How did we get to where we are now with regard to business objectives in our industry? Why are American-based life science companies so anxious to add to their quarterly profits that they would even give up their citizenship in the country which provides their qualified staff and employees’ education, government research support funds and lots of support infrastructure? Their goal is to stop paying taxes in the U.S. and, thereby, decrease costs. They disregard public duty and responsibility to help pay for benefits they enjoy from taxpayer supported business infrastructure environment and market access. It’s worrying to see the role “inversions” have been playing in M&A decisions, for example. The fact that Abbvie’s Board is now directing stockholders to vote against the Shire acquisition upon restudy of the tax implications under the new U.S. rules intended to discourage inversions tells me that the deal lacked merit other than financial savings for stockholders. What is the mission of their business? Are accountants driving their business strategy?

AbbVie’s claims that “although the strategic rationale of combining our two companies remains strong, the agreed upon valuation is no longer supported as a result of the changes to the tax rules and we did not believe it was in the best interests of our stockholders to proceed,” remarked AbbVie CEO Richard A. Gonzalez.” Abbvie noted that the new rules “eliminated certain of the financial benefits of the transaction, most notably the ability to access current and future global cash flows in a tax efficient manner as originally contemplated in the transaction.”

It appears that financial savings was the major basis of the deal rather than strategic. It seems to me that the business objective of delivering needed and innovative products was not the major reason for Abbvie’s inversion endeavor. How will our industry survive with the short-term thinking and movement away from what is in the best interest of the company’s mission long-term? Building companies and staff with a vibrant culture for the long-term seems to be less of the business rationale than previously. The beliefs expressed by the financial staff at companies like Roche, for example, that they can easily replace the culture of a highly successful company with buyouts of others startups frightens me. I see more than more of this short-term thinking–we need to increase profits this quarter to keep our stock price higher, so lay off a 100 or 1,000 employees with so thought as to the impact on the future of the company’s ability to innovate.

I recently read an insightful article from McKinsey and Company about capitalism. The authors Eric Beinhocker and Nick Hanauer suggest business needs to move away from the misguided idea that shareholder value is the primary objective of business. See their article entitled “Redefining capitalism: Despite its ability to generate prosperity, capitalism is under attack. By shaking up our long-held assumptions about how and why the system works.

I quote “But some argue that elevating the creation of shareholder value to the status of primary objective is based on a faulty assumption—that capital is the scarcest resource in an economy, when in reality it’s knowledge that’s the scarce, critical ingredient in solving problems. It has also led to a myopic focus on quarterly earnings and short-term share-price swings, to say nothing of a decline in long-term investment. This is in startling contrast to the attitudes of even the recent past. If you asked a CEO in the 1950s, an era of tremendous prosperity growth, what his job was, his first reply would probably have been “to make great products and services for customers.” After that, the CEO might have said something about looking after his company’s employees, making profits to invest in future growth—and then, finally, giving the shareholders a decent, competitive return.

Elsewhere in the article they state recommendation “We believe that a reorientation toward seeing businesses as society’s problem solvers rather than simply as vehicles for creating shareholder returns would provide a better description of what businesses actually do. It could help executives better balance the interests of the multiple stakeholders they need to manage. It could also help shift incentives back toward long-term investment—after all, few complex human problems can be solved in one quarter.”

Highlights for Week of Oct. 19 Life Science Events in the Bay Area

  • BioCentury This Week, See new program Webcast Starting Sunday, Oct. 19, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Chilling Reality: What Next for ALS? Speakers: Brett Morrison, Physician and Assistant Professor of Neurology, Johns Hopkins University; Richard Garr, CEO, Neuralstem; Mary Woolley, President, Research America; Benjamin Corb, Director of Public Affairs American Society for Biochemistry and Molecular Biology
  • Bio2Device Group, Tuesday Morning, Oct. 21, 2014; Topic: Improving Access to Healthcare – A Global Perspective; Speaker: Burt Houtz, CLS, PMP, President, Leadership With Health
  • BioScience Forum, Wednesday Evening, Oct. 22, 2014; Topic: “Designing Clinical Research in Challenging Times;” Speaker: Peter Blaisdell, Ph.D., Executive Director, Global Study Management, Amgen
  • ASQ, Wednesday Evening, Oct. 22, 2014; Topic: Medical Mobile App & HIPAA; Moderator: George Marcel; Speakers: Mobile Medical App Security (Geetha Rao) and HIPAA (Bill Kurani)
  • PBSS, Thursday Afternoon, Oct. 23, 2014; Topic: “Biomarkers in Drug Development: Translation of Biomarkers from Early Discovery to the Clinic;” Speakers: Bob Yauch, PhD (Genentech), Scott Fountain, PhD (P¬zer), Kristin Wildsmith, PhD (Genentech), Leigh Anderson, PhD (SISCAPA), Ian McCaery, PhD (Genentech); Organizers: Alyssa Morimoto (Genentech), Kristin Wildsmith (Genentech)
  • BayBio, Thursday Mid Day, Oct. 23, 2014; Event: “Lunch and Learn: Next Generation Sequencing;” Speaker: Jennifer Friel Goldstein
  • Biotech Bay Career Fair, Thursday Afternoon, Oct 23, 2014; Event: Job fair

