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Archive for the ‘Pharmaceutical Industry Competitive Intelligence’ Category


Expedite Use of Agents in Clinical Trials: New Drug Formulary Created – The NCI Formulary is a public-private partnership between NCI, part of the National Institutes of Health, and pharmaceutical and biotechnology companies

Reporter: Aviva Lev-Ari, PhD, RN

 

Wednesday, January 11, 2017

New Drug Formulary Will Help Expedite Use of Agents in Clinical Trials

The National Cancer Institute (NCI) today launched a new drug formulary (the “NCI Formulary”) that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The NCI Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.

The NCI Formulary is a public-private partnership between NCI, part of the National Institutes of Health, and pharmaceutical and biotechnology companies. It is also one of NCI’s efforts in support of the Cancer Moonshot, answering Vice President Biden’s call for greater collaboration and faster development of new therapies for patients. The availability of agents through the NCI Formulary will expedite the start of clinical trials by alleviating the lengthy negotiation process — sometimes up to 18 months — that has been required for investigators to access such agents on their own.

“The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner,” said NCI Acting Director Douglas Lowy, M.D. “Rather than spending time negotiating agreements, investigators will be able to focus on the important research that can ultimately lead to improved cancer care.”

The NCI Formulary launched today with fifteen targeted agents from six pharmaceutical companies:

  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Genentech
  • Kyowa Hakko Kirin
  • Loxo Oncology
  • Xcovery Holding Company LLC

“The agreements with these companies demonstrate our shared commitment to expedite cancer clinical trials and improve outcomes for patients,” said James Doroshow, M.D., NCI Deputy Director for Clinical and Translational Research. “It represents a new drug development paradigm that will enhance the efficiency with which new treatments are discovered.”

The establishment of the NCI Formulary will enable NCI to act as an intermediary between investigators at NCI-designated Cancer Centers and participating pharmaceutical companies, facilitating and streamlining the arrangements for access to and use of pharmaceutical agents. Following company approval, investigators will be able to obtain agents from the available formulary list and test them in new preclinical or clinical studies, including combination studies of formulary agents from different companies.

The NCI Formulary leverages lessons learned through NCI’s Cancer Therapy Evaluation Program (CTEP) and the NCI-MATCH trial, a study in which targeted agents from different companies are being tested alone or in combination in patients with genetic mutations that are targeted by these drugs. As the use of genomic sequencing data becomes more common in selecting cancer therapies, requests for access to multiple targeted agents for the conduct of clinical trials are becoming more common.

“We are very pleased that several additional pharmaceutical companies have already pledged a willingness to participate and are in various stages of negotiation with NCI,” said Dr. Doroshow, who is also director of NCI’s Division of Cancer Treatment and Diagnosis. “By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary.”

CTEP staff continue to discuss the NCI Formulary with pharmaceutical companies to make additional proprietary agents available for studies initiated by investigators at NCI-designated Cancer Centers.

The Formulary will complement NIH’s plans for another new public-private partnership in oncology, the Partnership to Accelerate Cancer Therapies (PACT). Through PACT, the NIH, U.S. Food and Drug Administration, biopharmaceutical groups in the private sector, foundations, and cancer advocacy organizations will come together to support new research projects to accelerate progress in cancer research as part of the Cancer Moonshot. PACT research will center on the identification and validation of biomarkers of response and resistance to cancer therapies, with special emphasis on immunotherapies. PACT will also establish a platform for selecting and testing combination therapies. PACT is expected to launch in 2017.

About the National Cancer Institute (NCI): NCI leads the National Cancer Program and the NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at cancer.gov or call NCI’s Cancer Information Service at 1-800-4-CANCER.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

SOURCE

https://www.nih.gov/news-events/news-releases/new-drug-formulary-will-help-expedite-use-agents-clinical-trials

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Top 32 Pharma companies: Perception of Pharma Companies Pairing of the Most Admired Pharma Companies – A Survey by eyeforpharma, its mission is to make Pharma companies more open and valued

Reporter: Aviva Lev-Ari, PhD, RN

Perception of Pharma Companies Pairing

Pfizer or Otsuka?

Pfizer
Otsuka

*2Eli Lilly or Celgene?

Eli Lilly
Celgene

*3Sanofi or Merck KGaA (EMD)?

Sanofi
Merck KGaA (EMD)

*4Amgen or Bristol-Myers Squibb?

Amgen
Bristol-Myers Squibb

*5Janssen (J&J) or Valeant?

