Thursday, June 7, 2012

ASCO Highlights: Two Innovative Trial Designs

 
The annual scientific meeting for the American Society of Clinical Oncology (ASCO) recently concluded. As expected there was a constant flow of new data being released for products in various stages of development for all forms of cancer. The volume of new data is exciting, even though the decks are stacked against these approaches and their odds for commercial success are slim.

As I scanned articles summarizing data presented at the meeting two studies stood out to me because they have superior efficacy data, but also data on endpoints that answer the question of “value”. These two studies demonstrated bold thinking on the behalf of the companies. First, these companies designed products that are tolerable and don’t take away from patients’ quality of life, which is unheard of for the majority of cancer treatments. Additionally, these companies designed clinical trials to demonstrate efficacy and tolerability, which provides meaningful and valuable data to physicians, payers, and patients.

To proactively seek data to differentiate a product is a risky move. However, this is exactly what payers, physicians, and patients are asking for. We are going to see more of this in the future. The studies also demonstrate the importance of meeting patients’ strong desire for efficacious, tolerable, and safe drugs.

These are tremendous first steps, but in thinking and acting boldly, let’s do more to support patients and caregivers during treatment. We all know the time constraints on healthcare providers, an additional opportunity for life science companies is to provide robust patient and caregiver support programs that educate, inform, and guide patients. Treating cancer is a difficult journey. The more support patients receive the more likely they are to remain on treatment, which dramatically improves their outcomes.

Are you interested in knowing the two studies presented at ASCO that jumped out to me? They are…

1. The study GSK launched in patients with renal cell carcinoma evaluating patient preference for Votrient® (pazopanib) and Sutent® (sunitinib). In the study pazopanib (a late entrant into the market) went head-to-head against sunitinib (the 1st line treatment of choice). Both products have similar efficacy rates. The head-to-head study showed that 70% of patients who completed both treatments prefer pazopanib, 22% of patients that completed both treatments prefer sunitinib, and 8% of patients did not have a preference. The primary reasons patients preferred pazopanib were 1) better quality of life, and 2) less fatigue. This study demonstrates the value of evaluating not only efficacy data, but also patient tolerability preferences too.

2. The Roche/Genentech study with TDM-1, which is the Herceptin® antibody trastuzumab combined with the cytotoxic emtansine. The study of this investigational compound versus Xeloda® (capecitabine) + Tykerb® (lapatinib) in patients with HER2+ relapsed metastatic breast cancer showed a progression-free survival benefit with TDM-1, and lower rates of Grade 3 adverse events (41% versus 57%) and very little gastrointestinal toxicity. This study demonstrates the possibility of developing an efficacious product that has decreased side effects.

I’d like to hear from you. Have you considered, or are planning, a head-to-head trial in order to demonstrate your product's unique differences? Also, what ASCO presentations stood out to you? Please share the studies and why you think these are important trials.

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Thursday, May 31, 2012

ASCO: Celebrate Successes and Prepare to Support Patients in the Future

The annual scientific meeting for the American Society of Clinical Oncology (ASCO) starts this weekend in Chicago. This meeting is the premier scientific meeting for new clinical data in oncology. Reflecting on this important meeting I’m reminded of the significant advances that have been made in the last 15 years in treating cancer. Several trends fill me with hope for the future, including…

1) Increasing use of oral therapies
2) Molecularly targeted therapies offer decreased side effects versus traditional chemotherapy
3) The possibility that cancer, in many cases, can be treated as a chronic condition with an emphasis on on-going therapy
Cancer treatment is certainly much more effective, manageable, and tolerable than it was 15 years ago. While there are many advances in oncology treatment to celebrate, significant challenges remain including…  

* Patient adherence to treatment—As more oral treatments are used for treating cancer, patients and their caregivers take on a greater role for ensuring treatments are taken regularly and at prescribed doses. With treatments administered in a physician’s office or medical center the nurses see patients regularly and ensure treatments are administered as prescribed and at appropriate times. 

* Changing needs of patients and caregivers—As patients and caregivers take on more responsibility for administering treatments, they are also taking on more responsibility for monitoring and managing side effects to treatment. This can be a frightening responsibility for caregivers and more can be done to support them in this role.  

