Designed for Professionals in
the Pharmaceutical and Biotech industries
The expiration of patents on therapeutic biological
products raises major technological and policy questions
about potential "generic" equivalents – so-called
biosimilar or follow-on biologics. While there may be great
opportunities for manufacturers and professionals in the
biosimilars field, parallel concerns regarding
manufacturing, clinical trials, economics, intellectual
property, analytical methods, safety and efficacy arise.
The UW Conference on Biosimilars will provide updates and
explore potential solutions to these concerns. It is
designed to serve the needs of professionals in the
pharmaceutical and biotech industries who work on clinical
development, process development, safety and quality
assurance, regulatory compliance, legal affairs and
corporate strategic planning.
Join us to for this intensive
experience to
- Update your knowledge
- Acquire pertinent resources
- Connect with other professionals in the field
UW Tower
4th Floor Auditorium
Day One
7:00-8:30Check-In &
Registration
8:30Welcoming
Remarks
8:40-10:00Presentation/Q&A Session
"Immunologic Identity and Biosimilars: How
Close is Close Enough?"
Kirsten L. Vadheim, Ph.D., RAC
BioCompliance Consulting, Inc.
10:00-10:30Networking
Break (refreshments will be provided)
10:30-12:00Presentation/Q&A Session
"The Same or Different? IP Issues for
Pioneers and Generics in Drugs, Devices, and
Biologics"
Sean O'Connor
Associate Professor, School of Law
Co-Director, Graduate Program in IP Law & Policy
Faculty Director, Entrepreneurial Law Clinic Of Counsel,
Seed IP Law Group
www.SeedIP.com
University of Washington
12:00-1:30Lunch (on
your own or host a group)
1:30-3:00Presentation/Q&A Session
"Regulatory Considerations for Biosimilars:
Attitudes of the FDA"
Lauret Ballsun, RN, BSN
LBC Pharmaceutical Professionals, LLC
Specializing in Pharmacovigilance and Risk Management
3:00-3:30Networking
Break (refreshments will be provided)
3:30-5:00Presentation/Q&A Session
"What is happening where biosimilars are
currently available? – The case of Latin
America"
Rafael Alfonso, MD, MSc
Research Associate, School of Pharmacy
Pharmaceutical Outcomes Research & Policy Program
University of Washington
Day Two
7:30-8:30Check-in &
registration
8:30-10:00Presentation/Q&A
"Economic Considerations for Biosimilars:
Theory and Examples"
Brian W. Bresnahan, PhD
Research Assistant Professor, Radiology
Adjunct Research Assistant Professor
Pharmaceutical Outcomes Research & Policy Program
School of Pharmacy
University of Washington
Seattle, WA
10:00-10:30Networking
Break (refreshments will be provided)
10:30-12:00Presentation/Q&A Session
"Biosimilars and Clinical Trials: What are
the Issues?"
Janet Rose Rea, MSPH, RAC
Vice President, Regulatory Affairs and Quality
Poniard Pharmaceuticals
12:00-1:30Lunch (on
your own or host a group)
1:30-3:00Presentation/Q&A Session
"Biochemical and Biophysical
Characterization of Proteins"
David Goodlett, MS, PhD
Professor, Department of Medicinal Chemistry
School of Pharmacy
&
Carlos Enrique Catalano, Pharm.D., Ph.D.
Professor, Department of Medicinal Chemistry
School of Pharmacy
University of Washington
3:15-4:00Conference
Summary and Take-away Points
Thomas A Baillie, Dean, School of
Pharmacy
4:00-4:30Networking
(refreshments will be provided)
Conference Director
Thomas K. Hazlet, Pharm.D.,
Dr.P.H.
Associate Professor
Pharmaceutical Outcomes Research & Policy Program
School of Pharmacy
University of Washington
Seattle WA
Presenters
Rafael Alfonso, MD, MSc
Research Associate, School of Pharmacy
Pharmaceutical Outcomes Research & Policy Program
University of Washington
Seattle, WA
Thomas A Baillie
Dean, School of Pharmacy
University of Washington
Seattle, WA
Lauret Ballsun, RN, BSN
LBC Pharmaceutical Professionals, LLC
Brian W. Bresnahan, PhD
Research Assistant Professor, Radiology
Adjunct Research Assistant Professor
Pharmaceutical Outcomes Research & Policy Program
School of Pharmacy
University of Washington
Seattle, WA
Carlos Enrique Catalano, Pharm.D.,
Ph.D.
