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Event Blog


  • June 12, 2017

  • CMO Speaker, Dr David Schenkein Writes About Bringing Clinical Trials to Patients

    Recently, the Conference Forum presented Clinical Research as a Care Option, which was chaired by Katherine Vandebelt, Formerly, Global Head, Clinical Innovation, Eli Lilly and Jeff James, CEO, Wilmington Health. So we were thrilled to see that Dr David Schenkein, CEO, Agios Pharma, who keynoted in 2015 at the Chief Medical Officer Summit recently published […]

    Recently, the Conference Forum presented Clinical Research as a Care Option, which was chaired by Katherine Vandebelt, Formerly, Global Head, Clinical Innovation, Eli Lilly and Jeff James, CEO, Wilmington Health. So we were thrilled to see that Dr David Schenkein, CEO, Agios Pharma, who keynoted in 2015 at the Chief Medical Officer Summit recently published on Linkedin his view on the topic of bringing trials closer to patients. See below:

    To Get Patients into Clinical Trials, We Need to Get Clinical Trials to Patients

    The other day, an Agios employee, Holly, took an Uber to make a midday meeting. The driver mentioned that he was from out of town and welcomed any shortcuts to get to their destination. She asked where he was from, and during her brief ride, she learned that he drove an elderly woman from New Hampshire to Boston twice a week so she could participate in a clinical trial for a new cancer treatment at Mass General Hospital. It was a two-hour trip each way, and the treatment took four hours, so he filled that time giving rides close to the hospital.

    For the rest of the day, this woman’s story clung with Holly, who found herself wondering if she had friends or family with her at the hospital, what investigational medicine she was taking and if it made her sick on the long drive home. When Holly shared her experience with me, despite the pangs of sympathy, I found solace in the fact that this woman lives within driving distance of one of the leading cancer centers in the U.S., giving her access to the most advanced cancer care and potentially lifesaving clinical trials.

    Though the time commitment is significant and the cost of transportation is likely high, her situation is a stark contrast to the estimated 85 percent of cancer patients around the country who receive care in a community setting, where clinical trials are less likely to be offered. I’ve written before about my own experiences with the harsh emotional reality of participating in studies of new treatments, but low enrollment can also be attributed to geography. The truth is, most patients don’t live near a hospital or academic center that offers clinical trials, which can often be life-saving options for people who have already received approved therapies. Recent studies suggest that outcomes can vary widely depending on where patients receive care.

    There are many factors driving the inequities between cancer care and clinical trial access at academic health centers vs. community hospitals – including infrastructure costs, required FDA guidelines for clinical trials, necessary staff support, etc. Bridging that divide is something a colleague and friend of mine, Keith Flaherty, M.D., has spent much of his career trying to address. Dr. Flaherty is the Director of Developmental Therapeutics Clinical Research at the Massachusetts General Hospital Cancer Center and professor of medicine at Harvard Medical School. He also serves as the principal investigator for a clinical trial called NCI-MATCH, which is a study launched in August 2015 that analyzes patients’ tumors to determine whether they contain gene abnormalities for which a targeted drug exists and assigns treatment based on the abnormality. This study brings genomic testing and access to 30 targeted therapies to 6,000 patients at hundreds of hospitals and more than 1000 healthcare locations across the U.S. at no cost to the patient or treatment center.

    I spoke with Dr. Flaherty a few weeks ago to get his perspective on NCI-MATCH and the future of clinical trial access outside of big research centers. Here’s what he had to say.

    David:
    What does the future look like for clinical trials over the next few years?

    Dr. Flaherty:
    It’s suffice to say there’s a big gap and a big unmet need, and we must figure out how to move forward given that NCI-MATCH is about to end and a large clinical investigation community is going to lose access to genetic testing and clinical trial options. I recently co-founded a company called Strata Oncology, which aims to potentially perform an NCI-MATCH-like function. We’re focusing on driving clinical trial participation in regional networks outside of academic medical centers, which allows patients to stay in their community and creates a much more efficient process for matching them to clinical trials of targeted therapies.

    David:
    Certainly this addresses one of the bigger issues of identifying patients for biomarker-driven studies, which is critical. How has NCI-MATCH created the infrastructure in smaller community settings to make it easier to put a patient on a study and/or get a sponsor to use a small hospital that may only bring in one or two patients?

    Dr. Flaherty:
    Providing small hospitals with the genomic tests to identify biomarkers is pretty straightforward and a good place to start. Creating the necessary clinical trial infrastructure piece is doable. It just requires stripping out some of the bells and whistles. Part of this is reducing the amount of data that these hospitals are required to collect for trials. With fewer resources, community centers can only do so much, so studies have to be structured in a way that allows them to capture registration-quality data, which isn’t feasible if they’re being asked for 1,000 data points per patient.

    David:
    As you look ahead of the next 5 years, in terms of a change to the model and how we conduct clinical trials, do you believe we’ll see more biomarker-driven trials being offered in communities?

