Archive for the ‘Drug development’ Category

Harvard Personalized Medicine Conference Showcases Progress in the Field

December 3, 2012

Great themes emerged at the Harvard Personalized Medicine Conference last week. This is the third year that I’ve attended and there’s a palpable sense of progress. Examples abound on how precise molecular profiling tools are now being used in clinical practice and the potential going forward is huge.

But this transformation is causing a number of new considerations to come into focus. Working in industry, we have to think about what do these opportunities mean for business? Where can we best add value; what parts of medicine are currently underserved? How can we bring industrial and operational strengths to the emerging new paradigm? And how is the regulatory environment likely to change…for therapies and for diagnostics?

The opportunities and the challenges are breathtaking. Contributors spoke of the opportunity for sequencing data integration into the Electronic Medical Record (EMR) and the subsequent effect on medical decision making. And, the emerging Personalized Medicine paradigm should provide opportunity for the sector to make the case of the value of innovation, both clinical and economic. But what will people make of a new generation of EMRs containing contextual individual information across a continuum of patient care…from predisposition, through screening, diagnosis to therapy selection and monitoring.

The audience-sourced data demonstrated how peoples’ acceptance of precision medicine has increased over the years in which the conference has been held. And although oncology still dominates, pharma representatives described case studies in cystic fibrosis and cardiology. Those same pharma contributors acknowledged the absolute necessity for powerful diagnostics to complement the delivery of personalized medicine.

On the first day of the conference, I moderated a session entitled: Business Models for Genetic Information.” Thought leaders from Siemens, PerkinElmer and Oracle described their companies’ visions for the molecular and digital age.

We had interesting audience feedback. Over 50% of the respondents felt that DNA sequence will become a routine part of an individual’s medical record within the next 10 years. Also interesting was the fact that only about 10% felt that availability of science or technology was the biggest obstacle to the adoption of personalized medicine in the clinic.

We discussed how personalized medicine can become mainstream. This isn’t about enabling personalized medicine for the few, but using technology and scale to deliver to the many. Doing this right not only will benefit patients, but input at the conference from regulators, drug manufacturers, and payors, told us there are a lot of parties interested in the success of this new paradigm. 

Making sense of all this data is a real challenge – how to format; how to integrate? Some contributors spoke of a data-driven industry transformation as has happened in other industries – financial services, retail, and communications. The result has been efficiency and transparency and the appearance of new interested parties – such as those capable of integrating workflow and data. 

The need for workflow integration will continue to be important as well. There are many players out there making individual contributions – from platforms, to molecular markers, to infrastructure, ordering, fulfillment, billing, and reimbursement. But who should take on the task of integration – which is surely needed if the benefits and efficiencies of personalized medicine are to be realized?

Less May Be More

November 12, 2012

Personalized Medicine has come to be strongly associated with drug-diagnostic combinations (companion diagnostics).  While this is a very important aspect of personalized medicine, it is not the goal.  The goal of personalized medicine is to find the best possible care for each individual patient so as to maximize the likelihood of the individual achieving his/her personal life goals.  While this may seem obvious, this principle has become increasingly harder to identify in every day medical care.

A variety of different motivations has encouraged the healthcare enterprise to view illnesses, or even everyday complaints as the opportunity – if not obligation – to do something for the patient.  The better approach is to ask: What is the best thing one can do for a patient, including the possibility of doing nothing?

As we develop better drug-diagnostic combinations, this will become increasingly apparent.  Soon we will have the ability (through use of precise molecular diagnostics) to know with reasonable certainty whether there is little or no benefit for a particular individual to pursue a therapy which had historically been the standard of care.

But, are we truly ready to forgo a potential therapy even if such a decision is based on strong scientific data?  Or, will we continue to use a therapy on the off chance it might work?  Our desire to do something has to include the possibility that the best treatment might be no therapy, based on the risks to the patient, the likely benefits, and the life goals of the individual.  In the end, patients want their healthcare providers to help them make the best choice and personalized medicine can be a strong tool to do that.  This will provide the largest benefit for patients as they avoid the risks that come with all therapies when no benefit is realistically to be had.

