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Real Time Coverage @BIOConvention #BIO2019: June 4 Morning Sessions; Global Biotech Investment & Public-Private Partnerships

Reporter: Stephen J Williams PhD @StephenJWillia2

Each country have their own needs and most important drug cost structure. Must involve patients and providers.
BCI survey: countries output different, who improved who didnt
Is industry having collaboration with government? hardly ten percent by survey and worse vice versa
Transparancy and holistic view important for collaboration
Korea: lack of communication need input from government on pricing; wants global open innovation and enhance RD investments
Tawain: price, price but based on efficacy; pharma needs to talk with doctors hospital patients, find balance
Pitts: we need trust; staff that country offices with people who know that country. Price not defining value
Columbia:  need to attract investors

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Real Time Coverage @BIOConvention #BIO2019: What’s Next: The Landscape of Innovation in 2019 and Beyond. 3-4 PM June 3 Philadelphia PA

Reporter: Stephen J. Williams, PhD @StephenJWillia2

 

Results from Clarivate
In 2018 most of deals were in CART area but now we are seeing more series A rounds that are on novel mechanisms as well as rare diseases.  US is still highest in venture capital series A but next is China. 10 of top ex US VC are from China, a whole lot of money.
Preclinical is very strong for US VC but China VC is focused on clinical.  First time this year we see US series A break above 100.  But ex US the series A is going down.  Although preclinical deals in US is coming back not like as good as in 2006.  But alot of > 1 billion $ deals.  Most of money into mAbs and protein therapy;  antisense is big and cell therapy is big too; small molecule not as much
ClearView Healthcare
Which innovation classes attracted VC in 2018?
  • Oncology drives a disproportionate focus could be driven by pharma focus on oncology; however there is some focus on neuro and infectious disease
  • therapeutic classes: shift to differentiated technology…. companies want technologic platforms not just drugs.  Nucleic Acid tech and antibody tech is high need platforms.  Startups can win by developing a strong platform not just a drug
There are pros and cons of developing a platform company versus a focused company.  Many VCs have a portfolio and want something to fit in so look for a focused company and may not want a platform company.  Pfizer feels that when alot of money is available (like now) platform investing is fine but when money becomes limited they will focus on those are what will be needed to fill therapy gaps.  They believe buy the therapy and only rent the platform.
Merck does feel the way Pfizer does but they have separate ventures so they can look and license platforms.  they are active in looking at companies with new modalities but they are focused on the money so they feel best kept in hands of biotech not pharma.
At Celgene they were solely focused on approvals not platforms.  Alot of money is required to get these platforms to market.  Concentration for platform companies should be the VCs not partnering or getting bought out by pharma.  it seems from panel speakers from pharma that they are waiting for science to prove itself and waiting for favorable monetary environments (easy money).  However it seems they (big pharma) are indicating that money is drying up or at least expect it too.
At Axial and with VCs they feel it is important to paint a picture or a vision at the early stage.
At Ontogeny, they focus on evaluating assets especially and most important, ThE MANAGEMENT TEAM.  There are not that many great talented drug development management teams he feels out there even though great science out there.

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Real Time Coverage of BIO 2019 International Convention, June 3-6, 2019 Philadelphia Convention Center, Philadelphia PA

Reporter: Stephen J. Williams, PhD @StephenJWillia2

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

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@pharma_BI

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# Hashtags

#BIO2019 (official meeting hashtag)

Please check daily on this OPEN ACCESS JOURNAL for updates on one of the most important BIO Conferences of the year for meeting notes, posts, as well as occasional PODCASTS.

 

The BIO International Convention is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities, and provides insights and inspiration on the major trends affecting the industry. The event features keynotes and sessions from key policymakers, scientists, CEOs, and celebrities.  The Convention also features the BIO Business Forum (One-on-One Partnering), hundreds of sessions covering biotech trends, policy issues and technological innovations, and the world’s largest biotechnology exhibition – the BIO Exhibition.

The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO). BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

 

Keynote Speakers INCLUDE:

Fireside Chat with Margaret (Peggy) Hamburg, MD, Foreign Secretary, National Academy of Medicine; Chairman of the Board, American Association for the Advancement of Science

Tuesday Keynote: Siddhartha Mukherjee (Author of the bestsellers Emperor of All Maladies: A Biography of Cancer and  The Gene: An Intimate History)

Fireside Chat with Jeffrey Solomon, Chief Executive Officer, COWEN

Fireside Chat with Christi Shaw, Senior Vice President and President, Lilly BIO-Medicines, Eli Lilly and Company

Wednesday Keynote: Jamie Dimon (Chairman JP Morgan Chase)

Fireside Chat with Kenneth C. Frazier, Chairman of the Board and Chief Executive Officer, Merck & Co., Inc.

