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Top women in biopharma 2015

Larry H. Bernstein, MD, FCAP, Curator

LPBI

Article ID #191: Top women in biopharma 2015. Published on 11/1/2015

WordCloud Image Produced by Adam Tubman

 

Top women in biopharma 2015
http://www.fiercebiotech.com/special-reports/top-women-biotech-2015

 

This year’s fiercest women in biopharma are seemingly doing it all.

Pioneering a fully integrated biotech in China? Check. Leading aging research at Google’s mysterious new life sciences upstart? Check. Changing the game for biotech innovators? Running the world’s largest consumer health player? Blazing the off-P&L financing trail? Check, check, check.

But while at times our 12 honorees have made it look easy, it hasn’t necessarily been that way. Biopharma is still a world dominated by men, which, according to Kleiner Perkins‘ Beth Seidenberg, means women “need to be the champions.”

“It’s a 50-50 world, but we see that 15% of founders or CEOs are women. Only 15% in the 50% that are women have good ideas? Come on,” she says.

Sometimes, though–as several of the women on this list know–being the champions means more than just leading by example, and they’re doing their parts to help others to the same levels of success through recruiting, volunteering and mentoring.

“Leadership is about creating futures that are not a direct path,” says the Broad Institute‘s Samantha Singer. “It’s about being courageous and being willing to speak about and talk about futures that aren’t obvious to other people. Take a stand for a future you can see, one you know can happen even when you can’t see how.”

As for the future we can see? It’s one that includes putting those they’ve inspired on this list sometime soon. — Carly Helfand (email | Twitter)

Revisit our previous Women in Biopharma features: 2014, 2013, 2012, 2011, and 2010.

Samantha Du
China biotech pioneer

Company: ZAI Lab
Title: Chairman and CEO

A lot of people want some of Samantha Du’s time as they pass through China, banking on the depth of her contacts and experience in the pharmaceutical industry’s commercial and regulatory landscape for a clearer path.

For Du, the mother of two sons in addition to her very full-time job as chairman, CEO and adviser at ZAI Lab, her own path to this spot started with a willingness to ask questions during a crucial management stint in licensing at Pfizer ($PFE).

“That was an important job for me professionally and personally,” Du said in a phone interview from Shanghai with FiercePharmaAsia. “I learned to ask questions to establish my own credibility.”

She did indeed manage to establish credibility in the development of multiple early- and late-stage products, two of which were approved and launched globally by Pfizer.

The experience opened up a new direction as managing director for Sequoia Capital China looking at healthcare investments. “That was a big step, making decisions on investments, but I had that other experience as well.”

That would have been as co-founder and effective chief scientific officer atHutchison China MediTech, which she helped lead to a 2006 IPO in London.

“I look back and the reward was always about building an enterprise for China biotech,” she said. “So ZAI Lab is the next stage and the aim is to have a fully-integrated biotech in China. We are not alone. It is so exciting now, so many biotech companies are now in China–and many will not make it. But the drive and building are real.”

That drive sees her sit on the boards of China-focused BGI Tech, JHL Biotech and Beta Pharma–as she easily walks between multinationals and growing companies.

Du holds a doctorate in biochemistry from the University of Cincinnati. She serves as an adjunct professor at Fudan University as well as an adviser to China on broad healthcare issues.

In September, ZAI Lab in-licensed global rights to a first-in-class monoclonal antibody aimed at treating autoimmune and other inflammatory diseases from Belgium’s UCB, following an in-licensed novel multikinase inhibitor aimed at a non-small cell lung cancer target from Sanofi ($SNY) in August.

ZAI Lab also in-licensed China rights to the Phase III liver cancer drug brivanib, an oral kinase inhibitor for oncology indications including hepatocellular carcinoma, from Bristol-Myers Squibb ($BMY) in March.

Overall, the biotech has successfully taken 5 novel drug candidates into clinical trials in China, conducted multiple IND trials in the U.S. and brought the first China-discovered drug into global Phase III trials. Not bad for a company that got its start in 2013.

 

Belén Garijo
From bedside to boardroom

Company: Merck KGaA
Title: CEO of Merck Healthcare

A doctor who entered the Spanish workforce among an oversupply of medical graduates, Belén Garijo practiced medicine for 6 years before joining the pharma industry. There was a “very high output of physicians that couldn’t get jobs easily,” she toldThe Wall Street Journal in a 2014 interview. So, she looked for other avenues to continue helping patients.

“I saw [pharmaceuticals] as an opportunity to continue to develop myself and serve the patients from a different place,” she told the newspaper.

But while the capacity in which she serves patients has changed, her fundamental approach has not. Her experience as a physician has influenced her management style, as CEO first of Merck Serono, and beginning in January this year, CEO of Merck Healthcare.

“I look at the business as I used to look at my patients. I recognize the symptoms. I go to the root cause to treat my business,” Garijo said.

She started out as medical director at Abbott’s ($ABT) Spanish affiliate and then moved to Abbott headquarters in Illinois as director of international medical affairs. In 1996, she joined Rhône-Poulenc Rorer in Spain as director of the oncology business unit. Following Rhône-Poulenc’s merger with Hoechst AG to form Aventis, Garijo then served as global vice president of oncology for the new company in New Jersey.

2003 saw her return to Spain, where she became the general manager of Sanofi-Aventis and led the merger in 2004. From there, she moved on to Paris, trading in Spain for all of Europe as she became Sanofi’s ($SNY) senior vice president of global operations Europe. Garijo oversaw Sanofi’s acquisition of Genzyme as its global integration leader.

In 2011, Garijo joined Merck KGaA as chief operating officer, before rising to president and CEO in less than three years. And barely a year later, she was named CEO of Merck Healthcare, which encompasses its biopharma, consumer health, allergopharma and biosimilars divisions.

When it comes to developing managerial expertise, Garijo brushes aside the idea of a “magic recipe.”

“I learned by making mistakes. I learned by taking risks. I learned by consulting with others. I don’t think it’s a magic recipe, but you know, just being aware of what do you do well and what can you do better?” she told the WSJ. “I think self-awareness is actually something that’s super important. You have to be very self-confident because you have to give this confidence to others every day.

 

Kristen Hege
Complacency is not an option

Company: Celgene
Title: VP of Translational Development, Hematology/Oncology

For Dr. Kristen Hege, Celgene’s ($CELG) San Francisco site lead, the decision to enter the field of biotech and medicine was born of her familial history and a passion for drug discovery. Throughout her career, that passion–in addition to her optimism–has allowed her to navigate the field successfully in spite of challenges along the way.

