Audrey’s Selected Meeting List for January 2008



Audrey’s Life Science Meeting Picks for Nov., 2009

(Nov. 17th Edition)

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Fountain Blue Life Science Forum, Monday Evening, November 16, 2009

Topic: Personalized Medicine, Biomarkers, Invitro Diagnostics: The Science

Advances, The Business Opportunities, The Cultural Dilemmas

Date & Time: Monday, November 16 from 5:30 - 7:30 p.m.

Location:    UCSC Extension in Silicon Valley, 2505 Augustine Drive, Suite 100, Santa Clara*   

• Facilitator Linda K. Molnar, LKM Strategic Consulting

• Panelist Doug Dolginow, PhD, BOD, Advisor, Founder CSO/CMO, Veracyte, Inc, and CEO and BOD, NanoValent

• Panelist Kimberlee Caple, Vice President, Genetic Systems Division, Applied Biosystems, part of Life Technologies Corporation

• Panelist Ted Driscoll, Venture Partner, Claremont Ventures; Active Member, Life Science Angels; Founding Director, Sand Hill Angels

• Panelist Kendall Wu, Product Manager, Cytogenetics Portfolio, Affymetrix

• Presenting Entrepreneur Richard A. Goozh, Sr. VP, Strategy & Finance, Wave 80 Biosciences; Managing Director, Cambrian Partners

• Presenting Entrepreneur Dick Haiduck, Partner to the CEO, Implicit Bioscience and Compugen, advisor to the Queensland Australia government

• Presenting Entrepreneur Massimo Bocchi, Chief Technology Officer, MindSeeds Laboratories s.r.l. and Fulbright scholar

Cost:                 $20 members, $30 partners, $40 general, plus a $1-2 fee.

$100 plus fee for FountainBlue Ongoing membership, admission, and free gift

Registration:     Please pre-register by noon on 11/13 using the PayPal link at .. Registrations received after the deadline

will be applied to next month's event, unless you've registered for the $100

ongoing or the $40 on-site payment, plus fees, regardless of membership

status.

Audience:     Entrepreneurs, intrapreneurs and investors, no service

providers please

For more information and to register, visit .

Facilitator Linda K Molnar, LKM Strategic Consulting

Dr. Linda Molnar is a biotechnology consultant specializing in applications of advanced technologies to biological research and medicine, particularly personalized medicine.  She has been successful advising venture capital firms on current and potential investment opportunities and also in the obtainment of significant non-dilutive funding for a variety of start-up organizations.

 

From May of 2005 to September of 2008, Linda was a Principal Management Consultant (serving as a Program Officer) in the Office of Technology and Industrial Relations (OTIR), Office of the Director, at the National Cancer Institute (NCI). In this role, she managed the business and technical requirements for the nation's largest investment in nanomedicine, the NCI's Alliance in Cancer Nanotechnology, a $144.3M investment. In her Program Officer role, Linda worked closely with lead investigators on technical and strategic management issues to de-risk novel technologies for future investment.  Among other accomplishments, she was instrumental in the successful launch of the Alliance in 2005 providing strategic planning, implementation, and technical expertise.

 

Linda has a breadth of experience in collaborations and partnerships between academic institutions, large companies and biotechnology start-ups for the successful translation of fundamental research into products and businesses.  Her background includes the research and business development of nanotechnology in a variety of applications and employments including Rohm and Haas Company, Caliper Technologies, and the NASA Ames Research Center.  She also maintains a Top Secret security clearance.

 

Linda received her Ph.D. in Materials Science and Engineering from the Massachusetts Institute of Technology and her B.S. in Chemistry with Honors from the University of Pittsburgh (magna cum laude). Linda also completed the Wharton Management Program to solidify her expertise in the technology/business interface.

Andy Felton, Director of Capillary Electrophoresis Product Line, Applied Biosystems, a Life Technologies Company

Andy Felton is currently Director of Capillary Electrophoresis Product Line at Applied Biosystems which is a part of Life Technologies Corporation. Life Technologies has annual revenues in excess of $3B and is a provider of instruments, reagents, software and services to the life science community. Andy has been with Applied Biosystems for 15 years, managing various product areas including launching systems for Real-Time or Quantitative PCR, Nucleic Acid Sample Preparation and DNA Synthesis, most recently launching a new capillary electrophoresis platform for the Molecular Diagnostic market in Europe. The capillary electrophoresis business is part of a broader Genetic Systems business with annual revenues in excess of $800M, encompassing products for Next Generation or massively parallel sequencing, with the promise of bringing the cost of a personal genome sequence to less than $1000.

Andy received his BSc Chemistry from Liverpool John Moores University, PhD in Chemistry/Biochemistry from Oxford John Moores University on Synthesis of peptide analogues of epidermal growth factor by a new active ester method.

Panelist Y. Dougls Dolginow, PhD, BOD, Adviser, and Founderat Veracyte Inc. and CEO and BOD of NanoValent

Beginning in 1993, Y. Douglas Dolginow has been involved in obtaining funding and launching over 10 biotechnology companies, has raised more than $380M in public and venture capital funds, and served on multiple public and private boards, including most recently Veracyte, a private company in South San Francisco that he founded and launched with backing  from KPCB, TPG, and Versant Ventures.  

