SDBN July 28th 2014 Speed Networking Event: Caution, Connections Ahead!

Posted by Mary Canady July 7th, 2014 .
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SDBN July 28th 2014 Speed Networking Event: Caution, Connections Ahead!

Our downtown events during AACR and BIO were very successful and we gained a lot of momentum, so in July we’re speeding back to the heart of San Diego biotech, Sorrento Valley and Green Flash Brewery! Join us July 28th for our ever popular speed networking, where you’ll race towards reaching the limit of biotech professionals you can connect with in one night. Hone your 30 second elevator speech and bring lots of business cards, you’ll run through them in no time. If you haven’t been to one of our speed …

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San Diego Entrepreneurs Exchange (SDEE) Intensive Workshop for Entrepreneurs on Grant Writing

Posted by Roberta Alexander July 15th, 2014 .
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The San Diego Entrepreneurs Exchange (SDEE) held an intensive workshop last night, 11 July 2014, at the Hera Hub in Sorrento Mesa to help entrepreneurs get funded through National Institute of Health (NIH) or National Science Foundation (NSF) grants called SBIR grants, i.e. Small Business Innovation Research grants.

The event was attended by almost 30 entrepreneurs or aspiring entrepreneurs, eager to learn from the masters how to write a grant, how the scoring system works, and how to increase their chances to get the money! The event started with a networking opportunity over snacks, followed by presentations by seasoned San Diego entrepreneurs: Scott Thacher, founder of Orphagen Pharmaceuticals, Curt Becker, founder of Molecular Assemblies, and Scott Struthers, founder of Crinetics Pharmaceuticals. The attendees had the opportunity to ask questions during the presentations and afterwards, when they broke into three small discussion groups led by each of the presenters.

So, how do you write a grant that has some chances to get funded? I cannot give here all the precious advice of successful grant writers: I encourage you to join SDEE and/or their LinkedIn group and to attend the workshops that SDEE organizes every couple of months.

There are a few pointers, though, that I want to share.

Highlight the commercial potential (including job creation, patents, etc.) and what is innovative in your proposal. The Specific Aims is the most important section. Write the grant in a clean and easy to understand manner, keeping in mind that the reviewers, differently from reviewers of RO1 grants, may not be knowledgeable of what you are writing about. Make it interesting to open minded scientists: they need to like your idea first and foremost. Use good English grammar, not too much jargon and, in the words of Scott Struthers, “no BS”… if you write a lot of BS, the reviewer is going to toss your stuff away without even bothering to give you feed back. And remember: feedback can be actually very valuable to get funded next time, especially if your proposal gets rejected. Address the reviewers’ comments carefully and respectfully. Add a list of abbreviations, maybe in the references section; schematics or other visual tools help, too. Preliminary data can be literature data for a Phase I grant; for a Phase II, you better have your own data relevant to the project that you want to get funded. Get letters of support from colleagues. They can be extremely important especially when you are just starting out and don’t even have a lab: letters of support can specify that you can use the facility, labs, and instruments of a colleague. Fortunately, San Diego is a good and collaborative environment, where entrepreneurs are willing to help one another: a rising tide lifts all boats, and the SDEE is certainly playing a big part in rising the tide.

The presenters during the panel discussion. From Left: Scott Thacher, Scott Struthers, and Curt Becker.

The presenters during the panel discussion. From Left: Scott Thacher, Scott Struthers, and Curt Becker.

Panel discussion with Scott Struthers.

Panel discussion with Scott Struthers.

One on one discussion with Scott Thacher.

One on one discussion with Scott Thacher.

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The Face of Biotech is Changing: Summary of the #SDBNJune Event

Posted by Leah Cannon June 27th, 2014 .
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Panelists Claire Weston, Joseph Jackseon, Ethan Perlstein, Ryan Bethencourt, and moderator Jamie Bacher at SDBN's June 24th event.

Panelists Claire Weston, Joseph Jackseon, Ethan Perlstein, Ryan Bethencourt, and moderator Jamie Bacher at SDBN’s June 24th event.