Hege lost her parents–both physicians–by the age of 20, and her brother in the 1990s AIDS epidemic. The loss of her parents–she thinks of her mother as a “pioneer” in her field–taught Hege to be pragmatic and have a “deep appreciation for good health.” Later in life, she served as her brother’s primary caregiver until his death just one year before effective AIDS meds hit the market.

“That had significant impact on me and how much time matters when you are talking about new drug development,” she told FierceBiotech. “The difference of a year or two in delivery of these significant new drugs to the patient really does matter. Complacency is not an option in this world when there are these real lives that are cut short because they happen to not have a drug approved at that moment in time.”

Hege completed her MD at the University of California, San Francisco, and her residency in internal medicine at Brigham & Women’s Hospital, afterward returning to the Bay Area for her fellowship in hematology and oncology at UCSF. It was during the ’90s, though, that she began to notice a lot of innovation in the biotech sector.

After talking about her interests with her program’s visiting doctor, Stephen Sherwin, the two agreed “basically on a handshake” that she could complete her two years of fellowship research at Sherwin’s biotech, Cell Genesys, Hege explained, a move that would end up sparking her fascination with the industry side of things. Six months after returning to UCSF for the academic career she’d always imagined, she had an epiphany, realizing she was more excited about the company’s technology. It wasn’t long before she ended up at the company where she’d spend 14 years, though she never gave up her UCSF appointment.

 

Cynthia Kenyon
Continuing her life’s work on aging with the power of Google

Company: Calico (Google)
Title: Vice President of Aging Research

Google’s ($GOOG) Calico has kept very quiet in most respects, shrouding its research and business prospects in a blanket of generalities about aging and longevity. What has generated the most excitement, however, is the crack team Calico has assembled over the past couple of years, including one of the foremost experts on aging from the University of California in San Francisco: Cynthia Kenyon.

Kenyon, a renowned geneticist, left UCSF last year for Calico after advising the startup in its first few months, though she has also remained an emeritus professor at the school. She serves as the vice president of aging research at the Google-owned company, joining CEO Art Levinson and R&D chief Hal Barron, in a who’s who of biotech insiders.

At UCSF, Kenyon gained notoriety for decades of work on aging in roundworms, for which her genetic modifications could effectively double the lifespan. Her first foray into clinical therapies was the co-founding of Elixir Pharmaceuticals in 1999, which closed a few years ago after a Novartis ($NVS) buyout fizzled due to cash concerns during the economic recession. And that’s where Google’s deep pockets will likely allow Kenyon and the rest of the team at Calico to reverse course and take their work to the next level.

 

Samantha Singer
Forging a nontraditional path

Company: The Broad Institute
Title: Chief Operating Officer

Samantha Singer’s journey toward becoming chief operating officer at the Broad Institute has followed a unique trajectory. Singer joined the institute in April 2014 after a long tenure at Biogen ($BIIB) and worked in healthcare and biomedical consulting at different points in her career.

“I wanted to follow my interests and passions,” Singer told FierceBiotech. “Because I haven’t had a path that is based on specific expertise, I haven’t had a series of opportunities that someone can map out. It’s not an obstacle or a challenge, but it’s something that has made it more challenging than for someone with a functional expertise.”

Before jumping into the biotech industry, Singer started a PhD program in molecular biology at Rockefeller University. But “working at the lab bench wasn’t for me,” she said, and she decided to complete a master’s degree instead.

From there, Singer started working in management consulting. She concentrated mostly on the research side of things at the global management consulting firm Boston Consulting Group, but found herself acting as a translator between the research and business departments. The experience prompted Singer to get an MBA from Harvard University. “I wanted to think through what strategy and business looked like,” she said.

Singer then decided to pursue an entrepreneurial partnership, which led to her first encounter with her now-employer, she said. Along with her business partner at the time, Singer wrote the Broad’s initial business plan, setting the wheels in motion for not only the institute but also her next career move. “I got really interested less in strategy but in how you execute the strategy. How do you help people execute against a vision you have?” she said.

Soon thereafter, Singer started working for Biogen in the company’s Organization Effectiveness group. During her 7 years at Biogen she led the biotech’s Supply Chain operations for new product launches and also served as chief of staff for CEO George Scangos.

Since joining the Broad a year and a half ago as COO, Singer has worked with different teams to refine the organization’s vision and to make it more effective, she said. In the past year alone, the Broad has inked deals with key biopharma and med tech players, lending its expertise to companies’ R&D initiatives. In March, Bayer said it would use the Broad’s genomic analysis expertise to find new therapies for cardiovascular diseases. In June, the institute announced it would partner with tech titan Google ($GOOG) on a Big Data initiative.

“We have these technological platforms, leading edge organizations that do technological development and we work with scientists across the institute to execute broad ambitions they have. We’re looking ahead over the next 10 years, asking, how do we do that?” Singer said.

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Kite and Alpine Immune Sciences Join Forces to Deliver Personalised Cancer Treatments

Curator: Rosalind Codrington, PhD

This curation was attributed to Stephen J. Williams, PhD as a result of 12/7/2022 e-mail:

From: Rosalind Codrington <rcods@hotmail.co.uk>
Date: Wednesday, December 7, 2022 at 8:32 AM
To: Aviva Lev-Ari <aviva.lev-ari@comcast.net>
Subject: Website

Hello Aviva,

How are you? I hope that you remember me. I used to be a content writer (Rosalind Codrington) at LPBI. Would you be able to remove my profile from your website, please because I am not in science anymore.

Thank you, best regards

Rosalind

 

Kite Pharma is joining forces with Alpine Immune Sciences to target the immune synapse, the communications area between the antigen presenting cell and the T lymphocyte (FierceBiotech). Their approach is to specifically modify the T cells in the patient’s peripheral blood so that these T cells will target the patient’s tumour. Their engineered Autologous Cell Therapy (eACT) platform, allows them to modify in vitro the patient’s T cells so that they will express either chimeric antigen receptors (CAR) or T cell receptors (TCR).

They have devised single chain antibodies linked to intracellular T-cell activating domains and TCR to specifically target the tumour antigen in the patient. These modifications are introduced into the T-cells via a viral vector to express the CAR and TCR on these cells.

The CAR products are specifically engineered to target cell membrane antigens on the tumour cells, whilst the TCR products are able to target both the cell membrane and the intracellular antigens, giving these products a well rounded approach to targeting both solid tumours and haemtalogical malignancies.

Kite and Alpine Immune Science’s potential for delivering personalised tumour therapy is now being tested in clinical trials.

