Diagnostics, Drug Development, Featured, SDBN Blog »

The Future of Personal Genetic Testing and Diagnostics with Pathway Genomics

Posted by Lara August 26th, 2011 .
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pathway genomics, sdbnThe Pathway Genomics business model is based on bridging a gap in personalized medicine.  As Ed MacBean, their VP of Product Development, explained at SDBN’s August 16th event, in a nutshell they connect clients through their physicians with their own genetic information.   For those interested in self-monitoring, tracking and the impact of personal genetics, a genetic report could teach you how your genetic data can act as a guide in defining a personally-optimized lifestyle.

Pathway Genomics is a genetic and diagnostic health services company based in San Diego. Genotyping and sequencing services are performed using technology platforms from Illumina and Fluidigm, and Sequenom. From only two ml of your saliva, Pathway Genomics will provide you with your genetic profile, tailored to one of several customized Reports.

MacBean explained that their tests they are currently available only through physicians until FDA regulations are determined.

Services

Inside your individual report is information you can use to create a personalized healthy lifestyle using your genetic data as a guide.  This isn’t the place to review all the details about each report, because much can be found on their website, but below are highlights of each plus some insights offered by MacBean.

Report 1 – Complex Health Conditions

This testing series analyzes how a person’s genetics impacts complex diseases like diabetes, various forms of cancer and heart disease.  Some notes:

  • Report is an analysis of many factors
  • The test is ethnic and gender specific (e.g., it may be difficult, but you must choose – Caucasian, Asian, etc.)
  • No monogenic disease testing, no highly predictive testing such as Huntington’s, breast cancer
  • Challenge – Due to high turnover by patients. healthcare providers are less than willing to shell out expenses for prevention that may not be seen for 15 years (well after they predict you will leave them for another provider)

Report Results: Pathway Genomics results are presented within categories.  For example, if you are otherwise totally healthy with no recognized genetic risks showing up for a certain area, you could see a “Live a Healthy Lifestyle” recommendation.  This recommendation consists of suggested ways you could use these particular genetic testing results to leverage your diet, behavior, and exercise potential.

And what if you are someone who exhibits genetic factors that suggest strongly increased risk for certain diseases or conditions?  Then you may receive a recommendation like “Take Action” which would suggest specific lifestyle choices, nutrition, and exercise regiments that would not only be valuable to you based on your genetic profile, but which would be most helpful to you in negating some of your higher risk areas.

Report 2 – Pre-pregnancy Planning
The effects of the diseases tested here are generally not experienced by the person being tested – this test is about what you could potentially pass on to your children.

  • Currently 76 total recessive genetic diseases are analyzed, including cystic fibrosis
  • Carriers of recessive genetic diseases are more common than you think – about 50% of clients do carry a recessive genetic condition
  • Challenges in distributing testing like this include reluctance on the part of the payers, claiming only “medically necessary” testing is covered.  Comprehensive testing such as this, can be commonly excluded, regardless of price.

Report Results: Discusses your potential for passing on any of the Pathway Genomics panel of recessive genetic diseases to your offspring.

Report 3 – Medication Response

  • Your analyzed genome can help you determine how you may react to certain medications.
  • Replaces a one-size-fits-all approach to medications
  • Improvement in overall patient health can stem from the genetic determination of reactions to medications that may be encountered throughout one’s lifetime
  • Currently about 70 FDA-labeled “black box” drugs exist that do not require genetic testing to be performed but which contain recommendations to do so

Report Results: Your genetic profile reveals potential sensitivity to certain drugs, the effect of your metabolism on that drug (determining effective dose and frequency), toxicity, and other adverse effects.

Report 4 – Pathway Fit
Pathway Genomics’ newest Report, this test focuses on personalizing aspects of your health such as your nutrition, rather than only personalizing your medicine. Recommendations include sharing the type of diet that may be benefical for optimizing your health based on information in your genetic profile.

The report also accounts for, and makes suggestions based on behavioral aspects of your profile, such as inability to feel satiated when eating food in general. Here are some other results you can see:

  • Specific recommendation of type of diet&em;low-fat, low-carb, Mediterranean diet, or balanced diet
  • Exercise – does your profile suggest that high intensity or endurance is best for your long-term health results?
  • Your risk for developing certain types of injuries
    Disease risks associated with obesity such as high cholesterol and diabetes

Challenges
Regulatory – As MacBean noted, “The pace of knowledge, discovery and information, as it is becoming available and technologically capable of being done, is incredibly outpacing government regulations’ ability figure out how to manage it and how to keep up with it.”