Fireside Chat: Understanding the Voices of Patients: Unique Perspectives on Healthcare

Fireside Chat: FDA Town Hall

 

ALSO SUPERSESSIONS including:

Super Session: What’s Next: The Landscape of Innovation in 2019 and Beyond

Super Session: Falling in Love with Science: Championing Science for Everyone, Everywhere

Super Session: Digital Health in Practice: A Conversation with Ameet Nathawani, Chief Digital Officer, Chief Medical Falling in Love with Science: Championing Science for Everyone, Everywhere

Super Session: Realizing the Promise of Gene Therapies for Patients Around the World

Super Session: Biotech’s Contribution to Innovation: Current and Future Drivers of Success

Super Session: The Art & Science of R&D Innovation and Productivity

Super Session: Dealmaker’s Intentions: 2019 Market Outlook

Super Session: The State of the Vaccine Industry: Stimulating Sustainable Growth

 

See here for full AGENDA

Link for Registration: https://convention.bio.org/register/

The BIO International Convention is literally where hundreds of deals and partnerships have been made over the years.

 

BIO performs many services for members, but none of them are more visible than the BIO International Convention. The BIO International Convention helps BIO fulfill its mission to help grow the global biotech industry. Profits from the BIO International Convention are returned to the biotechnology industry by supporting BIO programs and initiatives. BIO works throughout the year to create a policy environment that enables the industry to continue to fulfill its vision of bettering the world through biotechnology innovation.

The key benefits of attending the BIO International Convention are access to global biotech and pharma leaders via BIO One-on-One Partnering, exposure to industry though-leaders with over 1,500 education sessions at your fingertips, and unparalleled networking opportunities with 16,000+ attendees from 74 countries.

In addition, we produce BIOtechNOW, an online blog chronicling ‘innovations transforming our world’ and the BIO Newsletter, the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

 

Membership with the Biotechnology Innovation Organization (BIO)

BIO has a diverse membership that is comprised of  companies from all facets of biotechnology. Corporate R&D members range from entrepreneurial companies developing a first product to Fortune 100 multinationals. The majority of our members are small companies – 90 percent have annual revenues of $25 million or less, reflecting the broader biotechnology industry. Learn more about how you can save with BIO Membership.

BIO also represents academic centers, state and regional biotech associations and service providers to the industry, including financial and consulting firms.

  • 66% R&D-Intensive Companies *Of those: 89% have annual revenues under $25 million,  4% have annual revenues between $25 million and $1 billion, 7% have annual revenues over $1 billion.
  • 16% Nonprofit/Academic
  • 11% Service Providers
  • 7% State/International Affiliate Organizations

Other posts on LIVE CONFERENCE COVERAGE using Social Media on this OPEN ACCESS JOURNAL and OTHER Conferences Covered please see the following link at https://pharmaceuticalintelligence.com/press-coverage/

 

Notable Conferences Covered THIS YEAR INCLUDE: (see full list from 2013 at this link)

  • Koch Institute 2019 Immune Engineering Symposium, January 28-29, 2019, Kresge Auditorium, MIT

https://calendar.mit.edu/event/immune_engineering_symposium_2019#.XBrIDc9Kgcg

http://kochinstituteevents.cvent.com/events/koch-institute-2019-immune-engineering-symposium/event-summary-8d2098bb601a4654991060d59e92d7fe.aspx?dvce=1

 

  • 2019 MassBio’s Annual Meeting, State of Possible Conference ​, March 27 – 28, 2019, Royal Sonesta, Cambridge

http://files.massbio.org/file/MassBio-State-Of-Possible-Conference-Agenda-Feb-22-2019.pdf

 

  • World Medical Innovation Forum, Partners Innovations, ARTIFICIAL INTELLIGENCE | APRIL 8–10, 2019 | Westin, BOSTON

https://worldmedicalinnovation.org/agenda-list/

https://worldmedicalinnovation.org/

 

  • 18th Annual 2019 BioIT, Conference & Expo, April 16-18, 2019, Boston, Seaport World Trade Center, Track 5 Next-Gen Sequencing Informatics – Advances in Large-Scale Computing

http://www.giiconference.com/chi653337/

https://pharmaceuticalintelligence.com/2019/04/22/18th-annual-2019-bioit-conference-expo-april-16-18-2019-boston-seaport-world-trade-center-track-5-next-gen-sequencing-informatics-advances-in-large-scale-computing/