Dr. Stephen Eck will be moderating a panel discussion on Wednesday, November 28, 2012 at the 8th Annual Personalized Medicine Conference in Boston, Massachusetts.  Join the discussion at #PMConf. 

Do Not Stymie Innovation by Denying Reimbursement

October 4, 2012

Last week the public comment period closed for the Centers for Medicare and Medicaid Services (CMS) proposed payment determination for Multianalyte Assays with Algorithmic Analyses (MAAAs) in the CY 2013 New and Reconsidered Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Payment Determinations (“the Preliminary Determination”).

MAAAs are procedures that utilize multiple results derived from assays of various types. The American Medical Association gives the following definition: “Algorithmic analysis, using the results of these assays as well as other patient information (if used), is then performed and reported typically as a numeric score(s) or as a probability. MAAAs are typically unique to a single clinical laboratory or manufacturer. The results of individual component procedure(s) that are inputs to the MAAAs may be provided on the associated laboratory report; however these assays are not reported separately using additional codes.”

MAAAs are not new.  CMS and private payers routinely pay for them and many of them, having been added to clinical care guidelines, are now considered standard of care.

The proposal, as it stands, will likely prevent providers from receiving reimbursement for MAAAs. Without a clear reimbursement pathway, we risk stifling innovation by sending a powerful message to developers and providers that they cannot recoup investments made in the development, clinical validation, and commercialization of innovative diagnostic products.

Innovators focused on developing new therapies and accompanying diagnostics have difficult decisions to make regarding what products to invest in and bring to market. They must have confidence that future innovative diagnostics will be recognized and valued or improvements in patient care could be at risk.

At the urging of our members, the Personalized Medicine Coalition (PMC) sent a letter to CMS on this issue, noting that the Preliminary Determination:

  • Reverses current practice as many of the MAAAs are well-established tests that have been covered and reimbursed by Medicare for several years and are medically necessary given their status as the standard of care in treatment guidelines;
  • Jeopardizes personalized medicine and medical innovation by not separately recognizing and valuing the MAAA CPT codes; and
  • Represents a lack of transparency in the CMS decision-making process.

PMC recommended that the Preliminary Determination be altered to take into consideration these perspectives, shared by all PMC member organizations, to ensure that the decision does not inadvertently impact current patient care and the future of biomedical innovation.

Healthcare delivery and our research enterprise continue to change as innovators apply new scientific discoveries to the development of new therapies to treat and manage illnesses.  Our reimbursement policies must also adjust in step in order to support our evolving healthcare system.

Today, physicians across the country use sophisticated diagnostics to guide treatment decisions, a trend that we expect will continue. The rise in personalized medicine will lead to efficiencies in the healthcare system that increase the quality of patient care while saving patients exposure to unnecessary treatments that may not help them. Let us not halt innovation in healthcare by hasty policy decisions, such as the Preliminary Determination, that are not fully vetted for unintended consequences.

Approaching One-Year Anniversary at FDA, Stephen Spielberg Highlights Agency’s Progress in Personalized Medicine

August 20, 2012

In his address to the Personalized Medicine Coalition (PMC) Policy Committee at our most recent meeting, Stephen Spielberg, M.D., Ph.D., Deputy Commissioner for Medical Products and Tobacco at the U.S. Food and Drug Administration (FDA), announced that the Agency will develop a catalog of personalized medicine-related activities. The catalog, as Dr. Spielberg described, will provide a full accounting of the activities at the agency, including all regulatory divisions and regulatory science.

While reflecting on his 11-month tenure at the agency, Dr. Spielberg also noted that the largest area for advancing personalized medicine was through communication among stakeholders and FDA Centers.  He noted that “PMC is so important because we need dialogue; no one has a lock on complete information.”

