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

 

Posted by: Audrey Erbes | February 1, 2015

Some Political Stories of Note Plus Events and Jobs

We all know that drug development takes too long, costs too much and is becoming more difficult to manage as scientific and technology advances occur even more rapidly.

“Today’s revolution in biomedical science has raised new hope for the prevention, treatment, and cure of severe illnesses. However, there is a growing concern that many of the new basic science discoveries made in recent years may not quickly yield more effective, more affordable, and safe medical products for patients. This is because the current medical product development path is becoming increasingly challenging, inefficient, and costly.” FDA Critical Path Report, 2004

Senate Republicans have addressed this problem and related trends and issues in a report entitled Innovation for Healthier Americans. See full downloadable report at http://www.help.senate.gov/imo/media/Innovation_for_Healthier_Americans.pdf

On this same note, President Obama addressed this issue via his request for $215 million for his precision medicine initiative in the budget. The initiative, mentioned last week in his State of the Union address, is designed to promote wider use of patient-specific medical care, with the aim of delivering new and more effective treatments for diseases. See article entitled “Obama Puts a Price on Precision Medicine” by Alex Philippidis.

The majority of the proposed funding—$130 million—will be provided to NIH toward the development of the research cohort, envisioned as including a million or more volunteers. “Researchers will be given broad access to the cohort, and its data is envisioned to include medical records; gene profiles, metabolites, microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.” Other smaller funds will be given to the FDA.

What do you think Medtech news is this week?—a heated discussion over the impact of the device tax on employment which seems to have drawn some mighty tall tales about the dire impact on hiring and layoffs in the industry. And here I thought it had more to due with slowdown in investments in new startups. See MassDevice.com article “Medical device tax: What we talk about when we talk about job losses”  to view the numbers from both sides of the issue.

Upcoming Bay Area Meetings This Week

  • Bio2Device Group, Tuesday Morning, Feb. 3, 2015; Topic: “From the Patient and Agency lens – Drug Development and Approval ;” Speaker: Chitra Sharma, Technical Consultant .
  • QB3, Tuesday Afternoon, Feb. 3, 2015; Topic: “Best practices in taxes and accounting for startups;” Speakers: Ryan Fischesser, Partner, BHLF; Brent Hillberg, Partner, BHLF and Robbie Lewis, Partner, BHLF
  • Medtech Frontiers, Thursday Evening, Feb. 5, 2015; Topic: “Scalable Microfluidic Design to Advance Precision Bioseparations;” Speaker: Professor Amy E. Herr, University of California, Berkeley
  • CIE, Saturday Afternoon, Feb. 7, 2015; Event: “Explore the Future Technologies;” Speakers: Dr. Sunil Pandit, Director of Science at Affymetrix, Inc.; Mr. Luke Peterson, Director of Research & Strategy from Imagination Technologies; Mr. Michael Hendricks, Product Line Manager, Automotive, Altera Corp; and Mr. Nick Chong, Head of Product Marketing at Zoom Video Communications

You can download Audreys Picks Feb. 1, 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. 1, 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 | January 25, 2015

Status of Biotech Jobs Plus Events and Jobs

Announcement about JLABS Opportunity and Latest Figures on Jobs

In honor of the upcoming Grand Opening of JLABS @South San Francisco (JLABS @SSF), Johnson & Johnson Innovation has launched a Quick Fire Challenge to award up to three new game-changing early-stage innovation companies with the use of a bench and access to the JLABS @SSF community for one year. The winners will be announced on Mar 2, 2015 on stage at CALBIO 2015. APPLICATION DEADLINE: Tuesday, 02/03/15 at 5:00 pm

Read More at http://conta.cc/14LwfKu

There is some news that growth in new biotechs means more new jobs, but old companies are still cutting. The good news is that there were far fewer job cuts in 2014 vs. 2013 with a total of 17,636 announced jobs cuts in 2014—down 20% from 22,161 in 2013, according to the December Job Cut Report of Challenger, Gray & Christmas. See details in article entitled JobWatch: Pace of Layoffs Slows Down at http://www.genengnews.com/keywordsandtools/print/3/37227/

John A. Challenger, CEO of Challenger, Gray & Christmas, provided news that Biopharmas can be expected to continue picking up the pace of hiring in 2015 as the U.S. economy picks up steam, more new products reach the market, and demand for drugs grows due to aging populations in the U.S., Western Europe, and Japan: “2015 should be relatively benign in terms of layoffs and relatively strong in terms of job growth.”

In the past the large companies had stable numbers of staff but  now the levels are unstable year to year. I see new jobs being created by startups which is good news but the continuing risk that those jobs will disappear as soon as those products and companies are acquired worries me. These new companies no longer remain on the playing field as they used to.