Pathway Genomics is still waiting on guidance from Laboratory Diagnostic Testing (LDT) from a year ago, while advances in the industry continue to develop.
Medical / Bioethical – Although bioethics discussions surrounding genetic testing encompass a wide range of concerns, Pathway Genomics notes that current technology and testing services can be used to lower the cost of healthcare and improve the lives of patients worldwide.

Even with these benefits, and the Genetic Information Nondiscrimination Act (GINA) in place, issues are complicated with real issues such as anxiety among employers and employees regarding sharing information this detailed and sensitive. Although GINA is designed to protect people from improper use of their genetic information, issues surrounding these boundaries are still working themselves out.

What Personal Genetic Testing Means for Scientists and Patients
People continue to search for ways that technology can help us improve lifestyle and health outcomes – add personal genetic testing to the list. As our guests from Quantified Self San Diego already know, the more you know, the more you can improve about yourself.

As MacBean noted, more data can now be collected for less money than ever before. Both scientists and patients can benefit from the rise in the use of diagnostic testing (and “opinion diagnostics”) as the global population gains more access to personalized medical choices and the industry grows.

Several interesting conversations followed during the networking afterwards – ranging from bioethics discussions to potential for job growth.

We’d love to hear your thoughts on any of the many topics surrounding genetic testing – as it relates to the biotech and healthcare industry, and as a diagnostic tool.

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Drug Discovery, Featured, SDBN Blog, Uncategorized »

Virtual Biotech Part 1: What We Learned About Effectively Outsourcing a Drug Discovery Program

Posted by Lara July 28th, 2011 .
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virtual drug discovery SDBN EventThe first in our Virtual Biotech series, our July 19th event was a success.  Thanks to our participants – some of San Diego’s leading virtual drug discovery scientists and CROs – for sharing their valuable insights and advice for scientists managing or considering how to manage an outsourced drug discovery project.

We’ve compiled some of the key tips and highlights of the night including:

  • What activities should you outsource?
  • Finding the right CRO for your objectives
  • Managing your CRO relationship successfully every time
  • Virtual tools to help manage and build your CRO network
  • Finding the funding and resources you need for your virtual drug discovery projects

What Activities Should You Outsource?

Our panelist Scott Struthers, Founder & CSO of Crinetics Pharmaceuticals, summed up this topic with a simple, “…what you’re good at, you do in-house; what you can afford you do in-house.”

Struthers’ team looks to outsourcing when dealing with capital- or labor-intensive projects and this was the consensus among panel members.  By focusing on the activities your team does best, your efficiency and productivity are maximized – all else can be outsourced.

Finding a CRO to Become Part of Your R&D Network

Finding a CRO you can trust is critical.  Here are some tips and practices from our panelists for finding the perfect CRO for your project:

  1. Seek recommendations from colleagues and friends.  Whether referrals are from scientists within your long-term network or a colleague in your current company, peer reviews are incredibly valuable for obvious reasons.  These recommendations can also help you distill your initial CRO options down to a few, making the search more manageable.
  2. Leslie Hickle, VP Business Development at BioAtla, LLC, identified the following three key areas to consider when determining if a CRO will be a fit for your project:
    • Quality – Do they have referrals?
    • Cost – Are their services cost-effective for this project?
    • Speed – Do they deliver on time?

    Hickle also notes that you will need to clearly determine your own expectations for each of these categories so you can easily compare CROs.

  3. Once a CRO is a fit, never, ever, ever – ever – let them go.  They are now part of your Virtual R&D Network.

Managing Successful CRO Relationships

While several elements comprise a successful strategy when managing a CRO, this statement truly sums up the hallmark characteristic of successful, long-term CRO relationships:

“…the really successful projects are the ones where we become like an extension of the project team, where we’re looked on as collaborators.”

- Panelist Diana Wetmore, Vice President of Business Development at Emerald BioStructures

Manage your CRO relationship as if it were another branch of your existing team. Speakers note that this extends to all areas of a project.  To successfully manage a CRO relationship, a strategy is required that consists of:

  • Partnership – Viewing your CRO as a member of your team will optimize your project’s productivity and overall success; CROs will give you input and documentation to help you with your budget, your strategy, and many other areas of your project.
  • Communication -
    • High frequency especially at the beginning of a project is important
    • Milestones and goals are clearly identified so no grey area exists
    • Virtual tools are extremely helpful throughout the entire project, and online video tools were identified as especially useful when establishing a new relationship
    • Problems or issues are communicated and handled as team
  • Dedicated Management – A dedicated person who manages the virtual meeting and collaboration process is essential.  This person leads and organizes the virtual meeting space, including: communications, coordinating attendee schedules, managing the call itself, gathering and sharing any relevant documents, following up with attendees, tracking the project and managing online communication platforms for team
  • Alignment – Be On the Same Page: To achieve success, both the CRO and the client need to be on the same page.  Know what you want and expect, and have the conversations early to establish the foundation for your relationship and ensure consistent successes.