Kite Pharma

Alpine Immune Sciences

Read Full Post »

Victoria Hale: Pharmaceutical Pioneer

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Bringing Life-Saving Medicine to Those Who Can Least Afford It

http://www.genengnews.com/insight-and-intelligence/victoria-hale-pharmaceutical-pioneer/77900545/

The quest for innovative, affordable, and sustainable medical solutions for women has driven Victoria Hale, Ph.D., to start multiple companies. [iStock/© zodebala]

http://www.genengnews.com/media/images/AnalysisAndInsight/Oct27_2015_iStock_22080713_FamilyPoverty1381802542.jpg

http://www.genengnews.com/Media/images/AnalysisAndInsight/oct27_2015_VictoriaHale_Headshot5521815813.jpg

  • Three years into working for Genentech, Victoria Hale, Ph.D., faced a pivotal moment. Her career was on track to becoming a high-ranking, well-paid executive in one of the major pharmaceutical companies. Instead, she quit her job to create a whole new model for the way pharmaceuticals are developed.

Prior to Genentech, while working at the FDA, she witnessed an example of what happens to medicines for unprofitable markets. A pharmaceutical company was developing one new drug for two promising indications, one a potential blockbuster and the other an orphan disease. Corporate executives decided to focus on the blockbuster and abandon the orphan disease because it distracted the team from the more profitable indication.

Dr. Hale saw this as a glaring injustice.

“I felt that it was important to make drugs for everyone who needs them, regardless of whatever level they can pay,” she says. “People cannot develop medicines themselves. Experienced, trained professionals are the only ones who know how to do this. There are people who have medicines for any disease here, while 5,000 miles away babies are dying for lack of simple medications.”

Observing the inequities in how drugs were distributed, she asked a fundamental question: “What if we removed the profit requirement? What if we created a nonprofit model for developing pharmaceuticals?”

As someone with a Ph.D. in pharmaceutical chemistry from the University of California San Francisco, Dr. Hale was well aware that bringing a new drug to market can cost in the billions. Her strategy, with a future nonprofit, was to find drugs with patents that had expired or which were not being used because of low profit margins. Even so, getting governmental approval for a new use for an existing drug can cost $50 million.

  • Struck a Chord

Nevertheless her vision of creating a nonprofit model for addressing injustices in how drugs are distributed began attracting donors. Her first major fundraising success came when the Gates Foundation provided her with a $4.7 million check for seed money. In the years since, she has been granted $150 million in total for several programs. Other philanthropic organizations have continued to fund her efforts, and, surprisingly, if not amazingly, Dr. Hale was able to find an anonymous donor who provided an $82 million grant to fund low-cost highly effective contraception efforts.

Dr. Hale can point to many examples of how this nonprofit approach has successfully played out in practice. One example is the work that the company she founded in 2000, OneWorld Health, is doing in providing a cure for black fever. This is a disease that has historically infected a million people a year in India leading to 300,000 death annually.

Black fever, or visceral leishmaniasis, is a disease of the poor. A malnourished person may have a compromised immune system, making him or her vulnerable to the parasite that causes leishmaniasis.

“When I was first looking into black fever,” remembers Dr. Hale, “there was a treatment available, but the cost was more than $100, and families faced the choice of going into debt for three generations or allowing the family member to die.”

Dr. Hale learned of an injectable antibiotic, paromomycin, that was apparently effective against the parasite in the laboratory setting. It hadn’t been formally studied in people for use against black fever, and there was no money to continue further research on it, so although a cure existed, it hadn’t been proven and it wasn’t available for those who needed it. However, using her nonprofit approach, Dr. Hale and her colleagues were able to raise the $50 million from the Gates Foundation for clinical trials in India, and succeeded in demonstrating efficacy and safety.

Today, Dr. Hale, who was awarded the 2015 Award for Leadership in Women’s Health Worldwide at the 23rd Annual Congress of the Academy of Women’s Health, and her colleagues are able to produce paromomycin for $10 per treatment. As a result, and combined with other public health interventions, India may soon be free of this scourge.

Another of Dr. Hale’s concerns is unwanted pregnancy. Her organization Medicines360 is able to provide an IUD that has a 40-fold greater success rate than the pill, it lasts for three years, and is sold for $50 each to women who lack adequate insurance. Medicines360 makes it available to family planning clinics that provide services to low-income women. The consequences for women and for society are incalculable.

Like OneWorld Health, Medicines360 is also a new approach to pharmaceuticals. Medicines360 is particularly aimed at pharmaceuticals for women, and it has a unique operating model: it reinvests profits generated through commercial sales revenue and puts these profits into advocacy, education, research, and development. The goal is to provide innovative, affordable, and sustainable medical solutions for women.

For Medicines360, profits aren’t the motive; they’re the means to a mission. Dr. Hale believes that her nonprofit can be a model for other nonprofit pharmaceutical companies and also for hybrid companies that could get part of their funding from philanthropists and part from traditional sources. She already knows that there are young idealistic people who will carry the model forward and who are pushing this agenda.

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Curation of Recently Halted Oncology Trials Due to Serious Adverse Events – 2015

Curator: Stephen J. Williams, Ph.D.

The following is reports of oncology clinical trials in 2015 which have been halted for Serious Adverse Events (SAE), in most instances of an idiopathic nature. For comparison I have listed (as of this writing) the oncology drug approvals (8) for 2015. (from CenterWatch.com)

Oncology Drugs Approved in 2015

Farydak (panobinostat); Novartis; For the treatment of multiple myeloma, Approved February 2015

Ibrance (palbociclib); Pfizer; For the treatment of ER-positive, HER2-negative breast cancer, Approved February 2015

Lenvima (lenvatinib); Eisai; For the treatment of thyroid cancer, Approved February 2015

Lonsurf (trifluridine and tipiracil); Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015

Odomzo (sonidegib); Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015

Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015

Unituxin (dinutuximab); United Therapeutics; For the treatment of pediatrics with high-risk neuroblastoma, Approved March 2015

Varubi (rolapitant); Tesaro; For the prevention of delayed nausea and vomiting associated with chemotherapy, Approved September 2015


Death Forces FDA to Place Clinical Hold on Advaxis (ADXS) Cancer Drug

from Biospace News

October 7, 2015
By Alex Keown, BioSpace.com Breaking News Staff

PRINCETON, N.J. – Following the death of a patient, the U.S. Food and Drug Administration (FDA) placed a hold on Advaxis (ADXS)’s experimental cancer treatment axalimogene filolisbac, which is currently in mid-stage trials.

In a statement issued this morning, Advaxis maintains the patient’s death was a result of the severity of her cancer and not due to the company’s experimental cancer treatment. It is seeking proof from the FDA that the drug was not a factor in the death. Still, the hold on the experimental cancer drug will cause the company to halt four clinical trials, Advaxis said. Other clinical trials, including those with the experimental ADXS-PSA and ADXS-HER2, are not affected by this hold. The company said it will continue to actively enroll and dose patients.

