ISPE San Francisco/Bay Area Chapter
http://www.atdevents.net/register.php
Announces its next Dinner Meeting
Wednesday, January 28, 2015
5:30 - 9:00 pm
CEO Night
Featuring Talks from Industry Leaders
Location:
South San Francisco Conference Center
255 South Airport Blvd., South San Francisco, CA 94080
Presenters:
Sarvajna Dwivedi, PhD, Co-founder/Chief Scientific Officer, Pearl Therapeutics, a group company of AstraZeneca Inc.
R. Andrew “Andy” Ramelmeier, PhD, Senior VP, Biologics Technical Operations, Portola Pharmaceuticals
Peter Watler, Ph.D., Chief Technical Officer, Coherus Biosciences
"Meeting the demand, quality and GMP compliance of biosimilars with efficient hybrid modular manufacturing
facilities"
This presentation will address facility design, timeline, costs & in-process data to assure product quality and safety for the
emerging biosimilar markets.
Schedule:
5:30 - 6:30 pm
Registration and Networking Reception
6:30 - 7:15 pm
Dinner
7:15 - 9:00 pm
CEO Night Presentations
About the Presenters:
Sarvajna Dwivedi, PhD, is co-founder and chief scientific officer of Pearl Therapeutics, a group company of AstraZeneca
Inc. Pearl develops inhaled medicines for globally prevalent respiratory illnesses by using a novel particle engineering
platform. Pearl raised $167.5M in venture capital, progressed a dual bronchodilator combination into Phase III clinical testing,
and struck a $1.15b acquisition deal with AstraZeneca, all in less than six years from its start in 2007.
Dr. Dwivedi is a 2014 Ernst and Young Northern California Entrepreneur of the Year Finalist, and Pearl is a three time TiE50
top startup award winner, Drug Delivery Partnership Innovation Award winner, a Fierce 15 Biotech company, and a
FierceBiotech Top 15 Venture Deal maker. Dr. Dwivedi was trained in basic pharmaceutics at IIT, BHU, and in pharmaceutical
research at the University of British Columbia in Canada. He is a TiE Silicon Valley Charter Member, an advisor to emerging
companies, and a mentor to entrepreneurs.
CEO Night
Wednesday, January 28, 2015
About the Presenters:
R. Andrew “Andy” Ramelmeier, PhD has served as senior vice president of biologics technical operations since October
2014. He has 20 years of experience and a strong foundation in the development and manufacturing of biopharmaceuticals,
including monoclonal antibodies, vaccines, enzymes and other therapeutic proteins. Dr. Ramelmeier was responsible for the
licensure of several commercial products, process improvements to several other commercial products, and the design,
construction and operation of six biologics production facilities, totaling over $400MM in investment. His technical expertise
spans from cell culture and fermentation through purification, formulation and parenteral fill/finish.
Prior to joining Portola, Dr. Ramelmeier served as vice president, global manufacturing and facilities, at BioMarin
Pharmaceutical, a biotechnology company specializing in enzyme replacement therapies. In that position, he was responsible
for bulk manufacturing of three commercial biologics products, clinical manufacturing of pipeline product candidates, and
facilities maintenance and engineering. Previously, Dr. Ramelmeier was vice president, process sciences at Centocor /J&J,
where he was responsible for technical support of J&J’s BioPharm manufacturing plants. He held roles of increasing
responsibility in R&D at Centocor and in BioProcess R&D at Merck & Co.
Dr. Ramelmeier received a B.S. in chemical engineering from Johns Hopkins University and a PhD in chemical engineering
from the University of California, Berkeley. He conducted post-doctoral work at the Institute for Enzyme Technology in
Germany.
Peter Watler, Ph.D., Chief Technical Officer, Coherus Biosciences
Dr. Watler has over 32 years of biopharmaceutical process development and manufacturing experience, nearly half of which
was gained in process development and manufacturing at Amgen. He is highly experienced with the development and scaleup of biopharmaceutical processes including key unit operations such as fermentation, centrifugation, filtration, and
chromatography. Dr. Watler brings a strong skillset for process modeling, economic analysis, manufacturing operational
excellence, process control and validation. His regulatory experience includes co-authoring two IND submissions, four BLA
submissions, and participation in several FDA inspections and GMP audits.
Dr. Watler is a 12-year veteran of Amgen, which he joined in 1990. While at Amgen, he held roles leading process scale-up,
manufacturing technical services and pilot plant operations. As Associate Director of Process Engineering, he oversaw the
start-up of a 30,000 square foot pilot plant for monoclonal antibody development. In this role he implemented systems to
accelerate technology transfer and scale up from the laboratory through to clinical production for over ten product candidates.
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He also led teams responsible for the process validation of Neupogen , Stemgen , Kepivance and Infergen .
Dr. Watler most recently served as Chief Technology Officer of Hyde Engineering + Consulting, Inc. He led projects for GMP
manufacturing facility design where he employed state-of-the-art technologies to drive down capital costs while enhancing
cGMP compliance and operational efficiency. Dr. Watler has presented extensively in the US, Canada, China, Europe and
Japan on the latest ICH, FDA and ASTM approaches to pharmaceutical risk management, process validation and Quality by
Design.