 

  • Translating Genetics into Medicine, April 25, 2019, 8:30 AM – 6:00 PM, The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich St Fl 40, New York

https://pharmaceuticalintelligence.com/2019/04/25/translating-genetics-into-medicine-april-25-2019-830-am-600-pm-the-new-york-academy-of-sciences-7-world-trade-center-250-greenwich-st-fl-40-new-york/

 

  • 13th Annual US-India BioPharma & Healthcare Summit, May 9, 2019, Marriott, Cambridge

https://pharmaceuticalintelligence.com/2019/04/30/13th-annual-biopharma-healthcare-summit-thursday-may-9-2019/

 

  • 2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies, May 17, 2019, Harvard Law School

http://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

https://pharmaceuticalintelligence.com/2019/01/11/2019-petrie-flom-center-annual-conference-consuming-genetics-ethical-and-legal-considerations-of-new-technologies/

 

  • 2019 Koch Institute Symposium – Machine Learning and Cancer, June 14, 2019, 8:00 AM-5:00 PM  ET MIT Kresge Auditorium, 48 Massachusetts Ave, Cambridge, MA

https://pharmaceuticalintelligence.com/2019/03/12/2019-koch-institute-symposium-machine-learning-and-cancer-june-14-2019-800-am-500-pmet-mit-kresge-auditorium-48-massachusetts-ave-cambridge-ma/

 

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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.

Click to search for life sciences jobs

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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Recents Thoughts of Biotech Innovation: 2015 2016

From WorldofDTCMarketing

Can’t innovate ? Buy small biotech companies that can

cloud-innovationOn a week where a lot of people are taking their final summer vacations the news is that Amgen is buying Onyx and AstraZeneca Plc took a further step to bolster its pipeline of new cancer drugs on Monday by agreeing to acquire privately held U.S. biotech company Amplimmune for up to $500 million.  On paper it’s a good business move but as big pharma companies gobble up small biotech companies they bring with then antiquated processes and business people who are thinking about the bottom line rather than patients.  The results ?  Innovation that led these smaller biotech companies to develop new drugs will be stymied by a bureaucratic business model.

There is a reason why, after being acquired, that so many employees of smaller biotech companies leave.  Either they don’t want to work for big a big pharma bureaucracy or the acquiring company determines that these people are not needed and shows them the door.  Behind all this are people who provided the start-up funding and want to cash in without awaiting the lengthy process of developing new drugs.  In the end however it’s patients who loose.

bureaucracy

Last week Steve Ballmer, the CEO of Microsoft, announced his resignation.  There is a correlation between what happened at Microsoft and the challenges for big pharma.  Steve was forced out because Microsoft became a huge bureaucracy and could not innovate fast enough.  Those of us who have worked in pharma know of the endless 9-5 meetings to move even small projects forward.  Amgen’s culture revolves around back-to-back meetings with executives from other big pharma companies who are trying to put their power on display.  It’s only a matter of time before people from Onyx leave because of Amgen’s prohibitive culture.

Unknown

Until the costs of developing and launching new drugs is lower more and more innovative biotech firms are going to have a for sale sign hanging in the window hoping big pharma can help investors cash in.

And in a Commentary on CNBC

This is biotech’s real problem

Robert J. Mulroy, president and CEO of Merrimack

Thursday, 1 Oct 2015 | 9:38 AM ET

1

COMMENTJoin the Discussion

Here’s a challenge — name a biotech that’s not a small company with one potential blockbuster in the works or an industry giant that’s acquiring the hottest new technologies. Got one? Great! Now try to name four more.

Biotech

Jian Wan | Vetta | Getty Images

The fact is, midsize biotechs (Ironwood Pharmaceuticals andMedivation are couple of examples) are a rarity these days, and that’s a problem for patients, doctors and investors. Start-ups that are in the process of developing and drawing from a foundation of knowledge are often acquired once they have a promising candidate in the pipeline. If the associated research teams aren’t immediately jettisoned (just when their potential for broader breakthroughs is surging), the top innovators go off to launch another venture that doesn’t build on their current research.

There’s also enormous pressure to focus on that “next big thing” that can crowd out other innovations for patients, while blocking valuable, in-depth examination of existing treatments. In oncology, drug combinations (like Genentech’s combination of Herceptin, pertuzumab and docetaxel to treat HER-2 breast cancer) are making huge strides in prolonging patients’ lives. Such combinations require understanding how specific tumors grow, and designing diagnostics that tell doctors whether a patient’s tumor fits that profile. The problem? Not enough small biotechs have the luxury of developing that understanding before they’re acquired so that big biotechs can gain another drug candidate.