The FDA placed a hold on the drug on Oct. 2 after the company submitted a safety report to the regulatory agency that week. The drug is being developed to treat patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy. Phase I trials released at the end of September showed treatment with axalimogene filolisbac resulted in a 38.5 percent 12-month overall survival rate in 26 patients. Patients typically fighting PRmCC who have failed at least one line of therapy have a typical survival rate of four to seven months.

Read full story here


FDA Halts Trial of Halozyme’s PEGPH20 for Pancreatic Cancer

Apr 9, 2014 Alex Philippidis

Halozyme Therapeutics acknowledged today that the FDA placed a formal clinical hold on its troubled Study 202 assessing its experimental drug PEGPH20 in patients with pancreatic cancer—less than a week after the company temporarily halted enrolling and dosing patients in the ongoing Phase II trial.

The agency told Halozyme it placed the clinical hold following the company’s pause in study activity. The trial’s independent data monitoring committee is evaluating data from the trial to learn why patients treated with PEGPH20 as well as nab-paclitaxel and gemcitabine saw a higher rate of blood clots and other thromboembolic events compared with patients treated with nab-paclitaxel and gemcitabine alone.

“We will be providing this information to the data monitoring committee and the FDA in parallel so they can complete their respective assessments,” Helen Torley, M.B. Ch.B., M.R.C.P., Halozyme’s president and CEO, said in a statement.

“Pancreatic cancer has one of the lowest survival rates of any cancer. We remain committed to evaluating PEGPH20 as a possible therapy to address this devastating disease,” Dr. Torley added.

As with Halozyme’s statement last week, the company’s latest remarks did not indicate when Halozyme expects to resume enrolling and dosing patients in Study 202, or how many patients had been enrolled and dosed when the temporary halt occurred.

The trial was envisioned as having 124 subjects, divided evenly between a treatment arm of PEGPH20 and nab-paclitaxel, and a gemcitabine arm, preceded by eight subject “run-in” phase assessing safety and tolerability, according to Study 202’s page on ClinicalTrials.gov (NCT01839487), last updated on January 27.

The study is one of two Phase II trials for PEGPH20; the other, SWOG, also aims to assess the drug for pancreatic cancer.

PEGPH20 is an investigational PEGylated form of Halozyme’s FDA-approved recombinant human hyaluronidase rHuPH20 (marketed as Hylenex®), designed to dramatically increases the half-life of the compound in the blood and allow for intravenous administration.

The temporary halt for Study 202 came two months after Halozyme publicly cited “potential acceleration of the PEGPH20 program” among several R&D programs for which it raised funds through a public offering of common stock that closed in February and generated approximately $107.8 million in net proceeds.

Read more at GenNEWS


FDA orders CytRx to halt patient enrollment after death of a cancer patient

CytRx ($CYTR) has run into an unexpected roadblock with its cancer drug conjugate aldoxorubicin, slamming the brakes on new patient recruitment in all their clinical trials after the FDA dropped a partial clinical hold on the program. According to the biotech the hold was forced by the death of a patient who was given the drug through a compassionate use program.

LA-based CytRx execs say that patients already enrolled in the studies will continue to receive the therapy as investigators added new safety measures, retooling trial protocols to include an “appropriate inclusion/exclusion criteria, an additional patient screening assessment and an evaluation of serum electrolytes prior to aldoxorubicin administration.” The patient who died, they added, had not qualified for any of its studies.

As it stands now, the biotech doesn’t know exactly how long the partial hold will last, but their announcement sought to calm jumpy investors, saying they expected to resolve the FDA’s demands “expeditiously” and can stick to their current timelines. CytRx says it expects to report preliminary results from their mid-stage study of Kaposi’s sarcoma in the second quarter of 2015 and preliminary results from the ongoing Phase II clinical trial of aldoxorubicin in glioblastoma multiforme in the first half of 2015. The company added that it is committed to completing enrollment in their Phase III trial by the end of next year.

hat reassurance appears to have helped with investors, who seemed to count this as more of a temporary setback than a catastrophe. Shares for CytRx were down about 9% in mid-morning trading.

Aldoxorubicin uses a linker molecule to attach to albumin in the blood and concentrate in tumors, where the acidic environment releases the chemotherapy doxorubicin in doses up to four times higher than what’s used now. Late last year their stock soared after their drug scored promising results for progression-free survival in a Phase IIb trial.

This case illustrates one reason why biotechs often quietly squirm under the pressure of compassionate use programs. They can be expensive to operate, time-consuming and raise fresh concerns when a patient dies or experiences a setback. On the other hand, if regulators take action like this following the death of an advanced stage cancer patient, there may have been something about the case that triggered broader concerns for the entire patient population


Clot risk in Lilly lung-cancer drug raises FDA concerns

July 7, 2015

Eli Lilly and Co.’s experimental lung cancer drug has raised concerns with U.S. regulators that it may increase patients’ risk of suffering potentially deadly blood clots.

The drug, known as necitumumab, improved patients’ overall chances of survival, yet people taking the medicine also experienced more risk, Food and Drug Administration staff said in a report Tuesday. Indianapolis-based Lilly is seeking to sell the medicine to treat a subset of the most common type of lung cancer.

FDA advisers will meet Thursday to discuss the risks and benefits of necitumumab for patients with advanced squamous non-small cell lung cancer, in combination with chemotherapy. The FDA is expected to decide if Lilly can sell the drug by the end of the year.

While the safety of necitumumab reflects that of similar drugs, the increased danger of clotting “in this already high risk population is of concern,” FDA staff wrote.

One study showed that out of 538 patients taking necitumumab and chemotherapy, 9 percent experienced a serious clot, compared with 5 percent of 541 patients given only chemotherapy, according to the staff report.

Squamous lung cancer accounts for 25 percent to 30 percent of all lung cancer, according to the American Cancer Society.

Patients in a clinical trial who took necitumumab lived a median of 11.5 months, 1.6 months longer than those who got only chemotherapy, the FDA staff report said.

Opdivo Side Effects Center (as seen on Rxlist.com) (NOTE:TRIAL NOT HALTED)

Last reviewed on RxList 10/05/2015

Opdivo (nivolumab) is a human monoclonal antibody used to treat patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor; and to treat metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. Common side effects of Opdivo include fatigue, rash, itching, cough, upper respiratory tract infection, swelling of the extremities, shortness of breath, muscle pain, decreased appetite, nausea, vomiting, constipation, diarrhea, weakness, swelling, fever, abdominal pain, chest pain, joint pain, and weight loss.


