Strategies to protect Intellectual Property


Image result for bio2device


George Willman
, Partner at Reed Smith LLP, in areas of technology, transactions, patents, and IP conseling and Nina Borders, associate in the firm’s IP litigation group, focusing on patent and trademark prosecution and litigation, talked on Intellectual Property Protection Strategy at http://www.bio2devicegroup.org event.

Companies approach IP protection with twin goals of building value and creating an asset and avoiding infringement, said Willman. Willman and Borders spoke about the four major categories of IP, each protected differently with different body of law.

** Trade Secrets: Trade secrets help protect secret information and examples include secret formula, source code, manufacturing process, customer list and so on. The types of information that can be protected are broad, and trade secret protection may be available before a patent is filed and published. Also, unlike other forms of IP, there is no trade secret “application.” Most states require that you use reasonable measures to protect the trade secret in order for the trade secrets to be legally protected. Reasonable measures include – marking documents confidential, ensuring secure access to the building, and using NDAs and confidentiality provisions in agreements. Trade secrets can be reverse engineered or independently developed (assuming this is not breaching a confidentiality agreement or obligation or using other intellectual property such as a patent). In fact, the law encourages reverse engineering of trade secrets.

Venture capitalists do not typically sign NDAs. However, a presenting company should mark as confidential any slides, try not to leave material behind and not reveal entire secret sauce, said Willman. Whenever possible, the presenting company should file patent application prior to public presentations.

** Patents – Patents protect the right of the patent owner by excluding others from making, using, or selling the invention claimed in the patent without prior permission, said Borders. The most common patents are design and utility patents. Patents last for 20 years from the date filed and then the invention is in the public domain. The Patent’s subject matter is important. Utility patent for instance, protects the structure and function of the apparatus or system, the process of making or using something in an original way, or the composition of the matter. Design patent protects the ornamental or aesthetic features of a new or original design but does not cover the functional aspects of the design. Patents may be filed in the United States and in the respective patent offices of other countries if international patent protection is sought. There is no such thing as a world wide patent, said Borders.

Patent application filing must include white paper-like description of the invention plus all drawings and claims which set forth the key aspects of the invention. In order for an invention to be patentable, it must meet the requirements of novelty, utility and nonobviousness, said Borders. Also inventor can file a provisional patent as a placeholder and would have a year to convert and file a full application for examination. What may not be patentable are laws of nature, natural phenomena, and abstract ideas like algorithms.

** Trademarks: Trademarks are any word, design, slogan, tagline, color or sound that serves as a source identifier for the company and where a consumer may see it and identify it with the company may be a trademark. It can be a word, name, phrase, symbol design or combination, and it may identify and distinguish the source of the product or service. Trade dress, which is the look and feel of something such as package design or the motif of a restaurant or retail store may also serve as a trademark, said Borders. Common law rights, arising from use, allow the owner to accrue trademark rights and enforce the mark against someone using a similar mark solely based on the use of the mark, however there are definitely benefits to registration too, said Borders. Trademark can be registered at the federal level for protection in all 50 states or it can be filed in a particular state or states. Trademark filing is different in different countries and most countries, outside US, don’t recognize rights in use. A trademark can last as long as the trademark is in use and, for a registered trademark, as long as the trademark registration continues to get renewed. With proper use, trademarks can last indefinitely, said Borders. Inventor can licence all IP or trademarks to others to use and they should control and monitor the propriety of use.

** Copyrights: Copyrights give the owner legal protection for works of authorship, including things like books, movies, paintings and so on, and important for technology companies, softwareThe bar for copyright protection is very low and requires originality. One cannot get copyright protection on ideas, or the underlying processes of software. However, copyright can protect source code from copying. If you can get it, a patent can provide broader protection than a copyright, since patent claims can cover broad classes of solutions.. However, in certain industries like the movie world, copyright is the standard form of protection.

Recaping different strategies for protection, Willman said that a patent costs the most and can offer the highest level of protection whereas the cost for copyright can be relatively low but generally may offer less protection. On the other hand, trade secrets and trademarks offer mid range protection and cost in the mid range as well, said Willman.

The session was followed by Q & A.

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JOBS – February, 2016


Program Management Leader – San Jose, CA

Innovative, drug-delivery startup with disruptive technology has an exciting opportunity for program and project management leader.  This individual will drive the program/ project teams to scope and schedule baselines; will remain focused on delivering to all committed milestones and hold project teams accountable; and will communicate regularly to peers and management to set expectations and remain in alignment on deliverables.  Strong background and deep understanding of engineering, technology, tooling, and manufacturing is absolutely required.

