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  • February 9, 2017

  • 3rd Annual Immuno-Oncology 360° Led by Dr Axel Hoos (GSK) and Dr James Gulley (NCI)

    A 360-degree approach addressing business aspects, clinical advancements and scientific data to transform the way cancer is treated. The 3rd annual Immuno-Oncology 360° (IO360) event took place February 1-3, 2017 in NYC. Designed by lead advisors Dr Axel Hoos (GSK) and Dr James Gulley (NCI), the program provided a unique 360-degree approach addressing the most-up-to-date […]

    A 360-degree approach addressing business aspects, clinical advancements and scientific data to transform the way cancer is treated.

    The 3rd annual Immuno-Oncology 360° (IO360) event took place February 1-3, 2017 in NYC. Designed by lead advisors Dr Axel Hoos (GSK) and Dr James Gulley (NCI), the program provided a unique 360-degree approach addressing the most-up-to-date information regarding business aspects, clinical advancements and scientific data that helped to accelerate clinical trials and FDA approval, ultimately transforming the way cancer is treated.

    Day one’s plenary sessions covered “Preclinical Science,” chaired by Dr Patrick Mayes, Director & Early Development Leader, GlaxoSmithKline and “Translational Science and New Technologies,” chaired by Dr Renee Donahue, Scientist, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute. Highlights include:

    1.    Can Agonist Antibodies Play a Role in Immunotherapy?

    Though the concept of incorporating agonist antibodies into an immunotherapeutic treatment regimen is still a long way from durable viability, Dr Mayes shared that there is at least some reason for optimism.
    “We believe that immune agonist antibodies have some significant potential and promise as cancer therapies, and I think that’s been illustrated by the explosion of agents that have entered the field in the last five years.”

    Dr Mayes said developing agonist antibodies for immunotherapy presents a number of unique challenges, one of which being the elevated need for precise dose selection. “Dose level is critical when it comes to these agents,” he said. “It’s not about dosing high, it’s about finding the right dose level to achieve significant activation.”

    Another issue limiting the development of viable agonist antibodies is the degree to which FcyR and IgG interactions differ between animal and human test subjects, which Dr Mayes said complicates the translation of functional data.
    “It means that interpretations that we’re able to make in a mouse system or even a monkey system aren’t necessarily going to translate, since the IgG specifically is such an important characteristic for agonist antibodies. We need to be very careful about how we interpret our data.”

    2.    Sequencing of Combination Agents

    Another emerging concept highlighted in several presentations on Wednesday was the combination of immunotherapy with certain types of chemotherapy, despite their inherent contradiction in function.
    “It’s actually not as bad an idea as some might think,” said Dr Charles Drake, director of genitourinary oncology and associate director for immunotherapy at the Columbia University Medical Center’s Herbert Irving Comprehensive Cancer Center.

    Dr Drake noted there is a growing body of research that suggests the addition of chemotherapy to a regimen of immunotherapeutics can improve the overall efficacy of the treatment. Exactly how successful the tactic can be may depend on how carefully timed the integration of therapies is on a repeatable basis. “Research shows that if you introduce an anti-PD1 during the initial antigen encounter right at the time the T-cell sees its target antigen, you can actually reprogram that T-cell to continue having an effect or a function further down the line, and can actually see longer survival as a result.”

    3.    Immunosequencing in Cancer Treatment

    Dr Lanny Kirsch, SVP, Translational Medicine, Adaptive Biotechnologies, said his focus has been refining and expanding the application of immunosequencing in cancer treatment.
    “In order to expand the benefit of immunotherapy to the greatest number of patients, it would be extremely useful to be able to assess the immune status of a patient and the tumor that resides inside of them. Immunosequencing is one approach to doing that. It’s the enumeration, specification and quantification of each and every B or G cell in any biological sample.”

    Dr Kirsch also shared that he is particularly interested in the prospect of using immunosequencing to develop blood-borne biomarkers that could more accurately track the effects of an immunotherapy, rather than relying on biopsied tissue.
    “We think that could be of significant use in the care of patients receiving immunotherapy.” “We hope we’re becoming more refined and sophisticated in terms of being able to apply a computational matrix to better extract critical information from these kinds of analyses,” Kirsch later added.


    Day two featured plenary sessions on “Trends & Collaborations in the IO Space,” chaired by Dr Ramy Ibrahim, VP and Head of R&D, Parker Institute for Cancer Immunotherapy, “Clinical Advancements Part 1,” chaired by Dr James Gulley, Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute and “Imaging Methodologies & Techniques for Immunotherapy,” chaired by Dr Andrea Perrone, Associate Vice President, Translational Medicine, Merck Research Labs. Key takeaways from day two include:

    1.    New Details on FNIH’s Forthcoming Partnership for Accelerating Cancer Therapies

    In 2016, the Foundation for the National Institutes of Health announced plans to develop a new program under the Cancer Moonshot initiative, noting at the time the lack of cohesion within the industry when it came to generating and managing clinical data.
    “We have a lot of knowledge gaps and duplicative deployment of resources, and I think we could probably do much better with a much more systematic and uniform approach, particularly in the area of biomarker development,” said David Wholley, MPhil Director, Research Partnerships Division, FNIH.