    Dr. Flaherty:
    I do believe that some version of democratizing clinical trial access will happen. I think it has to start with a coalition of sponsors who are looking for sparsely distributed, genetically defined patients in order to make it reasonably efficient. Together, we need to figure out a geographically smart way to get these clinical trials to where patients are, and streamline what we’re asking for in these community settings. This could easily double the percentage of patients who enroll in trials nationwide.

    For the benefit of the millions of people with cancer who are or will be treated in a community hospital, I hope Dr. Flaherty is right.

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  • May 1, 2017

  • David Schenkein, MD, Previous CMO Summit Keynote, on Patient Access to Data

    At the Conference Forum’s 2015 Chief Medical Officer’s Summit, David Schenkein, MD, CEO at Agios Pharmaceuticals, gave a personal keynote sharing his journey as a Physician CEO. In this recording of the session, listeners can gain an insight into Dr Schenkein’s views on leadership in running a biotech company. Recently, Dr Schenkein published an article on “The […]

    At the Conference Forum’s 2015 Chief Medical Officer’s Summit, David Schenkein, MD, CEO at Agios Pharmaceuticals, gave a personal keynote sharing his journey as a Physician CEO. In this recording of the session, listeners can gain an insight into Dr Schenkein’s views on leadership in running a biotech company.

    Recently, Dr Schenkein published an article on “The Promise and Problems of Patient Access to Medical Records,” wherein he discusses the inherent power of access to information and data.

    “Armed with data, patients can play an active role in their healthcare, better understand treatment options and ask their physicians more informed questions. Outside of the hospital, giving patients the ability to share their data with researchers can have significant benefits for understanding diseases and advancing new therapies. Imagine the possibilities if researchers could aggregate molecular and clinical data from large numbers of patients with the same disease. This has the potential to facilitate novel target discovery in ways not possible now.”

    Read the entire article on LinkedIn.

    Learn more about the 5th annual CMO Summit, May 10-11, 2017, in Boston.

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  • March 21, 2017

  • 5th Annual Chief Medical Officer Summit Announced by The Conference Forum

    Peer-to-peer gathering in Boston, MA, for CMOs and investors in emerging biotechs confirms program leaders from Molecular Templates, MassBio, Massachusetts Life Sciences Center, Lysosomal Therapeutics, Flagship Pioneering, SR One and HIG Capital. The Conference Forum has announced the launch of the 5th Annual Chief Medical Officer Summit (CMO Summit) to be held on May 10-11, 2017, at […]

    Peer-to-peer gathering in Boston, MA, for CMOs and investors in emerging biotechs confirms program leaders from Molecular Templates, MassBio, Massachusetts Life Sciences Center, Lysosomal Therapeutics, Flagship Pioneering, SR One and HIG Capital.

    The Conference Forum has announced the launch of the 5th Annual Chief Medical Officer Summit (CMO Summit) to be held on May 10-11, 2017, at the Colonnade Hotel in Boston, MA. The CMO Summit is the only emerging biotech event in the country specifically for Chief Medical Officer peer-to-peer learning, benchmarking and support.

    “The Chief Medical Officer faces a unique set of challenges at small and emerging biotechs, often with limited resources,” explains Jennifer Moran, Producer at the Conference Forum. “The CMO Summit addresses the particular struggles of this role–which can be an isolated one, with all the responsibility for driving clinical development and CRO management while meeting the needs of investors. We recognized early-on the need for an event that brought CMOs together to start building a network of support.”

    Program leadership for 2017 includes Chair Dr David Valacer, CMO at Molecular Templates; Bob Coughlin, President and CEO at MassBio; Travis McCready, CEO at Massachusetts Life Sciences Center; Kees Been, President and CEO at Lysosomal Therapeutics; Dr Michael Rosenblatt, CMO at Flagship Pioneering; Ken Getz, MBA, Tufts CSDD; Vikas Goyal, Senior Associate at SR One and Alex Zisson, Managing Director at H.I.G. Capital.

    2017 Keynotes Announced

    2017 Keynote, Dr Rosenblatt, a former Merck CMO, will share his observations on career path decision-making and will compare the experiences and lessons learned from being the CMO on the drug development versus the biotech investor side of the industry.

    Kees Been is also keynoting with an address on the Critical Stages in the Growth of a Biotech Start Up. As the current CEO at Lysosomal Therapeutics and the former CEO of EnVivo, Mr Been offers valuable insights into what it takes to meaningfully advance through the stages of the biotech lifecycle.

    Returning by popular demand, Ken Getz will present an annual keynote on the Impact of M&A on Drug Development Performance and Collaborations.

    Political Impact on Biotech Address

    Bob Coughlin and Travis McCready will deliver the Impact of Current Politics and Policy on Biotech R&D. As the leaders of two organizations that advocate for the growth and success of biotech, they are up-to-date and mindful of outside influences on the sector. They will strategize and offer advice on: Whether the 21st Century Cures Act is more hype than reality? What does the change in administration mean for biotech? What should CMOs be thinking about and acting on in 2017?