Old funding and research methods are no longer working for small biotechs, big pharma or academic scientists. The flip side of this crisis is breeding innovation at every stage of the drug discovery pipeline. As part of BIO 2014, SDBN gathered a panel of innovators to talk about “Reinventing California Biotech.” The panelists were optimistic about new funding sources, new industry infrastructure and the collaborative nature of San Diego biotech.

Joseph Jackson is CEO of Bio, Tech and Beyond, San Diego’s largest community lab and biotech accelerator. He stressed the importance of thinking outside the box when it comes to funding. Traditional funding sources (government grants and venture capital) are drying up, but there is now a rise of ‘venture philanthropy’ from high worth individuals. Patient advocacy groups are also becoming more sophisticated. There is a lot of capital out there, it just isn’t efficiently matched to research talent because scientists don’t know how to market themselves.

Ethan Perlstein has marketed himself very effectively and turned the academic research model on its head. He used social networks and crowd funding to woo investors to fund his research. Then he set up his lab in QB3@953, one of the biotech incubators springing up around the world. Ethan said there are three keys to lean biotech startup: networking on social media, incubation and outsourcing.

Networking and refreshments provided by Alchemy San Diego before the panel presentation.

The SDBN June event was held downtown in a warehouse to fit the DIY theme, about 100 attendees networked and enjoyed California-sourced food and drink from Alchemy San Diego.

Claire Weston founded Reveal Biosciences in a garage two years ago. She now runs this successful biotech using a hybrid business model that uses contract services to fund technology development. Claire also commented on the importance of outsourcing. It is now possible to run a biotech company from a laptop in your bedroom by coordinating the right people toward the same goal. Social media opens up the global marketplace. She emphasized that the San Diego life sciences community is really collaborative – many universities and large companies are willing to rent high end equipment for a nominal fee. “If you need help,” Claire said, “You just need to ask.”

Joseph and Ryan Bethencourt, CEO of Berkeley Biolabs, a Bay Area biotech incubator, both talked about the importance of open source alternatives to disrupt the current market for reagents and equipment. They envisage lightweight modular machines that can be reconfigured in the lab to perform different tasks. This, combined with cheaper reagents, would drastically reduce the cost of setting up a lab. Ryan went on to say that the whole drug pipeline will radically change as technologies become easier to use and available to everyone. People will be able to synthesize their own drugs. He did caution that regulatory systems are not keeping up with rapid technological advances in biotech.

It was clear from the panel discussion that change is happening in the biotech industry. If we embrace it, it will bring exciting new opportunities.

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Promoting Innovation While Ensuring Safety of Biosimilars: Two Perspectives at #BIO2014

Posted by Greg Mrachko June 27th, 2014 .
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Image courtesy the Biotechnology Industry Organziation.

Image courtesy of the Biotechnology Industry Organziation.

The second day of BIO 2014 International Convention, Tuesday June 24th, presented at least two opportunities to learn about biosimilars, which haven’t only been gaining momentum from research and development over the last several years, but also from receiving attention by the US Food and Drug Administration (FDA) as biosimilars get closer to being marketed in the US.  I basically thought that the sessions, to a lesser or greater degree would essentially review and or summarize recent documents published by the FDA to help guide the biopharmaceutical industry develop and gain approval of a biosimilar product.  However, I realized after attending the second session that I had come away with seeing the biosimilars approval landscape from two perspectives.  The first perspective was that from the eyes of the patient and healthcare professionals and the second perspective was from that of the drug manufacturer complying with FDA requirements.  My first thought was that I could report on the two sessions in a point counterpoint format, but I chose to instead present them as two perspectives for the reader since the two parties were not speakers in the same session participating on a moderated panel discussion that potentially would be a point counterpoint opportunity.