Dr. Dolginow is currently BOD, Advisor, Founder CSO/CMO at Veracyte, Inc, as well as CEO and BOD of NanoValent. Dr. Dolginow also serves as adviser to Celula, Cellective, Skyline, Expression Pathology, Aueon,  MLCDx, Lineagen, CHLA.Previously, Dr.Dolginow was CEO, BOD, and Founder of Calderome, Inc and on the board of XCEED Molecular. Prior to that he had served as Executive Vice President, Pharmacogenomics for Gene Logic Inc. as well as President, COO, BOD and Founder of ONCORMED Inc.

Y. Douglas Dolginow, M.D. received his MD. from the University of Kansas in 1978, completed an internship in Pathology at Stanford University in 1979 followed by a fellowship and residency at UCSF in 1982.  He is board certified in Clinical Pathology and has been on the Clinical Faculty of UCSF Laboratory Medicine since 1984. 

Panelist Ted Driscoll, Venture Partner, Claremont Ventures; Active Member, Life Science Angels; Founding Director, Sand Hill Angels

Prior to his venture capital experience, Ted Driscoll helped found five successful companies in imaging-related markets. He was founder and CEO of Be Here Technologies, a pioneer in Internet, Broadcast and Videoconferencing technologies. He served as a Division President and CTO of Diasonics, with responsibility for its MRI, ultrasound, digital X-ray, lithotripsy and acoustic ablation technology areas. He had earlier directed the Diasonics technology team that developed the first commercial MRI scanners and numerous advances in MR imaging. Previously, Ted was also Vice President of Engineering and R&D of Identix, now a world leader in fingerprint and face recognition; and Director of R&D at International Imaging Systems, an early pioneer in remote sensing. His research and patents in ultrasound therapy and acoustic hemostasis also led to the founding of another company, Therus, now partnered with Boston Scientific.

Ted holds a PhD from Stanford University in Digital Imaging, Masters degrees from Harvard University in Computer Graphics and Remote Sensing and a Bachelor's degree from the University of Pennsylvania. Ted holds 40+ granted US and foreign patents in image-related fields, with approximately 30 additional pending applications.

Panelist Kendall Wu, Product Manager, Affymetrix

Dr. Wu currently manages the cytogenetics product line at Affymetrix and is responsible for the arrays, reagents, and software components of the recently released Cytogenetics Research Solution.  Prior to joining Affymetrix, he was a postdoctoral scholar at Stanford University working to understand the mechanisms of aging but has also has done research in areas ranging from breast cancer prevention to entomology and plant biology.  Dr. Wu received a bachelor's degree in the biological sciences from Cornell University and a doctor of philosophy in molecular and cellular biology from Baylor College of Medicine.  He has a personal interest in personalized medicine, biomarkers, and diagnostics following the field since the early days of Her2/neu testing for breast cancer treatment to more recent developments with direct-to-consumer genetic testing.

Presenting Entrepreneur Richard A. Goozh, Sr. VP, Strategy & Finance, Wave 80 Biosciences

Richard Goozh is currently SVP, Strategy & Finance at Wave 80 Biosciences and Managing Director at Cambrian Partners. Previously, he was Director at Rutberg & Company and Vice President at C.E. Unterberg, Towbin. 

Richard is a graduate of Northwestern University - Kellogg School of Management and University of Pennsylvania - The Wharton School

Presenting Entrepreneur Dick Haiduck, Partner to the CEO, Implicit Bioscience and Cytopia

Richard T. Haiduck is an experienced life sciences executive with background in building value in young biotech and medical device companies.  He is currently Chief Business Advisor of Cytopia and Implicit Bioscience, two leading Australian life sciences companies. He works on a part time basis for each company as a senior member of the management team, with particular emphasis on value creation strategy and execution.  In addition, he works as Commercialization Consultant to the companies in the Washington Biotech and Biomedical Association.

He has 25+ years of extensive general management experience with prominent life sciences companies, during which time he has completed more than a half billion dollars of transactions.  Most recently, he was Managing Director in the Merchant Banking Group at Burrill & Company.  He has previously held 6 CEO or Managing Director roles for BioStreet, Desmos, LifeScreen and multiple US and international operations of Abbott Laboratories.  Mr. Haiduck has his undergraduate degree in Marketing from Miami University, Oxford, Ohio and his MBA in Finance from Xavier University, Cincinnati, Ohio. 

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Bio2Device Group, Tuesday Morning, November 17, 2009

Topic: “Puzzles, Mysteries, and Complexities: Problem Solving in Life Science Organizations"

Speaker: Jerry L. Talley, JLTalley and Associates and Deborah Lynne Lombardo, Executive Associate with Barnes & Conti Associates

Date and Time: Tuesday, November 17, 2009, 8:30 – 10:30 am

Location: Sunnyvale City Council Chambers, 456 W. Olive, Sunnyvale, CA (across the street from Sunnyvale Public Library)

Cost: Free

Parking: On street and in NOVA and library parking lots across the street.

Topic Description

On the door of every manager, project managers, or team leader an invisible sign that says "Bring your problems to me", or at least that's how people behave. –And in an industry characterized by innovation and research, you can be guaranteed a high volume of problems to solve. If you're lucky you have your team members to deal with their own problems.