You can download Audreys Picks Oct. 19, 2014 with complete details on the above and other meetings and conferences through Dec. by right clicking on the highlighted titles. Also see JobsThatCrossedMyDeskThrough Oct. 19, 2014 for your information.

Audrey

Posted by: Audrey Erbes | October 12, 2014

Bay Area Life Science Events and Jobs Oct. 12, 2014

Life Science Events During The Week of Oct. 12, 2014

  • BioCentury This Week, See new program Webcast Starting Sunday, Oct. 12, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Coming Soon: Biosimilars in the U.S.,“ Speakers: Geoffrey Eich, executive director for external affairs at Amgen Biosimilars; Janet Woodcock, director of CDER; and Mark McCamish, global head of biopharmaceutical and oncology injectables development at Sandoz
  • HBA and J&J, Tuesday Evening, Oct 14, 2014; Event: 2nd annual Johnson & Johnson WLI and HBA SF chapter collaborative west coast event entitled “Diversity and Inclusion: The Business Case for Women Leaders in Healthcare”
  • Free Webinar by CliniPace, Tuesday Morning, Oct. 14, 2014; Event: “Opportunities and Challenges Using Biomarkers in Oncology Drug Development,” Speakers: Lee Schacter, PhD, MD, FACP and medical oncologist.Martha Bonino, Director, Strategic Accounts, Clinipace Worldwide
  • Bio2Device Group, Tuesday Evening, Oct. 14, 2014, Topic: “If you build it, who will pay for it?” Speaker: Mark Rayan, Senior Director of Managed Care and Strategic Accounts, CardioDx
  • HealthTech Capital and Stanford Hospital, Tuesday and Wednesday, Oct. 14-15; Event: “HealthTech Conference – Growing Your Business in the New Healthcare Ecosystem”
  • ASQ, Wednesday Evening, Oct. 15, 2014; Topic: “Evolving Standards,Impact on IT, Healthcare, & Medical Devices“ (Second of Two Joint Sessions) Presented by ASQ:Silicon Valley Section & Biomedical Division Northern California Discussion Group, Speakers: Geetha Rao, PhD, is Vice President, Emerging Technologies for Triple Ring Technologies in Newark, CA.; Bill Kurani, MSRA (SDSU), MSEE (LSU), BC (Stanford), RA/QA expert
  • San Francisco AWIS, Wednesday Evening, Oct. 15, 2014, Event: “Open House at Buck Institute for Research on Aging,” Speakers: Judith Campisi,PhD, Professor; Julie K. Andersen, PhD, Professor; Shona Mookerjee, PhD, Adjunct Assistant Professor
  • EMBS, Wednesday Evening, October 15, 2014; Topic: “Electrodes in the Brain – where do you want to put them and how do you get them there?” Speaker: Eric Sabelman, PhD, Functional Neurosurgery bioengineer, Department of Neurosurgery. Kaiser Permanente Medical Center, Redwood City
  • BayBio, Thursday Evening, Oct. 16, 2014; Event: BayBio’s Life Science Pub Night.
  • AMDM, Thursday and Friday, Oct. 16-17, 2014; Event: “AMDM IVD Focus Meeting 2014”
  • NCC ACRP, Thursday Evening, Oct. 16, 2014; Event: “NCC ACRP East Bay Networking Event “

You can download Audreys Picks Oct. 12, 2014 with complete details on the above and other meetings and conferences through Dec. by right clicking on the highlighted titles. Also see JobsThatCrossedMyDeskThrough Oct. 12, 2014or your information.

Audrey

One expects that Western industrialized societies would have no problems handling an Ebola-type threat. That’s what our top U.S. health officials are telling us. They remind us that we have one of the best, if not the best, health care system in the world in facing the threat from Ebola. One assumes the health care and public health care systems are ready with necessary protocols to protect our citizens. But I’m not too sure about the U.S.’s readiness after hearing about the bungling of the Ebola patient from Liberia, Mr. Duncan, and his attempt to seek care in Dallas.