    About the Chief Medical Officer Summit:

    The CMO Summit is dedicated to accomplishing two goals:

    1. To bring together CMO and R&D leadership from emerging biotechs to address the unique challenges in directing all R&D functions with limited resources, while raising capital and strategizing for appropriate exits.

    2. To create a network of CMOs and R&D Leadership from small to mid-size life science companies to benchmark, share ideas, solutions and support.

    Learn more about the CMO Summit. Register here.

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  • March 16, 2017

  • 5 Features of the 5th Annual Chief Medical Officer Summit

    The Chief Medical Officer Summit is the distinguished annual gathering for CMOs and investors in emerging biotechs to navigate the advancement of R&D. 1. New To The Program a. Face-to-Face Time with Board Members b. The Impact of Pricing Trends c. R&D Efforts that Translate to Approvals d. Strategizing for Global Drug Development e. Guidance […]

    The Chief Medical Officer Summit is the distinguished annual gathering for CMOs and investors in emerging biotechs to navigate the advancement of R&D.

    1. 1. New To The Program
      a. Face-to-Face Time with Board Members
      b. The Impact of Pricing Trends
      c. R&D Efforts that Translate to Approvals
      d. Strategizing for Global Drug Development
      e. Guidance on Navigating JP Morgan
    2. Learnings From A Life Sciences Leader
      Industry veteran, Dr Michael Rosenblatt, shares insights and lessons learned on a career that has included titles such as scientist, academic, hospital executive, large pharma R&D leader and most recently CMO of a biotech venture capital firm. What factors affected his decision making? What advice can he offer? The do’s and don’t’s of a life sciences leader.
    3. Annual Keynote Address: Ken Getz, Tufts CSDD
      Annual Keynote Address presented by Ken Getz, Tufts CSDD, will discuss the Impact of M&A on Drug Development Performance and Collaboration.
    4. Political Update Impacting Biotech
      Industry leaders Travis McCready (MLSC) and Bob Coughlin (MassBio), highlight Federal and State Leadership Supporting R&D, and discuss forging a path forward in the current political climate. They will strategize and advise CMOs on how to approach potential policy changes in the coming cycle and knowing their support network.
    5. Networking & Peer-To-Peer Learning
      The conference provides a unique setting for peer-to-peer networking with primarily biotech CMOs where the group benchmarks ideas and shares best practices. This is an R&D leadership event for heads of R&D in the emerging biotech space responsible for driving all drug development functions, while providing support to the CEO. Networking includes breakfast, luncheons, reception and breaks. A partnering tool will be provided to facilitate easier on-site meeting planning.

    Claim your seat for #CMOBoston before the Early Bird pricing expires.

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  • April 12, 2016

  • Hear Agios CEO, Dr David Schenkein’s Keynote from the 2015 CMO East Summit

    At the 2015 Chief Medical Officer Summit in Boston, David Schenkein, MD, CEO, Agios provided a warm and personal keynote sharing his journey as a Physician CEO. In this recording of the session, gain an insight into Dr. David Schenkein’s journey from physician to CEO of a biopharmaceutical company leading the way in the field […]

    At the 2015 Chief Medical Officer Summit in Boston, David Schenkein, MD, CEO, Agios provided a warm and personal keynote sharing his journey as a Physician CEO. In this recording of the session, gain an insight into Dr. David Schenkein’s journey from physician to CEO of a biopharmaceutical company leading the way in the field of cancer metabolism. More specifically:

    • The journey
    • The people and mentor ships
    • Prioritizing resources
    • Successes and failures
    • Overcoming hurdles
    • Strategic partnerships
    • Business planning

    Listen to Dr Schenkein’s Session Here: http://www.blogtalkradio.com/pharmatalk/2015/09/21/the-journey-of-a-physician-ceo-with-david-schenkein-md-ceo-agios


    About David Schenkein, MD, CEO, Agios
    Dr Schenkein led the development of several first-in-class cancer therapeutics through all stages of development including the submission and approval of numerous NDAs, sBLAs and INDs. Dr. Schenkein served as Senior Vice President, Clinical Hematology/Oncology at Genentech with responsibility for leading the medical and scientific strategies for the Development BioOncology portfolio, as well as overseeing the BioOncology Clinical Science and Medical Science Liaison functions with a staff of more than 130 people. He is currently an adjunct Professor of Medicine at the Stanford University Cancer Center. Before his tenure at Genentech, he served as Senior Vice President of Clinical Research at Millennium Pharmaceuticals. While there, he led the clinical development of the drug candidate, Velcade® (bortezomib), which was approved during his tenure and has since become a blockbuster cancer therapy, significantly helping the lives of cancer patients. Prior to Millennium he was Director of the Cancer Center and Lymphoma Service at Tufts Medical Center.

    The 2016 event is this May 11-12 in Boston. Learn more here.

