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Real Time Coverage @BIOConvention #BIO2019: Keynote Address Jamie Dimon CEO @jpmorgan June 5 Philadelphia

Reporter: Stephen J. Williams, PhD @StephenJWillia2

 

  • Dr Janet Woodcock from FDA was given the BIO Heritage award for leading the FDA from safety focus of 90s to the Voice of the Patient. She became a champion for advocacy groups
  • Governor Phil Murphy, Governor of New Jersey, received the Governor of the Year Award.  New Jersey known as medicine chest of the world, have first 3D printed drug on market and number two in biotech and number one on drug approvals.  We must do more to foster stem education.  It will take private and public capital investment.  New Jersey matches federal dollars and had doubled the angel investor tax credit.
  • Dr. Kakkis CEO of Ultragenix wins the Genzyme Henri Termeer Award for visionary work.  Dr. Termeer recently passed.  Dr. Kakkis is awarded for work with patients of rare diseases and help formulating legislation to help patients with rare disease have access to investigational drugs quickly.
  • Dr. Jeremy Levin from OVID named new chair of BIO

Interview with Jamie Dimon, CEO of JPMorgan

  • Mr Dimon had recently survived throat cancer and now has a renewed dedication to improving people’s lives.  With Amazon had embarked on a nonprofit experimental model to streamline healthcare for their employees.  He said the hardest part of going through cancer was telling his parents and children.
  • On the bailout he said it was a lie all banks needed TARP but could not just give to some and not all.  He says the financial system in US is very solid so next downturn will not come from financial sector and never is from geopolitical but trade issues could be a catalyst. Policy usually always does the opposite of what is intended.  He announced no intention of running for President of US.
  • We need to keep a growth agenda which includes education and infrastructure, without these competitive business tax relief does no account for much.  We need a better conversation of how government handles finances
  • Immigration, education very important.  Higher education needs to reduce costs and incentivize the people they bring in to stay here.
  • on healthcare:  JPM had reduced the deductables to zero for workers making $60,000 or less

Please follow LIVE on TWITTER using the following @ handles and # hashtags:

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@pharma_BI

@AVIVA1950

@BIOConvention

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#BIO2019 (official meeting hashtag)

Other Article on this Open Access Journal on Global Partnerships, Global Investing and JPMorgan Include:

 

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37th Annual J.P. Morgan HEALTHCARE CONFERENCE: News at #JPM2019 for Jan. 8, 2019: Deals and Announcements

Reporter: Stephen J. Williams, Ph.D.

From Biospace.com

JP Morgan Healthcare Conference Update: FDA, bluebird, Moderna and the Price of Coffee

Researcher holding test tube up behind circle of animated research icons

Tuesday, January 8, was another busy day in San Francisco for the JP Morgan Healthcare Conference. One interesting sideline was the idea that the current government shutdown could complicate some deals. Kent Thiry, chief executive officer of dialysis provider DaVita, who is working on the sale of its medical group to UnitedHealth Group this quarter, said, “We couldn’t guarantee that even if the government wasn’t shut down, but we and the buyer are both working toward that goal with the same intensity if not more.”

And in a slightly amusing bit of synchrony, U.S.Food and Drug Administration (FDA)Commissioner Scott Gottlieb’s keynote address that was delivered by way of video conference from Washington, D.C., had his audio cut out in the middle of the presentation. Gottlieb was talking about teen nicotine use and continued talking, unaware that his audio had shut off for 30 seconds. When it reconnected, the sound quality was reportedly poor.

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bluebird bio’s chief executive officer, Nick Leschlygave an update of his company’s pipeline, with a particular emphasis on a proposed payment model for its upcoming LentiGlobin, a gene therapy being evaluated for transfusion-dependent ß-thalassemia (TDT). The gene therapy is expected to be approved in Europe this year and in the U.S. in 2020. Although the price hasn’t been set, figures up to $2.1 million per treatment have been floated. Bluebird is proposing a five-year payment program, a pledge to not raise prices above CPI, and no costs after the payment period.

Eli Lilly’s chief executive officer David Ricks, just days after acquiring Loxo Oncologyoffered up projections for this year, noting that 45 percent of its revenue will be created by drugs launched in 2015. Those include Trulicity, Taltz and Verzenio. The company also expects to launch two new molecular entities this year—nasal glucagons, a rescue medicine for high blood sugar (hyperglycemia), and Lasmiditan, a rescue drug for migraine headaches.

CNBC’s Jim Cramer interviewed Allergan chief executive officer Brent Saunders, in particular discussing the fact the company’s shares traded in 2015 for $331.15 but were now trading for $145.60. Cramer noted that the company’s internal fundamentals were strong, with multiple pipeline assets and a strong leadership team. Some of the stock problems are related to what Saunders said were “unforced errors,” including intellectual property rights to Restasis, its dry-eye drug, and Allergan’s dubious scheme to protect those patents by transferring the rights to the Saint Regis Mohawk Tribe in New York. On the positive side, the company’s medical aesthetics portfolio, dominated by Botox, is very strong and the overall market is expected to double.