Project Management Leader – San Jose, CA – FILLED

Innovative  drug-delivery company has an exciting opportunity for project management leader with pharmaceutical development background.  This individual will drive the team to meet deliverables on time and within budget, and will communicate regularly with peers and management to set expectations and remain in alignment on deliverables.  Strong understanding of analytical chemistry, molecular biology, and in vivo pharmacology is absolutely required.

Director of Manufacturing Engineering – San Jose, CA

Innovative medical device company has a very exciting opportunity for Director of Manufacturing Engineering.  This position will be responsible for leading the team from R&D to manufacturing with a relentless focus on equipment and processes to drive maximum efficiency, maximize reliability and minimize cost.  This position is ideal for someone with a mechanical engineering background and someone who likes to build machines and is a tinkerer.  Additional background in pharma would be a huge plus.

Director of Quality – San Jose, CA

An Exciting drug delivery company has an immediate opening for Director of Quality.  This position requires a rich quality background and strong experience in either class III devices or pharma.  Requires experience of implementing quality systems and with running a strong quality organization with several direct reports.

Research Associate/ Scientist – Milpitas, CA – FILLED
Innovative, well funded startup has immediate opening for scientist/ research associate.  Requirements include, solid track record in bioanalytical assays.  Additonal proficiency in HPLC, Elisa immunoassays, luminescence assays, fluorescence assays or related, a huge plus.  Absolutely required, a bachelors in biochemistry, molecular biology or related field, PLUS several years work experience.

Senior Scientist – Milpitas, CA – FILLED

Innovative, well funded startup has an immediate opening for senior scientist.  Requirements include, proficiency in HPLC, Elisa immunoassays, luminescence assays, fluorescence assays or related.  Experience in quantitative analysis, variability analysis in tissue and plasma, experience in pharmacokinetics, and experience in biologics a big plus.  Stocks and benefits make this a highly attractive opportunity to be involved in cutting edge technology, at grounds level.

Mechanical Engineer with deep Injection Molding Experience – Milpitas, CA

Experience of working 8+ years in medical device arena is absolutely required.

Analog Design & Embedded Systems Engineer – Milpitas, CA

 

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Understanding Trump Effect during US Elections


A potential voter recently declared “I will vote for Donald Trump (and to a lesser extent Bernie Sanders)”.  Another one said, “He will expect greatness from us, he will tell us how to get to great, he will inspire people to be better than they are and have the hope that their efforts will not be thwarted by bigger government.”   Yet another one said, “Many are right; it’s not about trusting Trump; it’s a collective middle finger to the establishment….”  Here are some more comments on why people are enamored with Trump and would vote for him, “ONLY TRUMP has ever BUILT any REAL THINGS”; “Trump makes brash and uncompromising statements about issues many people feel very passionate about”; “On the two primary issues as to why I’m supporting Mr. Trump he has remained stunningly consistent.”

One can’t argue with the fact that Mr. Donald Trump has remained “stunningly consistent” in insulting his way through to the top of his party.
So what is the lure of Mr. Trump in the US?
Unlike what the liberals would like to believe, it is not because Trump has the support of white supremacists, or right wing conservatives, or the religious right, that he is beating his rivals to a pulp.  Many potential voters are also very liberal and many of them voted for Mr. Obama in the past.  I have listened in on some call-in shows where potential voters call in, gushing about Trump as they declare that they are changing parties to vote for Mr. Trump.

Here is a feeble attempt to understand this curious phenomenon based on the messages Mr. Trump sends out and how he sends them out.

  • Sharing information about threats makes one appear more reliable.  Trump’s entire candidacy is based on making assertions about how everyone else has put the country in harm’s way.

In one study, people read two descriptions of the same product.  However, one had an additional sentence “If you press control keys during installation, the software may damage your hard disk”.  People rated the writer of the threatening description to be more competent.  Trump’s entire campaign is built on how the world is a big, scary place and he can make America great again.

Consider these statements: Hillary Clinton was the worst Secretary of State in the history of the country. The world came apart under her reign as Secretary of State”; “Obama has no solutions. Obama has failed the country and its great citizens…”; “What a waste of time being interviewed by@andersoncooper”; “Jonah Goldberg @JonahNRO of the once great @NRO#National Review is truly dumb as a rock”; “What people don’t know about Kasich- he was a managing partner of the horrendous Lehman Brothers when it totally destroyed the economy!”.  Speaking of Mexican drug lord, he tweeted, “Can you envision Jeb Bush or Hillary Clinton negotiating with ‘El Chapo” and said he however, “would kick Chapo’s ass!”.  About McCain, “He’s not a war hero”; about Mexico, “US has become a dumping ground for everyone else’s problems”; about Bernie Sanders,  “[Sanders] knows the country is ripped off. And I know the country is being ripped off, The difference is that I can do something about it and he can’t”.

