Audrey’s Life Science Meeting Picks for June 2013 - January 2014 Complimentary Service of AudreysNetwork.com Revised June 16, 2013
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BioCentury This Week, See new program Webcast Starting Sunday, June 16, 2013 www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT
Date: Original broadcast Sunday, Starts June 16, 2013
New weekly shows go online at 9:00 a.m. EST on Sundays. Prior shows available 24/7 in the online
Program Archive. 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
Topic Description Avandia is the poster child for debates about drug safety. The drug, made by GlaxoSmithKline, came
under attack six years ago from academics and members of FDA’s review staff, who charged the diabetes drug posed grave risks of heart attack and cardiovascular mortality. With Congress
looking on, FDA put severe restrictions on Avandia in 2010. But the debate didn’t end. Last month, Duke University researchers re-examined GSK’s safety data and confirmed Avandia poses little or no
cardiovascular risk. Then — for a third time — a 26-member FDA advisory committee poured over the data and decisively
recommended that the Avandia restrictions be relaxed. The controversy disrupted the lives of diabetics, raised hurdles for testing new drugs, and cost GSK billions in lost sales, fines and legal costs. Is this the best way for FDA to make real-world risk-benefit decisions? On the newest edition of
BioCentury This Week television, the newsmakers in the Avandia story discuss what — if anything — has been learned from the controversy.
• Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, who will have the final word on the agency’s response to its advisory committee.
• Dr. Murray Stewart, SVP and head of the cardiovascular unit at GSK, who presented the pharma’s data to the advisory panel.
• Dr. Kenneth Mahaffey, who led the re-adjudication of the Avandia data 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.
Date and Time: Tuesday, June 17, 2013, 5:30 -7:00 pm Location: Li Ka Shing Berg Hall, Stanford University Fee: Public $45 advanced, $60 at the door; Stanford Alumni $35 adv, $40 door; Biodesign Alumni
Fellows $25 Stanford students, faculty, staff Free but please register
Register at http://biodesign.stanford.edu/bdn/networking/workbench.jsp ***********************************************************
Palo Alto AWIS, Monday Evening, June 17, 2013
Event: Volunteer Meeting Date and Time: Monday, June 17, 2013
Location: Xerox PARC Auditorium, 3333 Coyote Hill Rd, Palo Alto, CA Cost: Free Register at http://www.pa-awis.org/ where you can find details for this and other events. There are
several chapters for AWIS in the Bay Area. Check out East Bay AWIS, Event Description Would you like to learn about AWIS, its mission, activities, and structure? Would you like to take your
support to an active level? Please join other supporters and active volunteers with PA-AWIS to btrainstorm for ideas and seminar
topics for next year. Become an active supporter and volunteer to open positions within the organization. By volunteering you can expand your network, make meaningful connections, learn about career paths,
and increase your chances of getting a job. PA-AWIS needs help with membership, monthly programs, newsletter,industry outreach and website.
AWIS success relies on dedicated volunteers like you! ************************************************************* Bio2Device Group, Tuesday Morning, June 18, 2013
Topic: “Hypertension: A historical and philosophical perspective” Speaker: Michel Accad. M.D., Physician, UCSF
Date and Time: June 18, 2013, 8:30am Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
Free parking available on street and in Sunnyvale Library parking lot Topic Description Hypertension remains a leading cause of cardiovascular mortality and morbidity worldwide. Despite the availability of potent drug therapies, it is estimated that millions of patients do not respond adequately
to treatment. This problem is partly due to pervasive derangements in blood pressure control mechanisms that remain poorly understood. Another part of the problem may also be due to a deficient
understanding of the nature of hypertension. This talk will review the history of our understanding of the significance of an elevated blood pressure, highlight the shortcomings of current definitions of
hypertension, discuss epidemiological data that provide some insights into the problem, and identify challenges and opportunities for new research ventures to move the field forward.
Speaker Bio Dr. Accad obtained a bachelor of science degree in mathematics from the University of Texas at Austin
and a medical doctorate from the University of Texas Medical School in Houston. He completed his residency in internal medicine at the Texas Medical Center where he also served as chief medical
resident. He obtained his clinical and research training in cardiovascular diseases at the University of California in San Francisco.
Dr. Accad holds board certifications in internal medicine, cardiovascular diseases, and interventional cardiology. He is in solo practice in San Francisco and holds a clinical appointment at UCSF. Dr. Accad
previously served as chief medical officer at Maya Medical, Inc., and contributed to the development of second generation renal denervation therapies for the treatment of resistant hypertension. Dr. Accad has published numerous original research articles, reviews, and editorials in peer-reviewed medical
journals. ************************************************************ EMBS, Wednesday Evening, June 19, 2013, 7:30 PM
Topic; “The Magellan Robotic Catheter System”
Speaker: Francis Macnamara, Vice President, Hansen Medical, Inc. Date and Time: June 19, 2013, 7:30 pm; Hospital Cafeteria, 6:15 PM (no host, no reservations)
Location: Location: Room M-114, Stanford University Medical School Our website for the Santa Clara Valley EMBS chapter, http://www.ewh.ieee.org/r6/scv/embs, provides the latest abstracts for upcoming
presentations as well as past presentations. Topic Description
This talk will focus on the design and performance of the Magellan Robotic System, an intravascular catheter system that received FDA clearance in June
2012. The Magellan System is the successor to the company's Sensei X Robotic System, which has been used on more than 10,000 patients.
The talk will begin with an overview of Hansen Medical Inc., a Mountain View company founded in 2002. It will then provide a background on flexible
robotics, followed by a detailed presentation of the Magellan Robotic System. After a clinical review of intravascular cases to date, it will
offer observations about the future of intravascular robotics.
Speaker Bio Francis Macnamara is vice-president of Advanced Technology at Hansen Medical
Inc. in Mountain View. Before joining Hansen Medical five years ago, he was with Boston Scientific for the eleven years, serving in various R&D roles, first in Ireland and then in Boston. He has launched eight medical devices
ranging from coronary stents and disposable endoscopes to robotic catheter systems. He is the named inventor on five patents. He holds an MBA from
Santa Clara University and a degree in mechanical engineering from the University of Limerick in Ireland.
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WIB, Wednesday Evening, June 19, 2013
Topic: “Fireside Chat with Gail Maderis”
Date and Time: Wednesday, June 19, 2013, 6:30 – 8:30 pm Location: Stanford Faculty Club, 439 Lagunita Drive, Stanford, CA 94305
Space is limited so please register early. Registered guests are welcome. Parking:http://facultyclub.stanford.edu/Default.aspx?p=DynamicModule&pageid=339286&ssid=238721
&vnf=1 Cost: Members - $25.00; Non-Members - $55.00
Stanford students - $5.00 (limited to 45 attendees, must have a Stanford email account) To obtain the code for the student pricing please email [email protected] Early registration ends on Apr 29, 2013.
Regular registration starts on Apr 30, 2013 and ends on Jun 19, 2013. Late registration starts on Jun 20, 2013.
All times are 12:00am (GMT-05:00) Eastern Time (US & Canada). See details at
https://netforum.avectra.com/eweb/DynamicPage.aspx?Site=WIB&WebCode=EventDetail&evt_key=7eec7c6a-3695-40ef-8e46-d3c1ac62a16a
Event Description Please join us in conversation with Gail Maderis President and CEO of BayBio at the
Stanford Faculty Club, Palo Alto, CA. Get the inside scoop on strategies that Gail has utilized to engage in an exciting career. Make sure to bring questions. As always, wine, hors d’oeuvres, and time to
network before and after the chat. *****************************************************************************
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
Date & Time: June 19, 2013, 9:00 am to 10:00 am Cost: FREE
Find details and registration at http://www.reimbursementintelligence.com/webinar-series-pt-advisor-can-you-identify-physicians-standing-between-your-brand-and-millions-of-lives/
Who are the ad hoc physician advisors to formulary decision making?
How can we understand the role and participation of these advisors in determining product
How will our brand be supported or evaluated by these key stakeholders?
What messaging is required to grow and protect our brand from current and future competitors?
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UC Berkeley Extension Course, Thursday and Friday, June 20-21, 2013 Course: “Life Science Business Development,” (formerly known as Biotechnology Business Development) 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 Cost: Fall term—fee: $895, (EDP 405118). Register at
http://extension.berkeley.edu/catalog/course2005.html Course Description This intensive course including two days of classroom and balance of term for individual research is designed to provide participants with an understanding of the critical role business development and
licensing functions play in the commercialization of new products or technology and to the development of a successful life science company. The term assignment is designed to give students the opportunity
to put the knowledge and materials from class to immediate and practical use with resulting document for inclusion in their portfolio.
Upon successful completion of the course, participants will: Understand the various aspects of the business development function in the life science industry
and appreciate the skills required to be effective in business development and licensing roles
Appreciate types of deals and their role in commercialization strategies and funding of a company
Understand importance of IP status and patent life cycle planning
Who Will Benefit from This Course
This course is suitable for marketing and business development professionals as well as scientific professionals working in bioscience companies, especially those considering a career move into BD.