Johnson & Johnson (Janssen)
Valeant

*6AstraZeneca or UCB?

AstraZeneca
UCB

*7Roche (Genentech) or Biogen?

Roche (Genentech)
Biogen

*8Teva or Servier?

Teva
Servier

*9Novartis or Astellas?

Novartis
Astellas

*10Bayer or Boehringer Ingelheim?

Bayer
Boehringer Ingelheim

*11Gilead or Eisai?

Gilead
Eisai

*12Allergan or Daiichi Sankyo?

Allergan
Daiichi Sankyo

*13GlaxoSmithKline or Mylan?

GlaxoSmithKline
Mylan

*14Abbvie or Shire?

Abbvie
Shire

*15Merck & Co (MSD) or Takeda?

Merck & Co (MSD)
Takeda

*16Novo Nordisk or CSL?

Novo Nordisk
CSL
SOURCES

From: Andy Robertson <arobertson@eyeforpharma.com>

Reply-To: Andy Robertson <arobertson@eyeforpharma.com>

Date: Wednesday, January 11, 2017 at 8:33 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Novartis vs Astellas – who wins?

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Projected Sales in 2020 of World’s Top Ten Oncology Drugs

Reporter: Aviva Lev-Ari, PhD, RN

 

 

Top Oncology Medicines

Projected Sales in 2020

Revlimid (Celgene)

Generic Name: Lenalidomide

$10,110 Million

 

Imbruvica (AbbVie/J&J)

Generic Name: Ibrutinib

$8,213 Million

 

Avastin (Roche)

Generic Name: Bevacizumab

$ 6,733 Million

 

Opdivo (BMS)

Generic Name: Nivolumab

$ 6,201 Million

 

Xtandi (Medivation & Astellas)

Generic Name: Enzalutamide

$5,700 Million

 

Rituxan (Roche)

Generic Name: Rituximab

$5,407 Million

 

Ibrance (Pfizer)

Generic Name: Palbociclib

$4,722 Million

 

Perjeta (Roche)

Generic Name: Pertuzumab

$4,669 Million

 

Herceptin (Roche)

Generic Name: Trastuzumab

$4,573 Million

 

Keytruda (Merck)

Generic Name: Pembrolizumab

$3,560 Million


SOURCE

https://igeahub.com/2016/04/01/worlds-top-ten-cancer-drugs-by-2020/

World’s Top Ten Cancer Drugs by 2020

Igea gives professionals, patients and investors interested in pharmaceuticals, biotechnology, healthcare technology, diagnostics and medical devices the most relevant, actionable news, information and analysis available anywhere. Our goal is to provide expert insights, analysis and information from industry leaders with a deep understanding of life sciences, medicine and healthcare. Created and curated by Luca Dezzani, MD, Global Medical Director at Novartis Oncology*, Igea offers an insider’s view on the most important developments in life sciences, healthcare technology, digital health and more.


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Milestones in Physiology & Discoveries in Medicine and Genomics: Request for Book Review Writing on Amazon.com


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Milestones in Physiology

Discoveries in Medicine, Genomics and Therapeutics

Patient-centric Perspective 

http://www.amazon.com/dp/B019VH97LU 

2015

 

 

Author, Curator and Editor

Larry H Bernstein, MD, FCAP

Chief Scientific Officer

Leaders in Pharmaceutical Business Intelligence

Larry.bernstein@gmail.com

Preface

Introduction 

Chapter 1: Evolution of the Foundation for Diagnostics and Pharmaceuticals Industries

1.1  Outline of Medical Discoveries between 1880 and 1980

1.2 The History of Infectious Diseases and Epidemiology in the late 19th and 20th Century

1.3 The Classification of Microbiota

1.4 Selected Contributions to Chemistry from 1880 to 1980

1.5 The Evolution of Clinical Chemistry in the 20th Century

1.6 Milestones in the Evolution of Diagnostics in the US HealthCare System: 1920s to Pre-Genomics

 

Chapter 2. The search for the evolution of function of proteins, enzymes and metal catalysts in life processes

2.1 The life and work of Allan Wilson
2.2  The  evolution of myoglobin and hemoglobin
2.3  More complexity in proteins evolution
2.4  Life on earth is traced to oxygen binding
2.5  The colors of life function
2.6  The colors of respiration and electron transport
2.7  Highlights of a green evolution

 