Our health care system has a long way to go to deliver evidenced-based medicine but even the protocols for diagnosing and treating simple infectious diseases like the flu and colds are suspect and uneven across the country. The flu epidemics each year despite the availability of flu shots, the growing resistance of antibacterial drugs due to poor screening of patients prior to the prescription of an antibiotic and the growing failure to vaccinate children are all signs of a system which hasn’t prepared for infectious disease and needed protocols to properly treat patients. The high number of uninsured further contributes to the problem.

It appears that the Dallas nurse who interviewed Mr. Duncan was not informed about any protocols for identifying potential Ebola patients—especially, one who even informed her he just arrived from Liberia. The head of the Dallas hospital where the patient was sent home initially claims that they had trained their staff the previous week but perhaps the nurse involved had missed the training. Nurses claim that our hospitals are not prepared and recent surveys of hospitals support that claim. See “U.S. Nurses Say They Are Unprepared To Handle Ebola Patients.

American hospitals have been notorious for not practicing anti-infection practices until their profits are threatened. These protocols should be mandatory. Was this a result of lack of financial incentive until CMS started to refuse to pay for second treatments or readmission for infections acquired in the hospital?

Today’s citizenry is ill informed about protecting themselves and their families from disease contamination. Our young children have started receiving instructions about sneezing into their elbows rather their hands, for example, but this good practice was never translated to or reinforced by adult behavior in our health care system. Unfortunately, there’s no incentive for our for-profit medical system to provide education on sound public health practices.

It used to be common knowledge that one needed to avoid the risk of catching and spreading disease by not sharing drinks from the same container, spitting, etc. Awareness that it’s a good idea to wash one’s hands with soap and water after shaking hands or using the restroom is not a common practice. Most schools today no longer have this public health disseminator, a school nurse, on staff. Where I grew up in New York City, the public health system worked closely with schools and provided support for this education along with public health dissemination to the public. I worry that the lack of active role of our health care system along with much diminished public health education and lack of school nurses suggests the U.S. is not prepared for thwarting a major epidemic.

Upcoming Events During the Week of Oct. 5, 2014

  • BioCentury TV, See new program Webcast Starting Sunday, Oct. 5, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Transplant Ethics: Kidney Shortfall, “ Speakers: Dr. Sally Satel, Practicing Psychiatrist & Scholar, American Enterprise Institute, Received a life-saving kidney transplant; Dr. Robert Veatch, Professor, Kennedy Institute of Ethics, Former Board Member, Washington Reg. Transplant Consortium and Dr. Clive Callender, Professor of Surgery, Howard University
  • Bio2Device Group, Tuesday Morning, Oct. 7, 2014, Topic: “Economic Benefit of Advanced Hemodynamic Monitoring in three key areas, ER-Trauma, Anesthesia, & Critical Care,” Speaker: Barbara Byers, RN, Hemodynamic Sales Specialist, Cheetah Medical Inc.
  • EPPIC, Tuesday Evening, Oct. 7, 2014, Topic: “Digital Health Trailblazers,” Speakers: Michelle Longmire, Founder, Medable and Anoo Nathan, Founder and CEO, Smart Monitor
  • Golden Gate Polymer Forum October Dinner Lecture, Thursday Evening, Oct. 9, 2014; Topic: “Shape Memory and Other Functional Polymers for Biomedical Applications: From Benchtop to Startup,” Speaker: Prof. Robin Shandras, Professor & Chair Dept. of Bioengineering, and School of Medicine, University of Colorado, Denver
  • The Bay Area Pk/Pd Network Lunch Seminar, Thursday Mid Day, Oct. 9, 2014
  • ASQ, Saturday, Oct. 11, 2014, Topic: ASQ- B113 – Preparing & Submitting 510K’s & PMA’s

You can download Audreys Picks Oct. 5, 2014a with complete details on the above and other meetings and conferences through Dec. by right clicking on the highlighted title. Also see JobsThatCrossedMyDeskThrough Oct. 5, 2014 for your information.

Audrey

Posted by: Audrey Erbes | September 28, 2014

GSK Found Guity of Bribery in China Plus Events and Jobs

Glaxo Found Guilty of Bribery in China

Glaxo has to pay a fine of almost $500 million dollars and five top managers at the company in China received suspended prison sentences.  The Wall Street Journal reports “For foreign companies in China, it shows their vulnerabilities to inside informants and to an opaque justice system ultimately controlled by the Communist Party, adding risk to the promise of China’s growth potential.”There are additional investigations into Glaxo bribery underway in the UK and US. Glaxo previously acknowledged investigating claims employees bribed doctors in Poland, Iraq, Syria, Jordan and Lebanon. So GSK appears to have suspect business practices that go beyond problems in a problematic environment of China.

We know that Communist China was not the same terrain as that in other Asian countries, but I believe that the size of the market opportunity in China blinded top executives at non-Chinese companies to the risks. We have seen these risks played out as far back as the foray into China by IBM and more recently, GM.

