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

 

I’m back on American soil and gradually getting over jet lag. Although I didn’t write blogs for the month I was in Vienna, Austria, I did read about the life science industry via a continuing stream of newsletters to which I subscribe on my small netbook. Perhaps because I was in the EU, I found the growth of “company inversions” in our industry most noteworthy news. Those who know me recognize I’m always looking at the industry’s activities in terms of the impact on the workforce as well as the major focus on the development of innovative products and related improved health and well-being of Americans.

I’ve been concerned for years with the increasing role of financial managers and their short-term thinking—laying off thousands of employees to improve this quarter’s profits, for example—in place of a “stakeholder” perspective of what’s good for the employees is good for the company and its future success. Those of us in the industry in business development and R&D recognize that destroying the company’s “knowledge and know- how base” to improve the numbers can easily start the “death spiral” that has afflicted many a company. Negative hiring attitudes that lead to laying off more experienced and naturally higher paid workers to be replaced by recent graduates at a lower price not only destroy trust among staff but demotivate employees.

I believe in international companies and commerce but don’t support giving non-U.S. companies the same benefits as U.S.-based companies that invest in their communities and play a supportive role of the larger country. Paying their fair share of taxes and supporting the benefits they enjoy provided by taxpayer dollars isn’t just patriotic but good business. Some would say it’s time for citizens to shame these companies like Mylan and Medtronics along with the other 45 American-based companies that have done corporate inversions. (See Jonathan Alter’s article August 4th article entitled “The United States Needs Corporate Loyalty Oaths” in the Daily Beast.)

See another article “Congress Moves to Punish Medtronic and other Corporate Deserters” in +Mass Device newsletter.

I worry that the bottom line focus of these companies’ under another country management will further distance them from the welfare of U.S. patients along with that of their U.S. employees. Making important decisions based solely on shareholder return for the quarter is taking our industry away from their mission of providing improved health care.

Overview of Upcoming Life Science Events This Coming Week

  • BioCentury This Week, See new program Webcast Starting Sunday, August 10, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT. Watch on the Web Any Time. biocenturytv.com. Topic: Emotional Contagion: Facebook Experiment
  • PBSS, Monday Afternoon, Aug. 11, 2014. Topic: Excipient – Drug Interaction: understanding the physical, chemical, physiological and biochemical interactions and impact on pharmaceutical and pharmacokinetic. Speakers: Tian Wu (Amgen), Helming Tan (Amgen), Harvey Wong (Genentech)
  • Joint Bio2Device Group and EPPIC, Tuesday Evening, Aug. 12, 2014. Topic: “Diabetes and Cardiovascular Disease Risk Factors in Multi-Ethnic Groups: Comparison Study Findings from the MASALA Study.” Speaker: Alka M. Kanaya, M.D., Professor of Medicine, University of California, San Francisco
  • Golden Gate Polymer Forum, Tuesday, Aug. 12. 2014. Topic: Golden Gate Polymer Forum August Dinner Lecture: Light- and Air-Induced Reversible Self-Repairing Polymer Networks. Speaker: Prof. Marek W. Urban, Department of Materials Science & Engineering and Center for Optical Materials Science & Engineering, Clemson University
  • WIB, Wednesday Evening, August 13, 2014. WIB-San Francisco Bay Area Presents: South Bay Speed Networking

You can find the complete list of events included in Audreys Picks August 10, 2014with full details and the latest list of JobsThatCrossedMyDeskThrough August 10, 2014 by right clicking on the highlighted documents or on my blog found at www.Audreysnetwork.com.

Audrey

Posted by: Audrey Erbes | July 8, 2014

Life Science Industry Events until Oct. Plus Jobs

I am sending highlights for the next two weeks, but you can download details for the events for the next three weeks. See at end of list.

I will be away for a month and not writing my blog again until Aug. 10. I took time to enjoy the Fourth of July weekend and then got very involved in preparing for my month absence. If you need to reach me during that time, send an email which I will be checking infrequently. I’m going offline as much as possible as I focus on other things.