As the CEO of a cancer-focused biotech that’s spent the last 15 years building a diverse product pipeline — the lead candidate is under FDA review with a decision expected next month — my view is that pursuing individual drug targets will bring limited success. Cancer is the ultimate engineering challenge, and effective treatments need to address more than a single facet of the problem.

The real winners in the industry will be the companies that understand how their therapies work in combinations with their own and competing therapies, and help physicians make sense of the explosion of new treatments via companion diagnostics. In fact, regulators could potentially require a more integrated approach to manage the ever-increasing influx of new drugs and data. In August, the American Society of Clinical Oncology issued guidelines for doctors on interpreting multi-gene tests for cancer susceptibility, acknowledging the need for more education and regulation.

Most oncology biotech start-ups dream of developing such an integrated approach. But it takes time and money, and an environment that prioritizes in-depth scientific research.

Doing well by patients, doctors and investors means pursuing sustainable innovation, not just one-offs or single-use purchases. Innovation drives value and can build on itself to address complex challenges. And while innovation takes time and entails risk, it mitigates that risk in the long term.

For example, if you have a deep understanding of how your drug works — say, the tumor-growth mechanisms it disrupts — you can determine whether there are signs that the mechanism it targets is present in a particular patient and then enroll only those patients in clinical trials. That allows for smaller, less expensive trials — and a higher chance of success.

An integrated approach across the industry would allow drug developers to identify responders, and then eliminate the non-responders from clinical trials and from the target population post-approval, ensuring patients only receive treatments likely to benefit them and don’t waste their time enrolling in irrelevant trials.

The current cycle of big pharma acquiring start-ups and dismantling the research teams while divesting in their own R&D appears self-perpetuating, but cracks are showing in the high cost — now in the billions — of bringing a single drug to market.

These companies are dealing with outside pressures that stymie progress. Less than 10 percent of experimental oncology drugs ever get approved. A tactical approach to the pipeline makes sense from a risk-aversion perspective. But sustainable growth requires strategy and investments in the fundamental science work that drives innovation.

Commentary by Robert J. Mulroy, president and CEO of Merrimack, a biotech company focused on cancer treatments. Prior to joining Merrimack, Mr. Mulroy worked as a management consultant in the pharmaceutical and health-care industries. He has served as an advisor to multiple start-up companies in the biotechnology industry.

The New Biotechnology Innovation Organization

Jim's CornerAt BIO, new discoveries in research and development are constantly being made by our members. We take pride in the contributions they have made across a diverse range of biotechnology industries, including: healthcare, agricultural, industrial and environmental.

As one of the world’s strongest catalysts for innovation, our role within the biotechnology community requires us to reflect on who we are, what we do and how we can better serve our members in future.

Biotechnology scientists and entrepreneurs are not just industrious – they are revolutionary, imaginative, inspired, creative, ingenious and inventive. It is these traits that produce innovation.

BIO Logo Vertical RGBAs you may already know, starting today, the Biotechnology Industry Organization will become the Biotechnology Innovation Organization. It’s a one-word name change – from industry to innovation – but the implications are substantial.

Today is a time of tremendous innovation. So much so that our current name no longer best describes our members and our role as one of the world’s leading innovators.

BIO’s members are on the cutting-edge of science and we believe our new name will allow us to build upon our relationships, create new ones and provide our members with better educational and research opportunities.

Our members are discovering scientific breakthroughs and bringing new and innovative therapies to the marketplace. With the help of biotechnology, people are living longer and healthier lives. Our industry embodies innovation and made the world a better place for people everywhere.

Our meaningful innovations also provide the tools to help feed more people, develop new sustainable fuels and products to help protect the planet and devise unique clean technologies to make our environment safer.

In the more than 22 years since its founding, BIO has united scientists, policymakers and the public in a partnership to drive our remarkable progress even further.

It’s important to note that we are not becoming a different organization. We are not altering our mission or the value we deliver to our members.

We will, however, continue to blaze the trail to accelerate cures – connecting thought leaders, building a stronger, more advanced economy and creating jobs to raise the world’s standard of living.

In the coming years, BIO’s diverse membership – from promising startups to global companies in a wide array of biotechnology and related fields – will drive health, life expectancy and improve quality of life for millions of people.

