publication date: Jan. 16, 2016

Did Patrick Soon-Shiong attempt to scoop President Barack Obama’s State of the Union address?

Several days before Obama announced the federal government’s moonshot to cure cancer, Soon-Shiong put out a draft press release, claiming that the White House, NIH, FDA and pharmaceutical companies have united in “Cancer MoonShot 2020,” an immunotherapy clinical trials program he devised.

Soon-Shiong, founder and CEO of NantWorks and the Chan Soon-Shiong Institute of Molecular Medicine, ultimately announced his moonshot on Jan. 11, a day before Obama announced his.

Sources said government officials asked Soon-Shiong to remove federal agencies from the press release.

In the final version of the release, Soon-Shiong stated that “the ambitious goals of the Cancer MoonShot 2020 Program were presented at a meeting hosted by Vice President Joseph Biden at his Naval Observatory residence in Washington, D.C. on Dec. 1, 2015, where members of the coalition presented their shared vision for translating the promise of precision medicine through the delivery of combination immunotherapy to routine clinical cancer care, as well as their shared commitment to accelerate the development of immunotherapy and vaccine therapy as the next generation evolution of cancer care,” the statement reads.

In other documents, Soon-Shiong lists the names of the “members of the coalition”—staff members from the White House, NCI and FDA. Three hours before Obama’s address, Soon-Shiong and other coalition members reiterated that the program has the backing from government personnel, during a public webcast at the JP Morgan Healthcare Conference Jan. 12. He repeated this claim in a conversation with this reporter Jan. 14. The conversation appears here.

Soon-Shiong said his moonshot and Biden’s moonshot have “common goals.”

“By November, after [Biden] made the decision not to run [in the 2016 presidential race], he came quietly to Los Angeles and spent three hours on our campus,” Soon Shiong said. And then I gave him the second white paper, and I said to him, ‘Look, we can convene all the right people to make it happen,’ because he said to me, ‘Patrick, what can do to make this move faster?’ So the vice president and I have common goals here to accelerate the development of drugs so we can actually get to the path of the cure as fast as we can.”

White House insiders said that while Biden and his staff have participated in dozens of listening sessions, the vice president and other federal agencies are not involved in Soon-Shiong’s moonshots program.

NCI and FDA have been supportive of the Cancer MoonShot 2020 program, Soon-Shiong said to The Cancer Letter.

“I’ve got to tell you, what was incredibly exciting is there wasn’t any roadblock from the regulatory agencies,” Soon-Shiong said. “I mean, the FDA was amazingly supportive—Bob Califf [who has been nominated to serve as the next FDA commissioner] and Janet Woodcock [director of the FDA Center for Drug Evaluation and Research] and Peter Mark [deputy director for the FDA Center for Biologics Evaluation and Research] were incredibly supportive.

“This weekend is going to be very exciting, where I will be working with investigators at the NCI in drafting the clinical trial design.”

NCI and FDA are not involved with Soon-Shiong as formal partners and the two moonshots are unrelated, said NIH Director Francis Collins.

“I think there has been some confusion and some misunderstanding, and maybe the word moonshot has been utilized by lots of people over time, and in this case, is somewhat a source of confusion,” Collins said during a press call Jan. 14. “Dr. Soon-Shiong obviously is a highly-regarded entrepreneur, very interested in this space, but the program that he talked about at JP Morgan earlier was not one that involves the NCI or the FDA in a partnership way.

“We’re obviously interested in all groups that have something to contribute here, but make no mistake, what the vice president announced in terms of his blog and what the president was talking about in the State of the Union is not the same thing as what was discussed at JP Morgan.”

Soon-Shiong said that two NCI investigators, Jeffrey Schlom, chief of the NCI Laboratory of Tumor Immunology and Biology and James Gulley, chief of the NCI Genitourinary Malignancies Branch, and director of the NCI Medical Oncology Service at the Office of the Clinical Director, are intimately involved in clinical trial designs for the coalition.

“Well, I can only tell you the fact that Jeffrey Schlom is actually spending three days with me right now designing clinical trials this weekend. You’re welcome to call him and James Gulley,” Soon-Shiong said. “I just got off the phone 10 minutes ago saying how he’s flying to Miami this weekend to talk to one pharma company, and I told him I spoke to the CEO of another pharma company and we’re talking about an anti-PDL1 that he’s designed. So all I can tell you is what we are doing.”

In response to an inquiry about NCI staff meeting with Soon-Shiong, officials said that Schlom and Gulley’s participation should not be construed as an endorsement from the institute.

“NCI intramural researchers are participating in a scientific meeting in Santa Cruz, Calif., hosted by Patrick Soon-Shiong. Their involvement and support, however, are limited to the activities under the terms of their CRADA with Etubics,” NCI Acting Director Doug Lowy said to The Cancer Letter. “Often CRADAs provide for participation in scientific meetings, as is the case in this situation. The participation by NCI investigators should not be taken in any way as endorsement of the coalition that Dr. Soon-Shiong has recently announced.

Soon-Shiong said Collins isn’t involved in his Cancer MoonShot 2020 initiative.

“I think it is unfair, frankly, to ask a member of the government who wasn’t at the meeting [with Soon-Shiong, Biden and other alleged members of the coalition],” Soon-Shiong said. “This is very complex.