Professor, Department of Medicinal Chemistry
School of Pharmacy
University of Washington
Seattle, WA
David Goodlett, MS, PhD
Professor, Department of Medicinal Chemistry
School of Pharmacy
University of Washington
Seattle WA
Sean O'Connor
Associate Professor, School of Law
Co-Director, Graduate Program in IP Law & Policy
Faculty Director, Entrepreneurial Law Clinic
Of Counsel, Seed IP Law Group
www.SeedIP.com
University of Washington
Seattle, WA
Janet Rose Rea, MSPH, RAC
Vice President, Regulatory Affairs and Quality
Poniard Pharmaceuticals
Seattle, WA
Kirsten L. Vadheim, Ph.D., RAC
BioCompliance Consulting, Inc.
7710 196th Ave N.E.
Redmond WA 98053
Conference Location
UW Tower
4333 Brooklyn Ave. NE
Seattle, WA
- Main entrance at the corner of
Brooklyn Ave. NE and NE 45th St.
- Second entrance from parking garage
via skybridge over 12th Ave. NE. Note: the parking garage
is closed on Saturdays.
Driving Directions
Traveling I-5 South — Take the
45th Street exit from I-5 (exit # 169.). At the traffic
light at NE 45th Street turn left heading east (towards the
main UW Seattle campus.) The UW Tower is about 5 blocks up
on the right between 12th Ave. NE and Brooklyn Ave. NE.
Traveling I-5 North — Take the
45th Street exit from I-5 (exit # 169.) Get into the far
right turn lane. At the traffic light turn right onto NE
45th Street heading east (towards the main UW Seattle
campus.) The UW Tower is about 5 blocks up on the right
between 12th Ave. NE and Brooklyn Ave. NE.
Parking
A car is not necessary for conference participants who
will be staying in University area hotels. The recommended
hotels are walking distance from the UW Tower or a shuttle
is provided by the hotel. For participants who will be
arriving by car, Parking for UW Tower is available on
surrounding streets (Brooklyn, 43rd, 12th) or in University
of Washington parking lots. UW Tower garage parking is not
available to visitors in the evening or on weekends.
Bicycle parking is available in front of the UW Tower, and
major METRO bus routes run near the building.
UW Visitors Information Link with travel information and
campus maps:
http://depts.washington.edu/mediarel/temp/vc.shtml
Seattle Weather
Summer temperatures in Seattle are generally mild. The
average daytime high temperature in June is 69°F and
the average nighttime low temperature is 52°F. National
Weather Service for Seattle, WA
Ten things you can see and do in Seattle...
The Space Needle
Seattle Center, 400 Broad St.; 206.905.2100;
www.spaceneedle.com
A 41-second elevator ride takes you up 520 feet to the
observation deck of the Space Needle, built for the 1962
World's Fair. Enjoy a meal at SkyCity, the restaurant at
the top that revolves 360
Pike Place Market
Between First Ave. and Western, from Pike to Virginia
streets www.pikeplacemarket.org
Born in 1907, Seattle's Pike Place Market is the granddaddy
of farmers' markets. Today, it's a major tourist attraction
with 200 businesses operating year-round, 190 craftspeople
and 120 farmer booths - plus street performers and
musicians. Flowers by the bucketful, flying fish, fresh
pastries and fruit, handmade cheeses, local honey, wine, an
assortment of restaurants, import goods, antiques,
collectibles and lots of surprises are around every
corner.
Ferries
www.wsdot.wa.gov/ferries
Traveling by ferry is a state of mind as much as a means of
transportation to some of the Puget Sound's most historic
and scenic sites. Views of the Olympic and Cascade
mountains, the Seattle cityscape and the green shorelines
will draw you out onto the deck to feel the salt breeze on
your face. The state ferry system takes passengers and
their vehicles from Seattle and nearby departure points to
Vashon Island, the Kitsap Peninsula, the San Juan Islands
and Canada. For privately operated ferries, see the
Sightseeing & Tours (page 35) and Visitors
Services/Travel & Transportation (page 120) listings in
this guide.
Seattle Aquarium
206.386.4300
www.seattleaquarium.org
Meet Alki, the sea otter pup born at the Aquarium. Walk
under the water in a glass dome as bluntnose sixgill sharks
and other Elliott Bay creatures swim all around you. Touch
a sea anemone. Learn about the lives of salmon at the
world's first aquarium-based salmon ladder. Marvel at the
impossibly bright-colored coral reef fish. And don't forget
to wave to the giant Pacific octopus.
The Seattle Waterfront
Piers 52 to 70 on Alaskan Way
ci.seattle.wa.us/tour/water.htm
A bustling collection of attractions, restaurants and
shopping, as well as starting points for ferries, cruise
ships, the Victoria Clipper and Argosy boat tours are
located here. Feed the seagulls at the statue of Ivar
Haglund in front of Ivar's Acres of Clams, stroll by the
fountains on the wooden piers of Waterfront Park, admire
the view or shop for souvenirs.