    Read More

  • April 12, 2016

  • Conference Forum Speaker, Ken Getz quoted in WSJ on the Challenges of Patient Recruitment

    Conference Forum Speaker, Ken Getz, Tufts CSDD quoted in the Wall Street Journal article on the challenges of patient recruitment and the longstanding issue of excessively expensive clinical trials. From the WSJ: Researchers conduct clinical trials to test new drugs and medical treatments, but the rate at which they are able to recruit and retain […]

    Conference Forum Speaker, Ken Getz, Tufts CSDD quoted in the Wall Street Journal article on the challenges of patient recruitment and the longstanding issue of excessively expensive clinical trials.

    Jamie Macdonald and Kenneth Getz at Patients

    Jamie Macdonald, INC Research (Left) with Kenneth Getz, Tufts CSDD (Right) at the Patients as Partners in Clinical Research Conference

    From the WSJ:

    Researchers conduct clinical trials to test new drugs and medical treatments, but the rate at which they are able to recruit and retain patients is at an all-time low.

    Studies indicate that fewer than 10% of Americans participate in clinical trials, and only 3% to 5% of patients sign up for trials of new cancer therapies. Patients often aren’t aware that trials are an option, and their doctors may not suggest them.

    Some patients mistrust the research process and fear being a guinea pig, but for patients who do want to volunteer, complicated protocols and eligibility requirements can be discouraging. About 40% of clinical trials don’t recruit enough patients to meet their goals.

    “The challenges of identifying, recruiting and retaining volunteers for clinical trials drive up the direct and indirect costs of drug development and significantly delay the introduction of new medical interventions,” says Ken Getz, an associate professor at Tufts University School of Medicine’s Center for the Study of Drug Development and board chair of the nonprofit Center for Information & Study on Clinical Research Participation.

    Read the rest of the article here: http://www.wsj.com/articles/clinical-trials-need-more-subjects-1460407076

    Ken will be speaking at the upcoming Chef Medical Officer Summit East (May 11-12, 2016, Boston).

    Read More

  • March 27, 2016

  • Alnylam Pharmaceuticals’ Akshay Vaishnaw, MD, PhD to Deliver Keynote Address at Boston’s Chief Medical Officer Summit

    Following numerous recommendations, we are delighted to announce: Akshay Vaishnaw, MD, PhD, EVP of R&D, and CMO, Alnylam Pharmaceuticals has been confirmed as a keynote speaker for the 4th Annual Chief Medical Officer Summit on May 11-12th in Boston, MA. Dr Vaishnaw will address the “Challenges and Opportunities in Pursuing a New Therapeutic Modality from […]

    Following numerous recommendations, we are delighted to announce: Akshay Vaishnaw, MD, PhD, EVP of R&D, and CMO, Alnylam Pharmaceuticals has been confirmed as a keynote speaker for the 4th Annual Chief Medical Officer Summit on May 11-12th in Boston, MA.

    Dr Vaishnaw will address the “Challenges and Opportunities in Pursuing a New Therapeutic Modality from its Inception”. As the CMO at a leading RNAi therapeutics company Dr Vaishnaw is perfectly positioned to offer valuable insights into what to expect from undertaking a new therapeutic modality.

    About Akshay Vaishnaw, MD, PhD
    Akshay VaishnawDr Akshay Vaishnaw joined Alnylam in 2006, coming from Biogen, Inc (now Biogen Idec Inc), where he was most recently Senior Director, Translational Medicine. In his seven years at Biogen he was involved in many aspects of clinical research and business development, and led the effort for the approval of alefacept (Amevive™) for psoriasis. Akshay received his MD from the University of Wales College of Medicine, UK, with Distinctions in Pathology and Medicine, and his PhD from the University of London, UK, in Molecular Immunology. He is a Member of the Royal College of Physicians, UK. Akshay is a member of the Scientific Advisory Board of Scholar Rock, and a member of the Board of Directors for Visterra, Inc. In addition, he has published papers in leading scientific journals and authored a number of textbook chapters relating to autoimmune disease.

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  • March 21, 2016

  • The New England Journal of Medicine’s Editor-in-Chief, Dr. Jeffrey Drazen, Announced as Keynote Speaker at CMO East 2016

    We are delighted to announce that the May 11th Keynote Session will be delivered by Jeffrey Drazen, MD, Editor-in-Chief, The New England Journal of Medicine. The New England Journal of Medicine is one of the most prestigious medical journals in the world, and Dr. Drazen has been at the helm for the past 15 years. […]

    We are delighted to announce that the May 11th Keynote Session will be delivered by Jeffrey Drazen, MD, Editor-in-Chief, The New England Journal of Medicine.

    New-England-J-M-logo1The New England Journal of Medicine is one of the most prestigious medical journals in the world, and Dr. Drazen has been at the helm for the past 15 years. We are honored to welcome him to the program to address: The Play of Chance: The Rise of Evidence, using tuberculosis as the example of improving evidence-based understanding and shares his point of view on academic-industry relationships.

    The Chief Medical Officer Summit will be held at the Colonnade Hotel on May 11-12, 2016 in Boston, MA.