“Dr. Francis Collins is not FDA nor NCI, right? He’s the head of the NIH, and I don’t know if you want to mix this up with the Precision Medicine Initiative. If Dr. Francis Collins said he had nothing to do with it, I think he’s correct.

“But I think, look, what happened was, you know, Robert Califf was at the meeting.”

FDA officials said that the agency isn’t involved in Soon-Shiong’s program either.

“The FDA is not participating in the National Immunotherapy Coalition announcement,” FDA officials said in a statement to The Cancer Letter. “We look forward to joining our HHS colleagues and working with the Vice President to determine how the FDA might enhance efforts to further new and innovative ways to fight cancer.”

 

Draft Press Release Quotes Government Officials

Soon-Shiong’s draft press release—which was not published, but was obtained by The Cancer Letter—included laudatory comments by NCI and FDA officials. In a conversation with this reporter, Soon-Shiong said the quotes were sent to him by the individuals to whom they were attributed.

“Let me just set the facts straight. Every member of the FDA or NCI—they actually sent me their quotes,” Soon-Shiong said. “So I’m not sure how could they…okay?”

The text of the draft press release follows:

 

HISTORIC CANCER ALLIANCE FORMED: THE NATIONAL IMMUNOTHERAPY COALITION TO LAUNCH THE CANCER MOON SHOT 2020 PROGRAM

 

Nation’s Most Comprehensive Cancer Collaborative Initiative Comprising Large Pharma, Biotech, FDA, NCI, DOD, Community Oncologists, NCI Designated Academic Cancer Centers, National Insurance Carriers and Fortune 500 Self-Insured and Technology Companies Seeking to Accelerate the Development of Next Generation Immunotherapy Combination Cancer Therapies Across All Tumor Types

 

San Francisco – January 12, 2016 Today, leaders from major pharmaceutical and biotech companies, NCI-designated academic cancer centers, community oncologists, national and regional insurance carriers, together with Fortune 500 self-insured and technology companies announced the launch of  ‎The National Immunotherapy Coalition (NIC), a historic coalition formed with the support of the U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Immunology and Medical Oncology NCI branches , having a singular focus on accelerating the development of paradigm changing combination immunotherapies as the next generation standard of care in patients with cancer.

Integrating a diverse group of stakeholders from the private sector and government, the National Immunotherapy Coalition, is a unique translational medical platform, guided by the Chiefs of the Immunology and Medical Oncology branches of the NCI in collaboration with FDA, pharma and payors, with a goal to validate the potential of next generation panomic molecular analysis and novel combination immunotherapies. The Coalition will design, initiate and complete randomized clinical trials in cancer patients at all stages of disease in up to 20 tumor types in as many as 20,000 patients by the year 2020: The Cancer Moon Shot 2020 Program (http://www.cancerMoonShot2020.org). A nationwide clinical trial and master protocol will be designed under the guidance of the Branch Chiefs of Tumor Immunology‎  and Biology Laboratory and Medical Oncology at the NCI, in collaboration with the FDA, together with academic cancer centers, pharma and biotech partners participating in the National Immunotherapy Coalition.

‎This master protocol, entitled the QUILT Trial (Quantitative Integrative Lifelong Trial), is designed to harness and orchestrate all the elements of the immune system (including dendritic cell, T cell and NK cell therapies) by testing novel combinations of vaccines, cell-based immunotherapy, metronomic chemotherapy, low dose radiotherapy and immunomodulators, in patients who have undergone next generation whole genome, transcriptome and quantitative proteomic analysis, with the goal of achieving durable, long-lasting remission for patients with cancer. These immunotherapy based, genomically and proteomically informed clinical trials will pave the way to delivering cancer therapy with the lowest toxicity and the highest quality of life.

The mission of the Cancer Moon Shot 2020 Program is to rapidly enroll and complete randomized Phase 2 clinical trials to validate the potential of pan-omic (whole genome, transcriptome and proteomic) analyses and to evaluate novel combination immunotherapies as the next generation standard of care. Utilizing a cloud -based infrastructure to integrate and enable the participation of both major academic and community oncologists at a national scale, the goal is to complete randomized clinical trials in patients with cancer at all stages of disease, across up to 20 tumor types in 20,000 patients within the next 24-36 months. By comparing standards of care to the next paradigm of less toxic immunotherapy combination therapy, the findings of these randomized QUILT trials will inform the design of Phase 3 registration trials, with the goal of bringing transformative advances in combination immunotherapies to cancer patients by 2020.

The ambitious goals of the Cancer Moon Shot 2020 Program were presented at a meeting hosted by Vice President Biden at his Naval Observatory residence in Washington DC on December 1, 2015 where members of the coalition, including leadership at FDA and branch chiefs of the NCI, presented their shared vision for translating the promise of precision medicine through the delivery of combination immunotherapy to routine clinical cancer care, and their shared commitment to accelerate the development of immunotherapy and vaccine therapy as the next generation evolution of cancer care.

Attendees of that meeting, convened and chaired by Dr. Patrick Soon-Shiong, Founder of the Chan Soon-Shiong Institute of Molecular Medicine (CSSIOMM), a non-profit medical research institute, and NantWorks, an ecosystem of healthcare companies, included leadership from the immunotherapy and medical oncology branches of the NCI, leadership from the FDA, leadership from the DOD, leadership from the pharmaceutical industry including Amgen, GlaxoSmithKline, Pfizer, leadership from national payors including Blue Cross and Bank of America and healthcare leaders from security and interoperability organizations including CEOs from Allscripts and Blackberry.