Both the FBI and the U.S. Securities and Exchange Commission are investigating GSK’s activities in China. U.S. authorities have been reviewing the company’s overseas dealings since 2010 for possible violations of the Foreign Corrupt Practices Act. The U.K.’s Serious Fraud Office is also conducting an investigation.

It’s a whole new ballgame for pharma companies already but this latest development in punishment for unjust practices in emerging markets puts them at even greater risk for economic survival. One might have said that bribery is embedded in the culture in these emerging markets and GSK was just following patterns practiced in these markets, but in a society which lacks the rule of law, foreign enterprises will be singled out for punishment while others might not.

Highlights of Bay Area Life Science Events This Coming Week

  • BioCentury This Week, See new program Webcast Starting Sunday, Sept. 28, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Kids, Cancer and Congress: Plus Profiles in Innovations the Hedgehog Pathway;” Speakers: Rep. Michael McCaul (R-Texas), Founder and Co-Chair, Congressional Childhood Cancer Caucus; Rep. Chris Van Hollen (D-Md.), Co-Chair, Congressional Childhood Cancer Caucus; Nancy Goodman, Founder and Executive Director, Kids v Cancer; Dr. Frederic de Sauvage, Vice President of Molecular Oncology, Genentech Inc.
  • 24th Annual PSA: The Pharmaceutical Strategy Conference, Sept. 29-Oct. 1, 2014, Topic: “Pharma’s Strategies for Success In A Value Driven World: Rewarding Risk & Innovation”
  • Bio2Device Group, Tuesday Morning, Sept. 30, 2014, Topic: “Rocket Science Meets Biotech At The Frontier of Digital Health;” Speaker: Chris Melton, CEO & Founder, Corvectra
  • HBA, Tuesday Evening, Sept. 30, 2014, Event: “Healthcare Networking Social in Palo Alto”
  • Medtech Frontiers, Thursday Evening, Oct. 2, 2014, Event: “Parallel Computing Using Graphics Cards for Medical Imaging Applications;” Speakers: Dr. Tobias Funk, Triple Ring and Oleg Konings
  • Stanford Mechanical Engineering, Thursday Mid Day, Oct. 2, 2014; Event: “Sarcomere level function in human heart failure,” Speaker: Ken Campbell, University of Kentucky
  • Chinese Bioscience Association, Saturday, Oct. 4, 2014, Conference: “New Waves in the Biotech Industry: The 17th Annual Chinese Bioscience Association Conference,” Confirmed Speakers: Dr. Frank McCormick, Professor, UCSF, Founder of Onyx; Dr. Joseph Wu, Professor, Stanford University, Founder of Stem Cell Theranostics; Dr. Jo Shen, Co-founder & former CEO, ScinoPharm; Mr. Stephen T. Isaacs, Chairman and CEO, Aduro BioTech; Dr. Joan Lau, Founder and Managing Partner of Militia Hill Ventures; Dr. Chandler Robinson, CEO, Tactic Pharma; Dr. Christopher Bunker, VP Business Dev., Advanced Cell Diagnostics; Dr. Gabriel Chao, RD Director, iXensor; Dr. Yiyou Chen, CEO NewMab Bioscience Inc.; Mr. Zander Strange, VP Strategy and Corp. Dev., Zosano Pharma; Dr. Maninder Hora, SVP, Pharma. Dev. & Manuf., Nektar Therapeutics

You can download Audreys Picks Sept.28, 2014 with complete details on the above and other meetings and conferences through Dec. in the attachments. Also see JobsThatCrossedMyDeskThrough Sept. 28, 2014 for your information.

Audrey

The world of life science pricing is being turned on its head as the various sectors struggle to achieve a valuation for their new product that is “just right”—that which achieves profitability for investment but that still enables reimbursement by payers. I just heard one of the best talks ever on reimbursement by Jessica Holmes, Director of Reimbursement Argenta Advisors, at this past week’s Bio2Device Group meeting. Jessica provided a systems approach to reimbursement in Medtech which also applies equally to pharmaceuticals. Instead of looking at just one part of reimbursement she looked at how the overall healthcare system, payers, physicians, and other stakeholders struggle to find ways to reimburse the best value-based care products and keep within bounds of financial constraints by taking a look at how all the environmental factors interplay with each other.

Health care systems merge as it becomes more difficult for small organizations to meet demands of more efficient, improved medical care for large numbers of patients with value-based pricing. Company forecasters will find their task becomes even more difficult to project income let alone viable pricing for their new products.

I checked into progress at Real Endpoints to provide (1) solutions to payers for select products for reimbursement and (2) useful market intelligence to manufacturers to handle their needs to price correctly. I share with you the business tools provided by RE via their Reimbursement Intelligence products. Pricing and reimbursement are very complex and RI provides the information needed to track the various factors that need to be explored. See recent blogs which discuss the issues in pharma pricing and reimbursement.