Opdivo FDA Prescribing Information: Side Effects
(Adverse Reactions)

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The data described in the WARNINGS AND PRECAUTIONS section and below reflect exposure to OPDIVO in Trial 1, a randomized trial in patients with unresectable or metastatic melanoma and in Trial 3, a single-arm trial in patients with metastatic squamous non-small cell lung cancer (NSCLC).

Clinically significant adverse reactions were evaluated in a total of 691 patients enrolled in Trials 1, 3, or an additional dose finding study (n=306) administering OPDIVO at doses of 0.1 to 10 mg/kg every 2 weeks [see WARNINGS AND PRECAUTIONS].

Unresectable or Metastatic Melanoma

The safety of OPDIVO was evaluated in Trial 1, a randomized, open-label trial in which 370 patients with unresectable or metastatic melanoma received OPDIVO 3 mg/kg every 2 weeks (n=268) or investigator’s choice of chemotherapy (n=102), either dacarbazine 1000 mg/m² every 3 weeks or the combination of carboplatin AUC 6 every 3 weeks plus paclitaxel 175 mg/m² every 3 weeks [see Clinical Studies]. The median duration of exposure was 5.3 months (range: 1 day to 13.8+ months) with a median of eight doses (range: 1 to 31) in OPDIVO-treated patients and was 2 months (range: 1 day to 9.6+ months) in chemotherapy treated patients. In this ongoing trial, 24% of patients received OPDIVO for greater than 6 months and 3% of patients received OPDIVO for greater than 1 year.

In Trial 1, patients had documented disease progression following treatment with ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. The trial excluded patients with autoimmune disease, prior ipilimumab-related Grade 4 adverse reactions (except for endocrinopathies) or Grade 3 ipilimumab-related adverse reactions that had not resolved or were inadequately controlled within 12 weeks of the initiating event, patients with a condition requiring chronic systemic treatment with corticosteroids ( > 10 mg daily prednisone equivalent) or other immunosuppressive medications, a positive test for hepatitis B or C, and a history of HIV.

The study population characteristics in the OPDIVO group and the chemotherapy group were similar: 66% male, median age 59.5 years, 98% white, baseline ECOG performance status 0 (59%) or 1 (41%), 74% with M1c stage disease, 73% with cutaneous melanoma, 11% with mucosal melanoma, 73% received two or more prior therapies for advanced or metastatic disease, and 18% had brain metastasis. There were more patients in the OPDIVO group with elevated LDH at baseline (51% vs. 38%).

OPDIVO was discontinued for adverse reactions in 9% of patients. Twenty-six percent of patients receiving OPDIVO had a drug delay for an adverse reaction. Serious adverse reactions occurred in 41% of patients receiving OPDIVO. Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in 2% to less than 5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase.


FDA Approves Eisai’s LENVIMA™ (lenvatinib) for the Treatment of Patients with Locally Recurrent or Metastatic, Progressive, Radioactive Iodine-Refractory Differentiated Thyroid Cancer

– Press release from Eisai (NOTE: TRIAL NOT HALTED)

Feb 13, 2015

WOODCLIFF LAKE, N.J., Feb. 13, 2015 /PRNewswire/ — Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the company’s receptor tyrosine kinase inhibitor LENVIMA™ (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC). LENVIMA was approved following a priority review by the FDA, which is designated for drugs the FDA believes have the potential to provide a significant improvement in the treatment of a serious condition. LENVIMA demonstrated a statistically significant progression-free survival (PFS) prolongation and response rate in patients with progressive, differentiated thyroid cancer who had become refractory to radioactive iodine (RAI) therapy.

In the clinical trial, adverse events led to dose reductions in 68% of patients who received LENVIMA and 5% of patients who received placebo. Some patients will need to discontinue treatment for serious adverse reactions. In the trial, 18% of patients treated with LENVIMA and 5% who received placebo discontinued treatment. The most common adverse reactions (at least 10%) that resulted in dose reductions of LENVIMA were hypertension (13%), proteinuria (11%), decreased appetite (10%), and diarrhea (10%).

AstraZeneca halts a pair of lung cancer trials over a safety scare

From October 9, 2015 | By of FierceBiotech

“AstraZeneca ($AZN) is pressing pause on trials combining two of its most important pipeline cancer treatments after tracking reports of lung disease, halting enrollment as it gathers more information.

The company is testing a combination of AZD9291 and durvalumab, formerly MEDI4736, in two studies involving patients with non-small cell lung cancer. Late last month, AstraZeneca hit the brakes on enrollment in both trials due to an increase in reports of interstitial lung disease, which can lead to dangerous scarring and impaired pulmonary function. The pauses are temporary, the company stressed in an emailed statement, and patients already enrolled in the study will be given new consent forms to ensure they understand the risks before choosing whether keep getting treatment.”

Other posts on this site on Cytotoxicity and Cancer include

Novel Approaches to Cancer Therapy [11.1]

Misfolded Proteins – from Little Villains to Little Helpers… Against Cancer

Multiple Lung Cancer Genomic Projects Suggest New Targets, Research Directions for Non-Small Cell Lung Cancer

A Synthesis of the Beauty and Complexity of How We View Cancer

Good and Bad News Reported for Ovarian Cancer Therapy

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Future of the Pharmaceutical Industry in Japan and South Korea

Reporter: Gerard H Loiseau, ESQ

 

Japan and South Korea are both top-ten global pharmaceutical markets with governments determined to ensure domestic drug manufacturers capture as much of those markets as possible. The national agencies responsible for regulating these two pharmaceutical markets have been very active creating initiatives and incentives aiming to steer market growth while minimizing healthcare spending, though the approach and ultimate goals of these agencies differ greatly.

 

SOURCE

http://lsconnect.thomsonreuters.com/how-japan-and-south-korea-are-preparing-for-their-pharmaceutical-futures/

 

Other articles on the Pharmaceutical Industry in Japan published in this Open Access Online Scientific Journal include the following: 

Japan’s Ceramics and Glass Industries

 

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Drug ‘Chemputer’

Curator: Larry H Bernstein, MD, FCAP

 

Revised 9/30/2015

 

The ‘chemputer’ that could print out any drug

When Lee Cronin learned about the concept of 3D printers, he had a brilliant idea: why not turn such a device into a universal chemistry set that could make its own drugs?

http://www.theguardian.com/science/2012/jul/21/chemputer-that-prints-out-drugs

 

Professor Lee Cronin is a likably impatient presence, a one-man catalyst. “I just want to get stuff done fast,” he says. And: “I am a control freak in rehab.” Cronin, 39, is the leader of a world-class team of 45 researchers at Glasgow University, primarily making complex molecules. But that is not the extent of his ambition. A couple of years ago, at a TED conference, he described one goal as the creation of “inorganic life”, and went on to detail his efforts to generate “evolutionary algorithms” in inert matter. He still hopes to “create life” in the next year or two.

