Breakthroughs from BIO 2017
BIO Conference addresses biotech sector advances and challenges
BIO 2017 drew 16,123 biotech leaders from around the globe, hosted more than 41,400 partnering meetings and gave attendees unique perspectives on the great opportunities and complex challenges ahead for the biotech industry. Held at the Convention Center in San Diego from June 19 to 22, BIO 2017 included over 1,800 exhibitors, more than 800 speakers at 400 educational sessions and company presentations and seven fireside chats.
The word “breakthrough” was heard and seen throughout BIO’s annual event. David Cameron, the former Prime Minister of the UK, and Ann Romney, the wife of Mitt Romney and a staunch patient advocate delivered keynote addresses that touched on challenges in both the political and health arenas. Biocom, California Life Sciences Association (CLSA) and Southern California Biomedical Council (SoCalBio) hosted this year’s international convention.
Early in the week, BIO signed Memorandum of Understanding (MOU) for Cooperation with the Pharmaceutical Association Committee (RDPAC). RDPAC, a non-profit organization located within the China Association of Enterprises with Foreign Investment (CAEFI), has a membership of 38 multi-national companies with pharmaceutical R&D capabilities in China. Continuing the longstanding relationship between BIO and RDPAC, the agreement deepens cooperative efforts to advance advocacy and outreach for the biotechnology industry in China. Together the two organizations plan to continue to highlight the value of this industry in benefiting society and addressing global health challenges.
On Tuesday, a panel discussed the current environment for expanded access to investigational drugs, at “Modern Solutions for Pre-Approval Expanded Access.” Because patients with serious or life-threatening conditions may have no treatment options when approved therapies are exhausted, they sometimes consider the use of an investigational medicine, such enrolling in a clinical trial. Access to investigational drugs could be provided through expanded access, but the process can be difficult.
Jess Rabourn, managing director of WideTrial (www.WideTrial.com), raised the possibility of creating a system in which multiple EA programs could be operated and managed simultaneously. WideTrial is the first organization to serve as a third-party platform for sponsoring and conducting well-designed Expanded Access (EA) programs under license by originating therapeutics manufacturers, offering centralized expertise and advisory services to drug companies, clinical research centers and disease foundations, as well as direct support via multi-party collaborations and sponsorship of large-group Expanded Access trials.
Kay Holcombe, senior vice president for science policy at BIO, described a new tool to facilitate expanded access from patients and physicians. The Reagan-Udall Foundation Expanded Access Navigator enables a one-step shop for information and assistance to doctors and patients seeking access to investigational medicines and answers questions like “What clinical trials are available? What is expanded access? How can I talk with companies about potentially promising investigational medicines for my disease?” Available at http://navigator.reaganudall.org, the Navigator includes information specific to questions doctors may have about their responsibilities when administering an unapproved drug, and their FDA and IRB requirements, as well as patient-focused information, such as defining clinical trials and expanded access and a tutorial on using clinicaltrials.gov, the NIH sponsored website for clinical trials. The Navigator company directory links users to company expanded access policies, such as the contact for more information.
As panelists explained, companies must now publicly post their expanded access policies under a new requirement contained in the 21st Century Cures Act, to ensure that patients and physicians can easily find information on requesting access to investigational drugs. Companies can accomplish this requirement by posting on their own website or by submitting their information to the Reagan-Udall Navigator at http://navigator.reaganudall.org/expanded-access-company-directory-submission-form.
The last morning of the 2017 BIO International Convention featured an oncology panel called, “Shooting for the Moon: Creating the Next Generation of Cancer Killers.” With the “Cancer Moonshot” promoting the acceleration of oncology research, the biotech industry is hurrying to create a new generation of cancer killers and developing powerful new tools. Using the latest genomic and computational technology, innovators in oncology research are developing approaches such as developing a universal cellular immunotherapy to treat multiple cancers, unlocking the potential of bicyclic peptides to target tumors, creating oncolytic viruses to kill cancer cells but avoid healthy cells and developing next-generation active immunotherapies that enable the body’s immune system to fight cancer.
Mandy Jackson, managing editor of US Commercial News at Scrip/Pink Sheet, moderated the panel. Panelists were Dr. John Beadle, chief executive officer, PsiOxus; Nicholas Keen, chief scientific officer, Bicycle Therapeutics; Jan ter Meulen, chief scientific officer, Immune Design; and Dr. Charles Wilson, president and chief executive officer, Unum Therapeutics.
As to unmet needs, Beadle said immune therapies are promising, but many patients do not respond, and we fail to understand why they do not respond to immunotherapy. Keen emphasized the role for industry and academia in fixing this, saying that developing a better understanding of combination toxicology would be beneficial. In terms of overcoming immunosuppression systemically in the patient, Ter Meulen explained that the real promise of immunotherapy is the longevity of response. He added that immunotherapy is the only therapy that can prevent cancer recurrence and that surrogate endpoints based on biomarkers are needed. According to Wilson, providing a high response rate with more sustained and durable responses is what patients need. Some existing therapies detract from the value they provide, because certain patient groups may not respond or be able to afford them.
The 2018 BIO International Convention will bein Boston from June 4 to 7 to celebrate 25 years of innovation.
Here is a video we shot at BIO 2017 to highlight some business development strategies you can utilize at your next conference.