The recent announcement of Gilead regarding the licensing of Sovaldi to 7 generic companies in India to develop and manufacture product for 91 countries outside the U.S. reinforces the burden of pricing for innovative drugs for so many patients who are infected.  I wonder how long it will take for American health care systems to provide paid vacations for their covered patients to travel to these sourced countries for treatment at huge saving to U.S. provider. This will surely provide a big boost for medical tourism. Perhaps that’s why Mexico is not one of the covered countries—too easy to cross border for low priced treatment.

Highlights of This Coming Week’s Events

  • BioCentury This Week, See new program Webcast Starting Sunday, Sept. 21, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Room to Run: Prices, Stocks, and NIH;” Speakers: Steve Usdin, Washington Editor, BioCentury; Erin McCallister, Senior Editor, BioCentury and Eric Pierce, Publisher, BioCentury
  • Bio2Device Group, Tuesday Morning, Sept. 23, 2014; Topic: “Leveraging Wearable Technology to Monitor Chronic Health Conditions, Speaker: Anoo Nathan, CEO, Smart Monitor
  • Janssen Labs, Tuesday, Sept. 23, 2014, Topic: “Digital Diagnosis – Harnessing Digital Technology to Improve Personal Health,” Panelists: Rick Beberman, Digital Health and Health IT Investment and Corporate Development Professional; Daniel Kraft, MD, Physician / Scientist at Stanford Medical School, Faculty & Medicine Track Chair for Singularity University; Ashwin Ram, Area Manager & Chief Innovation Officer, Interactive Intelligence, PARC, a Xerox Company ; Nirav Sheth, Director of Market Development, Medical, MC10 Inc. ; Casper de Clercq, Partner, Norwest Venture Partners. moderator
  • MIT Club of Northern California, Tuesday Evening, Sept. 23, 2014, Topic: “Can Big Data Cure Cancer?” Speaker: Dr. Marty Tenenbaum, Cancer Commons
  • BioScience Forum, Wednesday Evening, September 24th, 2014, Title: “Anti-Cancer Agents Targeting Protein Homeostasis: A Novel Approach using p97 Inhibitors,” Speaker: Mark Rolfe, Ph.D., President and Chief Scientific Officer, Cleave Biosciences Inc.

You can download Audrey’s Picks with complete details on the above and other meetings and conferences through Dec. by right clicking on Audreys Picks Sept.21, 2014. Also see JobsThatCrossedMyDeskThrough Sept. 21, 2014with same method.

Audrey

New At the FDA

The FDA has been busy in 2014 with statistics that show positive performance for the agency but also versus other regulators outside the U.S. They have approved 27 novel new drugs, including biologics, so far this year and have chance to match the high of 39 approvals in 2012. The achievement so far matches that for the whole of 2013.

In recent news we learn that the agency has published a list of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations in the form of the “Purple Book.” This is in keeping with the first acceptance of a biosimilar application in July from Sandoz, a unit of Novartis AG.“The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.”

BioCentury noted last week that the Purple Book is supposed to be the equivalent of the Orange Book which “lists all approved generic equivalents for a drug, along with patent and exclusivity information.”