Chapter 3. Evolution of New Relationships in Neuroendocrine States
3.1 Pituitary endocrine axis
3.2 Thyroid function
3.3 Sex hormones
3.4 Adrenal Cortex
3.5 Pancreatic Islets
3.6 Parathyroids
3.7 Gastointestinal hormones
3.8 Endocrine action on midbrain
3.9 Neural activity regulating endocrine response

3.10 Genomic Promise for Neurodegenerative Diseases, Dementias, Autism Spectrum, Schizophrenia, and Serious Depression

 

Chapter 4.  Problems of the Circulation, Altitude, and Immunity

4.1 Innervation of Heart and Heart Rate
4.2 Action of hormones on the circulation
4.3 Allogeneic Transfusion Reactions
4.4 Graft-versus Host reaction
4.5 Unique problems of perinatal period
4.6. High altitude sickness
4.7 Deep water adaptation
4.8 Heart-Lung-and Kidney
4.9 Acute Lung Injury

4.10 Reconstruction of Life Processes requires both Genomics and Metabolomics to explain Phenotypes and Phylogenetics

 

Chapter 5. Problems of Diets and Lifestyle Changes

5.1 Anorexia nervosa
5.2 Voluntary and Involuntary S-insufficiency
5.3 Diarrheas – bacterial and nonbacterial
5.4 Gluten-free diets
5.5 Diet and cholesterol
5.6 Diet and Type 2 diabetes mellitus
5.7 Diet and exercise
5.8 Anxiety and quality of Life
5.9 Nutritional Supplements

 

Chapter 6. Advances in Genomics, Therapeutics and Pharmacogenomics

6.1 Natural Products Chemistry

6.2 The Challenge of Antimicrobial Resistance

6.3 Viruses, Vaccines and immunotherapy

6.4 Genomics and Metabolomics Advances in Cancer

6.5 Proteomics – Protein Interaction

6.6 Pharmacogenomics

6.7 Biomarker Guided Therapy

6.8 The Emergence of a Pharmaceutical Industry in the 20th Century: Diagnostics Industry and Drug Development in the Genomics Era: Mid 80s to Present

6.09 The Union of Biomarkers and Drug Development

6.10 Proteomics and Biomarker Discovery

6.11 Epigenomics and Companion Diagnostics

 

Chapter  7

Integration of Physiology, Genomics and Pharmacotherapy

7.1 Richard Lifton, MD, PhD of Yale University and Howard Hughes Medical Institute: Recipient of 2014 Breakthrough Prizes Awarded in Life Sciences for the Discovery of Genes and Biochemical Mechanisms that cause Hypertension

7.2 Calcium Cycling (ATPase Pump) in Cardiac Gene Therapy: Inhalable Gene Therapy for Pulmonary Arterial Hypertension and Percutaneous Intra-coronary Artery Infusion for Heart Failure: Contributions by Roger J. Hajjar, MD

7.3 Diagnostics and Biomarkers: Novel Genomics Industry Trends vs Present Market Conditions and Historical Scientific Leaders Memoirs

7.4 Synthetic Biology: On Advanced Genome Interpretation for Gene Variants and Pathways: What is the Genetic Base of Atherosclerosis and Loss of Arterial Elasticity with Aging

7.5 Diagnosing Diseases & Gene Therapy: Precision Genome Editing and Cost-effective microRNA Profiling

7.6 Imaging Biomarker for Arterial Stiffness: Pathways in Pharmacotherapy for Hypertension and Hypercholesterolemia Management

7.7 Neuroprotective Therapies: Pharmacogenomics vs Psychotropic drugs and Cholinesterase Inhibitors

7.8 Metabolite Identification Combining Genetic and Metabolic Information: Genetic association links unknown metabolites to functionally related genes

7.9 Preserved vs Reduced Ejection Fraction: Available and Needed Therapies

7.10 Biosimilars: Intellectual Property Creation and Protection by Pioneer and by

7.11 Demonstrate Biosimilarity: New FDA Biosimilar Guidelines

 

Chapter 7.  Biopharma Today

8.1 A Great University engaged in Drug Discovery: University of Pittsburgh

8.2 Introduction – The Evolution of Cancer Therapy and Cancer Research: How We Got Here?

8.3 Predicting Tumor Response, Progression, and Time to Recurrence

8.4 Targeting Untargetable Proto-Oncogenes

8.5 Innovation: Drug Discovery, Medical Devices and Digital Health

8.6 Cardiotoxicity and Cardiomyopathy Related to Drugs Adverse Effects

8.7 Nanotechnology and Ocular Drug Delivery: Part I

8.8 Transdermal drug delivery (TDD) system and nanotechnology: Part II

8.9 The Delicate Connection: IDO (Indolamine 2, 3 dehydrogenase) and Cancer Immunology

8.10 Natural Drug Target Discovery and Translational Medicine in Human Microbiome

8.11 From Genomics of Microorganisms to Translational Medicine

8.12 Confined Indolamine 2, 3 dioxygenase (IDO) Controls the Homeostasis of Immune Responses for Good and Bad

 