Highlights for this Coming Week’s Life Science Meetings in Bay Area

  • BioCentury This Week, No new programs until February when a new digital format is introduced. Meanwhile, check out their archives for some great complimentary programs.
  • Personalized Medicine World Conference, Monday – Wednesday, January 26-28, 2015, Event: “Personalized Medicine World Conference” January 26-28, 2015, Co-hosted with Stanford Health Care and Oracle Health Sciences, See full program at http://2015sv.pmwcintl.com/program.php
  • Palo Alto AWIS, Monday Evening, Jan. 26, 2015, Topic: “A career path is a series of transitions, and it’s not always linear!”
  • Bio2Device Group, Tuesday Morning, Jan. 27, 2015, Topic: “See What You’re Missing! – High Performance Computing Discovers Hidden Biomarkers,” Speaker: Jeffrey N. Peterson, Chairman, Veritomyx
  • QED at Qb3, Tuesday Afternoon, Jan. 27, 2015, Event: How to Solve Immigration Issues Faced by Entrepreneurs, Speakers: Norman Plotkin, Partner, Jackson & Hertogs and Atessa Chehrazi, Partner, Jackson & Hertogs
  • NCDG Roundtable, Wednesday Evening, Jan. 28, 2015, Topic: “Process Definition & Process Risk Management, Speaker: Gary Seeger, Quality Assurance, Regulatory Affairs and Document Control activities, Stellartech Research Corporation, Moderator: Thi Nguyen, CQE, CSQE, Principal Quality Engineer, TheraNova, will facilitate the session.
  • NorCal BioPharma PM, Wednesday Evening, Jan. 28, 2015, Event: 2015 New Year Mixer
  • WIB, Thursday Evening, Jan. 29, 2015, Event: Peninsula Speed Networking Event
  • AAPS-BADG, Thursday Evening, Jan. 29, 2015, Topic: “Implications of Phase Transitions on Stability of Pharmaceuticals and Biotechnology Products,” Speaker: Dr. Raj Suryanarayanan, Professor at University of Minnesota and William & Mildred Peters Endowed Chair

You can download Audreys Picks Jan. 25 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 Jan. 25, 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 | January 19, 2015

What Happened in San Fran Last Week? Plus Events and Jobs

So What Happened in San Francisco at Life Science Gathering of Investors?

I found just one article written about the JP Morgan Conference entitled “Platforms — no, not shoes — are in vogue again with biotech investors”  (Jan 14, 2015) by Ron Leuty of the San Francisco Business Times that wasn’t collection of notes or observations via other people’s Tweets. I guess industry journalists covering the JP Morgan week have forgotten how to write text with some analyses on timely basis. Instead they passed on snippets in the form of selected Tweets. Hopefully, they will provide us more to chew on after they recover from their attendance at this frenetic life science gathering.

Senior Editor Casey McDonald of Pharmaceutical Executive provides collection of Tweets in the Pharma Exec.com blog. While Vince Galloro provided JP Morgan Healthcare Conference: Tweets from the annual healthcare investors conference (#JPM15), with a focus on healthcare service providers.

Another Tweet catalogue focused on OneMed meeting under title Results for #JPM15 .

Highlights of Upcoming Bay Area Life Science Events

  • BioCentury This Week, See three new program Webcasts Starting Sunday, Dec. 28, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT. No new program this week, but plenty of past programs available online. Started Dec. 28, 2014, Topic: “Profiles in Innovation: how gene therapy has finally hit its stride,” Speaker: Dr. Elias Zerhouni, president of global R&D at Sanofi
  • Bio2Device Group, Tuesday Morning, Jan. 20, 2015, Topic: “How to build a successful culture in a medical startup – learning through failures,” Speaker: Salmaan Hameed, VP R&D, Advantis Medical Systems
  • CACO-PBSS Workshop, Tuesday, Jan. 20, 2015, Workshop Topic: “Preclinical and Clinical Mass Balance and Metabolite Profiling Studies: Objectives, Techniques, Applications and Case Studies,” Speakers: Chandra Prakash, Bernard Murray, Kirk Henne, Cyrus Khojasteh, Donglu Zhang
  • PM360 Webinar, Tuesday Morning, Jan. 20, 2015, Topic: “The New Healthcare Trifecta: Pharma, Patients and Advocacy,” Hosted by Paul Kidwell ; Speakers: Thomas P. Sellers, MPA, Sr. Director, Patient Advocacy & Corporate Philanthropy Takeda Oncology; Ronny Mosston, Vice President of Patient Advocacy & Public Affairs, OvaScience and Brenda Snow, Founder & CEO, The Snow Companies
  • Palo Alto AWIS, Tuesday Evening, Jan. 20, 2015, Topic: “Persuasive Interviewing,” Speaker: Antoine de Morrée, PhD, Cofounder, Stanford Leaders in Communication,
  • Cognizant, Tuesday Morning, Jan. 20, 2015, Topic: “Improving Compliance, Increasing Innovation: Effective Strategies for Medical Device Companies” presented by Cognizant Technology Solutions; Panelists: Ronnie Toddywala, Ph.D., MBA, CEO of Nostrum Technologies, LLC; Janet Trunzo, Senior Executive Vice President, Technology & Regulatory Affairs, AdvaMed; Sriraman Nagarajan, Vice President, Life Sciences Practice, Cognizant Technology Solutions
  • ShareVault Webcast, Wednesday Morning, Jan. 21, 2015, Topic: “The Art & Science of High M&A Valuation: Maximum Value and Best Terms for the Sale of Your Technology Company,” Speaker: David Stastny, Managing Director of Centaur Partners
  • Engineering in Medicine and Biology Society (EMBS), Wednesday Evening, Jan. 21, 2015, Title: “How to power a pacemaker that is smaller than a grain of rice,” Speaker: Ada Poon, Ph.D., Department of Electrical Engineering, Stanford University.
  • BioScience Forum, Wednesday Evening, Jan. 21, 2015, Topic: “Identification of Novel Immune Checkpoints as Targets for Cancer Immunotherapy,” Speaker: John Hunter, Ph.D., Vice President of Antibody R&D and Site Head, Compugen

You can download Audreys Picks Jan. 18, 2015 with complete details on the above and other meetings and conferences through April 2015 by right clicking on the highlighted titles. Also see JobsThatCrossedMyDeskThrough Jan. 18, 2015f 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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