The Biotechnology Innovation Organization will be there to support our members in their tireless effort to make the world a better place to live.

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Bad News this Week for Biotech Deals?

 

Curator: Stephen J. Williams, Ph.D

 

Last week in biotech ( 3/7-3/11/2016) had a plethora of disappointing stories related to biotech drug development and hits to biotech investing and VC.  Since October of 2016 the biotech index has lost 35% to today (see Biotech ETFs Hit 52-Week Lows: Time to Buy?) however were the hit back in October a signal of some of the listed events below (as shown on Biospace News) and includes:

  •  an long-time biotech startup with failure of mesothelioma trial who has struggled in the past
  • multiple clinical trial failures forces the de-listing of a NASDAQ company (other biotechs this year had similar problems)
  • more problems with drug development for Duchenne’s Muscular Dystrophy

GlaxoSmithKline dumps Five Prime’s cancer drug in the midst of Phase I

March 11, 2016 | By Damian Garde

GSK gave Five Prime a 180-day notice that it’s nixing its license to the company’s FP-1039, which is designed to block the spread of cancer by interrupting protein signaling. The decision follows GSK’s January move to stop developing FP-1039 in squamous non-small cell lung cancer due to the rise of immuno-oncology therapies from Merck ($MRK), Bristol-Myers Squibb ($BMY) and others, citing a “change in treatment paradigms.”GlaxoSmithKline ($GSK) is cutting ties with Five Prime Therapeutics’ ($FPRX) in-development cancer therapy, backing out in the middle of a mesothelioma trial.

Now GSK is set to abandon a drug it inherited through its $3 billion acquisition of Human Genome Sciences in 2012, leaving Five Prime to go it alone in an ongoing Phase Ib study testing FP-1039 against mesothelioma. Five Prime said it plans to work with GSK to complete enrollment in the study, adding that it “continues to be encouraged” by the drug’s potential in mesothelioma.

Embattled Bay Area XOMA  (XOMA) Terminates Gevokizumab Trials, Slashes Headcount by 50%

3/11/2016 6:39:17 AM

March 11, 2016
By Alex Keown, BioSpace.com Breaking News Staff

BERKELY, Calif. – Troubled XOMA Corp. (XOMA) is terminating half of its workforce after a late-stage failure of its experimental drug gevokizumab for treatment of pyoderma gangrenosum, the San Francisco Business Times reported this morning.

Following the announcement, Xoma’s stock is down this morning about 5 percent, trading at 91 cents per share as of this writing.

Xoma said it is interested in divesting itself of gevokizumab. In a statement, the company said several companies have approached Xoma about acquiring the drug. Gevokizumab binds to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine. Xoma said it will make all information about the drug and study information available to potential buyers. Gevokizumab has had a troubled history with Xoma. The company has halted several trials with the drug for various diseases, including diabetes and a blinding eye disease, the Times reported. In 2014, Xoma was forced to stop testing gevokizumab as an arthritis treatment after the drug did not show significant benefit against placebo after a six-month period.

Struggling Eleven Biotherapeutics (EBIO) Gets Delisting Notice from Nasdaq After Back-to-Back Clinical Trial Failures

3/10/2016 6:07:38 AM

March 10, 2016
By Mark Terry, BioSpace.com Breaking News Staff

With one piece of bad news after another, Cambridge, Mass.-based Eleven Biotherapeutics Inc. (EBIO) filed a Form 8-Kwith the U.S. Securities and Exchange Commission, addressed a delisting notification it received from the Nasdaq on Mar. 3.

The Nasdaq informed the company that its stock dropped below $1 a share, and that the stockholder equity didn’t comply with the $5,000,000 minimum stockholders’ equity requirement. As a result, it has 180 days to comply with Nasdaq rules.

On Jan. 10, the company announced that its Phase III clinical trial of EBI-005 (isunakinra) for severe allergic conjunctivitis did not meet its primary endpoint.

In May 2015, the company reported that its drug, EBI-005, for moderate to severe dry eye disease, failed to prevent damage to the cornea or reduce eye pain in comparison to the control group.

In a January statement, Abbie Celniker, president and chief executive officer of Eleven Biotherapeutics, said, “We are disappointed that isunakinra failed to meet its primary endpoint, and based on these overall results we see no immediate path forward in allergic conjunctivitis. Our efforts will be focused on submitting an investigational new drug application (IND) for EBI-031 in diabetic macular edema in the first half of 2016.”

EBI-031 was designed for intravitreal delivery using the company’s AMP-Rx platform. The drug blocks both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R). The compound is being developed to treat diabetic macular edema (DME) and uveitis.

