Hi,

Supreme Court Ruling on Patentability of Human Genes

The Supreme Court has declared that naturally occurring human genes can’t be patented but that cDNA, synthetically produced genetic material, can. PhRMA is negative about the impact of the ruling as they see broad implications for the pharmaceutical, biotech and gene-testing industries. The article “The Sky Isn’t Falling” appearing in BioCentury’s June 17th issue raises concern about need for clarity about the distinction between isolated DNA and cDNA going forward.

“Critics said the ruling would not only hurt Myriad Genetics, but also the bottom line of companies that sell genetic tests. It could also discourage investment in genetic sequencing research.” But those interested in developing products in the human gene area formerly blocked by patent holders like Myriad are delighted. Previously there was no possibility for competition with Myriad’s BRCA1 and BRCA2-based products.

The court’s ruling was unanimous which was welcome in this world of strong bipartisanship. The downside of the ruling is balanced by clearing up this contentious issue that has impacted life science investment negatively. The opinion written by Justice Clarence Thomas declares while isolated human genes are not patentable, forms of DNA that have been manipulated in the lab in a way that alters their natural state can be patented. BioCentury also notes that the Thomas writing reinforces the patentability of “method” and “use” claims involving human DNA. The lawyer for Myriad was happy about the final ruling because Myriad has already moved to develop manipulated genes for future products. They warn potential competitors that they are many patents they hold that will stand in this newly revised world.

In summary, we expect that opinions will vary about the real impact but agree with BioCentury that the sky isn’t falling.

Upcoming Life Science Meetings

Please send in July announcements to me at audreyerbes@aol.com prior to June 20^th so they can be included in my month overview of July to be published Saturday, June 22^nd.

I have listed this coming week’s picks for meetings below:

• BioCentury This Week, See new program Webcast Starting Sunday, June 16, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Six Years of Avandia: What Did We Learn;” Speakers: Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research; Dr. Murray Stewart, SVP and head of the cardiovascular unit at GSK; Dr. Kenneth Mahaffey at the Duke Clinical Research Institute; Dr. Robert Califf, Professor of Cardiology and Vice Chancellor for Clinical Research at Duke
• BioDesign, Monday Evening, June 17, 2013; Event: “From the Innovators Workbench;” Speaker: John Dineen, Chief Executive Officer and President of GE Healthcare Ltd. and GE Medical Systems, Inc.
• Palo Alto AWIS, Monday Evening, June 17, 2013; Event: Volunteer Meeting
• Bio2Device Group, Tuesday Morning, June 18, 2013; Topic: “Hypertension: A historical and philosophical perspective;” Speaker: Michel Accad. M.D., Physician, UCSF
• EMBS, Wednesday Evening, June 19, 2013, 7:30 PM; Topic: “The Magellan Robotic Catheter System;” Speaker: Francis Macnamara, Vice President, Hansen Medical, Inc.
• WIB, Wednesday Evening, June 19, 2013; Topic: “Fireside Chat with Gail Maderis”
• Reimbursement Intelligence, Wednesday Morning, June 19, 2013; Topic: “Reimbursement Intelligence P&T Advisor™: Can You Identify Physicians Standing Between Your Brand and Millions of Lives?” Speakers: John Whang, MD, FACC, COO, President of Market Research, Reimbursement Intelligence; Jessica DiPaolo, MPH, VP, Business Development, Reimbursement Intelligence
• UC Berkeley Extension Course, Thursday and Friday, June 20-21, 2013; Course: “Life Science Business Development,” (formerly known as Biotechnology Business Development); Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Recap LLC; Dates and Time: Thursday and Friday, June 20-21, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market   St., 8th Floor, San Francisco, CA; Cost: Fall term—fee: $895, (EDP 405118).   Register at http://extension.berkeley.edu/catalog/course2005.html

Not Too Late To Enroll

It’s not too late to sign up for my business development course taking place   this coming Thursday and Friday. You can enroll as late as the start of the    class on Thursday morning. The two days of intensive provide expert guest speakers in the trenches who influence the alliances, deals and collaborations process that is now critical to the funding of new and ongoing biomedical companies. Individuals have the opportunity to work on projects of their choice over two subsequent months which qualify the attendance for credit toward a certificate but also provide valuable work to include in their career portfolio.

Course Deliverables

Students will receive a printed reader with copies of speaker slides and lists of online resources developed by instructor as well as gratis access to subscription database resources graciously provided by BioCentury and Thomson Reuters (formerly Deloitte) Recap. I preach the value of hands on work to really incorporate the skills taught in the classroom into one’s own skill set or otherwise risk forgetting most of the knowledge conveyed. We know from adult learning theory that passive learning is not very effective versus active involvement this course provides.

You can download the list of  Audreys picks June 16, 2013 which includes all the details for upcoming meetings through next January 2014 of which I’m aware and Jobs That Crossed My Desk Through June 16 2013 which includes the latest plus previous two weeks’ jobs for your information. Just right click on the highlighted titles.  Share with colleagues who might find these useful. You can also download these lists found in my blog at my website www.AudreysNetwork.com at any time.