* Increased costs for treatment—On average targeted therapies cost significantly more than traditional chemotherapeutic agents. The increased cost is an issue for all stakeholders involved in oncology treatment including patients, caregivers, healthcare providers, payers, and life science companies. Patient co-pay and financial assistance programs are critical in helping many patients pay for their treatment.
For life science companies these challenges are significant, and they are also opportunities to engage with patients, caregivers, and healthcare providers. To begin, ensure you…  

* Understand the patient’s treatment journey, and in particular, the barriers they face in remaining adherent and compliant with treatment 

* Develop and implement comprehensive patient support programs that are a resource and guide for patient’s during their treatment journey  

* Inform and educate healthcare providers on the details of patient and caregiver support programs
As a pharmaceutical call center, we provide as-needed call-in support for patients, caregivers, and healthcare providers to answer questions about a product and its side effects, enroll patients in a support program, and connect patients with co-pay assistance resources. Our Medical Advisory Board works with us to design programs focused on meeting the needs of patients, caregivers, and healthcare providers.

I’d like to hear from you. What challenges does your oncology product(s) face? Please join the conversation and share your thoughts, challenges and questions.

I’ll be in Chicago at the ASCO meeting. If you’ll be at ASCO, please send me an e-mail and we’ll schedule a time to get together. I always enjoy learning about the challenges you're facing.

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Monday, May 7, 2012

Keep it Simple: Focus on the Patient with Adherence Programs

Hi, I'm Moriah Weissman and I'm a Clinical Director at Tunstall AMAC. I work with Lou and our life science company clients to provide clinical insights for the development of patient, caregiver, and healthcare provider support and communication programs. Lou invited me to contribute to the blog, and I look forward to sharing insights and thoughts with you, as well as learning more about your challenges.

In working with our clients there is a lot of interest in life science companies about maintaining patients on a treatment. A number of articles and studies have been published about patient adherence, and I certainly believe patient adherence can be a driver in your business. In looking at many of the patient adherence articles that have been published two thoughts come to my mind…

1. Why do most patient adherence programs seem so complicated?
2. Patient adherence programs are expensive, time-consuming, and difficult to implement!

Many of the patient adherence articles quickly become lost in the data, in analysis paralysis, or in defining whether or not a program is truly patient adherence based solely on whether or not it’s driving “behavior change”.

Perhaps I have over simplified the definition of patient adherence. To me, patient adherence is keeping a patient on a specific treatment. There are many ways this can be done, and certainly I agree that it’s important to embark on a discovery process that helps you to understand the patient journey and a patient’s desire to manage their condition. Without this it’s easy to develop a program that doesn’t drive the right actions. In fact an earlier blog post by Lou Shapiro provided suggestions for understanding the patient journey and resources for understanding a patient’s desire to manage their condition.

I believe two critical success factors for effective patient adherence programs are…

1. Develop meaningful programs that engage patients.
2. Collect feedback and data so the program can be continuously improved.

We offer four straightforward solutions to help our clients build effective patient adherence programs. These include…

1. Our focus is the patient. Start with the patient and keep them, and their needs, at the center of your solution.

2. Our AMAC Medical Advisory Board. We have relationships with healthcare providers in a number of therapeutic areas. We engage these experts to help us understand a particular disease-state/condition, current care delivery models as well as patient needs and challenges. We then work with our Medical Advisory Board to develop custom healthcare communication solutions that meet patients’ needs.

3. Our clinical program directors. They have advanced life science degrees in nursing and pharmacy. We tap into their clinical expertise to understand the patient journey and barriers to treatment as well.

4. Our pharmaceutical call center operators. They talk with healthcare providers and their offices, as well as patients and caregivers each day. They hear first-hand about the challenges patients have in managing their condition. Whether the challenges have to do with side effects, dosing, or cost, our call center operators can describe in detail what the obstacles are that patients face.

To build an effective program we take these insights and evaluate them against the product’s goals and needs. Next, we start putting together solutions that we, as a pharmaceutical call center, can provide. We also work with our clients to integrate other services, such as customized direct mail fulfillment, as appropriate.