The first session was titled Ensuring the Safety and Commercial Success of Biosimilars in the United States, which was monitored by Brian Rye (Senior Health Care Analyst for Bloomberg Government) and included speakers Dr. Robert Yapundich (board certified neurologist), Phillip Schneider (Associate Dean and Professor at the University of Arizona College of Pharmacy), and Marcia Horn (President and CEO of the International Cancer Advocacy Network).  Dr. Yapundich cares for post-stroke and multiple sclerosis patients and mentioned his use of botulinum toxin.  He presented a slide depicting the structures of aspirin and botulinum toxin.  He noted that aspirin is prepared by synthesis in the lab whereas botulinum toxin is made biologically by a living organism and involves recombinant DNA technology.  Aspirin is a much smaller molecule than botulinum toxin and is far less complex with respect to structure.  Yapundich noted his concerns over proper storage and stability of the biologic with respect to its safety and efficacy and discussed other similar aspects such as preparation of the drug for administration involving dissolution in water for injection which requires proper technique in order to prevent inactivation by denaturation or unfolding of its higher order structure by excessive vigorous shaking.  Yapundich also emphasized the importance of communication between a healthcare team for a patient which could involve a family or primary care physician, a specialist physician, and a pharmacist, all of whom should be kept informed about their patients prescriptions.  One apparent point of contention had to do with the physician and patient being informed about a pharmacist dispensing a substitution for a prescribed drug because there should be no mistake that a substitution by a generic drug is not in the same league as a substitution involving a biologic with respect to efficacy and safety.

Another topic discussed by Yapundich had to do with the naming of biosimilars such that naming should specifically be linked to the manufacturer and the lot number because of the complexity of a biologic and for post-marketing surveillance.  Professor Schneider emphasized the establishment of standards for measurement and performance of medical use systems with respect to biosimilars to identify gaps in efficacy, monitor adverse events and address and prevent conflict arising from innovation and affordability of biosimilars.  A medication use system for a drug and its use for treatment or prevention involves the five steps of prescribe, prepare, dispense, administer, and monitor.  Schneider offered that advances and improvement in the medical use system for biosimilars involved collaboration between the pharmacist and physician, expansion or modification of the rules for formulary access, a clear distinction between interchangeability and substitution of drugs, and evidence-based clinical practice.  Horn also touched on some of the things mentioned by Yapundich and Schneider such as continuous communication between the patient’s health care team.  She also presented BIO’s five principles on biologic substitution which are 1) substitution should occur only when the FDA has designated a biologic product as interchangeable, 2) the prescribing physician should be able to prevent substitution, 3) the prescribing physician should be notified of the substitution, 4) the patient should be notified of the substitution, and 5) the pharmacist and physician should keep records of the substitution.

The second session was entitled Navigating the Biosimilars Landscape: Dispelling the Myths presented by Dr. Sarfaraz Niazi, Chairman and CEO of Therapeutic Proteins International (TPI), as part of the BioProcess Theatre in the convention exhibit hall.  I also conducted a short interview the day after Niazi’s presentation with Celina Dopoulos, Director of Global Strategy and Business Development at TPI.  The five most common misconceptions were discussed and disproved with the following facts, as outlined by Niazi in his presentation, were 1) approved biosimilars are not inferior to the reference product, 2) an approved biosimilar has no greater safety risk than the reference product, 3) there is more than one approval pathway for a follow-on biologic, 4) there are numerous ways to manufacturer the same biologic product, and 5) evolving thinking in approval process and novel technologies allow for impactful savings.

Niazi also depicted aspirin and a large protein molecule in his presentation to demonstrate the complexity in molecular structure of a biological compared to a small molecule synthesized in the lab. Yapundich expressed concern over decrease in efficacy or safety due to the fragility of the complexity of a biosimilar and its potential for becoming nonidentical to the reference product for example during prescription preparation for administration. Niazi pointed out in his presentation that not only will a biosimilar never be identical to the reference product, but that variability is intrinsic to biologics including the existence of batch to batch variability in the reference product. Dopoulos pointed out that the FDA approaches the 351(k) biosimilar approval process with the same rigor as the 351(a) traditional biologic approval process. The FDA is additionally involved with the biological drug sponsor at every stage of the stepwise process that makes up the 351(k) biosimilar approval pathway. The goal of the sponsor is the elimination of all residual uncertainty that there is any meaningful difference between a biosimilar and a reference product by leveraging analytical methods at each stage of the production process as well as any additional clinical studies the FDA may require based on the biosimilarity profile. An FDA approval means is the product is judged as safe and as efficacious as the reference product and by nature of the 351(k) pathway, may qualify for indication extrapolation with respect to intended use compared to the reference product. The first guidance document on the determination of biosimilarity was released by the FDA in 2012 and a second draft is nearly at the end of its open review period during which the public may submit constructive criticism.