Licensing, potential entrepreneurs, scientific, clinical, regulatory financial, legal and auxiliary personnel will also benefit from insights gained in the course. Although there are no format prerequisites, those
who have been exposed to the life science industry and/or the Drug Development Process course will most benefit from the course. Deliverables Lectures, discussion, and guest expert lecturers will address business development topics and issues.
Student will be exposed to templates and primers for major business development documents and offered mentoring by instructor in researching and developing their term project. They will have access
to two major industry databases for use in researching their project during the term. These include
Deloitte’s Basic Recap.com, a life science deal database, and BioCentury’s Report on BioBusiness
and access to latter’s archives. An extensive hard-copy reader, including lecture slides for note-taking, templates for frequently-used
business development documents and a sizable online accessible reference list, will be prepared and distributed by the instructor for use by students during and after class. Course Instructor Audrey Erbes, Ph.D., Principal, Erbes & Associates and www.audreysnetwork.com, is a life-science
business development and marketing consultant and developer of customized executive education. With more than 30 years of managerial experience in the biotech and pharmaceutical industry, she
was Executive Vice President and cofounder of Kowa Research Institute, a biopharmaceutical licensing and investment subsidiary of Kowa Company Ltd., Japan and before that held U.S. and
global management positions at Syntex Corp. (acquired by Roche) in market research, product management, strategic marketing and planning, and business development. Guest Speakers and Their Topics Bill McMillan, CSO, founder and owner of Profusa, Inc., where he is currently working with a group of scientists and engineers to prepare to launch his company founded in 2009. He provided consulting
services to diagnostic and biopharma companies since leaving Cepheid of which he was a co-founder in 1996. At Cepheid he created and guided its R&D organization. Previously, he was Program Manager for
the development of a range of products, including a rapid, automated immunoassay analysis system for Syva Company, a subsidiary of Syntex Corporation. Bill holds over 30 patents in his field. Prior to moving into industry, Bill was a research public health microbiologist at the California State Department
of Health, Microbial Diseases Laboratory. He graduated from San Jose State University with a BS in Chemistry and a MA in Microbiology.Topic: “Cepheid: How to Build Your Own Biotech Company” Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC has over twenty-five years
experience in Finance, Operations and Information Technology, including over ten years serving as a CFO, COO and interim CEO. Hal’s extensive international and domestic experience includes medial
devices, software development, medical information publishing, Internet/data security and Homeland security systems. Hal had earlier worked for Siemens Medical Systems for nearly 17 years in Manufacturing Operations, Divisional Sales and Service, Corporate Finance and Information Systems.
After Siemens, Hal was the CFO/COO for a medical laser manufacturer and has served as a financial planning consultant for 3 medical device businesses. Most recently he has just completed four major
Sarbanes-Oxley projects where he successfully helped his client firms through their internal audits resulting in SOX certified SEC filings. Topic: “Financial Planning and Funding for a Bioscience Venture: New, Emerging and Growing Entities” Carolyn Feamster, MBA, a business strategy and analysis consultant, has over 25 years experience in the pharmaceutical and biotech therapeutics, diagnostics and drug delivery systems. She has broad expertise across numerous therapeutic areas, including oncology, CNS, transplantation, autoimmune
disease, women’s health and urology. Carolyn worked in R&D and pharmaceutical marketing at Syntex, where her responsibilities included the major brands Naprosyn and Cellcept. In 1995, Carolyn joined
ALZA Corporation as Senior Director of New Product Marketing with commercial responsibility for building and managing the pipeline products. She shepherded three products onto the market and was
instrumental in evolving the three ALZA therapeutic franchises: urology, CNS and oncology. Carolyn was VP of New Product Planning at Corixa Corporation and, most recently, Vice President of Business
Strategy and Analysis at Clearview Projects. Topic: "Preparing for and Planning Deals for Maximum Strategic Impact" Gilbert R. Mintz, Ph.D., President of GRM Associates, a biotechnology business development, licensing, strategic planning consulting firm, has expertise in building early-stage companies by
focusing their strategic planning and licensing activities, and raising money through venture capitalists. His 20-plus years in the biotechnology industry include general and laboratory management and
executive level business development roles. He has executed technology platform, corporate and
academic collaborations; in/out licensing of late-stage products for partnerships in the US, Europe and
Japan; as well as analyzed and managed intellectual property activities. He has consulted with Affymetrix and other biotechnology companies; served as the President and CEO, Director of an early-
stage cancer company; and provided transactional and strategic planning advice to numerous pre-IPO biotechnology companies. He has held senior management positions at Genelabs Technologies, Anergen (Corixa), Cygnus and Trega Biosciences. 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, concentrates her practice on counseling and providing strategic advice to emerging and established
public companies in the biotechnology, medical device, and pharmaceutical industries. She advises clients on domestic and international patent matters, including worldwide patent protection and
enforcement strategies; freedom-to-operate issues; intellectual property due diligence; and analysis of third-party patents. Corporate experience included role with Genentech’s in-house legal department. Topic: "What You Need to Know about Patents Working in Business Development" Chris Dokomajilar, Manager, Senior Biopharma Analyst at Deloitte Recap LLC, provides advisory
services to clients in the Life Sciences, including Biotech and Pharmaceutical companies, and Legal and Venture Capital firms. His focus areas include alliances, M&A, financing, and pharmaceutical
manufacturing. Prior to joining Recap, Chris managed international labs and clinical trials at the University of California San Francisco. His research on trends in infectious diseases has been published
in medical and scientific journals. Before transitioning into science, Chris held finance positions at Bank of America. Chris holds bachelor’s degrees from the University of California Berkeley in Molecular and Cell Biology and in Integrative Biology. Topic: “BioPharma Alliances: Trends in the Marketplace Course Content Outline
The Function of Business Development In A Bioscience Company
Financing The Development And Commercialization Process Of Life Science Products And
Developing And Protecting The Product’s Intellectual Property Status
Business development from the entrepreneurial perspective
Alliance Deals: Trends in the Marketplace
*********************************************************** CACO Workshop and Webcast, Monday Afternoon, June 24, 2013
Topic: “Pro-drugs: Principles, Design, PK, and Regulatory Issues”
Speakers: Valentino Stella (Univ Kansas), Richard Mackman (Gilead), Adrian Ray (Gilead), Bernard Murray (Gilead)
Date and Time: Monday, June 24, 2013, 12:45- 17:30 pm Location: SF Bay Area: Foster City Crowne Plaza See http://www.caco-ca.org/aspx/chemist.aspx for details for workshop and webcast
Webcast is broadcast from the workshop site.
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MIT Chemical Engineering Dept., Monday Evening, June 24, 2013
Topic: “Addressing Today’s Health and Energy Challenges through Chemical Engineering” Speakers: Klavs F. Jensen, Department Head, Warren K. Lewis Professor of Chemical Engineering
Paula T. Hammond, David H. Koch Professor of Engineering Gregory Stephanopoulos, W. H. Dow Professor of Chemical Engineering
Date and Time: Monday, June 24, 2013 | 6:00 to 9:00 p.m. PDT Event Schedule
9:00 p.m. Evening Concludes Location: Grand Salon, Sofitel San Francisco Bay, 223 Twin Dolphin Drive, Redwood City, CA 94065
Cost: Free Register at http://alumic.mit.edu/s/1314/03-alumni/wide.aspx?sid=1314&gid=13&pgid=14645&content_id=18557
Using bio-engineering, novel materials, and innovative concepts, MIT faculty and alumni are working to address the biggest challenges to today’s world population: burgeoning healthcare needs and
sustainable energy. MIT Chemical Engineering professors Paula Hammond ’84 PhD ’93 and Greg Stephanopoulos will share some of their latest research: bone and tissue engineering, targeted
therapies for cancer, and bioengineering approaches to a more sustainable biofuels. Department Head Klavs F. Jensen will give an overview of other current work in the Chemical Engineering Department including nanotechnology and new approaches to pharmaceutical manufacturing. We hope you will join
us. *************************************************** Bio2Device Group, Tuesday Morning, June 25, 2013
Topic: “A brief history of how one company helped pioneer a novel therapy and a new wave of
innovation” Speakers: Ben Clark, Engineering Manager, Medtronic/Ardian Medtronic
Date and Time: Tuesday morning, May 21, 2013, 8:30am Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
Renal denervation (RDN) is a novel procedure that has gained significant attention from the medical device community, including researchers across many disciplines, device companies, and entrepreneurs. This presentation will begin by describing the roles of the kidneys and renal nerves
within the sympathetic nervous system. Then Ben will share his unique startup experience of developing various technologies before arriving at a customized approach of radiofrequency (RF)
ablation to help pioneer a novel therapy and a new wave of scientific and device innovation. Speaker Bio: Ben Clark is an Engineering Manager at Medtronic's Renal Denervation division. He has been leading
catheter development projects for renal denervation since he joined Ardian in 2005. While at Ardian he worked with a startup team to pioneer renal denervation as a treatment for hypertension by developing the Symplicity catheter, developing novel methods for preclinical evaluation, and supporting early
clinical trials in Australia and Europe. Prior to joining Ardian, Ben worked as a Research & Development and Manufacturing Engineer for startup companies developing mechanical devices for arterial access
site closure (Perclose, acquired by Abbott Laboratories), and crossing chronic total occlusions (LuMend, acquired by Johnson & Johnson). Ben has a BS in Mechanical Engineering from Cal Poly State University
in San Luis Obispo and is a licensed professional engineer in the state of California. He currently holds 8 issued US patents.