If you are interested in keeping up with life science industry developments, check out the Battelle Report at http://goo.gl/RhjlDo . Ernst and Young has just published their review of biotech for 2013 in their annual report Beyond Borders. Find latter at http://www.ey.com/GL/en/Industries/Life-Sciences/Beyond-borders-Matters-of-evidence-biotechnology-industry-report-2013—Point-of-view-matters-of-evidence. The latter is excellent in that it provides continuity over 25 years with the same definitions used during the history of biotechnology.

  • BioCentury This Week, See new program Webcast Starting Sunday, July 7, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Will Truvada Prevent AIDS;” Speakers: Dr. Richard Elion, Clinical Research Director at the Whitman-Walker Clinic, the largest AIDS healthcare provider in Washington D.C.; Tom Myers, Chief of Public Affairs and General Counsel for the AIDS Healthcare Foundation; and Dr. Joel Kupersmith, former Head of Medical Research at the Veterans Health Administration
  • Bio2Device Group, Tuesday Evening, July 8, 2014, Event: “Ca2+ Sensitizers – Opportunities in Drug Development;” Speaker: Ullrich Steven Schwertschlag, M.D, PHD, FACP, FCP , Pharmaceutical Drug Developer
  • Medtech Frontiers, Thursday Evening, July 10, 2014; Topic: “Bring Joy to Medical Technologies with Anthropology;” Speaker: Richard Sheridan, co-founder of Menlo Innovations
  • Bio2Device Group, Tuesday Morning, July 15, 2014; Topic: “Challenges in Developing Drugs for Orphan Indications: The Story of Neuraltus and ALS;” Speaker: Richard L. Casey, President and CEO, Neuraltus Pharmaceuticals
  • WIB-San Francisco Bay Area, Thursday Evening, July 17, 2014; Event: “Chocolate and Talk a Lot!”
  • NCC ACRP, Thursday Evening, July 17, 2014; Event: Peninsula Networking Event

You can find the complete list of events included in Audreys picks July 8, 2014 with full details and the latest list ofJobsThatCrossedMyDeskThrough July 8, 2014 by right clicking on the bolded titles or on my blog found at www.Audreysnetwork.com.

 

Audrey

We live in a country whose citizens like to believe has the most advanced medical system in the world, yet the U.S. ranks last in health care ratings among 11 industrialized countries on health care quality and access according to an analysis by the Commonwealth Fund published June 16, 2014. The U.S. spent $8,508 per person on health care in 2011 compared with $3,406 in the United Kingdom which ranked first in the Commonwealth Fund study. Noticeably, the U.S. ranked last on infant mortality among the eleven countries. More than 1/3 of U.S. adults skipped recommended tests or treatment due to cost and 41% who showed up at emergency rooms would have been treated by a physician if one had been available. The latter is blamed on the lack of access to primary care in this country. We hope that the Affordable Care Act will improve health care delivery as it expands it to millions otherwise not receiving it.

It’s a real surprise to me to learn that the failure to have obtained childhood vaccinations now resulting in epidemics of measles and pertussis is among well-educated and middle class families. In BioCentury This Week available online at no cost, the topic what’s behind parents not obtaining vaccinations for children is explored. Being among those living adults who suffered or lost family members to diseases for which there were no vaccinations available when they were children, I find it hard to comprehend that educated people could forego vaccinations that protect our children and society from suffering and risking the adverse events associated with these diseases. As a child I had measles, mumps and chicken pox but I gladly had my son receive all the vaccinations available because I recognized the risks and consequences of not doing so. When I was pregnant, I didn’t have to worry about getting measles from a sick child. A google search can quickly uncover the scientific basis for vaccinations so why do parents choose to believe the sensational media reports.

When I experience the whooping cough of youngsters now in public places, I wonder if they received their childhood pertussis vaccinations. Why are these epidemics happening with so much information available including the debunking of rumors about vaccinations causing autism. I found the interview of Dr. Paul Offit, Chief of the Division of Infectious Diseases at Children’s Hospital of Philadelphia and his findings fascinating.