As for safety, Niazi pointed out the history of withdrawals of new molecular entities, which includes drugs and biologics. A product is withdrawn completely from the market because of risks to the patient. Only 44 drugs have been withdrawn from the market since 1980 and zero have been therapeutic proteins or biosimilars. Niazi additionally referenced a pooled analysis of 5 post-approval studies of EU approved filgrastim biosimilar Zarzio, which has been on the market since 2009. No new safety signals or clinical concerns were determined from exposure to the EU biosimilar filgrastim market leader over the five years analyzed which translated to safety data over a period of 4.5 million patient days involving 1302 patients spanning 12 countries.

Schneider held some concerns over the designation of being an interchangeable biosimilar. The term interchangeable as described by the FDA refers to a biological product that can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. This is essentially a nontopic since there does not yet exist a guidance document issued by the FDA on the protocol for conducting switching trials in order to be approved as an interchangeable biosimilar. Nonetheless, the FDA has the authority to designate a biosimilar as interchangeable under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) with the provision that interchangeable products may be substituted for the reference product without the intervention of the prescribing healthcare provider. This portion of the BPCIA,which was signed into law by President Obama in 2010, has been controversial with industry stakeholders There continues to be enactment of legislation on a state by state basis pertaining to notification of the patient and physician by the pharmacist in the event of substitution by a biosimilar which contradicts the BPCIA as written which is evident by the most recent being MA Governor Patrick signing House Bill 3734.

In conclusion, it seems that in some cases, such as regarding the safety of biosimilars that a point/counterpoint would have been evident if all the speakers had been part of one session; whereas, in others, such as naming of biosimilars, that the debates are premature until the FDA issues a guidance document.  Although there is a mechanism for filing a Citizen Petition with the FDA regarding policy, both existing and perceived as necessary, there is also a period for submitting comments to an issued draft FDA guidance as part of the process of its finalization.

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#BIO2014 Career Fair Thursday During BIO

Posted by Roberta Alexander June 27th, 2014 .
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BIO 2014 Career Fair, photo courtesy Biotechnology Industry Organization.

BIO 2014 Career Fair, photo courtesy Biotechnology Industry Organization.

A career fair was held on the last day of BIO, June 26th, 2014 from 2 to 7 pm, at the Marriot Marquis and Marina, in one of the ballrooms at the lobby level. The room was big, but it felt really small: it was absolutely packed!

BIO volunteers in their bright orange shirts registered and welcomed the job seekers as they came in. Approximately 400-500 job seekers pre-registered, and another 300-400 registered today, all to talk with 22 exhibitors… The exhibitors were standing behind their tables and most of them were giving away candies, pens, and various gadgets.

There were two recruiting firms, Aerotek and BioPhase Solutions, an academic institution, California State University, a consulting firm, BioStrategies, the supply company VWR, and several other companies, ranging from Johnson and Johnson, to Amgen (or, rather, Oxyx), Allergan, Illumina, Dynavax, Boehringer-Ingelheim, etc. As one can imagine, the lines at Illumina and Johnson and Johnson were particularly long. Foreseeing the big demand, Illumina had many Human Resources representatives on site, all wearing a black T-shirt that said: Illumina is hiring!

There were also Nature and Science promoting their job searching engines, http://www.nature.com/naturejobs/science/ and http://sciencecareers.sciencemag.org.

There were several organizations from out of town, such as St. Jude Children’s Hospital from Tennessee, Acorda Therapeutics from New York, representatives from Research Triangle Park, AGTC from Florida, Prince Edward Island (PEI) BioAlliance from Canada, Integrated Project Management, and Wake County Economic Development.

Job seekers young and old, novice and experienced, tried to form lines at each table. All representatives were very friendly; however, they could not spend more than a few minutes with each applicant.

BIO did a great job in organizing the career fair and in posting ads on the website well ahead of the event, but the actual event was disappointing. It was my first career fair, and may also be the last. I found it chaotic, too busy, and not particularly useful, neither to find a job, nor to network. As the career fair ended at 7 pm tonight, it concluded BIO in San Diego. Next year, BIO will do it all over again in my “other US hometown” of Philadelphia!

