Amazing!! For profit companies are recognizing that it’s in their interest to share data. It only takes some careful planning to protect their assets. The extremely high cost of drug R&D has now made it clear that collaboration is necessary to be successful. We are seeing new efforts to speed up discovery by sharing data, where possible, rather than repeating expensive mistakes separately. Perhaps now the war on cancer can advance more rapidly. The success of this initiative has depended on the buy in by top executives, or almost all of them.

Those of us working in new drug development as well as other development of associated treatments for cancer welcome more collaboration to help uncover needed information about cancer and   potential   treatment solutions. Back in 2001 a CEO Roundtable on Cancer was formed to address a challenge from then President George H.W. Bush to address cancer prevention, diagnosis, and treatment within their families as well as within their corporate family. See http://www.businesswire.com/news/home/20140408005149/en/CEO-Roundtable-Cancer-Launches-Project-Data-Sphere

After dealing with recognized legal, privacy and technology issues in making the sharing of patient data from commercial as well as nonprofits possible, the Life Science Consortium an offshoot of the not-for profit CEO Roundtable on Cancer launched Project Data Sphere LLC . “The goal is to improve the design and efficiency of clinical trials by developing new disease models and improving the understanding of patient risk factors and how comparator arms behave,” according to Erin McCallister, Senior Editor, BioCentury in the article “Unlocking Cancer Data” in their April 14, issue. Access to this information will help researchers design improved trial protocols and move innovation faster and with possibly lower cost by cutting on the waste.

The website will provide independent researchers as well as those affiliated with companies, hospitals and institutions free access to de-identified, patient-level data from the comparator arms of Phase III cancer trials sourced by academia and industry. The website currently includes nine data sets covering 3,500 patients provided by AstraZeneca plc, Bayer AG, Celgene Corp, the Janssen Research and Development LLC unit of J&J, Pfizer Inc., Sanofi and Memorial Sloan-Kettering Cancer Center. An additional 25 data sets are anticipated to be added soon.

The CEO Roundtable includes chief executives from 30 companies, cancer non-profits and cancer research centers of which, unfortunately, Genentech/Roche is noticeably absent. I was disappointed that this high profile cancer company with huge profit from oncology products is not participating. See list of Roundtable members at http://www.ceoroundtableoncancer.org/member. The above-mentioned BioCentury article notes that Roche and Genentech have opted out of participation.

Upcoming Bay Area Life Science Events

  • BioCentury This Week, See new program Webcast Starting Sunday, April 13, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Compassionate Access — Who Decides?” Speakers: Aimee Hardy, the mother of Josh Hardy; Richard Klein, Director of FDA’s Patient Liaison program; Dr. Darshak Sanghavi, Managing Director of the Brookings Institution’s Engelberg Center for Health Care Reform and Nancy Goodman, Executive Director of Kids v Cancer
  • Bio2Device Group, Tuesday Morning, April 15, 2014; Topic: “Path to developing cost effective solutions for therapeutic monoclonal antibodies;” Speaker: Amita Goel, Founder and CEO, Celltheon Corporation
  • Janssen Labs, Tuesday, April 15, 2014; Topic: “Meet with…Correlation Ventures;” Speaker: David Coats, Founder and Managing Director, Correlation Ventures
  • UCSF, Tuesday Evening, April 15, 2014; Event: “Speakers Series: Blazing the Precision Medicine Trail: Genomic Health’s Journey;” Speaker: Kim Popovits, Chairman of the Board, CEO & President. Genomic Health
  • Science Webinar, Wednesday Morning, April 16, 2014; Topic: “Visualizing Cell Signaling: Current Trends and New Technologies;” Participants: Mark Hollywood, Ph.D. Dundalk Institute of Technology, Dundalk, Ireland; C. Peter Bengtson, Ph.D. University of Heidelberg, Heidelberg, Germany; Colin Coates, Ph.D., Andor Technology, Belfast, Ireland
  • EMBS, Wednesday Evening, April 16, 2014; Topic: “Point of Care CD4 Testing and the BD FACSPresto;” Speaker: Scott Bornheimer, Ph.D.,BD Biosciences
  • BayBio Pub Night, Thursday Evening, April 17, 2014; Event: “BayBio Pub Night”
  • CABS Science and Technology Workshop, Friday Afternoon, April 18, 2014: Topic: “The Road to Personalized Medicine: Science, Commercialization and Clinical Application;” Speakers: Drew Watson, VP of Research, Genomic Health, Kunbin Qu, Director of Research-Bioinformatics, Genomic Health, Zhanzhi Hu, Sr. Scientist, Veracyte, Jonathan Hirsh, Founder and President, Syapse

Life Science Business Development Course: An Intensive Course June 19-20 at UC Extension in San Francisco

This course which focuses on dealmaking, collaboration and alliances includes two days of intensive classes and then two months of project time with help of resources and access to BioCentury and Thomson Reuters Recap deal databases. See details at http://tinyurl.com/mao7hjh. Registration is now open.

Find all the details for this coming week’s upcoming events plus those through June 2014 in Audrey’s Picks. You can download the pdf of JobsThatCrossedMyDeskThrough April 13 2014 along with Audreys Picks April 13, 2014 by right clicking on the highlighted titles. This latter list includes the latest three weeks of positions.

You can always find my weekly blog and listings at http://audreysnetwork.wordpress.com/ or direct others who are interested there.

Audrey

Posted by: Audrey Erbes | April 6, 2014

Landmark Obamacare Enrollment Reached plus Events and Jobs

I’ve sat in amagement at how some critics of Obamacare continue to discredit the plan and some Congressmen have even tried to overturn the law 52 times even in the face of the Supreme Court decision. My take on this is that half of the public is gullible enough to believe their spokespeople’s scare tactics even when the statements that underlay their criticism are untrue. The issue still makes for a good rallying call for politicians organizing people who share their beliefs to gain votes in 2014 elections even though they may have individually accepted the inevitability of the new law.

Those of us in the health care industry have known for a long time that the system is broken and that there can’t be unlimited, escalating costs for a care system that isn’t serving our citizen patients very well. Of course, there needs to be changes to get the costs under control and some of those changes will threaten industry’s bread and butter as well. The smart companies recognize that changes are inevitable and will research the changes and potential scenarios and survive.

Citizens want improved health care but many won’t invest in the time to research the issues or perhaps know where to find accurate information. They want to believe the media that they gravitate to even if it tells them that killing Obamacare is in their interest. They are looking for a simple answer for an admittedly a very complex subject. The average citizen isn’t alone in wondering how all the related policies will work out and the impact on them. Just as many develop conspiracy theories when they don’t have access to correct information as in the case of the missing Malaysian airliner, many are subject to scare tactics about the unknown in the face of major changes of any kind. I imagine any political discussion of a serious reform of the tax code would be even more difficult?

Obamacare is a big change and there will be many adjustments to be made not just by patients, but by physicians and industry. It will just take time to resolve the scariness for all. Americans survived the introduction of Social Security, Medicare, Part D drug coverage and now will survive Obamacare, but the rhetoric will likely continue. There was a lot of negative criticism prior to their acceptance.

I’m heartened by the enrollment reaching 7 million at the end of March 31st. Just as those who support the politicians who want to slash budgets for health care but don’t want their Medicare benefits touched also don’t want to return to lack of coverage for preexisting conditions, the slashing of care for their children and taking away coverage for their adult children under 26 under their policies. Politics aren’t always rational but the public is enrolling in keeping with their interest even when some of them are going against the rhetoric of their political icons.