One of the big areas of conversation is so-called “flyover tech.” Biopharma startups are dominant in Boston and in San Francisco, but suddenly venture capital investors have realized there’s a lot going on in between. New York City-based Radian Capital, for example, invests exclusively in markets outside major U.S. cities.

“At Radian, we partner with entrepreneurs who have built their businesses with a focus on strong economics rather than growth at all costs,” Aly Lovett, partner at Radian, told The Observer. “Historically, given the amount of money required to stand up a product, the software knowledge base, and coastal access to capital, health start-ups were concentrated in a handful of cities. As those dynamics have inverted and as the quality of living becomes a more important factor in attracting talent, we’re not seeing a significant increase in the number of amazing companies being built outside of the Bay Area.”

“Flyover companies” mentioned include Bind in Minneapolis, Minnesota; Solera Health in Phoenix, Arizona; ClearDATA in Austin, Texas; Healthe, in Eden Prairie, Minnesota; HistoSonics in Ann Arbor, Michigan; and many others.

Only a month after its record-breaking IPO, Moderna Therapeutics’ chief executive officer Stephane Bancelspent time both updating the company’s clinical pipeline and justifying the company’s value despite the stock dropping off 26 percent since the IPO. Although one clinical program, a Zika vaccine, mRNA-1325, has been abandoned, the company has three new drugs coming into the clinic: mRNA-2752 for solid tumors or lymphoma; mRNA-4157, a Personalized Cancer Vaccine with Merck; and mRNA-5671, a KRAS cancer vaccine. The company also submitted an IND amendment to the FDA to add an ovarian cancer cohort to its mRNA-2416 program.

One interesting bit of trivia, supplied on Twitter by Rasu Shrestha, chief innovation officer for the University of Pittsburgh Medical Center, this year at the conference, 33 female chief executive officers were presenting corporate updates … compared to 19 men named Michael. Well, it’s a start.

And for another bit of trivia, Elisabeth Bik, of Microbiome Digest, tweeted, “San Francisco prices are so out of control that one hotel is charging the equivalent of $21.25 for a cup of coffee during a JPMorgan conference.”

Other posts on the JP Morgan 2019 Healthcare Conference on this Open Access Journal include:

#JPM19 Conference: Lilly Announces Agreement To Acquire Loxo Oncology

36th Annual J.P. Morgan HEALTHCARE CONFERENCE January 8 – 11, 2018

37th Annual J.P. Morgan HEALTHCARE CONFERENCE: #JPM2019 for Jan. 8, 2019; Opening Videos, Novartis expands Cell Therapies, January 7 – 10, 2019, Westin St. Francis Hotel | San Francisco, California

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Aprecia Pharmaceuticals Set to Advance 3D Printed Drug Pipeline

Reporter: Irina Robu, PhD

 

UPDATED on @2/1/2016 by Stuart Cantor, PhD

 

Aprecia Pharmaceuticals has successfully developed the ZipDose® technology, which is a unique delivery platform for high-dose medications that utilizes three-dimensional printing (3DP) instead of a traditional tablet press. In fact, this is the first time that 3DP technology has been utilized to manufacture drug products. Tablets can be produced which can dissolve almost instantaneously (within 10 seconds) with just a sip of liquid. This is ideal for infants, the elderly, and those who have difficulty swallowing medicines (dysphagia) or who have symptoms of dry mouth.

Powder-liquid 3DP technology was first developed at the Massachusetts Institute of Technology (MIT) in the late 1980s. This patented technology uses an aqueous fluid to bind multiple layers of powder together to create orodispersible tablets. Aprecia Pharmaceuticals now owns the exclusive license to market the technology developed at MIT. The benefits of this technology are several: 1) highly porous structures can be developed even at high levels of drug loading (up to 1000 mg); 2) enhanced taste-masking techniques can be applied; and 3) the use of 3DP enables precise and uniform dosing, especially important for drugs intended for the central nervous system. Aprecia now has the rights to more than 50 patents related to various pharmaceutical applications of 3DP and has filed patent applications to protect this proprietary manufacturing system through 2033.

The company’s first New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) on October 1, 2014 and SPRITAM® (levetiracetam) was approved in July 2015 for four tablet dosage strengths of 250 mg, 500 mg, 750 mg, and 1000 mg for the treatment of epilepsy and seizure disorders (i.e., partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures) in children and adults. Each dose is individually packaged making it convenient for consumers.

 

Aprecia Pharmaceuticals Company specializes in three-dimensionally printed (3DP) prescription medicine it has completed a $35 million preferred stock financing. The financing was led by Deerfield Management Company LP and included participation by JW Asset Management.  The finances will support the commercialization of SPRITAM (levetiracetam) through an exclusive sales and marketing alliance with inVentiv Health will accelerate the development of additional 3D printed drug formulations utilizing Aprecia’s novel 3DP technology platform. SPRITAM, the world’s first 3D printed medicine approved by the US Food and Drug Administration, is expected to launch in the first half of 2016.

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