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Patheon and QB3, Tuesday Afternoon, June 25, 2013
Topic: “Addressing Development Challenges from Preclinical to Proof of Concept and Readiness for
Out-Licensing” Speakers: Anil Kane, Ph.D., Executive Director, Global Formulation Sciences, PDS at Patheon
Jason M. Vaughn, Ph.D., Director of Formulation and Product Development at Patheon
Khalid Shah, Ph.D., Senior Director of Formulations Development, Manufacturing and Clinical Supplies
at Exelixis Jamie Topper, M.D., Ph.D., General Partner, Menlo Park, Frazier Healthcare
Date and Time: Tuesday, June 25, 2013, 12:00pm-6:00pm Location: Byers Auditorium – UCSF – Genentech Hall, 600 16th St, San Francisco, CA
Cost: Free Register a http://www.patheon.com/marketing/SF_eblast_SFDC/invitation_linkedin.html
Given the increasing R&D investment and regulatory hurdles that must be navigated precisely in order to get new drugs to global markets, setting the right course early in clinical development is critical. The
framework for deciding to progress to first-in-man studies, and the goals and expectations of early clinical development requires critical appraisal. This seminar provides insight into some of the current issues in getting a molecule from the preclinical through to early clinical development in humans with
the aim in providing better decision making. Most virtual to mid-size biotech and pharmaceutical specialty companies plan to select a partner to
progress their molecule. Readiness for due diligence and partnering discussions are key to progressing the molecule faster to the next stage of development.
During this seminar, hosted by Patheon and Qb3, you will hear case studies and analysis from industry leading experts on preformulation and formulation development for IND enablement and regulatory
strategies for IND Submission. You will also hear a venture capitalist experience on business models of in-licensing /out-licensing and readiness for partnering along with case studies. ************************************************************* BioScience Forum, Wednesday Evening, June 26, 2013
Topic: "Selective Targeting of Cancer Cells with a Hypoxia-Activated Prodrug: Preclinical and Clinical
Studies" Speaker: Charles Hart, Ph.D., Vice President, Biology, Threshold Pharmaceuticals
Date and Time: June 26, 2013, 6:00 pm-9:00 pm; 6 pm - 7 pm networking 7 pm - 8 pm dinner 8 pm - 9 pm presentation
Location: The Holiday Inn, 275 S. Airport Blvd., South San Franicisco, CA 94080 Event Registration ($3 service fee will apply) General Pre-Registration
Pre-Registration ends Monday, June 24th, at 9 pm Cash or check accepted on the day of the event
Register at http://biosf.org/ Or you can pay with a check made out to "BioScience Forum" and sent to:
BioScience Forum 1442A Walnut Street, #308
Berkeley, CA 94709-1405 Please do not mail checks later than Thursday, June 13th If paying with check, do not complete online registration with Cvent
Hypoxia is a prevalent feature of the microenvironment of solid tumors and leads to a more aggressive, invasive, and metastatic cancer phenotype as evidenced by dozens of published clinical studies.
However, the specific molecular and cellular pathophysiological mediators that underlie this hypoxia-
enhanced malignant phenotype continue to be characterized. Both diffusion-limited (chronic, stable)
and perfusion-limited (acute, transient) hypoxia have been described. Hypoxic cancer cells exhibit complex cell:cell, paracrine, and metabolic interrelationships with the other cellular components of the
tumor microenvironment (which include oxic tumor cells, endothelial cells, fibroblasts, and macrophages). Hypoxia is also associated with the diseased bone marrow in hematological malignancies such as leukemia and multiple myeloma.
The hypoxia-targeted drug TH-302 is a bioreductively-activated prodrug designed to selectively release
a DNA cross-linker in a hypoxia-selective manner. It has been found to exhibit efficacy both as a monotherapy and when combined with other therapeutic agents that complement its activity. The other
agents include conventional chemotherapeutics that selectively target the highly proliferative compartment in the well-oxygenated tumor microenvironment, anti-angiogenic agents that can lead to
an increase in the hypoxic fraction of the tumor microenvironment, and signal transduction modulators that can potentiate the activity of the released DNA cross-linking effector. Given the distinct nature of the complementarity of different TH-302 combinations we have modeled in preclinical systems, the
sequences and scheduling of TH-302 and the other agents explored in combination to maximize the therapeutic index of the combination. The results of these studies have been used to help guide the
clinical administration of the combinations. TH-302 is currently being used in combination with chemotherapeutics in two Phase 3 clinical trials and several earlier stage trials, including those of combinations with anti-angiogenics, and in hematological
malignancies. The clinical efficacy and safety profile continues to be promising and will be discussed in the context of the preclinical findings. Speaker Bio Charles Hart joined Threshold Pharmaceuticals in 2004 and became Vice President of Biology in 2008.
He is responsible for both in vitro and in vivo preclinical translational studies, and is currently project co-leader for the global clinical development program for the hypoxia-targeted anticancer drug TH-302,
a partnership with Merck-Serono (Merck KGaA). Prior to joining Threshold he was Senior Director of Biology at Galileo Pharmaceuticals from 2001 to 2004, Director of Drug Discovery at Signature
Bioscience from 2000 to 2001, and a Research Unit Director at Affymax from 1990 to 2000. Charles received his A.B. in cell biology from the University of California at Berkeley in 1977, an M.S. in developmental biology from Stanford University in 1980, and a Ph.D. in molecular biology and genetics
from Yale University in 1987. Charles completed a postdoctoral fellowship at the University of Strasbourg, France.
**************************************************************************** ASQ NCDG, Wednesday Evening, June 26, 2013
Speaker: Bruce Haggar, President, MedQ Systems, Inc. Moderator: Thomas Lypka, CEO TSL Quality Inc, RAC Date and Time: Wednesday, June 26, 2013, 7:00 – 9:00 pm
Location: Triple Ring Technologies, 29655 Eureka Drive, Newark, CA 94560 Price; $30 employed; $20 unemployed
Register at http://www.acteva.com//booking.cfm?bevaid=235000 Program Description This program will provide guidance on preparing for an FDA inspection. Specifically it will give an
outline of the questions asked during a typical FDA inspection, the quality system areas the FDA will focus on and the areas that most often create regulatory actions by FDA. Additionally, the program will provide a road map of how to manage an FDA inspection based on the compliance risk. Finally, the
program will give guidance on how to prepare the company for each of the specific areas of FDA emphasis.
Bruce Haggar is currently the president of MedQ Systems, Inc. a leading Biomedical Industry consulting
organization specializingin Design Control, Process Validation, FDA inspection management and FDA/Regulatory consulting and auditing. He is widely recognized as one of the nation's experts in
quality system development and consulting, process validation, medical device auditing, risk management and medical device design control. He is a past Chair of the ASQ/Biomedical Division and the editor of the Biomedical Quality Auditor Handbook. Bruce Haggar is a Biomedical Engineer with
experience in a variety of biomedical technology firms in product development, manufacturing, and regulatory/quality assurance. He was a primary developer of the external automatic defibrillator
technology in the late 1980's at Cardiac Resuscitator Corporation and First Medical Devices Inc. He is active in various industry organizations and a regular conference presenter including venues such as
the ASQs Biomedical Division, Advamed, AAMI, ORCA, WBBA and RAPS. He also served as an Investigator for the US FDA.
Formal discussion and questions will end between 8:30 - 8:45 pm to allow time for networking after the roundtable presentation. Attendees will earn 0.2 RU's (recertification units) from ASQ, with certificates distributed at the event.Please pass this announcement along to others within your organization, plus colleagues at other
companies. ************************************************************************** BayBio, Thursday Evening, June 27, 2013
Event: “Baybio Life Science Pub Night”
Date and Time: June 27, 2013, 5:30-7:30 pm Location: MoMos in San Francisco, CA
Register at BayBio website or facebook page. http://baybio.org/pub-night-2013-06-27/ Event Description
Join your friends and colleagues at BayBio’s Life Science Pub Night. Come to Momo’s in San Francisco on June 27th from 5:30 to 7:30pm.