The attendees of the policy meeting were pleased to hear that already, less than a year into Dr. Spielberg’s appointment at the agency, he was working to encourage collaboration and communication across divisions.  Dr. Spielberg was previously Director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital, one of the founding members of the PMC and so has experience in bringing groups together to advance personalized medicine.

Dr. Spielberg outlined his optimism for personalized medicine at the FDA, noting that one third of the new drug approvals currently in review are for targeted or orphan indications.  He said that by year’s end, we could expect guidance documents on companion diagnostics and co-development, as well as the previously mentioned catalog.

These guidance documents and a FDA catalog may prove to be additional stepping stones to a broader understanding of the impact of personalized medicine on scientific research and clinical medicine.  At PMC, we will continue to work with FDA to promote broader engagement across the ecosystem of stakeholders and greater transparency around research and drug development.  We look forward to the issuance of these materials later this year and will engage a public discourse about them.

From The Catalyst (blog) – Conversation with Margaret Foti, Ph.D., M.D. (h.c.), CEO, American Association for Cancer Research

June 11, 2012

This entry is reposted with permission from PhRMA’s blog, The Catalyst.

ASCO’s Annual Meeting this week highlighted some of the exciting advances that are emerging in the fight against cancer. PhRMA has joined with many other organizations in supporting a conference next week, “Turning the Tide Against Cancer Through Sustained Medical Innovation,” which is focused on the critical issue of how we sustain this progress in an era of increasing cost-cutting pressure. Conference participants will examine how we measure the value of new treatments and how we can promote high quality, patient-centered care.

The conference is being convened by the American Association of Cancer Research, the Personalized Medicine Coalition, and Feinstein Kean Healthcare. We sat down with each of the conference co-hosts about the event and progress in cancer care.

Conversation with Margaret Foti, Ph.D., M.D. (h.c.), CEO, American Association for Cancer Research


Q: In looking at where we want to go in progress against cancer, we sometimes lose sight of where we’ve come. Set the stage for us – how has scientific progress changed the outlook for patients against cancer in recent years? 

Marge Foti: We have made tremendous progress against cancer.  There are more than 12 million cancer survivors in America today and cancer mortality rates continue to decline. This progress is thanks to scientific discoveries that have revealed the underlying biology of a cancer cell and how the survive and grow in our bodies—knowledge that has given us a new understanding that cancer is not, in fact, a single disease but more than 200 diseases, each with unique causes and characteristics that require different treatments. New advanced technologies have improved our ability to turn this knowledge of how cancer works against cancer. We now are better able to prevent, detect and treat cancer.

Q: AACR put out a great report last year, the Cancer Progress Report, which describes many of the exciting advances being made in cancer research. What big trends do you expect we will hear about at the upcoming conference? What big challenges? 

Marge Foti: Personalized medicine is more than just a buzz word; it is offering great promise to transform the outlook for many forms of cancer. We are truly entering an era when every patient’s tumor can be characterized at the molecular level, which is helping us redefine how we prevent, diagnose, and treat cancer.  While this unprecedented progress is the direct result of fundamental discoveries from the past 40 years, further exploiting this knowledge to improve the outlook for cancer patients is going to require that our national policies keep pace with the continual advances that take place in science.  For example, the recent approval of two new cancer medicines along with companion diagnostics is marking a new day of progress, but also is one that poses new challenges to researchers, companies, and regulators.

In addition, cancer’s complexity is astounding and exists at all levels–from populations, to individuals, to specific cancers, to the genes that underlie cancers.  A major hurdle in the treatment of cancer is that that there is a high degree of variability in gene mutations—even within a single tumor in a single patient—and the variability increases with later stage disease.

Cancer research takes time and progress builds over time as new treatments are added on to one another in a step-wise fashion. Our growing scientific knowledge has the potential to change the face of drug development, to combine therapies in a rational way based on the mutations within an individual patient’s tumor. This is an enormous scientific and regulatory challenge, but the science is telling us this is the path forward.

Q: Why is it important to connect the science to policy?