Audrey

Further Clarification on “Breakthrough” Pathway

Richard Pazdur, head of the FDA’s office of hemotology and oncology products, provided some clarification on the meaning of “breakthrough drugs” classification which is new to the regulatory arena at the recent annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. It is not just another “fast track” regulatory path but a unique one permitting much faster approval based on better collaboration between the FDA and company involved. “Breakthrough” equals transformative drugs according to Pazdur. The clinical trial size and manufacturing issues which have often slowed down the progress of the development of a drug can be streamlined to fit the breakthrough drug under development.

“The designation is meant to trigger more frequent communications between a breakthrough drug’s developer and FDA staff, including senior agency officials, Dr. Pazdur said. These are meant to go beyond the traditional “landmark” meetings between FDA and drug developers, such as at the end of phase 2 midstage clinical trials.” The breakthrough designation includes a more intense and continuous dialogue between the FDA and the company sponsor which can result in development plan changes, such as making changes in clinical trial if preliminary results suggest less patients are needed. “ See details in Peter Loftus’ June 3^rd article entitled “What Makes a Breakthrough Cancer Drug.”

Upcoming Life Science Meetings

• BioCentury This Week, See new program Webcast Starting Sunday, June 9, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Prior shows available 24/7 in the online Program Archive: Topic: “Patient Scientists: Medicine in the Crowd;” Speaker: Ben Heywood, Co-Founder and President, PatientsLikeMe
• Palo Alto AWIS, Monday Evening, June 10th, 2013; Event: “Ice Cream Social & Networking Workshop;” Speaker: Carla Vaccarezza Assistant Director of Career Advising & Program Development at Stanford University
• Bio2Device Group, Tuesday Evening, June 11, 2013; Topic: “Digital Pathology;” Speaker: Syed Zafar Hamdani, President and CEO, XStor Medical Systems
• RoseRyan, Wednesday Morning, June 12, 2013; Topic: “Will your IPO or M&A be everything it could be? Only if you plan for it;” Speakers: Pat Voll, Vice President, RoseRyan; James D. Fay, Vice President and CFO, NeoPhotonics Corporation; E. Thom (Todd) Rumberger Jr., Partner, Foley & Lardner LLP and Yoomin Hong, Vice President, Goldman, Sachs & Co.
• BayBio/BioCom CALBIO 2013, June 12-14, 2013; Event Title: “CALBIO 2013: Success Redefined”

Next Upcoming UC Berkeley Extension Business and Marketing Courses

It’s not too late to sign up for my upcoming business development course which provides expert guest speakers in the trenches who influence the alliances, deals and collaborations process that are now critical to funding of new and ongoing biomedical companies. The classroom sessions are concentrated during two days with individual work on projects of student’s selection over two subsequent months with help of provided database resources graciously provided gratis by BioCentury and Deloitte Recap. I preach the value of hands on work to really incorporate the skills taught in the classroom into one’s own skill set or otherwise risk forgetting most of the knowledge conveyed. We know from adult learning theory that passive learning is not very effective versus active involvement this course provides.

• UC Berkeley Extension Intensive Course, Thursday and Friday, June 20-21, 2013; Course: “Life Science Business Development;” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Deloitte Recap LLC; Dates and Time: Thursday and Friday, June 20-21, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Fee: $895, (EDP 405118). Register at http://extension.berkeley.edu/catalog/course2005.html

You can download all the details about this week’s life science events through next Oct listed in REVAudreys picks June 9, 2013  and Jobs That Crossed My Desk Through June 9 2013 which includes the latest plus previous two weeks’ jobs by right clicking on the highlighted titles.  Feel free to share with colleagues who might find these useful. You can also download these lists found in my blog at my website www.AudreysNetwork.com at any time.

Note BioScience Forum meeting originally scheduled for June 19 has been postponed. A new program will take place on Wednesday, June 26th. See details in revised list of events.

Audrey

 

Will Fee for Service System Survive?

The growing unacceptable costs of the U.S. health care system aren’t going away anytime soon and without a battle. Experts are trying to figure out how to change the incentives to produce higher quality preventive as well as chronic care at a lower cost yet at the same time satisfy the multiple stakeholders. Politically a single payer system as practiced in the EU is not acceptable as a replacement of our current structure due to the legacy systems in place in the U.S.

A May 23rd article in the New England Journal of Medicine recommends the elimination of the fee-for-service physician payment system as the means to cut costs of health care. The authors Steven A. Schroeder, M.D., and William Frist, M.D. (former Senator from Tennessee) in behalf of the National Commission on Physician Payment Reform state “The fee-for-service mechanism of paying physicians is the major driver of higher health care costs in the United States. It contains incentives for increasing the volume and cost of services (whether appropriate or not), encourages duplication, discourages care coordination, and promotes inefficiency in the delivery of medical services.”

Their article entitled “Phasing Out Fee-for-Service Payment” found in pdf at http://www.nejm.org/doi/pdf/10.1056/NEJMsb1302322 makes 12 recommendations for reform of physician payments.

The long-range solution is a system that provides appropriate and high-quality care and emphasizes disease prevention and the management of chronic conditions rather than treatment of illness as well as values examination and diagnosis as much as medical procedures. This implies a shift from a payment system based on a fee-for-service model to one based on value through mechanisms such as bundled payment, capitation, and increased financial risk sharing. Note the authors readily admit that changing from the current model of care to one that is value-based cannot be accomplished overnight. It will require a transition period, with the likely end point being a blended system with some payment based on the fee-for-service model and other payment based on capitation or salary.