Whether you work on your own or through a team,, your fluency in problem solving is a key component of your success. Dr. Jerry Talley (Professor of Sociology at Stanford University-retired) and Lynne Lombardo of Barnes & Conti Associates will share some new thinking in the art and science of problem solving that can give you a faster, more powerful way to think through the inevitable problems in any endeavor. Dr. Talley’s research over 10 years of examining business problems and how people solve them revealed that there are really only 6 types of problems and each problem has a best strategy for finding a solution. By accurately identifying the fundamental type of a problem rather than treating every problem with the same approach, you and your team members will save time, resources and increase good will -- not to mention fewer sleepless nights. Please join us to learn about the 6 problem types, the components of an ideal problem-solving group, and key skills you’ll need in your role as leader or facilitator.

Speaker Bios

Jerry L. Talley is a veteran of multiple careers. He started with 18 years on the Stanford University faculty in the department of Sociology. While there he also had a private practice as a Marriage Family Therapist for 10 years. And almost 30 years ago he moved into organizational development consulting. He has worked with over 300 clients in the Bay area, nationally, and some international. He has consulted to companies in high tech, pharmaceuticals, hospitals and health care, banking and finance, consulting houses, the military, manufacturing, public utilities, public sector, not-for-profits, publishing, hospitality, entertainment, and one organic grocery store. He specializes in strategic planning, non-profit governance, and advanced problem solving and decision-making. His practice is summarized on .

Deborah Lynne Lombardo has more than 25 years’ experience in providing creative and practical approaches to developing high performance in organizations. At UCLA’s Anderson School of Management, she became convinced that the true challenge of any endeavor is to mobilize human talent, energy, and brilliance to achieve extraordinary results. This has been her focus ever since.

Lynne’s career has built a broad base of management, sales, and consulting experience that have benefited organizations on every continent except Antarctica. Her clients have come from nearly every sector of the economy: financial, manufacturing, high tech, communications, insurance, biotech/pharmaceutical, education, transportation, energy, health-care and not-for-profit theaters such as The Marsh and ACT in San Francisco. Her interest these days is on building high performance through better problem solving approaches; and helping companies to grow through innovative sales approaches.

Among other affiliations, Deborah Lynne is an Executive Associate with Barnes & Conti Associates who has partnered with Jerry to bring his problem solving methodology to a wider audience. Learn more at

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CPR, South Australia, Tuesday Morning, Nov. 17, 2009

Topic: “Outsourcing Early Phase Clinical Trials to Australia”

Speakers:

LUANA PESCO KOPLWITZ, MD, PhD, President and CMO & CSO, Duck Flats Pharma

RICHARD LOWENTHAL, Founder, Pacific-Link Regulatory Consulting

YVONNE LUNGERSHAUSEN, Director of Clinical Services, CPR Pharma Services

ANDREW DINAN, Director of Analytical Services, CPR Pharma Services

Date and Time: Tuesday, November 17, 2009, 8:00 – 10:30 am

• 8:00 AM  Open for Check-in, Breakfast, and Networking

• 8:40 AM  Introductory Remarks

• 8:45 AM  Session 1: Strategic Drug Development

• 9:10 AM  Session 2: Advantages of Conducting Trials in Australia

• 9:35 AM  Session 3: Managing and Implementing Trials in Australia

• 10:05 AM  Session 4: Bioanalytical Considerations

• 10:30 AM  Wrap-up Discussion and Q&A

Location: Embassy Suites, 250 Gateway Blvd,, SSF, CA 94080, 650.589.3400

REGISTRATION INFORMATION

Cost: $35/person with advanced registration;$45/person at the door



QUESTIONS

Please call Karen Chu, (510) 882-3134 or Teresa Johnk, (415) 246-6018, Greenbrae, CA 94904

Seminar Description

The Australian regulatory approval pathways for conducting clinical research offer significant advantages over other countries in the Organization for Economic Co-Operation and Development (OECD). The simplicity of the Clinical Trial Notification (CTN) Scheme is an important competitive differentiator that helps attract the interest of pharmaceutical and biotechnology companies to Australia. This scheme allows clinical trials to start quickly. By incorporating Australia in the early phase of your drug development program a reduction in time can be achieved to obtain quality data, even prior to an IND submission. This facilitates important decision-making (e.g. "Go/No Go") concerning the next steps in the product development process.

Four aspects of conducting clinical trials in Australia will be addressed by clinical professionals with international experiences in small to large pharmaceutical/biotechnology companies including J&J, GropPep Limited, and Maxim Pharmaceuticals.

• Session 1: Strategic Drug Development from Nonclinical to Clinical: Get to First-In-Man without an IND

• Session 2: Advantages of Conducting Early Phase Trials in Australia Compared to EU, Japan, and US

• Session 3: Managing and Implementing Early Phase Trials in Australia: How to be Successful in a Long Distance Relationship

• Session 4: Bioanalytical Considerations: Seek Key Capabilities

Speaker Bios

Dr. Koplowitz is a clinical pharmacologist with over 26 years experience in global R & D, and management, from pre-IND to NDA for both pharmaceutical and biotechnology compounds. She had extensive responsibilities on a total of 16 NDAs, 9 sNDAs and 25 INDs in 8 different therapeutic areas across large to small pharmaceutical/biotechnology companies. During her career, Luana held positions as CMO/CSO at Research Assist, Group Director of Global Clinical Pharmacology and U.S. Non-Clinical Development at Janssen Research Foundation (Johnson & Johnson), and Associate Director of Pharmacology at Knoll Pharmaceuticals.