  • Research shows that messages of concrete threat (as opposed to vague threat) are deemed more believable.  Trump makes threats very explicit, concrete and immediate:

In one study, concrete threat message like “the site you are about to visit has been confirmed to include software that poses a significant risk and will infect your computer and will try to steal credit card details” was found to be much more believable than vague threat like “we have blocked your access to this page because it is possible that he page contains software that may harm your computer”.  Now consider this message from Trump about people from Mexico, “they are bringing drugs, they are bringing crime, they are rapists” versus this statement from Governor Kasich, in one of the debates “I’ll tell you about Wall Street: There’s too much greed.”  Trump gets specific about the threats. including threats from things that did not happen.  For instance, he has repeatedly asserted claims that he watched television footage of “thousands of Muslims celebrating 9/11 in Jersey City”.  The more he makes specific assertions like that, the more believable and therefore Presidential, he appears.

  • People who talk big are more likable and appear more reliable. Trump is nothing but empty big talk.  

These big talkers  make our problems appear simple and easy to solve, even when they are not.  Trump said, “If somebody has no money and they’re lying in the middle of the street and they’re dying, I’m going to take care of that person.”

  • Identifying concrete action steps for real or potential problems, makes one appear more reliable.

Trump is not just being specific about the threats but he also givens specific action steps to deal with the problem.  For instance, to secure the border, he says, “I will build a great, great wall on our Southern border and I will make Mexico pay for that wall”.  Of course, if he would be asked to break down his assertions on further specifics on how exactly he plans to do what he says he will do, then it would crumble like the Berlin Wall.  But there are two things that work for him.  1) He follows the principle “attack is the best form of defense” and so he is rarely on the defensive end and 2) He has refused to participate in the debate where potential candidate would be put on the spot regarding such whimsical assertions.

  • Repeat statements of threat (even when known to be false), can still go viral and carry significant weight.  If this finding is stretched a bit further, Trump’s ongoingly throwing random insults at people, make his insults more credible, instead of less.

In one of the most disturbing findings that has emerged in recent research, it was found that reading a false statement (for instance, “The Atlantic Ocean is the largest ocean on Earth”) made people more likely to rate the statement as true when they read it a second time, even when they were told on both occasions that it might be false and even when they later showed that they knew that the Pacific was the largest ocean.  Trump’s repeated false assertions are now getting carved in people’s minds as if they are truisms and not Trumpisms.  

  • To persuade people, one can use arguments that fit within the moral framework of the constituents, rather than the opposing candidates – exactly what Trump does.  

Most candidates campaign as if the entire campaign is a debate against other candidates.  Short of hurling insults, Trump never responds to any substantive remarks by other candidates.  Instead, he tries to identify with simplistic statements that resonate with his beaten down, anti-establishment constituents. For instance, consider these statements, “I feel a lot of people listen to what I have to say”; “A certificate of live birth is not the same thing by any stretch of the imagination as a birth certificate”; “All of the women on The Apprentice flirted with me – consciously or unconsciously. That’s to be expected”; “You know the funny thing, I don’t get along with rich people. I get along with the middle class and the poor people better than I get along with the rich people”.  

Trump is not going to make US great.  United States of America IS a great country because we have a vibrant democracy, with a healthy respect for diverse perspectives.  Regardless of the entertainment that ensues from the campaign theatrics, in the end, people take their responsibility to vote seriously.  In the end, people study the issues and cast their votes to reflect their position on substantive issues. Big money plays a big role in America.  But in the end, “internet” and “google.com” were born in America; majority here supports “net neutrality”, and “Wikipedia”; people often check facts on sites like “snopes.com” and “factcheck.org”; all that going to show that there is great value for substantive facts and information.  and In the end, often silent and honest people who may not have time to attend the rallys, exercise their most precious democratic right; the right to vote.  It is no small feat that it is the people who make and keep America great.

