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 Feature Industry Articles 
Wednesday, May 20 2015
Elements to Success: Discoveries, Clusters, and Incentives in the Biotech/Pharma Industry

By Lisa A. Bastian

Much progress continues to be made worldwide in the biotech areas of food, feed, energy - and especially the life sciences - using pioneering research platforms. Advances in areas such as immuno-oncology, personalized medicine and infectious disease solutions easily grab the media's attention - and often the funding as well. According to Dow Jones VentureSource, biopharmaceutical venture capital investment alone rose 17 percent, from $4.52 billion in 2013 to $5.29 billion in 2014.

Every other day it seems a biotechnology company is publicizing a new planet-shifting concept or beyond-blockbuster drug destined to shake up medical science - or at least garner some investor attention. Sometimes the euphoria is justified; sadly, sometimes not.

Exciting World-Class Bio-Pharma Discoveries
It's so true: People don't seem to appreciate what they have until it's gone - or no longer useful.  Scientists are working feverishly to ensure that does not apply to antibiotics.

Last year, a World Health Organization (WHO) report warned a "post-antibiotic era" is near due to the increasing ineffectiveness of antibiotics and other antimicrobial agents in every region of the planet. The culprit? The report cites overuse of antibiotics by practitioners and hospitals, and overuse in agriculture/livestock growth programs, has supported the growth and spread of drug-resistant bacteria. It's been found that drug-resistant infections already kill hundreds of thousands of people a year globally, and by 2050 that figure could top 10 million and cost the world economy $100 trillion. Moreover, in July 2014 a U.K.-government report stated 700,000 deaths worldwide are due to resistance to antimicrobials, the class of drugs that includes antibiotics, antivirals, antiparasitics and antifungals.

But medical miracles are here or on the horizon.

In January, the amazing discovery of Teixobactin was announced in Nature. NovoBiotic Pharmaceuticals of Massachusetts owns the patent rights to this new "game-changer" class of antibiotic, yet to be tested on humans, which destroys a wide range of drug-resistant bacteria including MRSA, tuberculosis and countless other life-threatening infections.  Then there's community-acquired bacterial pneumonia (CABP), the number one cause of death from an infection. Each year five to 10 million Americans get CABP.  To the rescue is Austria's Nabriva Therapeutics AG, which has attracted $120 million in funding commitments (led by U.S.-based investors Vivo Capital and OrbiMed), much of which will push its unique bacterial-pneumonia therapy toward regulatory approval. Later this year the firm expects to start Phase III clinical trials for CABP patients with Lefamulin, its drug in the new class of antibiotics called pleuromutilins. Another dog in the fight is Cempra of North Carolina, a pharma company developing new antibiotics to treat drug-resistant diseases, too. Its two lead product candidates in advanced clinical development include Solithromycin (for CABP), and Taksta (for refractory staphylococcal infections in bones and joints).  

"Personalized medicine" is often defined as “the right treatment for the right person at the right time," but it's actually a layman's phrase used to describe pharmacogenomics, a science exploring the relationships between a person's genetics and targeted, individualized diagnostics/therapies resulting in better patient outcomes. In the past decade apprehensions about it have been fading, as more and more pharma companies implement some aspect of it in clinical trials of promising drugs.

Personalized medicine in particular is redefining the fight against cancer as many but not all cancer tumors can be battled with this treatment approach. New centers focused on personalized cancer care are popping up every year; most are at major cancer facilities. A renowned one is MD Anderson Cancer Center’s Institute for Personalized Cancer Therapy, which employs T-200 (an “ultra-deep research platform”) to analyze a patient’s tumor against 200 different genetic aberrations. The Center also created a public website for doctors to search to find out if there is an approved drug or clinical trial in existence that can be used to target a patient's unique genetic mutations causing a health problem.

Finding the right cancer drug (from among up to 100 or so options) to kill an individual's tumor has always been tricky - until now. Earlier this year it was reported that chemical engineers at MIT's Koch Institute for Integrative Cancer Research, have invented a rice-sized implantable device used to deliver small doses of up to 30 different drugs into a tumor. Researchers then monitor the tumor to find out which drugs are most effective at treating the cancer cells, and then select the one (or ones) that work best for that patient.

Immunotherapy is an innovative treatment using certain parts of a person's immune system to fight diseases, such as cancer, by targeting and destroying the rogue cells. New "checkpoint inhibitors" are drugs that prevents cancer from putting on an "invisibility cloak" that shields it from the body's immune system. For some people they seem to work well against multiple cancer types, including cancers of the kidneys, bladder, head and neck, and even the breast.

For example, Merck's new Keytruda (pembrolizumab) drug was approved by the FDA last September to treat metastatic melanoma. But it's also being studied for its impact on over 30 types of cancers, so more good news may be in the future. Dendreon's Provenge is the first and only FDA-approved immunotherapy for advanced prostate cancer. And in Iowa State University Research Park, NewLink Genetics has a promising pipeline of immunotherapies as well as pathway inhibitors (they work similar to immune checkpoint inhibitors) to help kill tumors associated with pancreatic, melanoma, prostate, renal and/or metastatic breast cancers, among others.