 

Dr. Koplowitz is a member and the secretary of the former FDA/PhRMA QTc Working Group Committee (now part of ICH). Additional professional organizations include an invited member of the Advisory Committee of the FDA/Pharma-sponsored Cardiac Safety Research Consortium (CSRC) and a member of the Association of Pharmaceutical Physicians' and Investigators pharmaceutical medicine development committee. She obtained her MD from Rutgers Medical School and her PhD from Rutgers University College of Pharmacy and Columbia Pacific University.

Mr. Richard Lowenthal is an executive with over 20 years of Regulatory Affairs and Quality Assurance experience in various roles at both small and large pharmaceutical or biotechnology companies. Mr. Lowenthal has extensive experience with strategic global development as well as product registration of new drugs, biologics and drug/device combinations in the United States, Europe and Japan. As founder of Pacific-Link Regulatory Consulting, Mr. Lowenthal is now dedicated to the support of pharmaceutical, biotechnology, device, and investment companies, providing leadership and mentoring on Regulatory Affairs, Quality Assurance, Licensing and Investment opportunities. Mr. Lowenthal has served as Vice President, Regulatory Affairs and Quality Assurance for Cadence Pharmaceuticals, Head of Worldwide Regulatory Affairs, Quality Assurance and Drug Safety for Maxim Pharmaceuticals, Inc., Vice President of Regulatory Affairs and Quality Assurance for AnGes, MG, Inc. (a Japanese based Gene Therapy company), and Global Project Leader and Global Director Regulatory Affairs for Janssen Research Foundation (a division of Johnson & Johnson).

 

Mr. Lowenthal holds an M.S. in Organic Chemistry from Florida State University and Masters in Business Science for Executive Leadership from the University of San Diego. Mr. Lowenthal has served as past Chair of the San Diego region for AAPS (2005/2006), as Member of the USP Biotechnology Expert Committee (2005/2006), Chair of the Virology Working group (2005/2006), Member of the National Organization of Rare Disease (NORD) Corporate Council (2002-Present), and several PhARMA and ICH Working Groups. 

Ms. Lungershausen has more than 18 years' of clinical trial experience, encompassing all phases of the drug development process (Phase I through Phase IV). Yvonne has worked as a clinical manager for a Phase I contract research organisation and as the clinical development manager in a leading Australian biotech company. Her extensive experience in clinical team management and project management has developed through work across most therapeutic areas for both national and international companies.

 

Mr. Dinan has over 15 years' bioanalytical development experience, including five years developing bioanalytical methods using tandem mass spectrometry and eight years managing a bioanalytical facility. Andrew has extensive experience developing quality systems such as GLP and ISO 17025, has lead a laboratory through an FDA audit and spent two years as a consultant for BioInnovation SA, developing the quality systems for various laboratories.

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Palo Alto AWIS, Wednesday Evening, November 18, 2009

Topic: “10 Top Tips for Using Linked In Effectively”

Speaker: Patrice Reid, Career Management Consultant,

Right Management

Date and Time: Wednesday, Nov. 18 2009, 7:00 pm - 9:00 pm

Schedule

7:00-7:30 pm Networking and light supper

7:30-7:45 pm Announcements

7:45-8:45 pm Program

8:45-9:00 pm Discussion

Location: Palo Alto Research Center (PARC), 3333 Coyote Hill Road, Palo Alto Directions to PARC.

For details and to register,

Welcome!!  You don’t need to be a member to attend.

All scientists, students, and their friends are welcome.  Men too!

Members pay $5 and non-members pay $10 to offset the cost of food.

Topic Description

LinkedIn is the tool that people and organizations are using to connect and build relationships. For scientists, it provides a rich source of information on "who", "what" and "where" that can lead to new sources of collaboration, funding and career opportunity.

How can LinkedIn and other social media tools like Twitter and Facebook advance your career? Among the topics we'll be covering are: profile completeness, expanding your connections, handling recommendations, joining groups, and posting status messages. This presentation will be particularly helpful if you are using LinkedIn but not really optimizing it.

Speaker Bio

Our speaker, Patrice Reid, is a Career Management Consultant with Right Management in San Francisco. Patrice specializes in providing career transition, workshop facilitation and career consulting services for both companies and individuals. Her specialties include startup/entrepreneurship coaching and the use of social media tools in career management.

Directions from 280:

Take Hwy 280 and exit at Page Mill Rd and go East towards Palo Alto (if coming from the South, turn right, if coming from the north, turn left onto Page Mill. Turn RIGHT onto Coyote Hill Rd. Turn LEFT into PARC (formerly Xerox PARC).  Follow signs to the Auditorium on your left at end of parking area, down flight of outdoor stairs.

Directions from Stanford: Take Foothill SOUTH towards Los Altos. Turn RIGHT on Hill view and PARC is 2nd driveway on the right. Park and follow signs to the Auditorium (walk uphill through parking lot then down a flight of outdoor stairs).

See also  for map.