Bring your bioscience business card for 1 free drink! ******************************************************
HBA, Thursday Evening, June 27, 2013 Topic: “Investment Trends in the Healthcare Industry” Speakers: Pat Salber, CEO of Health Tech Hatch; Alexandra Laforge, Director of Membership &
Programs at Investors’ Circle; Dayton Misfeldt, Investment Partner at Bay City Capital Date and Time: 06/27/2013 - 6:00 pm – 8:15 pm
6:00 PM - 6:40 PM Registration/Networking/Appetizers 6:40 PM - 7:40 PM Panel Discussion 7:40 PM - 8:00 PM Q&A
8:00 PM - 8:15 PM Evaluations/Adjourn Location: Genentech 651 Gateway Blvd, Building 82 Room, 15A South San Francisco, CA
Registration Information Event is open to: HBA members and nonmembers; Onsite (walk-in) registration: Is allowed
Member rate: $35 until 05/31/2013; $40 after 05/31/2013 Nonmember rate:$45 until 05/31/2013, $52 after 05/31/2013
Student: $25 until 05/31/2013, $30 after 05/31/2013 Space is limited to 65 registrants. Cancellations/Refunds
Is this event refundable? Yes If yes, must be submitted in writing to [email protected] by 06/20/2013; no refunds are available
The HBA San Francisco bay area chapter is delighted to welcome Pat Salber (CEO of Health Tech
Hatch), Alexandra Laforge (director of membership and programs at Investors’ Circle), and Dayton Misfeldt (investment partner at Bay City Capital) for an exciting panel discussion about current
investment trends in the healthcare industry. The evening will start with ample networking time, wine and heavy appetizers. During the panel discussion our speakers will share their insights about:
• Changes occurring in the healthcare investment community • Responses to these changes by different types of investors (e.g. VCs, Angels, Crowdfunding
platforms) • Opportunities and challenges innovators might face pursuing a certain funding source
• Promising innovations across the healthcare industry This event is for anyone interested in learning about key changes to the investment landscape and
promising innovations in the healthcare space. The audience will have an opportunity to interact with our engaging and experienced speakers during a twenty minute Q&A session. Learning Objectives
1. Learn about key investment trends in the healthcare industry 2. Explore investment ecosystem
3. Understand the pros and cons of different funding sources 4. Learn about promising innovations across the healthcare industry
Event Questions/Support - Program contact for event details: Contact email [email protected] and/or phone 415-404-2303
- Membership questions: [email protected] or 973-575-0606 - Trouble with online registration: [email protected] or 919-890-5230 ********************************************************* NorCal BioPharmaPM Breakfast Meeting, Friday Morning, June 28, 2013
Topic: “PM Culture—Why and How: A Case Study”
Speaker:Courtland LaVallee, Director, Project Management, Theravance Date and Time: June 28, 2013; 8:00-10:00 AM, presentation begins at 8:30 sharp
Location: Cerexa, 2100 Franklin Street, Suite 900, Oakland, CA 94612 RSVP: [email protected]Registration closes Wednesday, June 26th 2013 For Directions and simple BART instructions: www.cerexa.com/contact.aspx Topic Description PM Leadership is more than implementing the PMI PMBOK processes and
methodologies. PM Leadership also means establishing values and philosophies that underpin the performance of project management; in
other words, to create a PM culture. In 2006 I was hired by Genentech to create a Project Management group for the Development organization, essentially from scratch. When I started in March of 2006, there was one
PM hired in advance of my arrival; when I left in December of 2009 the group numbered 34 PMs plus four admin assistants, and it was wellrespected
for the quality of the service provided to the Development Sub- Teams. How did this happen and what did I do to establish internal
credibility and collaboration? Key points:
• Defining the PM philosophy (how it drives everything else) • Establishing a PM identity (what does this do for you) • Articulating a vision and mission (and why)
• The PM value statement and how to use it • Justifying resources – an objective methodology
• Measuring performance 2 PDUs will be granted to all attendees. Questions? Contact [email protected]
Courtland LaVallee (Corky) has been leading Project Management organizations in the biopharmaceutical industry for the last 15
years, and a practitioner for at least 25 years. He is an enthusiastic proponent of the PM disciplines and will happily talk your ear off about what great Project Management looks like.
****************************************************** Bio2Device Group, Tuesday Morning, July 9, 2013
Topic: “Restoring hearing through the teeth – the SoundBite™ Hearing System”
Speaker: Amir Abolfathi, Sonitus Medical Date and Time: June 18, 2013, 8:30am
Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA Cost: Free No registration required
Free parking available on street and in Sunnyvale Library parking lot Topic Description The SoundBite™ Hearing System is the world's first non-surgical and removable prosthetic hearing
solution that relies on bone conduction to imperceptibly transmit sound via the teeth. It is intended to help patients who are essentially deaf in one ear regain spatial hearing ability and rejoin the
conversation of life. Nearly invisible when worn, the SoundBite system consists of an easy to insert and remove ITM (in-the-mouth) hearing device with piezoelectric actuator, custom made to fit around the upper back molars, and a small BTE (behind-the-ear) microphone unit which communicates wirelessly
with the ITM. Currently FDA cleared and being marketed for the treatment of single sided deafness and Conductive Hearing Loss, the SoundBite system has intended future indications for hearing disorders
such as mixed hearing loss and tinnitus, as well as consumer and covert communications. Speaker Bio Amir founded Sonitus Medical, Inc. in 2006, leveraging 20 years of experience in founding, building,
and managing medical device companies. Prior to Sonitus, Amir served for six years as an Officer, Vice President of R&D at Align Technology Inc. (NASDAQ: ALGN), creators of a unique, invisible orthodontic product. Previously, Amir was the first member of the senior management team at Embolic Protection
Inc., where he was a consulting VP of Operations. EPI was successfully acquired by Boston Scientific in 2001. In early 1995, Amir co-founded EndoTex Interventional Systems, developers of minimally
invasive solutions for treatment of carotid artery disease, which was also acquired by Boston Scientific in 2006. Amir has also held various management and engineering positions at Pfizer, Guidant, and
Baxter-Edwards. As a seasoned entrepreneur, Amir has over 60 issued and pending patent applications, including 11 publications in peer review journals. Amir received his M.S. in Engineering Management
from the University of Southern California and a B.S. in Biomedical Engineering from UC San Diego.
********************************************************************
CACO MiniSymposium, Friday Afternoon, July 12, 2013
Topic: “Minisymposium: DMPK/ADME Problem-Solving Case Studies”
Speakers: Kevin Beaumont (Pfizer) & other presenters Date and Time: Friday, July 12, 2013, 12:45 – 5:30 pm
Location: SF Bay Area: Foster City Crowne Plaza Find details and register at http://www.caco-ca.org/aspx/chemist.aspx Presentations:
• Keynote Presentation: The current state of art for in vivo clearance prediction using in vitro data:
causes for under prediction (Kevin Beaumont, Research Fellow and PDM Principal Investigator, Pfizer) • Identification of a Novel Metabonate from Incubations of Nefazodone with Human Liver Microsomesin
the Presence of KCN (Chenghong Zhang, Genentech)
• Elucidation of the Mechanism of Ribose Conjugation (Peter Fan, Genentech)
• Assessment of In VivoEnantiomeric Interconversion(Joyce James, Cytokinetics) • Overcoming the problem of generating human metabolism data for inhaled drug products (Iain Shaw,
Quotient Clinical) • Pharmacokinetic optimization of 4-substituted methoxybenzoyl-aryl-thiazole and 2-aryl-4-benzoyl-imidazole for improving oral bioavailability (Chien-Ming Li, UCSF)
• Impact of the effects of fluorine substitution and chirality on small molecule MET inhibitors (BiancaLiederer, Genentech)
• “Where does it end?”: Building a relevant transporter package for global regulatory approval (Richard Egolf, Absorption Systems)
• Investigation of in vitro in vivo clearance (IVIVC) disconnect and utilization of low dose cassette dosing to support scaffold lead optimization (Richard Zang,Norvartis)
Keynote Abstract: The in vitro prediction of human clearance in combination of optimization of compound physicochemistry has revolutionized drug discovery over the past 2 decades. Previously, many high
molecular weight, lipophilic CYP substrates failed in the clinic due to unacceptable pharmacokinetics (high clearance, low oral bioavailability and short half life). The development of high throughput in vitro
metabolism assays for CYP metabolism combined with the ability to use the data to predict human CYP-mediated clearance preclinically has enabled the optimization of candidate molecules for predicted
human CYP-mediated clearance. However, a further evolution of drug discovery approaches involving a shift in pharmacological target/safety physicochemistry and over-optimization on CYP-mediated clearance has driven a shift in the predominant clearance mechanisms for candidate drugs.
Consequently, tools derived to successfully predict CYP-mediated human clearance may now under-predict in vivo clearance. The reasons for under-prediction of human clearance from in vitro data will be
discussed along with opportunities to address IVIVC issues. *********************************************************
HBA, Thursday Evening, July 18, 2013
Event: Healthcare Networking Social for Device, Diagnostic and Pharmaceutical Companies Date and Time: Thursday, July 18, 2013, 5:30 – 8:00 pm Agenda
5:30 PM - 6:00 PM Registration/Arrivals 6:15 PM - 6:30 PM Welcome/Introductory Remarks
6:30 PM - 7:45 PM Structured Networking Reception with heavy appetizers 7:45 PM - 8:00 PM Closing and Evaluation/Feedback/Adjourn
Location: Cooley, LLP, 3175 Hanover Street, Palo Alto, CA 94304 Cost: Member rate: $30 until July 11, 2013, $35 after July 11, 2013; Nonmember rate:
$40 until July 11, 2013, $45 after July 11, 2013 Registration Information Register at
https://netforum.avectra.com/eweb/DynamicPage.aspx?Site=HBA&WebCode=EventDetail&evt_key=f2b28833-84e8-403d-98cf-4b0a43f35fdd
Event is open to: HBA members and nonmembers. Onsite (walk-in) registration: Is allowed Space is limited to 100 registrants.