Highlights of This Coming Week’s Many Life Science Events

  • BioCentury This Week, See new program Webcast Starting Sunday, Sept. 14, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT, Topic: “Battling Ebola: Racing Against Time;” Speakers: Dr. Anthony Fauci, Director, NIH’s National Institute of Allergy and Infectious Diseases; Dr. Robin Robinson, Director, Biomedical Advanced Research and, Development Authority and Donna Altenpohl, Vice President of Public Policy, GlaxoSmithKline
  • Bio2Device Group, Tuesday Morning, Sept. 16, 2014; Topic ”Opportunities and Challenges for MedTech Companies in Evolving Reform and Reimbursement Landscape,” Speaker: Jessica Holmes, Director of Reimbursement, Argenta Advisors
  • Janssen Labs, Tuesday, Sept. 16, 2014; Topic: “Meet with… NEA;” NEA Participating Representatives: Frank Torti, Principal, New Enterprise Associates, Inc. | Josh Makower, MD, Venture Partner, New Enterprise Associates, Inc. | Ed Mathers, Partner, New Enterprise Associates, Inc.
  • Engineering in Medicine and Biology Society (EMBS), Wednesday Evening, Sept. 17, 2014; Topic: “Modeling Health Behaviors Using Mobile Sensing;” Speaker: Anmol Madan, co-founder and CEO, Ginger.io
  • SVForum, Wednesday Evening, Sept. 17, 2014; Topic: “Sensors, Wearables, and Interoperability SVForum Healthcare IT Special Interest Group”
  • Life Science Leader and GE Healthcare, Thursday Morning, Sept. 18, 2014; Event: “Webinar: Five questions to ask before selecting a raw materials supplier;” Speakers: David Radspinner, PhD . General Manager, HyClone™ Cell Culture Products, GE Healthcare; Trisha Gladd, Contributing Editor, Life Science Leader Magazine and Ed Miseta, Executive Editor, Life Science Leader Magazine
  • ShareVault Free Webinar, Thursday Morning, Sept. 18, 2014; Webinar: “What’s Hot & What’s Not in Oncology Licensing;” Panelists: Linda Pullan, Ph.D, Pullan Consulting; Jeff Bockman, Ph.D, Vice President, Defined Health; Paul Juniewicz, Vice President, Oncology Business Opportunities, Sanofi and Ferran Prat, Ph.D, VP of Strategic Industry Ventures, MD Anderson
  • NCC ACRP, Thursday Evening, Sept. 18, 2014; Topic: “Changing our Approach: Practical Applications of Root Cause Analysis (RCA) and Corrective and Preventive Action Plans (CAPAs);” Speaker: Nikki Christison, BS., CCRA, Owner, Clinical Resolutions, Inc.
  • PBSS, Friday Afternoon, Sept. 19, 2014; Topic: “LC-MS/MS PK Assays for Proteins and Antibodies: Fundamentals, Advances, and Regulatory Considerations;” Speakers: Luna Liu (Genentech), Mark Rose (Amgen), Doug Leipold (Genentech)
  • Northern California BioPharmaceutical Project Management, Friday Morning, Sept. 19, 2014; Topic: “Antibacterial Drug Development and Commercialization: Avoiding the pitfalls in pre-market AST device development for post-market success; Speaker: Kevin Krause, Associate Director – Clinical Microbiology, Cerexa, Inc

You can download Audrey’s Picks with complete details on the above and other meetings and conferences through Dec. when you right click on the highlighted title Audreys Picks Sept.14, 2014. I’ve also included JobsThatCrossedMyDeskThrough Sept. 14, 2014 for your information.

Audrey

BioCentury has lead article this week “Betting Big on Hearts” by Emily Cukier-Meisner, Senior Writer, discussing a breakthrough drug for cardiovascular disease developed by Novartis. LCZ696 for heart failure will replace ACE inhibitors widely, so long as its price is not prohibitive. The Novartis pulled out all the stops in designing a study that provides the kind of evidence that is hard to ignore on part of payers, hospitals, and physician groups. Ms. Cukier-Meisner notes “The study design is a model for how companies can provide robust data — even against generics — in the brave new world in which regulators, payers, physicians and patients all have different data requirements.” The protocol was designed with the trial goals (1) that would show outcomes relevant to multiple stakeholders and (2) thoroughly supplant angiotensin-converting enzyme inhibitors in the indication of heart failure.

We hope the drug is affordable for this large indication and not priced like a specialty drug. The article notes that at the end of August, Novartis Pharmaceuticals Division Head David Epstein said LCZ696 won’t be priced like a generic, but that Novartis doesn’t think a high price is necessary for the company to continue developing products. “Companies have a responsibility to price reasonably, and we will do that,” he (Epstein) said.

With the large number of patients with heart failure in the U.S. alone, there’s no need to price the drug exorbitantly to reach blockbuster status. The volume of patients with the indication will produce blockbuster sales easilty for the drug if approved. The CDC provides the following statistics on the disease:

Heart Failure in the United States

  • About 5.1 million people in the United States have heart failure.1
  • One in 9 deaths in 2009 included heart failure as contributing cause.1
  • About half of people who develop heart failure die within 5 years of diagnosis.1
  • Heart failure costs the nation an estimated $32 billion each year.3 This total includes the cost of health care services, medications to treat heart failure, and missed days of work.”

Source: http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm; Statistics based on articles 1. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, et al. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation. 2013;127:e6–e245 and 3. Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011;123(8):933–44.

Mental Health Diagnosis

The National Institute of Mental Health wants a new system for classifying mental health in place of the traditional Diagnostic and Statistical Manual of Mental Disorders (DSM) and announced they won’t fund research based on the Manual in the future. Hear about the controversy on BioCentury This Week’s program “Signs and Symptoms: Defining Mental Health.” See how to access this free program plus last week’s below under Highlights of Upcoming Events.