Marge Foti: Continued progress is not a given. Advancing care for patients is an incredibly long, complex and expensive process. We need to provide continued support for basic research, and we need to preserve strong incentives for private sector investments in this process. Without a good understanding of the science, we risk taking policy approaches that will hamper the progress we so desperately need to make for current and future cancer patients.

From The Catalyst (blog) – A Conversation with Edward Abrahams Ph.D., President, Personalized Medicine Coalition

June 11, 2012

This entry is reposted with permission from PhRMA’s blog, The Catalyst.

ASCO’s Annual Meeting this week highlighted some of the exciting advances that are emerging in the fight against cancer. PhRMA has joined with many other organizations in supporting a conference next week, “Turning the Tide Against Cancer Through Sustained Medical Innovation,” which is focused on the critical issue of how we sustain this progress in an era of increasing cost-cutting pressure. Conference participants will examine how we measure the value of new treatments and how we can promote high quality, patient-centered care.

The conference is being convened by the American Association of Cancer Research, the Personalized Medicine Coalition, and Feinstein Kean Healthcare. We sat down with each of the conference co-hosts about the event and progress in cancer care.

A Conversation with Edward Abrahams Ph.D., President, Personalized Medicine Coalition

Q:  What are the implications of personalized medicine’s growing role in research and patient care in oncology?

Ed Abrahams:  Technological improvements in genetic sequencing and molecular profiling of tumors have given researchers and clinicians a new ability to understand the molecular and genetic characteristics of cancer patients and their tumors.  By more accurately classifying disease, patients can benefit from targeted treatments that are more likely to work.

Simply put, personalized medicine means better patient care. Personalized treatment regimens allow clinicians to select treatments that are more likely to attack specific tumor types.  But personalized medicine also delivers better value to patients and the health system because it enables clinicians to spare patients the expense and side-effects of treatments that are not likely to provide tangible benefits and thereby to help address the challenge of rising health care costs.

We believe that the future of cancer therapeutics lies in molecular biology and genomics, supported by electronic health data systems and advanced health information technologies that support a rapid learning health care system.  Increased collaboration between academia, the biopharmaceutical industry, philanthropic organizations, and patient advocacy groups will maximize the development of new personalized medicine technologies and treatments.

Q:  What are some of the barriers to personalized medicine that need to be addressed to facilitate the adoption of personalized medicine?

Ed Abrahams:  Clearer regulatory and reimbursement pathways are needed to ensure that developers of new personalized medicine products – therapeutics, diagnostics, and others laboratory services – have a reasonable pathway to get their products approved by regulatory agencies and to ensure that products are reimbursed at rates reflective of the innovative value of the product and the investment necessary to develop it.

We must also aligning comparative effectiveness research (CER) with the science of personalized medicine and the fact that we are not always aware of all of the uses for a new therapy at the time of its approval. If we rush to judgment about value too early, we will cut short the process of continuous learning through which value emerges. If we take a traditional “one size fits all” approach to CER that judges “average” value at a point in time, we will stifle innovation.

Finally, our education system must evolve to ensure that our health care workforce is trained in genetics, genomics, and the technologies needed to integrate personalized medicine into cancer treatment decision-making.

Q:  What is your goal for the conference?

Ed Abrahams: This conference will provide stakeholders a forum to discuss major developments in oncology research and development and link the science of personalized medicine with public policy.

We intend the high-level discussion at the conference to illuminate policy solutions that will spur the development of new personalized medicine approaches to cancer.  By brining patients, payers, industry, and academe, we hope to identify ways to continue to deliver high value care in a cost constrained environment and to sustain innovation to improve cancer patient outcomes.

Progress in Cancer Highlighted by NEJM Retrospective; Turning the Tide Conference to Catalyze Comprehensive Dialogue on How to Sustain Cancer Innovation

June 8, 2012

In honor of the New England Journal of Medicine’s (NEJM’s) 200th Anniversary, the journal examined how medicine has evolved over the last two centuries, looking in particular at oncology diagnosis, prevention, and treatment. But while there has been tremendous progress in cancer, questions remain:  Where do we go from here?  And how do we get there in an era of immense fiscal discipline?  These are questions that we plan to address on Tuesday at our conference, Turning the Tide Against Cancer Through Sustained Medical Innovation.