Global or Local?

Resoundingly, the quality of the relationship, not where the CRO was located, seemed to be the most important ingredient.  However, here are some pros and cons of global vs. local CROs listed by our participants:

Global Pros 

  • Expanded CRO options
  • Virtual tools go a long way to reduce the barriers to leveraging global CRO options
  • Reduced cost
Global Cons 

  • Time differences can impede access to CRO team when you need them – establish the CRO’s availability early to ensure you choose one that meets your needs
  • IP protection may be less secure
  • Takes more time to build trust if a new relationship
Local Pros 

  • IP protection more secure
  • Easier to establish a relationship with the CRO
  • Time zone is not as big of an issue – availability when you need it
  • Easier to locate specialty CROs
  • Referrals are easier to find
  • Prices can be comparable to international rates
Local Cons 

  • May be more expensive
  • Limiting your CRO options

 

Best Virtual Tool to Help Manage Outsourcing

Participants appreciated the abundance of online tools and resources available to help build their global networks of outsourced R&D.  Useful tools included:

  • Virtual meeting spaces – Online video and audio programs allow easy, inexpensive, and (most importantly) frequent communication.
  • Virtual file-sharing spaces -  Sharing content quickly and securely helps to increase efficiency

How to Find Funding and Resources

Our participant, Jim Hauske, President and Founder of Sensor Pharma, notes four key questions that need to be answered to obtain funding, or the possibility of funding:

  1. Who owns the company?
  2. What is the therapeutic, or technology focus?
  3. What, if anything, has been accomplished?
  4. What is the IP estate?

And where to find that funding?

  • VCs
  • Pharma
  • SBIR grants (Small Business Innovation Research) – low hurdle for startups
  • Disease organizations
  • Patient Advocacy groups
  • High net worth individuals and their non-profit organizations
  • Self funded
  • Micro-funding (individuals, small private groups)

Resources: In addition to finding funding, resources are available for virtual drug discovery companies, such as San Diego Entrepreneur’s Exchange.  SDEE is a virtual incubator and social networking tool for San Diego startups.  This site allows scientist’s access to resources such as equipment and lab space and helps teams find other scientists with which to collaborate and potentially partner.

How are “risk sharing” deals really structured?

CROs can help to shoulder some of the risk involved with a project.  For example, Diana Wetmore explained that her CRO may determine the structure of a risk-sharing deal by assessing a project, then binning into one of three levels – low- , mid- , and high-risk projects.  Varying levels of commitment are proposed by the CRO, according to perceived probability of success.

In an extreme example of sharing the risk burden Richard Lin, moderator and President and CEO of Explora BioLabs, emphasized flexibility and creativity when assessing a risk-sharing deal.  He explained that his CRO performed an entire project for no fee, and received double the normal payment when the client achieved Phase I funding – a risk, but a clear win for both sides.

Bottom Line

You and your CRO are on the same team.  Utilize your network and online tools to find your CRO.  Then build a successful relationship by defining your expectations, communicating frequently, and including your CRO partner in all processes along the way.

We hope these tips and practices will help you to effectively manage your Drug Discovery outsourcing.

If all of your questions weren’t answered here, stay tuned for more in our Virtual Biotech series or leave a question or comment below.

Or, are you a CRO or virtual drug discovery scientist with some insights our community could use?  We’d love to hear from you!

Thanks to Our Virtual Drug Discovery Participants:

Jim Hauske, President and Founder,Sensor Pharma (Bio)

Virtual Drug Discovery panelists:

Leslie Hickle,VP, Business Development, BioAtla, LLC (LinkedIn)

Daniel Holsworth,Co-founder/Board of Directors, ODIN Therapeutics AS(LinkedIn)

Richard Lin (Moderator), President and CEO, Explora BioLabs (LinkedIn)

Ajay Madan, Senior Director of Development, Neurocrine Biosciences (LinkedIn)

Scott Struthers, Founder & CSO,Crinetics Pharmaceuticals (LinkedIn)

Diana Wetmore, Vice President of Business Development, Emerald BioStructures (Bio)

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Drug Development, Featured, SDBN Blog »

2011 Poll Results: Drug Development, Networking Top Interests

Posted by Mary Canady February 4th, 2011 .
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2011 San Diego Biotech Network Poll Results Word CloudThanks to everyone who took our 2011 poll, the results are IN! See the slideshare presentation below which summarizes the results. Check out the word cloud based on the essay answers, with largest words representing those used the most frequently by respondents, helping you to understand the results as a whole visually. We had a fairly small sample size (37), and still welcome input, leave your response here or on the LinkedIn post.