Source:  I used the article below in Atlantic Monthly as a jumping off resource and then researched more for other information via google search.  http://www.theatlantic.com/magazine/archive/2015/11/tall-tales/407836/

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“Hershey Felder as Irving Berlin” – Play Review


Inspiring story of “America’s Composer” Irving Berlin comes to life in the musical “Hershey Felder as Irving Berlin”, currently playing at www.theatreworks.org .  Directed by Trevor Hay, based on lyrics and music of Irving Berlin and based on a book by Hershey Felder, this absolutely must-see performance comes to life through incredible acting and music of Hershey Felder.  

 

Though born in Russia, Berlin embraced his new homeland and began writing songs in his youth, which made him “a legend” before he turned thirty.  Many of his songs reflect the challenging atmosphere in the country as he lived through World War I and then the Great Depression and then World War II.  Besides chronicling the historical events, his compositions marked each stage of his life and all his relationships, through the “gift of a song”.  At the tender age of 13, when his father passed away, Berlin left his home to make his mark on the world.  He married beautiful young girl Dorothy, who passed away soon after their honeymoon.  At the insistence of his brother-in-law, he wrote this touching song.  

I lost the sunshine and roses
I lost the heavens of blue
I lost the beautiful rainbow
I lost the morning dew
I lost the angel who gave me
Summer the whole winter through
I lost the gladness that turned into sadness
When I lost you

Felder says, though his lyrics, Berlin wrote, “basic truths, muscially told”.  Entire audience erupts into singing when Felder sings the song below and Felder says he loves the audience singing along.

Hip hip hooray
We haven’t got long to stay
So how about one bouquet
For the Navy?

Berlin composed a song to give a comic perspective on military life, shortly after he was drafted.   Although he composed the song Oh! How I Hate to Get Up in the Morning” without commercial intent, it became popular with the soldiers and it eventually appeared in three different Broadway shows and Berlin made $83,000 on it.  

Few years later, Berlin met Ellin Mackay, 15 years his junior, and a heiress, who was disowned by her father for marrying Berlin.  They remained together for 62 years, until Dorothy’s death at the age of 85.  Ellin and Irwin had several children and Berlin composed some great songs to mark the birth of each of their children.  Berlin was a savvy businessman as well.  He built and owned The Music Box Theatre on Broadway and bought back the rights to all his songs.

In 1933, there were 24 lynchings in the South.  Berlin put on a show on Broadway to tell their story and it was a huge success.  During his long lifespan and particularly towards the end of his life, Berlin went through phases when he did not compose anything and lived as a recluse.  And yet, during his life, Berlin wrote an estimated 1,500 songs, including several for 19 Broadway shows and 18 Hollywood films.  Eight times, several films with his songs were nominated for Academy Awards.  Here’s a song that was made famous by Fred Astaire dancing to the lyrics.

 Heaven… I’m in heaven,

And my heart beats so that I can hardly speak.
And I seem to find the happiness I seek,
When we’re out together dancing cheek to cheek.

When US entered World War II, Berlin composed God bless America, land that I love, and after it was sung by Kate Smith, it became an instant hit.  In a move that marks his love for his new homeland and a mark of his generosity and grace, Berlin drafted instant legal instructions that are in effect to this day, donating all proceeds from the royalties to Boy Scout and Girl Scout programs in impoverished and disadvantaged areas.  So far, more than $10 million have been distributed, as per his request.  

Berlin produced his last musical, “Mr. President”, when he was 74 years of age.  The original 1962 Broadway production ran for 265 performances.

On Hershey Felder
Hershey Felder, 47, a Canadian-born artist does solo shows across America, on great composers like Gershwin, Bach, and Beethoven and he explains and embodies them and plays their music.  Combining his phenomenal musical genius with superb storytelling, In Irwing Berlin, Felder has created character portrayal and musical performance that is nothing short of dazzling.   “Hershey Felder as Irving Berlin” is a must-see show.  In addition to interesting and gripping aspects of Berlin’s personal life, it weaves the history of the country, and of show business, in the narration, that is entertaining and endearing, and ultimately moving.

“Hershey Felder as Irving Berlin” will be running at www.theatreworks.org till February, 14 .  This is an absolutely not-to-miss performance of this theater season in the bay area, where you will come away inspired, entertained, and awed.  Additionally,  there is a special one-night only presentation of Hershey Felder’s Great American Songbook Sing-Along, on February, 15.  

Enjoy lyrics to my favorite and Berlin’s famous song below.

There’s no business like show business like no business I know
Everything about it is appealing, everything that traffic will allow
Nowhere could you get that happy feeling when you are stealing that extra bow

There’s no people like show people, they smile when they are low
Even with a turkey that you know will fold, you may be stranded out in the cold
Still you wouldn’t change it for a sack of gold, let’s go on with the show

The butcher, the baker, the grocer, the clerk
Are secretly unhappy men because
The butcher, the baker, the grocer, the clerk
Get paid for what they do but no applause.
They’d gladly bid their dreary jobs goodbye for anything theatrical and why?