Major academic cancer centers represented at this meeting included center directors from Massachusetts General Hospital, Johns Hopkins University, University of Miami, University of Utah, Tufts Cancer Center and the Walter Reed National Military Institute as well as representatives from the oncologists in the community.

“There are unique times in history when events and advancements in technology converge to elicit a quantum leap in medical care. This is not only a unique time, but also a unique inflection point in the history of cancer,” said Patrick Soon-Shiong, M.D., Founder and Chief Executive Officer of NantWorks and the Chan Soon-Shiong Institute of Molecular Medicine. “Our knowledge in the science of genomics, proteomics, immunology and immunotherapy has advanced and converged at an unprecedented speed, making now the time for the rapid deployment and orchestration of immunotherapy for the benefit of millions of cancer patients. The Cancer Moon Shot 2020 Program, the National Immunotherapy Coalition and the QUILT Trial are designed to do just that—to bring together a diverse group of visionary leaders and stakeholders to pool resources working together to develop and bring to patients, a dramatic improvement in cancer care.”‎

“Every day, Independence Blue Cross is reimagining health care in hopes to help our members succeed on their path to improved health and high quality care,” said Daniel J. Hilferty, Independence Blue Cross, President and Chief Executive Officer and Chairman of the Blue Cross and Blue Shield Association Board of Directors (BCBSA), comprised of 36 Independent Blue Cross Blue Shield companies that together cover nearly 105 million individuals – 1 in 3 Americans. The National Immunotherapy Coalition is allowing Independence to further enhance our contribution to the future of health care through our active involvement in this one-of-a-kind collaboration.” Hilferty stated. “We look forward to continuing our work with this incredible team to develop the most innovative cancer fighting strategy in our lifetime. Through our Blue Cross Blue Shield Association we cover 1 in 3 Americans and insure individuals across every zip code in the country – this initiative is important to all Americans”.

At the meeting with the Vice President and Dr. Soon-Shiong, the Deputy Commissioner for Medical Products and Tobacco of U.S. Food and Drug Administration (FDA), Robert M. Califf, M.D., stated, “There come moments in time where we ask why drugs tested do not work? I can remember that moment in cardiology 30 years ago where we took out things that did not work and kept things that did. We may be at that moment in time with cancer. The FDA is here to act as the ‘cattle prod’ to accelerate this moment when we are beginning to figure out how cancer works. The FDA is ready to be part of this historic coalition where we can provide clinical trial guidance for the combination of novel innovative agents brought into the coalition from the Cancer Moon Shot Program 2020 members,” he said. “By adopting innovative and adaptive clinical trials, the QUILT coalition will shepherd in a period accelerated by innovation in cancer treatment.”

Janet Woodcock, M.D., U.S. Food and Drug Administration (FDA), Director of the Center for Drug Evaluation and Research (CDER) has led many of FDA’s drug initiatives. She introduced the concept of risk management in 2000 as a new approach to drug safety. Since 2002, she has led the “Pharmaceutical Quality for the 21st Century Initiative,” FDA’s highly successful effort to modernize drug manufacturing and its regulation. In 2004, she introduced FDA’s “Critical Path” Initiative, which is designed to move medical discoveries from the laboratory to consumers more efficiently.  At the National Immunotherapy Coalition meeting hosted by Vice President Biden, Dr. Janet Woodcock made insightful comments and voiced the sentiments of many participants present at the meeting in support of the goals of the National Immunotherapy Coalition and the Cancer Moon Shot 2020 program, stating, “Current clinical trials are organized around disease rather than immunology approaches. This traditional approach takes too long.  You can only answer one question at a time and it may take you four years to answer one question about one drug and one tumor. It takes too long and doesn’t give you enough information. We need a large network to enroll a large number of patients. Almost all cancer patients are never enrolled in clinical trials. Almost all of them are never treated with investigational therapies. With regard to combinations, FDA issued guidance a number of years ago about investigational combinations.  Development of Hepatitis C drugs is an example.”

“My personal opinion: I believe we are approaching the science wrong,” she added, “We have great basic science, we learn all this information but we don’t test it in the clinic in an efficient manner. Anything we learn from a mouse or human pathology is an hypotheses, and often the hypothesis is wrong when we test it in people.  In complexities such as we face today in cancer where we have next generation sequencing, when we wish to combine chemotherapy with immunotherapy, when we wish to explore multiple combinations, you’re often asking five questions, not one. We need an engine that can turn around this knowledge rapidly and a process to help answer these questions effectively.”

“An important issue is our need to involve the community, that’s where the patients are,” Dr. Woodcock continued. “To date, trials have been centered around major medical centers and these trials are slow to accrue, since patients do not want to leave their community and doctors do not want to send them to remote centers. We need to build an infrastructure that will support these community doctors and allow them to participate and have their patients participate in these clinical trials without losing their patients and without having their patients to go away. “

Peter W. Marks, M.D., Ph.D., U.S. Food and Drug Administration (FDA), Deputy Director for the Center for Biologics Evaluation and Research (CBER) echoed the FDA’s support of accelerating clinical trials through the QUILT process, stating, “Our goal is to enable important pathways for progress to get important therapies to patients. We will not be the impediment on the critical path at the FDA. Evidence generation needs to happen and we will work to streamline the process for vaccine development.”

Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute (NCI), directs a translational research program in cancer immunotherapy. He has pioneered the use of novel immunotherapeutics, both as monotherapy and in combination therapies, for a range of human cancers. His studies involve the translation of hypothesis-driven preclinical studies to science-driven clinical trials. Dr. Schlom’s studies involve the design and development of novel therapeutic cancer vaccines, immunocytokines, and checkpoint inhibitor monoclonal antibodies.

His longstanding experience in the biology of cancer and the efforts needed to rapidly address immunotherapy drug development through a collaborative national immunotherapy coalition were shared with the Vice President on December 1st stating, “This coalition that has been brought together by Dr. Soon-Shiong to address cancer‎ is one of the most comprehensive sets of talents, and is quite unique. I’ve seen it all but I’ve never seen anything quite like this in my years. I’ve been there at the original war on cancer during the Nixon Administration and saw the bureaucracy on how it played out.”‎

“The issue we face today in cancer care is a paradox. It is clear that immunotherapy can work in managing cancer but this approach is only working in about 20% of patients now. The problem we face today is that there are about 2 dozen drugs in immunotherapy in the clinic right now and they are all being developed in silos by each individual company. This National Immunotherapy Coalition is designed to solve this problem. I’m extremely proud to be a part of this and have never seen a situation like this where we can get these trials done so rapidly. I’ve been revitalized, regenerated through this whole process.”‎ he said at the historic DC meeting.

Dr. James L. Gulley who has served at the National Cancer Institute (NCI) for 18 years also participated in the meeting with the Vice President and Dr. Soon-Shiong. In his role as ‎Branch Chief, Dr. James L. Gulley, Director of the Medical Oncology Service, Office of the Clinical Director. Dr. Gulley echoed the sentiments of Dr. Schlom stating, “We are seeing a sea change on how we are treating patients with cancer with immunotherapy. We are seeing deep durable and rapid responses to these new immunotherapy agents that unfortunately are only in the minority of patients and in some cancers there’s no responses at all. The best way to address these failures is to explore combination therapies and this National Immunotherapy Coalition is the vehicle to break down these silos and test these combinations rapidly. That’s the way we are going to make progress. I am proud to be part of this important and historic immunotherapy initiative.”

Col. Craig Shriver, MD, FACS (DOD) at the John P Murtha Cancer Center at Walter Reed Military Hospital and United States Army where he served for 30 years, provided his viewpoints as it related to the Military DOD Health Care and cancer care stating, “There are five requirements for the QUILT coalition that we are proud to be part of and they’re directly related with what we do at our cancer center. We validate big science through our clinical trials network. There are 1.2 million active duty military members, 9.3 million beneficiaries that receive military DOD health care. That’s a huge network. Just in our active duty force, we get a thousand active duty members a year that come down with cancer. If a thousand active duty members were still getting injured in Afghanistan or Iraq, we would not accept this. So it’s the same thing with how militaries respond to infectious diseases… things that affect the readiness of our active force. So cancer is that threat. Care coordination is what we can provide since we have five other sites in our health system. We have a synergistic relationship with the NCI and that will broaden the access for these patients to these clinical trials. I am honored to serve and be part of this remarkable Coalition that Dr. Soon-Shiong has convened.  ”

“The DOD and Col. Shriver have established a long standing partnership with the Windber Research Institute and through our collaborative efforts the DOD and Windber were responsible for providing over 90% of the breast cancer tissue genetically analyzed by the NIH Cancer Genome Atlas study.  This human tissue repository is the nation’s foremost Platinum-rated, CLIA CAP certified bio-repository for cancer tissue housing over 90,000 tissue specimens, and will be utilized as the tissue repository resource to support the QUILT Trial,” said Tom Kurtz, CEO of Windber Medical Center and Windber Research Institute. “We are proud to be involved in this historic national initiative and to expand the efforts to elucidate the biologic mysteries of cancer and build on our work that has been so strongly supported by the DOD and NIH over the last decade” he said.

Attendees of the historic gathering hosted by Vice President Biden at his Naval Observatory residents included representatives from all elements of the health care ecosystem:

 

Government

Robert M. Califf, M.D., U.S. Food and Drug Administration (FDA), Deputy Commissioner for Medical Products and Tobacco

Janet Woodcock, M.D., U.S. Food and Drug Administration (FDA), Director of the Center for Drug Evaluation and Research (CDER)

Peter W. Marks, M.D., Ph.D., U.S. Food and Drug Administration (FDA), Deputy Director for the Center for Biologics Evaluation and Research (CBER):

Jeffrey Schlom, Ph.D., Center for Cancer Research, National Cancer Institute (NCI), National Institutes of Health (NIH) Chief  – Laboratory of Tumor Immunology and Biology

James L. Gulley M.D., Ph.D., F.A.C.P., Center for Cancer Research, National Cancer Institute (NCI), National Institutes of Health (NIH) Head – lmmunotherapy Section, Chief – Genitourinary Malignancies Branch, Director – Medical Oncology Service

Col. Craig Shriver, MD, FACS (DOD), Walter Reed National Military Medical Center Colonel, Medical Corps, United States Army Director, John P.  Murtha Cancer

 

Academia/Medical Institutions/Community Oncology

Ralph H. Hruban, M.D., Johns Hopkins University, Professor of Pathology & Oncology at Johns Hopkins University School of Medicine Director of The Sol Goldman Pancreatic Cancer Research Center