Highlights for The Coming Weeks Bay Area Events

  • BioCentury This Week, See new program Webcast Starting Sunday, April 6, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “The New IPO Age: Onward and Upward;” Speakers: Jeffrey Abbey of Argos Therapeutics Inc; Dr. Scott Koenig of MacroGenics Inc.; and Tim Mayleben of Esperion Therapeutics Inc.
  • Bay Area Medical Device Group, Monday Evening, April 7, 2014; Event: Bay Area Medical Device Networking
  • UC Berkeley Extension, Monday – Friday, April 7-11, 2014; Course: “Bioscience Essentials for Industry Professionals: An Intensive Seminar” MCELLBI 1001
  • Bio2Device Group, Tuesday Evening, April 8, 2014; Topic: “Coming Out of the Dark Ages of Stroke Healthcare;” Speaker: Dr. Mark Borsody, Chief Medical Officer, Nervive Inc.
  • SF AWIS, Wednesday Evening, April 9, 2014; Topic: “Science and Sustainability;” Speaker: Jill Kauffman-Johnson, Director of Sustainability at Solazyme, Inc.
  • UC Berkeley Extension Course, Thursday and Friday, April 10-11, 2014; Course: “Life Science Business and Marketing: Their Integral Role for Success”

All registered students will have free access to Elsevier’s premier licensing/deal database Strategic Transactions covering all industry sectors plus In Vivo, Start Up, Medtech Insight, and The RPM Report during two month period following intensive classroom work. It’s an opportunity to do a project with guidance from the instructor and gain access to these great resources in addition to extensive listing of online resources developed by the instructor. You can locate course online and register at http://tinyurl.com/kqbu2rx

  • Janssen Labs, Thursday Mid-Day, April 10, 2014; Topic: “Social Media 101: How to Raise Your Company’s Voice;” Speaker: Barbara Lavery | President, Zoomedia

 

Find all the details for this coming week’s upcoming events plus those through June 2014 in Audreys picks April 6, 2014. You can download the pdf of JobsThatCrossedMyDeskThrough April 6, 2014 along with Audrey’s Picks by right clicking on the highlighted titles. This latter list includes the latest three weeks of positions.

 

You can always find my weekly blog and listings at http://audreysnetwork.wordpress.com/

Audrey

 

 

Posted by: Audrey Erbes | March 30, 2014

This Coming Week’s Life Science Events and Job Listing

Hi,
Thank you for all your notes this past week in reference to my tribute to a valiant patient last week. Your thoughtful comments are very much appreciated and are very supportive in these difficult times.
Highlights of Upcoming Events This Week

BioCentury This Week, See new program Webcast Starting Sunday, March 16, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Fueling the Fire: Wall Street, ACA and Prices”
CACO, Monday, March 31, 2014; Workshop Topic: “Applications of PK-PD and TK-TD Modeling in Drug Discovery and Development;” Speakers: Wade Adams, Harvey Wong (Genentech), Weijan Pan (Alexion)
Bio2Device Group, Tuesday Morning, April 1, 2014; Topic: “Novel approaches to immune therapy and monitoring;”Speaker: Dr. Russell Pachynski, Cofounder and Chief Scientific Officer, CombImmune
ASQ, Wednesday Evening, April 2, 2014; Topic: “Risk Management Demystifying European, FDA and ISO Requirements Roundtable;” Speaker: Sam Lazzara
Science, Thursday Morning, April 3, 2014; Topic: “Refilling the Drug Discovery Pipeline: The Role of New Technologies;” Participants: Stephen Rees, AstraZeneca, Macclesfield,UK and Paul Belcher, Ph.D., GE Healthcare, Piscataway, NJ
MedTech Frontiers, Thursday Evening, April 3, 2014; Topic: “A Pharmaceutical with an App – a Fraught Combination?” Jafar Shenasa, Senior Director of Regulatory Affairs at Proteus Digital Health

A reminder that you can still enroll in “Life Science Business and Marketing: Their Integral Role for Success” on April 10-11. This course now offered in its 12th year provides a great opportunity for you to better understand the life science industry including its pharmaceutical, medical device, diagnostics and tool sectors. I designed this class for life science professionals from all sectors, functions and levels.

All registered students will have free access to Elsevier’s premier licensing/deal database Strategic Transactions covering all industry sectors plus In Vivo, Start Up, Medtech Insight, and The RPM Report for two months. It’s an opportunity to do a project with guidance from the instructor and access to these great resources in addition to extensive listing of online resources developed by the instructor. You can locate course online and register at http://tinyurl.com/kqbu2rx

Course Content Outline
The Discipline of Marketing in the Bioscience Industry
• Unique bioscience industry marketing characteristics
• The core marketing functions
• Pivotal documents associated with marketing functions
• The critical role of marketing at all stages of a product’s development
Marketing Research and Analysis
• Use of market research to optimize product planning, development and marketing
• Role of market research throughout development of company and product
• Defining the objectives, planning and implementation of the research
• Types of market research and methodologies
Impact of Managed Care System on Marketing Bioscience Products
• Review healthcare industry trends/data that impact cost and reimbursement
• Define “who/what is the U.S. healthcare system” and how it influences the commercialization process
• Define reimbursement from Managed Care perspective
Success Parameters for Products and Companies
Dealing with Regulatory Environment and Product’s Approvability
The Role, Function, Objective of Selected Major Marketing Functions
• Business Development and Licensing Process, Contract and Terms
• Product/Technology Opportunity Assessment Research and Recommendation
• Strategic Planning and Strategic Plan
• Product Management and Product Marketing Plan
• Sales and Distribution

Instructor: Audrey Erbes, Ph.D., Principal, Erbes & Associates and http://www.audreysnetwork.com, a life-science business development and marketing consultant and developer of customized executive education.
Guest Speakers : Joyce Chiarenza, Regulatory Consultant; Linda Schock, Director, Commercial Compliance and Government Programs, CIS; Carol Gonzalez-Sheak, Ph.D., co-founder and consultant with MindSeed Café; Julie Tompkins, MBA, Sr. Vice President, Timely Data Resources, Inc.
Life Science Business Development Course: An Intensive Course June 19-20

This course which focuses on dealmaking, collaboration and alliances includes two days of intensive classes and then two months of project time with help of resources and access to BioCentury and Thomson Reuters Recap deal database. See details at http://tinyurl.com/mao7hjh. Registration opens April 7.

Find all the details for this coming week’s upcoming events plus those through June 2014 in Audrey’s Picks. You can also download the pdf of JobsThatCrossedMyDeskThrough March 30, 2014 along with Audreys picks March 30, 2014 by right clicking on the highlighted titles. This latter list includes the latest three weeks of positions.

You can always find my weekly blog and listings at http://audreysnetwork.wordpress.com/
Audrey

 

A Tribute to A Brave Patient

This week I want to pay tribute to John “Jay” Geddes Erbes who despite living a productive life filled with good diet and  exercise from all manner of sports passed as a result of malignant Stage IV glioblastoma for which our industry has found no cure. After five months of enduring an initial attempt to remove the aggressive tumor with a craniotomy and then receiving the highly toxic medications included in the guideline therapy for this aggressive cancer of the brain, he died of an apparent side effect from a biologic drug. We were fortunate and grateful to have had the outstanding expertise and excellent patient care by the team of physicians and nurses at UCSF and the surgery performed by a Palo Alto Medical Foundation neurosurgeon trained at UCSF. El Camino Hospital in Mountain View was an outstanding center of surgical care as well as care of the families of the patients. We learned that those in our geographic area are truly blessed with outstanding medical access.

Jay  was a valiant patient and never gave up. Our current healthcare expertise failed him and spurs me on to support investment in innovation in oncology. He carried around a cell phone with both a video of his winning a foot race in Olympia, Greece in July and an MRI film of his tumor only partially removed in August. He told folks that he had fulfilled his bucket list and got in his one final wish for a “jog” at Pismo Beach on the Central Coast on Jan. 14th, when we experienced an unusually hot week prior to his sudden and unexpected death from a drug side effect. We need to continue to work on developing more efficacious cures without the side level of side effects for most cancer therapies.