There’s no business like show business and I tell you it’s so
Traveling through the country is so thrilling, standing out in front on opening nights
Smiling as you watch the theater filling, and there’s your billing out there in lights

There’s no people like show people, they smile when they are low
Angels come from everywhere with lots of jack, and when you lose it, there’s no attack
Where could you get money that you don’t give back? let’s go on with the show

(There’s no business like show business like no business I know)
You get word before the show has started that your favorite uncle died at dawn
Top of that, your pa and ma have parted, you’re broken-hearted, but you go on

(There’s no people like show people, they smile when they are low)
Yesterday they told you you would not go far, that night you open and there you are
Next day on your dressing room they’ve hung a star, let’s go on with the show!!

 

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Pulmonary Diseases – Talk by Dr. Sanjay Agarwal at B2DG


Dr. Sanjay Agarwal talked on “Idiopathic Pulmonary Fibrosis (IPF)” at www.bio2devicegrou.org event.  Dr. Agarwal is CEO of the Comprehensive Sleep Center and is affiliated with several hospitals in the Bay area, CA.  He specializes in Pulmonology, Critical Care Medicine, Internal Medicine, and Sleep Medicine.

Dr. Agarwal reviewed different types of pulmonary diseases, including pathogenesis, diagnostic modalities, and treatment considerations, with an emphasis on pulmonary fibrosis.  Pulmonary fibrosis (PF) is one of the family of related diseases called Interstitital Lung Diseases (ILD) that can result in lung scarring.  As the lung tissue becomes scarred, it interferes with a person’s ability to breathe.  There are four main classifications.  In some cases, the cause of pulmonary fibrosis can be found and that can point to a treatment modality.  But in majority of cases of pulmonary fibrosis have no known cause and that falls under the classification of idiopathic pulmonary fibrosis (IPF). 

IPF is chronic, progressive fibrosing interstitial pneumonia occurring primarily in older adults.  Not only the cause is unknown, but it takes an unpredictable clinical course and always leads to progressive lung function decline and eventually to death.  There are about 40,000 new cases of IPF each year, in the US.  

Generally, repeat and epithelian injury leads to initiation of normal repair mechanisms that release pro-fibrotic mediators into alveolar lumen and that leads to wound clot formation.  Epithelial tissue usually responds to injury through a sequence of highly regulated and overlapping events for successful tissue repair and barrier integrity.  However, when normal response to tissue injury becomes dysregulated then abnormal responses occur that lead to fibrosis and thickening of the walls.  The progression thus goes from injury to activation of repair response to imbalance to endothelium epithelium fibrolasts to eventual fibrosis.  TGF Beta is linked to pathologic activities in IPF.  

In the last 20-30 years, it had been assumed that inflammation was one of the primary causes that led to IPF.  However, recent research, including patient biopsy samples, indicates that not to be the case, said Agarwal.  Also, anti-inflammatory therapies like steroids, do not work and in fact have proven to be harmful.  

In addition to genetic factors, various environmental factors are assumed to predispose an individual to IPF.  Risk factors include smoking and various enviornmental pollutants.  Certain professions considered to be high-risk for IPF include hair cutting salons, stone cutting, polishing, exposure to livestock, animal dust and so on.  Viral infections and also infections from micro bacteria, can lead to fibrosis.  Strong GERD or acid reflux disease is also implicated to be a factor.

Generally, patient comes in complaining of unexplained chronic exertional dyspnea, chronic cough, bibasilar inspiratory crackles and finger clubbing.  In IPF patients, physicians also follow some important parameters, including total lung capacity (TLC), diffusing capacity of the lungs for carbon monoxide (DLCO), and forced vital capacity (FVC) change.   But none of these measures are consistent predictors of the progression of the disease.  There is a very high inter and intra subject variability in rate of disease progression, said Agarwal.  Generally however, the prognosis in IPF is very poor with less than 4 years in median survival rates.  Compared to other ILD, the IPF prognosis is worse, said Agarwal.  Several related factors including clinically significant depression, loss of independence, inability to perform routine daily tasks, also drastically impact the quality of life.  And IPF dramatically increases healthcare costs due to higher admission rates, longer hospital stays, and utilization of more outpatient services.  