At the same time, one branch of that thinking has itself evolved into a new project: the notion of creating downloadable chemistry, with the ultimate aim of allowing people to “print” their own pharmaceuticals at home. Cronin’s latest TEDtalk asked the question: “Could we make a really cool universal chemistry set? Can we ‘app’ chemistry?” “Basically,” he tells me, in his office at the university, with half a grin, “what Apple did for music, I’d like to do for the discovery and distribution of prescription drugs.”

The idea is very much at the conception stage, but as he walks me around his labs Cronin begins to outline how that “paradigm-changing” project might progress. He has been in Scotland for 10 years and in that time he has worked hard, as any chemist worth his salt should, to get the right mix of people to produce the results he wants. Cronin’s interest has always been in complex chemicals and the origins of life. “We are pretty good at making molecules. We do a lot of self-assembly at a molecular level,” he says. “We are able to make really large molecules and I was able to get a lot of money in grants and so on for doing that.” But after a while, Cronin suggests, making complex molecules for their own sake can seem a bit limiting. He wanted to find some more life-changing applications for his team’s expertise.

A couple of years ago, Cronin was invited to an architectural seminar to discuss his work on inorganic structures. He had been looking at the way crystals grew “inorganic gardens” of tube-like structures between themselves. Among the other speakers at that conference was a man explaining the possibilities of 3D printing for conventional architectural forms. Cronin wondered if you could apply this 3D principle to structures at a molecular level. “I didn’t want to print an aeroplane, or a jaw bone,” he says. “I wanted to do chemistry.”

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Cronin prides himself on his lateral thinking; his gift for chemistry came fairly late – he stumbled through comprehensive school in Ipswich and initially university – before realising a vocation for molecular chemistry that has seen him make a series of prize-winning, and fund-generating, advances in the field. He often puts his faith in counterintuition. “Confusions of ideas produce discovery,” he says. “People, researchers, always come to me and say they are pretty good at thinking outside the box and I usually think ‘yes, but it is a pretty small box’.” In analyzing how to apply 3D printing to chemistry, Cronin wondered in the first instance if the essentially passive idea of a highly sophisticated form of copying from a software blueprint could be made more dynamic. In his lab, they put together a rudimentary prototype of a chemical 3D printer, which could be programmed to make basic chemical reactions to produce different molecules.

 

First Complete Structural Study Of A Pegylated Protein

http://www.technologynetworks.com/Proteomics/news.aspx?ID=183266

Significant data obtained at NUI Galway reports first crystal structure of a protein modified with a single PEG chain.

Protein PEGylation is a technique routinely used to improve the pharmacological properties of injectable therapeutic proteins. PEG stands for polyethylene glycol, a synthetic polymer that is attached to proteins. The PEG chain artificially increases the size of the protein and improves its retention in the bloodstream. By remaining longer in the blood stream the protein therapeutic is more effective than normal.

Since PEGylation was developed in the 1970s, PEGylated proteins have significantly improved the treatment of several chronic diseases, including hepatitis C, leukemia, arthritis, and Crohn’s disease. PEGylated interferon is one of the most powerful therapeutics used to treat chronic hepatitis. Despite their importance the structure of PEGylated proteins has remained elusive. Now the first crystal structure of a protein modified with a single PEG chain has been determined through research at NUI Galway.

This important research was developed at NUI Galway by Italian PhD student Giada Cattani working with Dr. Peter Crowley, the lead author of the paper. The work also involved collaboration with Dr. Lutz Vogeley from the School of Biochemistry and Immunology at Trinity College Dublin and the crucial X-ray data was collected at the Diamond synchrotron in Oxford, UK.

Commenting on the research findings Dr. Peter Crowley from the School of Chemistry, NUI Galway commented, “The crystal structure reveals an extraordinary double helical arrangement of the protein! It is significant that this data was obtained at NUI Galway, the only Irish University to offer a degree programme in Biopharmaceutical Chemistry. This attractive programme provides training in an area that is essential for the development of new medicines and contributes to the Irish economy.”

A common approach to understand proteins is to crystallize them and determine their structure by using X-ray crystallography. This is necessary to understand what the protein looks like and how it functions. Thousands of research papers have been published about PEGylated proteins. Until the recent findings at NUI Galway there had been no success in  crystallizing a PEGylated protein. The knowledge obtained by the Crowley lab has implications for understanding how PEGylated proteins work. The NUI Galway team is also looking at ways to engineer protein assemblies based on this result.

 


Drugs Go Under Cover as Platelets to Destroy Cancer

  • Scientists say they have for the first time developed a technique that coats anticancer drugs in membranes made from a patient’s own platelets, allowing the drugs to last longer in the body and attack both primary cancer tumors and the circulating tumor cells that can cause a cancer to metastasize. The work reportedly was tested successfully in an animal model.
  • “There are two key advantages to using platelet membranes to coat anticancer drugs,” says Zhen Gu, Ph.D., corresponding author of a paper on the work and an assistant professor in the joint biomedical engineering program at North Carolina State University and the University of North Carolina at Chapel Hill. “First, the surface of cancer cells has an affinity for platelets; they stick to each other. Second, because the platelets come from the patient’s own body, the drug carriers aren’t identified as foreign objects, so last longer in the bloodstream.”
  • “This combination of features means that the drugs can not only attack the main tumor site, but are more likely to find and attach themselves to tumor cells circulating in the bloodstream, essentially attacking new tumors before they start,” adds Quanyin Hu, a Ph.D. student and lead author of the paper (“Anticancer Platelet-Mimicking Nanovehicles”), which appears in Advanced Materials
  • Here’s how the process works. Blood is taken from a patient (a lab mouse in the case of this research) and the platelets are collected from that blood. The isolated platelets are treated to extract the platelet membranes, which are then placed in a solution with a nanoscale gel containing the anticancer drug doxorubicin (Dox), which attacks the nucleus of a cancer cell.
  • The solution is compressed, forcing the gel through the membranes and creating nanoscale spheres made up of platelet membranes with Dox-gel cores. These spheres are then treated so that their surfaces are coated with the anticancer drug TRAIL, which is most effective at attacking the cell membranes of cancer cells.
  • When released into a patient’s bloodstream, these pseudo-platelets can circulate for up to 30 hours as compared to approximately six hours for the nanoscale vehicles without the coating. When one of the pseudo-platelets comes into contact with a tumor, three things happen more or less at the same time.
  • First, the P-Selectin proteins on the platelet membrane bind to the CD44 proteins on the surface of the cancer cell, locking it into place. Second, the TRAIL on the pseudo-platelet’s surface attacks the cancer cell membrane. Third, the nanoscale pseudo-platelet is effectively swallowed by the larger cancer cell. The acidic environment inside the cancer cell then begins to break apart the pseudo-platelet, thus freeing the Dox to attack the cancer cell’s nucleus.
  • In a study using mice, the researchers found that using Dox and TRAIL in the pseudo-platelet drug delivery system was significantly more effective against large tumors and circulating tumor cells than using Dox and TRAIL in a nano-gel delivery system without the platelet membrane.
  • “We’d like to do additional pre-clinical testing on this technique,” notes Dr. Gu. “And we think it could be used to deliver other drugs, such as those targeting cardiovascular disease, in which the platelet membrane could help us target relevant sites in the body.”