Upcoming Events This Week

  • Highlights for this Coming Week’s Life Science EventsBioCentury This Week, See new program Webcast Starting Sunday, March 16, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT;  Topic: “Profiles in Innovation: VEGF Visionary; Also ASCO’s Ominous Forecast”
  • Bio2Device Group, Tuesday Morning, March 25, 2014; Topic: “Arbor Vita’s OncoE6TM Cervical Test – a novel, simple and specific approach to meet challenges of worldwide screening for HPV induced cancers;” Speaker: Johannes Schweizer, Vice President of Research and Development, Arbor Vita Corporation
  • GGPF Dinner Lecture, Tuesday Evening, March 25, 2014; Topic: “Beyond Ethanol:  Development of Advanced Biofuels at the Joint BioEnergy Institute;” Speaker: Blake A. Simmons, Ph.D., Vice-President, Deconstruction Division, the Joint BioEnergy Institute
  • BioDesign, Wednesday Evening, March 26, 2014; Topic: “From the Innovator’s Workbench;” Speaker: André Michel Ballester, Chief Executive Officer, Sorin Group
  • Clinipage Worldwide, Wednesday Morning, March 26, 2014; Webinar Topic: “Mapping a Path to Market—Creating a Comprehensive Drug Development Strategy;” Panelists: Brenda Fielding, Executive Vice President, Regulatory Affairs, Clinipace Worldwide; Monika Frey, Vice President, Global Clinical Operations, Clinipace Worldwide and Nik Burlew, Vice President, Quality Systems, Clinipace Worldwide
  • BOLD, Thursday Morning, March 27, 2014; Topic: “Disruption and Opportunity: The Leaders’ Role in Creating the Future of Work;” Guest Speakers: Steven Kowaiski, PH.D., Executive Development, Genentech;Ann Bamesberger, Head of Workplace Effectiveness, Genentech; Mark Bagnall, most recently President and CEO of GenturaDx and Kaye Foster-Cheek, most recently Senior Vice President, Global Human Resources for Onyx Pharmaceuticals
  • AAPS-BADG / CACO-PBSS, Thursday Evening, March 27, 2014; Topic: ”AAPS-BADG / CACO-PBSS Joint Dinner Seminars:
    • Pediatric Drugs—A Review of Commercially Available Oral Drug Products (Dr. Robert Strickley, Principal Scientist, Gilead Sciences)

    and Discovery of a New Drug Candidate for Transthyretin-Folding Diseases

    •  (Dr. Mamoun Alhamadsheh, Assistant Professor, Dept. of Pharmaceutics & Medicinal Chemistry, University of the Pacific)
  • EPPI, Saturday, March 29, 2014; Topic: “EPPICon 2014: Interdisciplinary Innovations in Life Sciences”

I hope to see some of you at my upcoming course April 10-11. I remind you that “Life Science Business and Marketing: Their Integral Role for Success” provides a great opportunity for you to better understand the life science industry including its pharmaceutical, medical device, diagnostics and tool sectors. All registered students will have free access to Elsevier’s premier licensing/deal database Strategic Transactions covering all industry sectors plus In Vivo, Start Up, Medtech Insight, and The RPM Report for two months. It’s an opportunity to do a project with guidance from the instructor and access to these great resources in addition to extensive listing of online resources developed by the instructor. You can locate course online and register at http://tinyurl.com/kqbu2rx

Deliverables

Students receive an extensive student reader with lecture slides for note taking, lists of Internet-accessible information resources and gratis access to selected otherwise paid Elsevier subscription databases to assist in researching their optional term project.

Who Will Benefit from This Course

Experienced and newer business and marketing professionals–as well as scientific, clinical, regulatory, and legal professionals–can benefit from this introduction to the important business and marketing aspects of the life science industry and how to research and develop solutions to handle its challenges.

Course Director

Audrey Erbes, Ph.D., is a global life-science business development and marketing consul­tant, industry blogger at http://www.AudreysNetwork.com, organization leader, public speaker and developer of customized executive education. She is known for her industry blog publications on Audreysnetwork.com. She had 25 years of corporate managerial experience in the biopharmaceutical industry including Executive Vice President and Cofounder of Kowa Research Institute, a biopharmaceutical licensing and investment subsidiary of Kowa Company Ltd., Japan. Before that she held both U.S. and international man­agement positions at Syntex Corp. (acquired by Roche) in market research, product management, strategic marketing, and business development with a special emphasis on Europe and Asia/Pacific/Canada.

Guest Speakers and Their Topics

Joyce L Chiarenza, Chiarenza Consulting, L.L.C. is a regulatory affairs, labeling expert and clinical compliance certified professional with over 40 years of pharmaceutical and biotech experience. She held managerial positions in quality control, quality assurance, compliance and regulatory affairs. After more than 16 years at Genentech, Inc., she became a regulatory affairs consultant, specializing in labeling, advertising and promotion, and clinical compliance. Prior to Genentech she worked in quality with Abbott Laboratories and for three years worked in area of vitamins, food supplements and cosmetics.

Joyce holds a B.S. degree in Child Psychology and Special Education Credentials from California State University at Northridge. In 2010, she received her certification as a Clinical Compliance Professional. Topic: “Operating in the U.S. Regulatory Environment: Is Product Approvable”

Linda L. Schock is the Director of Commercial Compliance & Government Programs at Compliance Implementation Services (CIS) and responsible for opening the CIS West Coast office in Burlingame, California.   Ms. Schock brings over 20 years of industry experience ranging from distribution, pricing, Commercial and Government contracting, reimbursement and Patient Support Programs. Prior to joining CIS, Ms. Schock worked at NeurogesX as Director, Commercial Operations from 2009-2011 and CV Therapeutics from 2005 2009. From 2001 to 2005 Ms. Schock was Associate Director, Distribution and Reimbursement within Commercial Operations at Actelion Pharmaceuticals where she was involved in the launch of Tracleer® and the risk management program T.A.P.   Ms. Schock began her career at Genentech, Inc. where she worked in Commercial Operation positions of increasing responsibility from 1987 to 2001. Topic: “Building Effective & Compliant Commercial and Government Contracting Operations: A Case Study”

Carol Gonzalez-Sheak, Ph.D., is currently co-founder and consultant with MindSeed Café. She has more than 25 years healthcare industry experience in the pharmaceutical and biotech, medical devices, and diagnostics. Recently she has worked as an independent consultant and Principal at CG Biomedical Associates. Prior to that, she was at Merck as Associate Director, Global Customer Insights. She has also served as Director Marketing Research at NPS Pharmaceuticals, and held a prior biotech marketing planning role at Serono. She has also held managerial positions in medical devices market research and planning, and business development at Becton Dickinson, and Kendall Healthcare (Covidien), and Syva/Syntex . She holds a B.A. in Human Biology from Stanford University, and a Ph.D. in Biopsychology from the University of Georgia, Post Doctoral Fellowship in Psychobiology, Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences. Topic: “The Impact of U.S. Health Care System on Marketing Life Science Products”

Julie Tompkins, MBA, is Sr. Vice President at Timely Data Resources (TDR), a healthcare market research and consulting firm.  She has more than 30 years experience in the pharmaceutical and biotech arenas, including 12 years in industry and more than 20 years in market research consulting, and has worked with pharmaceuticals, diagnostics, and drug delivery systems.  At Syntex (acquired by Roche), Julie worked in both R&D and Marketing, including positions as Analytical Chemist, Market Research Analyst, Manager of New Product Planning, and Manager of Market Analysis.  She spent most of her time in Marketing as the primary liaison between Marketing and R&D, serving as a key member on multi-disciplinary project teams and strategic planning committees.  After leaving Syntex, Julie was President and Founder of MedSearch, a primary market research company that merged with TDR in January 2000.  She holds a B.A. in Human Biology from Stanford University and an MBA from Santa Clara University. Topic: “The Role of Market Research in Product Planning, Development and Marketing”

Find all the details for this coming week’s upcoming events plus those through June 2014 in Audreys Picks March 23, 2014. You can also download the pdf of JobsThatCrossedMyDeskThrough March 23, 2014 along with Audrey’s Picks by right clicking on the highlighted titles. This latter list includes the latest three weeks of positions.