    About Jeffrey Drazen, MD
    ©2011 Jon Chomitz Photography 3 Prescott street, Somerville, MA 02143 www.chomitz.com jon@chomitz.com 617.625.6789Jeffrey M. Drazen, MD, joined the New England Journal of Medicine (NEJM) as editor-in-chief in July of 2000. At NEJM, Dr. Drazen’s responsibilities include oversight of all editorial content and policies. His editorial background includes service as an associate editor or editorial board member for the Journal of Clinical Investigation, the American Journal of Respiratory Cell and Molecular Biology, and the American Journal of Medicine.

    A specialist in pulmonology, Dr. Drazen maintains an active research program. Dr. Drazen has published more than 300 articles on topics such as lung physiology and the mechanisms involved in asthma. In 1999, he delivered the Amberson Lecture, the major research address at the annual meeting of the American Thoracic Society. In 2000, he received the Chadwick Medal from the Massachusetts Thoracic Society for his contributions to the study of lung disease.

    Dr. Drazen is the Distinguished Parker B. Francis Professor of Medicine at Harvard Medical School, professor of physiology at the Harvard School of Public Health, and a senior physician at Brigham and Women’s Hospital. In 2003, he was elected as a member of the Institute of Medicine. Dr. Drazen has served on numerous committees for the National Institutes of Health, including the Respiratory and Applied Physiology Study Section; the Lung Biology and Pathology Study Section; the Pulmonary Disease Advisory Council; the National Heart, Lung, and Blood Institute Advisory Council; the Public Access Working Group; and the National Heart, Lung, and Blood Institute’s Division of Lung Disease Executive Planning Committee. He has also served on the Veterans’ Administration National Research Advisory Committee. He currently serves on the Global Initiative for Asthma Science Committee, the World Health Organization’s Scientific Advisory Group on Clinical Trials Registration, and co-chairs the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation.

    Dr. Drazen earned his bachelor’s degree and graduated summa cum laude from Tufts University. He received his medical degree from Harvard Medical School and completed his internship and residency at Peter Bent Brigham Hospital in Boston. Dr. Drazen has received honorary degrees from the University of Ferrara, Italy, and the National and Kapodistrian University of Athens, Greece.
    A native of Missouri, Dr. Drazen lives with his wife in Winchester, Massachusetts. They are the parents of two grown sons.

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  • March 15, 2016

  • CMO Summit Speaker, Nancy Simonian, MD, Syros Pharmaceuticals Featured in Boston Globe

    In Robert Weisman’s Boston Globe interview “Five Things You Should Know About Nancy Simonian,” Dr Simonian describes drug development as “a team sport” and discusses the importance of working well with team around you and how to get the most out of what you have. We couldn’t agree more. Dr. Nancy Simonian joins the Chief […]

    Nancy Simonian1In Robert Weisman’s Boston Globe interview “Five Things You Should Know About Nancy Simonian,” Dr Simonian describes drug development as “a team sport” and discusses the importance of working well with team around you and how to get the most out of what you have.

    We couldn’t agree more. Dr. Nancy Simonian joins the Chief Medical Officer Summit in May to discuss her journey from CMO to CEO. The Summit addresses the challenges faced by CMO’s who find themselves in the unique role with limited resources at small and/or emerging biotechs. Learn more about the summit here.

    From the Boston Globe:

    Dr. Nancy A. Simonian took the helm at Syros Pharmaceuticals Inc. in Watertown in 2013, the latest step on a path that has taken her from practicing medicine at Massachusetts General Hospital to the executive ranks of biotechs Biogen Inc. and Millennium Pharmaceuticals Inc. Two-year-old Syros was founded by Flagship Ventures and Arch Venture Partners based on science from the Dana-Farber Cancer Institute and the Massachusetts Institute of Technology. Simonian, 54, is working with her team to develop drugs that regulate genes that cause cancer and other diseases. The Waukegan, Ill., native talked about her entrepreneurial venture and other pursuits.”

    Read the rest of the article here.
    Read more on the Chief Medical Officer Summit here.

    Read More

  • March 14, 2016

  • The Chief Medical Officer Summit 2016 Announces 2 New Co-Chairs

    We are delighted to announce women leadership at the 4th Annual Chief Medical Officer Summit. ShiYin Foo, MD, PhD, CMO, Cardioxyl and Catherine Wheeler, MD, CMO, SVP Clinical Development, Acetylon Pharmaceuticals are confirmed to co-chair the event on May 11-12th in Boston, MA. Drs Foo and Wheeler will provide valuable insight and leadership during the […]

    We are delighted to announce women leadership at the 4th Annual Chief Medical Officer Summit. ShiYin Foo, MD, PhD, CMO, Cardioxyl and Catherine Wheeler, MD, CMO, SVP Clinical Development, Acetylon Pharmaceuticals are confirmed to co-chair the event on May 11-12th in Boston, MA. Drs Foo and Wheeler will provide valuable insight and leadership during the course of the Summit, as we tackle the unique challenges faced by CMOs of emerging biotechs. We are honored to have them.