Vivian S. Lee, M.D., Ph.D., M.B.A., University of Utah Senior Vice President for Health Sciences Dean of the School of Medicine, CEO, University of  Utah Health Care

Stephen D. Nimer, M.D., University of Miami Health System, Director, Sylvester Comprehensive Cancer Center Professor of Medicine, Biochemistry & Molecular Biology and Professor of Medicine

Mark C. Poznansky, M.D., Ph.D., Harvard Medical School, Director – Vaccine & lmmunotherapy Center, Harvard Medical School, Physician at Massachusetts General Hospital

Azra Raza, M.D., Columbia University, Director of the MOS Center, Professor of Medicine

Andrew M. Evens, DO, MSc, FACP, Tufts University School of Medicine, Professor & Chief, Division of Hematology/Oncology, Director of Tufts Cancer Center

Tom Kurtz, CEO of Windber Medical Center and Windber Research Institute

 

Private Foundation and Health Care Industry

Patrick Soon-Shiong, M.D., FRCS(C), FACS, NantWorks & Chan Soon-Shiong Institute of Molecular Medicine (CSSIOMM) Founder & Chairman

Paul M. Black, Allscripts, Chief Executive Officer & Director

Pharmaceutical and Biotech Companies

Paul Seligman, M.D., MPH, Amgen, Chief of R&D Policy

Patrick Vallance, GlaxoSmithKline, President, Pharmaceuticals Research & Development

Mikael Dolsten, M.D., PhD, Pfizer, President, Worldwide Research & Development

Frank Jones, M.D., PhD, Etubics Corporation, Chairman, President, Chief Executive Officer, Chief Scientific Officer

 

Payors and Technology

Daniel J. Hilferty, Independence Blue Cross, President & Chief Executive Officer, Chairman of the Blue Cross and Blue Shield Association (BCBSA) Board of Directors

Jim Huffman, Bank of America, Senior Vice President, Head of U.S. Health and Wellness Benefits

John Chen, Blackberry, Executive Chairman & Chief Executive Officer

 

Shared Vision and Support for the National Immunotherapy Coalition and Cancer Moon Shot 2020:

There was a universal agreement amongst all who attended this historic meeting that the time for this important initiative was at hand and that with the close collaboration of this comprehensive group of stakeholders, meaningful advances could be made rapidly in cancer.

Statements in support of the Cancer Moon Shot Program are below:

 

Government

Robert M. Califf, M.D., U.S. Food and Drug Administration, Deputy Commissioner for Medical Products and Tobacco: At the meeting with the Vice President and Dr. Soon-Shiong, Robert M. Califf, M.D., Deputy Commissioner for Medical Products and Tobacco of U.S. Food and Drug Administration, stated, “There come moments in time where we ask why drugs tested do not work?  I can remember that moment in cardiology 30 years ago where we took out things that did not work and kept things that did. We may be at that moment in time with cancer.  The FDA is here to act as the ‘cattle prod’ to accelerate this moment when we are beginning to figure out how cancer works. The FDA is ready to be part of this historic coalition where we can provide clinical trial guidance for the combination of novel innovative agents brought into the coalition from the Cancer Moon Shot Program 2020 members,” he said. “By adopting innovative and adaptive clinical trials, the QUILT coalition will shepherd in a period accelerated by innovation in cancer treatment.”

Janet Woodcock, M.D., U.S. Food and Drug Administration (FDA), Director of the Center for Drug Evaluation and Research (CDER) has led many of FDA’s drug initiatives. She introduced the concept of risk management in 2000 as a new approach to drug safety. Since 2002, she has led the “Pharmaceutical Quality for the 21st Century Initiative,” FDA’s highly successful effort to modernize drug manufacturing and its regulation. In 2004, she introduced FDA’s “Critical Path” Initiative, which is designed to move medical discoveries from the laboratory to consumers more efficiently.  At the National Immunotherapy Coalition meeting hosted by Vice President Biden, Dr. Janet Woodcock made insightful comments and voiced the sentiments of many participants present at the meeting in support of the goals of the National Immunotherapy Coalition and the Cancer Moon Shot 2020 program, stating, “Current clinical trials are organized around disease rather than immunology approaches. This traditional approach takes too long.  You can only answer one question at a time and it may take you four years to answer one question about one drug and one tumor. It takes too long and doesn’t give you enough information. We need a large network to enroll a large number of patients. Almost all cancer patients are never enrolled in clinical trials. Almost all of them are never treated with investigational therapies. With regard to combinations, FDA issued guidance a number of years ago about investigational combinations.  Development of Hepatitis C drugs is an example.”

“My personal opinion: I believe we are approaching the science wrong,” she added, “We have great basic science, we learn all this information but we don’t test it in the clinic in an efficient manner. Anything we learn from a mouse or human pathology is an hypotheses, and often the hypothesis is wrong when we test it in people.  In complexities such as we face today in cancer where we have next generation sequencing, when we wish to combine chemotherapy with immunotherapy, when we wish to explore multiple combinations, you’re often asking five questions, not one. We need an engine that can turn around this knowledge rapidly and a process to help answer these questions effectively.”