Highlights of Upcoming Life Science Events This Week

  • BioCentury This Week, See new program Webcast Starting Sunday, June 15, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Vaccine Crusader: The Case for Vaccines,” Speaker: Dr. Paul Offit, Chief of Division of Infectious Diseases, Children’s Hospital of Philadelphia
  • Bio2Device Group, Tuesday Morning, June 24, 2014, Topic: “Health Information Technology (HIT): The Promise of a Better Healthcare System?” Speaker: Salim Kizaraly, SVP Business Development and Founder, Stella Technology
  • Palo Alto AWIS, Tuesday Evening, June 24, 2014, Topic: “Yourself as the Product: How to present yourself in an interview,” Speaker: Emmie Thomas, CEO and Co-founder of Knowji Inc., a mission-based education technology company.
  • ASQ, Wednesday Evening, June 25, 2014, Topic: “Design Transfer Procedures and Practices: Planned and Unplanned Change in the Product Development Lifecycle”
  • Nova, Wednesday Morning, June 25, 2014, Event: Biotechnology & Healthcare Panel”
  • Stanford Law School, Thursday Mid Day, June 26, 2014, Topic: “Speaking Truth to Patents: The Case for a Better Patent System,” Speaker: The Honorable Michelle K. Lee, Deputy Under Secretary of Commerce for Intellectual Property & Deputy Director, United States Patent & Trademark Office
  • NorCal BioPharma Project Management, Thursday Evening, June 26, 2014, Event: “NorCal BioPharma Project Management First Annual Summer Kick-off Mixer
  • SF AWIS, Saturday Morning, June 28, 2014, Event: “sfAWIS Networking Hike Lands End”

The HO Family Scholarship (CBA) SCHOLARSHIP

The HO Family Scholarship is established in memory of Ellen & Tony C. Ho.  Every year the Scholarship will consist of two awards of $500 each for high school juniors or seniors in the Bay Area.  Application deadline is 31 August. For eligibility and application information, please check http://www.cbasf.org/wp-content/uploads/2014/06/HO-scholarship-final.pdf.

You can find the complete list of events included in Audreys Picks June 22, 2014 with full details and the latest list of JobsThatCrossedMyDeskThrough June 22, 2014by right clicking on the bolded titles or on my blog found at www.Audreysnetwork.com.

Audrey

I hope to see you at some upcoming events.

Upcoming Life Science Events This Coming Week

  • BioCentury This Week, See new program Webcast Starting Sunday, June 15, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Event:” Right to Try: States Experiment;” speakers: Lucy Caldwell, Communications Director of the Goldwater Institute;Diane Dorman, Vice President for Public Policy at the National Organization for Rare Disorders (NORD) and Sjaak Vink, CEO of myTomorrows.
  • FDA, Monday and Tuesday, June 16-17, 2014; Event: Spring FDA Small Business REdI Conference 2014
  • Bio2Device Group, Tuesday Morning, June 17, 2014; Topic: Using a Case Study Approach to Describing the Key Drivers of Reimbursement Strategy Planning, Speaker: Susan Rowinski, Rowinski Group
  • Innocation HealthJam, Tuesday – Thursday, June 17-19, 2014
  • National Cancer Institute, Wednesday, June 18, 2014; Event: NCI SBIR&STTR: Advancing the Commercialization of New Cancer Innovations; Panelists: Ming Zhao, PhD | Program Director, SBIR Development Center, National Cancer Institute and Todd Haim, PhD | Program Director, SBIR Development Center, National Cancer Institute.
  • BioScience Forum, Wednesday Evening, June 18, 2014; Topic: “Challenges and Opportunity in Life Science R&D: Rethinking the Approach to Innovation;” Speaker: Mark Goldsmith, M.D., Ph.D., Partner, Third Rock Ventures
  • CBA and BayBio, Thursday Evening, June 19, 2014; Topic:“Investing Across Borders: Asian Biotech Investors Panel & Reception;” Investor Panel: Dr. Graeme Martin, Takeda Ventures; Dr. Wenbao (Wayne) Li, Morningside Group; Dr. Sofie Qiao, WuXi Venture and Dr. Min Cui, Decheng Capital; Moderator: Dr. Michelle Chen

The HO Family Scholarship (CBA) SCHOLARSHIP

The HO Family Scholarship is established in memory of Ellen & Tony C. Ho.  Every year the Scholarship will consist of two awards of $500 each for high school juniors or seniors in the Bay Area.  Application deadline is 31 August. For eligibility and application information, please check http://www.cbasf.org/wp-content/uploads/2014/06/HO-scholarship-final.pdf.