DMD Setback Prompts Sarepta (SRPT) to Shutter West Coast Location and Consolidate to Massachusetts, 30 Jobs Gone

3/9/2016 6:13:13 AM

March 9, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Cambridge, Mass.-based Sarepta Therapeutics (SRPTannounced yesterday that it was shuttering its research-and-development manufacturing facility in Corvalis, Ore. Most of the employees there are expected to move to Sarepta’s facilities in Andover and Cambridge, Mass. About 30 people are expected to be laid off.

On Jan. 21, Sarepta announced that, with an impending snowstorm on the east coast, the U.S. Food and Drug Administration (FDA)’s meeting to review the company’s New Drug Application (NDA) for eteplirsen to treat Duchenne Muscular Dystrophy (DMD) was postponed.

DMD is a muscle wasting disease caused by mutations in the dystrophin gene. The disease is progressive and generally causes death in early adulthood. Complications include serious heart or respiratory-related problems. It mostly affects boys, about 1 in every 3,500 to 5,000 male children.

On Jan. 15, an FDA advisory committee decided to reschedule the meeting, at which point a recommendation or approval decision will be made. That meeting of the Peripheral and Central Nervous System Advisory Committee has not been rescheduled yet, but Sarepta believes it will be prior to May 26, which is the PDUFA date. The Prescription Drug User Fee Act (PDUFA) is a law that allows the FDA to collect an application fee from drug companies when an NDA or Biologics License Application (BLA) is submitted.

The DMD drug arena has been fraught with failures and bad news this year. San Rafael, Calif.-based BioMarin Pharmaceutical Inc. (BMRN)’s application for its DMD drug Kyndrisa (drisapersen) was turned down by the FDA on Jan. 15. The FDA argued that Kyndrisa didn’t show enough benefit.

On Jan. 25, Cambridge, Mass.-based Akashi Therapeuticsannounced that it had halted its DMD trial for HT-100 after one of its patients developed serious, life-threatening health problems. In that DMD is a serious, life-threatening health problem in itself, it’s not clear if the patient’s problems are directly related to the drug. The patient was receiving the highest dose in the HALO trial, while others in the trial with lower doses were not showing adverse side effects.

 

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Starting a Biotech the European Way

Author:  Stephen J. Williams, Ph.D.

A wonderful post by Tony Marcel in Nature Biotechnology highlights some of the structural differences in the way biotech startups are formed in Europe contrasted with bio-entrepreneurship as conducted in the United States.  Tony Marcel is currently the CEO of FGene S.A. and gives a personal experience  of the European biotech startup scene and highlights the differences, as he sees it, in the unique business development models occurring in Europe versus the US.  This post will highlight features from the article.

  • US model of biotech is not easily transferable to how Europe does business
  • US model involves developing a specific technology platform then selling that tool, service or platform to pharma for R&D $ and royalties
  • European perspective is to build networks instead of platforms which can deliver capabilities or one product to pharma
  • The article discusses three weaknesses identified in the biotech world with respect to Europe and the US

Three ” weaknesses” identified which may affect decision to start a biotech in Europe include:

  1. European academic scientists have trepidation making deals with big pharma
  2. European scientists are not as eager as US counterparts to start a biotech
  3. biotechs still are not as good as pharma in drug development so even their pipeline of “hits” are failing in clinical trials

The article aims to use these weaknesses to define a European way involving

  • defining management players and market niche early on
  • reducing the barriers to entry (i.e. legal)
  • establishing the relationships to increase viability

 

The full article can be found at the following link:

http://www.nature.com/bioent/2003/030101/full/nbt0299supp_9.html

 

An emerging European model for bioentrepreneurship

Tony Marcel

Tony Marcel is CEO of FGene S.A., 91, Avenue Kléber, 75116 Paris, France

e-mail:  tonymftmcgene@compuserve.com.

The US model for biotechnology is not easily exportable to Europe, but an alternative European business model may be adaptable everywhere.

There is a widespread opinion that biotechnology companies worldwide need to follow business models initiated in the US. These models, generally speaking, are based on development of a specific technology platform. The prevailing wisdom suggests this technology can be sold as a tool or service to pharmaceutical companies or can be used to develop a lead compound that can then be sold to big pharma for R&D dollars and single-digit downstream royalties.