    Mr Wholley hopes to eliminate those disconnects and redundancies with the launch of FNIH’s Partnership for Accelerating Cancer Therapies (PACT), which he said will establish a network of core laboratories to conduct, standardize and validate biomarker assays.
    “We decided to focus our efforts on a problem that was urgent for everyone, but also tractable and highly relevant to the types of resources that NCI was already developing. The focus here is building out a more systematic and robust effort to develop and validate biomarkers for immunotherapy and, particularly, combination trials.” Assuming a successful fundraising campaign, the PACT is expected to launch in the third quarter of 2017. The partnership’s other primary objectives will include:

     – Funding the development of new exploratory biomarkers and assays
     – Incorporating biomarker modules into trials
     – Creating a comprehensive database of biomarker module and clinical data

    2.    Clinical Advancements and Challenges

    Dr Roy Baynes, SVP and Head, Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, provided an update on expanding the approved monotherapeutic uses of PD-1 antibodies in the treatment of various cancers.
    “As we look at the goal of trying to establish PD-1 as being transformational in cancer, I believe we are making fairly good progress,” Dr Baynes said.
    Having already established its PD-1 antibody Keytruda as a standard-of-care monotherapy for advanced melanoma, Dr Baynes said Merck recently achieved global approval for PDL-1 high front-line and PDL-1 positive second-line lung cancer patients. The company has also gained approval for its PD-1 antibody in the treatment of head and neck cancer, and is under priority review for indications within Hodgkin’s Lymphoma and MSI-H cancer. Additionally, Dr Baynes said Merck is exploring recent positive clinical outcomes in the treatment of first- and second-line bladder cancer.

    Dr Baynes also participated in a panel discussion moderated by Dr Gulley, also including Dr Alessandra Cesano, Chief Medical Officer, nanoString Technologies, Dr Patrick Hwu, Head, Division of Cancer Medicine/ Department Chair, Melanoma Medical Oncology/ Department Chair, Sarcoma Medical Oncology, MD Anderson Cancer Center and Robert Millham, MS, MSc, PharmMed SVP & General Manager, Hematology & Oncology, inVentiv Health. The panel focused on key clinical challenges facing the IO field and addressed increasing the rate of patient responses to immunotherapy, refining the field’s approach to combination therapies, reducing the risk of toxicity in combination trials and establishing a uniform system of generating, collecting and managing clinical data.

    3.   New Modifications to RECIST 1.1 for Immunotherapeutics

    Dr Elisabeth de Vries, Professor, Medical Oncology, University Medical Centre Groningen, outlined the RECIST Working Group’s recommendations for a new guideline for imaging data collection and management in clinical immunotherapy trials, dubbed iRECIST.
    “The rationale for developing iRECIST was the fact that we know that there is an atypical pattern of response in multiple immunotherapy trials, but the true frequency is unknown,” Dr de Vries said. “We also know that there are different interpretations of immune response criteria across trials, which makes it very difficult to compare the trials.”

    Primary among the changes proposed under the iRECIST guideline is the difference in time point response after a RECIST 1.1 progressive disease identification. The first RECIST 1.1 progressive disease would be termed an “unconfirmed” progressive disease and must be confirmed at the next assessment 4-8 weeks afterward. Also, the time point for tumor response would be dynamic and based on a change from baseline or from nadir, as well as the last I-response. Dr de Vries said the full iRECIST guideline will be published later this year in Lancet Oncology. Dr Patricia Keegan, Director, Division of Oncology Products 2 (DOP2), OHOP, OND, CDER, FDA, said the FDA will continue to use RECIST 1.1 as the primary criteria for tumor-based endpoint imaging, but that she was “very eager to see how this plays out, in terms of whether this criteria or something based on it, would provide better information and better correlate to clinical outcomes.”


    Day three concluded the conference with plenary sessions, “Business Aspects of Immuno-Oncology,” chaired by Mark Simon, MBA, Partner, Torreya Partners and “Clinical Advancements Part 2,” chaired by Dr Jeffrey Legos, SVP, Oncology Global Development & Medical Affairs, Novartis Pharmaceuticals.

    1.    Improving Patient Experiences in Clinical Trials

    Based on his own experiences finding, joining and completing clinical trials in immunotherapy, T.J. Sharpe’s (Melanoma Survivor, Patient Advocate and Cancer Blogger) keynote address implored physicians in the IO field to find ways of making the clinical trial process easier for patients. Diagnosed with Stage 4 melanoma in August 2012, Mr Sharpe said he only knew to inquire about the possibility of joining a clinical trial because of prior professional experience and a network of contacts in the pharmaceutical industry.
    “Patients don’t always know to look for different treatments, particularly immunotherapy trials. I was able to find a trial because I had a lot going for me.”

    Though grateful for the PD-1 treatments that to-date have aided in an 85% reduction in measurable tumor burden, T.J. said the process of obtaining those treatments is fraught with complexity and bureaucracy, which many cancer patients may find discouraging or prohibitively difficult to navigate.
    “It might just be a document to you, but it’s my life,” Sharpe said. “The average contract for a clinical trial takes about 18 weeks to execute. That’s more than 3,100 melanoma patients who will die the next time a contract goes from beginning to end. I know we can’t save all of them, but how many T.J.’s are out there trying to get into your trial to try your new therapy and are waiting for a piece of paper to be signed?”

    2.   The Growing Need for New Reimbursement Models

    As public and political pressures mount on the pharmaceutical industry over the rising cost of specialty drugs, it is critical that the industry work with healthcare payers and providers to develop new reimbursement models for high-cost curative therapies, according to Dr Lindee Goh, Partner at Tapestry Networks.
    “Developing a drug isn’t very helpful if there isn’t market access to that drug,” Dr Goh said. “If patients can’t get it because they can’t afford it, then the innovation is wasted and patient lives are left at risk.”

    Dr Goh outlined several potentially sustainable reimbursement models that could ease the financial pressure on patients, including rebates, amortization, payer-backed annuities, reinsurance and government-issued bonds. However, reaching a consensus on new systems of reimbursement will require a concerted and collaborative effort among stakeholders in the healthcare industry, considering the multitude of regulatory, political and economic challenges that must be addressed.
    “There’s been a lack of leadership across the stakeholder groups,” Dr Goh noted. “There isn’t any clear industry champion saying that they want to change the model, and there’s a lot of political downside to being a lead in this area.”