For more info: pa-, or email awis.pa@

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IEEE, Engineering in Medicine and Biology Society (EMBS), Wed. Evening, Nov. 18

Topic: “The development of the LATITUDE Patient Management System”

Speaker: Ken Hoyme, Sr. Fellow – Systems Engineering, Boston Scientific – Cardiac Rhythm Management

Date and Time: Wednesday,  November 18, 2009,  7:30 pm

New location:  Room M-114, Stanford University Medical School 

Optional dinner, new location: Nexus Cafeteria in the Clark Center, 6:15 pm (no host, no reservations)

Topic Description   Patients who have implantable cardiac therapy devices (pacemakers and defibrillators) are required to make regular visits to a cardiac device specialist to ensure that the device is working properly, and optimized for that person’s specific needs. These visits can be a burden, both for the patient as well as their device physician, and the frequency of these visits are a balance between that burden and the benefit if a condition is detected that needs attention. More recently, cardiac resynchronization therapy has been shown to benefit patients suffering from heart failure, a disease that requires frequent monitoring to avoid recurring hospitalization. In-home remote patient monitoring systems have become the solution to these needs.

The LATITUDE Patient Management System® was developed to address these needs for patients implanted with Boston Scientific’s implantable cardiac devices. This system has well over 100,000 active patients. This talk will focus on some of the key technical challenges in creating this system, including power management, safety, security and making this work within the workflow of a monitoring clinic.

Speaker Bio

Ken Hoyme has over 25 year experience working in the systems engineering of complex, safety critical systems. His is currently Senior Fellow within the Cardiac Device Telematics group, responsible for defining the company’s future directions in patient management. He was the technical leader for the development of the LATITUDE Patient Management System. Prior to coming to Boston Scientific, Mr. Hoyme was a Senior Fellow at Honeywell’s corporate research center, where his research focused on safety critical control systems for commercial aircraft.

Mr.Hoyme received his BS and MS in Electrical Engineering from the University of Minnesota. He is a member of the IEEE and is a Certified Systems Engineering Professional (CSEP) from INCOSE.

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Bioscience Science Forum, Wednesday Evening, Nov. 18, 2009 

Topic: "Infectious Disease Research in the 21st Century"

Speaker: Hans Reiser, M.D., Vice President, Biology, Gilead Sciences, Inc

Date and Time: Wednesday, November 18th, 2009

Time: 6pm Networking, 7pm Dinner, 8pm Presentation

Location: Location: The Clarion Hotel, 401 East Millbrae Ave., Millbrae, CA

Registration is $50 ($35 for full-time students). Parking $4. On-site registration: add $10 to pre-registered price. Register online at go/biosf before Monday, November 16th, 2009 at 11:55pm.

(We can only accept cash or checks at the door. There is an ATM machine in the hotel lobby.)

Or you may pay with a check made out to  "BioScience Forum" and sent to

    BioScience Forum

    1442A Walnut St. #308

    BerkeleyCA94709-1405

Please do not mail checks later than Thursday, November 12th, 2009 

 

Topic Description

 Infectious diseases continue to afflict mankind. Infectious diseases are a leading cause of death both in the developed and in the developing world. In addition, infectious agents such as viruses and bacteria cause secondary mortality and morbidity, including cancer, autoimmunity and neurodegenerative disorders. Dr. Hans Reiser will discuss biomedical challenges facing human populations, including the need for more effective methods of detection, prevention of outbreaks and transmission, and for novel therapeutics. Focusing primarily on HIV/AIDS and viral hepatitis as examples, Dr. Reiser will describe key tools and approaches that are being developed to address these challenges.

Speaker Biography           

Hans Reiser studied medicine (MD 1985; summa cum laude) at the University of Heidelberg, Germany. Upon graduation, he spent two years as a post-doctoral fellow in the laboratory of Baruj Benacerraf and Kenneth Rock at Harvard Medical School where he characterized the structure and function of murine Ly-6 proteins. In 1987, Dr. Reiser joined the faculty of the Harvard Medical School and began to characterize co-stimulatory molecules concerned with T cell activation. He generated the first antibody against mouse CD80, co-discovered a second member of the B7 family, and characterized the function of these proteins in the activation of antigen-reactive and T cells in a variety of animal models. This research was supported by grants from the National Institutes of Health and a Junior Faculty Research Award from the American Cancer Society. Dr. Reiser rose through the ranks and was ultimately appointed an Associate Professor (2004). He moved to Imperial College in 1996 as Professor of Molecule Immunology, where he continued his work on B7 molecules and also discovered the interaction between the CD48 and 2B4 receptors. His research in London was funded by grants from the Medical Research Council, the Wellcome Trust and the British Heart Association.

 

In 1998, Dr. Reiser left academia for an appointment as head of immunology and inflammation research at Boehringer Ingelheim Pharmaceuticals in Connecticut, where he focused on the discovery of small molecules for the treatment of rheumatoid arthritis, Crohn’s Disease, multiple sclerosis, and psoriasis. In 2004, he joined Gilead as Vice President, Biology, where he has been predominantly involved in the discovery and development of compounds for the treatment of viral infections (HIV, HBV, HCV, HPV, respiratory viruses) and cancer.

 

Dr. Reiser has published more than 60 research papers in leading scientific journals, including Cell, Science, The Journal of Experimental Medicine, and P.N.A.S. 