GEN'S Top 10 Biotech Clusters
In March, Genetic Engineering & Biotechnology News (GEN) announced its 2015 "Top 10 U.S. Biopharma Clusters List."  The publication noted NIH's fiscal year-to-date funding has increased by one-third ($312.797 million vs. the previous year's $201.4 million), and that "nearly all regions saw significant increases" in a post-Sequestration reality. Another observation: The VC vmarket seems to be recovering, but not all regions are benefitting.

Here's a summary of GEN comments about the winners:

  • #10. Chicagoland:  In 2014 garnered $146.608 million of VC in six deals, and at least one significant VC award already this year.
  • #9. Los Angeles: LA and nearby Orange County make up California’s third biotech cluster, after the Bay Area and San Diego. A new “Biotech Master Plan” will identify biotech opportunities at all five LA County medical campuses.
  • #8. Raleigh-Durham, NC (includes Research Triangle Park, NC):  Big Pharma as well as contract research organizations and biotechs have expanded here in recent years.
  • #7. Seattle:  Attracted more than $300 million in private capital since 2013; lags a bit in lab space. #6. Greater Philadelphia:  Enjoyed a VC financing boost of nearly 30 percent over 2013 to $211.376 million in 23 deals made last year.
  • #5. Maryland/D.C. Metro: Home of the NIH, FDA and CDC can claim #3 ranking in patents (3,531), of which 51 percent (1,798) are held by the parent of all three agencies, the U.S. Dept. of Health and Human Services.
  • #4. San Diego:  Scored well in VC funding (#3 with $494.46 million in 42 deals), and also did well in patents (2,644) compared to three much larger regions.
  • #3. New York/New Jersey:  Best for jobs (77,645 estimate) and lab space (20.6 million sq. ft.); prized as America's largest region with many research institutions and a sizable "heritage" pharma industry.
  • #2. San Francisco Bay Area:  Boasts the most patents (8,851); finishes a very close second to Boston-Cambridge in 2014 VC ($1.816 billion in 110 deals), and fourth in NIH funding ($143.9 million) and jobs (50,038).  Another lab space leader with 20 million sq. ft.
  • #1. Boston-Cambridge: Second in patents (5,002) but tops in 2014 VC ($1.82 billion in 88 deals), NIH funding ($312.797 million) and lab space (21.204 million s.f.).

Biotech Incentives of Note
About 400 partners from the worlds of academia, government, industry, nonprofits and investment converged at the first Maryland Regional Biotech Forum in April 2015. Organizers expect the event will help the region become one of the nation's top three biotech hubs by 2023. Already ranked among the top 10 U.S. biotech clusters, the Maryland, Virginia and Washington, D.C. area is home to over 800 life sciences companies, 70 federal labs, and many world-class academic and research institutions.

After the forum, conference-goer Ellen Harpel, Ph.D., wrote a recent blog post on smart incentives needed to grow a successful "biotech ecosystem."  (This founder of Smart Incentives is also president of Business Development Advisors, an economic development and market intelligence consulting firm.)  Harpel cited a few incentives tips shared by conference participants:

  • Hubs need "top talent with the right skills, values and experience, linked through a strong networked community."
  • Critical to hub development are "collaboration and strategic partnerships among industry, academia and federal institutions [requiring] both broad cultural change and high-quality programmatic initiatives to identify and develop commercial opportunities." Harpel cited a few examples:  the Virginia Biosciences Health Research Corporation funds, the BioHealth Innovation Entrepreneur-in-Residence program, and programs at the National Heart, Lung and Blood Institute's Office of Translational Alliances and Coordination.
  • Even when the aforementioned factors are in place, economic development incentives for biotech and life sciences firms may be necessary "to generate a thriving set of companies to propel economic growth in that hub...ranging from start-ups to well-established industry leaders."
  • It's important to make Investments "in assets that can be used by both academia and industry, such as the UMBC High Performance Computing Facility."
  • Other smart incentives: "Free, inexpensive or discounted land and facilities" which may include subsidized lab space, incubator or accelerator facilities, "or even land for facilities"; and tax credits/grants "designed for the needs and characteristics of the industry, such as Maryland’s Biotechnology Investment Incentive Tax Credit and the Montgomery County Biotechnology Investor Incentive Program

"Our [company's] takeaway is that while incentives can’t create the essential elements of a successful biotech cluster," noted Harpel, "they do play an important role in facilitating company formation and expansion in the ecosystem."

Bio: Veteran business communicator Lisa A. Bastian is an award-winning journalist and editor who has authored well over 500 articles for national magazines focused on economic development, global trade and related industries. Since 1986 she has served clients nationwide with her editorial and copy writing skills (see Lisa lives in San Antonio, TX, with her family, and is a former president/board member of the local chapter of the International Association of Business Communicators.

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