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Cancer Biology and Genomics for Disease Diagnosis (Vol. I) Now Available for Amazon Kindle

Cancer Biology and Genomics for Disease Diagnosis (Vol. I) Now Available for Amazon Kindle

Reporter: Stephen J Williams, PhD

Article ID #179: Cancer Biology and Genomics for Disease Diagnosis (Vol. I) Now Available for Amazon Kindle. Published on 8/14/2015

WordCloud Image Produced by Adam Tubman

Leaders in Pharmaceutical Business Intelligence would like to announce the First volume of their BioMedical E-Book Series C: e-Books on Cancer & Oncology

Volume One: Cancer Biology and Genomics for Disease Diagnosis

CancerandOncologyseriesCcoverwhich is now available on Amazon Kindle at                          http://www.amazon.com/dp/B013RVYR2K.

This e-Book is a comprehensive review of recent Original Research on Cancer & Genomics including related opportunities for Targeted Therapy written by Experts, Authors, Writers. This ebook highlights some of the recent trends and discoveries in cancer research and cancer treatment, with particular attention how new technological and informatics advancements have ushered in paradigm shifts in how we think about, diagnose, and treat cancer. The results of Original Research are gaining value added for the e-Reader by the Methodology of Curation. The e-Book’s articles have been published on the Open Access Online Scientific Journal, since April 2012.  All new articles on this subject, will continue to be incorporated, as published with periodical updates.

We invite e-Readers to write an Article Reviews on Amazon for this e-Book on Amazon. All forthcoming BioMed e-Book Titles can be viewed at:

http://pharmaceuticalintelligence.com/biomed-e-books/

Leaders in Pharmaceutical Business Intelligence, launched in April 2012 an Open Access Online Scientific Journal is a scientific, medical and business multi expert authoring environment in several domains of  life sciences, pharmaceutical, healthcare & medicine industries. The venture operates as an online scientific intellectual exchange at their website http://pharmaceuticalintelligence.com and for curation and reporting on frontiers in biomedical, biological sciences, healthcare economics, pharmacology, pharmaceuticals & medicine. In addition the venture publishes a Medical E-book Series available on Amazon’s Kindle platform.

Analyzing and sharing the vast and rapidly expanding volume of scientific knowledge has never been so crucial to innovation in the medical field. WE are addressing need of overcoming this scientific information overload by:

  • delivering curation and summary interpretations of latest findings and innovations
  • on an open-access, Web 2.0 platform with future goals of providing primarily concept-driven search in the near future
  • providing a social platform for scientists and clinicians to enter into discussion using social media
  • compiling recent discoveries and issues in yearly-updated Medical E-book Series on Amazon’s mobile Kindle platform

This curation offers better organization and visibility to the critical information useful for the next innovations in academic, clinical, and industrial research by providing these hybrid networks.

Table of Contents for Cancer Biology and Genomics for Disease Diagnosis

Preface

Introduction  The evolution of cancer therapy and cancer research: How we got here?

Part I. Historical Perspective of Cancer Demographics, Etiology, and Progress in Research

Chapter 1:  The Occurrence of Cancer in World Populations

Chapter 2.  Rapid Scientific Advances Changes Our View on How Cancer Forms

Chapter 3:  A Genetic Basis and Genetic Complexity of Cancer Emerge

Chapter 4: How Epigenetic and Metabolic Factors Affect Tumor Growth

Chapter 5: Advances in Breast and Gastrointestinal Cancer Research Supports Hope for Cure

Part II. Advent of Translational Medicine, “omics”, and Personalized Medicine Ushers in New Paradigms in Cancer Treatment and Advances in Drug Development

Chapter 6:  Treatment Strategies

Chapter 7:  Personalized Medicine and Targeted Therapy

Part III.Translational Medicine, Genomics, and New Technologies Converge to Improve Early Detection

Chapter 8:  Diagnosis                                     

Chapter 9:  Detection

Chapter 10:  Biomarkers

Chapter 11:  Imaging In Cancer

Chapter 12: Nanotechnology Imparts New Advances in Cancer Treatment, Detection, &  Imaging                                 

Epilogue by Larry H. Bernstein, MD, FACP: Envisioning New Insights in Cancer Translational Biology

 

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Drug Discovery & Structural Biology: A Massively Multitask Networks Architecture – Collaboration between Stanford and Google

Reporter: Aviva Lev-Ari, PhD, RN

Massively Multitask Networks for Drug Discovery

Bharath Ramsundar*,†, ◦ RBHARATH@STANFORD.EDU

Steven Kearnes*,† KEARNES@STANFORD.EDU

Patrick Riley◦ PFR@GOOGLE.COM

Dale Webster◦ DRW@GOOGLE.COM

David Konerding◦ DEK@GOOGLE.COM

Vijay Pande† PANDE@STANFORD.EDU

( *Equal contribution, †Stanford University, ◦Google Inc.)

Abstract

Massively multitask neural architectures provide a learning framework for drug discovery that synthesizes information from many distinct biological sources. To train these architectures at scale, we gather large amounts of data from public sources to create a dataset of nearly 40 million measurements across more than 200 biological targets. We investigate several aspects of the multitask framework by performing a series of empirical studies and obtain some interesting results:

(1) massively multitask networks obtain predictive accuracies significantly better than single-task methods,

(2) the predictive power of multitask networks improves as additional tasks and data are added,

(3) the total amount of data and the total number of tasks both contribute significantly to multitask improvement, and

(4) multitask networks afford limited transferability to tasks not in the training set.