Some of the early IPF therapeutic research focused on triple drug therapy versus placebo.  Though initially deemed a medical success, the triple drug regimen actually led to worse outcomes, including greater mortality, than a placebo or inactive substances.  Warfarin was tried and was found to not work well for IPF.

Not only causal factors remained unclear but there wasn’t a clear guideline on ideal treatment modality.  Patient education, and pulmonary rehabilitation with extensive exercise regimen to tone the muscles seemed to be helpful.  Long term oxygen therapy was found to be helpful in some cases.  For some patients lung transplantation was an option.  Mechanical ventilation was the course of action for patients ending up in ICU but was not frequently used and was not an ideal modality because it was challenging to get these patients off the ventilators.  

Two newer therapies include the drugs Pirfenidone and Nintedanib.  Both are orally administered and have some antiinflammatory and antioxidant properties and reduce decline in FVC, slow down progression of the disease and improve quality of life.  There is some evidence that they lead to statistically significant improvement in lifespan.  

Dr. Agarwal highly advocated a comprehensive approach to treating this complex disease.  Many hospitals follow multi-disciplinary treatment approach.  For instance GERD affects up to 90% of patients with IPF and may be clinically silent factor with chronic microaspiration of gastric secretions and may play a significant role in pathogenesis of IPF.  GERD medication is associated with less radiologic fibrosis and longer survival time.  Additionally, pulmonary hypertension is highly prevalent in patients with IPF and should be treated upfront.  IPF is also associated with changes in sleep.  In IPF, the REM sleep is decreased and its efficiency is greatly reduced, leading to reduced amount of deep sleep, with a lot of fragmentation.  Enhancing quality of sleep can impact the progression of the disease.  And in summary, patient education, training, enhancing functional exercise capacity, and several behavior modification approaches can together have a significant impact on this progressive and irreversible disease with high morbidity and mortality.

The session ended with Q&A.

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JOBS – January, 2016


Earlier this month, startups, partnering companies, and pharma, biotech and medtech professionals, along with investors were out in record numbers, in various conferences and evening receptions.  The 34th annual J.P. Morgan Healthcare Conference, 9th annual OneMedForum and 8th annual Biotech Showcase events, in San Francisco, kicked off the year in high gear.  Opportunities below are for candidates located in the United States only.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

Project Management Leader with BioChem background – Milpitas, CA

This is an exciting opportunity with a huge potential upside in stocks, in an innovative company with unique drug delivery technology.     Background in pharma chemistry, and 10+ years experience with microsoft projects may be ideal.  Drug delivery device experience, a big plus.

Project Management Leader with Engineering background – Milpitas, CA

This is an exciting opportunity with a huge potential upside in stocks, in an innovative company with unique drug delivery technology.    Engineering background with 10+ years experience in project management may be ideal.  Drug delivery device experience, a huge plus.  More details will be posted soon.

Senior Mechanical Engineer – San Jose, CA

Requires 8-10 years of experience.  Polymer science background and angioplasty experience may be ideal.  I am awaiting more details, but send resume ASAP, if interested.  This will be an exciting opportunity to work on disruptive technology that will alter treatment options for diseases like diabetes to various inflammatory diseases.

Analog Design & Embedded Systems Engineer – San Jose, CA

Requires 8-10 years of experience.

Director of Quality Engineering – Milpitas, CA

There is an immediate opportunity for Director of Quality Engineering.  Requires 10+ years experience with implantable devices.  Some pharma and/or drug delivery device experience highly desired.  Experience in implementing QE systems, a great plus.  This is very exciting opportunity to be involved in multiple projects with a huge potential upside, in stocks.

Director of Manufacturing Engineering – Milpitas, CA

There is an immediate opening for Director of Manufacturing that requires 10+ years experience with implantable devices.  Experience with injectible drugs, highly desired.  Strong hands-on expertise in tooling is required.  This is an exciting opportunity to be involved in multiple projects with a huge upside, in stocks potential (a once in a lifetime kind of an opportunity).

Junior Biochem Scientist/ Research Associates- San Jose, CA

Requires BS or MS in Biochemistry, Molecular Biology, Pharmacology or related area of science and several years of bioanalytical experience.

Senior Biochem Scientist- San Jose, CA

More details will be posted soon.  Meanwhile, senior scientists with strong bioanalytical background and drug delivery experience, please contact me.

Post-doc opportunity – San Jose, CA

If you have have engineering related post-doc from top notch university, could get excellent references, and have a passion for engineering, then feel free to send me your resume.

Senior Quality Engineer – San Antonio, TX

There is an immediate opening for senior quality engineering with strong QE experience in medtech and biotech, in San Antonio, TX.  If interested, feel free to send me your resume. (see details in previous jobs post).