Woodland Park Zoo
South Gate: 750 N. 50th St
206.684.4800
www.zoo.org
See more than 1,000 animals of 300 different species, from
elephants and gorillas to piranhas and penguins, in
naturalistic exhibits at the Woodland Park Zoo. Drop by at
scheduled feeding times and talk with the people who care
for the animals.
Bill Speidel's Underground Tour
608 First Ave.
206.682.4646
www.undergroundtour.com
After the Great Seattle Fire of 1889, the city was rebuilt
over the top of the ruins. This guided tour takes visitors
through the hidden subterranean passages that once were the
main roadways and storefronts of old downtown Seattle and
tells stories of the frontier people who lived and worked
there.
The Seattle Public Library
1000 Fourth Ave.
206.386.4636
www.spl.org
Designed by world-renowned Dutch architect Rem Koolhaas,
the award-winning glass and steel structure of the new
Central Library makes the building seem a little off-kilter
and translucent - allowing passersby on the street to look
in.
Tillicum Village
Blake Island
206.933.8600
www.tillicumvillage.com
A short, narrated cruise takes you to an island village,
where you'll feast on salmon cooked in the authentic Native
American way. A stage show of traditional dances and
stories entertains and teaches you about the people who
lived in the Northwest first.
Ride the Ducks of Seattle
516 Broad St, Seattle
206.441.DUCK (3825)
www.ridetheducksofseattle.com
Tour Seattle by land and water on a WWII amphibious landing
craft. This 90-minute adventure tour will have you
"quacking up" through the streets of Seattle. You'll see
the major sights of the Emerald City on land before you
head out to the funky Fremont neighborhood where you'll
splash into Lake Union.
Explore the online Visitors Guide for more
attractions
Credit: Seattle Convention and Visitors Bureau
Lodging
Please mention that you are attending a University of
Washington conference and request the UW rate. This rate is
subject to room availability.
University Inn
Web: http://www.universityinnseattle.com
Phone: (206) 632-5055
Reservations: (800) 733-3855
Fax: (206) 547-4937
4140 Roosevelt Way NE
Seattle, WA 98105
102 rooms, AAA approved. Rates are for one person. Short
walk west of University campus; free parking; breakfast
buffet, afternoon snack 4-5 pm, free local shuttle service
(available by reservation); hotel wide wireless internet
access and computer station in the lobby to check your
email; non-smoking hotel; seasonal outdoor swimming pool;
nearby shops and restaurants; free local calls; newly
renovated hotel.
Watertown Hotel
Web: http://www.watertownseattle.com
Phone:(206) 826-4242
Reservations: (866) 944-4242
Fax: ( 206) 315-4242
Email: reservations@watertownseattle.com
4242 Roosevelt Way NE
Seattle, WA 98105
Short walk west of University campus; three miles from
downtown and four blocks from the University of Washington;
complimentary breakfast buffet; free parking; free local
shuttle service (available by reservation); HBO, ESPN, and
CNN; free parking and high speed cable internet access.
Silver Cloud Inn - University District
For online reservations go to http://scinns.com/09home.htm
"Group or Corporate ID" is UWCONF
Web: http://www.scinns.com/universi.htm
Phone: (206) 526-5200
Reservations: (800) 205-6940
Fax: (206) 522-1450
5036 25th Avenue NE
Seattle, WA 98105
179 rooms, AAA approved. Complimentary shuttle service
to/from campus. Near University Village Shopping Mall.
Facilities include indoor pool, spa, fitness center, guest
laundry, free high speed wireless internet access, and free
on-site parking. Refrigerators and microwaves in all rooms.
Complimentary breakfast is included.
Hotel Deca (formerly University Tower Hotel)
Web: http://www.hoteldeca.com/
Phone: (206) 634-2000
Reservations: (800) 899-0251
Fax: (206) 547-6029
4507 Brooklyn Avenue NE
Seattle, WA 98105
155 rooms, AAA approved. Fully renovated, panoramic
views, short walk west of University of Washington campus,
complimentary deluxe continental breakfast, 100%
non-smoking, Restaurant, lounge, and Tully's coffee shop
onsite, complimentary parking for overnight guests,
complimentary e-mail access available in lobby, in-room
coffee, hairdryer, iron/board, data-ports, voicemail, cable
TV with HBO, delivered newspapers, pay-per-view movies and
Web TV, 24-hour fitness facility, onsite business
center
Please check back for
registration details.
Questions
This conference is presented by the UW
School of Pharmacy. Conference organization and
management is provided by UW Educational Outreach. If you
have questions about this program, please call 206-685-8936
in the greater Seattle area, or 888-469-6499, or e-mail us
at: extnadvising@extn.washington.edu
For questions about specific conference content, please
contact:
Mona Kunselman
UW Extension
206-685-6514
mkunselman@extn.washington.edu
Questions about registration or arrangements may be
directed to:
Sara Kellman
skellman@u.washington.edu
UW
Conference Management