You can find the complete list of events included in Audreys Picks June 15, 2014 with full details and the latest list of JobsThatCrossedMyDeskThrough June 15, 2014 by right clicking on the bolded titles or on my blog found at www.Audreysnetwork.com.

Audrey

Posted by: Audrey Erbes | June 8, 2014

Pharma R and D and Cost Issues plus Events and Jobs

There’s been a lot of press recently about the high cost of new specialty drugs, especially, those for cancer of which the majority only deliver perhaps two months of added life rather than remission or a cure which all would like if paying cost of more than $100,000 for course of therapy. Pharma companies justify the high cost based on their accounting of the high cost of development across all efforts that involves more failures than successes. The discussion about the price of Sovaldi from Gilead will be interesting to follow as the basis for cost is discussed in Congress. Sovaldi is a special case in that the prevalence of patients numbers in millions vs. the much smaller number of cancer patients for which payers used to not question high prices. But that is changing as the costs of supplying these drugs threatens to bankrupt the healthcare system.

A recent article in AARP magazine questions the quoted $1 billion dollar cost of developing a drug as basis for the high costs. Cancer Rx: The $100.000 Myth” by Donald W. Wright and Hagop Kantarjian challenges the pharmaceutical industry explanation for pricing. Part of the problem with the arguments is the lack of transparency. We also don’t know how much money is wasted on unnecessary research or maintaining large fiefdoms inside these companies. Based on the tens of thousands of layoffs of R&D professionals working in these companies, I suspect waste is a part of the problem. Innovation is difficult at these giants and they are moving more toward focusing on licensing in promising research from startups and then directing attention to development which they can do so much better than small companies. We just hope that the management understands the need to maintain the critical development expertise of their staff and doesn’t equate “all FTAs” the same.

BioCentury This Week has a two-part series on “Cures, Curing the System” with Part I starting on June 1st and Part II starting today which address the side issues in the environment as well as others head on.

Upcoming Life Science Events This Coming Week

  • BioCentury This Week, See new program Webcast Starting Sunday, June 1, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT’ Topic: “Cures: Curing the System, Part II;” Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, Jonathan Leff, Partner at Deerfield Management and Chairman of the Deerfield Institute and Allan Coukell, Senior Director of Drugs and Medical Devices at The Pew Charitable Trusts
  • XTalks and Xcenda, Monday Morning, Monday, June 9, 2014; Topic: “Current and Future Access Challenges for Specialty and Biotechnology Products”
  • AWIS, Monday Evening, June 9, 2014; Webinar Topic: Building Your Leadership Credibility: Real-Life Strategies in Action
  • Bio2Device Group, Tuesday Evening, June 10, 2014; Topic: Critical Issues in International Women’s Health; Speaker: Anne Firth Murray, International Women’s Health
  • WSGR, Thursday, June 12, 2014; Event: WSGR 22nd Annual Medical Device Conference
  • PBSS, Friday Afternoon June 13, 2014; Topic: “Transporter ITC update: latest development in transporter science;” Speakers: Kathy Giacomini (UCSF), Xiaoyang Chu (Merck), Maciej Zamek-Gliszczynski (Lilly)
  • El Camino Hospital, Los Gatos, Saturday, June 14, 2014; Event: 1 Free Health Screening + 1 Free Men’s Health Fair

You can find the complete list of events included in Audreys Picks June 8, 2014 with full details and the latest list of JobsThatCrossedMyDeskThrough June 8, 2014 by right clicking on the bolded titles or on my blog found at www.Audreysnetwork.com.

 

Audrey

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