Upcoming Events the Week of Sept. 7, 2014

  • BioCentury This Week, See new program Webcast Starting Sunday, Sept. 7, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT;Watch on the Web Any Time at biocenturytv.com, Continuously available, Topic: “Signs or Symptoms: Defining Mental Illness;”Speakers: Dr. Thomas Insel, Director, NIH’s National Institute of Mental Health; Dr. Darrel Regier, Vice Chair, DSM-V Task Force and Dr. William Carpenter, Member, DSM-V Task Force, Advisor, NIMH’s initiative to create a new mental illness classification system; August 31, 2014 Program, Topic: “Profiles in Innovation: Targeted Therapies Also Biosafety;” Speakers: Dr. Brian Druker, Director, Oregon Health Sciences University, Knight Cancer Institute; Dr. Carlos Moreno, Associate Professor, Department of Pathology & Laboratory Medicine, Emory University School of Medicine and Dr. Daniel Perez, Professor, University of Maryland
  • Bio2Device Group, Tuesday Evening, Sept. 9, 2014; Topic: “Reimbursement Challenges for Class II Medical Devices”-Daniel Cher, MD-09/09/2014 – 6:00pm; Speaker: Daniel Cher, MD, Vice President of Clinical Affairs, SI-Bone
  • RAPS, Wednesday Evening, Sept 10, 2014; Topic: “RA/QA Career Development and Networking Event”
  • SFAWIS, Wednesday Evening, Sept. 10, 2014; Event: “Networking Social”
  • GGPF, Thursday Evening, Sept. 11, 2014; Topic: “Customizing Biodegradable Polymer Properties and Degradation Characteristics for Device Applications,” Speaker: Kurt Breitenkamp, Ph.D., Managing Scientist, Polymer Science and Materials Chemistry, Exponent Inc
  • CABS, Friday, Sept. 12, 2014, Event: CABS Science & Technology Mini-Symposium: “Advances in Immuno-oncology, An Evolving Approach to Cancer Therapies”

You can download Audrey’s Picks with complete details on the above and other meetings and conferences through Dec. when you right click on the highlighted title Audreys Picks Sept. 7, 2014. I’ve also included JobsThatCrossedMyDeskThrough Sept. 7, 2014 for your information.

Audrey

Posted by: Audrey Erbes | September 1, 2014

Upcoming Bay Area Life Science Events and Job Listing

Highlights of This Coming Week’s Bay Area Life Science Events

  • BioCentury This Week, See new program Webcast Starting Sunday, August 31, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Profiles in Innovation: Targeted Therapies Also Biosafety,” Speakers: Dr. Brian Druker, Director, Oregon Health Sciences University, Knight Cancer Institute; Dr. Carlos Moreno, Associate Professor, Department of Pathology &Laboratory Medicine, Emory University School of Medicine and Dr. Daniel Perez, Professor, University of Maryland
  • Bio2Device Group, Tuesday Morning, Sept. 2, 2014, Topic: “Bio-Mimicry Concepts for Targeted Drug Delivery,” Speaker: Jayakurma Rajadas, Director, BIOADD AND Assistant Director OF CV Pharmacology, BIOADD Service Center, Stanford
  • Janssen Labs, Sept. 3, 2014, Topic: “Excited About Your Story: Unleashing the Power within…” Speaker: John Bates | Chief Executive Officer, Executive Speaking Success & Business Coaching
  • Medtech Frontiers, Thursday Evening, Sept. 4, 2014, Topic: “Global Implementation of Molecular Diagnostics for Tuberculosis,” Speaker: David Persing, MD, PhD
  • PBSS, Friday Afternoon, Sept. 5, 2014, Topic: Nonclinical Safety and PK/TK Assessments for Small Molecule and Biologic Therapeutics (Jointly with Bay Area PK/PD Network); Speakers: Tao Wang (Novartis), Hong Wang (Genentech), Carol Green (SRI)

Special Announcement: Biodesign Innovation Fellowship

Spend a year learning the ins and outs of medtech innovation – from exploring needs in a hospital setting to selecting just the right one to work on. Next, you and your team will come up with dozens of potential solutions and file patents on your best ideas.

Companies have come out of the program, but that’s not the end game for everyone – find out what makes medtech tick and where you fit in the product lifecycle. Our Medical Device Fellowship may be just the thing for you.Your future in medtech is here!

APPLICATION DEADLINE: September 5

Applications now being accepted for the 2015-16 Innovation Fellowship. Prepare by reading the application instructions.

Details are available at http://biodesign.stanford.edu/bdn/fellowships/bif.jsp

Contact for announcement: Christine Kurihara, Sr. Associate Director, Global and Communication, Stanford Biodesign Program @biodesignfellow

You can download Audrey’s Picks with complete details on the above and other meetings and conferences through Dec. when you right click on the highlighted title Audreys Picks August 31, 2014. I’ve also included JobsThatCrossedMyDeskThrough August 31, 2014 for your information.

