Posted by: Audrey Erbes | March 16, 2014

Tiny Funding Increases for NIH and FDA in 2015 Budget Proposal Plus Events and Jobs

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 https://audreysnetwork.wordpress.com/

Audrey

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