You can always find my weekly blog and listings at http://audreysnetwork.wordpress.com/

Audrey

The negative impact on research spending as result of cutbacks in NIH funding is unsettling. Alex Philippidis writes in GEN article “NIH Dry Spell Parches Researchers: Proposed budget hike unlikely to reverse lab job losses, research delays” about the glass half empty side of life science innovation. This research is the bedrock of science innovation that eventually becomes available for companies to develop.

Philippidis quotes Neil Schluger, M.D., chairman of TBTC’s steering committee of Tuberculosis Trials Consortium (TBTC) which lost portion of funding due to sequestration’s impact on NIH budget: “Younger researchers… see their mentors and other established investigators struggling to get grants renewed and things like that, and wonder how much lower NIH and CDC funding will sink: They say, ‘Why should I do this? How can anybody live this way? What’s the future in that?’ We really are in the process of losing a generation of people who otherwise might have pursued careers in research.”

Philippidis sums up his article “And if that happens, the U.S. will lose more than simply leadership in research, but the brainpower needed to tackle the field’s most challenging questions, and as a result, lives that otherwise could have been saved.”

In another article “Stakeholders blast Obama’s budget for FDA, NIH” it is noted that  proposals for increases for the FDA and NHI in President Obama’s prosed fiscal year 2015 budget are only 1.0% and 0.7%, respectively. See comments from stakeholders.

Highlights for this Coming Week’s Life Science Events

  • BioCentury This Week, See new program Webcast Starting Sunday, March 16, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; ”Waxman’s Legacy: The Hand of Government”
  • CACO-PBSS Workshop, Monday Afternoon, March 17, 2014; Workshop: “Drug-Device Combination Products;” Speakers: Deepa Deshpande (Universal Regulatory, Inc.), Ed Smith (Zogenix), Igor Gonda (Aradigm Corporation), Peter Staehr (Abott Vascular Inc.)
  • Bio2Device Group, Tuesday Morning, March 18, 2014; Topic: “The How-to for Improving Physician Adoption of Technology;” Speaker: Akhil Sakhlecha, General Partner, Artimen Ventures
  • Palo Alto AWIS, Tuesday Evening, March 18, 2014; Topic: “Girls and Women in Science;” Speaker: Katherine Nielsen, MA, MS. Co-Director of Science and Health Education Partnership at UCSF
  • BioScience Forum, Wednesday Evening, March 19, 2014; Title: “A Novel Antibody Target for Alzheimer’s and Related Tauopathies;” Speaker: Nancy Stagliano, Ph.D., Chief Executive Officer, iPierian, Inc.
  • EMBS, Wednesday Evening, March 19, 2014; Topic:  “The Whole is Greater than the Sum of the Parts: Nano-Patterned Lipid particles for targeted drug delivery therapeutics;” Speaker:  Jayakumar Rajadas, Ph.D., Biomaterials and Advanced Drug Delivery Laboratory, Stanford Cardiovascular Pharmacology, Division  of Cardiovascular Institute
  • Janssen Labs, Thursday Afternoon, March 20, 2014; Topic: “Show Me The Money: Alternative Sources of Capital;” Speaker: Bob More, Head of Venture Investing, Bill & Melinda Gates Foundation; Panelists: Bob More | Head of Venture Investing, Bill & Melinda Gates Foundation; Todd Meyerrose, PhD | Portfolio Manager, Poliwogg; Melissa Stevens | Deputy Executive Director, FasterCures; Una Ryan, PhD, OBE | Member, Astia Angels; and Managing Director, Golden Seeds (Silicon Valley)
  • HBA, Thursday Evening, March 20, 2014; Topic: ”Orphan disease program, part 2 – small markets with big opportunities;” Speakers: Jennifer Hotchkin, Associate director, ERA franchise marketing, Actelion Pharmaceuticals US, Inc.; Ruth Suter, Senior director of market access and patient services, BioMarin Pharmaceutical Inc; Wendy S. White, Founder and president, Siren Interactive; Moderator: Christine A. Nash, Sr. vice president and chief commercial officer, Hyperion Therapeutics, Inc.
  • CABS, Friday, March 21, 2014; Workshop: “Large Molecule Drug Discovery and Development (Part III): Novel Antibody Technology Platforms and Case Studies on Therapeutic Antibody Discovery and Development”

Upcoming UC Berkeley Life Science Business Extension Courses

Course: “Life Science Business and Marketing: Their Integral Role for Success,” April 10-11, 2014

Applies for credit toward Professional Program in Life Sciences Business (see flyer at http://extension.berkeley.edu/upload/lifesciences_business.pdf)

Dates and Time: Thursday and Friday, April 10-11, 2014; 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, course ID is BUS ADM X442.4

See more details and register now. You can locate course online and register at http://tinyurl.com/kqbu2rx

Course Description

The life science industry presents very different challenges found in other industries and requires specialized knowledge and skills to navigate the unique regulatory path requirements, lengthy development times, expensive clinical trial process, FDA control of advertising and labeling, and impact of managed care on reimbursement and pricing. This course conveys the foundational research and analysis skills needed on the job to make good marketing and business recommendations and decisions across company functions.

Course includes two days of intensive classroom work and mentoring by instructor available for balance of term while completing optional term project.  Students will learn how to research and analyze markets and environments for making recommendations and decisions useful for all professional functions in bioscience companies. They will learn how to do typical business and marketing assignments common to the workplace and receive templates/outlines for documents. In the process students will develop a basic understanding of the role and benefits of various business and marketing functions involved in company’s success, underscoring their roles across all stages of company and product lifecycle. Participants will learn what makes the industry “tick,” identify challenges and opportunities critical to the success of a company and its products that might otherwise be overlooked until too late in the development process. Students will complete business investment analysis of a company and its technology/products of their choice for term project

Deliverables

Students receive an extensive student reader with lecture slides for note taking, lists of Internet-accessible information resources and gratis access to selected otherwise paid Elsevier subscription databases to assist in researching their optional term project.

Who Will Benefit from This Course

Experienced and newer business and marketing professionals–as well as scientific, clinical, regulatory, and legal professionals–can benefit from this introduction to the important business and marketing aspects of the life science industry and how to research and develop solutions to handle its challenges.

Course Director

Audrey Erbes, Ph.D., is a global life-science business development and marketing consul­tant, industry blogger at http://www.AudreysNetwork.com, organization leader, public speaker and developer of customized executive education. She is known for her industry blog publications on Audreysnetwork.com. She had 25 years of corporate managerial experience in the biopharmaceutical industry including Executive Vice President and Cofounder of Kowa Research Institute, a biopharmaceutical licensing and investment subsidiary of Kowa Company Ltd., Japan. Before that she held both U.S. and international man­agement positions at Syntex Corp. (acquired by Roche) in market research, product management, strategic marketing, and business development with a special emphasis on Europe and Asia/Pacific/Canada.

Guest Speakers and Their Topics

Joyce L Chiarenza, Chiarenza Consulting, L.L.C. is a regulatory affairs, labeling expert and clinical compliance certified professional with over 40 years of pharmaceutical and biotech experience. She held managerial positions in quality control, quality assurance, compliance and regulatory affairs. After more than 16 years at Genentech, Inc., she became a regulatory affairs consultant, specializing in labeling, advertising and promotion, and clinical compliance. Prior to Genentech she worked in quality with Abbott Laboratories and for three years worked in area of vitamins, food supplements and cosmetics.