Our results underscore the need for greater data sharing and further algorithmic innovation to accelerate the drug discovery process

SOURCE

http://arxiv.org/pdf/1502.02072v1.pdf

Large-Scale Machine Learning for Drug Discovery

Posted: Monday, March 02, 2015

Discovering new treatments for human diseases is an immensely complicated challenge; Even after extensive research to develop a biological understanding of a disease, an effective therapeutic that can improve the quality of life must still be found. This process often takes years of research, requiring the creation and testing of millions of drug-like compounds in an effort to find a just a few viable drug treatment candidates. These high-throughput screens are often automated in sophisticated labs and are expensive to perform.

Recently, deep learning with neural networks has been applied in virtual drug screening1,2,3, which attempts to replace or augment the high-throughput screening process with the use of computational methods in order to improve its speed and success rate.4 Traditionally, virtual drug screening has used only the experimental data from the particular disease being studied. However, as the volume of experimental drug screening data across many diseases continues to grow, several research groups have demonstrated that data from multiple diseases can be leveraged with multitask neural networks to improve the virtual screening effectiveness.

In collaboration with the Pande Lab at Stanford University, we’ve released a paper titled “Massively Multitask Networks for Drug Discovery“, investigating how data from a variety of sources can be used to improve the accuracy of determining which chemical compounds would be effective drug treatments for a variety of diseases. In particular, we carefully quantified how the amount and diversity of screening data from a variety of diseases with very different biological processes can be used to improve the virtual drug screening predictions.

Using our large-scale neural network training system, we trained at a scale 18x larger than previous work with a total of 37.8M data points across more than 200 distinct biological processes. Because of our large scale, we were able to carefully probe the sensitivity of these models to a variety of changes in model structure and input data. In the paper, we examine not just the performance of the model but why it performs well and what we can expect for similar models in the future. The data in the paper represents more than 50M total CPU hours.

SOURCE
http://googleresearch.blogspot.com/2015/03/large-scale-machine-learning-for-drug.html

Google, Stanford say big data is key to deep learning for drug discovery

The researches explain the Premise of their methodology:

The efficacy of multitask learning is directly related to the availability of relevant data. Hence, obtaining greater amounts of data is of critical importance for improving the state of the art. Major pharmaceutical companies possess vast private stores of experimental measurements; our work provides a strong argument that increased data sharing could result in benefits for all.

More data will maximize the benefits achievable using current architectures, but in order for algorithmic progress to occur, it must be possible to judge the performance of proposed models against previous work. It is disappointing to note that all published applications of deep learning to virtual screening (that we are aware of) use distinct datasets that are not directly comparable. It remains to future research to establish standard datasets and performance metrics for this field.

. . .

Although deep learning offers interesting possibilities for virtual screening, the full drug discovery process remains immensely complicated. Can deep learning—coupled with large amounts of experimental data—trigger a revolution in this field? Considering the transformational effect that these methods have had on other fields, we are optimistic about the future.

SOURCE

https://gigaom.com/2015/03/02/google-stanford-say-big-data-is-key-to-deep-learning-for-drug-discovery/?utm_content=bufferb1e92&utm_medium=social&utm_source=linkedin.com&utm_campaign=buffer

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Re-Creation of the Big Pharma Model via Transformational Deals for Accelerating Innovations: Licensing vs In-house inventions

Reporter: Aviva Lev-Ari, PhD, RN

SOURCE

Teva-Allergan Buy Likely Heralds More Big Deals Teva’s acquisition of Allergan’s generic-drugs unit for $40.5 billion is likely to trigger more deal-making in the already-frenzied health-care sector. Bernstein analyst Ronny Gal said investors had highlighted

  • AbbVie,
  • Amgen,
  • Pfizer and
  • Biogen as potential transaction partners.

“Allergan clearly spells interest in using this case for acquisitions,” he said. (denise.roland@wsj.com; @deniseroland)

SOURCE

Market Talk is a stream of real-time news and market analysis that is available on Dow Jones Newswires.

Allegan

“We will have the potential to add scale in existing therapeutic areas, expand into new therapeutic areas and geographies and evaluate strategic transformational deals as we continue to build on our position as the most dynamic branded growth pharma company,” Allergan CEO Brent Saunders said.

In a sign of its continuing ambition, Allergan announced a deal on Sunday, saying it will pay $560 million upfront for Naurex Inc. and its antidepressant-drug candidate.

SOURCE

http://www.wsj.com/articles/teva-to-buy-allergan-generics-for-40-5-billion-1437988044

Allergan: Pharma’s Biggest Dealmaker Is On The Hunt Again

by Matthew Herper Forbes Staff – My favorite Write @Forbes on Pharma and HealthCare

For investors in the generic business, this may be a bit of a warning that stock prices are getting too heady. Saunders (I spoke to him between meetings this morning, as he went on just an hour of sleep) says he expects Teva stock to rise over the long-term, and thinks that the deal for Allergan will improve as that happens. But he also agrees that he’s getting an amazing multiple, and says that two factors led him to the “bittersweet” decision to sell: the great price, and the fact that consolidation among drug purchasers (CVS, Walgreens) and insurers (Aetna buying Humana, Anthem buying Cigna) led Saunders and Bisarro to realize that they had to either bulk up or get out. And they didn’t want to bulk up. Investors in Mylan Pharmaceuticals, which spurned Teva’s advances: Beware.

Saunders is obviously game. One thing that distinguishes him from Valeant billionaire Michael Pearson, the drug industry’s other great consolidator, is that Saunders comes to this from a different place. A decade ago, it looked like he was being groomed by Hassan to potentially take over Schering-Plough before that company ran into problems and got bought by Merck. Unlike Pearson, he’s not looking so much to dismantle the big pharma model as to re-create it.

SOURCE

http://www.forbes.com/sites/matthewherper/2015/07/27/allergan-pharmas-biggest-dealmaker-is-on-the-hunt-again/?utm_medium=email&utm_campaign=Daily%20Digest%20Send%20Control%202015-07-27&utm_source=Sailthru&utm_term=Daily%20Digest%20Horizon%20Control

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SACHS FLYER 2014 Metabolomics SeriesDindividualred-page2

We welcome Book Reviews on Amazon.com

Metabolic Genomics & Pharmaceutics

Volume Author, Curator, Editor

Larry H Bernstein, MD, FCAP

Leaders in Pharmaceutical Business Intelligence

http://www.amazon.com/dp/B012BB0ZF0

Introduction

Chapter 1: Metabolic Pathways

Chapter 2: Lipid Metabolism

Chapter 3: Cell Signaling

Chapter 4: Protein Synthesis and Degradation

Chapter 5:  Sub-cellular Structure

Chapter 6: Proteomics

Chapter 7: Metabolomics

Chapter 8.  Impairments in Pathological States: Endocrine Disorders; Stress Hypermetabolism and Cancer

Chapter 9: Genomic Expression in Health and Disease 

Summary 

Epilogue

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