In a similar vein to what Siddhartha Mukherjee, M.D., a special guest speaker at the conference, lays out in his book The Emperor of All Maladies: A Biography of Cancer, the authors of the NEJM article “Two Hundred Years of Cancer Research” provide a timeline of major discoveries and advances in cancer research and care.

They show how each milestone is built on the ones that came before it and trace the evolution of cancer progress from the early efforts to control the disease through surgery, advances in radiation, chemotherapy, and the targeted therapies that are redefining cancer treatment today.

The underlying science that made these treatment advances possible takes years to translate into clinical benefits for patients, but the original investments pay off. Our understanding of the genetic basis of cancer became possible only after decades of work on the basic biology of DNA beginning in the 1940s and 50s, but it was not until after the sequencing of the human genome that researchers were able to begin to translate genetics knowledge into new medicines.

Genetic understandings of cancer have led to breakthrough new medicines such as Xalkori® (for non-small cell lung cancer) and Zelboraf® (for melanoma) and more targeted therapies are on the way.  A new report issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) found that there are 981 new medicines and vaccines for cancer in development today, many of which are likely to be personalized medicines.

Tomorrow’s progress in cancer therapies and treatment approaches depend on today’s policy makers recognizing the need for policies that holistically support cancer research and innovation.  In advance of next week’s conference, a Discussion Paper “Sustaining Progress Against Cancer in an Era of Cost Containment” coalesces the views of the conference advisory committee and other leading cancer experts about new models for cancer innovation, how to define value in cancer care, and how policy can support continued progress against cancer.

PCORI’s Selby Defines Research Agenda; Tells PMC that Institute Will Solicit Continued Feedback to Ensure CER Supports Personalized Medicine

April 30, 2012

The Patient-Centered Outcomes Research Institute’s (PCORI) Board of Governors held a conference call meeting Wednesday afternoon.  During the call, they announced the finalization of their research agenda and discussed changes made from the initial draft in response to stakeholder comments.

Given the many criticisms PCORI received for being too broad and vague in its draft, I was surprised by how quickly the research agenda was finalized.  I was gratified that the Institute publicly detailed how stakeholder comments shaped the final agenda, as urged by the Personalized Medicine Coalition (PMC) in our letter to the Institute last month.

Last week, PCORI Executive Director Joe Selby also addressed PMC’s public policy committee, discussed the Institute’s rationale for its agenda – which was short on specifics – and answered questions from PMC members.

During his talk, Selby shared that PCORI’s goal for its research agenda was to be a foundation for future work.  Through funding announcements, the Institute hopes to solicit a broad range of research proposals that will offer many options on approaches to implement and conditions to study.

Selby suggested that PCORI aims to keep the door open to provide funding for comparative effectiveness research (CER) studies that may benefit small subpopulations or rare disease research, and not to fund only research addressing common conditions such as heart disease, depression or diabetes.  However, several PMC members pointed out that ultimately PCORI’s funding decisions will pick winners and losers.

Selby encouraged the submission of proposals to the Institute for studies designed to demonstrate what types of treatments will work for different subgroups of patients (as PMC believes all CER studies should aim to do).  PMC was disappointed that he did not commit the Institute to such an approach as we believe the statute requires, although he noted that research announcements will solicit thematic proposals in addition to disease-specific ones that may address some personalized medicine topics.

PMC Members asked Dr. Selby about the development of PCORI’s infrastructure and questioned whether the Institute has what it needs to align CER with personalized medicine.  As I noted previously, PMC does not believe that the Institute has developed the internal structure necessary to carry out its mission at this time.  Dr. Selby informed the PMC policy committee that PCORI welcomes its feedback about how to assure that funded CER-studies align with personalized medicine through its open meetings, public comments, and advisory committees.