Cancellations/Refunds; Is this event refundable? Yes. If yes, must be submitted in writing to [email protected] by July 17, 2013; no refunds are available after this date.
Event Questions/Support - Program contact for event details: Contact email [email protected] and/or phone
925.462.2900 - Membership questions: [email protected] or 973-575-0606 ext 1
- Trouble with online registration: [email protected] or 973-575-0606 ext 3 Event Description
The San Francisco chapter of HBA (Healthcare Businesswomen’s Association) cordially invites all bay
area healthcare professionals to join us in a special evening of networking across industries. Whether
you're a networking newbie or a seasoned pro, you won't want to miss HBA's summer cocktail event, where you'll enjoy afterwork drinks, hors d'oeuvres, and prime networking at Cooley's campus'
beautiful gardens in warm, sunny Palo Alto. Learn about the programs HBA is offering this fall for all types of interests – from physician education to healthcare PR and investment trends to other educational topics and programs for personal and professional growth.
For the networking newbie, there will be a special kick-starter, covering everything from icebreakers to closers (so you make sure you leave with a business card.or several!) that will turn even the shyest of
people into a social butterfly. And be sure to come ready to share your own favorite networking tip, trick, or best practice for the chance to win an exciting prize! Of course, once introductions have been
made and you're ready to take your networking to the next step, Cooley's garden offers plenty of space to comfortably perch and engage in deeper conversation.
Heavy Appetizers, Beer and Wine are included Raffle for free four-hour career coaching session Learning Objectives 1. Supercharge your network through planned networking activities with colleagues from across
industries 2. Learn more about the HBA's mission and planned activities
3. Enjoy an evening of afterwork drinks and socializing 4. Bring your own networking tip, trick, or best practice for the chance to win a special prize!
Date and Time: Agenda 5:30 PM - 6:00 PM Registration/Arrivals 6:15 PM - 6:30 PM Welcome/Introductory Remarks
6:30 PM - 7:45 PM Structured Networking Reception with heavy appetizers 7:45 PM - 8:00 PM Closing and Evaluation/Feedback/Adjourn
Event Location Location: Cooley, LLP, 3175 Hanover Street, Palo Alto, CA 94304
Cost: Member rate: $30 until July 11, 2013, $35 after July 11, 2013; Nonmember rate: $40 until July 11, 2013, $45 after July 11, 2013
Registration Information Event is open to: HBA members and nonmembers Onsite (walk-in) registration: Is allowed
Capacity Is there capacity? Yes. Space is limited to 100 registrants. Cancellations/Refunds
Is this event refundable? Yes. If yes, must be submitted in writing to [email protected] by July 17, 2013; no refunds are available after this date.
Event Questions/Support - Program contact for event details: Contact email [email protected] and/or phone
925.462.2900 - Membership questions: [email protected] or 973-575-0606 ext 1 - Trouble with online registration: [email protected] or 973-575-0606 ext 3
******************************************************
CACO, Friday Mid-Day, July 19, 2013
Topic: “Beyond PEGlation: the Next Generation of Polymer Conjugation Technologies to Enhance PK/Safety/Efficacy Propoerties of Small Molecule and Biologic Drugs” Speaker: Stephen Doberstein, Ph.D. (CSO, Nektar)
Date and Time: Friday, July 19, 2013, 11:00 am – 1:30 pm Location: SF Bay Area: Foster City Crowne Plaza
See further details and register at http://www.caco-ca.org/aspx/chemist.aspx ************************************************************
Bio2Device Group, Tuesday Morning, July 23, 2013
Topic: “Changing Medical Device Regulations in Europe” Speaker: Dr. Martine Dehlinger-Kremer, Global Vice President, Regulatory Affairs RPS
Research Pharmaceutical Services Date and Time: Tuesday, July 23, 2013, 8:30 – 10:30 am
Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA Cost: No charge
No registration required Topic Description The EU is proposing updated regulations on medical devices in order to ensure these products are safe, and can be freely and fairly traded throughout the EU.
The existing EU rules – dating back to the 1990s – have not kept pace with the enormous
technological and scientific progress in the past 20 years. The EU countries interpret and implement the current rules in different ways. Manufacturers need clearer rules, easier
trading between EU countries. What will change? There will be a wider, clearer scope for EU legislation on medical devices, extended to
include, for example, implants for aesthetic purposes, and clarified as regards genetic tests; a stronger supervision of independent assessment bodies by national authorities and more
powers for assessment bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections.
The New rules include stricter requirements for clinical evidence to support assessments of
medical devices and an updated classification rules dividing medical devices into 4 different risk categories and health & safety requirements, including labeling rules. Speaker Bio Dr. Martine Dehlinger-Kremer has more than 27 years of experience in the research industry, including more than 23 years of progressively higher levels of Regulatory Affairs
leadership responsibility. For the past 18 years, she served as a Vice President of International and Global Regulatory Affairs as well as Vice President of Global Medical
Affairs, in global CROs with headquaters in the US. Prior to that, Dr. Dehlinger-Kremer worked as a Research Associate at CNRS Institute of Physiology in Strasbourg and the Max-Planck Institute of BioPhysic in Francfort.
Dr. Dehlinger-Kremer has been involved in the global development of numerous products,
across worldwide from early development stage through to clinical studies and to final registration. She participated in over 100 NDAs/MAAs in local and CTD/eCTD/NeeS format
and was involved in numerous clinical studies, from phase I to phase IV including device studies. Dr. Dehlinger-Kremer was has also been involved in the development of Orphan
drugs and Biosimilars. Dr. Dehlinger-Kremer has a solid experience in Pediatrics. Since 2008, she is the Chair of
the Pediatric Working Group of EUCROF, the EU CRO Federation. In that role she is working on the improvement of clinical research in children. Dr. Dehlinger-Kremer is also a lead of
Dr. Dehlinger-Kremer holds a Masters of Sciences from the University Moulin de la Housse in Reims, France and a PhD from the University of J.W. Goethe in Frankfurt, Germany. Dr.
Dehlinger-Kremer is a registered TOPRA Member. ***********************************************************************
HBA San Francisco Bay Area, Wednesday Evening, July 24, 2013 Topic: “Review of Lean In by Sheryl Sandberg Speaker: Kimberly Farrell, CEO, Unlimited Performance Training, Inc.
Date and Time: Wednesday, July 24 - 5:30 PM – 8:30 pm Agenda 5:30 PM - 6:15 PM Registration/Structured Networking Reception w light meal
6:15 PM - 6:30 PM Welcome/introductions and Program Overview 6:30 PM - 8:15 PM Book Review, Discussion/Q&A and Leadership Application
8:15 PM - 8:30 PM Closing and Evaluation/Feedback/Adjourn Location: Theravance, Inc, 901 Gateway Boulevard, South San Francisco, CA 94080 650-808-6000
Registration Information Event is open to: HBA members and nonmembers
Onsite (walk-in) registration: Is allowed Member rate: $40 until July 3, 2013; $45 after July 3, 2013
Nonmember rate: $50 until July 3, 2013; $55 after July 3, 2013 Capacity
Is there capacity? Yes Space is limited to 100 registrants.
Register at https://netforum.avectra.com/eweb/DynamicPage.aspx?Site=HBA&WebCode=EventDetail&evt_key=86955428-ff21-42b8-826e-7c525100db02
Join the HBA San Francisco chapter for an exciting evening of group discussions on the insights shared by Sheryl Sandberg in her new book, Lean In.
Kimberly A. Farrell, CEO, Unlimited Performance Training, Inc. will facilitate an engaging discussion among the those attending in order to leverage the intellectual capital of the
group for a dynamic and stimulating discussion about “Leaning In.” Engage in an interactive discussion on the book on women in leadership everyone is talking about – Lean in! Discuss key components of her book and calibrate your experience vs. hers – what resonates with you? Are you in your way? Do work/life balance issues trip you up and make you want to ‘opt out’? Do you lack ambition or is something else holding you
back? Come join us for an exhilarating evening of dialog, thought provoking discussions and leadership development. Please note: While reading the book in advance will help you gain maximum value and
insight from this interactive event, it is not a pre-requisite, so if you have not yet had time to read "Lean In", simply come along and learn what the buzz is all about!
1. Exchange ideas with women of various cultural backgrounds to expand your insights into how other women manage work and life.
2. Articulate how fear helps or impedes your professional progress and debate ways to remove unwanted obstacles to career success. 3. Analyze the key lessons from the book, the group discussion and your own reflections to
choose how to develop yourself according to your standards, as a successful woman leader.
Please note: While reading the book in advance will help you gain maximum value and
insight from this interactive event, it is not a pre-requisite, so if you have not yet had time to read "Lean In", simply come along and learn what the buzz is all about.