“An important issue is our need to involve the community, that’s where the patients are,” Dr. Woodcock continued. “To date, trials have been centered around major medical centers and these trials are slow to accrue, since patients do not want to leave their community and doctors do not want to send them to remote centers. We need to build an infrastructure that will support these community doctors and allow them to participate and have their patients participate in these clinical trials without losing their patients and without having their patients to go away. “

Peter W. Marks, M.D., Ph.D., U.S. Food and Drug Administration, Deputy Director for the Center for Biologics Evaluation and Research (CBER): “Our goal is to enable important pathways for progress to get important therapies to patients. We will not be the impediment on the critical path at the FDA. Evidence generation needs to happen and we will work to streamline the process for vaccine development.”‎

Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute (NCI), directs a translational research program in cancer immunotherapy. He has pioneered the use of novel immunotherapeutics, both as monotherapy and in combination therapies, for a range of human cancers. His studies involve the translation of hypothesis-driven preclinical studies to science-driven clinical trials. Dr. Schlom’s studies involve the design and development of novel therapeutic cancer vaccines, immunocytokines, and checkpoint inhibitor monoclonal antibodies.

His longstanding experience in the biology of cancer and the efforts needed to rapidly address immunotherapy drug development through a collaborative national immunotherapy coalition were shared with the Vice President on December 1st, stating “This coalition that has been brought together by Dr Soon-Shiong to address cancer‎ is one of the most comprehensive sets of talents , and  is quite unique. I’ve seen it all but I’ve never seen anything quite like this in my years. I’ve been there at the original war on cancer during the Nixon Administration and saw the bureaucracy on how it played out.”‎

“The issue we face today in cancer care is a paradox. It is clear that immunotherapy can work in managing cancer but this approach is only working in about 20% of patients now. The problem we face today is that there are about 2 dozen drugs in immunotherapy in the clinic right now and they are all being developed in silos by each individual company. This National Immunotherapy Coalition is designed to solve this problem. I’m extremely proud to be a part of this and have never seen a situation like this where we can get these trials done so rapidly. I’ve been revitalized, regenerated through this whole process.”‎ he said at the historic DC meeting.

Dr. James L. Gulley who has served at the National Cancer Institute (NCI) for 18 years also participated in the meeting with the Vice President and Dr. Soon-Shiong. In his role as ‎Branch Chief, Dr. James L. Gulley, Director of the Medical Oncology Service, Office of the Clinical Director. Dr. Gulley echoed the sentiments of Dr. Schlom stating, “We are seeing a sea change on how we are treating patients with cancer with immunotherapy. We are seeing deep durable and rapid responses to these new immunotherapy agents that unfortunately are only in the minority of patients and in some cancers there’s no responses at all. The best way to address these failures is to explore combination therapies and this National Immunotherapy Coalition is the vehicle to break down these silos and test these combinations rapidly. That’s the way we are going to make progress. I am proud to be part of this important and historic immunotherapy initiative.”‎

Col. Craig Shriver, MD, FACS (DOD), Walter Reed National Military Medical Center Colonel, Medical Corps, United States Army Director, John P.  Murtha Cancer: He provided his viewpoints as it related to the military DOD health care and cancer stating, “There are five requirements for the QUILT coalition that we are proud to be part of and they’re directly related with what we do at our cancer center. We validate big science through our clinical trials network. There are 1.2 million active duty military members, 9.3 million beneficiaries that receive military DOD health care. That’s a huge network. Just in our active duty force, we get a thousand active duty members a year that come down with cancer. If a thousand active duty members were still getting injured in Afghanistan or Iraq, we would not accept this. So it’s the same thing with how militaries respond to infectious diseases… things that affect the readiness of our active force. So cancer is that threat. Care coordination is what we can provide since we have five other sites in our health system. We have a synergistic relationship with the NCI and that will broaden the access for these patients to these clinical trials.  I am honored to serve and be part of this remarkable Coalition that Dr. Soon-Shiong has convened.”

 

Academia/ Medical Institutions/Community Oncology

Ralph H. Hruban, M.D., Professor of Pathology & Oncology at Johns Hopkins University School of Medicine and Director of The Sol Goldman Pancreatic Cancer Research Center: We are at a crossroads, a time of discovery that’s transforming the ways we manage cancer. Johns Hopkins researchers and clinicians are working tirelessly to understand cancer better and to move treatments from bench to bedside so that patients can have a better shot at beating the disease. It is my hope that the National Immunotherapy Coalition, and others like it, will advance the understanding of cancer, not by small steps, but instead by leaps and bounds.”

Vivian S. Lee, M.D., Ph.D., M.B.A., University of Utah Senior Vice President for Health Sciences, Dean of the School of Medicine, CEO, University of Utah Health Care: “There really is a no more fascinating or promising time to be in medicine. The National Immunotherapy Coalition is an amazing opportunity to discuss obstacles that may impede the successful moon shot for cancer and reach the goal of establishing an effective vaccine for this disease in 5 years instead of 20. The University of Utah is deeply committed to solving these dilemmas and I, for one, am heartened that we will help lead the way.”

Stephen D. Nimer, M.D., Director of the Sylvester Comprehensive Cancer Center and a Professor of Medicine, Biochemistry & Molecular Biology at the University of Miami’s Miller School of Medicine: “Every day, the physicians and scientists within Sylvester Comprehensive Cancer Center’s site disease groups and multidisciplinary research programs, are working to make exciting breakthroughs that can transform the way cancer patients are diagnosed and treated. We look forward to working for the National Immunotherapy Coalition and developing the most innovative strategies to fight the most deadly forms of cancer.”