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New #BIO2014 Session on Digital Health: Empowering the Healthcare Consumer

Posted by Jill Roughan June 26th, 2014 .
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Wain Fishburn, moderator of Digital Health Forum at #BIO2014 speaks to the audience prior to panel discussion.

Wain Fishburn, moderator of Digital Health Forum at #BIO2014 speaks to the audience prior to panel discussion.

A NEW BIO Convention forum on Digital Health was added to this year’s agenda. Throughout the day on Tuesday, it attracted hundreds of attendees and was a tsunami of engaging discussions, meetings, Q&A and interviews.  The sessions highlighted digital health’s role in all phases of healthcare, from discovery of new drugs, to monitoring clinical trials, mobile prescription handling, and preventive medicine apps.  Digital health, also known as mHeath or mobile health is facilitated through development of new devices, apps, and data management tools, but at its core, it is really about connecting.  Connecting people with data and adapting this info to help them make more informed healthcare decisions.  Panel discussions, presentations and Q&A sessions by key thought leaders were moderated by Wainwright Fishburn, Jr., founding partner of Cooley LLP’s San Diego office, and a prominent venture capital attorney.

The Digital Health Forum was well on its way and the discussion quickly focused on the healthcare epidemic in the US.  Whereby, the US annual healthcare spending hit $3.8 trillion this year and is estimated to crawl to $4 trillion by 2015, according to a report by Dan Munro in Forbes.   These numbers are very concerning and can seem daunting but some would argue that this is really where digital health can make a  substantial impact.  If we can get real-time data on how patients are responding to drugs in a clinical trial, obtain fast, non-invasive diagnostics devices and derive personal health data directly to the patient in a readable format, this not only makes healthcare choices wiser but less expensive.

With the influence of accurate and up-to-date information, doctors, nurses, clinicians, researchers, patients can be making better decisions.  For example, drug companies will know what drugs to focus on because clinical trial data will be delivered in real-time, rather than after a couple years of pushing paperwork.  Right now, so-called blockbuster drugs are only successful in a proportion of people taking them.  So will digital health eliminate blockbusters drugs?  Not really, it will let us determine what the blockbusters really are.

Moderator Mr. Fishburn  says “We’re beginning to see a lot of early success stories. There has been a wave of consumer adoption with rudimentary fitness sensors, like googleFit.  In the last 3 years combined, we’ve seen $3B in investment in digital health yet we’ve already seen $2B investments in the first half of this year.”  When asked where the funding was coming from, Mr. Fishburn continues, “The funding is coming from classic venture capital but also cross-over investors which signal the maturing nature of first generation of companies in this sector so, large scale financing is starting to take place”.  In fact, just this week, a Boston based start-up, Whoop, just rose $6M for continuous heart rate wristband.  Also, a recently published paper in Nature Nanotechnology (1) describe the development of a smartphone for cancer diagnosis via breath analysis. Looking ahead to keep the momentums moving was panelist Aenor Sawyer of UCSF Center for Digital Health Innovation who discussed how they have leveraged the bridge between healthcare needs and technology with collaborations with tech savvy engineers at Samsung and brilliant scientists at UCSF.  She noted that we need more partnering like this to enable us to move this field faster and make a real difference in people’s lives.

Right here in San Diego, there is a history of merging of healthcare and digital world with partnering of Qualcomm and J&J Innovation Center.  And thanks to the Wireless-Life Sciences Alliance, who actively engage the community to identify ways in which wireless health can achieve more efficiency and global access to care, education and partnerships between a diverse group of people are enable effective changes.  Here in San Diego with over 450 biotech companies, thousands of technology companies, and incubator programs like CommNexus, this sort of collaboration will only grow larger in the coming years therefore it was only fitting that San Diego was the place to kick-start this new session at BIO on Digital Health.
Reference
1. Peng G, Diagnosing lung cancer in exhaled breath using gold nanoparticles. Nature Nanotechnology 2009; 4:669-73 PMID: 19809459

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