R&D Engineer – Phoenix, AZ

Details will be posted soon.

 

All above opportunities are for candidates located in the United States only.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

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To be Takei – Movie (documentary) Review


 

Director Jannifer M. Kroot’s documentary, “To be Takei” is a beautifully put together kaleidoscope view of the life of “Star Trek” actor, George Takei.  Witty, personable, gay rights activist, and actor, now 77, is still a beloved figure with over 7 million Facebook fans.  

Takei is active in social media and uses his fan base to spread the message on gay rights.  His life partner, Brad Takei (yes, he has taken on the Takei name) is efficient and highly organized, if somewhat controlling.  Brad competently manages the business and their home (including taking care of George’s aged mother, till she died).  He handles the details of his celebrity husband’s event-filled days.  At public events, Brad collects money for the autographs that George signs, keeps the line moving, and keeps George stress-free, so George can focus on being personable to his fans.

Tracing his earlier life history, Takei talks about his childhood spent in a Japanese-American internment camp during World War II.  “We were incarcerated simply because we looked like people who bombed Pearl Harbour and then we were put behind barbed wires; no charges, no trial”, he says.  Takei blamed his father for not standing up for his family, against the Government.  Ruefully he says, “my father was the kindest person on earth”, and internment ordeal to his parents was about “enduring with dignity, to have fortitude under the most trying circumstances”.  Eventually, in his adult life, he has channeled his grief and regret into a musical “Allegiance”, about the internment camps and their effect on future generations.  

The documentary does not center around “Star Trek” but there is some footage and some history is shared including some witty repartee between William Shatner (Captain Kirk) and George Takei.  There is some antagonism between the two that has lasted throughout three seasons of the TV show, six movies, and five decades.    

Jennifer Kroot and Editor, Bill Weber has beautifully put together the story of eclectic and vibrant, George Takei.  Transitions between different periods of his life and about different parts of his life seem natural, the story keeps moving forward, and all the pieces eventually seem to be woven together into a beautiful tapestry of Takei’s life.  On a scale of 1-5, with 5 being excellent, I rate it as 4.2 .  

 

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Digital Entrepreneurs: VLAB event Panel Preview


 

Entrepreneurs generally focus on finding a product or service that solves a problem, find a way to monetize it, drive revenue and lead a right team to scale up to a steady growth.  Millennials, fast emerging new breed of entrepreneurs, are using digital technology to create a niche or are finding ways to offer their services and scale through the use of digital strategy and marketing.

At VLAB event to be held at SRI International on January 26, 2016, young panelists on the startup runway who have sparked investors’ interest, will share their stories.   The event will be moderated by Adam Draper, Founder and Chief at BoostVC, a Silicon Valley based, seed stage accelerator that invests in block chain and virtual reality startups.

The panelists include Anne Wootton, Co-founder at Pop Up Archive, Pelu Tran, President, CCO and Co-Founder, Augmedix and Stanley Tang, Co-Founder at DoorDash.

Pop Up Archive is in the disruptive space of making sound searchable, through the use of cutting edge speech-to-text technology.  It allows content creators to store, search, and access audio files from anywhere in minutes, with additional features like ability to edit the audio transcripts using key commands to pause and rewind, accept or reject tags from a list of machine generated keywords, and more.  This offers a high quality workspace and audio search tool to journalists and archivists.

A wide range of likely benefits like improved patient care & participation, improved care coordination & diagnosis, improved patient outcomes and cost savings, are all driving a slow but sure move from paper records to EHR or electronic medical records and companies like Augmedix are spearheading the transition.  With wearable technologies like Google Glass, Augmedixa HIPAA-compliant documentation service, makes it easy for physicians to efficiently chart the progress, take notes, and improve patient satisfaction.

Found in 2013, DoorDash aims to use logistics services to offer food delivery from restaurants on-demand.  Found by a group of Stanford students and launched in the South Bay, CA, DoorDash has since expanded to several other markets and has raised nearly $60M over several financing rounds.  

This panel of young entrepreneurs will share their stories at VLAB event, at SRI on January 26, from 6 to 8:30pm.  The panelists will share the challenges they overcame in their entrepreneurship journey thus far, share tips and lessons learned that would help others navigate towards success, and will answer questions about founding a startup and raising money.  Register for the event at www.vlab.org .