To facilitate personalized medicine, CER must explain not only what works best – but also for whom.  The future of medicine depends on a careful and critical answer to this critical question.  We are not yet sure that PCORI has embraced this idea.  For example, when the Board met to discuss altering the research agenda based on public comment, it tried to more clearly define the need to study personalized medicine. It failed to cite the most common definition of personalized medicine, and instead, discussed mostly demographic characteristics. The PMC will respond to the altered language with the expectation that the definition of personalized medicine will be accepted into the research agenda language. This is the most basic, first step to aligning CER with personalized medicine.

We valued Dr. Selby’s willingness to dialog with the PMC community and look forward to continued engagement with PCORI to ensure that CER can be supportive of quality health information, tailored to patients’ values and individual biology.

Understanding the Complexities of Cancer and Progress in Personalized Medicine

March 14, 2012

Personalized cancer care holds much promise; it gives us confidence that targeted treatments will eliminate cancers and spare us the one-size-fits-all cancer treatments of our past. For the sake of simplicity, we want to think of personalized cancer care as a lock and key; each tumor has a specific puzzle interface, and when the puzzle piece is identified then the cancer melts. This simple message of “lock and key” is comforting because it suggests that we can achieve a new reality where we assess a tumor and choose a treatment in a very simple way, based on a tumor’s genetic makeup.

We have many exciting new targeted cancer treatments in our toolbox – consider, crizontinib (Xalkori®) for non-small cell lung cancer and vemurafenib (Zelboraf®) for BRAF mutation-positive metastatic melanoma. These therapies have been effective in patients with specific gene mutations. At the same time, as the science advances, research continues to reveal the underlying complexities of cancer and the diversity of tumors.

In the March 8 issue of The New England Journal of Medicine, the authors of “Intratumor Heterogeneity and Branched Evolution Revealed by Multiregion Sequencing” provide an exquisite roadmap of how heterogeneous and complex one individual’s cancer can be with many mutations lurking within each tumor mass, and the mutations themselves evolving over time. The picture presented by Gerlinger and colleagues, suggests the need for many keys to a myriad of locks, each tailored for a particular tumor at a particular point in time. The simple message of lock-and-key personalized medicine, where simple one-to-one decisions can be achieved, would not hold true.

This may create concern that a personalized medicine approach has created a false sense of hope. I don’t think that it is false hope, but rather a false sense of the simplicity.

There is hope. While a single needle biopsy may not create a complete picture of a cancer, biopsies are still a crucial part of characterizing tumors, using growing scientific knowledge to understand which treatments might work best. Biopsies are a starting point. A number of institutions are conducting genetic and genomic analyses on tumors. This is probably not the Holy Grail, but rather an iterative step in a long trail of scientific advances that will support personalization of cancer medicine.

In addition, new technologies are needed to improve on the information gathered, including methods to understand whole tumor heterogeneity. If we believe a personalized approach is simple, we are at risk of not building the systems needed to deal with the deluge of complex information that will need to be sorted, understood, and applied clinically in real time.

We need both the science and the information technology solutions to keep improving. New understandings highlight new opportunities to target more central cancer mutations, and to create more thoughtful treatment cocktails.

The underlying message here is that although we have made great progress, we are still early in our journey. In reality, this is a very comforting message. It would be disheartening if we had already exhausted the targeted treatment toolbox and that the best we could achieve is delayed cancer progression but not cures. By embracing the complexity of more individualized information for any particular patient and tumor, we really do have the hope of achieving personalized cancer care.

As we uncover new and unimagined pathways during the scientific discovery process, we should not be deterred or disheartened. We just aren’t there yet. We need to ensure that public policies support the continued investment of energy, attention to detail and resources required to achieve a vision for personalized cancer care.

Adriana Jenkins and the Case for Personalized Medicine

December 12, 2011

Adriana Jenkins passed away on February 9, 2011 after battling breast cancer. Known for her tenacious advocacy on behalf of targeted therapies, Kelly Lindenboom, honored her passionate work within the personalized medicine community at the Boston Reception hosted by the Personalized Medicine Coalition on November 8, 2011.