    3.    Talent Management Issues in the IO Space

    Adam Millinger, Founding Partner, ProMotion Career Management, described the competition for talent in the IO field as an “arms race” fueled not only by a shortage of qualified candidates, but also systemic shortfalls in talent management strategies within the industry.
    “It will come as no surprise that there’s a big gap between supply and demand for talent. [The IO space] is a new area, and as much as people are being trained, there just aren’t enough folks out there at the moment,” Mr Millinger said. “What you also have is the group that rode in on the early wave of IO that are now extremely senior within the industry, and the less-seasoned people coming in aren’t able to fill that mid-level gap.”

    Mr Millinger noted other contributing factors to the IO field’s talent shortage include a reticence among traditional oncologists to learn a new discipline and companies’ weakened ability to negotiate salaries and titles with those who do have the requisite experience. As difficult as the competition for qualified talent can be, Mr Millinger thinks the industry’s larger problem appears to be retaining the talent they are able to attract, due primarily to a misalignment of motivations among new hires and executive-level management, as well as a lack of proactive career development and succession planning.
    “For the people in the trenches doing the work, there’s a strong feeling that IO is a harsh, unforgiving space where companies are really pushing people to their stress limits,” Millinger said. Executives, on the other hand, are stuck in a “mercenary mindset, where they think that people who do have the experience are taking advantage and chasing titles and paychecks.” “There needs to be a better alignment of people and motivations to actual outcomes,” he added.

    The Conference Forum will present the next program in the IO space, the 2nd annual Rational Combinations 360°, on June 28-29, 2017, at The New York Academy of Medicine in New York City. Designed by lead advisors Dr Axel Hoos (GSK), Dr Ian McCaffery (Corvus Pharmaceuticals) and Dr Patrick Hwu (MD Anderson), #IOCombos360 provides the most up-to-date progress on combination developments from business aspects, clinical advancements and scientific data that will help prioritize the best cancer treatments for individual patients and tumor types. Register here.

    Save the date for 4th Annual Immuno-Oncology 360° in NYC, to be held February 7-9, 2018, in NYC.

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  • August 2, 2016

  • IO360° Keynote, Dr Carl June Featured in NYT’s Article on Setting the Body’s “Serial Killers” Loose on Cancer

    The New York Times continues to showcase stories on how cancer immunotherapy developments are transforming the way cancer is treated. Several of the Immuno-Oncology 360° (IO360°) speakers were profiled in yesterday’s article “Setting the Body’s ‘Serial Killers’ Loose on Cancer.” Featured was IO360° Keynote, Dr Carl June of University of Pennsylvania, who discussed his personal […]

    The New York Times continues to showcase stories on how cancer immunotherapy developments are transforming the way cancer is treated. Several of the Immuno-Oncology 360° (IO360°) speakers were profiled in yesterday’s article “Setting the Body’s ‘Serial Killers’ Loose on Cancer.”

    Carl-JuneFeatured was IO360° Keynote, Dr Carl June of University of Pennsylvania, who discussed his personal journey behind researching and developing CAR-T cells that has resulted in several cases of remission and even instances where the cancer has disappeared entirely. Mentioned in the article was 11-year old Emily Whitehead, the first child to receive CAR-T therapy and who is widely-know for her miraculous recovery from acute lymphoblastic leukemia after receiving the treatment from Dr June and his team at University of Pennsylvania. Emily and her parents attended IO360° this past year to share Emily’s experience with CAR-T therapy and her journey to leading a cancer free life.

    The New York Times also highlighted IO360° speakers Dr Arie Belldegrun, President and CEO, Kite Pharma and Dr Renier Brentjens, director of cellular therapeutics at Memorial Sloan Kettering Cancer Center.

    To read the full New York Times article visit:
    http://www.nytimes.com/2016/08/02/health/cancer-cell-therapy-immune-system.html?_r=0

    For more information on Immuno-Oncology 360° visit: http://theconferenceforum.org/conferences/immuno-oncology-360/overview/

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  • August 1, 2016

  • NYT’s Cover Story on Harnessing the Immune System to Fight Cancer

    This past weekend, the New York Times cover story featured several patients who have participated in cancer immunotherapy clinical trials and profiled a number of the IO360 speakers. The article gives hope for the future of IO. Immuno-Oncology 360° speaker Dr Jedd Wolchok of Memorial Sloan Kettering Cancer Center commented that “this [immunotherapy] is a […]

    This past weekend, the New York Times cover story featured several patients who have participated in cancer immunotherapy clinical trials and profiled a number of the IO360 speakers. The article gives hope for the future of IO. Immuno-Oncology 360° speaker Dr Jedd Wolchok of Memorial Sloan Kettering Cancer Center commented that “this [immunotherapy] is a fundamental change in the way that we think about cancer therapy.”

    Screen Shot 2016-08-01 at 4.17.04 PM

    From the New York Times Article

    The article also features 2017 Immuno-Oncology 360° keynote speaker Dr James Allison of MD Anderson Cancer Center, who discusses the importance of the preclinical work using mouse models that displayed positive results of the antibody he developed to block the checkpoints and launch T-cells against cancer. The antibody, known now as BMS’ Yervoy was further developed for humans and was approved in 2011 to treat advanced melanoma.

    To read the full New York Times article visit: http://mobile.nytimes.com/2016/07/31/health/harnessing-the-immune-system-to-fight-cancer.html?_r=0

    For more information on Immuno-Oncology 360° visit: http://theconferenceforum.org/conferences/immuno-oncology-360/overview/

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  • July 28, 2016

  • FDA Accepts Investigational New Drug Application for a Cancer Vaccine Developed by Neon Therapeutics

    We are pleased to hear Neon Therapeutics, founded by Immuno-Oncology 360° keynote and MD Anderson Immunology Chair, Dr James Allison, has received the FDA’s acceptance of their IND application for their lead cancer vaccine program NEO-PV-01.   Neon Therapeutics recently shared data this month at IO360°’s Rational Combinations conference in New York on how they […]

    We are pleased to hear Neon Therapeutics, founded by Immuno-Oncology 360° keynote and MD Anderson Immunology Chair, Dr James Allison, has received the FDA’s acceptance of their IND application for their lead cancer vaccine program NEO-PV-01.