************************************************************** BioScience Forum, Wednesday Evening, July 24, 2013
Speaker: Thomas Musci, M.D., Vice President, Clinical and Medical Affairs, Ariosa Date and Time: Wednesday, July 24, 2013, 6:00 pm-9:00 pm; 6 pm - 7 pm networking 7 pm - 8 pm dinner
8 pm - 9 pm presentation Location: The Holiday Inn, 275 S. Airport Blvd., South San Franicisco, CA 94080
Event Registration ($3 service fee will apply) General Pre-Registration $45.00
General On-Site Registration $55.00 Student Pre-Registration $35.00
Student On-Site Registration $45.00 Pre-Registration ends Monday, July 22, at 9 pm Cash or check accepted on the day of the event
Register at http://biosf.org/ Or you can pay with a check made out to "BioScience Forum" and sent to:
BioScience Forum 1442A Walnut Street, #308
Berkeley, CA 94709-1405 Please do not mail checks later than Thursday, June 13th
If paying with check, do not complete online registration with Cvent Please check BioScience Forum website (www.biosf.org) for details as I’m posting this ahead of their announcement being available.
*****************************************************************
RAPS, Friday, July 26, 2023
Save the Date! Event: 2013 FDA Pacific Region Update and Case for Quality Forum
Jan Welch, deputy director for regulatory affairs, CDRH, US FDA
William (Bill) MacFarland, director, Division of Enforcement B, CDRH, US FDA
Eugene Reily, Division of Risk Management Operations, CDRH, US FDA
Mark Roh, regional food and drug director, Pacific Region US FDA
Judy Stojny, deputy regional food and drug director, Pacific Region US FDA
Donna Godward, cheif quality officer, MD&D, Johnson & Johnson
Date and Time: 26 July 2013, 8:30 am–4:30 pm Location: Biltmore Hotel and Suites, Santa Clara, CA
Price: List price- $150; member price-$125 Register at http://www.raps.org/membership-amp-benefits/chapters/raps-san-francisco-chapter-26-july-2013.aspx
Save the date Friday, 26 July, for the 2013 FDA Pacific Region Update and Case for Quality
Forum. This full-day meeting with representatives from the San Francisco district FDA and CDRH will cover the Case for Quality in the morning with an afternoon session focused on
2013 compliance issues for devices and drugs.
RAPS San Francisco Chapter’s first all-day meeting presents Case for Quality, the FDA’s interactive forum that gives members of the medical device community a chance to share
thoughts on best practices, what works and what inhibits quality efforts, directly with FDA representatives. You will learn more about the initiative, timelines for short- and long-term
goals, mechanisms for stakeholder involvement and plans for how this initiative will be implemented at the national and regional levels.
Then, Mark Roh, regional food and drug director, Pacific Region FDA, and his team will
speak about 2013 FDA compliance issues from regional and national perspectives for devices and drugs as well as how regulatory challenges of globalization have impacted FDA and regulated Industries. The speakers will highlight some of the changes FDA has had to
make with regard to expanding the agency’s capabilities and regulatory authority in response to increasing globalization and the rapidly changing regulatory environment in
order to ensure global product safety The day will end with an open Q&A session that will help clarify any questions for the FDA
and industry representatives. Continental breakfast and lunch will be served. Registration opens next week. *********************************************************
Bio2Device Group, Tuesday Morning, July 30, 2013
Topic: “TBA” Speaker: Akhsar Kharebow
Date and Time: Tuesday, July 30, 2013, 8:30 – 10:30 am Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
Cost: No charge No registration required ********************************************************************* Bio2Device Group, Tuesday Evening, August 13, 2013
Topic: “Understanding the Value of Advanced Diagnostics: Aligning Labs, Clinicians and
Payers to Make Better Decisions” Speaker: Matt Zubiller, VP, Decision Management, McKessonDate and Time: Tuesday,
August 13, 2013 – 6:00 – 9:00 pm Location: Wilson Sonsini Goodrich & Rosati, 650 Page Mill Road, Palo Alto CA Cost:
$6 - Students/In-transition - Members only $11 - Early-bird Registration - Members only
$20 - Late Registration and Non-Members $25 - Walk-ins
Matt Zubiller is Vice President of McKesson’s Decision Management business. Matt leads McKesson’s InterQual business and related point-of-care decision support solutions. Before joining McKesson, Matt worked for a global strategy consulting firm in London, co-founded a
spin-off from a leading Enterprise Resource Planning software and services vendor, and then founded and sold a boutique consulting practice working with early stage technology
companies, entrepreneurs and venture capitalists in the US, UK, and India. Matt holds an MBA from London Business School, a management of technology degree from the Berkeley
College of Engineering and the Haas Business School, and was recently named to Healthspottr’s “Future Health 100” as a healthcare innovations leader.
Topic Description As the healthcare industry continues the transition to care delivery and reimbursement
strategies that recognize value over volume, laboratories, clinicians and payers are collaborating in new ways to move discussion into action. Taking a fresh look at the decision support tools used to identify and track diagnostics tests at the point of care can open up
new avenues for partnership among healthcare stakeholders. Adding specificity to the use, identification, reporting and tracking of molecular diagnostic tests will enable healthcare
stakeholders to effectively measure the clinical and financial impact of molecular diagnostics testing in order to make better informed test selection, coverage, and payment decisions.
This session will focus on the need for molecular diagnostic test identifiers which enable labs, clinicians and payers to identify care events at very granular levels in order to gain
more insight into the clinical value of each event. That, in turn, would help drive better decisions about care delivery and reimbursement and which can quickly scale beyond diagnostics to consider any care event (next gen/ whole genome sequencing, allergy
testing, DME, episodes of care, and more) that needs a more granular level of identification in the pursuit of true healthcare value.
******************************************************************** CACO Workshop, Friday Afternoon, August 23, 2013
Topic: “Clinical Formulation Development and Registration for Small-Molecule NCEs” Speakers: David Baker, (WriteResource), Zedong Dong (FDA CDER), Sanjeev Kothari
(Genentech), Minli Xie Date and Time: Friday, August 23, 2013, 12:45 – 5:30 pm
Location: San Francisco Bay Area See details and register on CACO website at http://www.caco-ca.org/aspx/chemist.aspx
Clinical formulation development is a dynamic and evolving process that has to take into considerations of route of administration, therapeutic areas, stage of development, patient populations and PK, efficacy and safety requirements as well as stability, manufacturability
and scalability. A thorough preformulationcharacterization is critical in setting a solid foundation for clinical formulation development. Typically, formulations used for early-phase
clinical studies are relatively simple to prepare as fit-for-purpose to achieve clinical proof-of-concept. On the other hand, formulation aimed for late-phase clinical studies should
essentially be representative of future commercial formulation in performance, safety, composition and manufacturing processes. Aging patient population on multiple
medications, accelerated clinical studies for break-through therapies as well as QbD requirements are some of the new challenges posed to formulation scientists. This workshop aims to provide a frame work of strategies and considerations for oral and injectable clinical
formulation development from initial design to optimization, QbDassessment, registration and process validation for new chemical entities (NCEs, aks synthetic small molecule drugs).
Speakers will share scientific fundamentals, process experiences, case studies as well as FDA perspectives on formulation development and registration.
The workshop includes but not limited to the following topics:
• Clinical Formulation Development for Phase I and prior to Proof-of-Concept Ø Physical Form of Drug Substance and preformulation
Ø Considerations and development for Phase I oral and parenteral formulations Ø Safety assessment of clinical formulation
Ø Case studies • Injectable Formulation Development and Registration
Ø Key developmental activities Ø QbD considerations
Ø Comparability strategy Ø Registration and Process Validation
Ø Case studies • Solid-dosage Formulation Development and Registration
Ø Key developmental activities Ø QbD considerations Ø Comparability strategy
Ø Registration and Process Validation Ø Case studies
• Regulatory Perspectives on Formulation Development and Registration for NCEs Ø Regulations and guidancesrelated to clinical formulation development and registration
Ø Regulatory perspectives on formulation development in IND stage and registration in NDA stage
David Baker, Ph.D., is VP of Writeresource Inc.(www.writeresource.net), a pharmaceutical consultancy offering CMC and medical writing expertise. Dr Baker was educated in the UK,
completing his undergraduate and his doctorate in Physical Organic Chemistry at King’s College, London. He has held a variety of positions in big and small pharma, including
Senior Director of Product Development (Pfizer), VP of Pharmaceutical Sciences (Anadys) and President (QLT Plug Delivery) leading and managing functional groups in the
development of oral, parenteral and ophthalmic dosage forms and devices. Specialties include formulation, process and device design, mathematical modeling/optimization, kinetic and statistical analysis, elucidation of degradation mechanism and solubility enhancement.
Soft skills include problem solving and team building/coaching. Author of multiple product development sections from IND to NDA and European filings. Global experience in
pharmaceutical science regulatory requirements for registration of new drugs, devices, and product-line extensions. Experience includes the development of multiple commercialized
products from concept, through clinical trials, tech transfer and production scale-up/validation. Device experience for both parenteral and ophthalmic drug delivery, including
development of sustained release dosage forms. Processes developed to commercialization include traditional aseptic dosage forms, prefilled syringes, lyophilized formulations, blow fill seal processes and containment of an aseptic filling process for cytotoxics.
