speaking for other patients. 

My part of the panel focused on how Pharma could use social media and the internet to reach out to patients during drug shortages. Not just health care providers but patients who are on IV chemotherapy need shortage information too in order to plan their treatment going forward. I suggested that in addition to letters to physicians that pharma reach out to patients through a patient press release and infographics to explain processing steps, etc. I also highlighted the Doxil Supply page www.doxilsupply.com/ and twitter account @supplyupdate as examples of a good way to reach patients and how I wish it had been available more quickly. After the pane,l I was thrilled to have a chance to speak to Lisa, a digital marketing director from Janssen about the Doxil page.  

So yesterday I got a chance to share my feelings as a survivor and customer but I also learned. I learned that the FDA is responsible for notifying the public and patients regarding drug shortages. There are no FDA  rules for internet/ social media use by the pharmaceutical companies.  I think a new goal of mine should be how to get the FDA to better communicate information about IV shortages with us. Anyone know who I can write to at the FDA to get the ball rolling? 

Dee

Every Day is a Blessing!

Doxil Available

I first wrote about the Doxil Shortage back in November of 2011. It has been a year of anxiety for oncologists and patients.

As of Oct 15, 2012 doctors have full access to Doxil . Janssen the manufacturer issued  a statement that you can read in full here.

Hopefully with through the work of ASCO , the FDA and other organizations situations like this will not occur in the future.

Dee
Every Day is a Blessing!

ASCO - Ovarian Cancer Phase 1 trials

Part two of my ASCO report. This one is about some of the many  phase 1 trials I learned about.

The part of ASCO I liked best were the poster sessions. Many times there was a researcher present at the session to answer questions about the studies being done and most were very happy to share information with patient advocates. In addition to those posters specific to ovarian cancer I also started to look closely at  research that involved solid tumors since ovarian cancer is a solid tumor.

I saw research on small molecules that inhibit different pathways in cancer proliferation and also research combining those therapies with standard chemotherapy drugs.

Here some phase 1 trials I found most intriguing:

Abstract 3082

A phase I study of R04929097, an oral gamma secretase inhibitor, in combination with gemcitabine in patients with advanced solid tumors (PHL-078/CTEP 8575).

"RO4929097 (RO) is an oral inhibitor of gamma-secretase that disrupts Notch signaling." 

Conclusion: "RO and GEM can be safely combined." Notch signaling pathway is a transmembrane ( outside the cancer cell to inside the cell) protein. The protein signals the cell to reproduce. 

Abstract 3088

A phase I study of dovitinib (TKI258) in Japanese patients with advanced solid tumors

"Dovitinib is a tyrosine kinase inhibitor with demonstrated inhibitory activity against FGFRs, VEGFRs, and PDGFRs in vivo."  
Conclusion: Dovitinib(TK1258) was used in this phase I trial and found the MTD (maximum tolerated dose) to be 500mg.

Abstract 3054

A phase I study of chronically dosed, single-agent veliparib (ABT-888) in patients (pts) with either BRCA 1/2-mutated cancer (BRCA+), platinum-refractory ovarian cancer, or basal-like breast cancer (BRCA-wt).

"Veliparib(ABT-888) is an oral, potent inhibitor of PARP 1/2. Preclinically, PARP inhibitors have activity in tumors with defective homologous recombination (HR), particularly those that are BRCA+." 

Conclusion: Veliparib(ABT 888) ,an oral drug, was found to be tolerable at the MTD of 500mg and was also found to show evidence of anti-cancer activity in BRCA1 and 2 patients. I was pleased to see that  researchers in this study included oncologists from CINJ.

Abstract 3044

SORAVE: Phase I study for the treatment of relapsed solid tumors with the combination of sorafenib and everolimus.

"Dual inhibition of signaling pathways interfering with angiogenesis and cell proliferation may increase anti-tumor efficacy. We evaluated the combination of the VEGFR inhibitor sorafenib (S) and the mTOR inhibitor everolimus (E)" 

Conclusion:Relasped patients tolerated a combination of E everolimus at 7.5 mg/day and Sorafenib at 400 mg per day. It was found to be safe and feasible. Sorafenib is a multi-kinase inibitor and everolimus is an mTor inhibitor.