Joyce holds a B.S. degree in Child Psychology and Special Education Credentials from California State University at Northridge. In 2010, she received her certification as a Clinical Compliance Professional. Topic: “Operating in the U.S. Regulatory Environment: Is Product Approvable”

Linda L. Schock is the Director of Commercial Compliance & Government Programs at Compliance Implementation Services (CIS) and responsible for opening the CIS West Coast office in Burlingame, California.   Ms. Schock brings over 20 years of industry experience ranging from distribution, pricing, Commercial and Government contracting, reimbursement and Patient Support Programs. Prior to joining CIS, Ms. Schock worked at NeurogesX as Director, Commercial Operations from 2009-2011 and CV Therapeutics from 2005 2009. From 2001 to 2005 Ms. Schock was Associate Director, Distribution and Reimbursement within Commercial Operations at Actelion Pharmaceuticals where she was involved in the launch of Tracleer® and the risk management program T.A.P.   Ms. Schock began her career at Genentech, Inc. where she worked in Commercial Operation positions of increasing responsibility from 1987 to 2001. Topic: “Building Effective & Compliant Commercial and Government Contracting Operations: A Case Study”

Carol Gonzalez-Sheak, Ph.D., is currently co-founder and consultant with MindSeed Café. She has more than 25 years healthcare industry experience in the pharmaceutical and biotech, medical devices, and diagnostics. Recently she has worked as an independent consultant and Principal at CG Biomedical Associates. Prior to that, she was at Merck as Associate Director, Global Customer Insights. She has also served as Director Marketing Research at NPS Pharmaceuticals, and held a prior biotech marketing planning role at Serono. She has also held managerial positions in medical devices market research and planning, and business development at Becton Dickinson, and Kendall Healthcare (Covidien), and Syva/Syntex . She holds a B.A. in Human Biology from Stanford University, and a Ph.D. in Biopsychology from the University of Georgia, Post Doctoral Fellowship in Psychobiology, Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences. Topic: “The Impact of U.S. Health Care System on Marketing Life Science Products”

Julie Tompkins, MBA, is Sr. Vice President at Timely Data Resources (TDR), a healthcare market research and consulting firm.  She has more than 30 years experience in the pharmaceutical and biotech arenas, including 12 years in industry and more than 20 years in market research consulting, and has worked with pharmaceuticals, diagnostics, and drug delivery systems.  At Syntex (acquired by Roche), Julie worked in both R&D and Marketing, including positions as Analytical Chemist, Market Research Analyst, Manager of New Product Planning, and Manager of Market Analysis.  She spent most of her time in Marketing as the primary liaison between Marketing and R&D, serving as a key member on multi-disciplinary project teams and strategic planning committees.  After leaving Syntex, Julie was President and Founder of MedSearch, a primary market research company that merged with TDR in January 2000.  She holds a B.A. in Human Biology from Stanford University and an MBA from Santa Clara University. Topic: “The Role of Market Research in Product Planning, Development and Marketing”

Course Outline

The Discipline of Marketing in the Bioscience Industry

•        Unique bioscience industry marketing characteristics

•        The core marketing functions

•        Pivotal documents associated with marketing functions

•        The critical role of marketing at all stages of a product’s development

Marketing Research and Analysis

•        Use of market research to optimize product planning, development and marketing

•        Role of market research throughout development of company and product

•        Defining the objectives, planning and implementation of the research

•        Types of market research and methodologies

Impact of Managed Care System on Marketing Bioscience Products

•        Review healthcare industry trends/data that impact cost and reimbursement

•        Define “who/what is the U.S. healthcare system” and how it influences the commercialization process

•        Define reimbursement from Managed Care perspective

Success Parameters for Products and Companies

Dealing with Regulatory Environment and Product’s Approvability

The Role, Function, Objective of Selected Major Marketing Functions

•        Business Development and Licensing Process, Contract and Terms

•        Product/Technology Opportunity Assessment Research and Recommendation

•        Strategic Planning and Strategic Plan

•        Product Management and Product Marketing Plan

•        Sales and Distribution

Course: “Life Science Business Development,” June 19-29, 2014

Applies for credit toward Professional Program in Life Sciences Business (see flyer at http://extension.berkeley.edu/upload/lifesciences_business.pdf)

  • Dates and Time: Thursday and Friday, June 19-20, 2014; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project with gratis access to leading life science database for deals and industry articles
  • Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105
  • Cost: $895, course ID is BUS ADM x 440.8
  • See more details and register now. You can locate course online and register at http://tinyurl.com/mao7hjh
  • Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and www.AudreysNetwork.com
  • Guest Speakers and Their Topics:
  • Jessica L. Holmes, Director for Reimbursement, Argenta Advisors.  Topic: “Developing and Positioning Technology in the Evolving Healthcare Reimbursement Landscape”
    • Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC. Topic: “Financial Planning and Funding for a Bioscience Venture: New, Emerging and Growing Entities”
    • Carolyn Feamster, MBA, a business strategy and analysis consultant. Topic: “Preparing for and Planning Deals for Maximum Strategic Impact”
    • Gilbert R. Mintz, Ph.D., President of GRM Associates. Topic: “Working Your Way through the Bioscience Licensing Process: Negotiating and Writing  Deal Contract”
    • Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP’s intellectual property practice group. Topic: “What You Need to Know about Patents Working in Business Development”
    • Chris Dokomajilar, Director, Business Intelligence, BioCentury. Topic: “BioPharma Alliances: Trends in the Marketplace

Find all the details for this coming week’s upcoming events plus those through June 2014 in Audreys Picks March 16, 2014. You can also download the pdf of JobsThatCrossedMyDeskThrough March 16, 2014 along with Audrey’s Picks by right clicking the highlighted titles. This latter list includes the latest three weeks of positions.

You can always find my weekly blog and listings at http://audreysnetwork.wordpress.com/

Audrey

Every meeting I attend I hear from entrepeurneurs that funding for startups is very tight. This week’s BioCentury lead article entitled “Innovator Capital Rationing” written by Michael Flanagan tackles the assumption that VCs aren’t funding early-stage research companies. The article notes that companies with a lead program in discovery or preclinical development have received 20% of venture dollars or more than $1 billion on average annually. They represent 30% of all deals.

Some early stage investors believe this is sufficient funding to provide needed capital to the companies they believe have the best ideas to merit funding and/or have removed some initial risk from the deal to make the deal more appealing. A big question is whether or not this level of capital is enough for research stage companies to move forward sufficiently to be attractive to later-stage investors. Another question is whether there is sufficient funding available for the academic research to break out into viable companies. The article explores the role of Big Pharma and other organizations in funding these important research ideas, noting the innovation centers established by several large companies.

There are admittedly more potential companies looking for funding than there are funds even with VCs increasing their plays in early stage. With the big gains in biotech in the last year, more VCs are returning. We will just have to see if innovations suffer from the level of financing.

Highlights for this Coming Week’s Life Science Events

  • BioCentury This Week, See new program Webcast Starting Sunday,March 9, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Medicare Part D: Why Change?” Speakers Douglas Hoey, CEO of the National Community Pharmacists Association; Chris Holt, Director of Health Care Policy at the American Action Forum;  Edith Rosato, CEO of the Academy of Managed Care Pharmacy and Andrew Sperling, Director of Federal Legislative Advocacy at theNational Alliance on Mental Illness
  • CACO-PBSS Workshop, Monday, March 10, 2014; Topic: “Clinical Trials Design & Management Intensive Workshop”
  • Bio2Device Group, Tuesday Evening, March 11, 2014; Topic: “Building a Pearl,” Speaker: Sarvajna Dwivedi, Executive VP of R&D and Co-Founder, Pearl Therapeutics
  • BayBio Lunch and Learn, Tuesday Mid-Day, March 11, 2014; Topic: “BayBio Lunch & Learn:Facilitating R&D Collaborations through the Cloud;” Speaker: Sri Chilukuri, Vice President of Product Marketing for Intralinks
  • BayBio Lunch and Learn, Wednesday Mid-Day, March 12, 2014; Topic: “BayBio Lunch and Learn: Market Access and Reimbursement in a Value-Driven Healthcare Ecosystem;” Speakers: Michael del AquilaHead, Global Pricing and Market Access function in Commercial Planning and Operations, Gilead; Becky Foster, Director of Managed Care for Crescendo Bioscience; and Nina Hill, Senior Director of HEOR at Medivation
  • San Francisco AWIS, Wednesday Evening, March 12, 2014; Topic: “Science and Patent Law;” Panelists: Cara Coburn, PhD, JD- patent attorney, Genentech; Karin Immergluck, PhD- Dir. Tech Mgmt, UCSF Innovation Technology and Alliances; Geeta Kadambi, PhD- CEO and Founder, Riddhi IP LLC
  • Women in Bio, Thursday Afternoon and Evening, March 13, 2014; Event: Mini-conference focused on career opportunities and job environments; Evening Event Speaker: Karen Antman, M.D., Internationally-Known Cancer Researcher, Dean of Boston University Medical School
  • NC ACRP, Thursday Evening, March 13, 2014; Topic: “Clinical Audits and Inspections – Risk Assessment and Mitigation;” Speaker: Michael Donatelli, BS, President and CEO, Insite Quality Assurance, Inc.