I believe the recommendations recognize the difficulties in changing the system by which so many profit centers in our health care market of corporations, managed care organizations and hospitals depend on increasing their profits each year to satisfy investors. I suspect that there will be a mighty backlash against this reform from groups and corporations who depend on the open ended nature of business volume of the fee-for-service system to deliver increasing profits. Biologic drugs have increased cost to compensate for smaller patient numbers using their product but this method will no longer work for drug companies in the future. It will be interesting to witness how the stakeholders will share the “cost” of decreasing health care costs and see how stakeholders might actually work together to achieve the objective of decreasing costs while maintaining quality for all.

Upcoming Meetings in Next Two Weeks

• BioCentury This Week, See new program Webcast Starting Sunday, June 2, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Learning by Doing: 21^st Century Medicine;” Speakers: Dr. Joel Kupersmith, Chief Research and Development Officer of the Veterans Health Administration; Dr. Sean Tunis, President & CEO of the Center for Medical Technology Policy, and former Chief Medical Officer at the Centers for Medicare & Medicaid Services; Dr. Claudia Grossmann, Senior Program Officer at the Institute of Medicine’s Roundtable on Value & Science-Driven Health Care
• EMBS, Monday Evening, June 3, 2013; Topic: “Unraveling Your Professional Network: The Secrets to a Successful Career;” Speaker: Krista Canfield
• Bio2Device Group, Tuesday Morning, June 4, 2013; Topic: “Will Medical Devices Survive the Headwinds of Change in the new Healthcare Ecosystem;” Speaker: Reenita Das, Partner, Healthcare and Life Sciences Frost & Sullivan
• French-American Mixer, Thursday Evening, June 6, 2013
• Biospace Biotech Bay Career Fair, Thursday Afternoon, June 6, 2013
• Medtech Frontiers, Thursday Evening, June 6, 2013; Topic: “Reshaping Medicine with Conformal Electronics: Not just big data… good data. Enhanced sensing and feedback enabled by conformal electronics;” Speaker: Amar Kendale
• Bio-X Frontiers, Thursday Afternoon, June 6, 2013; Topic: “Navigating the Labyrinth of the Inner Ear: Achieving “Balance” as a Clinician Scientist;” Speaker:Lloyd B. Minor, M.D.; Carl and Elizabeth Naumann Dean of the School of Medicine, Professor of Otolaryngology Head & Neck Surgery, Professor of Bioengineering and of Neurobiology; Hosted by: John Oghalai, Associate Professor, Otolaryngology
• BayBio Lunch and Learn, Thursday, June 6, 2013; Topic: “Strategic Considerations for Companion Diagnostics;” Speakers: Kurt Calia, Partner, Covington & Burling LLP; Scott D. Danzis, Partner, Covington & Burling LLP and Emily Leonard, Partner, Covington & Burling LLP
• BioCentury This Week, See new program Webcast Starting Sunday, June 9, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT
• Bio2Device Group, Tuesday Evening, June 11, 2013; Topic: “Digital Pathology;” Speaker: Syed Zafar Hamdani, President and CEO, XStor Medical Systems
• RoseRyan, Wednesday Morning, June 12, 2013; Topic: “Will your IPO or M&A be everything it could be? Only if you plan for it;” Speakers: Pat Voll, Vice President, RoseRyan; James D. Fay, Vice President and CFO, NeoPhotonics Corporation; E. Thom (Todd) Rumberger Jr., Partner, Foley & Lardner LLP and Yoomin Hong, Vice President, Goldman, Sachs & Co.
• BayBio/BioCom CALBIO 2013, June 12-14, 2013: Event Title: “CALBIO 2013: Success Redefined”

Next Upcoming UC Berkeley Extension Business and Marketing Courses

It’s not too late to sign up for my upcoming business development course which provides expert guest speakers in the trenches who influence the alliances, deals and collaborations process that are now critical to funding of new and ongoing biomedical companies. The classroom sessions are concentrated during two days with individual work on projects of student’s selection over two subsequent months with help of provided database resources graciously provided gratis by BioCentury and Deloitte Recap. I preach the value of hands on work to really incorporate the skills taught in the classroom into one’s own skill set or otherwise risk forgetting most of the knowledge conveyed. We know from adult learning theory that passive learning is not very effective versus active involvement this course provides.

• UC Berkeley Extension Intensive Course, Thursday and Friday, June 20-21, 2013; Course: “Life Science Business Development;” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Deloitte Recap LLC; Dates and Time: Thursday and Friday, June 20-21, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Fee: $895, (EDP 405118). Register at http://extension.berkeley.edu/catalog/course2005.html
• UC Berkeley Extension Course, Thursday and Friday, Oct. 3-4, 2013; Course: “Life Science Business and Marketing: Their Integral Role for Success,” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Joyce Chiarenza,  Regulatory Consultant; Linda Schock, Director, Commercial Compliance and Government Programs, CIS; Bev Hudson, MBA, Executive Director/SVP of Clinical Research, Oklahoma Foundation for Cardiovascular Research; Julie Tompkins, MBA, Sr. Vice President, Timely Data Resources, Inc. Dates and Time: Thursday and Friday, Oct. 3-4, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Fee: $795, online registration available in early August; Register at http://extension.berkeley.edu/catalog/course190.html

You can download Audreys picks June 2, 2013  which includes all the details for upcoming meetings through next Oct. by right clicking on the highlighted title. I’ve provided Jobs That Crossed My Desk Through June 2 2013 which includes the latest plus previous two weeks’ jobs for your information. Again right click on the highlighted title to open the list in a new window. Share with colleagues who might find these useful. You can also download these lists found in my blog at my website www.AudreysNetwork.com at any time.