    Dr. James P. Allison in his laboratory

    Dr James Allison, MD Anderson Immunology Chair and IO360° 2017 Keynote Speaker

     

    Neon Therapeutics recently shared data this month at IO360°’s Rational Combinations conference in New York on how they are developing further treatment modalities including next-generation vaccines and T-cell therapies targeting both personalized as well as shared neoantigens. The FDA’s acceptance of the IND enables Neon Therapeutics to initiate their first clinical trial investigating the combination of a NEO-PV-01 with BMS’ Nivolumab in advanced melanoma, NSCLC and bladder cancer. The trial is expected to begin this year.

    Dr James Allison will be delivering a keynote address on Immune Checkpoint Blockade in Cancer Therapies: New Insights and Opportunities for Cures at the 3rd Annual Immuno-Oncology 360° program taking place January 31- February 3rd, 2017 in NYC.

    To read the full press release: http://www.businesswire.com/news/home/20160729005446/en/Neon-Therapeutics-Announces-FDA-Acceptance-Investigational-Drug

    To learn more about the 3rd Annual Immuno-Oncology 360° conference visit: http://theconferenceforum.org/conferences/immuno-oncology-360/overview/

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  • July 6, 2016

  • Dpharm Europe Speaker Alexander Masters on Crowd Funding Cancer Cures

    We are delighted to highlight the latest piece printed in the London Telegraph by DPharm Europe speaker, Alexander Masters on the latest in a new financial paradigm to help fight cancer. From the Telegraph: The first person in the world to receive the only crowd-funded cancer drug in history will be Jan Smørlung, a village […]

    Alexander Masters, Author, Campaigner and Co-Founder, iCancer.org.uk

    Alexander Masters & Craig Lipset at DPharm Europe

    We are delighted to highlight the latest piece printed in the London Telegraph by DPharm Europe speaker, Alexander Masters on the latest in a new financial paradigm to help fight cancer.

    From the Telegraph:

    The first person in the world to receive the only crowd-funded cancer drug in history will be Jan Smørlung, a village fire inspector, who doesn’t mind us pointing our camera lens at his groin. ‘Yes, thank you. I am happy to assist the world,’ he says.

    A plump, healthy-looking man with a fresh haircut, wearing a white T-shirt, he looks like someone who rows out into misty forest lakes to catch a fish for breakfast. He has two children, six grandchildren and not much time.

    For over a decade, Jan’s consultant, world famous clinician Kjell Öberg, has held back the inevitable with every treatment so far known to medicine, from chemotherapy to small radioactive balls dribbled into Jan’s blood.

    Continue Reading Here.

    Listen to Alexander’s Story on PharmaTalk Radio

    Craig Lipset, MBA, Head of Clinical Innovation, R&D, Pfizer speaks with Alexander Masters, Author, Medical Campaigner and Co-Founder, iCancer.org.uk on:

    • The story of the formation of iCancer.org.uk and the Oncolytic Virus Fund
    • An alternative way to make clinical trials more accessible
    • Ethical and moral issues
    • A possible disruptive and sustainable model for other neglected medicines

    Listen to the program here.

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  • May 16, 2016

  • EU Commission Approves the First and Only Immuno-Oncology Combination for Treatment of Advanced Melanoma

    Earlier this year, the FDA approved the combination of BMS’ ipilimumab (Yervoy) plus nivolumab (Opdivo) for metastatic melanoma and Europe soon followed with last weeks approval by the European Commission, making this combination Europe’s first and only approved combination of 2 immuno-oncology agents. We were delighted to have Dr Jedd Wolchok of Memorial Sloan Kettering […]

    Earlier this year, the FDA approved the combination of BMS’ ipilimumab (Yervoy) plus nivolumab (Opdivo) for metastatic melanoma and Europe soon followed with last weeks approval by the European Commission, making this combination Europe’s first and only approved combination of 2 immuno-oncology agents.
    Jedd_Kate

    Dr. Jedd Wolchok, MSCKK and Kate Woda, The Conference Forum

    We were delighted to have Dr Jedd Wolchok of Memorial Sloan Kettering Cancer Center present the most recent data regarding the Immuno-Immuno Combinations of Yervoy + Opdivo in Melanoma at the IO360° conference that took place in February in NYC. (For a copy of the slides from his session, see below)

    We look forward to addressing more on this topic at the Rational Combinations 360° conference, June 23-24 2016, NYC.

    To read the full article, click here.

    To access Dr Wolchok’s presentation from IO360°, click here.

    For more information about Rational Combinations 360° conference, see link below and utilize code BLOG10 for 10% off the registration, click here.

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  • May 5, 2016

  • Featured Business Panel at Rational Combinations 360°

    Rational Combinations 360°, an IO conference dedicated to combination immunotherapy approaches is delighted to confirm a buyside investment panel moderated by Mark Simon, MBA, Partner, Torreya Partners. This talk will address perspectives on investing in companies developing IO combination products. The panel will answer the following questions: Would you make an investment in an IO […]

    Rational Combinations 360°, an IO conference dedicated to combination immunotherapy approaches is delighted to confirm a buyside investment panel moderated by Mark Simon, MBA, Partner, Torreya Partners.