Adriana Jenkins had an intoxicating personality and lived every day to the fullest — until, earlier this year, when she died from a rare form of breast cancer at age 41. Adriana was in the prime of her life — she had a thriving career in biotech public relations, was an incredible artist and had an extensive network of friends, that to Adriana, were her family. I’m part of her family.

At age 32, Adriana was engaged to be married, getting ready to start a new job with an up-and-coming biotechnology company and excited for what was to be the best time of her life. And then came the phone call from her doctor that changed everything. With a diagnosis of stage 3B inflammatory breast cancer — a rare, aggressive form of the disease — she had limited options to consider.

With less than a 50 percent chance of survival beyond five years, Adriana was desperate to explore any and all options that might give her better odds. Unlike the majority of people who are diagnosed with cancer every year, Adriana possessed a unique and intimate understanding of the pharmaceutical industry and was able to be her own best advocate after her diagnosis. When a colleague suggested she look into an investigational therapy — Herceptin — being tested locally at the Dana Farber Cancer Institute (DFCI) in Boston, she jumped at the chance. And as it turned out, she was a perfect fit for the trial and was enrolled in the study.

While the clinical trial was not always easy, Adriana responded wonderfully to the Herceptin, which was eventually approved by the Food and Drug Administration and is used today to treat many women with the same type of genetic marker, HER2, that was present in Adriana’s cancer.

Because of her success with Herceptin, one of the first so-called personalized medicines to be approved for use, Adriana was able to beat the odds. Really beat the odds. She credited personalized medicine treatment for giving her the nearly 10 years she was told she wouldn’t have. And she was thankful for every day that she had.

Unfortunately, despite encouraging results, personalized medicine is still a rarity in most cancer treatments. In her article “A Dying Wish,” published in Forbes magazine, written shortly before her death, Adriana made an eloquent appeal for the broad adoption of personalized medicines for cancer and other diseases based on her own incredible, nearly decade-long fight with breast cancer. In the article, she posed a question related to personalized medicine:

How do we convince drugmakers to focus their shrinking R&D budgets on this area of scientific discovery?

And then offered this potential challenge to our nation’s pharmaceutical companies and lawmakers:

“One idea is to create an incentive for drugmakers comparable to that in the Orphan Drug Act. Passed in 1983, it encourages companies to develop drugs for diseases that have a small market (fewer than 200,000 patients in the U.S.). Under the law, companies that develop such a drug may sell it without competition for seven years, in addition to often receiving quicker “fast track” regulatory review… A comparable law could push drugmakers to develop PM drugs for cancer and other deadly ailments.”

At the end of the article she offered this plea:

I urge patients, physicians and insurers to create a similar group to support the commercialization of personalized cancer drugs.

After her diagnosis with cancer, Adriana had the word “hope” tattooed onto the inside of her wrist as a constant reminder to herself for how she wanted to embrace life.

In the years that followed her remission, Adriana remained a strong advocate for the potential of personalized medicine, putting her public relations know-how to work by partnering with Herceptin’s developers to share her experience with the media and bring awareness to other women receiving a new cancer diagnosis.

The week that Adriana passed away, her article about the power and potential of personalized medicine was published in Forbes. And today, her friends are supporting her vision — keeping her “hope” alive — through the Adriana Jenkins Foundation for Personalized Medicine and a fundraising team with Stand Up To Cancer. Formed in Adriana’s name, the goal of the group is to raise awareness and be a proponent for development of personalized medicines, like the one that gave Adriana the nearly 10 years she never expected she would have.

Cancer is an extraordinarily complicated problem, and will only be solved through new approaches and ideas. Personalized medicine is one of them.

These remarks were first made by Ms. Lindenboom at the Personalized Medicine Coalition Boston Reception on November 8, 2011. They were also posted on HuffingtonPost.com.


%d bloggers like this: