This week I refer you to the article entitled “Academia vs. BioPharma: Young Scientists Between A Rock and A Hard Place written by Stewart Lyman which covers all the points I’ve been trying to make regarding the future of R&D jobs much better than I. I found myself saying “yes, yes, yes” as I read the piece dated April 6, 2015. So here’s the citation for you– http://www.xconomy.com/seattle/2015/04/06/academia-vs-biopharma-young-scientists-between-a-rock-and-a-hard-place/

It’s important to identify the many different jobs out there for which your training might prepare you or preferably identify many options before you finish your education. It is far better to find out what learnings will help prepare you for jobs of interest earlier rather than later. Networking early is critical to learning about jobs. I remember that I was told the only jobs for women were teaching grammar school (or in my case, high school) or nursing by career counselors in high school. At the university I was encouraged to pursue medicine but they forgot to tell me that loans weren’t available for women for studying medicine in the 1960s when I was going to school. Was I surprised to learn after I began to speak with working professionals vs. career counselors in schools that there were a breadth of job categories for which I could prepare that I never knew about.

Although there was more discrimination against women of my generation entering the professions in the U.S., I understand that women from other cultures are still experiencing the same prejudice today.

I encourage current students to find role models and listen to program speakers with interesting jobs and ask to meet with women playing different roles in the life sciences. Clearly, there are insufficient academic and bench positions at companies available today. There’s a world of opportunity but you have to put yourself out there to learn what best fits you.

Upcoming Life Science Events Week of April 12

  • Bio2Device Group, Tuesday Evening, April 14, 2015, Topic: “Novel therapies for HIV patients who have failed anti-retroviral therapies,” Ramani Aiyer, Principal, Shasta Bioventures
  • GGPF, Tuesday Evening, April 14, 2015, Topic: “Anion Exchange Membranes for Electrochemical Energy Conversion and Storage,” Speaker: Prof. Andrew M. Herring, Dept. of Chemical & Biological Engineering, Colorado School of Mines, Golden, Co
  • CABS, Tuesday Evening, May 14, 2015, Topic: Case Studies – How to Protect Against and Avoid Legal Problems on Intellectual Property and Trade Secret in Business Partnerships, Tech Transfers, and Cross-Border Deals,” Speakers: Zheng Liu, Of Counsel, Orrick, Herrington & Sutcliffe; Tom Nolan, Trial lawyer, NAB Law LLC; Heather Newberry, Government Agent, FBI-San Francisco Division
  • JLABS, Wednesday Morning, April 15, 2015, Event: “From Chemical to Drug – The Path to a Small Molecule IND Best Practices When Filing Investigational New Drug Applications,” Speakers: Janssen Pharmaceutical Companies of Johnson and Johnson; Christopher Flores, Ph.D. | Janssen R&D; Michael Kelley, VMD, Ph.D. | Janssen R&D; Mark Krook, Ph.D. | Janssen R&D; Donald Heald, Ph.D. | Janssen R&D; Katherine Tsokas, J.D. | Janssen R&D read bio»
  • Stanford, Friday and Saturday, April 17-18, 2015, Topic: “The PTO And The Courts;” Speakers: Steve Baughman, Ropes & Gray LLP; Judge Scott Boalick, USPTO; Prof. Dan Burk, Univeristy of California, Irvine School of Law; Aaron Capron, Finnegan, Henderson, Farabow, Garrett & Dunner; Judge Peter Chen, USPTO; Professor Dennis Crouch, University of Missouri School of Law; Andy Culbert, Microsoft; Professor John Duffy, University of Virginia; Ian Feinberg, Feinberg, Day Alberti & Thompson; Professor Robin Feldman, Hastings College of the Law; Dmitry Karshedt, Stanford Center for Law and the Biosciences; Christina McCullough, Perkins Coie; Sonal Mehta, Weil, Gotchal & Manges LLP; Magistrate Judge Paul Grewal, United States District Court Northern District of California; Naveen Modi, Paul Hastings; Judge Kimberly Moore, United States Court of Appeals for the Federal Circuit; David O’Brien, Haynes and Boone; Sasha Rao, Maynard Cooper & Gale; Clement Roberts, Durie Tangri; Gregory Sobolski, Latham Watkins; Dr. Rose Thiessen, Knobbe Martens LLP; Lee Van Pelt, Van Pelt, Yi & James; Eliot Williams, Baker Botts L.L.P.
  • Silicon Valley ASQ, Friday Afternoon and Evening, April 17, 2015, Event: “50 Years, Your Partner in Quality”

You can download Audreys Picks April 12, 2015 with complete details on the above and other meetings and conferences through June 2015 by right clicking on the highlighted titles. Also seeJobsThatCrossedMyDeskThrough April 12, 2015 for your information. I list mostly jobs in California posted in the last three weeks but you can also find national listings at the websites mentioned.

Audrey

Posted by: Audrey Erbes | April 5, 2015

Handling Paradigm Shift in Jobs Plus Events This Coming Week

Issue of Declining Jobs Hit a Nerve

My blog on March 22 on Assault on R&D Jobs hit a nerve. I had the highest number of online reads for that posting versus all others since beginning of year. I asked question what impact increased use of artificial intelligence would have on jobs at EPPICon conference this past Saturday directed to speaker telling us that artificial intelligence was replacing human workers. He turned very serious and expressed his great concern about this potential and had no answers. Several subsequent speakers alluded to this problem and others mentioned articles they had read raising concern about sufficient jobs for population in future. I also had comments from many of my readers.

While only one of my readers told me he accepts larger numbers of professionals without work as inevitable in the economy in which we live, I find it hard to accept. This response reminds me of aristocrats from developing countries who say that there’s nothing that can be done to raise the standard of living of those in poverty—that it will always be that way.

I don’t see technology replacing teachers or healthcare workers and other service workers where the personal human touch is required. The computer was supposed to replace file cabinets and result in the paperless office back in early 1980s but it took until recent years to start to see great reductions in paper document storage. Students can listen to online lectures but still need human interaction with adult to tackle the learning, projects and assimilation of the information. Studies I’ve read show that replacing teachers with online instruction doesn’t work effectively, for example.

Our society faced these paradigm shifts with entry of industrialization and move of custom work from workshops to factories but we still need plumbers, electricians, firefighters, policemen, ambulance drivers, rescue workers and craftsmen to handle the interaction with us in our daily lives. We still need the surgeon to guide the robotic surgery tools.

We are reading that colleges are cutting back on liberal arts in favor of STEM education. I’m coming to believe that every well educated person should have a liberal arts degree or science/engineering degree with liberal arts classes to learn the cycle of history, cultural mores and how to successfully interact with other citizens and community members. We all need to know how to decipher truth and facts from opinion and how to work on a team. Music in high school has been shown to increase the success rate of students as well as the graduation rate.

I would encourage all students to also learn a skilled trade such as those mentioned above to help pay for school or use as fall back if their professional job disappears. Most of us can’t do the necessary repairs in our home on our own despite all the Home Depot and Lowes workshops. I have handymen now to handle repairs my husband used to do. Several of these had earlier careers in high tech but were fed up with the layoffs.

This issue will be a continuing one as we witness the fallout of our industry reaching the M&A heights as well as IPOs in this past year. Part of our education needs to ensure we can be flexible and adjust to these societal changes.

Upcoming Events This Week

It’s another short week of events this week as holdover from Passover and Easter holidays and spring breaks. I didn’t receive any new job listings this week so I’m not posting my usual Jobs That Crossed My Desk This Week.

  • Bio2Device Group—Serving Pharma, Biotech, Diagnostics and Devices, Tuesday Morning, April 7, 2015, Topic: “Dynamics of the Human Microbiot,” Speaker: Les Dethlefsen, PhD, Relman Lab, Stanford University
  • NCC- AWIS, Saturday Morning, April 11, 2015, Event: NCC-AWIS Career Development Workshop: Persuasive Interviewing, Keynote Speaker: Antoine de Morrée, Scientist and communication consultant that specializes in coaching other scientists in the art of persuasive communication.

You can download Audrey’s Picks with complete details on the above and other meetings and conferences through December 2015 by right clicking on the highlighted title Audreys Picks April 5, 2015.

Happy Holdiays!

Audrey

Posted by: Audrey Erbes | March 29, 2015

Drug Shortages Worsen Plus Life Science Events and Jobs

Drug Shortages Get Worse

Drug shortages with their related price increases, limitation of availaibility of product, increased flow of compounded products and increased counterfeiting to fill the vacuum have many explanations. The availability of API online as well as product containers and labels has changed the profitability of former supply situations. In the past, manufacturers and distributors had up to 3 months supply available to resolve these shortages. Now that the list which was normally in single digit numbers over 300 typically, we have to wonder if there is a solution.

Profitability issues have played a major role in limiting available alternative product sources. If there is shutdown or other closure or only available source, there is problem for patients, hospitals and physicians. An article entitled “Drug Shortages: Not Going Away Anytime Soon,” by Albert I. Wertheimer, Ph.D. published by Pharmexec.com on March 25, 2015 provides an outstanding coverage of this disturbing issue in biopharma. Unfortunately, there is no suggested solution.

Next week I’ll address the issue of declining R&D jobs as well as other life science jobs. Please provide your take on cause and more importantly, your ideas of possible solution.

Highlights of Upcoming Events

  • Bio2Device Group, Tuesday Morning, March 31, 2015, Topic: “Overexpression of Mcl-1 confers resistance to BRAFV600E inhibitor therapy in melanoma,” Speaker: Neel M. Fofaria, PhD Candidate, Texas Tech University Health Sciences Center, School of Pharmacy
  • BayBio, Tuesday Mid Day, March 31, 2015, Event: “Lunch & Learn | Harnessing The Power Of Big Data In Risk-Based Monitoring,” Speaker: Barbara Elashoff
  • Palo Alto AWIS, Tuesday Evening, March 31, 2015, Topic: “A color language for cultivating your intentional and inner leadership,” Speaker: Rose Chen, Founder of VegaLab Ventures
  • QB3, Wednesday Evening, April 1, 2015, Topic: “HOW TO PUT A PRICE TAG ON YOUR STARTUP,” Speaker: Burton Goldfield, President & CEO,TriNet
  • Medtech Frontiers, Thursday Evening, April 2, 2015, Topic: “Novel Fiber Optics Couplers for Biomedical Applications”

You can download Audreys Picks March 29, 2015 with complete details on the above and other meetings and conferences through May 2015 by right clicking on the highlighted titles and downloading the pdf files. Also see JobsThatCrossedMyDeskThrough March 29, 2015 for your information. I didn’t see many jobs this past week. Note I list mostly jobs in California posted in the last three weeks but you can also find national listings at the websites mentioned.

Audrey

Posted by: Audrey Erbes | March 22, 2015

Understanding the Assault on R&D Jobs Plus Event and Jobs

There appears to be a wholesale paradigm shift to run businesses with far fewer employees. A few entrepreneurs come up with new business concept, develop it and launch it. If it survives a buyout, it will be run with much smaller staff numbers than in the past. In industry we saw a reduction in overall employment, first, through technological improvements which allowed manufacturing to occur with fewer staff. We saw same trend in business jobs as modern technology replaced the need for several layers of typing and scheduling and administrative staff, for example. The administrator positon went out before that of secretary.

At Genentech, they turned over all computer research normally handled by company reference librarians to employees. The job scope of tasks increased as more “tools” became available. It isn’t clear whether or not that shift of responsibility was good or not. I suspect new positions were created in departments or the work was outsources to consultants to handle market research and analysis.

CROs replaced former large company clinical staffs which were subject to changes in need as products proceeded through development stages. CMS’s replaced need to fund and build manufacturing sites.

Then the offshoring in our industry followed that of high tech. Only those jobs which overseas staff couldn’t perform or were desirable to remain in U.S. to protect company IP had to remain in U.S. Some of the experiments to offshore life science haven’t proved to be successful as companies ran into repugnant overseas governmental actions, local country county preferences, tariffs, and local social unrest. The lack of rule of law in many of these offshore countries hadn’t been fully counted in the transactional costs.

A recent Robert Reich piece on March 16th suggests that there is a permanent trend to less available work for our citizens as result of technology innovations. “It’s now possible to sell a new product to hundreds of millions of people without needing many, if any, workers to produce or distribute it.” In his article entitled “The iEverything and Redistributional Imperative” on his website (http://robertreich.org/), he notes that “The two sectors of the economy harboring the most professionals — health care and education – are under increasing pressure to cut costs. And expert machines are poised to take over.”

It’s been noted elsewhere that Obamacare has generated many new businesses and jobs in response to its presence. These new service companies provided jobs. If Reich is correct, all those primary care docs and PAs might not be needed. And here I was hoping that resulting growth in need for medical professionals would provide new positions for displaced life science Ph. D’s, hopefully, earlier in their education.

I believe that the life science industry is undergoing a major paradigm shift with one of the changes–a massive downsizing of R&D bench jobs in biopharma. This change will also impact on the Ph.D. programs which continue to turn out more post docs for which there are not enough academic or industry jobs. This massive shift will be very painful for the professionals who developed their credentials with great personal expense, effort and sacrifice over many years. Thousands will need to reinvent themselves and transition into other professions or sectors and more will turn away from bench jobs as a career choice.

I’ve been in the industry for over 40 years and agree there have to be changes. It’s tragic that we are destroying a whole segment of jobs without any replacement for the large numbers of professionals affected. Coal miners and steel workers faced the same dilemma.

Upon reading the latest House Republican budget, I see little hope for resources to expand jobs in research or medicine. The controlling party in the House still wants to shut down Obamacare and cut into Medicaid and Social Security funding. I continue to look for hope, but my usual optimism is being challenged by the rush to save/make more money and pass the benefits on to a few in the society.

Highlights of Upcoming Life Science Events

  • PBSS, Monday, March 23, 2015, Topic: “Antibody Drug Conjugate (ADC) Based Anticancer Therapeutics: Discovery, Development, Regulatory Issues;” Speakers: Tom Pillow, Bogdan Olenyuk, Kedan Lin (Genentech); Samadhi Vithanrana (Takeda);
  • BioDesign, Monday, March 23, 2015, Event: From the Innovator’s Workshop, Speaker: Eric Topol, Director, Scripps Translational Institute, Professor of Genomics, The Scripps Research Institute
  • Bio2Device Group—Serving Pharma, Biotech, Diagnostics and Devices, Tuesday Morning, March 24, 2015, Event: “Building a medical device management team for successful growth through acquisition,” Speaker: William L. Mince
  • East Bay AWIS, Wednesday Evening, March 25, 2015, Topic: “Axygen Union City Manufacturing Tour Plus – East Bay AWIS Networking Event”
  • ASQ NCDG, Wednesday Evening, March 25, 3015, Event: “Medical Process Control Risk Management: Today’s Processes, Tomorrow’s Products,” Moderator:   Gary Seeger, CQE, CRE, VP QA/RA, Stellartech Research Corporation, Milpitas, CA, Program Chair, NCDG, RAPS/NCDG Program Chair 2009-1014, ASQ CQE, CRE; Speaker:Barry Craner, former VP QA/RA, Stellartech
  • BioScience Forum, Wednesday Evening, March 25, 2015, Topic: “Precision Drugs for Bad Bugs (“PD4BB”),” Speaker: David Martin, M.D., CEO, AvidBiotics
  • Northern California BioPharmaceutical Project Management, Friday Morning, March 27, 2015, Topic: “Ways to Accelerate Drug Development: Fast-Track, Breakthrough Designation, Accelerated Approval, Priority Review,” Speaker: Michele Bronson, Ph.D. – Vice President, Program Management, Portola Pharmaceuticals
  • EPPICon 2015, Saturday, March 28, 2015, Topic: “Digital Disruption in Life Sciences”

You can download Audrey’s Picks with complete details on the above and other meetings and conferences through May 2015 by right clicking on the highlighted titles. Also see Jobs That Crossed My Desk Through March 22, 2015 for your information. I list mostly jobs in California posted in the last three weeks but you can also find national listings at the websites mentioned.

Audrey

BioPharma Continues to Destroy R&D Staff and Facilties

I’ve written earlier about the purging of R&D staff when there’s a M&A or accountant who earns their bonus by sharply cutting costs through layoffs. Clearly, management doesn’t understand the long-term effect these short-term actions will take. John Carrol writes in FierceBio the article “Biopharma’s new normal: Constant makeovers leave R&D jobs at permanent risk” with details on the carnage with no good news as followup for these revolutionary changes. There doesn’t seem to be a successful model or plan for future behind these actions.

Tearing down institutions was recognized historically as bad idea. Case in point is the French Revolution. I guess Pharma management doesn’t study history or how such actions leads ultimately to the destruction of an industry.

There doesn’t seem to be any good solid organizational research, analysis and implementation strategies behind these apparent knee jerk moves. Has response to shareholder expectations for regular stock price increases replaced good management?

Upcoming Life Science Events This Coming Week

  • Bio2Device Group—Serving Pharma, Biotech, Diagnostics and Devices, Tuesday Morning, March 17, 2015, Topic: “Mapping the vasculature for better outcomes,” Speaker: Ron Bucher, Director Worldwide Customer Service, AccuVein
  • sfAWIS, Wednesday Evening, March 18, 2015, Event: Networking social
  • Bay Area Chapter, Project Management Institute, Wednesday Evening, March 18, 2015, March Evening Event: “Finding Joy in Project Management”
  • Engineering in Medicine and Biology Society (EMBS), Wednesday Evening, March 18, 2015, Topic: ”A start-up’s view of the challenges and opportunities in consumer healthcare,” Speaker: Greg Sommer, Founder and CEO,Sandstone Diagnostics, Inc.
  • JLABS, Thursday Morning, March 19, 2015, Event: “Meet With… California Institute For Regenerative Medicine,” California Institute for Regenerative Medicine Participating Representative:Neil Littman | Business Development Officer, California Institute for Regenerative Medicine
  • Patheon, Thursday Afternoon, March 19, 2015, Topic: “Api Supply: Key Strategies For Creating Value In Early-Stage Development;” Presentations: “Supply of API for Early Development,” James Henshilwood, Ph.D. Intermune; “API Continuous Process Considerations,” Peter Poechlauer, Ph.D., Patheon; “How IP Decisions Can Add Value,” Bernie Brown, Ph.D., J.D., Womble Carlyle Sandridge & Rice
  • NCC ACRP, Thursday Evening, March 19, 2015, Event: “IND Basics and How an IND Can Be Adapted to Support Global Clinical Trials,” NCC ACRP Educational Event – You do not need to be a ACRP member to attend, Speaker: Meredith Brown-Tuttle, Regulatory Affairs Consultant
  • Navigating a Career Transition into the Life Sciences, Saturday, March 21, 2015; Course: MCELLBI 1002 – 002 Navigating a Career Transition into the Life Sciences 2014-2015 – Spring 2015, Instructor: Toby Freedman, Ph.D., President, Synapsis Search, Executive Recruiting for the Life Sciences, http://www.synapsissearch.com; Author, Career Opportunities in Biotechnology and Drug Development, careersbiotech.com

You can download Audreys Picks March 15, 2015 with complete details on the above and other meetings and conferences through May 2015 by right clicking on the highlighted titles. Also see JobsThatCrossedMyDeskThrough March 15 2015 for your information. I list mostly jobs in California posted in the last three weeks but you can also find national listings at the websites mentioned.

Anyone have a current list of biotech, life science and medtech companies in the Bay Area? Predecessor organization to BayBio used to provide that for modest fee. I’m getting many requests from professionals having difficulties finding employment either as new graduates or those trying to transition into a new position or sector.

Audrey

Posted by: Audrey Erbes | March 9, 2015

BayBio Merges with CHI Plus Events and Jobs

Bay Bio in conjunction with BioCom once again provided an interesting and relevant program as part of CalBio 2015 at the Marriott Marquis Hotel in San Francisco on Monday-Tuesday, March 2-3, 2015. The panels covered the topics about the changes in funding of biotech companies and once again found early state startups were struggling to find funding as VC funding has for the most part left this area of financing the industry. They had panels covering the collaborations that have become such a large part of the landscape and the new build-to-sell drug deals that provide new route to survive for early stage start ups.

I wondered why the attendance was down versus the last BayBio Annual Meeting four years ago with 900 attendees and this year with only 750 despite representing the entire state of California this year. I don’t have details as to levels of attendees but felt that there were far fewer CEOs and founders in attendance at this meeting. I wonder if the new funding principally via M&A with the liquidation of the company staff and send off of the leadership with non-competes might be playing a role in the seeming loss of leadership in attendance. I missed the excitement of earlier meetings when top management participated in more panels and shared their progress and secret sauce.

I was disappointed to hear that Gail Maderis will be leaving BayBio as the organization she led is merged with the California Health Institute (CHI). The new entity will be named the California Biomedical Innovation Alliance, or CBI for short. The merger is expected to close imminently. Sara Radcliff will be the first president and CEO of the new entity. Her most recent position was executive VP of the Washington, D.C.-based Biotechnology Industry Organization. BioCom chose not to join in the new entity.

We will miss Gail Maderis and her high energy for biotech company founding and growth as well as special interest in promoting STEM education in California. Ms. Radcliffe is known as “policy wonk.” Only time will tell how that leadership will fare. In the early days of the Bay Area company group, the organization suffered under the leadership of a policy wonk from state government who had no industry understanding. A subsequent president recruited from the Washington, DC area to replace departing president moved the focus of the group to that of political group with lots of fanfare but seemed to forget what was best for organizations and working professionals in a very distinctive biotech cluster. Ms. Maderis was a refreshing change as someone who understood companies and their needs and is sensitive to the needs of maintaining a vibrant workforce.

The fate of the current staff of BayBio is not known. Radcliffe will determine the roles and responsibilities of the combined staffs. Hopefully, she will maintain staff who understand our industry vs. Gail’s predecessor who recruited lobbyists who lacked understanding.

Highlights of Upcoming Life Science Meetings This Coming Week

  • WIB, Monday Evening, March 9, 2015, Event: “WIB-San Francisco Bay Area Presents: Celebrate Women’s History Month with Women Leaders Building the Future of Biotech;” Panelists: Nathalie Stringfellow (Sangamo), Eileen deFeo (Verinata Health/Illumina), Ashley Dombkowski (Bay City Capital), and moderator Gail Maderis (BayBio); Dinner Speaker: Karen Bernstein (BioCentury)
  • Bio2Device Group, Tuesday Evening, March 10, 2015; Topic: “Active Investors and Exits in Venture Healthcare,” Speaker: Jonathan Norris, Managing Director for SVB’s Healthcare Practice
  • Biotech Bay Career Faire, Wednesday Afternoon, March 11, 2015

You can download Audreys Picks March 9, 2015 with complete details on the above and other meetings and conferences through May 2015 by right clicking on the highlighted titles. Also see JobsThatCrossedMyDeskThrough March 9, 2015 for your information. I list mostly jobs in California posted in the last three weeks but you can also find national listings at the websites mentioned.

Audrey

Posted by: Audrey Erbes | February 28, 2015

New Twist on Drug Pricing Issue Plus Upcoming Life Science Events

The high prices of drugs continues to fill the news. Now attempts to work around those prices are being stopped. Northeastern states have long been advocating for importing drugs for personal use but the Federal government then and now the courts have countered those attempts. It isn’t new that patients cross the border into Canada and Mexico to fill their prescriptions, but it was news to me that the state of Maine was purchasing Rx drugs from companies in selected countries of Australia, Canada, New Zealand and the U.K. since passage of a state law in 2013 permitting it. It isn’t surprising that these countries were selected for sourcing prescription drugs. Many Asian countries in the 1980s chose drugs from these along with the U.S. as basis for approval of drugs in their individual countries. They saved their governments the cost of creating expensive regulatory bodies.

But now some countries, especially India and Brazil, seek special pricing or threaten disavowal of patent laws covering these desired drugs in their countries with “compulsory licensing” actions. The industry has worried that China might copy their example and destroy the desired growth of company sales from new drugs in that emerging market. China has encouraged use of traditional medicines and generic drugs by citizens to avoid a rampant increase in overall drug costs so compulsory licensing hasn’t taken root there so far. But we know that they won’t accept these high costs for general coverage of their large population.

U.S. Chief District Judge Nancy Torresen ruled against Maine’s 2013 law allowing Maine residents to buy cheaper than Maine-sourced prescription drugs from Internet pharmacies from the above countries for personal use. She argued law jeopardizes the safety of the nation’s prescription drug supply and opens the door to counterfeit and tainted medications. “Torresen ruled that Maine infringed on the federal government’s established regulatory authority by allowing drug importation at the state level. Her decision nullifies the law, though the state could potentially appeal.” Unlike practices in the U.S. these other countries cap prices or negotiate prices with drug makers.

In the West, a California lawmaker proposed law to require pharma companies supply cost of drug data to California Office of Statewide Health Planning and Development. This isea is discussed in article entitled “California Lawmaker Wants Pharma to Reveal Costs for Pricey Drugs” by Ed Silverman. The basis of this new approach to limiting high prices results from frustration with lack of transparency on how the company established the price and the threat of adding so many high priced drugs to taxpayer-paid drug costs. This wasn’t an issue before the arrival of Rx drugs with over $10,000 cost per year or therapy. The bill would seek data on R&D costs incurred by a drug maker or a company from which a compound was acquired; R&D grants, including those from any government agency; costs for clinical trials, manufacturing and marketing; any costs associated with acquiring a compound, such as patents or licensing fees; and financial assistance provided to patients. See details at

Highlights of Upcoming Life Science Meetings This Coming Week

  • CalBio 2015, March 2-3, 2015, 8:30 am to end of day both days. Topic: “CalBio 2015: Turning Challenges into Opportunities,” Location: San Francisco Marriott Marquis, 780 Mission Street (at 4th Street). San Francisco, California 94103, Learn more at CalBio2015.org. See agenda at https://www.calbio2015.org/agenda/
  • Bio2Device Group, Tuesday Morning, March 3, 2015, Topic: “Surgery Without a Trace,” Speaker: Cal Huntzinger, Principal, De3 MedTech, LLC
  • Medtech Frontiers, Thursday Evening, March 5, 2015, Topic: “ACO + MCO + ACA = EMUA!! Lessons from a Hawaii Integrated Healthcare System CEO, Speaker: Charles A. (Chuck) Sted, former President and CEO of Hawai’i Pacific Health

You can download Audreys Picks Feb. 29, 2015 with complete details on the above and other meetings and conferences through May 2015 by right clicking on the highlighted titles. Also see JobsThatCrossedMyDeskThrough Feb. 29, 2015 for your information. I list mostly jobs in California posted in the last three weeks but you can also find national listings at the websites mentioned.

Audrey

Posted by: Audrey Erbes | February 22, 2015

Are Supplement Regulations Strong Enough? Plus Events and Jobs

Do Dietary Supplements Utilize Appropriate Standards of Manufacture and Purity?

Regulations for medical products are necessary to ensure we are receiving the product for which we paid while also providing the level of   effectiveness and the dose on the label. With the new dietary recommendations recently published, I hope that supplement standards will keep up. I’ve beginning to worry about whether the supplements I’m taking her worth it.

After the accusation by New York State Attorney General Eric Schneiderman that major retailers were selling fraudulent herbal supplements, consumers nationwide are questioning whether they can continue to accept claims of these major retailers without question. There is rightfully concern whether or not these supplements are pure or meet the labelling promise of contents and the associated question of under what manufacturing conditions they were packaged. It has always surprised me that supplements, so similar to other over-the-counter products don’t have similar good manufacturing requirements with inspections. They can’t complain that they don’t have enough income to pay for meeting higher standards with over $16 billion in sales in the U.S. each year.

When I learned that 90% of vitamin C sold in the U.S. is supplied by Chinese companies a few years ago, I began to ask the outlets where I purchased my vitamins the source of their products. Only Trader Joes would insure me that their products’ contents were not sourced from China. I worried about the potential for heavy metals being included in those products or melamine as experienced in consumer products like toothpaste and dog food manufactured with ingredients from China. I was pleased that in the past couple of years the FDA began to require that manufacturing of these supplements not be adulterated but there is actually no apparent testing or inspections to ensure that.

Now that these supplements are known to possibly interfere with prescription meds or medical observation of a patient, it’s even more important that their purity be assured.

Author Frank L. Jaksch Jr.’s article “Dietary Supplement s Need Higher Standards” published in the San Jose Mercury News, Feb. 19, 2015 suggests that  “Consumers should demand higher standards and the industry should deliver. To ensure high quality products and to ensure that the FDA’s current Good Manufacturing Practices (cGMP) are met, audits and inspections should be performed. Laboratory testing of ingredients and finished products should be implemented to confirm that they meet minimum testing requirements. The reality is that if a finished consumer product, even a well-tested one, was manufactured in a facility that is not FDA cGMP compliant, the product is adulterated.”

Highlights of Coming Week’s Bay Area Meetings

  • Bio2Device Group, Tuesday Morning, Feb. 24, 2015, Topic: “The Forth Modality,” Speaker: Dr. Roger Vertrees, CEO, Verthermia
  • BayBio Lunch and Learn, Tuesday Midday, Feb. 24, 2015, Event: Lunch and Learn: Review of the Sunshine Act | Lessons Learned
  • FDA, Tuesday Morning, Feb. 24, 2015, Webinar: “Overview of Medical Device Data Systems, General Wellness Devices, and Medical Device Accessories”
  • Rosenman Institute D-Series, Tuesday Evening, Feb. 24, 2015, Topic: “Loma Vista Medical: Lessons About Pivoting And The Hidden Dangers Of Product Launches”
  • Clinovo, Wednesday Evening, Feb. 25, 2015, Topic: “Paper Trials vs. EDC Solutions: Benefits, Challenges, and Best Practices,” Panelists: Esmeralda Sanjust Elixir Medical Sr. Director of Clinical Affairs; Ana Pulido Ferrer Digitaliza TXT, Chief Executive Officer and Victor Chen Align, Technology Director Clinical Affairs; Moderated by: Marc Desgrousilliers, Clinovo Chief Technology Officer
  • BioScience Forum, Wednesday Evening, Feb. 25, 2015, Topic: “Manipulation of the Immune Response to Cancer with Biologics,” Speaker: Gary Starling, Ph.D., Associate Vice President, Biologics Discovery Operations, Merck Research Laboratories, Palo Alto
  • BayBio, Wednesday Mid Day, Feb. 25, 2015, Event: “Lunch & Learn | Clinical Trial Transparency: How New Trends And Regulatory Changes Will Impact Your Company,” Speaker: Scott Cunningham, Partner at Covington & Burling LLP
  • WIB San Francisco Bay Area, Thursday Evening, Feb. 26,2015, Event: “Finding – and Getting – Your Worth: Negotiating Compensation,” Panelists: Dorian Hirth (Senior VP of Human Resources at Nektar), Mary Haak-Frendscho (Chairman of the Board at Compugen), plus others

Important Conference Coming to the San Francisco Bay Area Next Week

CalBio 2015, March 2-3, 2015 is a statewide business and development conference jointly sponsored by BayBio and Biocom held in Bay Area every two years. Theme: “CalBio 2015: Turning Challenges into Opportunities,” Location: San Francisco Marriott Marquis, 780 Mission Street (at 4th Street). San Francisco, California 94103. Life Science companies and their management from around the state will congregate in San Francisco. Learn more at www.CalBio2015.org

To discuss how CEOs and entrepreneurs perceive and manage risk within the turbulent life science industry, CALBIO2015 offers a platform for industry leaders in California to share ideas ranging from science to business to global issues.

The CALBIO2015 Conference provides an opportunity for a frank and thoughtful discussion on how to turn today’s challenges into tomorrow’s opportunities. The two-day statewide industry event attracts the world’s leading life science and pharmaceutical companies, investment funds, patient foundations and university technology transfer offices.

Registered attendees will receive access to a partnering/meeting online tool that will allow them to perform quick and advanced searches of registered companies and individual conference attendees to best identify potential business partners. This provides invaluable face-to-face meeting opportunities. See details at https://www.calbio2015.org/business-partnering/

See the detailed agenda at https://www.calbio2015.org/agenda/

You can download Audreys Picks Feb. 22, 2015 with complete details on the above and other meetings and conferences through May 2015 by right clicking on the highlighted titles. Also see JobsThatCrossedMyDeskThrough Feb. 22, 2015 for your information. I list mostly jobs in California posted in the last three weeks but you can also find national listings at the websites mentioned.

Audrey

Posted by: Audrey Erbes | February 15, 2015

CalBio 2015 Volunteers Needed Plus Events and Jobs

Special Announcement Regarding CalBio 2015

One of the best opportunities to network and meet California Life Science company top management will occur on Monday – Tuesday, March 2-3, 2015. Learn more and register at https://www.calbio2015.org/ This event only occurs in the Bay Area every other year.

If you would benefit from attending CalBio 2015 but can’s manage the registration fees at this time, consider volunteering. I received the following announcement from BayBio for posting:

“CalBio 2015 planners are looking for volunteers able to help at this year’s CALBIO 2015 on March 2nd-March 3rd 2015. The responsibilities for volunteers will be similar to previous years/events – they will need help at registration and directing people to the appropriate track rooms, exhibit area and room monitoring. If you are available and want to volunteer, please let Puja Bramania, Events Manager , BayBio know at puja@baybio.org. Information about the event can be found via the link below https://www.calbio2015.org/

Upcoming Life Science Events This Coming Week

  • Tri-Conference 2015, Sunday-Friday, Feb. 15-20, 2015 is a major science conference which brings notables from all over the world to San Francisco once a year. Location: Moscone North Convention Center, San Francisco, CA. Find details at http://www.triconference.com/ Exhibit hall pass is now $50 but provides entry to exhibit hall visited by registrants as well as three plenaries—great way to meet company staff that exhibit and buttonhole visitors who take coffee and treat breaks in the exhibit hall. Register at http://www.triconference.com/registration/
  • Bio2Device Group, Tuesday Morning, Feb. 17, 2015; Topic: “Telescopic contact lenses for low vision and other applications,” Speaker: M Goretty Alonso Amigo, PhD, EMBA, Paragon Vision Sciences
  • sfAWIS, Monday Evening, Feb. 16, 2015, Topic: “Unmasking the Imposter Syndrome: Outdated Gender Norms, Speaker: Maria Padilla, Education and Retention Specialist
  • CACO-PBSS Workshop, Tuesday Aftenoon, Feb. 17, 2015, Topic: “Good Laboratory Practices (GLP): fundamentals, regulatory requirements & best practices (in collaboration of SQA),” Speakers: Greg Furrow, Debi Garvin, Linda Palagi Lynn
  • Palo Alto AWIS, Tuesday Evening, Feb. 17, 2015, Topic: “Finding And Making Your Way To Biotech,” Speaker: Ken Kengatharan, Phd, Mba, Cooand Interim CEO Of Armetheon, Inc.,
  • Engineering in Medicine and Biology Society (EMBS), Wednesday Evening, February 18th, 2015, 7:30 PM, Topic: “Breast CT for breast cancer screening and diagnostic evaluation,” Speaker: John M. Boone, Ph.D., FAAPM, FSBI, FACR, Professor and Vice Chair of Radiology, Professor of Biomedical Engineering, University of California Davis Medical Center
  • JLABS, Thursday Morning, Feb. 19, 2015, Event: “Meet with…The Bill & Melinda Gates Foundation,” Participating Representative: Bob More | Head of Venture Investing, Bill & Melinda Gates Foundation
  • Qb3@953, Thursday Mid Day, Feb. 19, 2015, Topic: “Success In The New Medtech Paradigm: Aligning Product Development To Your Value Proposition,” Speaker: Dr. Tim Pelura, President and CEO of Surpass
  • Life Sciences Angel Pitch, Thursday Evening, Feb. 19, 2015, Moderator: Serdar Yeralan,PhD, Managing Partner, SYN2 LLC; Panelists: Roberta Lee, Retired MD, Startup Founder, Angel Investor, Keiretsu Forum; Bob Novelli, Retired Life Sciences Executive, Consultant, Angel Investor; Adam Schlifke, MD, MBA, Founder and Innovator; Ben Pensak, Morgan Lewis

Important Conference Coming to the San Francisco Bay Area Soon

  • CalBio 2015, March 2-3, 2015 is a statewide business and development conference jointly sponsored by BayBio and Biocom held in Bay Area every two years. Theme: “CalBio 2015: Turning Challenges into Opportunities,” Location: San Francisco Marriott Marquis, 780 Mission Street (at 4th Street). San Francisco, California 94103. Life Science companies and their management from around the state will congregate in San Francisco. Learn more at CalBio2015.org

You can download Audreys Picks Feb. 15, 2015 with complete details on the above and other meetings and conferences through May 2015 by right clicking on the highlighted titles. Also see JobsThatCrossedMyDeskThrough Feb. 15, 2015 for your information. I list mostly jobs in California posted in the last three weeks but you can also find national listings at the websites mentioned.

Audrey

Posted by: Audrey Erbes | February 8, 2015

Resignation of FDA Commissioner Plus Events and Jobs

Dr. Hamburg’s Resignation

The resignation of Margaret A. Hamburg, M.D., FDA Commissioner ends a 6 year era of stability and progress at the agency. During the previous administration there were three different Commissioners with long periods of vacancy and political controversy, during the period 2004 to 2006. One Commissioner served for just months. The FDA had been used as political arena during those vacancies which slowed the agency’s activities tremendously. Remember also that bureaucrats make decisions cautiously and when there is no head to the agency, it’s safer to just not make any decisions.

See the positive remarks made about Hamburg’s tenure in article by Alex Philippidis entitled “FDA Commissioner Hamburg Stepping Down.”

Friends of Cancer Research noted “She has changed the direction of the FDA, creating an environment of science-based collaboration that has fostered a new era of regulatory science focused on expediting the best treatments to patients,” Ellen Sigal, chair & founder of Friends of Cancer Research, noted “Commissioner Hamburg’s leadership and her commitment to patients are unsurpassed.”

At the same time trade groups also had positive comments: “These (FDA) programs have proven invaluable in bringing groundbreaking new therapies to patients more efficiently, while maintaining the FDA’s high standards for safety and efficacy. Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood said in a statement thanking Dr. Hamburg for her FDA service: “We look forward to continuing to work with Dr. Hamburg and her successor to ensure that the FDA’s regulatory capabilities and science continue to keep pace with the tremendous progress taking place in biotechnology innovation.”

You can also learn more about Dr. Hamburg’s views behind the positive changes made during her tenure in interview as part of Nov. 2013 BioCentury This Week.  The BioCentury Feb. 7 issue has in depth article covering her tenure.

Important Conferences Coming to the San Francisco Bay Area Soon

  • Tri-Conference 2015, Sunday-Friday, Feb. 15-20, 2015 is a major science conference which brings notables from all over the world to San Francisco once a year. Location: Moscone North Convention Center, San Francisco, CA. Find details at http://www.triconference.com/ Exhibit hall pass is now $50 but provides entry to exhibit hall visited by registrants and three plenaries—great way to meet company staff that exhibit and buttonhole visitors who take coffee and treat breaks in the exhibit hall. Register at http://www.triconference.com/registration/
  • CalBio 2015, March 2-3, 2015 is a statewide business and development conference jointly sponsored by BayBio and Biocom held in Bay Area every two years. Theme: “CalBio 2015: Turning Challenges into Opportunities,” Location: San Francisco Marriott Marquis, 780 Mission Street (at 4th Street). San Francisco, California 94103. Life Science companies and their management from around the state will congregate in San Francisco. Learn more at CalBio2015.org

This Coming Week’s Life Science Events in Bay Area

  • Bio2Device Group, Tuesday Evening, Feb. 10, 2015, Topic: “Decoding the brain’s functional alphabet;” Speaker: Dr. Jin Hyung Lee. Assistant Professor of Neurology, of Neurosurgery and of Bioengineering and, by Courtesy, of Electrical Engineering, Stanford University
  • GGPF, Wednesday Evening, Feb. 11, 2015, Event: Golden Gate Polymer Forum Feb. 2015 Dinner Lecture- “Selective Cleavage of Amphiphilic Block Copolymers: Synthetic Methods for Preparation, and Applications as Thin Films?” Speaker: Prof. E. Bryan Coughlin, University of Massachusetts Amherst, Polymer Science and Engineering Department
  • HBA, Thursday Evening, Feb. 12, 2015, Topic: “Lessons Learned on the Journey to Authentic Leadership,” Speaker: Shideh Sedgh Bina, Founding Partner, Insigniam

You can download Audreys Picks Feb. 8, 2015 with complete details on the above and other meetings and conferences through May 2015 by right clicking on highlighted titles.  Also see JobsThatCrossedMyDeskThrough Feb. 8, 2015 for your information. I list mostly jobs in California posted in the last three weeks but you can also find national listings at the websites mentioned.

Audrey

 

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