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Bay Bio Therapeutic Breakfast, Thursday Morning, November 19, 2009

Topic: “Running a Virtual Company”

Moderator: Carole-Lynn Glass, Director, Emerging Growth Services, RoseRyan, Inc.    

Panel Speakers:

William J Garner, MD, Chief Executive Officer, Urigen Pharmaceuticals, Inc.

Barbara K. Finck, M.D., Senior Vice President, Research and Development and

Chief Medical Officer, Osprey Pharmaceuticals, U.S.A., Inc.

Brian C. Cunningham, Senior Counsel, Morrison & Foerster LLP, CEO and Director

Clerigen Inc.

Date and Time: Thursday, Nov. 19, 2009, 8:00 – 10:00 am

Location: Theravance, Inc., 901 Gateway Blvd., South San Francisco, CA, 94080

Early Bird Registration through Nov. 17:

$10.00 - BayBio Members

$20.00 - Non-Members

On-Site Registration, Nov. 19:

$20.00 - BayBio Members

$40.00 - Non-Members

Register online at

Topic Description

All companies face daily decisions about what to activities should be contracted out. For many life sciences companies, the answer has been virtually everything, from discovery to manufacturing to clinical trials. Management in such virtual companies rely on a network of contractors to perform these key functions. This panel explores how best to balance cost vs. control and the benefits and challenges of relying on contractors and consultants.

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Special Event At Stanford University, Thursday Afternoon, Nov. 19, 2009

Topic: “Investing in Knowledge from Asia: Technology Areas and Opportunities”

Panel Discussion that includes Shirley Chen, Ph.D., Esq. talking about "sustainable health" using natural botanicals

Date and Time: Thursday, November 19, 2009, 4:15 PM - 5:30 PM

Location: Skilling Auditorium, Stanford University

There is no fee for this event

Speaker Bio

Dr. Chen will be part of a 2-person panel at Dr. Richard Dasher’s seminar titled "Investing in Knowledge from Asia: Technology Areas and Opportunities". Dr. Chen will talk about her new company (she is the founder and CEO), China’s health care industry in general, pharmaceutical development (West/Eastern Medicine) and the concept of "sustainable health" using natural botanicals for long term maintenance of personal health as her company’s approach to solving the health care problems in the West.

Dr. Chen grew up in extreme poverty in rural China during the Cultural Revolution. She completed her undergraduate training at Peking University before coming to the USA for her Ph.D. in Biochemistry at SUNY Stony Brook, followed by post doctoral work at UC Berkeley and UCSF and her law degree at Santa Clara University. She was a researcher at SRI International prior to joining Wilson, Sonsini, Goodrich & Rosati to practice Intellectual Property law. Before founding her new company, Dr. Chen was the President and CEO of MEBO International.

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East Bay AWIS, Thursday Evening, Nov. 19, 2009

Topic: "Effective Boss Management:Winning Strategies for Managing "UP"

Date and Time: Thursday, Nov. 19, 6:30pm – 8:30pm

Light supper*** and networking 6:30pm – 7:00pm

Location: Novartis, Building *X-310*, 5300 Hollis St, Emeryville, CA

REGISTER AT  

NOTE: When registering w/ Eventbrite, input $5 for members/students, $10 for

nonmembers.

Topic Description

When you engage with your boss it helps to be armed with awareness and tools so that you can prepare to make the best of any communication or situation. Some of you have difficult bosses and others have bosses with different styles that sometimes “rub.”  Others deal effectively and smoothly with their current boss, but other authority figures trigger negative reactions that could be managed with greater wisdom.  In this talk, we will explore different types of bosses and winning strategies for managing up effectively.

Speaker bio

*Rossella Derickson & Krista Henley,* M.A., LMFT, principals of *Corporate-

,** *have translated their business and organizational psychology

experience into Wisdom in the Workplace, consulting, training and coaching

modules that support healthy group and company dynamics. Their classes to

build business and leadership skills have been taught to CEO's, executives,

and entrepreneurs in High Tech, Biotech, Insurance, and many other

industries including leading universities.

*Donations will be collected at the door and no payment is due online.*

** This is a nonprofit organization and donations cover cost of food.*

*NON-SCIENTISTS and MEN ARE ALL WELCOME!*

** New parking and registration directions:  Park at lot located next to

Building X, on Hollis St., north of 53rd St.  Check-in at Building X.

See map for directions:



-

*Association of Women in Sciences, East Bay Chapter

; *Contact Ginger Jamias - **gjamias@*

* for more details!*

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Parenteral Drug Association (PDA), Friday, Nov. 20, 2009

Topic: Workshop on FDA’s New Guidance on Process Validation, November 20.

Sessions available to listen in on during the Workshop on FDA’s New Guidance on Process

Plenary Session 1: Process and Validation Program Design, Part 1

Fri. Nov. 20 | 8:45 a.m. – 10:00 a.m.

Validation (go to ) includes:

Topic Description

FDA Background on the Guidance – Edwin Rivera-Martinez, Chief, Manufacturing Assessment and Pre-Approval Compliance Branch, CDER, FDA

Stage 1 – Process Design 

Plenary Session 2: Process Validation Program Design, Part 2

Fri. Nov. 20 | 10:30 a.m. – 12:00 p.m.

Stage 2 – Facility and Process Qualification

Continued Process Verification 

Plenary Session 3: Practical Applications

Fri. Nov. 20 | 1:00 p.m. – 2:30 p.m.