    The Chief Medical Officer Summit will be held at the Colonnade Hotel on May 11-12, 2016 in Boston, MA.

    About ShiYin Foo, MD, PhD

    shi yin foo-colorDr Foo was appointed Chief Medical Officer in 2013. She joins Cardioxyl from Novartis, where she was responsible for the establishment and execution of multiple novel programs in heart failure and the cardiorenal space, and is a named inventor on several associated patents applications. She has served as clinical and translational medicine reviewer for numerous studies spanning the full spectrum of Phase I to Phase III clinical trials. Through her experience in both industry and practice, Dr Foo has developed deep expertise in both acute and chronic heart failure. Dr Foo previously was an Assistant Physician in Medicine, Division of Cardiology at Massachusetts General Hospital in Boston, where she served as an attending physician in heart failure/transplantation. Her research focused on the effects of diet on endothelial stem cells and on novel biomarkers to identify these stem cells in vivo. She received the GSK Cardiovascular Foundation Young Investigator Award for this work. Dr Foo obtained her MD and PhD in Immunology at Stanford University and her MMSc in the Clinical Investigator Training Program at Harvard Medical School. She also holds a BA in Molecular, Cellular and Developmental Biology from Princeton University. Dr Foo was a clinical fellow in Cardiology with subspecialty training in Heart Failure/Transplantation at Massachusetts General Hospital, where she was a winner of the Roman DeSanctis Clinical Scholar Award for clinical expertise. She is board-certified in Internal Medicine and in Cardiovascular Medicine.

    About Catherine Wheeler, MD

    Catherine Wheeler-colorDr Catherine Wheeler joined Acetylon in November 2010 from Roche Pharmaceuticals, Inc, (Hoffmann-La Roche) where she was Site Head, Translational Medicine, Oncology and served earlier as Head, Signal Transduction I and Ad Interim Head, Roche Oncology Clinical Development. Prior to Roche, Dr Wheeler was with AstraZeneca where she served as Vice President, Strategic Planning and Business Development, Oncology and Infection and previously in clinical development as Global Product Director Product Medical Director for the Emerging Product Team. She held multiple positions at PAREXEL International Corporation including Executive Director, Oncology Therapeutic Area Group and Medical Director. She was Clinical Director of the Bone Marrow Transplant Program at the Beth Israel Hospital in Boston, Massachusetts and was an Attending Physician and a Fellow at Beth Israel and the Dana-Farber Cancer Institute. Dr Wheeler is a graduate of Bennington College and received her MD degree with honors from the Abraham Lincoln School of Medicine at the University of Illinois. She is Board certified in internal medicine, hematology and medical oncology, was an American Cancer Society Clinical Fellowship, and serves as Clinical Associate Professor of Medicine at Harvard Medical School.

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  • October 15, 2015

  • Hear Agios CEO, Dr David Schenkein’s Keynote from the CMO East Summit

    At the 2015 Conference Forum’s Chief Medical Officer Summit in Boston, David Schenkein, MD, CEO, Agios provided a warm and personal keynote sharing his journey as a Physician CEO. In this recording of the session, gain an insight into Dr. David Schenkein’s journey from physician to CEO of a biopharmaceutical company leading the way in […]

    At the 2015 Conference Forum’s Chief Medical Officer Summit in Boston, David Schenkein, MD, CEO, Agios provided a warm and personal keynote sharing his journey as a Physician CEO. In this recording of the session, gain an insight into Dr. David Schenkein’s journey from physician to CEO of a biopharmaceutical company leading the way in the field of cancer metabolism. More specifically:

    • – The journey
    • – The people and mentor ships
    • – Prioritizing resources
    • – Successes and failures
    • – Overcoming hurdles
    • – Strategic partnerships
    • – Business planning

    Listen to Dr Schenkein’s Session Here: http://www.blogtalkradio.com/pharmatalk/2015/09/21/the-journey-of-a-physician-ceo-with-david-schenkein-md-ceo-agios


    About David Schenkein, MD, CEO, Agios
    Dr Schenkein led the development of several first-in-class cancer therapeutics through all stages of development including the submission and approval of numerous NDAs, sBLAs and INDs. Dr. Schenkein served as Senior Vice President, Clinical Hematology/Oncology at Genentech with responsibility for leading the medical and scientific strategies for the Development BioOncology portfolio, as well as overseeing the BioOncology Clinical Science and Medical Science Liaison functions with a staff of more than 130 people. He is currently an adjunct Professor of Medicine at the Stanford University Cancer Center. Before his tenure at Genentech, he served as Senior Vice President of Clinical Research at Millennium Pharmaceuticals. While there, he led the clinical development of the drug candidate, Velcade® (bortezomib), which was approved during his tenure and has since become a blockbuster cancer therapy, significantly helping the lives of cancer patients. Prior to Millennium he was Director of the Cancer Center and Lymphoma Service at Tufts Medical Center.