But my experience as a former academic medical researcher who has helped discover, develop, and market drugs for Hoechst, Laboratoires Roussel, Roussel-Uclaf, Rhône-Poulenc Sante, and Amgen has taught me that there is an appealing alternative to this model that may be more practical from the European perspective. Rather than building technologies, one can build networks that have the capability of delivering to big pharma the one product they cannot refuse: validated lead compounds for unmet medical needs.

Identifying a market niche

My background has taught me that an effective way to find solutions is to look at weaknesses perceived by the status quo, and then to develop a strategy to turn them into strengths. Biotechnology’s biggest weakness was its lack of products, in traditional pharmaceutical terms. Relatively few lead compounds have made their way through clinical trials and onto the market. So to separate your company from the crowd, my first conclusion is that it needs to be product-based. It should develop lead compounds that can be sold to big pharma, or take those compounds through clinical trials and to the market.

How do you accomplish this in Europe? I identified three weaknesses from a traditional biotechnology or pharmaceutical perspective that I felt could be developed into strengths. The first was that European scientists are much more risk averse than their American counterparts when it comes to setting up their own business. The legal, financial, and cultural infrastructure to take such a step is far more developed in the US than elsewhere.

The second was that European academic scientists tended to be mistrustful of big pharma’s intentions in licensing discussions. Taking the fruits of their research and developing it into a business is an uncharted area for most, and their unfamiliarity with this process made them cautious.

Finally, biotechnology startups everywhere, not just in Europe, are usually not very efficient in conducting pharmaceutical development. In general, they are discovery-focused companies that lack both the expertise and the contacts in these areas to efficiently manage this process.

These three weaknesses provide the basis for my product-based business plan. The fact that European scientists are not as ready to start companies as in the US makes Europe a source of world-class research not already tied up commercially. In addition, my experience in the pharmaceutical world has demonstrated that a commitment to building a relationship based on trust with scientists and their university licensing departments tremendously enhances the quality of these exchanges and, over time, provides remarkable access to a pipeline of innovative lead compounds.

Finally, the pharmaceutical industry’s move to outsource much of the development and clinical trials process has created a remarkable infrastructure for moving lead compounds through development. One only needed to know when this was appropriate and to have the money to commit to that project to realize a major portion of the development process.

The business model that results from uniting these strengths is a company dedicated not to a specific technology platform, but rather to the development of innovative compounds discovered and patented by academia. The company’s niche is to license in molecules at an early stage and demonstrate proof of principle, and take them through regulatory preclinicals, as well as phase I/II clinicals. At that point, the company licenses its products to big pharma. Profit is generated by the substantial risk-to-reward ratio between the cost of licensing in molecules and the outlicensing price to big pharma.

Management

Contrary to the way many US biotechnology companies are run, the management structure of such a company is not a one-person show. This strategy relies heavily on a supervisory board made up of representatives from European ministries and major European banks. It is also dependent on a scientific advisory board (SAB) with members from key European states. Unlike the boards of some biotechnology companies, the individuals selected are not merely figureheads. They must be committed to an operational role in which they are regularly consulted about the company’s plans.

The key to making this work is to maintain permanent links with academia, the source of new molecules, through publications, meetings, and also through SAB members. One also needs to develop comparable relationships in the pharmaceutical industry in order to keep abreast of licensing-in needs. Using this dual approach, a company will be able to identify discoveries relevant to a major pharmaceutical market before they are published. The company can then select candidates for licensing based on demonstrations of their potentially useful activity, the proof of pilot synthesis and purification capability, and sufficient intellectual property protection.

Given the academic scientist’s aversion to starting a business, where will this network of managers come from? In Europe, the merger and acquisition fever that has hit both the pharmaceutical and banking industries has created a large pool of experienced professionals, acquainted with science, marketing, and business. Some of these individuals will be at a point in their lives where setting up companies is an exciting alternative career.

The challenge for this new generation of European bioentrepreneurs will be to develop their ability to create a new level of cross-talk between inventors and developers. Their core responsibility will be much in keeping with their training: Build and nurture a portfolio of molecules at various stages of development.

Barriers to entry

If this model is so straightforward, why do pharmaceutical companies not eliminate the biotechnology middleman and reap the rewards directly? One of the three premises of this model is that a small biotech company is more able to concentrate on an academic alliance than a large pharmaceutical company. Biotechnology’s close identification with academia through the training of both its management and staff gives it a cultural advantage in assuming this role.

Historically, the model in which big pharma establishes a direct relationship with academia has never proven successful. For example, SmithKline and French invested much of its Tagamet earnings into developing academic alliances to fill its pipelines. Nonetheless, investing a substantial amount of money in these relationships over a significant period of time did not prevent this group from having to merge with Beecham. Nearly every working pharmaceutical executive today has a similar war story.