Zedong Dong, Ph.D.,is a senior CMC and Biopharmaceutics reviewer in the Office of New
Drug Quality Assessment at FDA. Dr. Dong received a B.S. degree (Pharmacy) in 1994 and a M.S. degree (Pharmaceutics) in 1997 from Beijing Medical University (now Peking
University Health Sciences Center). He received his Ph.D. in Pharmaceutics from the University of Minnesota in 2002. In the past five years at FDA, he received several center-
and FDA-level service awards/recognitions. Before joining FDA, Dr. Dong gained broad industrial experience in drug discovery, preformulationcharacterization, and formulation development during his tenure at Genentech (2002 – 2004) and Hoffmann-La Roche (2005
– 2008). He has published numerous original research articles, and has been invited to give presentations on several professional occasions.
Sanjeev Kothari, Ph.D, is a Sr. Scientific Manager in the Pharmaceutics group within SMPS at Genentech and joined the group in September 2010. Prior to joining Genentech, Sanjeev
was a Team Manager at AstraZeneca responsible for material science and process engineering for 3 years. Before moving to AstraZeneca, Sanjeevspent 10 years at Bristol-
Myers Squibb Company through various roles of responsibility in the formulation group and oversaw the development and launch of Abilify and Onglyza. Sanjeev gained significant
experience in QbD through the FDA pilotprogram between 2005 and 2007 via the Onglyza NDA submission as part of the pilot program. Sanjeevhas been a member of the QbD expert
group at Genentech/Roche and is actively working on ways to identify best practices for QbD implementation within gRED.
Minli Xie, Ph.D., is Assoc. Director of Small Molecule Pharmaceutics at Genentech. Dr.
Xiestarted her education at Peking University in Chemistry. She received a M.S. in Physical Organic Chemistry in 1994, and then Ph.D. in Pharmaceutical Chemistry in 1998 from the University of Kansas. In 1997, she started her career at DuPont Pharmaceutical Company
working on Discovery Pharmaceutics,Preformulation and Clinical Pharmaceutical Development. After the merger, she joined Bristol-Myers Squibb and led the pharmaceutical
support for discovery efforts in several therapeutic areas. In 2004, Dr. Xie joined Genentech Inc, to build a small molecule pharmaceutics group with expertise from discovery support to
NDA filing. She has been an integral part of the efforts to establish systems/processes suited for small molecule discovery and development at Genentech. Dr. Xiehas twenty
publications, Thirteen presentations, and invited speaker to several international conferences and universities. ******************************************************************** CACO-PBSS, Friday, Sept. 6, 2013
Topic: Antibody Drug Conjugates: Chemistry, Bioanalysis, Clinical Pharmacology and
Regulatory Issues Speakers: Steve Alley (Seattle Genetics), Leo Kirkovsky (Pfizer), Robin Marsden (Ambrx),
Sandhya Girish (Genentech) Workshop Organizers:
Surinder Kaur, Ph.D., Associate Director/Senior Scientist, Bioanalytical Sciences,
Chunze Li, Ph.D., Senior Scientist, Clinical Pharmacology, Genentech
Steve Alley, Ph.D., Director Bioanalytical, Seattle Genetics, Seattle
Leo Kirkovsky, Ph.D., Group Leader Clinical Assay Group, Global Clinical
Sandhya Girish, Senior Scientist/Group Leader, Clinical Pharmacology, Genentech
Date and Time: Friday, September 06, 2013; 12:45-17:30
Location: SF Bay Area Registration fee: Regular: $80; For unemployed: $0; For vendor-show reps: $0; Webcast:
$225; Webcast - for Boston members: $80; Webcast - for San Diego members: $80; For others, details available upon online login.
Vendor show vendors registered to date: (1)Pacific BioLabs Registration: http://www.PBSS.org Further Information:
Registration deadline: 8/22/2013 (it will close sooner if the seating cap is reached)
Antibody drug conjugates are complex biotherapeutics combining the specific targeting
properties of large molecules and the cytotoxicity of small molecule drugs. Due to their
complexity, the interdependence of diverse analytical methodologies and clinical pharmacology is crucial to understanding safety and efficacy relationships. There is a need
for sharing ADC analytical and clinical pharmacology information for mutual learning amongst scientists of different disciplines.
· Understanding ADC conjugation chemistries and heterogeneity · The complexity of ADCs requires using a multi-disciplinary, large / small molecule
bioanalytical approaches and sophisticated analytical techniques.
· Hybrid LC-MS/MS assays for large molecules
· Biotransformation data to understand the fate of ADCs in vivo · Bioanalytical assays for preclinical studies
· Clinical bioanalytical assay strategies · Clinical pharmacology and supporting clinical development · Regulatory submissions, and meeting post-approval commitments
*****************************************************************
CACO Seminar Luncheon, Friday Mid-Day, Sept. 20, 2013
Topic: “Up Close and Personal with Cancer: The Success Story of Plexxikon's Zelboraf®
(vemurafenib) for Melanoma Treatment and beyond” Speaker: K. Peter Hirth, Ph.D., Chief Executive Officer, Plexxikon Date and Time: Friday, Sept. 20, 2013, 11:00 am – 1:30 pm
Location: Crown Plaza, Foster City, CA Speaker Bio Dr. Hirthco-founded Plexxikon in December 2000, and has 25 years of biotechnology and
pharmaceutical discovery and development experience. Dr. Hirth was instrumental in the discovery and development of Zelboraf®, Plexxikon’sfirst oncology drug now approved in
the U.S. and many other countries, along with its companion diagnostic. Previously, he was president of Sugen, Inc. until the sale of the company to Pharmacia Corporation in 1999. At Sugen, he helped build the company from its inception and advanced several kinase
inhibitors through clinical trials for the treatment of oncology. This includes the drug Sutent, now owned by Pfizer through its acquisition of Pharmacia. Prior to Sugen, Dr. Hirthwas a
vice president in research with BoehringerMannheim where, among other responsibilities, he successfully led the company's erythropoietin program. Previously, he also was a research
scientist with the Max Planck Institute, following the completion of his post doctoral work at the University of California, San Diego. Dr. Hirth received his Ph.D. in molecular genetics
from Heidelberg University, Germany. ************************************************************************* Elsevier’s Pharmaceutical Strategy Conference, Monday – Wednesday, Sept. 23-25, 2013
Event: “Rebooting Growth: Maximizing the Value of Scientific and Business Model Innovation”
Date and Time: Monday, Sept. 23 starting at 1:30 pm through Wednesday Sept. 25, ending at 1:00 pm
Location: Millennium Broadway Hotel, New York, New York (Manhattan) Cost: Individual Attendee: $1595 (lower prices for past attendees and subscribers to Elsevier products) $400 Discount - Expires July 5, 2013
Cost includes: •Entrance to all sessions and workshops
•Conference materials, proceedings booklet, and copies of presentation slides as permitted by our speakers
•Admission to two cocktail receptions and all breakfasts/lunches/breaks (all networking functions)
•Conference materials, proceedings booklet, and copies of presentation slides, as permitted •15% off any Elsevier Business Intelligence product purchased at the conference.
See details on invited speakers and register at http://www.elsevierbi.com/mkt/Conf/PSA/2013Register
Event Description In the first decade of this century, industry has adopted more effective and efficient ways of
managing R&D, but will those changes be sustainable now that the urgency of the patent cliff is behind it? A rising class of stronger, bigger biotechs has lessons for the rest of the
industry on the kinds of innovation acceptable to the market. Are these the right models for this new era? At this year’s PSA: The Pharmaceutical Strategy Conference, we will explore
how various players in the biopharmaceutical ecosystem can gain the most value from scientific and business model innovation.
Industry still grapples with existential questions about the most effective approaches to developing meaningful new drugs; how it should collectively fund and reward their discovery and development; which therapies are ultimately worth paying a premium for, and how that
worth should be measured. We’ll hear from R&D and business development leaders about changing corporate priorities and strategies, and plans for building businesses in emerging
markets that can help resuscitate faltering businesses at home. We’ll also examine what large investors want from large pharma, and at the other end of the value chain, what
venture capitalists and entrepreneurs learned from the bloodbath of the past few years. Pharma now faces market access and pricing challenges that are more insidious, but just as
threatening as the familiar R&D and patent cliff issues it has grappled with for years. With the U.S. now fully immersed in implementing health care reform, and austerity abroad, biopharma’s core customer bases face challenges of their own. New information
technologies and resource constraints up-end traditional approaches to working with various constituents. Pharma’s responses to these changes continue to evolve. With near-term top-
and bottom-line pressures easing, and the broad outline of regulation and policy clearer, biopharma leaders can grow bolder – or more complacent. As industry drives growth in new
territories, in new therapeutic spaces, and by forging new kinds of relationships across the changing ecosystem, it may now have its greatest opportunity for transformation ahead of
it. Why do so many pharma companies send their leadership teams to PSA? PSA offers case studies about today's top biopharma issues from CEOs, Senior R&D and
Senior Business Development executives. Not only will they share lessons learned, and practical advice for sealing a deal, but these key opinion leaders will debate the issues that
are top of mind -- from enhancing R&D productivity to doing more with less in Business Development. In addition, attendees will also have the chance to:
Meet potential partners and network in a relaxed setting.