    The West Coast Chief Medical Officer Summit is this November 9-10 in San Francisco area. See www.theconferenceforum.org for more information. This program is dedicated to addressing the unique challenges faced by CMOs and their staff in emerging biotechs.

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  • April 9, 2015

  • Congratulations to CMO Summit East Chair Lee Allen on his feature in Profile Magazine

    Building Hope Through Medicine an article in the spring issue of Profile Magazine features CMO Summit East Chair Lee Allen. Dr. Allen discusses the complexities of his role as Chief Medical Officer of Spectrum Pharmaceuticals. From Building Hope Through Medicine: While developing new drugs is a part of Allen’s role as chief medical officer, his […]

    Building Hope Through Medicine an article in the spring issue of Profile Magazine features CMO Summit East Chair Lee Allen. Dr. Allen discusses the complexities of his role as Chief Medical Officer of Spectrum Pharmaceuticals.

    From Building Hope Through Medicine:

    While developing new drugs is a part of Allen’s role as chief medical officer, his job description is much more extensive. As a corporate officer, he has broad strategic leadership roles, including helping to prioritize the company’s portfolio, providing oversight for drug safety, supporting the marketing group with medical information, evaluating new business development opportunities, engaging key clinical leaders, and being the scientific and medical voice for the organization.

    To be successful, Allen focuses on three key factors: people—attracting, hiring, and retaining quality talent and developing researchers who have passion for their work; portfolio—the organization continually needs to prioritize opportunities that have the greatest impact on patients, value, and probability of success; and finally, process—building a solid infrastructure that ensures quality, efficiency, and compliance. Allen joined Spectrum because of the strong foundation the company already had in oncology, the promise of its portfolio, and his alignment with its core mission of bringing new drugs to cancer patients.

    Click here for full article.

    For more information on the CMO Summit click here.

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  • April 3, 2015

  • FDA’s Dr Richard Moscicki Confirmed for the Boston Chief Medical Officer’s Summit

    The Conference Forum is pleased to announce that Dr. Richard Moscicki, Deputy Center Director for Science Operations for the FDA is joining the Chief Medical Officer Summit. He joins the CMO Summit to help CMOs explore alternative regulatory pathways. Trends and case examples will be presented on: Breakthrough designation Fast Track Priority Review Orphan Designations […]

    The Conference Forum is pleased to announce that Dr. Richard Moscicki, Deputy Center Director for Science Operations for the FDA is joining the Chief Medical Officer Summit. He joins the CMO Summit to help CMOs explore alternative regulatory pathways. Trends and case examples will be presented on:

    • Breakthrough designation
    • Fast Track
    • Priority Review
    • Orphan Designations
    • Accelerated Approval
    • Other initiatives to early access to medicines

    “We are very excited to have Dr. Moscicki’s participation. It will allow our CMO attendees face-to-face time with the FDA and to engage in Q&A. With Dr. Moscicki’s guidance, our attendees will leave the Summit better armed with the knowledge required to best position their drug for approval” said Jennifer Moran, Conference Producer, CMO Summit.

    The Chief Medical Officer Summit brings CMOs together to help CMO’s

    • Drive value in their companies
    • Navigate the clinical and regulatory pathways
    • Support business development
    • Manage the expectations of the CEO and board
    • Provide strategic insights in corporate investments
    • Manage outsourcing
    • Share best practices in medical affairs and safety across therapeutic areas
    • Transitioning company growth to include staffing, culture and organizational structure
    • Prepare for exits

    Click here to Read Dr. Moscicki’s full bio.
    Click here for more information on the CMO Summit.

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  • October 21, 2014

  • A Program for Chief Medical Officers in Emerging Life Sciences, November 3-4, 2014

    The role of a Chief Medical Officer is one that takes courage given the numerous hats worn simultaneously. For a CMO in early, emerging and even midsize life science companies, it can be a solitary one. In addition to the responsibilities of driving clinical development, drug safety, medical affairs, regulatory strategy and CRO management, CMOs […]

    The role of a Chief Medical Officer is one that takes courage given the numerous hats worn simultaneously. For a CMO in early, emerging and even midsize life science companies, it can be a solitary one. In addition to the responsibilities of driving clinical development, drug safety, medical affairs, regulatory strategy and CRO management, CMOs may also need to meet the needs of investors and help position for an appropriate exit.

    On November 3-4 in San Francisco, our team is hosting a program designed for CMOs of Emerging Biotechs thanks to an idea suggested by Dr Elizabeth Stoner, Managing Director, MPM Capital. The program is dedicated to accomplishing two goals:

    1. To bring together CMO executives to address the unique challenges associated with directing and managing all R&D functions with limited resources, while raising capital, working and meeting with investors, and strategizing for appropriate exits.