    Simon_Mark

    Mark Simon, MBA, Partner, Torreya Partners

    This talk will address perspectives on investing in companies developing IO combination products. The panel will answer the following questions:

    • Would you make an investment in an IO idea where the monotherapy data was not strong but the combination data is?
    • Does the combination need to be in the hands of one company? Other words, do they need to have both arms of the combo or would you own both companies?
    • Interchangeability: If the target of one company was validated, would that make you invest in other companies with drugs of the same targets?
    • What are investor perspectives on managed care, pricing and financial models? How do you factor in pricing and how does reimbursement affect your investment strategy?
    • Do you look at CARs as a viable business or do you feel just giving drugs opposed to t-cell modification is easier? Do you think there is a sustainable business model in modifying patient’s own cells?
    • Have we overdone the investing in Immuno-oncology and are non IO cancer companies being overlooked, thus creating investment opportunities?

    Panelists Include:

    Wayne Rothbaum, Founder, Quogue Capital

    For more information about the Rational Combinations 360° Conference
    CLICK HERE

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  • April 7, 2016

  • Rational Combinations Supporting Partner, CRI launches Phase 1/2 trial of combination immunotherapy with Ludwig Cancer Research

    Cancer Research Institute, a supporting partner of Rational Combinations 360°, together with Ludwig Cancer Research have launched a Phase 1/2 clinical trial of combination immunotherapy for advanced ovarian cancer. From News-Medical.Net The international, multicenter trial is led by George Coukos, director of the Ludwig Institute for Cancer Research, Lausanne and Brad Monk, director of Gynecologic Oncology […]

    Cancer Research Institute, a supporting partner of Rational Combinations 360°, together with Ludwig Cancer Research have launched a Phase 1/2 clinical trial of combination immunotherapy for advanced ovarian cancer.

    From News-Medical.Net

    The international, multicenter trial is led by George Coukos, director of the Ludwig Institute for Cancer Research, Lausanne and Brad Monk, director of Gynecologic Oncology at St. Joseph’s Hospital and Medical Center. The study is being conducted through the CVC Trials Network, which is jointly managed by Ludwig and CRI, in collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, and the biopharmaceutical company VentiRx Pharmaceuticals Inc.

    “Ludwig has long supported the design and evaluation of new therapeutic strategies to improve the treatment options available to cancer patients,” said Jonathan Skipper, Ludwig’s executive vice president of Technology Development. “Employing immunotherapies in combination holds great promise in that endeavor. We are proud to be a part of this effort to bring investigational drugs being developed by different commercial partners to a single clinical trial and improve the standard of care for recurrent ovarian cancer, a disease for which patients today have few treatment options.”

    Continue Reading the Article here.

    Rational Combinations 360° (June 23-24,2016 in NYC) is the only event addressing business aspects, novel clinical trial designs and scientific developments for combination immunotherapies. For more information on the program, click here.

     

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  • April 6, 2016

  • Alternative Model to Transform a Funding Gap in Rare Disease Clinical Research: Neuroendocrine Cancer in the Pancreas

    Frustrated that a promising therapy for a rare cancer was sitting in a freezer due to the lack of a relatively modest amount of funding, author Alexander Masters helped lead a campaign to crowd-fund a clinical trial: the result, iCancer.org.uk. The money required was indeed raised – by one wealthy individual primarily, in return for […]

    Frustrated that a promising therapy for a rare cancer was sitting in a freezer due to the lack of a relatively modest amount of funding, author Alexander Masters helped lead a campaign to crowd-fund a clinical trial: the result, iCancer.org.uk. The money required was indeed raised – by one wealthy individual primarily, in return for being in the trial.

    Photo Mark Earthy www.earthyphotography.co.uk This image is protected by Copyright

    Craig Lipset interviewing Alexander Masters and Dr Magnus Essand at DPharm Europe

    At DPharm Europe, Pfizer’s Craig Lipset interviewed on stage Alexander Masters to share his innovative story. We are delighted to share the journey and the latest updates on PharmaTalk Radio. In this disruptive discussion, we address:

    • The remarkable story of the formation of iCancer.org.uk and the Oncolytic Virus Fund
    • An alternative way to make clinical trials more accessible
    • Ethical and moral issues
    • A possible disruptive and sustainable business model for other neglected medicines

    Listen to the show here.

    The next DPharm: Disruptive Innovations to Advance Clinical Trials event takes place September 20-21 in Boston. The DPharm Europe event is scheduled for early February 8-9, 2017 in London. For more information about these events or our Immuno-Oncology events (IO 360° and Rational Combinations 360°), visit www.theconferenceforum.org.

    Guest Host:
    Craig Lipset, MBA, Head of Clinical Innovation, R&D, Pfizer

    Guest:

    Alexander Masters, Author, Campaigner and Co-Founder, iCancer.org.uk

    Producer:
    Valerie Bowling, Executive Director, Conference Forum & Pharma Talk Radio

    Telegraph Article Referenced by Craig During the Program: It’s time to sell tickets for places on life-saving medical trials
    http://www.telegraph.co.uk/science/2016/04/05/its-time-to-sell-tickets-for-places-on-life-saving-medical-trial/

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  • March 30, 2016

  • Carl June, MD, Immuno-Oncology Pioneer Speaks with Valerie Bowling at IO360

    Conference Forum Executive Director, Valerie Bowling sat down with Immuno-Oncology pioneer, Dr Carl June, University of Pennsylvania at the IO360° conference. They covered a range of topics from how Dr June got involved in immuno-oncology when most scientists and oncologists did not focus on the space to current challenges and progress. Watch the interview below. […]

    Conference Forum Executive Director, Valerie Bowling sat down with Immuno-Oncology pioneer, Dr Carl June, University of Pennsylvania at the IO360° conference. They covered a range of topics from how Dr June got involved in immuno-oncology when most scientists and oncologists did not focus on the space to current challenges and progress. Watch the interview below.

