BIO2015

The Department of Community and Economic Development welcomed the 2015 BIO International Convention, June 15-18 at Pennsylvania Convention Center, Philadelphia, hosted by the Biotechnology Industry Organization. More than 15,000 leaders from 69 countries and 49 states were participated.

Here are highlights:

Keynote Speaker Tom Brokaw (on June 16)

Brokaw described his observations on the state of the U.S. and the world with important political headlines, economic challenges and social issues in the news—and the people behind the headlines. He mentioned about the challenges that face America in the new millennium and offered reflections on how we can restore America’s greatness. In 2014, President Obama awarded Brokaw with the Presidential Medal of Freedom.

He talked to Dr. Oz, in an interview, about beating multiple myeloma with a nagging back pain. Multiple myeloma is a cancer formed by malignant plasma cells. Brokaw said “what happens is that the white blood cells invade the bone marrow.” His cancer is now in remission, although he is still dealing with some bone damage that comes with this type of cancer. As a result he had some unexpected fractures in his back and in pelvic area but they’re beginning to heal.

Keynote Speaker Dr Eric Topol (on June 17)

Dr. Eric Topol mentioned the importance of the Precision Medicine Initiative as a way to further revolutionize how we improve health and treat disease with early diagnostic and personalized treatment.

He mentioned, in partnership with the Wireless-Life Sciences Alliance, the Digital Health program would explore the intersection of digital health, biotech and pharma. Industry thought leaders, stakeholders and innovators would highlight digital health’s role in drug development, clinical trials, medication compliance, prescribable apps, new business models, big data and much more.

Topics:

Start-ups get chance to shine at BIO convention

This year’s event attracted close to 16,000 industry leaders to Philadelphia, as well as Mayor Nutter, Gov. Wolf, and other government and civic leaders. Mayor said, “As home to an extraordinary lineup of education, health, and biotech-related organizations, our region set the tone for the high-energy buzz.”

One of the most exciting events of BIO was the Start-Up Stadium, which gave seed-stage companies the opportunity to pitch to potential investors, venture philanthropy groups, and other attendees from across the country and around the world. In the style of the popular Shark Tank TV show, the judges provided live feedback and interacted directly with the 30 start-up business owners, almost all of whom were based in Pennsylvania, New Jersey, or Delaware.

The innovative products that were showcased ranged from digital-health solutions to new methods of DNA testing and unique therapy delivery options.

The founder of Biomeme conducted a live demonstration of a testing device that enables health and government authorities to treat the sick and protect the healthy by using a hand-held device that lets them isolate and detect DNA and RNA in under an hour.

Another innovation on display was DenovoNow, a mobile platform that increases patient engagement by enhancing and further personalizing a patient’s relationship with his or her doctor at no additional cost to either party.

The other cutting-edge pharmaceutical and therapeutic treatments presented included a product developed by InteguRx Therapeutics described about one of their product that delivers once-daily anti-nausea treatment in a very small dose via a gel or patch to treat pregnancy-induced nausea and vomiting.

With the large pharmaceutical companies and biotech firms starting to look more to external sources for the next wave of innovation, the sessions were very well-attended. The investor community remains key to the success of these companies, and the Start-Up Stadium attracted investor judges from groups such as the Bill & Melinda Gates Foundation, New Enterprise Associates, Bristol-Myers Squibb, Flagship Vetnures, J&J Innovation Center, and Roth Capital Partners.

 Complexities of Rare Diseases Take the Spotlight at BIO

Nicole Boice, Global Genes Founder, addressed the BIO 2015 Orphan & Rare Disease Track by saying: “We’re all working to eliminate the challenges of rare diseases, but patients and their advocates aren’t always equipped to fight.” Organizations like Global Genes helped families affected by rare disease by connecting them with much needed tools and resources.

He said, “Understanding the distinctions is an important part of understanding the state of the orphan drug development worldwide, both where it’s going and where it needs to go. However, the various stakeholders involved in the development and administration of orphan drugs tend to define rare diseases differently. Regulators define rare diseases by the number of patients affected, FDA defines a rare disease as affecting less than 200,000 Americans per year.. Most importantly, for patients the concept of “rare” can manifest itself as isolation from others, which is a problem that industry should address as it also seeks to develop innovative orphan drugs. However, when taken together, rare diseases as a whole affect a large number of patients worldwide.”