    2. To create a network of CMOs from small to midsize life science companies to share ideas, solutions and support.

    Chaired by Dr Lee Allen, CMO, Spectrum Pharmaceuticals 
and Dr Pamela Palmer, CMO & Co-Founder, AcelRX Pharmaceuticals, Inc., the keynotes include:

    The Jazz Pharmaceutical Turn Around Case Study
    Dr Jeffrey Tobias, EVP, R&D & CMO, Jazz Pharmaceuticals

    Life of a CMO Pre and Post IPO
    Dr Jakob Dupont, CMO & SVP, OncoMed

    and

    Regulatory Approval and Market Access in Europe
    Dr Thomas Lonngren, 
Former Head, EMA

    The program also includes an entire afternoon on alternative clinical designs led by Onyx Pharmaceuticals. For more information on the CMOW event, please visit www.theconferenceforum.org.

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  • June 10, 2014

  • Former Head, EMA, Dr Thomas Lonngren Shares his View on US Payers and the Increasing Cost of New Drugs

    In May, I was invited to speak at the Chief Medical Officer Summit in Boston, attended by chief medical and scientific officers from US biotech companies. In my speech, I covered the EU regulatory framework and new developments. This included raising the discussion of the increasing demand from EU payers to demonstrate the cost effectiveness […]

    In May, I was invited to speak at the Chief Medical Officer Summit in Boston, attended by chief medical and scientific officers from US biotech companies. In my speech, I covered the EU regulatory framework and new developments. This included raising the discussion of the increasing demand from EU payers to demonstrate the cost effectiveness of new drugs, which is a topic of increasing interest to US companies planning to enter the EU market with their new drugs.

    This interest is also shared by US venture capitalists wanting to learn more about what is needed to get drugs to the EU market. To my surprise, however, several other speakers highlighted the increasing pressure US payers are placing on companies to get new drugs included in their health schemes. I have had an ongoing assumption that the US market would be willing to bear a much higher price for new medicines and that the uptake would be greater than in the EU and other countries. Apparently, this is an assumption I now have to reevaluate.

    One of the reasons for this change is well exemplified by Gilead Sciences’ hepatitis C drug Sovaldi. Its price tag of $84,000 for 12 weeks of treatment may have been a tipping point. This case in particular has forced payers to make difficult decisions about drug priorities within their available budgets. With many newly introduced high-priced therapies on the market, and more to come, US payers are being forced to prepare themselves for how to manage this growing burden in the future.

    How private insurers/payers will manage the drug selection priorities within their available funds without raising insurance premiums will be a real challenge.
    In my view, one scenario could be where a small number of patients with orphan indications consume a disproportionate amount of an insurance company’s available funds.

    Another may be one in which ground-breaking therapies for a larger population deplete a major portion of the insurance fund, treating just one condition.

    It is necessary to question whether the private insurance system in the US will be able to cope with such a development. If, for example, they apply health economics data and comparative effectiveness criteria as instruments for prioritization, individual private insurance companies would probably be too small to cover reimbursement for some premium-priced drugs. Adding wider health and economical gains for the treatment would in many cases be outside of their scope and would not provide any additional benefits for the insurance companies themselves. In saying this, the US insurance companies will need to apply some methodologies and strategies to support these difficult decisions for the reimbursement of new and expensive drugs. Nonetheless, how this will be done and the priorities made will be brought to question.

    From my point of view, it is obvious that to achieve a premium price to cover the return on investment, the drug will need to show substantial added benefits over other available alternatives. Therefore, in the early stages of a drug’s development process, companies will need to build in assessments of a payer’s acceptability of a new drug with a high premium price alongside regulatory approvability. This has been the case for many years for drugs entering the European market and it now appears more prevalent in the US as well. What remains to be seen, however, is how this will actually be put into practice.

    Thomas Lonngren B&W
    With kindest regards,
    Thomas Lönngren
    (Thomas will also be speaking at the 5th annual Global Clinical Trials event on September 10th in Boston. For more information about this event and the CMO event, please see information under the Conferences tab.)

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  • October 15, 2013

  • A Peek at CMO East 2013

    A Peek at the Chief Medical Officer Summit East 2013, May 5 – 6, 2013, Boston, MA. Presented by: Jeff Sherman, CMO & EVP, Development, Manufacturing, and Regulatory Affairs, Horizon Pharma, Inc.

    A Peek at the Chief Medical Officer Summit East 2013, May 5 – 6, 2013, Boston, MA.

    Presented by: Jeff Sherman, CMO & EVP, Development, Manufacturing, and Regulatory Affairs,

    Horizon Pharma, Inc.

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  • August 9, 2013

  • A Peek at the Chief Medical Officer Summit East 2013

    A presentation on ‘Two-Stage Adaptive Design in Late Stage Trials- Making best use of scarce resources’ from the Chief Medical Officer Summit East 2013, May 5 – 6, 2013, Boston, MA. Presented by: M. Scott Harris, MD, of Middleburg Consultants & Georgetown University. Scott Harris from ConferenceForum

    A presentation on ‘Two-Stage Adaptive Design in Late Stage Trials- Making best use of scarce resources’ from the Chief Medical Officer Summit East 2013, May 5 – 6, 2013, Boston, MA.

    Presented by: M. Scott Harris, MD, of Middleburg Consultants & Georgetown University.

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