    Dr June was one of the keynotes at the  IO360° conference where he gave an update on hematologic malignancies. For more information about the IO360° conference that was presented in February 2016, please click here.

    Carl June, MD, Director, Translational Research Program, Professor of Pathology and Laboratory Medicine, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania

    WhiteheadsDr Carl June with his first IO pediatric patient, Emily Whitehead and her parents Kari and Tom Whitehead

    The next scheduled conference in the Imunno-Oncology space is Rational Combinations 360° which will take place June 23-24,2016 in New York City.

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  • March 20, 2016

  • Mark Simon, Torreya Partners Discusses Business Aspects of Immuno-Oncology with Valerie Bowling, Conference Forum

    Valerie Bowling, Conference Forum sat down with Mark Simon to discuss the business aspects of Immuno-Oncology at the IO360° conference. Mark gives insights into the challenges of intellectual capital vs financial capital, prioritizing combinations, consolidation in the industry, the future of vaccines and more. Watch the full interview below. Mark Simon moderated our “sensational seven” […]

    Valerie Bowling, Conference Forum sat down with Mark Simon to discuss the business aspects of Immuno-Oncology at the IO360° conference. Mark gives insights into the challenges of intellectual capital vs financial capital, prioritizing combinations, consolidation in the industry, the future of vaccines and more.

    Watch the full interview below.

    Mark Simon moderated our “sensational seven” panel dedicated to business aspects of immuno-oncology at the IO360° conference, which took place in February 2016 in NYC. For more information about the IO360° conference, please click here.

     

    The next scheduled conference in the Imunno-Oncology space is Rational Combinations 360° which will take place June 23-24,2016 in New York City.

     

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  • March 15, 2016

  • New Rational Combinations for Immuno-Oncology Conference Announced for NYC Addressing Novel Trial Designs and Business Development Strategies

    The Conference Forum announced today the launch of Rational Combinations 360°, the first program to combine novel trial designs, business development and scientific data for immuno-oncology combinations. Scheduled for June 23-24, 2016 in NYC, Dr Roy Baynes, SVP, Global Clinical Development, Merck Research Labs and clinical section chair opens the program with the Evolving Landscape […]

    The Conference Forum announced today the launch of Rational Combinations 360°, the first program to combine novel trial designs, business development and scientific data for immuno-oncology combinations. Scheduled for June 23-24, 2016 in NYC, Dr Roy Baynes, SVP, Global Clinical Development, Merck Research Labs and clinical section chair opens the program with the Evolving Landscape of Combination Therapies on an Immuno-Oncology Backbone. Following Dr Baynes’ talk, the program will delve into the clinical section that discusses current combinations in the clinic, explores strategies for accelerating approvals and features case studies on novel combinations and trial designs. The program will also take a deeper look into the business aspects, identifying partnership strategies, reimbursement and investment opportunities along with exploring the scientific data that are driving immuno-oncology combinations.

    “There are potentially endless combinations and we felt an obligation to present a conference dedicated to understanding how to best prioritize immuno-oncology combinations,” said Kate Woda, Conference Director for the Rational Combinations 360° program.

    “The breadth of what we have is enormous and there is a lot of opportunity rising from it,” said Dr Axel Hoos, SVP, Operations R&D of GlaxoSmithKline and lead advisor of the program. “What it [combinations] also does is brings complexity. There are business complexities coming from the speed and collaboration that is required in order to bring assets together.”

    The Rational Combinations 360° program is developed in partnership with industry, academia, the investment community, government and providers to enable attendees to gain a 360-degree perspective. This includes creating novel trial designs, investigating scientific data and approaches to combination immunotherapies and how to capitalize on market opportunities that will ultimately help revolutionize the way cancer is treated.

    The speaking faculty at Rational Combinations 360° includes (as of 3/10/16):

    Robert Andtbacka, MD,CM, FACS FRCSC, Associate Professor, Surgical Oncology, Department of Surgery / Co-Director Melanoma Program / Co-Director Melanoma Clinical Research Program, University of Utah / Huntsman Cancer Institute
    Roy Baynes, MD, PhD, SVP, Global Clinical Development, Merck Research Labs
    Omid Hamid, MD, Chief, Translational Research and Immunotherapy / Director, Melanoma Therapeutics, The Angeles Clinic and Research Institute
    Priti Hegde, PhD, Anti-angiogenesis and Cancer Immunotherapy Franchises Biomarker Lead, Oncology Biomarkers, Genentech
    James Hodge, PhD, MBA, Senior Investigator / Head, Recombinant Vaccine Group, Laboratory of Tumor Immunology and Biology, National Cancer Institute
    Axel Hoos, MD, PhD, SVP, Oncology R&D, GlaxoSmithKline
    Robert Iannone, MD, Head of Immuno-Oncology, Global Medicines Development, AstraZeneca
    Laura Johnson, PhD, Director, Solid Tumor Immunotherapy Laboratory, Center for Cellular Immunotherapies / Adj. Asst. Professor, Department of Pathology and Lab Medicine, Perelman School of Medicine, University of Pennsylvania
    Lisa Johnson-Pratt, MD, Head, Pipeline Commercial Strategy, GlaxoSmithKline
    Michael Kalos, PhD, CSO, Cancer Immunobiology, Eli Lilly
    David Kaufman, MD, PhD, Executive Director, Translational Immuno-Oncology Lead, Oncology Clinical Research, Merck Research Labs
    Howard Kaufman, MD, FACS, Chief Surgical Officer, Associate Director / President, Rutgers Cancer Institute of New Jersey / Society for Immunotherapy of Cancer (SITC)
    Ira Klein, MD, MBA, FACP, Senior Director of Healthcare Quality Strategy, Strategic Customer Group, Janssen Pharmaceuticals
    Patricia Marinello, PharmD, Clinical Director, Oncology Clinical Research, Merck Research Labs
    Patrick Mayes, PhD, Director & Early Development Leader, GlaxoSmithKline
    Ian McCaffery, PhD, VP, Translational Sciences, Corvus Pharmaceuticals
    Anna Pavlick, DO, MD, Director, Melanoma Program, NYU Cancer Institute
    Ed Pezalla, MD, MPH, VP, National Medical Director for Pharmacy Policy and Strategy, Aetna
    Zachary Roberts, MD, PhD, Director, Clinical Development, Kite Pharma
    Mark Simon, MBA, Partner, Torreya Partners
    Peter Thompson, MD, FACP, Private Equity Partner, OrbiMed Advisors