Cost: PDA understands that travel and training budgets have become smaller in the past year. For a limited time, PDA is offering those who cannot attend this workshop in Puerto Rico the opportunity to listen in on specific sessions for just $30 each!

Statistics Useful for Validation

FDA’s Guidance for Industry Process Validation: Impact on Contamination Control and Support Processes 

For more information about these sessions, view the conference agenda at:

Register today for sessions during the Workshop on FDA’s New Guidance on Process Validation at:



Remember – each session is just $30! You cannot afford to miss these valuable discussions.

Parenteral Drug Association (PDA)

4350 East West Highway, Suite 150

Bethesda, MD 20814 USA

Tel: +1 (301) 656-5900

Fax: +1 (301) 986-1093

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CABS Scientific Workshop, Saturday Afternoon, Nov. 21, 2009

Topic: “Preclinical Development and IND Filing: the nuts, bolts, and best practices”

Speakers:

Cuiping “Tracy” Chen, Ph.D., Director, PK, Depomed Inc.

Linval Depass, Ph.D., Executive Director, Nonclinical Safety, Durect Inc.

Bert Ho, Head, Ph.D., Pharmaceutical Development, ChemoCentryx Inc.

Hua Mu, M.D. & Liang Fang, Ph.D., Genentech Inc. Date/Time: Sat., Nov 21, 2009; 12:30 – 5:30 PM (Check-in time: 12:30 – 1:00 pm)

Location: UCSF Mission Bay, Genentech Hall Auditorium, 600 16th Street, San Francisco, CA, 94158

Fees: Online $1 for CABS members, $10 for non-members;

         On-site: $5 for CABS members, $15 for non-members

         Slide Handout: $10 (online only).

Fees:

– Online: $1 for members, $10 for non-members;

– On-site: $5 for members, $15 for non-members

– Slide Handout: $10 (online only). Register at

Topic Description

Investigational new drug (IND) application is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations, and processes of assembling and filing an IND is the key to not only a successful filing but also a promising clinical development path forward. Therefore, keeping up to date on the regulatory requirements and the industry’s best practices in different aspects including non-clinical safety, PK, CMC, and clinical plan is paramount.  In this workshop, our speakers highly experienced with IND filings will discuss systemically the preclinical studies required for small molecule IND filings and the nuts, bolts, and best practices for putting together a high-quality IND package, as well as how to interact with various regulatory agencies. Below are the topics to be covered:

- Overview of preclinical development and IND filing

- Various preclinical studies required (Safety, DMPK & CMC)

- Clinical Development plans

- Interfacing with regulatory agencies including FDA

*****************************************************************************************Bioscience Business Development: Building Value, Thursday and Friday, Dec. 3-4, 2009

Intensive Course: Bioscience Business Development: Building Value, Thursday and Friday, Dec. 3-4, 2009 ((2 days of classroom and 2 months to complete project guided by instructor)

Instructors: Audrey S. Erbes, Ph.D., Principal, Erbes & Associates and and and Gilbert R. Mintz, Ph.D., President of GRM Associates

Expert Guest Speakers:

▪ Ginger Dreger, J.D., M.S., Goodwin Procter

▪ Harold (Hal) Etterman, MBA, Business Strategist

▪ Carolyn Feamster, MBA, VP, Business Strategy & Analysis

▪ Tom Gutshall, Chairman & Co-Founder of Cepheid

▪ Michael G. McCully, M.S., Director, Recombinant Capital

▪ Please see ucsc-extension.edu/biobizdev for complete biographies

Date & Time: Oct. 8-9, 2009, Thursday and Friday, 8:30am-5pm

Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa Clara, CA 95053

Fee: $770; $693 through Nov. 19

Topic Description

UCSC Extension in Silicon Valley presents a two-day intensive course that brings the breadth of the Bay Area’s biobusiness development expertise to our Cupertino classroom. Whether financing start-up activities, trying to keep pace with the current burn rate, or moving a product into the marketplace, bioscience companies, both large and small, have a critical need for business development at every stage of their evolution. Learn the key roles that business development and licensing play in the commercialization of a new product and the development of a successful bioscience company. Santa Clara, CA. For more information, see ucsc-extension.edu/biobizdev

Instructor Bios

Audrey Erbes, Ph.D., Principal, Erbes & Associates and has more than 35 years of marketing experience in the biotech and pharmaceutical industries, of which 25 years was in corporate management at Kowa Research Institute and Syntex Corporation.

Gilbert R. Mintz, Ph.D., President of GRM Associates, a biotechnology consulting firm with expertise in business development, licensing and strategic planning.

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San Jose Biocenter, Thursday Late Afternoon, Dec. 3rd, 2009

Topic: Trends in Financing Investor Panel & Holiday Celebration

Invited speakers include:

• Mike Powell, General Partner, Sofinnova Ventures

• Sigrid Van Bladel, PhD, Partner, New Enterprise Associates

• Casper de Clercq, Venture Partner, U.S. Venture Partners

• Jennifer Fonstad, Managing Director, Draper Fisher Jurvetson

• Doug Fisher, Principal, InterWest Partners LLC

• Janis Naeve, PhD, Director, Amgen Ventures

• Don Santel, Chief Executive Officer, Hyperion Therapeutics

Date and Time: Thursday December 3, 2009 | 3pm-6:30pm

Location: Orrick, Herrington & Sutcliffe LLP, 1000 Marsh Road, Building 1100, Menlo Park, CA 94025-1015

Click here for Venue Directions»

This event is typically sold out, so pre-registration is recommended to avoid disappointment on the day!

