Lobbying from the Perspective of a Physician and Former State Senator *
Kathleen (Kiki) Traylor MD, Amgen State Government AffairsSociety of Utah Medical Oncologists Fall Meeting, October 3, 2010
* The views expressed herein are those of the speaker and not necessarily those of Amgen
The views expressed herein are those of the speaker and not necessarily those of Amgen 2
A Career of Many Hats
• Practicing physician
• Former Colorado State Senator
• What’s next?
• Combine medical/scientific background with policy/ legislative background…and still see patients?
• Amgen State Government Affairs - the perfect world
What I Already Knew as a Physician
The views expressed herein are those of the speaker and not necessarily those of Amgen 3
• We don’t practice in a vacuum
• Legislation can dramatically affect our world
• You can react to legislation that already passed (not ideal)
Or you can proactively get involved in
legislation from the beginning (ideal)
What I Learned as a State Senator
The views expressed herein are those of the speaker and not necessarily those of Amgen 4
• Legislators are looking for (and need) good information
• Legislators will listen and learn but most have very little health care knowledge or experience
• Legislators listen and learn best when issues are framed objectively, with sound science and patient safety as top priorities. NO sales pitch.
• Physicians are respected by legislators – remember this!
The relationship between policy and politics is incredibly complex. Be patient.
The views expressed herein are those of the speaker and not necessarily those of Amgen 5
As a Physician and Former Senator who Now Lobbies: You can make a difference
• Laying the groundwork• Establish relationships• Build those relationships• Consider outside consultants• Get a physician elected• Build a coalition – who else is on
your side? Who is not? ALL stakeholders matter
• The white coat – to wear or not to wear
• Advocates at the state level can influence your Congressional delegation
As a Physician and Former Senator who Now Lobbies: You can make a difference
The views expressed herein are those of the speaker and not necessarily those of Amgen 6
• Drilling down to the Details• Meet with bill sponsors, meet with opposition. All stakeholders
matter• Educate and advocate• Remember, you are a respected expert• BUT keep it to 15 minutes or less• If you have an ask, ask it• Explain your issue in simple terms, no acronyms• Absolute Must: One page handout of Talking Points on your
issue and position - and list all coalition members on the back• Start with three points, end with three points• Leave your one-pager, your coalition list, and your contact
information with the legislator AND his/her staffer
Talking Points One-Pager
Example from the American Academy of Pediatrics’ 2010 legislation
(Shown with permission)
If You Testify
The views expressed herein are those of the speaker and not necessarily those of Amgen 8
• Prepare with your lobbyist or legislator• How to introduce yourself• How to address the committee chair and members• Answering questions
• Leave with every legislator on the committee • Your one-pager• Your coalition list• Your contact information
Stay involved
The views expressed herein are those of the speaker and not necessarily those of Amgen 9
• The process may take months (or years!)
• You might testify multiple times
• Amendments take time and often require legal review
• Mobilize your grassroots advocacy network
Grassroots Mobilization
Example of an URGENT ACTION email from Colorado Medical Society
(Shown with permission)
The views expressed herein are those of the speaker and not necessarily those of Amgen 11
Finally…
• If the bill passes: • Participate in the bill signing with the Governor!
• If the bill fails:• Regroup the coalition and legislators• Meet with opposition for compromise• Discuss next steps – try again next year? Different approach?
THE BIOSIMILARS PATHWAY
Example of recent lobbying on a bioscience health care issue
Remember…
The views expressed herein are those of the speaker and not necessarily those of Amgen 13
• …Relationship building
• …Coalition-building
• …State advocates can and will influence your federal/Congressional delegation
• …Educate about your issue, advocate for your position
• …Start with three points, end with three points
Amgen supports a responsible, science-basedlegal & regulatory pathway for biosimilars
that meets our guiding principles of:
Amgen’s position on biosimilars is based in sound science, patient focus and fair competition
14Amgen Policy Discussion. Kim Greco/Kiki Traylor, 6/21/10
Biosimilars EndorsementsPolitical/CongressionalHouse New Democrat Coalition
New Democrat Coalition
Third Way
California State Assembly
California State Senate
WA State House and Senate Economic Development Committee
PhysiciansAlliance of Specialty Medicine
American Association of Neurological Surgeons
American Association of Orthopaedic Surgeons
American College of Emergency Physicians
American College of Obstetricians and Gynecologists
American Gastroenterological Association
American Society of Cataract & Refractive Surgery
American Society of Plastic Surgeons
American Urological Association
Coalition of State Rheumatology Oranizations
InterAmerican College of Physicians and Surgeons
Medical Society of the State of NY
National Association of Spine Specialists
PatientsAIDS Institute
Alliance for Aging Research
Alliance for Health Education and Development
Alliance for Patient Access
ALS Association
AMC Cancer Research Center
American Autoimmune Related Diseases Association
*This list represents the most current endorsements as of September 30, 2009
Plasma Protein Therapeutics Association
RetireSafe
Sickle Cell Community Advisory Council
OldTimers Foundation
Men’s Health Network
National Alliance on Mental Illness
The Pain Foundation
Kidney Cancer Association
Lifespan Network
Community Access National Network
Congress of Neurological Surgeons
Heart Rhythm Society
Immune Deficiency Foundation
Candlelighters Childhood Cancer Foun.