The reason it has failed for the past 20 years, and is likely to continue to fail for the next 20, is that it concentrates efforts in the hands of the most powerful pharmaceutical companies and key research institutions. The resulting bureaucracy is so overwhelming it not only alienates the scientific innovators, but creates a stifling atmosphere in which decisions simply cannot be made.

But old habits die hard, and this model has long been a tradition in Europe—particularly in France. Therefore, it is likely, if for no other reason than to reap the potential financial returns of such a model, that pharmaceutical companies will continue to make this model work.

However, the important role that biotechnology can play in this process is being recognized by some individuals now in positions of responsibility in pharmaceutical companies, academic institutions, and government offices. These individuals are doing their best to support biotechnology’s role in the development of innovative new medicines.

Viability

If you have read this far, you are probably persuaded by the arguments, but may wonder, “If it is such a great business model, why hasn’t anyone done it before?” Well, they have. In 1995, FGene was founded in France as a company devoted to the development of biopharmaceutical products. The company was initiated by the willingness of the Paris-based Institut Pasteur, a major European academic institution, to license molecules to it. This relationship allowed the beginning of the process I have just described.

The resolve of the French government, key players in academia, the investment community, and the pharmaceutical industry to enhance the growth of biotechnology in France is an opportunity we have seized. We have tried to duplicate in Europe the remarkable links developed between biotechnology startups and academia in the US, and hope to create a viable business serving the needs of the world’s largest pharmaceutical companies that are literally in our backyard.

In three years of existence, FGene already boasts five products in its active development portfolio: a recombinant protein for the treatment of traumatic spinal section; a peptide for the prevention and therapy of cardiovascular and cerebrovascular ischemia, such as coronary diseases; a selective IL2 receptor agonist for the treatment of cancer; a peptide active on kidney and bone for the treatment of bone and mineral balance disorders, such as osteoporosis; and a peptide for improving male pattern sexual arousal.

We are encouraged that we have made this much progress in such a short time. While this model is still not proven in terms of financial success, it provides a much stronger foundation for growing a biotechnology company than most biotechnology business plans currently in use because costs are directly related to the development of marketable products.

Conclusions

For budding European bioentrepreneurs, this model recommends itself for three reasons: First, it uses unexploited resources that are difficult to access through traditional biotechnology or pharmaceutical models. Second, it is based on pharmaceutical customers’ high-priority needs. And third, it provides a company with a burn rate that is in direct proportion to the realization of a marketable product.

This model has first taken hold in France because of a unique set of circumstances, but its applicability seems uthe commitment of a network of individuals to build a new kind of biotechnology company.

My vision is that companies formed will reinvigorate the European pharmaceutical industry. In the end, everyone wins. Academic science has a new route to receive fair payment for their innovations, biotechnology companies show a rapid timeline to profitability, making investors happy, and pharmaceutical companies fill their pipelines with truly innovative medicines. But the real winner in the end will be the consumer—the rapid translation of genomic products will lead to medicines that improve healthcare at an affordable price, in a much shorter time frame than previously possible.

 

source: http://www.nature.com/bioent/2003/030101/full/nbt0299supp_9.html

More articles on BioEntrepreneurship in this Online Open Access Journal Include:

11:00AM – 10/1/2014: Scientific Collaborations @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

9:00AM 10/1/2014: Partnering I @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

BioTech Partnerships and the National Model in Israel

Four Startups After One Year: BioDesign Entrepreneurship Program @ Hebrew University-Hadassah Medical Center

Biotech Chinese and Israeli Strategic Collaboration: Pontifax and WuXi PharmaTech (Cayman) Inc. (NYSE: WX)

Top 10 Israeli medical advances to watch in 2014 @ ISRAEL21c

Israel’s Innovation System: A Triple Helix with Four Sub-helices

Helix Model of Innovation in Israel: The Global Scheme and its Local Application

i-CORE Participation In Israel: Hebrew University faculty leads and holds Scientific Management Positions in Five I-CORE Centers

Stem Cell Research — The Frontier is at the Technion in Israel

Next-generation Universal Cell Immunotherapy startup Adicet Bio, Menlo Park, CA is launched with $51M Funding by OrbiMed

Recent Breakthroughs in Cancer Research at the Technion-Israel Institute of Technology- 2015

BEYOND THE “MALE MODEL”: AN ALTERNATIVE FEMALE MODEL OF SCIENCE, TECHNOLOGY AND INNOVATION

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