We use the results to plan the 2011 schedule. Here is a summary of the results:

  1. Top interest areas for science-focused events: Drug Development, Research Tools, and Diagnostics. The top results are similar to the results in the 2010 poll, however of note is that Drug Discovery dropped from the No. 1 interest to No. 5, with only 5% responding that they’d like to hear about it (respondents were asked for their top choice only). I’ll reiterate the small sample size, but I think this is indicative of the desire to learn about other areas due to the many layoffs in 2010.
  2. We got a nice list of companies you’d like to hear from, with few companies getting more than one vote (which makes it difficult to decide, more reason to leave a comment below). Check out slide 8 for a full list.
  3. Charities: Again this was a bit of a mixed bag, but people are interested in activities related to research or disease areas. in 2010 we did one charity event which fell out of this area (Mary was approached by I Love a Clean San Diego), and are willing to participate in research-themed events in 2011 if someone would like to step forward to coordinate.
  4. Networking/Science Mix: almost identical to last year’s results–you’re happy for the most part with the mix of science and networking, with a slight bias towards more networking. The word cloud indicates this as well. We’ve had several people come to us with ideas for different types of events and venues which will help with us. Keep them coming!

We’ve got lots of great ideas for 2011 based on your feedback, and we’re beginning with our February 15th event featuring Althea Technologies, which is a company you requested. To help everyone plan, we’ll be doing most events on the third Tuesday of each month. Mark your calendars and contact us if there’s an event you’d like to help plan or sponsor!

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Happy 2nd Birthday SDBN! How Should We Celebrate?

Posted by Mary Canady October 13th, 2010 .
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San Diego Biotech Network 2nd Birthday

It’s hard to believe it, but two years ago in November of 2008, we had our first SDBN event featuring Sapphire Energy at Rock Bottom in La Jolla. We soon outgrew that venue and have found a nice home at Tango del Rey, a one-of-a-kind location in PB which we feel is amenable to networking. To facilitate interaction, we’ve also tried to keep the cost of the events as low as possible, and to have interesting events which draw a nice crowd.

We started the SDBN to foster communication between biotech professionals and companies locally, and it is here to serve your needs in this area. We are very grateful to all of the wonderful people who have participated in these two years, let’s celebrate by hosting an event for you in early December. We polled you in late 2009 to learn about what you wanted in 2010, and perhaps this is a good time to get your pulse on what you want and need from the SDBN. Let’s ‘crowdsource’ our this event by voting and getting ideas from you. To get you started, here are some ideas we’ve kicked around for the event:

  • Social Media Panel or Presentation
  • Virtual Biotech Company Panel
  • Ultra Quick Pitch, Open to All (5-10 minute presentations, consultants, co.’s, etc.)
  • A Party, Plain and Simple
  • Insert Your Idea Here

Here’s how to cast your vote. I’ve listed the choices as comments below, vote for your favorite (click on the thumb below your choice). Have a new idea? Leave a comment below with your idea, and it will be ‘in the running’ as people will be able to vote on it too. Let’s use the honor system, and realize that if we get a lot of requests for a company to sponsor, that the company will need to defray some of the costs of the event.

To share this post easily, cut and paste: Happy 2nd Birthday SDBN! How Should We Celebrate? http://sdbn.org/celebrate

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SDBN Volunteers Needed for Coastal Cleanup Day September 25th

Posted by Mary Canady September 6th, 2010 .
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California Coastal Cleanup

We all hear about the Great Pacific Garbage Patch, an ‘island’ estimated to be twice the size of Texas containing plastic and other waste. How can we help to prevent more trash from reaching our oceans? California Coastal Cleanup Day is September 25th, and we have a great opportunity to help clean up trash inland before the rainy season carries it to the ocean.

Coastal cleanups started in 1984 on the Oregon coast, and now includes California volunteers from all coastal counties, with 80,000 participating last year and 10,000 in San Diego county. This year, the SDBN has been asked to participate in the Ruffin Canyon area in Serra Mesa. Please join us 9-12 on September 25th, and for those who are interested, we’ll find a nice watering hole to have lunch at and network afterward. We’ll also take and share photos, and I’ll bring a memento for each of you who participate. Sign up on the website and also let me know you’ll be participating using SDBN’s volunteer form, or drop me a line if you have my email address.

To prepare for the event, be sure to wear long sleeves and pants, a hat and sunglasses, cover any exposed area with sunscreen, and bring a filled reusable water bottle (we will also have water on site). This year, event organizers are asking volunteers to bring reusable items to help minimize the use of disposable items. Please consider bringing buckets, garden gloves, and reusable bags. I’ll be sending more information before the event. Hope to see you there–as a group we can make a big difference!

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