Of course, I’ve simplified our development process for the sake of keeping this post brief. And my point is this: patient adherence programs are not rocket science. They can be straightforward and still be effective. I’m willing to bet that if you keep the patient, and their needs, at the center of your solution it will be a success.

Now, I want to hear from you. Do you agree, or do you think my oversimplified approach is wrong? Join the conversation and share your thoughts, challenges and questions.

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Tuesday, April 10, 2012

The Double Dip - Deliver Impact and Flexibility with Tele-Sales Solutions

The sales function in life science companies continues to evolve and become more complex. The pressure to increase sales in a cost-effective manner grows by the day and sales executives are eagerly searching for innovative and impactful ways to grow sales.

Tele-sales programs are flexible programs that efficiently and effectively augment sales and promotional activities in many ways including…

1) Scheduling visits with a field-based representatives to provide 1-on-1 interaction when it’s needed

2) Expanding territories and coverage to ensure all healthcare providers in a given territory have regular interactions with company representatives

3) Supporting promotional programs for new indications and offers such as support groups or prescription rebates

4) Building relationships with office staff to provide a venue for answers to their questions and for requesting samples and educational materials

5) Providing responsive handling of scientific and/or clinical questions by healthcare-trained representatives when the caller wants and needs it
I recently recorded a Podcast through PharmaVOICE sharing insights we’ve gathered from tele-sales programs we’ve worked on for our clients. Also, we recently published a White Paper on this topic. The White Paper offers three case studies that demonstrate how tele-sales solutions can be customized to meet a number of promotional needs and audiences including physicians, their office staff, and patients and caregivers.

If you’d like to listen to the podcast titled “Insights from the Field: Tele-Sales Solutions”, please click here to download. Additionally, if you are interested in a copy of the white paper titled "Seize the Moment: Tele-Sales Solutions Delivering Impact and Flexibility", please click here to request it. Please let us know what you think of these two resources—are they helpful or not? Also, would you like to have additional resources in other areas? If so, please let us know what areas interest you.

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Wednesday, April 4, 2012

Three Must-See Sessions at DTC Perspectives in April

The DTC Perspectives Conference starts next Tuesday, April 10 in Washington DC. The agenda looks great. I’m looking forward to hearing from executives at several life science companies on how they are changing their DTC programs to move away from brand promotion and awareness to focus on what patients need and want. When programs focus on what patients need and want we build engagement that can lead to commitment and loyalty.

There are three sessions that I’m particularly looking forward to...  

1) The New DTC: Using Technology to Build Relevance and Engagement with Paul Ewing and Todd Kolm at Pfizer. They are taking a case study approach to share insights into efforts to innovate consumer marketing at Pfizer.  

2) Effectively Reaching and Supporting Patients: A Novo Nordisk Case Study with Jeremy Shepler at Novo Nordisk and Rob Rebak at QualityHealth. They will be sharing key learnings from an integrated multichannel DTC program to drive educated doctor-patient interactions.  

3) Wake Up! Really, We Need to Wake Up! With Brian Lange at GSK. This presentation promises to help us recognize the cold hard reality that is in front of us each day, and will share tools to help us prepare for the next generation of DTC marketing initiatives.
I always look forward to learning from others, and the DTC Perspectives Conference is a great opportunity to engage with leaders that are boldly trying new things.

No doubt we live in exciting times. The opportunities to engage with patients and caregivers are rapidly changing, and the challenge is to develop patient programs that are meaningful and valuable. At PhoneScreen and AMAC we have been working with our life science company clients on a number of projects including tele-sales programs and patient support programs. These programs have the ability to quickly gather insights on the needs and challenges of patients, caregivers, and healthcare providers in managing a disease-state or condition. These insights enable our clients (and us) to develop meaningful programs.

If you are going to DTC Perspectives, please stop by our exhibit booth (look for the AMAC booth, which is number 29) and we’ll be happy to share with you how our programs can be customized to gather meaningful insights into what patients and caregivers need. If you would like to set up a time to meet at the DTC Perspectives meeting, please send me an e-mail and we’ll schedule a time to get together.

Hope to see you in Washington DC!

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