 

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Panel discusses perception of overpricing in Biopharma at 2016 Biotech Showcase


 

While attendance is limited at JP Morgan event, registration is open at the concurrently occurring Biotech Showcase at Park 55, Cyril Magnin Street in SF.  In addition to public and private company presentations, there are exciting panels and talks throughout the day.  Lunchtime panels are also highly exciting.  Yesterday, January 11, lunch panel focused on the drug pricing debate and moderator Mike Griffith, EVP at inVentiv Health, invited panelists to weigh in on the widespread perception that drug companies are constantly overpricing their product.  

Beth Roberts, Partner at Hogan Lovells said that those are soundbites and reality is more complex but complex explanations often lose against sensational sound bites.  Explaining the complex reality, Gregg Alton, EVP at Gilead said, industry regulations often prevent companies from talking freely.  Alton also defended high price of Gilead drugs and said that Gilead gives away many drugs in the developing countries.  He also said, drug pricing in US and Europe is very similar, contradicting the notion that drugs are available at much cheaper price in Europe.  He said, he sleeps well because over half a million people are cured of HepC, on account Giliead’s drugs.

Ron Cohen, CEO with Acorda Therapeutics and Chairman at Biotechnology Industry Organization (BIO), said, biopharma must not be blamed for price hikes.  At least 30% of increase in healthcare related costs is on account of increase in hospital costs.  He added, people have to understand that biotech innovation has to occur over a long period of time and success are few and far between many failures.  “When we seek breakthrough therapies, we have to allow outsize return because there will be failures before successes, and breakthough innovation can only be funded over a long term, added Cohen.  

Sara Radcliffe, President and CEO at California Life Sciences Association (CLSA) said that as long as there are deadly diseases and people are dying from them, it is imperative that biotech innovation continues.  However, biopharma industry often encounters the “good problem” which is, “when a drug is that good, people want it for free”.  According to Keith Kelly, MD at Pricing and Market Access, Campbell Alliance/ inVentiv Health Consulting, biopharma is an exceptional industry that focuses on healing.  Cohen added, we should be proud of the contribution we make to the quality of life.

All panelists emphasized the need to engage with the media and public at large and advance better explanations for people to understand what lies behind the pricing strategy.  Panelists also stressed the need to main integrity at all costs and keep the focus on quality of care and patient safety, at all times.

 

 

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2016 Biotech Showcase, JPM & OneMed Healthcare Events


Investor and networking conference at Biotech Showcase @EBDGroup in San Francisco this week, is abuzz with interesting panels, speakers, and limitless networking in between.  This is the busiest week for #healthcare industry, with primary anchor event at 34th annual JP Morgan Healthcare Conference, and two concurrent events at 9th annual OneMedForum and 8th annual Biotech Showcase.

Biotech Showcase offers a phenomenal networking opportunity for young biotechs.  Over 300 companies will present over the course of the three days.  As the outlook has improved recently, there is a great focus this year on companies and investors exploring funding opportunities and both Biotech Showcase and OneMed events will focus on facilitating connections between investors and companies.

Biotech startups are often birthplace for innovation and they frequently disrupt how healthcare is delivered.  Investors and pharma companies are keeping a close eye on many emerging biotechs participating this year.  Although compared to 2014, biotech IPOs slowed down in 2015, with 34 IPOs, it was the 4th highest yearly biotech total on record.  There have been over $5 billion worth of IPOs in 2015 and there were $605 billion worth of takeovers, and the trend is likely to continue.

The events in the city this week, along with multitude of evening receptions, offers unprecedented opportunity for information and networking.  Biotech Showcase has exciting lunch panels centered around variety of topics from healthcare pricing debate to State of the industry to Biotech Bubble trouble to Life Science 2016 small cap watchlist.  Other panels tackle exciting topics such as Regenerative Medicine, Digital Healthcare, Corporate VC funding and more.  Biotech Showcase is produced in partnership by Demy-Colton Life Science Advisors and EBD Group to help biotechnology and broader life science industry thrive.  To register for this event, go to www.ebdgroup.com .  Stay tuned for more blogs and send me a message if you would like to meet up in the city.

Here are links to some of my past blogs
http://bit.ly/Whb2g3 – 2013 JP Morgan Healthcare Conference: Pharma & Biotech company presentations
http://bit.ly/xzqghY – 2012 JP Morgan Healthcare Conference
http://bit.ly/1L0NNTk – 2015 OneMedForum – Partnership opportunities with China
http://bit.ly/1uknZXJ – 2015 OneMedForum
http://bit.ly/1fhRnZr – 2014 OneMedForum
http://bit.ly/10zBuce – 2013 OneMed Forum

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