    For more information about the Rational Combinations 360° program, visit http://theconferenceforum.org/conferences/rational-combinations-360/overview/

    About The Conference Forum:
    The Conference Forum develops specialized events for professionals in the life science and healthcare industries. We currently offer conferences for R&D leaders, clinical development professionals, biotech executives, VCs, drug delivery specialists and pharma/generic government directors. Our mission is to create the best content, exchange ideas and solutions among peers and provide quality networking for Pharmaceutical and Biotech professionals. http://www.theconferenceforum.org

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  • January 13, 2016

  • A Moonshot to Cure Cancer by Vice President Joe Biden

    We are pleased to hear the announcement that Vice President Biden will lead a new national mission to “moonshot” a cure for cancer. Below is his blog posting on what this will entail. Inspiring a New Generation to Defy the Bounds of Innovation: A Moonshot to Cure Cancer. Three months ago, I called for a […]

    Vice President Joe Biden - Immuno Oncology Blog We are pleased to hear the announcement that Vice President Biden will lead a new national mission to “moonshot” a cure for cancer. Below is his blog posting on what this will entail.

    Inspiring a New Generation to Defy the Bounds of Innovation: A Moonshot to Cure Cancer.

    Three months ago, I called for a “moonshot” to cure cancer.

     

    Tonight, the President tasked me with leading a new, national mission to get this done.

    It’s personal for me. But it’s also personal for nearly every American, and millions of people around the world. We all know someone who has had cancer, or is fighting to beat it. They’re our family, friends, and co-workers.

    If this disease has touched your life, I want to hear your story.

    Today, cancer is the leading cause of death worldwide. And that’s only expected to increase in the coming decades — unless we make more progress today.

    I know we can.

    From my own personal experience, I’ve learned that research and therapies are on the cusp of incredible breakthroughs. Just in the past four years, we’ve seen amazing advancements. And this is an inflection point.

    Over the course of the past few months, I’ve met with nearly 200 of the world’s top cancer physicians, researchers, and philanthropists.

    And the goal of this initiative — this “Moonshot” — is to seize this moment. To accelerate our efforts to progress towards a cure, and to unleash new discoveries and breakthroughs for other deadly diseases.

    The science is ready.

    Several cutting-edge areas of research and care — including cancer immunotherapy, genomics, and combination therapies — could be revolutionary. Innovations in data and technology offer the promise to speed research advances and improve care delivery.

    But the science, data, and research results are trapped in silos, preventing faster progress and greater reach to patients. It’s not just about developing game-changing treatments — it’s about delivering them to those who need them.

    Right now, only 5 percent of cancer patients in the U.S. end up in a clinical trial. Most aren’t given access to their own data. At the same time, community oncologists — who treat more than 75 percent of cancer patients — have more limited access to cutting-edge research and advances.

    So I plan to do two things.

    1.) Increase resources — both private and public — to fight cancer.

    2.) Break down silos and bring all the cancer fighters together — to work together, share information, and end cancer as we know it.

    And the goal of this initiative is simple — to double the rate of progress. To make a decade worth of advances in five years.

    Here’s how we can do it:

    Over the next year, I will lead a dedicated, combined effort by governments, private industry, researchers, physicians, patients, and philanthropies to target investment, coordinate across silos, and increase access to information for everyone in the cancer community.

    Here’s what that means: The Federal government will do everything it possibly can — through funding, targeted incentives, and increased private-sector coordination — to support research and enable progress.

    We’ll encourage leading cancer centers to reach unprecedented levels of cooperation, so we can learn more about this terrible disease and how to stop it in its tracks.

    Data and technology innovators can play a role in revolutionizing how medical and research data is shared and used to reach new breakthroughs.

    We will help the oncology community improve communication with doctors across the United States and around the world, so the same care provided to patients at the world’s best cancer centers is available to everyone who needs it.

    And we will ensure that the patient community is heard — so patients and their families are treated as partners in care, with access to their own data and the opportunity to contribute to research.

    And we’re getting started right away.

    This Friday, I’ll head to the Abramson Cancer Center at the University of Pennsylvania’s Perelman School of Medicine to talk to their physicians and researchers and continue this national dialogue.

    Next week, at the World Economic Forum in Davos, Switzerland, I’ll meet with a group of international experts to discuss the current state of cancer research and treatment, and opportunities to accelerate this fight.

    And later this month, I’ll convene and chair the first of several meetings with cabinet secretaries and heads of relevant agencies to discuss ways to improve Federal investment and support of cancer research and treatment.

    Fifty-five years ago, President John F. Kennedy stood before a joint session of Congress and said, “I believe we should go to the moon.”

    It was a call to humankind.

    And it inspired a generation of Americans — my generation — in pursuit of science and innovation, where they literally pushed the boundaries of what was possible.

    This is our moonshot.

    I know that we can help solidify a genuine global commitment to end cancer as we know it today — and inspire a new generation of scientists to pursue new discoveries and the bounds of human endeavor.

    That is the history of the journey of this country. If there’s one word that defines who we are as Americans, it’s “possibility.” And these are the moments when we show up.