Dr. Watler was previously Vice President, Manufacturing at VaxGen, a Genenetech spinoff formed to develop an AIDS
vaccine. He led the design, construction, and validation of a GMP facility for recombinant vaccine production. This fast-track
project featured systems from top tier suppliers and went from design through construction to start-up in just 12 months. Dr.
Watler was also responsible for managing supply chain and production operations, led the CMC team and prepared
submissions for the FDA, NIH and DHHS. He began his career with Allelix Biopharmaceuticals as a Process Development
Engineer optimizing fermentation mass transfer and product harvest operations.
Dr. Watler holds a Bachelor’s and a Master’s degree in Chemical Engineering from the University of Toronto where he
developed a prototype implantable insulin pump and a Ph.D. in Chemical Engineering from Yamaguchi University, Japan
where he implemented mechanistic modeling techniques for the scale-up and optimization of protein chromatography.
REGISTRATON FORM and INSTRUCTIONS
ISPE San Francisco/Bay Area Chapter
CEO Night
Wednesday, January 28, 2015
To Register and Receive an immediate receipt, use our on-line registration: http://www.atdevents.net/register.php
ISPE LA, SD, SF Members: If you are an ISPE Member in California, please do not set up a new account, as you
should already be in our system. Please email Rob Fleming (rob.fleming@yahoo.com) for assistance with your
username and/or password.
ISPE Members of other Chapters: If you are a Member of another ISPE Chapter, please fax your registration with
your Member number and Chapter affiliation.
Non Members: If you do not have an account on our system, you can set one up on the site using letters (not
numbers) as your username.
ALL: If you need help setting up your account or if you are having problems with the site or need a new
password, please email Rob Fleming (rob.fleming@yahoo.com) for assistance.
FAX REGISTRATION: Complete the Registration Form with a credit card payment and Fax the relevant page(s) to (949) 2668461.
PAY BY CHECK: If paying by check, please make check payable to: ISPE SAN FRANCISCO/BAY AREA CHAPTER, 5319
University Dr., Suite 641, Irvine, CA 92612. Chapter Tax ID #68-0282494. Contact Kimberly Syre: ksyre@cox.net with any
questions (or 949-387-9046). Name Badges will be given at the on-site registration desk.
Cancellations must be received in writing via fax or email to: ksyre@cox.net by January 19, 2015 for refund. After the
cancellation date if you have reserved a space but do not attend, your payment MUST be remitted, however, if your alternate
is a non-member, they will be required to pay the difference in fees. Name badges will be given at the event.
If paying by credit card, please check type of card:
____________ VISA
____________ MASTERCARD
Name on Card:
Card #:
Expiration Date:
Signature:
________$85 ISPE Members
________$125 NonMembers
NAME:
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ADDRESS with MAIL CODE:
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DRIVING DIRECTIONS
South San Francisco Conference Center
255 South Airport Blvd., South San Francisco, CA 94080
(650) 877-8787
http://www.ssfconf.com/
Getting to The South San Francisco Conference Center
Conveniently located on the San Francisco Peninsula just north of the San Francisco International Airport at the Highway 101
South Airport Boulevard exit.
Located 20 minutes away from both downtown San Francisco and Silicon Valley, The South San Francisco Conference
Center is visible from and located just east of Highway 101.
Arrival By Air
San Francisco International Airport (SFO) is the closest airport. South San Francisco Conference Center is close to the
airport. However, a rental car or taxi is recommended, as it is not walking distance from the airport.
BART
Take BART to South San Francisco Station. Shuttle service is available from the BART Station. Tell the shuttle driver that
your destination is the South San Francisco Conference Center.
CalTrain
Take CalTrain to South San Francisco Station. Shuttle service is available from the Cal Train Station. Tell the shuttle driver
that your destination is the South San Francisco Conference Center.
Bay Area Driving Directions
From the South (San Jose)
Take Highway 101 north to the South Airport Boulevard exit (which is two miles north of the San Francisco International
Airport). At the first stop light, drive straight across the intersection and directly into the parking lot. The South San Francisco
Conference Center is on the left.
From the North (San Francisco)
Take Highway 101 South to the South Airport Boulevard exit in South San Francisco. Stay to the right and turn east under the
freeway overpass. Make a right, at the Hungry Hunter Restaurant, onto South Airport Boulevard. The South San Francisco
Conference Center is located on the left.
From Marin County, 19th Avenue, Daly City
Take the Golden Gate Bridge to 19th Avenue and continue on to Highway 280 South. From Highway 280, take Highway 380
East to Highway 101 North (San Francisco). From Highway 101 North exit at South Airport Boulevard. At the first stop light,
drive straight across the intersection into the parking lot. The South San Francisco Conference Center is located on the left.
Note: There is a South Airport Boulevard exit off Highway 380. Do not take this exit. Please take the South Airport Boulevard
exit off of Highway 101 North.
Parking
Free parking at the South San Francisco Conference Center, however, it is limited. Carpooling is encouraged.
It is recommended that you look up driving directions from your own starting point.