UC Berkeley Extension Course, Thursday and Friday, April 10-11, 2014

Course: “Life Science Business and Marketing: Their Integral Role for Success”

  • Dates and Time: Thursday and Friday, April 10-11, 2014; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project with gratis access to leading life science database for deals and industry articles
  • Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105
  • Cost: $795, course ID is BUS ADM x442.4
  • See more details and register now. You can locate course online and register at http://tinyurl.com/kqbu2rx

Find all the details for this coming week’s upcoming events plus those through June 2014 in Audreys picks March 9, 2014. You can also download the pdf of JobsThatCrossedMyDeskThrough March 9 2014 along with Audrey’s Picks by right clicking the highlighted titles. This latter list includes the latest three weeks of positions.

You can always find my weekly blog and listings at http://audreysnetwork.wordpress.com/

Audrey

This week I would like to request former students of my courses to help promote the upcoming class “Life Science Business and Marketing: Their Integral Role for Success” and that others post the attached flyer at their place of work and talk up course with colleagues. I have included the agenda below so you can see the great program we provide in this course plus gratis access to Elsevier’s premier deal database and other periodicals like In Vivo and Start Up for two months following the two days of intensive classroom work. This course is unique in that it offers the classroom work but then coached projects of student’s choice during the balance of the term.

I created this course for professionals from all functions inside the industry so they could keep up with the changing business requirements and their interface with the business and marketing functions that make critical decisions affecting their work and their careers. As noted in the comments above, one has to look at the larger picture outside one’s immediate department or function. This course is great for giving all life science professionals a broader perspective on their career even as they achieve success for their company.

We need to use word-of-mouth marketing to get the word out about this great course offered for first four years at UC Berkeley in 2002-2005, 2011-present and UC Santa Cruz Extension (latter from 2005-2010). The name changed due to Extension ownership of course titles but the courses are the same. Many students took all three courses in the sequence to help start and develop their startups—writing an opportunity assessment in one, business plan in another and marketing plan in the third—or to move their companies to higher level of quality and success and advance their individual careers.

On Thursday morning, April 10, the following will be covered

  • Introductions and Logistics—Audrey Erbes, 8:30 – 8:45 am
  • “Overview of Bioscience Industry: What Makes It Tick:”—Audrey Erbes, 8:45 am –10:15 am

Break 10:15 to 10:30 am

  • “The Impact of U.S. Health Care System on Marketing Life Science Products”—Bev Hudson, 10:30 am-12:00 pm

Discussion of term project, 12:00 – 12:15

Lunch break – 12:15 until 1:15 pm

On Thursday afternoon, April 11th, the following will be covered:

  • Opportunity Assessment: Is the Product Profitable?”—Audrey Erbes, 1:15 – 2:45 pm

Break 2:45 – 3:00 pm

  • “Using Market Research To Optimize Product Planning, Development And Marketing”—Julie Tompkins, 3:00 – 5:00 pm

On Friday morning, April 11, the following will be covered:

  • “Operating in the U.S. Regulatory Environment: Is Product Approvable?”—Joyce Chiarenza, 8:30 am – 10:15 am

Break 10:15 – 10:30 am

  •  “Building Effective & Compliant Commercial and Government Contracting Operations: A Case Study”—Linda Schock, 10:30 – 11:00 am
  • “Business Development, Researching the Market and Staying Current”—Audrey Erbes, 11:00 am – 12:30 pm

Lunch break from 12:30 – 1:30 pm

On Friday afternoon, April 11, the following will be covered:

  • “Pillars of Success for Products and Companies”—Audrey Erbes, 1:30 –  3:00 pm

Break 3:00 – 3:15 pm

  • “Planning and Implementation”—Audrey Erbes, 3:15 – 4:30 pm
  • Wrap up 4:30 – 5:00 pm

 

Highlights of Upcoming Events This Week

  • BioCentury This Week, See new program Webcast Starting Sunday, Feb. 30, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “All For One: Collins, Chin Amplify AMP;” Speakers: Dr. Francis Collins, Director of the NIH; Dr. William Chin, EVP of Science and Regulatory Affairs at PhRMA; David Wholley, Director of Research Partnerships at the Foundation for the NIH; Sandra Raymond, CEO of the Lupus Foundation Of America
  • Bio2Device Group, Tuesday Morning, March 4, 2014; Topic: “The Histone Code as a Driver of Clinical Outcome: An Epigenetic Revolution Reveals a New Face of Cancer as a Metabolic Disease;” Speaker: Babak N. Alizadeh, Ph.D. Co-founder & Chief Operations Officer, PrognosDx Health Inc.
  • EPPIC, Wednesday Evening, March 5, 2014; Topic: “Technologies and Processes Empowering Biotherapeutic Production;” Panelists: Amita Goel (Moderator), CEO, Celltheon Corporation: Vinit Saxena, CEO, Sepragen Corporation; Raj Singh, Head of US Operations, Intrace Medical;
    Ian Larson, Owner, Purian LLC
  • MedTech Frontiers, Thursday Evening, March 6, 2014; Topic: “Technology and Aging;” Speaker: David Lindeman, Ph.D., Director of Health Care at the Center for Information Technology Research in the Interest of Society (CITRIS)
  • RAPS, Friday Evening, March 7, 2014; Topic: “EU Device Regulations, Unannounced Visits and Key Compliance Requirements–NB Expectations;” Speakers: Paul Brooks, senior vice president, healthcare solutions, BSI Healthcare; Laurel Macomber, MS, PMP, RAC, product expert, BSI Healthcare ; Ronald Rakos, PhD, RAC, team leader, vascular devices, BSI Healthcare; Ibim Tariah, PhD, technical director, BSI Healthcare
  • CACO-PBSS Workshop, Monday, March 10, 2014; Topic: “Clinical Trials Design & Management Intensive Workshop;” See details at http://www.caco-ca.org/aspx/homeSF.aspx when they appear

UC Berkeley Extension Course, Thursday and Friday, April 10-11, 2014

Course: “Life Science Business and Marketing: Their Integral Role for Success”

  • Dates and Time: Thursday and Friday, April 10-11, 2014; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project with gratis access to leading life science database for deals and industry articles
  • Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105
  • Cost: $795, course ID is BUS ADM x442.4
  • See more details and register now. You can locate course online and register at http://tinyurl.com/kqbu2rx

Highlights for Business Development Course Offered June 19-20, 2014

UC Berkeley Extension Course, Thursday and Friday, June 19-20, 2014; Course: “Life Science Business Development;” Lead Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and AudreysNetwork.com blog; Guest Speakers: Allison Dupuy, Ph.D., Senior Director in the Life Sciences division of Simon-Kucher & Partners; 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’s intellectual property practice group; Chris Dokomajilar, Director, Business Intelligence, BioCentury; Location: Downtown University of California, Berkeley Extension, 425 Market St., 8th Floor, San Francisco, CA 94105; Cost: Fall term—fee: $895, (440.8-001). Registration opens in April but you can find details now at http://tinyurl.com/lba26sq The url will change in April unfortunately but you can find via title of course.

Find all the details for this coming week’s upcoming events plus those through June 2014 in Audreys Picks March 2, 2014. You can also download the pdf of JobsThatCrossedMyDeskThrough March 2, 2014 along with Audrey’s Picks by right clicking on the highlighted titles. This latter list includes the latest three weeks of positions.

You can always find my weekly blog and listings on my website www.audreysnetwork.com. Select “blog” and then right click on blog title to link to the WordPress site.

Audrey

Posted by: Audrey Erbes | February 24, 2014

Gauging the Health of Life Science Industry Plus Events and Jobs

It’s difficult to make sense out of the data on the health and future trends impacting future health of the life science industry. Mergers and acquisitions are up as well as IPOs in biotech. But I worry about M&A outpacing the latter because as jobs disappear following the loss of one large business in each deal there’s need for job creation at startups. When large companies disappear, there needs to be many more startups which have typically less than 50 employees than when small companies are acquired. I suspect an imbalance in this loss of jobs vs. creation is the cause of the increase in job cuts reported last month. “JobWatch: Layoffs Show No Letup” reports January was worse than all of 2013 when there was a 57% jump in job cuts at 22,161 at biotech and biopharma companies versus 2012 with 14,150

The outplacement consultancy Challenger Gray & Christmas CEO John Challenger told GEN “The slump reflects pharma’s continued retreat from vertical integration following patent-cliff losses, plus rising costs associated with healthcare reform, the still-sluggish U.S. economy, and continued pressure from overseas regulators to contain drug prices.” While displaced business and marketing personnel can move into other industries, research personnel remain in the field. This latter buildup of R&D professionals can mean longer term unemployment as the industry fails to clear the backlog of those displaced in the economic downturn starting in 2008. Individuals have to be more strategic in their preparation for finding their next position and, especially, careful about which company they join. One needs to upgrade one’s professional skills to compete with larger numbers of available personnel.

Researchers may not be comfortable with networking but it’s critical to have a network when looking for a new job. I recommend that professionals attend at least 2 professional events a month where they can keep pace with new developments in the industry but also make one-on-one contacts which will be important in enhancing meaningful relationships for the future. One has to make room in one’s life for continuing to learn or risk being left behind. Carefully selected courses in addition to programs so readily available in the Bay Area make it easy to “sharpen the saw” and be prepared to be a solution to an employer’s problems. Those problems are changing rapidly in today’s dynamic industry so one needs to stay fresh and flexible.

The IPO window has been open in the last year and apparently with more highly valued companies so that’s good in providing more stability for growing companies and potentially larger workforces. There were 52 health care companies that went IPO raising $7 billion in 2013 compared to only 16 companies raising $1.1 billion in 2012. This is great news. Whether or not these companies grow large enough to replace lost jobs from Big Pharma’s severe layoffs still remains to be seen.

I haven’t seen a tally of the impact of new companies remaining virtual and utilizing outsourced employees, often from outside the U.S. Large pharma companies are experimenting with major changes in staffing to help the bottom line and short term profits. I worry about their experiments leaving them with insufficient qualified experienced staff to develop drugs, an important attribute of successful pharma companies. The tendency for company “bean counters” to be short sighted in their solutions for short term stock valuation declines is still out there. What appears to be a simple solution on paper utilizing layoffs can lead to a death spiral with its negative impact on future development of innovative teams.

One has to be careful not to rely on one indicator to predict the future health of the industry. One has to look at all the factors in the environment that impact the industry. I recommend a look at “Life Science Trends in 2014” prepared by Carlyle Conlan which is a compendium of leading short excerpted articles on the industry’s health and welfare in 2013. See full downloadable piece at http://www.carlyleconlan.com/refresh/tiny_mce/plugins/filemanager/files/lifesciencetrends.pdf.

This UpComing Week’s Bay Area Life Science Events

  • BioCentury This Week, See new program Webcast Starting Sunday, Feb. 23, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT;Topic: “Profiles of Innovation: The Orphan Drug Act, also Living with Sickle Cell Anemia”
  • Bio2Device Group, Tuesday Morning, Feb. 25, 2014; Topic: “Myths and Challenges of Cloud-based eClinical Systems: The Story of Cloud Clinica;” Speaker: Ale Gicqueau, CEO & President, Clinovo
  • NCCACRP, Tuesday Evening, Feb. 25, 2014; Topic: “Re-thinking Protocol and Site Feasibility Processes:  How to Ensure Complex Protocols Can Be Executed Flawlessly;” Speaker: Beth D. Harper, BS, MBA, President, Clinical Performance Partners, Inc., Encore Speaker from 2013
  • BayBio Lunch and Learn, Wednesday Morning, Feb. 26, 2014; Topic: “Compensation for Private Companies: The Ins and Outs of Equity;” Speakers: Kelley Wall, Director RoseRyan, Kyle Holm, Associate Partner, Radford
  • ASQ Biomedical Division, Wednesday Evening, Feb. 26, 2014; Topic: “February Roundtable – Design and Development Planning (Design Control Series – Session #2)
  • Golden Gate Polymer Forum Dinner Lecture, Wednesday Evening, Feb. 26, 2014; Topic: “Draping Materials: Enabling Advanced Adhesives and Multifunctional Technologies;” Speaker: Prof. Alfred J. Crosby, Polymer Science & Engineering Department, University of Massachusetts, Amherst
  • CACO, Friday Mid Day, Feb. 28, 2014; Luncheon Topic: “PK/PD in forensic science: the science of anesthesiology in the court case of Michael Jackson’s propofol overdose;” Speaker: Professor Steven Shafer (Stanford University)

My Next UC Berkeley Life Science Marketing and Business Class

UC Berkeley Extension Course, Thursday and Friday, April 10-11, 2014

I created this course for professionals from all functions inside the industry so they can keep up with the changing business requirements and their interface with the business and marketing functions that make critical decisions affecting their work and their careers. As noted in the comments above, one has to look at the larger picture outside one’s immediate department or function. This course is great for giving professionals a broader perspective on their career and achieving success for their company.

Dates and Time: Thursday and Friday, April 10-11, 2014; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project with gratis access to leading life science database for deals and industry articles

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

Cost: $795, course ID is BUS ADM x442.4

See more details and register now. You can locate course online and register at http://tinyurl.com/kqbu2rx

Event and Job Listings

Find all the details for this coming week’s upcoming events plus those through June 2014 in Audreys picks Feb. 23, 2014. by right clicking on the highlighted topics. You can also download the pdf of JobsThatCrossedMyDeskThroughFeb. 23, 2014 along with Audrey’s Picks. This latter list includes the latest three weeks of positions.

You can always find my weekly blog and listings on my website www.audreysnetwork.com. Select “blog” and then right click on blog title to link to the WordPress site.

Audrey

Posted by: Audrey Erbes | February 16, 2014

Bay Area Life Science Events and Jobs for Week of Feb. 16th

There will no special message today—just the list of upcoming events this coming week and short list of Jobs. I can’t explain the falloff in listing of jobs that crossed my desk in the past two weeks. Perhaps it’s the season and, hopefully, not a real decline in new job openings.

  • BioCentury This Week, See new program Webcast Starting Sunday, Feb. 16, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Biosimilars: Rules of the Road;” Speakers: Geoffrey Eich, Executive Director of R&D Policy at Amgen Inc., Craig Wheeler, President & CEO of Momenta Pharmaceuticals Inc., Brian Malkin, Partner at Frommer Lawrence & Haug LLP and former Regulatory Counsel in the Office of the FDA
  • Bio2Device Group, Tuesday Morning, Feb. 18, 2014; Topic: ” Home Use Medical Devices: Evolution and Future Wireless (Mobile Cloud) Trend;” Speaker: Sanjiv Tanna, Chief Technology Officer, Intanna Medical Devices Labs 
  • Janssen Labs, San Francisco Innovation Center, Tuesday Morning, Feb. 18, 2014; Topic: “The Road to the Biologic IND: Best Practices When Filing Biologic Investigational New Drug Applications;” Speakers: Barry Springer, PhD | VP of Technology, Strategy & Operations, Biotechnology Center of Excellence, Janssen R&D; Steven Lang, PhD, MBA | Director, Biologics Research Analytical Discovery, Cell Line Development, Biotechnology Center of Excellence, Janssen R&D; Pauline Martin, PhD | Senior Scientific Director, Biologics Toxicology, Biotechnology Center of Excellence, Janssen R&D; Hugh Davis, PhD | VP and Head of Biologics Clinical Pharmacology, Biotechnology Center of Excellence, Janssen R&D; and Salvatore Morello | Director Global Regulatory Affairs, Janssen R&D
  • BayBio Lunch and Learn, Wednesday Morning, Feb. 19, 2014; Topic: “Strategies for Protecting Biomarket Innovation in the U.S. and Abroad;” Speaker: Django Andrews
  • Palo Alto AWIS, Wednesday Evening, Feb. 19, 2014; Topic: “Lessons from starting a non-profit;” Speaker: Tzipor Ulman, Ph.D. Executive Director of Science is Elementary
  • EMBS, Wednesday Evening, Feb. 19, 2014; Optional dinner location: Stanford Hospital Cafeteria, 6:15 PM (no host, no reservations); Topic: “The Development of A Wearable Cardiopulmonary Sensor System;” Speaker: Dr. Sam Eletr, Acting CEO, Rhythm Diagnostic Systems, Inc.
  • BioScience Forum, Wednesday Evening, Feb. 19, 2014; Topic: “The Challenges of Building Shareholder Value in a Growing, Platform-Based Therapeutics Company;” Speaker: Edward Lanphier, President and CEO, Sangamo BioSciences, Inc.
  • BOLD, Thursday Late Afternoon, Feb. 20, 2014; Topic: “Science Trends, Issues and Advances that will Impact the Life Sciences Industry;” Speaker: Karin Lucas, Director of Training and Education at BioTech Primer

My Next UC Berkeley Life Science Marketing and Business Class

 This course was designed for all life science professionals to learn what makes the industry tick and how to interface with marketing professionals and business professionals successfully from their respective functional field inside an organization or company.

UC Berkeley Extension Course, Thursday and Friday, April 10-11, 2014

Course: “Life Science Business and Marketing: Their Integral Role for Success”

Applies for credit toward Professional Program in Life Sciences Business (see flyer at http://extension.berkeley.edu/upload/lifesciences_business.pdf)

Instructor: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and http://www.AudreysNetwork.com

Guest Speakers:

  • Joyce L Chiarenza, Chiarenza Consulting, L.L.C.
  • Linda L. Schock is the Director of Commercial Compliance & Government      Programs at Compliance Implementation Services (CIS)
  • Bev Hudson, MBA, is Executive Director/SVP of Clinical Research, Oklahoma Foundation for Cardiovascular Research (OFCR)
  • Julie Tompkins, MBA, is Sr. Vice President at Timely Data Resources (TDR),

Dates and Time: Thursday and Friday, April 10-11, 2014; 8:30 am – 5:00 pm for classroom intensive and balance of term for working on term project with gratis access to leading life science database for deals and industry articles

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

Cost: $795, course ID is BUS ADM x442.4

See more details and register now. You can locate course online and register at http://tinyurl.com/kqbu2rx

Find all the details for this coming week’s upcoming events plus those through June 2014 in Audreys picks Feb. 16 2014 You can also download the pdf of JobsThatCrossedMyDeskThroughFeb. 16, 2014 along with Audrey’s Picks by right clicking on the highlighted titles. This latter list includes the latest three weeks of positions.

You can always find my weekly blog and listings on my website www.audreysnetwork.com. Select “blog” and then right click on blog title to link to the WordPress site.

Audrey

Posted by: Audrey Erbes | February 9, 2014

Celebrate FDA Flexibility Plus Events and Jobs

Margaret Hamburg, M.D., Commissioner of FDA, responded to a recent AMA article challenging thoroughness of reaching drug approvals in her Feb. 6 blog.  The AMA found that between 2005 and 2012 the FDA used a range of clinical trial evidence in supporting their approval of 188 new drugs for 208 uses. Dr. Hamburg notes that the results are entirely consistent with the FDA’s mandate. “We believe varying approaches to clinical studies to support drug approval is good news, not bad.”

The article’s authors were concerned that more than a third of the drugs were approved based on just one pivotal trial and other some trials involved small groups of patients for shorter durations. Fortunately, the FDA doesn’t use a one-size-fits-all approach. Today’s serious disease and cancer patients without alternatives can’t wait for 10-15 years for a drug to be marketed in the traditional approach for drug development. Of course, there need to be safeguards to track these fast developed critical drugs after marketing but patients are willing to take a trade-off to have access to life-saving drugs earlier. Past patient demand for HIV as well as cancer drugs sooner support this FDA flexibility.

“Increased flexibility does not mean abandoning standards, and it certainly does not mean abandoning science. Just the opposite. We need to employ the best science in ways that will increase efficience, productivity and our shared ability to find creative solutions to the challenges that confront us.” Cheers to an enlightened FDA which seems to be moving in direction to enable personalized medicine and reasonably priced but safe drug development. This consistency of management without an empty commissioner seat over years as experienced in the past allows for progress in the regulatory process that all stakeholders should welcome.

Upcoming Events for Week of Feb. 9, 2014

It’s not too late to sign up for my upcoming Life Science Product Marketing starting Thursday which will be held for 6 Thursday evenings over 7 week period at the downtown campus of UC Berkeley Extension on corner of Market and Fremont. In seven weeks you will be able to develop a preliminary product marketing plan with your team for your selected life science sector product. See highlight below and details at http://tinyurl.com/k2aq8nr

  • BioCentury This Week, See new program Webcast Starting Sunday, Feb. 9, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT; Topic: “Chronic Challenges: Multiple Diseases;” Speakers: Dr. Anand Parekh, deputy assistant secretary for health at HHS; Dr. Robert Temple, deputy director of FDA’s Center for Drug Evaluation and Research; and  Myrl Weinberg, CEO of the National Health Council, a patient advocacy organization
  • Bio2Device Group, Tuesday Evening, Feb. 11, 2014; Topic: Magellan Robotics, Catheter System; Speaker: Francis Macnamara, Hansen Medical
  • SF AWIS, Wednesday Evening, Feb. 12, 2014; Topic: “Science and Entrepreneurship;” Speaker: Akhila Satish, CEO of CyberDoctor
  • UC Berkeley Extension, Thursday Evenings, Feb. 13-27, March 6-13 and 27; Topic: “Life Science Product Marketing: It’s All in the Plan;” See more details and register at http://tinyurl.com/k2aq8nr;Instructor: Audrey S. Erbes, Ph.D.;  Guest Speakers: Deb Donovan, Director of Marketing at Avantis Medical Systems; Stanley Skrzypczak, M.S., M.B.A., Senior Director, Commercial Development, Genomic Health; Charles Versaggi, President, Versaggi Biocommunications and Steven Wong, Senior Consultant, Plan A; and  John M. York, Pharm.D.; Principal and CEO, Akita Biomedical and Associate Editor, Cancer Control
  • HBA, Thursday Evening, Feb. 13, 2014; Topic: “Regulatory and clinical challenges and opportunities in orphan drug development;” Speakers: Michelle Rohrer. Vice president regulatory – Genentech Inc.; Jeffrey Siegel, Senior group medical director -Genentech Inc.; Jorge Tavel, Medical director – Genentech Inc.

Find all the details for these upcoming events plus those through June 2014 in Audreys Picks Feb. 9, 2014. You can also download the pdf of JobsThatCrossedMyDeskThroughFeb. 9, 2014 along with Audrey’s Picks by right clicking the highlighted titles. This latter list includes the latest three weeks of positions.

You can always find my weekly blog and listings on my website www.audreysnetwork.com. Select “blog” and then right click on blog title to link to the WordPress site.

Audrey

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