    We must move forward, right now. I know we can.

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  • December 23, 2015

  • Immuno-Oncology Drug Development: Challenges & Next Steps

    PharmaTalk Radio’s Valerie Bowling welcomes Immuno-Oncology 360° Co-Chair James Gulley, MD, PhD, National Cancer Institute as he leads a discussion with fellow Co-Chair, Axel Hoos, MD, PhD, GlaxoSmithKline. Together they discuss what’s currently happening in Immuno-Oncology and its impact on how cancer is being treated. They cover the latest challenges and next steps. More specifically […]

    Axel Hoos, MD, PhD, GlaxoSmithKline speaking at the Inaugural IO360° Conference

    PharmaTalk Radio’s Valerie Bowling welcomes Immuno-Oncology 360° Co-Chair James Gulley, MD, PhD, National Cancer Institute as he leads a discussion with fellow Co-Chair, Axel Hoos, MD, PhD, GlaxoSmithKline. Together they discuss what’s currently happening in Immuno-Oncology and its impact on how cancer is being treated. They cover the latest challenges and next steps. More specifically they address:

    • – Ipilumumab/Nivo/Pembro challenges
    • – What can we learn from the development of sipuleucel-T that may be applicable for other therapeutic vaccines?
    • – Challenges with the following modalities: Checkpoints, Oncolytic Virus’, Adoptive T-Cells, Cancer Vaccines
    • – Blinitumumab
    • – The more interesting agents in late stage development now in immunotherapy and its promise
    • – Immune related adverse events
    • – Adoptive cellular therapies, what is the most promising?
    • – Will IO become backbone therapies for cancer?
    • – What’s the next set of assets that are going to come out?-
    • – What can we expect within the next year or two?

    Guests:

    James Gulley, MD, PhD
    Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute

    Axel Hoos, MD, PhD, VP, Oncology R&D, GlaxoSmithKline

    Listen to the show here: http://www.blogtalkradio.com/pharmatalk/2015/12/21/immuno-oncology-drug-development-challenges-next-stepshttp://www.blogtalkradio.com/pharmatalk/2015/12/21/immuno-oncology-drug-development-challenges-next-steps

    The Immuno-Oncology 360° conference is scheduled for February 2-3, 2016  at the New York Academy of Medicine in NYC. For more information, please visit www.theconferenceforum.org.

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  • November 12, 2015

  • How Patient Research Changed the Way We Present Clinical Trial Conferences

    Valerie Bowling, Executive Director of The Conference Forum discusses how her research with patients changed the way she looks at and presents all clinical trials conferences. ____________________________________________________ Five years ago, Greg Simon, who was the Head of Policy at Pfizer at the time and is now CEO of Poliwogg, asked our DPharm audience when was […]

    GregSimon-1

    Greg Simon, CEO, Poliwogg challenging the first Dpharm audience.

    Valerie Bowling, Executive Director of The Conference Forum discusses how her research with patients changed the way she looks at and presents all clinical trials conferences.
    ____________________________________________________
    Five years ago, Greg Simon, who was the Head of Policy at Pfizer at the time and is now CEO of Poliwogg, asked our DPharm audience when was the last time you thanked your patients for being in a clinical trial. No one raised their hand. My immediate thought was that there was an urgent need for a conference on customer service for patients in clinical trials.

    JeriC

    Graphic illustration of Jeri Burtchell, Founder of PatientsinResearch.org and our first patient speaker!

    I began to research the topic within the pharmaceutical industry and received enlightening feedback: we can’t look at patients as customers, we can’t directly communicate with patients, there are privacy laws, we don’t directly work with patients, and more. I learned that often people who have direct contact with patients are not necessarily trained to work with patients to empathize with their condition and life style.

     

    What To Do?
    I knew that something drastically had to change and a paradigm shift in how the industry views and works with patients was paramount. I also realized that as a researcher, I needed to start with myself. I needed to make that paradigm shift in who and how I do research. With that, five years ago, for the first time I began to research directly with patients. Getting their feedback changed the way I produce conferences and, more importantly, how I can potentially affect positive change for patients through my conferences.

     

    What Patient Research Taught Me
    Patients taught me empathy with their disease, but also with their lifestyle and their struggles in finding and experiencing a clinical trial. In particular, I learned the vital need to cover sessions that:

    1. Understand and incorporate the patient’s voice in designing clinical trials and developing a clinical endpoint

    2. Vastly improve the patient’s entire experience in a clinical trial

    Patient Advocate Speakers

     

    Dpharm US, Dpharm Europe, Patients as Partners, and Immuno-Oncology 360 would not be possible without the many supportive patients and industry executives who helped my team and I gain a better understanding of the science of patient-centricity in clinical research. Thank you!

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  • November 10, 2015

  • Safety Elements of Cancer Immunotherapies Featured on Pharma Talk Radio

    In this episode of Pharma Talk Radio, we feature medical oncologist, Dr Anna Pavlick, Director of the Melanoma Program at the NYU Cancer Institute on Safety Elements of Cancer Immunotherapies. Dr Pavlick originally gave this presentation in June 2015 at the IO360 conference. We are pleased to bring this session to the public to help […]

    IOsqIn this episode of Pharma Talk Radio, we feature medical oncologist, Dr Anna Pavlick, Director of the Melanoma Program at the NYU Cancer Institute on Safety Elements of Cancer Immunotherapies. Dr Pavlick originally gave this presentation in June 2015 at the IO360 conference. We are pleased to bring this session to the public to help researchers, doctors, patients and care givers with some information on immune related adverse affects of immuno therapy.

    Listen to the episode here.

    The next IO360 conference will take place February 2-3, 2016 at the New York Academy of Medicine in NYC. For more information, visit is www.theconferenceforum.org

     

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