Understand externalization models and see how a company's approach meshes with
Benchmark the firm's dealmaking strategy against its competitors.
Understand the specifics driving biopharma dealmaking to better calibrate ongoing
View Top 10 reasons to attend Pharmaceutical Strategy Conference.
PSA is the only meeting to gather in one place the industry's top thinkers to explain solutions to the fundamental challenges facing biotech and pharma. In a limited period of
time, it will equip dealmakers like you with the insights, information and practical advice you need to strike successful deals. This program will sell out so register early.
At this year's event you'll hear from and network with senior industry executives about biopharma's most pressing strategic issues. Panel topics include:
Innovative approaches to market access.
Breakthroughs in business development.
What leading investors want from biopharma companies?
Balancing austerity and innovation in R&D
BD in China: Why it's the right time to partner with domestic biopharma.
Matchmaking and integration in the new world of diagnostics M&A.
Bringing brand sensibility to biosimilar strategies.
*********************************************************************** UC Berkeley Extension Course, Thursday and Friday, Oct. 3-4, 2013 Course: “Life Science Business and Marketing: Their Integral Role for Success,”
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 Meanwhile current information on course details found at http://tinyurl.com/ogahgdw 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 consul- tant, industry blogger at 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” Bev Hudson, MBA, is Executive Director/SVP of Clinical Research, Oklahoma Foundation for Cardiovascular Research (OFCR). Previously, she was Senior Vice President, Business
Development, Omnicomm Systems, Inc., a Web-based electronic data capture (EDC) and eClinical (eClinical) software and services company; VP and General Manager of Clinical Research Services at MedPoint Communications, Inc.; and earlier ran sales and operations
for Mayo Clinical Trial Services. She spent eleven years at Genentech in sales and marketing management roles. Topic: "The Impact of U.S. Health Care System on Marketing Life
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 Content Outline
The Discipline of Marketing in the Bioscience Industry
Unique bioscience industry marketing characteristics
Pivotal documents associated with marketing functions
The critical role of marketing at all stages of a product’s development
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
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
***************************************
CACO Workshop, Friday, Oct. 4, 2013
Topic: “Polymorph and salt selection: Advanced approaches for screening, preparation and characterization of small molecule drugs”
Speakers: X. Li (University of the Pacific), Peter Kitrinos (Gilead), Joe Lubach (Genentech), Jeff Stults (Genentech), Fang Wang Date and Time: Friday, Oct. 4, 2013, 8:45 am – 1:00 pm
Location: SF Bay Area: Santa Clara Convention Center (jointly with ACS Western Regional Meeting)
See details and register at http://www.caco-ca.org/aspx/chemist.aspx Topic Description Workshop Description:
Solid-state characterization of API and DP solid dosage forms is an integral part of the
pharmaceutical industry. Polymorph and salt selection are key decisions in the development process as they impact the biopharmaceutical properties and stability of the drug candidate. An understanding of these physical forms using methods of analysis, such as x-ray
diffraction, thermal and spectrophotometric techniques, are required to establish the solid-state form of the API. These tools are applied in the selection and development a drug
candidate. The final API or formulated products must be fully characterized to support regulatory submissions and tested according to specifications to guarantee identity,
strength, quality, purity and performance of the drug product. This workshop will provide an understanding of the fundamental principles and practical applications of a wide variety of solid-state characterization methods for new drug candidates as well as IP considerations for protecting new drug candidates. This workshop
will benefit scientists, scientific management, quality control and quality assurance, and regulatory affairs specialists currently working in the pharmaceutical/biopharmaceutical
industry who want to improve their understanding of the best practices for characterization of API and form selection. This workshop is also useful for non-pharmascientists who seek a
better technical understanding of processes, challenges and opportunities in the industry. Presentations: • Introduction & basic concepts of solid state properties (Dr. XiaolingLi, Ph.D., Associate Dean, University of the Pacific)
• PXRD & spectral techniques (Peter Kitrinos, Ph.D., Associate Scientist II, Gilead Sciences) • Thermal techniques: DSC/TGA and DVS (TBD)
• Solid State NMR (Joe Lubach, Ph.D., Scientist, Genentech) • Screening/crystallization during discovery/development (Jeff Stults, Ph.D., Senior
Research Scientist, Genentech) • Particle engineering and form selection (Fang Wang, Ph.D., Senior Research Scientist II,
Gilead Sciences) • IP considerations for solid formulations (TBD) ******************************************************************
Prescience International BioExec Institute, Thursday and Friday, Oct. 10-11, 2013
Topic: MODULE A - CREATING VALUE Day 1
New Models of Innovation “Big Bang Ideas.”
Where does innovation come from and how do we get more of it? There are few more important questions to the biopharma industry and this year's BioExec Institute will feature some of the industries most respected thought leaders on the subject of innovation
including Bernard Munos, Founder, InnoThink Center for Research in Biomedical Innovation and Mervyn J. Turner, Ph.D., Chief Strategy Officer, Merck & Co. Inc. & Sr. Vice President,
Emerging Markets, Merck Research Laboratories. Featured topics:
Emerging business opportunities in healthcare
New models of early stage innovation
The sustainability of the biopharma business model
Day 2 Disruptive Innovation - The External Insurrection
"High risk - high reward bets on innovation.” A focus on innovative and/or niche models represented at specific companies which may or
may not evolve into mainstream strategies. A high-level view of where current strategic investments are being made by ‘traditional’ biopharmas.
Innovative therapies and models including delivery, price-point, and product service
Outcomes-based contracts for specialty medications
Date and Time: Thursday and Friday, Oct. 10-11, 2013
Location: Berkeley, CA Fee: $2,400 Please contact our program consultant:
Call +1.510.642.7794 Email or Call +1.510.642.9167 Email
See details as they are announced at http://executive.berkeley.edu/programs/bioexec-
institute **************************************************************** Second HealthTech Conference, Wednesday, October 30, 2013 Event: “The HealthTech Conference: Building a Business in the New Healthcare Ecosystem” Date and Time: Wednesday, October 30, 2013, 8:30 am – 7:00 pm
Location: Computer History Museum, 1401 N. Shoreline Blvd., Mountain View, California Price: $695 through August 31, 2013
Register at http://www.eventbrite.com/event/5604898402# You can learn where new opportunities are emerging from the massive disruptions of our healthcare system and how to take advantage of them. Please click here to register. Charles Saunders, President of Strategic Diversification for Aetna, is the keynote speaker.
We have already over 19 panelists with an amazing gathering of CEOs, senior management, and venture capitalists - please see the full list here:
Our conference will provide practical explorations of unmet needs, payment and insurance changes, strategic partnering, mobile technologies for aging at home, and funding sources.
The Demo Hall will feature innovative start-up companies changing the world of health care. These Demo Exhibitors will have the opportunity to present
their companies to conference attendees and participate in the competition for the Most Promising Health Tech Company of 2013, to be awarded at the end of the day. ************************************************************** CACO Luncheon, Friday MidDay, Dec. 6, 2013
Topic: “Pharmacoeconomics: the Evolving Pharmaceutical Environment from the Managed
Care Perspective” Speaker: Elva Gao, PhD, MBA (Premara Blue Cross)
Date and Time: Friday, Dec.6, 2013, 11:00 am – 1:30 pm Location: Foster City Crowne Plaza Hotel, Foster City, CA
See details and register at http://www.caco-ca.org/aspx/chemist.aspx ************************************************************
PMWC, Monday and Tuesday, Jan. 27-28, 2014
Event: “Personalized Medicine World Congress” Date and Time: Monday and Tuesday, Jan. 27-28, 2014
Location: Silicon Valley Price: Registration (through July 1)
Additional $50 discount if you use my code AudreyErbes in registering prior to July 1. Register at http://pmwc2014.eventbrite.com/#. Event Description Early registration for PMWC 2014 Silicon Valley on Janaury 27-28 is now open until July 1: http://pmwc2014.eventbrite.com/# Some of the confirmed speakers are coming from UnitedHealth, NIH, Aetna, Pfizer, Novartis.and of course, Lee Hood whos a session chair. For those of you who are repeat attendees, we'll continue to feature fresh perspectives about the hottest topics in the field.
Kursorischer Streifzug durch die Geschichte der Neurowissenschaften aus neuroethischer und neurophilosophischer Perspektive „Wie andere erfolgreiche wissenschaftliche Disziplinen früherer Zeiten produziert die Neurophysiologie gegenwärtig einen weltanschaulichen Überschuss, der sich unter anderem in der Bestreitung menschlicher Freiheit, Verantwortungs- und Schuldfähigkeit äußert. So
Effects of Pulsed Electromagnetic Fields (PEMFs) on Stress The very presence of life means that stress is also present. The recognition of and the reaction to stressors is fundamental to physical and emotional existence. Our reactions to stressors are either healthy, that is, adaptive, or unhealthy, that is, maladaptive. Maladaptive reactions to stress create physical and psychological damage