Audrey

 

 

 

 

 

Hi,

New Thinking on Clinical Development

Changes in the biomedical industry with the accompanying shifting of paradigms confront us now regularly. The new much higher pricing of many of the oncology and rare disease drugs which are now the focus of the biopharma R&D has become unacceptable to payers as the industry’s solution to making acceptable level of profits from smaller populations of patients. Pricing and reimbursement alongside the need for uniqueness in power of efficacy and safety take their place as preeminant in the funding of research and companies. The newer targeted therapies need to actually slow or stop chronic diseases and not just show a positive short-term benefit in the future. The cost of R&D under the old procedures, especially, the regulatory piece with the clinical requirements has made the traditional industry’s ROI unacceptable.

I’ve heard talk of having standing clinical trials with primary care docs in place that would be utilized by multiple companies to cut down on the cost of drug development. Now Janet Woodcock, MD, head of the FDA’s Center for Drug Evaluation and Research stated at recent Personalized Medicine Coalition conference, “We are going to have to change the way drugs are developed. Period.”

Clearly the accepted trial processes that accompanied blockbuster drug development and approval in the past are no longer feasible for treatment populations that are quite small. She was speaking specifically about clinical requirements for targeted personalized medicines but I wouldn’t be surprised if a reevaluation of the traditional drug development process isn’t reconsidered. Over the years, the requirements increased without adjustment–piling greater cost burden on companies.

Upcoming Meetings Week of May 26th

• BioCentury This Week, See new program Webcast Starting Sunday, May 26, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: Topic: “BioDefense Bulwarks: Did Billions Buy Safety?” Speakers: Dr. Robin Robinson, Director of the Biomedical Advanced Research and Development Authority (BARDA) and Dr. Luciana Borio, FDA Assistant Commissioner for Counterterrorism Policy and Director of FDA’s Office of Counterterrorism and Emerging Threats.
• Bio2Device Group, Tuesday Morning, May 28, 2013; Topic: “Sleep Apnea”; Speaker: Nat Bowditch, founder and CEO of OrthoHub
• Quintiles Webinar, Tuesday Morning, May 28, 2013; Topic: “Oncology Molecule Value Demonstration: The Shifting Sands of Stakeholder Expectations, and the Role of Real-World Evidence;” Speakers: Dr. John Doyle, Senior Vice President and Managing Director, Dr. Harish P. Dave, Global Medical Strategy Head, Hematology/Oncology and Transplantation, and Dr. Jean-Louis Merot, Senior Project Management Director at Quintiles
• Silicon Valley LES Chapter Meeting, Wednesday, May 29, 2013; Topic: “Shhhh! It’s a (Trade) Secret – Trade Secrets in Licensing;” Panelists:Frank Bernstein, Partner, Kenyon & Kenyon LLP; Linda Rost, Partner, VLP Law Group LLP; Paul Stone, General Counsel and Chief Operating Officer, 5AM Ventures
• Palo Alto AWIS, Wednesday Evening, May 29, 2013; Event: “Leadership Series: Public Policy, Service, and Leadership,” Speaker: Belinda Seto, Ph.D. Deputy Director, National Institute of Biomedical Imaging and Bioengineering
• San Francisco State University, Thursday, May 30, 2013; Event: Personalized Medicine 6.0: Next Generation Sequencing for Targeted Therapeutics”
• Triple Ring Technologies, May 30, 2013; Event: Technology Frontiers Symposium: Medical IT Networks and Connected Medical Devices

Next Upcoming UC Berkeley Extension Business and Marketing Courses

It’s not too late to sign up for my upcoming business development course which provides expert guest speakers in the trenches who influence the alliances, deals and collaborations process that are now critical to funding of new and ongoing biomedical companies. The classroom sessions are concentrated during two days with individual work on projects of student’s selection over two subsequent months with help of provided database resources graciously provided gratis by BioCentury and Deloitte Recap. I preach the value of hands on work to really incorporate the skills taught in the classroom into one’s own skill set or otherwise risk forgetting most of the knowledge conveyed. We know from adult learning theory that passive learning is not very effective versus active involvement this course provides.

• UC Berkeley Extension Intensive Course, Thursday and Friday, June 20-21, 2013; Course: “Life Science Business Development;” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Deloitte Recap LLC; Dates and Time: Thursday and Friday, June 20-21, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Fee: $895, (EDP 405118). Register at http://extension.berkeley.edu/catalog/course2005.html

A subsequent intensive course in October focuses on how to do biomedical market and environment research in order to make more professional recommendations and decisions across all sectors and functions in the biomedical industry. The October course also provides the identification of online resources but also provides gratis access to selected Elsevier/Windhover resources.

• UC Berkeley Extension Course, Thursday and Friday, Oct. 3-4, 2013; Course: “Life Science Business and Marketing: Their Integral Role for Success,” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Joyce Chiarenza,  Regulatory Consultant; Linda Schock, Director, Commercial Compliance and Government Programs, CIS; Bev Hudson, MBA, Executive Director/SVP of Clinical Research, Oklahoma Foundation for Cardiovascular Research; Julie Tompkins, MBA, Sr. Vice President, Timely Data Resources, Inc. Dates and Time: Thursday and Friday, Oct. 3-4, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Fee: $795, online registration available in early August; Register at http://extension.berkeley.edu/catalog/course190.html

You can download Audreys picks May 26, 2013 which includes all the details for this week’s meetings but also listing of meetings through next Oct. by right clicking on the highlighted title. I’ve provided Jobs That Crossed My Desk Through May 26, 2013 which includes the latest plus previous week’s jobs for your information. Again right click on the highlighted title to open the list in a new window. Share with colleagues who might find these useful. We all know someone who is looking for a position as the job market although much improved in the past year still hovers at 8%.

Audrey

 

 

 

Upcoming Meetings This Week

• BioCentury This Week, See new program Webcast Starting Sunday, May 19, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Science Booster Shot: Europe Finds More Money;” Speakers: Dr. Ruxandra Draghia-Akli, Head of Health Research of European Commission
• HealthBeat 2013, Monday and Tuesday, May 20-21, 2013
• Bio2Device Group, Tuesday Morning, May 21, 2013; Topic: “Know Your Options: Implementation of Virtual Commercial Operations;” Speakers: Linda L. Schock, Director, Commercial Compliance and Government Programs, CIS Compliance Implementation Services
• BOLD, Tuesday Afternoon, May 21, 2013; Topic: The New Corporate Wellness – Navigating Stress and Sustaining Peak Performance with Brain Science;” Guest Speaker: Daniel Friedland, MD, board certified in Internal Medicine and the author of Evidence-Based Medicine.
• UC Berkeley Extension Free Information Session, Wed. Evening, May 22, 2013; Topic: “Free Information Session: All Life Science Industries Professional Certificates and Specialized Programs of Study”
• BioScience Forum, Wednesday Evening, May 22, 2013; Topic: “Building a Research-Based Discovery Engine in Biotech, and Why it Matters;”Speaker: Austin Gurney, Ph.D., Senior Vice President, Molecular and Cellular Biology, OncoMed Pharmaceuticals, Inc.
• Golden Gate Polymer Forum, Wednesday Evening, May 22, 2013;Topic: “Catalysis: The Enabling Science for Polymer Chemistry;” Speaker: Prof. Robert Waymouth, Department of Chemistry, Stanford University
• ASQ Northern California Discussion Group, Wednesday Evening, May 22, 2013; Topic: “Documentation Requirements for IEC 60601-1 3rd Edition;” Speaker: Annette Schaps, Medical Device Consultant; Moderator:  June Jenkins- Business Development Manager – Oxford & Associates
• NCC ACRP, Thursday, May 23, 2013; Topic: “Decoding Ethics: Applying Ethical Principles in Today’s Clinical Research Practice;” Speaker: Erica Heath, Director, Regulatory Affairs, Ethical & Independent Review Services, LLC

Next Upcoming UC Berkeley Extension Business and Marketing Course

• UC Berkeley Extension Intensive Course, Thursday and Friday, June 20-21, 2013; Course: “Life Science Business Development;” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Deloitte Recap LLC; Dates and Time: Thursday and Friday, June 20-21, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Fee: $895, (EDP 405118). Register at http://extension.berkeley.edu/catalog/course2005.html

I’ll be sending list of jobs midweek. You can download Audreys picks May 19, 2013 with all the details of upcoming meeting through end of June. Right click the highlighted title.

Have a great week!

Audrey

I was able to research recent life science jobs in California to add to my list yesterday that I typically send out each week with my blog and list of events.

I regret the delay but having no Comcast Internet access for a week set me back.

Here is the Jobs That Crossed My Desk Through May 13, 2013 report. I’ve also included the previous two weeks listings. You can access by right clicking on the highlighted title and pdf file will open in a new window.

Have a great week!

Audrey

Weakness of Internet Infrastructure

After lacking access to Comcast’s fast internet since Tuesday and the accompanying stress of operating without Internet access to do my online research at my home office, I was getting paranoid about what chaos “suppression” of online access highly technology-connected professionals can cause.  I was promised a serviceman visit by 6 overseas technicians over the course of three days to no avail. The promised 3 appointments failed to occur while no notification or apology was offered. Then yesterday I was advised by recording that there was an outage in my local area and could not speak with a service representative.

I was just about to call Comcast once again this morning when I used my computer to update my Audrey’s Picks list and discovered I once again had online access. It is very distressing that a large corporation like Comcast that operates along with AT&T as seeming monopolies on fast Internet access in the Bay Area could be so callous toward the needs of their customers and seemingly unaware that they had problem with service beyond me in Silicon Valley for 4 days. This is another major infrastructure weakness that our society is suffering.  I love all the new high tech technology that allows for improved research utilizing Big Data, the cloud, online webinars and teaching, etc. but worry about the weakness of the foundation on which all this depends.

Interesting footnote to my blog last week, Judge Edward Korman in a U.S. District Court in New York denied the Department of Justice’s request for a stay of the court’s April order compelling FDA to make emergency contraceptives containing levonorgestrel available OTC without any age restrictions. The FDA approved the age at 15 years and older but with proof of age.  In a hearing on Tuesday to discuss the DoJ’s request for a stay, Judge Korman said the FDA’s decision making on this product “had been corrupted by political influence.” He compared the requirement of proof of age for emergency contraception to requirements for voting suggesting they were both a form of “suppression.”   See details in article entitled “Judge refuses to delay ruling on Plan B,” by Maggie Fox, Senior Writer, NBC News.

Upcoming Meetings This Week

• BioCentury This Week, See new program Webcast Starting Sunday, May 12, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Biosimilar Report Card: Learnings from Europe;” Speakers: This Week television examines the European biosimilars record with: Dr. Peter Richardson, Head of Biologicals at the European Medicines Agency and Thomas Moore, Director of Value, Access and Policy at Amgen, and EuropaBio delegate to the EC Access to Medicines working group on biosimilars

• Merrill Data Site and California Healthcare Institute, Tuesday Morning, May 14, 2013; Topic: “Clinical Trial Communications: The Good, the Bad and the Necessary;” Speaker: Carin Canale-Theakston, President, Canale Communications Inc.
• Bio2Device Group, Tuesday Evening, May 14, 2013; Topic: “Ring! Ring! FDA Calling!” Speaker: Connie Hoy, Vice President of Regulatory Affairs and Quality Assurance, Cutera. Note this is a new presentation relevant beyond medtech
• Accretive Solutions, Wednesday Evening, May 15, 2013; Event: A Roundtable Discussion, The Sunshine Act: Moving from Darkness to Light
• RAPS San Francisco Chapter, Friday, May 17, 2013; Topic: “QA/RA Organizational Interfaces in the Medical Device Supply Chain;” Speakers: Chris Devine, president, Devine Guidance International Inc.; Connie Hoy, vice president, RA/QA, Cutera Inc.; Roger Stern, president, Stellartech Research Corporation; Michael A. Swit, JD, special counsel FDA Law, Duane Morris LLP

Next Upcoming UC Berkeley Extension Business and Marketing Course

• UC Berkeley Extension Intensive Course, Thursday and Friday, June 20-21, 2013; Course: “Life Science Business Development;” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Deloitte Recap LLC; Dates and Time: Thursday and Friday, June 20-21, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Fee: $895, (EDP 405118). Register at http://extension.berkeley.edu/catalog/course2005.html

You can download the complete list of meetings entitled Audreys picks May 12, 2013 by right clicking on the highlighted title. You can always download the list from my website at http://www.AudreysNetwork.com.

Since I wasn’t able to research the Jobs That Crossed My Desk this week due to the Comcast outage, I cannot provide that list at this time.

Hope you had a relaxing and refreshing weekend. And Happy Mother’s Day to all you mothers!

Audrey

 

Politics and FDA Approval of Drugs

Politics and contraception is once again an issue in the news. Many are shocked about the disagreements of the FDA with a recent court ruling about the age at which women can purchase over-the-counter “morning after” contraceptive pills—FDA will accept lowering the age from 17 to 15 years vs. the court ruling that females of any age should be able to purchase them. There are those for and against the lowering of the age. Some are against availability of the product without a prescription at all.

Unfortunately, approval of drugs by the FDA is impacted by public opinion and lobbying groups when it comes to female reproductive medicine. I find the FDA’s concern about proper usage of the pill by teenagers worthy of consideration based on efficacy and safety reasons warranted but not if it’s a reaction to outside pressure rather than based on scientific and medical grounds.  Here’s another viewpoint in favor of eliminating age requirement.

Bay Area Events This Upcoming Week

• BioCentury This Week, See new program Webcast Starting Sunday, May 5, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Affordable Innovation: Tower of Babble;” Speakers: Join BioCentury Washington Editor Steve Usdin and Avalere Health CEO Dan Mendelson in this second program on “Affordable Innovation,” joined by: Tony Coelho, former member of Congress from California and primary sponsor of the Americans with Disabilities Act, who now works as an advocate for patients with epilepsy and other diseases and Scott Gottlieb, former deputy commissioner of FDA and now Resident Fellow of the American Enterprise Institute.
• NCC AWIS, Monday Evening, May 6, 2013; Event: “19th Annual Awards Banquet”
• Bio2Device Group, Tuesday Morning, May 7, 2013; Topic: “Occupational Therapy Devices;” Speaker: Anupam Pathak, CEO, Founder, Lift Labs
• WIB-San Francisco Bay Area, Tuesday Evening, May 7, 2013; Topic:  “Funding your Idea: Growing From Concept to Reality”
• San Francisco AWIS, Wednesday Evening, May 8, 2013; Event: “Maximize your membership: Volunteer with sfAWIS! “
• BayBio, Thursday Evening, May 9, 2013; Event: “BayBio Spring Mixer and Open House”

Next Upcoming UC Berkeley Extension Business and Marketing Course

• UC Berkeley Extension Intensive Course, Thursday and Friday, June 20-21, 2013; Course: “Life Science Business Development;” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Deloitte Recap LLC; Dates and Time: Thursday and Friday, June 20-21, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Fee: $895, (EDP 405118). Register at http://extension.berkeley.edu/catalog/course2005.html

You can download the list of events from May through June—Audreys picks May 5, 2013—as well as the list of Jobs That Crossed My Desk Through May 5 for the past three weeks by right clicking on the highlighted titles. You can also find all my blogs and lists on my blog at www.AudreysNetwork.com/blog.

You can find me at the Bio2Device Group meeting on Tuesday morning.

Audrey

You’ve been probably hearing and reading about concerns about the future budget and its impact on revenues for bioscience companies. The Department of Health and Human Services budget section of the President’s 2014 budget has a lot of financial impact on manufacturers if they are enacted. You can see the full budget by right clicking on the highlighted title.

Chris Coburn, Senior Vice President of Commercial Compliance at CIS-Partners which specializes in compliance with government regulations did a fantastic job of highlighting the key points of interest to biopharma companies in a recent blog of his. There is additional money allocated in the budget to prevent and prosecute fraud and better enforce compliance of companies in meeting their obligations in area of rebates, etc. through increases provided to the Office of the Inspector General (OIG) and Justice Department. “This increase will enable OIG to expand CMS Program Integrity efforts for the Health Care Fraud Prevention and Enforcement Action Team and improper payments, and also enhance investigative efforts focused on civil fraud, oversight of grants, and the operation of Affordable Care Act programs.” There is also a multi-year investment to enable HHS and the Department of Justice to beef up their prevention and prosecution of fraud.

Some examples of financial impact on companies will come from the alignments of Medicare drug payment with Medicaid policies for low income patients and acceleration of manufacturer drug discounts currently at 50% to 75% for Medicare beneficiaries to better cover “donut hole.” Reimbursement for drugs administered in the physician’s office will be lowered from 106 percent of the Average Sales Price (ASP) to 103 percent of ASP. There will be prohibition of pay-for-delay agreements between brand and generic companies to delay entry of generic drugs and biologics into the market. Biologic manufacturers are concerned about effort to decrease 12 years of exclusivity for branded biologics to 7.

Thank you, Chris, for providing these insights into potential changes based on the 2014 President’s budget.

Highlights for Bay Area Life Science Events This Coming Week

• BioCentury This Week, See new program Webcast Starting Sunday, April 28, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: Topic: “Affordable Innovation: Cutting the Gordian Cord;” Speakers: Dan Mendelson , Avalere CEO; Gail Cawkwell, Vice President for Medical Affairs at Pfizer; Tony Coelho, former member of Congress from California and primary sponsor of the Americans with Disabilities Act, who now works as an advocate for patients with epilepsy and other diseases; Scott Gottlieb, former deputy commissioner of FDA and now Resident Fellow of the American Enterprise Institute; and Martin Marciniak, Vice President of U.S. Health Outcomes at GlaxoSmithKline.
• Recap Allicense 2013, Monday and Tuesday, April 29-30, 2013; Conference: “Allicense 2013”
• Bio2Device Group, Tuesday Morning, April 30, 2013; Topic: “Role of the CDC at Ports of Entry;” Speaker: Andre Berro, MPH, MS, Public Health Advisor, Center for Disease Control and Prevention (CDC)
• EMC and Hesperian Health Guides, Tuesday Evening, April 30, 2013; Topic: “Women who Dream Can Change the World: Health Solutions for All;” Speakers: Sarah Shannon, Executive Director, Hesperian Health Guides, Dorothy Tegeler, Assistant Director, Hesperian Health Guides, and Natasha Martin, Founder, GRACE Kenya
• CBA San Francisco, Thursday Evening, May 2, 2013; Event: CBA Career Development Workshop; Moderated by Dr. Lin Sun-Hoffman, President , CBA; Dr. Guoliang Yu, Executive Chairman of Crownbio; Dr. Wei Zhou, CEO at Centrillion Biosciences, Inc; Dr. SofieQiao, Executive Director at Russell Reynolds Associates; Dr. Hengwei Chang, CEO at CS Bio.; Dr. Jimmy Z. Zhang, Managing Director, China Merck & Co., Inc
• PRIME, Thursday Evening, May 2, 2013; Topic: “Big Data and Analytics in Life Sciences : Towards Better Patient Care;” Introduction by Eric Lameignere, Head of Genopole® Enterprises; Panel Speakers:Alex Bangs, CIO at Crescendo Biosciences; Eric Durand, Computational Scientist at 23andme; Ken Perez, Senior Vice President of Marketing and Director of Healthcare Policy at Medeanalytics; Moderated by Samir Elamrani, partner at Wilson Sonsini Goodrich & Rosati
• Medtech Frontiers, Thursday Evening, May 2, 2013; Topic: “Assistive Technology; Speaker: David L. Jaffe

Next Upcoming UC Berkeley Extension Business and Marketing Course

• UC Berkeley Extension Intensive Course, Thursday and Friday, June 20-21, 2013; Course: “Life Science Business Development;” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Deloitte Recap LLC; Dates and Time: Thursday and Friday, June 20-21, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Fee: $895, (EDP 405118). Register at http://extension.berkeley.edu/catalog/course2005.html

You can find all the details for the above events as well as those through June 2013 in Audreys picks  and the most current list of job postings for the last three weeks Jobs That Crossed My Desk Through April 28 by right clicking on the highlighted titles which will allow you to read the document in a separate window and download the document if you’d like. You can always find these along with my weekly blog at http://www.Audreysnetwork.com/blog.

Hope to meet you at one of the upcoming events!

Audrey

Not all the jobs are leaving the U.S. but still not enough new ones are being created to compensate for all the lost jobs with mergers and acquisitions in our industry. I shutter at the potential layoffs that might potentially be outcome of Massachusetts- based Thermo Fisher take out of California’s Life Technologies Corp. I’m not familiar with overlaps in their staff skill sets so perhaps it won’t be a bloodbath, but Ron Leuty of the San Francisco Business Times alerts us that Life Technologies has 1,200 staff in the Bay Area, including staff of more recently acquired Navigenics last summer and Ion Torrent in 2010.

I note that two pharma companies that have moved ahead thoughtfully with recovery business plans after loss of major blockbuster drug revenues include BMS and Eli Lilly. In the face of these heavy income losses from blockbusters, we are not surprised to hear of severe cuts in sales force headcount. With the changing face of marketing in the drug arena and barriers to large sales forces being able to make contact with enough physicians to be worthwhile, we know that the 3,000 person sales forces are disappearing.

We can celebrate that Bristol-Myers Squibb will expand their biologic facilities in the U.S. in Devens, Massachusetts. They will invest $250 million into the expansion of their large-scale biologics manufacturing facility there. They will be almost doubling their workforce with 350 new positions. The article by Patricia Resende, Managing Editor MHT- Boston Business Journal includes information about the incentives the company will receive for creating new jobs in Massachusetts although the company indicates that wasn’t the reason for the location there. California doesn’t appear to be competing with equivalent incentives to locate here.

Eli Lilly is making major cuts of 30% or 1,000 of its full time and contract sales force in the face of the second major drug revenue loss now with the patent expiration of its biggest drug, the antidepressant Cymbalta. The company lost 6% in profits with the loss of patent for schizophrenia drug Zyprexa last year. But at the same time, the company plans to add 300 people to its diabetes sales force. We continue to expect to see cutbacks in sales force personnel until the total number of representatives returns to 1990 levels.

Lilly confirmed in a statement that it is restructuring its sales force to adapt to changes to meet the challenges in the marketplace including the expiration of two patents.

This Coming Week’s Bay Area Events

This week is less hectic in the Bay Area, I suspect as many in the local industry travel to Chicago for the International BIO conference there. But there are still events and other activities for those of us here to consider. Now is a good time to catch up on webinars and other programs available online. I find the inventory of  BioCentury This Week free programs to be outstanding. There is now a list of past complimentary webcasts available on www.xtalks.com by Quintiles as well. Elsevier also offers pertinent webcasts at www.Elsevier.com of which some are complimentary while others are not.

• BioCentury This Week, See new program Webcast Starting Sunday, April 21, 2013 http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Gene Patent Faceoff: “ Where SCOTUS Could Go;” Speakers: Gregory Castanias of law firm Jones Day, who argued Myriad’s case before the high court and Sandra Park of the ACLU Women’s Rights Project and co-counsel for the challengers of Myriad’s BRCA1 and BRCA2 patents.
• Bio2Device Group, Tuesday Morning, April 23, 2013; Topic: “Obesity 360;” Speakers: Nat Bowditch, Darshana Nadkarni, and Alex Nedvetsky
• BioDesign, Tuesday Evening, April 23, 3013; Event: “From the Innovators Workbench;” Speaker: Omar Ishrak, CEO, Medtronic
• MM&M, Wednesday Morning, April 24, 2013; Event: “MM&M Virtual Summit”
• ASQ NCDG, Wednesday Evening, April 24, 2013; Topic: Mitigation Of FDA 483 Observations,Warning Letters, Recalls, And Field Corrective ACTIONS; Speaker: Connie Hoy – Vice President Regulatory Affairs And Quality Assurance Of Cutera, Brisbane, California; Moderator: June Jenkins- Business Development Manager – Oxford & Associates
• East Bay AWIS, Saturday Morning, April 27, 2013; Event: Informal and family friendly “Visit to Rosie The Riveter Exhibit”

If you are interested in an indepth intensive course covering life science company alliances and partnering that involves not only business development professionals but all other functions that touch on these processes, consider taking the next UC Berkeley Extension Life Science Business Development course running Thursday and Friday, June 20-21, 2013 at the downtown site of UC Berkeley Extension.  This course involves two days of intensive classroom work and then balance of two month term to complete special projects that allow you to grasp skills as part of your own skill set but to also make part of your career portfolio. Deloitte Recap and BioCentury provide gratis access to their selected databases for two months of term that are premier paid databases used by business development professionals in their work.

Course: “Life Science Business Development;” Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Bill McMillan, CSO, founder and owner of Profusa, Inc.; Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC; Carolyn Feamster, MBA, a business strategy and analysis consultant; Gilbert R. Mintz, Ph.D., President of GRM Associates; Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP; and Chris Dokomajilar, Manager, Senior Biopharma Analyst at Deloitte Recap LLC

Dates and Time: Thursday and Friday, June 20-21, 2013; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project

Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105

Fee: $895, (EDP 405118). Register at http://extension.berkeley.edu/catalog/course2005.html

You can download Audreys picks April 21, 2013 and JobsThatCrossedMyDesk April 21, 2013 by right clicking on the highlighted titles.

Audrey