 Can Vaccination, Diagnostics Help to Combat Antibiotic Resistance?

Resistance to antibiotics and other antimicrobials is growing worldwide, with deaths from resistant infections at about 700,000 per year, and estimated to rise to 10 million per year by 2050.

“The problem is so serious that it threatens the achievements of modern medicine,” the World Health Organization (WHO) wrote in a recent report. In late May, the WHO formally endorsed an international plan, which calls for all member states to have national plans in place by May 2017 to stop the growth of resistant germs globally. A major component of the plan is to develop novel antibiotics, but strengthening surveillance of these drugs is of utmost importance.

“Vaccines are not the solution, obviously, but this is an ‘all hands on deck’ problem,” said Bruce Gellin, deputy assistant secretary for health and director of the National Vaccine Program Office at the BIO International Convention 2015 in Philadelphia. “And vaccines need to be a part of the discussion.”

Targeting pathogens with antibiotic-resistant strains

 In 2005, a vaccine for Staph infection by Nabi Biopharmaceuticals failed to reduce infections among kidney patients in late-stage trials. Staph infections, caused by staphylococcus bacteria, can turn life-threatening if bacteria invade the bloodstream, joints, bones, lungs or heart. Treatment usually involves antibiotics and drainage of the infected area; however, some staph infections no longer respond to common antibiotics.

“It set the field back,” said Charles Knirsch, MD, MPH, vice president, therapeutic vaccines program lead, Vaccine Clinical Research and Development at Pfizer, referring to the failure of the single-antigen vaccine called StaphVax.

Currently, Pfizer is helping to usher in a new era of vaccine innovation — both to prevent and treat disease. Specifically, the company is working on a vaccine for methicillin-resistant Staphylococcus aureus (MRSA), the leading cause of hospital-acquired infections. MRSA infects an estimated 53 million people globally, and in the U.S. alone, MRSA kills 20,000 people each year. But rather than focus on a single target, Pfizer’s new approach, said Knirsch, contains four vaccine components to generate a broad immune response. “Sometimes, it’s more art than science getting those conjugates right, and we’ve been able to do it so far with these widely sharing antigens,” said Knirsch. “Because of the recurrent nature of this disease, we believe the vaccine would work like the pneumococcal vaccine, and reduce overall use of antibiotics.” Pfizer recently began enrollment in a Phase 2b clinical trial evaluating its investigational Staphylococcus aureus multi-antigen vaccine in adult patients undergoing spinal fusion surgery. Competitors, including GlaxoSmithKline, Novartis and Sanofi are also investigating Staphylococcus aureus vaccines.

Role and complexity of infectious disease diagnostics development

Inappropriate use, a reason for the rise in antibiotic resistance, includes starting patients on antibiotics before test results come back, putting them on a broad-spectrum antibiotics when it’s unknown what bacteria is causing an infection, or keeping them on medications even when tests come back negative.

“As a diagnostics company, how do we approach this paradigm?” asked Tom Lowery, Ph.D., chief scientific officer at T2 Biosystems in Lexington, Mass. Currently, a blood culture can take two to six days to process and what’s more, a blood culture often misses 50 percent to 60 percent of bloodstream and tissue-based infections, said Lowery. “Today, with the diagnostic paradigm, there’s a lot of guesswork, and with the significant delay, patients get put on broad-spectrum antibiotics unnecessarily.”

A solution? “Highly-sensitive, rapid tests that can give not only species identification but resistance identification within the first three to five hours,” said Lowery.

In that vein, T2 Biosystems’s FDA-approved diagnostic is the first sepsis pathogen diagnostic panel requiring no blood culture that identifies with 91.1 percent sensitivity the five clinically relevant species of Candida “directly from whole blood which enables physicians to initiate appropriate therapy on day zero,” according to the T2 Biosystems website. Candida is the most common cause of fungal infections worldwide.

Said Lowery, “This represents a new class of diagnostic test that can have the same, or better sensitivity, as blood cultures and deliver those results rapidly so that a clinician can put a patient directly on the targeted therapy that he should be on right away, without this waiting time, without this inappropriate therapy that can drive mortality rate up.”

____________

Storyline: The 2015 BIO spanned a range of topics from classics such as rare disease complexities, antibiotics resistance to the innovatives such as Digital Health Solutions and Start-Up stadium. This was topped by having Tom Brokaw and Eric Topol  as the keynote speakers.

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