Chapter 9. BioPharma – Future Trends

9.1 Artificial Intelligence Versus the Scientist: Who Will Win?

9.2 The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy

9.3 The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC

9.4 Heroes in Medical Research: The Postdoctoral Fellow

9.5 NIH Considers Guidelines for CAR-T therapy: Report from Recombinant DNA Advisory Committee

9.6 1st Pitch Life Science- Philadelphia- What VCs Really Think of your Pitch

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

9.8 Heroes in Medical Research: Green Fluorescent Protein and the Rough Road in Science

9.9 Issues in Personalized Medicine in Cancer: Intratumor Heterogeneity and Branched Evolution Revealed by Multiregion Sequencing

9.10 The SCID Pig II: Researchers Develop Another SCID Pig, And Another Great Model For Cancer Research

Epilogue

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Agenda @Biotech Week Boston: WHERE THE HEART, TECHNOLOGY AND BUSINESS OF SCIENCE CONVERGE, Conference: October 4 – 7, 2016 | Exhibition: October 5-7, 2016 Boston Convention and Exhibition Center

Reporter: Aviva Lev-Ari, PhD, RN

Conference: October 4 – 7, 2016 | Exhibition: October 5-7, 2016

Boston Convention and Exhibition Center,
Boston, MA

WHERE THE HEART, TECHNOLOGY AND BUSINESS OF SCIENCE CONVERGE

#BIOTECHWEEKBOSTON

https://lifesciences.knect365.com/biotech-week-boston

October 6, 2016 – Key Sessions

Toni Hoover, Ph.D.

Harnessing Science, Technology and Innovation to Improve Global Health

Bill & Melinda Gates Foundation

Rick Berke

STAT Panel Discussion – President Clinton or President Trump: What Our Next President Will Mean for Biotech and Pharma

STAT (STATnews.com)

October 6, 2016

7:30 am 30 mins

Single-use XCell™ ATF Systems for Continuous Processing: 100% Cell Retention, 8x Faster Set-up, No autoclave

12:35 pm 30 mins

cGMP Biologics Production Using Corynex ® : A Highly-Productive Gram-Positive Microbial Protein Secretion System

12:35 pm 30 mins

Advanced Materials for Single Use Systems

12:35 pm 30 mins

Fast Trak Your Molecule to Market: When, Why and How to Outsource Biomanufacturing

12:35 pm 30 mins

An Integrated BalanCD ® CHO Media Solution for Early Therapeutic Antibody Development, Scale-Up and Commercial Supply

12:35 pm 30 mins

Reveal Information that Gives Insights – New Approaches to Sub-Visible Particle Characterization

9:15 am 525 mins

BWB Exhibit Hall Open

9:30 am 45 mins

Harnessing Science, Technology and Innovation to Improve Global Health

  • Toni Hoover, Ph.D., Bill & Melinda Gates Foundation

10:30 am 10 mins

Asahi Kasei Product Presentation

10:40 am 10 mins

How to Reduce Costs, Make Informed Decisions and Gain Insight for Innovation Through BioSolve

10:50 am 10 mins

Increasing Protein Production with Novel Cell-Ess Supplement without Affecting Metabolic Profile

12 pm 60 mins

Oral Poster Presentations

 1:10 pm
10 mins

Lonza Presentation

1:20 pm 15 mins

Distek Presentation

1:35 pm 10 mins

PendoTECH Presentation

2:15 pm 90 mins

Town Hall Forum: An Update on Single-Use Standardization and Alignment

4 pm 10 mins

Sartorius Presentation

4:10 pm 20 mins

Catalent Presentation

4:30 pm 10 mins

Asahi Kasei Presentation

4:40 pm 10 mins

Meissner Filtration Products Presentation

5 pm 60 mins

STAT Panel Discussion – President Clinton or President Trump: What Our Next President Will Mean for Biotech and Pharma

  • Rick Berke, STAT (STATnews.com)
  • Mason Tenaglia, IMS Institute for Healthcare Informatics, Payer & Managed Care Insights
  • Damien Garde, STAT (STATnews.com)
  • Dylan Scott, STAT (STATnews.com)