Audrey

 

I recently read a commentary entitled “Biopharma’s Echo Chamber” by Roger Longman, CEO, Real Endpoints, LLC in the Aug. 4, 2014 issue of Biocentury. I’ve reread it several times and marked up the article because I believe it contains some really paradigm shifting thoughts and advice on pricing. Longman has been speaking about the need to better understand the shifting standards of value for drugs and this piece hits home the hardest—“Either Pharma helps its customers create the standards on which the full value of their drugs will be measured relative to their competitors—or they’ll have it done for them.”

Longman notes that historically pharma executives used to educate physicians (their focused customer in the past) to prefer their drug versus the competition based on advantage in their product’s label. But with the skyrocketing costs of specialty drugs, payers and PBMs who used to just push generics to increase their profits, now joined by risk-sharing physicians and institutional providers, are turning their attention to defining “their (drugs) relative value in new ways and with new energy, creating more restrictive coverage policies and ultimately limiting formulary choices.”

The advice is that biopharmas accept that they need to provide the information their customers want and need to compare the drugs more effectively or risk that they (the customers) will just use net cost as basis for decisions about formulary acceptance. Longman suggests a “complete framework of value—one that takes into account most elements of value, and measuring each competitor on each of those elements.” Unfortunately, companies only have labeling for other companies’ products and lack in depth information beyond the label except for their own product. Achieving the goal of “framework of value” would be extremely difficult without doing costly comparative trials which wouldn’t be possible without collaborative work across companies. I’ll be watching for new developments. Meanwhile, I expect we will be seeing more NICE-type decisions on acceptance of payment for these new high priced drugs.

Highlights of Upcoming Bay Area Life Science Events This Week

  • BioCentury This Week, See new program Webcast Starting Sunday, August 24, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “FDA’s History: Seeking Safety”
  • Bio2Device Group, Tuesday Morning, August 26, 2014; Topic: “Drug Development in silico: Models and Their Utility,” Speaker: Toufigh Gordi, President, ROSA and Company Drug Development Advisors
  • BioScience Forum, Wednesday Evening, Aug 27, 2014; Topic: “M&A to Spur Product Development, Growth and Value Enhancement – The Astex Pharmaceuticals Story,” Speaker: James Manuso, Ph.D., Chairman & CEO, Talifinium Investments, Inc
  • NorCal Biotech / Medical Device Industry, Wednesday Evening, August 27, 2014; Topic: “Current Trends & Impacts: Quality Skills in Demand – What, Why, & How to Succeed,” Moderator: George Marcel, Quality Management & Compliance Consultant and Harry Wachob ,Ph.D., Founder & President, Bio2Device Group; Panel: Guna Selvaduray, Ph.D., Director, Biomedical Engineering Program; Professor, Materials Engineering, College of Engineering, San Jose State University; Marieann Shovlin, ASQ Silicon Valley Section Education Chair; and Barry Craner, Chair, ASQ Northern California Discussion Group, VP, QA/RA, Stellartech

You can download Audreys picks August 24, 2014 with complete details on the above and other meetings and conferences through Dec. when you right click on the highlighted title Audrey’s Picks. I’ve also included JobsThatCrossedMyDeskThrough August 24, 2014 for your information.

Audrey

I’ve updated the list of life science events this week but have no new job listings. The end of summer and return to school for students next week means this week provides a last vacation opportunity for many so I’m not surprised at a decrease in events as well as job listings.

See this week’s BioCentury This Week which offers program with issues related to corporate inversion entitled “Taxing Innovation: Inversion or Evasion.” Creating value and what is value and its definition are themes in this week’s news. Wilson Sonsini has a new report on first half of 2014 Venture Financing entitled The Entrepreneur Report.

Highlights of This Week’s Upcoming Meetings

  • BioCentury This Week, See new program Webcast Starting Sunday, August 17, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT, Topic: “Taxing Innovation: Inversion or Evasion”
  • Bio2Device Group, Tuesday Morning, August 19, 2014, Topic: “What ASQ can mean for you in Silicon Valley,” Speaker: Marieann Shovlin, founder of Peak Process
  • HBA, Wednesday Evening, August 20, 2014, Workshop: “Branding Yourself: Keys to Making a Professional and Personal Impact,” Workshop Leader: Mark Perkins, San Francisco Bay Area corporate trainer, consultant and speaker.
  • Shomir Dighe Organizer, Wednesday Morning, August 20, 2014, Seminar Topic: “Wearable Technology – Seminar and Tabletop Exposition”

You can download Audreys Picks August 17, 2014 for complete details on the above and other meetings and conferences through October by right clicking on the highlighted title.

Enjoy the last vestiges of summer and get prepared for onslaught of the beginning of a new season.

Audrey

 

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