Abstract 3041

Phase I, first-in-human trial of an oral VEGFR tyrosine kinase inhibitor (TKI) x-82 in patients (pts) with advanced solid tumors

"VEGFR TKIs have shown benefit in the treatment of various tumor types. Side effects of the TKIs have affected the duration of therapy pts can tolerate, as well as the combinability with chemotherapy. X-82 is a highly potent VEGFR/PDGFR TKI with a smaller volume of distribution and limited tissue accumulation designed to minimize side effects while maintaining target effect." 

Conclusion:Oral X-82 is well tolerated with reduced the side effects.

Abstract 5061

A phase Ib study of the combination of temsirolimus (T) and pegylated liposomal doxorubicin (PLD) in advanced or recurrent breast, endometrial, and ovarian cancer.

"PLD is active in metastatic breast, endometrial and ovarian cancer. Preclinical studies suggest that mTOR inhibitors (mTORi), such as T, have an additive therapeutic effect to chemotherapy and resistance to doxorubicin can be reversed by adding an mTORi.: 

Conclusion : "The combination of T and PLD is safe and tolerable. The MTD was assessed at PLD 40 mg/m² once every 4 weeks and T 15 mg weekly. The activity of this combination in breast, endometrial and ovarian cancer pts is promising and warrants further studies. "Temsirolimus is a kinase inhibitor which would be working with a chemotherapy drug.

I understand that many of these treatments may not be effective in terms of increasing overall survival but this very small review depicts that there is a good body of work being conducted to to improve the treatment of Ovarian Cancer.


Dee
Every Day is a Blessing!

Doxil Shortage Update - a Source in India

The FDA informed USA Today on Monday that a source of Doxil ( doxorubicin HCL Liposome) has been found in India. The FDA will allow the drug to be imported from Sun Pharma Global, which has been inspected by the FDA .

Information on Lipodox can be found here.

The job now is to prevent this shortage situation from happening again with other generic drugs critical to the survival of cancer patients.

Dee

Every day is a Blessing

doxorubicin HCl liposome injection

Doxil Shortage Development

On the Doxil web page Rob Bazemore , the president of Janssen Products ( J&J is the parent company) , states;

"I am saddened to share news today that Ben Venue Laboratories, Inc. (BVL), our third-party supplier who manufactures DOXIL^®, announced its temporary suspension of manufacturing and distribution of drug products. Click here to read a posting on the BVL website announcing this news and here to read our related official communication to healthcare providers.

This voluntary decision is a result of an internal BVL review, which indicated that routine preventive maintenance did not happen at a specified time for some manufacturing equipment. This required maintenance included steps to ensure that machinery meet all qualifications before being used again. BVL is halting production to conduct a site-wide assessment to determine the potential impact, if any, and will implement any corrective actions if needed.

This temporary suspension of manufacturing by BVL impacts the production and release of DOXIL^®, which is currently in short supply and not available beyond product already allocated to patients in the DOXIL^® C.A.R.E.S. Physician Access Program. We are not able to estimate timing when DOXIL^® may return to the market as BVL has not provided a commitment on when its manufacturing operations will resume. In light of this situation, patients should speak with their physicians about alternate treatment options.

"

For the complete statement please see http://www.doxil.com/doxil-supply-shortage.

Doxil is a doxorubicin Hydrochloride encapsulated in liposomes for intravenous use. The manufacture of Doxil includes a fermentation process ( a streptomyces bacterium is used) and subsequent chemical conversion processes to reach the final drug stage. In Europe, Doxil is know as Caelyx. The patent on Doxil expired in 2009 but it has orphan drug exclusivity until May 2014 . Orphan Drug status is given to those drugs that are used to treat rare conditions with less than 200,000 patients using it per year. Yes, ovarian cancer is considered a rare condition with ~25,000 women diagnosed a year. That status protects J&J from generic drug competition and allows the company to recoup its development and marketing costs.

Prior to teaching I was a process chemical engineer for an over -the-counter product manufacturer. I understand the need for maintenance. I remember how long it took for the manufacturing plant to break apart the pipes , clean & sterilize them and restart. It is not an overnight procedure. It may take upwards of two weeks. Then the fermentation must begin again so that also adds time to the process. My hope is that J&J does not wait to find a new back-up contract manufacturer. In this economy there may be other manufacturers just waiting to fill the void. It will take them the same time to startup the process but then all the women who need it will have access to the drug. Or J&J can give up it's drug exclusivity and allow other manufacturers to produce the drug.

Please don't wait J&J, women's lives are at stake.

Dee

Every Day is a Blessing!