October 7, 2016

Key Sessions

Steve Wozniak

Innovation & Customer Centricity – Sponsored by Pall Life Sciences

Apple Computer Inc

7:15 am 30 mins

Accelerating Mammalian and Microbial Culture with Single-Use Technology

12:35 pm 30 mins

Unlocking Downstream Efficiency

9:10 am 330 mins

BWB Exhibit Hall Open

9:15 am 60 mins

Innovation & Customer Centricity – Sponsored by Pall Life Sciences

Pall Life Sciences
  • Steve Wozniak, Apple Computer Inc

10:15 am 10 mins

Steve Wozniak Meet & Greet at Pall Lounge

12:30 pm
60 mins

Panel Discussion: Immuno-oncology: What’s Next?

1:30 pm 30 mins

Passport Prize Drawing

10:50 am 20 mins

Innovations in Live Banking of Bio-Specimens: Prospective Advantages to the Retrospective Clinical Failures

11:10 am 20 mins

Innovations in Cell & Gene Therapy

11:30 am 60 mins

PANEL DISCUSSION: Innovations and Technology to Drive Improvements in Healthcare Delivery

SOURCE

https://lifesciences.knect365.com/biotech-week-boston

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Announcement from LPBI Group: key code LPBI16 for Exclusive Discount to attend Boston’s Discovery on Target (September 19-22, 2016, CRISPR: Mechanisms to Applications on 9/19/2016)

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Leaders in Pharmaceutical Business Intelligence (LPBI) Group is a Media Partner of CHI for CHI’s 14th Annual Discovery on Target taking place September 19 – 22, 2016 in Boston.

As a proud partner of this event, Leaders in Pharmaceutical Business Intelligence Group has secured a special discounted price for you to attend, resulting in a $200 discount on a commercial registration and $100 discount on an academic registration!

*This offer is valid for new registrants only, does not apply to previously registered attendees or short courses, and cannot be combined with any other offer. You must mention key code LPBI16 to receive this discount.

Don’t miss your opportunity to network with 1,100+ of your peers at this year’s event. Special early registration savings are currently available through Friday, August 12.

Preliminary AGENDA and Registration Link

http://www.DiscoveryOnTarget.com

For sponsorship & exhibit information, please contact: Jon Stroup, Sr Business Development Manager,
(+1) 781-972-5483, jstroup@healthtech.com

 

See us in CHI’s Media Partners section online:

http://www.discoveryontarget.com/Discoveryontarget_content.aspx?id=125312

Contact: 617-244-4024, avivalev-ari@alum.berkeley.edu

@pharma_BI

@AVIVA1950

ANNOUNCEMENT

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

pharma_bi-background0238

will cover in REAL TIME

Cambridge Healthtech Institute’s

Discovery on Target

September 19-22, 2016,

CRISPR: Mechanisms to Applications 

September 19, 2016

Westin Boston Waterfront, Boston, MA

In Attendance, streaming LIVE using Social Media

Aviva Lev-Ari, PhD, RN

Editor-in-Chief

http://pharmaceuticalintelligence.com

and

Stephen J Williams, PhD

Senior Editor

http://pharmaceuticalintelligence.com

flyer2forApril2016BioWorld

 

Leaders in Pharmaceutical Business Intelligence (LPBI) Group is a Media Partner of CHI for CHI’s 14th Annual Discovery on Target taking place September 19 – 22, 2016 in Boston.

 

As a proud partner of this event, Leaders in Pharmaceutical Business Intelligence Group has secured a special discounted price for you to attend, resulting in a $200 discount on a commercial registration and $100 discount on an academic registration!

*This offer is valid for new registrants only, does not apply to previously registered attendees or short courses, and cannot be combined with any other offer. You must mention key code LPBI16 to receive this discount.

Don’t miss your opportunity to network with 1,100+ of your peers at this year’s event. Special early registration savings are currently available through Friday, June 3.

 

Preliminary AGENDA and Registration Link

http://www.DiscoveryOnTarget.com

For sponsorship & exhibit information, please contact: Jon Stroup, Sr Business Development Manager,
(+1) 781-972-5483, jstroup@healthtech.com

 

See us in CHI’s Media Partners section online:

http://www.discoveryontarget.com/Discoveryontarget_content.aspx?id=125312

Contact: 617-244-4024, avivalev-ari@alum.berkeley.edu

@pharma_BI

@AVIVA1950

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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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