• Regular Price: $60

• Partners' Network: $50

• BioCenter Members: Free (please RSVP to Aurélie)

• On-site Registration: add $10 to the above

Topic Description

Steady capital is a must for all companies.  The first step in funding is knowing where to look.  Join experts from the investment world to understand the types of financing that are occurring in your industry today, and what can be expected for 2010.

Our Panel discussions are candid, interactive and informal. We want you to walk away with the real story behind how things work so you can make it happen yourself. This Panel will be followed by a Holiday Celebration Networking Reception.

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Northern California Analytical Chemists, Friday Lunch, Dec. 4, 2009

Event Name: Use of Nano Particle Technology to Enhance Performance of Pharmaceutical Products

Speakers: Niels Ryde, Ph.D., Elan Drug Technologies

Date and Time: Friday, December 04, 2009, 1100-1330

Location: Foster City Crowne Plaza

Event fee:$0 online before closing; $40 on site.

Online registration and further details:

Registration deadline: 12/2/2009  (it will close sooner if the seating cap is reached)

Additional Details: Visit the luncheons page Visit CACO website

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UCSC Extension in Silicon Valley, Saturday Dec. 5, 2009

Course: Biotechnology Basics for Non-Scientists

Date and Time: Saturday, Dec. 5, 2009, 9:00 am – 4:00 pm

Location: UCSC Extension in Silicon Valley, 2505 Augustine Drive, Santa Clara

Tuition: $235; Early enrollment discount $211.50

Course Description

Biotechnology focused articles appear in the newspapers almost every day. For the layperson, it can be a challenge to understand and appreciate this technology and its potential implications for human health, public policy and the Bay Area economy. This seminar provides non-scientists with an accessible and stimulating introduction to the world of biotechnology. The course begins with an overview of the basic concepts in molecular biology and genetics that serve as a foundation for biotechnology. The instructor then highlights gene-based technology and important biotechnology breakthroughs, especially as they relate to Bay Area companies and institutions. He explores the impacts and the future of this cutting-edge discipline, and students leave the course with a new vocabulary and a solid understanding of the power and potential of biotechnology. No scientific background is assumed.

Instructor Background

Raxit J. Jariwalla, Ph.D., is senior researcher in nutrition and infectious diseases at the Dr. Rath Research Institute in Santa Clara, California. He was formerly head of the virology and immunodeficiency research program at the Linus Pauling Institute of Science and Medicine, and principal research investigator at the California Institute for Medical Research. Dr. Jariwalla is recognized for his contributions to virology, carcinogenesis, immunodeficiency disease and nutrition research.

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Bio2Device Group, Tuesday Evening, Dec. 8, 2009

Topic: “Science + Commercialization = Valuation. Building a Commercial Story that Resonates with Prospective Partners.”

Speaker: Harris Kaplan, President and Chief Executive Officer, Healogix

Date and Time: Tuesday, Dec.. 8, 2009, 6:00 – 9:00 pm

Location: Location: TIPS Group Law Offices , 1000 Elwell Court, Palo Alto, CA 94303

Advanced registration is required see website for details a week prior to event.

Cost: Fee for light dinner with range depending on timing of registration:

Topic Description

The biotech IPO window has been closed for some time now and is unlikely to reopen anytime soon. As a result, biotech executives are increasingly reliant on a big pharma or big biotech to provide the capital needed to continue to develop promising new compounds and the competition for pharma or biotech dollars is intense. The larger companies differ significantly from financial investors. They are at least as concerned about how the product will perform in the market post launch as they are about the science. Thus, it is as important for a biotech executive understand the commercialization opportunity and to make that story come to life for an executive. Think venture capital but without a requirement that “monies have to be put to work.”  A biotech executive has to make one of these larger companies want to do a deal with your company.

This talk will focus on how biotech executives go about building a robust commercial story – what elements need to be included in that story and how to position compounds so they are very attractive to pharma and big biotech scientists and business development executives. Most biotech deals get one opportunity to present their technology and/or product. This talk will help company executives make that one time count.

Speaker Bio

Harris Kaplan is currently President and Chief Executive Officer of Healogix, a consultancy formed in late 2005 that advises companies on how to create and maximize the value of new products in development.

Harris has extensive experience in the pharmaceutical industry both on the client and consulting side of the business and has worked on the introduction of more than 75 new products including Lipitor, Crestor, Nexium, Rituxan, and Herceptin.

Harris co-founded Migliara-Kaplan Associates which became the world’s largest custom marketing research company serving 19 of the top 20 pharmaceutical companies. Migliara-Kaplan Associates specialized in helping companies identify new product opportunities and then maximizing the commercial potential of new products in development. Migliara-Kaplan was acquired by NFO in 1996 and is now part of TNS Healthcare. Harris was also cofounder of Cozint Interactive which was acquired by GFK, the German based research company. Harris serves as an advisor to several venture capital funds and is on the Board of Directors of Informedix and the Kernan Orthopedic Hospital.

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