Mark C. Poznansky, M.D., Ph. D. Director – Vaccine & Immunotherapy Center, Physician – Massachusetts General Hospital, Associate Professor, Harvard Medical School: “The time is now to create an accelerated path, and advance medical science forward to save lives and improve health worldwide. The National Immunotherapy Coalition clearly unites and leverages the resources and expertise of a diverse network of medical and business professionals to safely and rigorously accelerate the pace of discovery, development and actualization of cancer treatment. By accelerating the development of new safe and cost effective therapies combating cancer, we can bring them to those that are most in need faster and more cost effectively than current approaches.”

Manuel Hidalgo, M.D., Ph. D. Chief, Division of Hematology/Oncology and Clinical Cancer Center Director, Beth Israel Deaconess Medical Center, Harvard Medical School: “We are now glimpsing the potential of modulating the immune system to treat cancer in an effective way. Integrating multiple treatment strategies in innovative clinical trials protocols is the path to make a real impact in cancer care.  At BIDMC we struggle on a daily basis to discover and implement new treatments for our patients.  We are very excited to work with The National Immunotherapy Coalition and join efforts to advanced cancer medicine.”

Azra Raza, M.D., Columbia University, Director of MDS Center, Professor of Medicine: “We are very pleased to have the opportunity to work with the National Immunotherapy Coalition and collaborate with a world-class team who share a commitment to reduce cancer incidence and to improve the quality of life of those affected by cancer. Being able to pool resources and agents, we will be able to make a significant leap in developing new immunotherapeutic and combinations that will most benefit patients with various cancer types and stages.”

Andrew M. Evens, DO, MSc, FACP, Professor & Chief, Division of Hematology/Oncology, and Director of the Tufts Cancer Center at Tufts Medical Center: “Tufts Cancer Center is honored to join a group of world-renowned expert physicians, scientists and researchers who have a shared passion for fighting cancer. We understand that cancer can affect every aspect of a person’s life — and the lives of their loved ones. That’s why we are dedicated to research focused on helping bring new and innovative treatments to patients in less time.”

Tom Kurtz, CEO of Windber Medical Center and Windber Research Institute: “The DOD and Col. Shriver have established a long standing partnership with the Windber Research Institute and through our collaborative efforts the DOD and Windber were responsible for providing over 90% of the breast cancer tissue genetically analyzed by the NIH Cancer Genome Atlas study.  This human tissue repository is the nation’s foremost Platinum-rated, CLIA CAP certified bio-repository for cancer tissue housing over 90,000 tissue specimens, and will be utilized as the tissue repository resource to support the QUILT Trial,” said Tom Kurtz, CEO of Windber Medical Center and Windber Research Institute. “We are proud to be involved in this historic national initiative and to expand the efforts to elucidate the biologic mysteries of cancer and build on our work that has been so strongly supported by the DOD and NIH over the last decade” he said.

 

Private Foundation and Healthcare Industry

Patrick Soon-Shiong, M.D., FRCS(C), FACS, NantWorks & Chan Soon-Shiong Institute of Molecular Medicine (CSSIOMM) Founder & Chairman: “There are unique times in history when events and advancements in technology converge to elicit a quantum leap in medical care. This is not only a unique time, but also a unique inflection point in the history of cancer,” said Patrick Soon-Shiong, M.D., Founder and Chief Executive Officer of NantWorks and the Chan Soon-Shiong Institute of Molecular Medicine. “Our knowledge in the science of genomics, proteomics, immunology and immunotherapy has advanced and converged at an unprecedented speed, making now the time for the rapid deployment and orchestration of immunotherapy for the benefit of millions of cancer patients. The Cancer Moon Shot 2020 Program, the National Immunotherapy Coalition and the QUILT Trial are designed to do just that—to bring together a diverse group of stakeholders to pool resources working together to develop and bring to patients, a dramatic improvement in cancer care.”

Paul M. Black, Allscripts, Chief Executive Officer & Director: “The National Immunotherapy Coalition is an exciting step towards a more efficient future in cancer treatment, partnering research and health information technology in an entirely new way. As a leader in healthcare information technology solutions, we are making a commitment to this initiative to ensure that our clients can combine the cutting edge research being done by Nant with the power of their Allscripts clinical information solutions to better harness the enormous volume of newly available data. When new research and genomic analysis is presented in the clinicians’ workflow in a way that feels natural to them, it allows them to focus first and foremost on the well-being of all those dealing with cancer.”

 

Pharmaceutical and Biotech Companies

Stefan Oschmann, Vice Chairman and Deputy CEO at Merck KGaA: In 2014, Merck KGaA and Pfizer formed a global strategic alliance to jointly develop immuno-oncology compounds. Both Pfizer and Merck KGaA have now joined the National Immunotherapy Coalition to accelerate their development of their Immuno-Oncology portfolio such as their PD-L1 Antibody in clinical trials.Forging strong partnership between academia and healthcare industry is of strategic importance to share knowledge and more effectively address existing challenges in cancer care. We are very pleased to be part of this initiative that will help combine forces to improve patient outcomes through combining highly innovative novel- novel combinations in the field of Immune-Oncology.”

Mikael Dolsten, M.D., Ph.D., President, Worldwide Research & Development, Pfizer Inc. Dr. Mikael Dolsten attended the meeting in Washington DC in support of the goals of the National Immunotherapy Coalition and the Cancer Moon Shot 2020 program. He stated, “The challenge of cancer is far too great for any of us to tackle alone. Pfizer welcomes the collaboration of NCI and FDA in the creation of clinical master protocols that allow for the effective testing of novel oncology drug combinations from several companies or institutions.  It is our hope that the joining together of the health innovation ecosystem under the National Immunotherapy Coalition will further accelerate the development of game changing, combination immunotherapies for the benefit of cancer patients.”   

Patrick Vallance, GlaxoSmithKline, President, Pharmaceuticals Research & Development who went from leading an academic department at University College London to his current role heading up our R&D operations at GlaxoSmithKline (GSK). He has refocused GlaxoSmithKline’s oncology efforts to immunotherapy stated at the Washington DC meeting, “Is it possible to change cancer care to what we are doing with Malaria research? Everyone believes combinations are essential. No one should believe that a single molecule would do the trick. The problem is not about making the medicine; we have a lot of medicines, its knowing how to combine them and knowing what works in patients.  Those combinations aren’t going to work out sequentially by individual companies. It’s going to take 30-40 years going at it alone. Its imperative we collect the data from patients already getting these today. We need to work electronically to gather these data points and assemble this data together in this National Immunotherapy Coalition.”

Robert J. Hugin, Chairman and Chief Executive Officer, Celgene Corporation: Celgene has made a significant commitment to the field of immunotherapies and is a leader in the field of IMiDs, a novel class of immunomodulators, treating diseases such as multiple myeloma and Myelodysplastic syndrome.  At a Pancreatic Cancer advocacy event, Robert J. Hugin, Chairman and CEO of Celgene Corporation stated, “We, too, are fully committed to your Vision of Progress goal to double survival for pancreatic cancer by 2020. When we took on pancreatic cancer and the development of the Abraxane® compound that eventually won FDA approval, we knew it was a bold and ambitious challenge. Conducting a trial that would show significant survival benefit in advanced pancreatic cancer had only been accomplished three times in the last 23 years. But we live and breathe a culture of innovation and determination. We don’t back down in the face of tough odds. We know that research and the development of more effective treatments for patients call for novel approaches, bold science and a strong vision. We need more feet in the fight. We need more companies to step in and join.” Celgene has made a commitment to combine their library of important molecules, both approved and in the development pipeline to participate in the QUILT Trials which will play an important role in the rapid advancement of immuno-oncology for patients with life-threatening cancer.

Paul Seligman, M.D., MPH, Amgen, Chief of R&D Policy: At the gathering in Washington DC on December 1, 2015, Paul Seligman stated, “At AMGEN, we’ve been intimately involved to translate genetics into biology and then biology into therapies. This is precisely the type of initiative we need to have. We can’t go it alone anymore. Science needs to work together. I worked at the FDA before working at AMGEN. This is not just a regulatory question, but how we work together as a community in developing products and developing a stable generation of research. It requires a network that’s sustainable over a long period of time.  This is a perfect example of public private partnerships in creating sustaining networks. I can certainly speak for AMGEN, finding the right ways to share our materials and use them in the best way possible is something we are profoundly dedicated in doing.”

Frank R. Jones, PhD, Chairman, President, and Chief Executive Officer of Etubics Corporation: “At Etubics, we specialize in developing innovative immunotherapies and vaccines for a wide-range of resilient diseases including cancer, so it goes without saying that we are extremely excited about this new initiative. We recognize the value in an immune stimulation treatment approach and look forward to volunteering our agents for combination clinical trials that we anticipate will produce groundbreaking results.

 

Payor and Technology Sectors

Daniel J. Hilferty, Independence Blue Cross, President and Chief Executive Officer: “Every day, Independence Blue Cross is reimagining health care in hopes to help our members succeed on their path to improved health and high quality care,” said Daniel J. Hilferty, Independence Blue Cross, President and Chief Executive Officer and Chairman of the Blue Cross and Blue Shield Association Board of Directors (BCBSA), comprised of 36 Independent Blue Cross Blue Shield companies that together cover nearly 105 million individuals – 1 in 3 Americans. The National Immunotherapy Coalition is allowing Independence to further enhance our contribution to the future of health care through our active involvement in this one-of-a-kind collaboration.” Hilferty stated. “We look forward to continuing our work with this incredible team to develop the most innovative cancer fighting strategy in our lifetime. Through our Blue Cross Blue Shield Association we cover 1 in 3 Americans and insure individuals across every zip code in the country – this initiative is important to all Americans.”

John Chen, Blackberry CEO: “At Blackberry, we understand the value that lies at the intersection of healthcare and technology, which is why we are constantly making advancements to reflect the ever-changing healthcare landscape. As we already power many of the tools that clinicians rely on heavily, we are confident that our involvement in the National Immunotherapy Coalition will be an asset to the future of Cancer treatment. This unique collaboration is pioneering extraordinary solutions to cancer care and we are truly honored to be a part of it.”

Jim Huffman, Senior Vice President, Head of US Health and Wellness Benefits, Bank of America said, “We provide coverage for about 500k employees and their families.  IT gives us a unique perspective of what we are paying for, which is $2 billion dollars. It’s about are we getting the best product to our employees and their families?”

Copyright (c) 2018 The Cancer Letter Inc.