Academic/InnovationAmarillo Biosciences
Association of American Universities
Axial Biotech
BioAdvance – Biotechnology
Greenhouse of Southeastern PA
Boulder Ventures
California Healthcare Institute
California Institute for Regenerative
Medicine
Hershey (PA) Center for Applied
Research
Missouri State Legislature
National Venture Capital Association
NC State University
Texas Life Sciences Center
Texas Research and Technology
Foundation
Texas Healthcare and Bioscience Institute
University Science Center of Philadelphia
University of Utah
Silicon Valley Leadership Group
California Institute for Regenerative Medicine
Rocky Mountain Venture Capital
Association
Texans for the Advancement of
Medical ResearchPennsylvania House Life Science Caucus
Q Therapeutics
Duke University
NC State University
University System of Maryland
State Biotech OrganizationsCouncil of State Bioscience Associations
Arizona BioIndustry Association
Bio Nebraska Life Sciences Association
BIOCOM (California)
BioFlorida
BioForward (Wisconsin)
BioHouston
BioMed SA
BioNJ (New Jersey)
BioOhio
Biotechnology Association of Maine
Biotechnology Industry Organization
Colorado BioScience Association
CURE, the Center of Connecticut’s
BioScience Cluster
Delaware BioScience Association
Georgia Bio
MichBio (Michigan)
Missouri Biotechnology Association
Hawaii Science & Technology Counci
Iowa Biotechnology Association
Kansas Bio
Kentucky BioAlliance
LifeScience Alley (Minnesota)
Life Sciences Greenhouse of
Greater Pennsylvania
New England Biotech Association
Massachusetts Biotechnology Cncl.
Illinois Biotechnology Industry
Organization (iBIO)
Indiana Health Industry Forum
Montana Bioscience Alliance
Governors
Gov. Ritter (CO)
Gov. Schwarzenegger (CA)
Gov. Markell (DE)
Gov. Patrick (MA)
Gov. O’Malley (MD)
Gov. Rendell (PA)
Gov. Perry (TX)
Gov. Gregoire (WA)
Gov. Corzine (NJ)
Gov. Rell (CT)
Gov. Daniels (IN)
Gov. Kulongoski (OR)
Gov. Fortuno (PR)
Gov. Carcieri (RI)
Gov. Perdue (NC)
Gov. Quinn (IL)
Economic Development
Baltimore County Chamber of
Commerce
Colorado Office of Economic
Development
Greater Raleigh Chamber of
Commerce
North Carolina Department of
Commerce
Greater Pittsburgh Chamber of Commerce
Business Council of NYS, Inc.
Texas Association of Business
Jefferson Economic Council
Broomfield Economic Council
Metro North Chamber of Commerce
San Antonio Chamber of Commerce
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Biosimilars are similar, not identical to original biopharmaceutical products
Different cell lines
Different manufacturing processes
....but not identicalBiosimilars are similar...
Impact of small differences in either biological or manufacturing process could lead to different clinical efficacy and safety for patients1,2
1Roger SD. Nephrology. 2006;11:341-346;2Power DA, et al. J Pharm Pract Res. 2008;38:137-139.
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Biologics are larger & more complex than chemical medicines
Aspirin~180 daltons
Insulin51 amino-acids~5,800 daltons
Somatropin191 amino-acids~22,000 daltons
IgG1 antibody>1000 amino-acids~150,000 daltons
Images not to scale. Data sources: www.jtbaker.com, http://www.umass.edu/microbio/chime/antibody/abquests.htm and Genazzazi, AA et. al. (2007) Biosimilar Drugs: Concerns and Opportunities. Biodrugs 2007; 21 (6) ppg 351-356
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Biosimilars differ from generics in molecular properties and complex manufacturing1–4
1Sharma BG. EJHP Practice. 2007;13:54-56; 2Prugnaud JL. Br J Clin Pharmacol. 2007;65:619-620; 3Roger SD. Nephrology. 2006;11:341-346; 4Power DA, et al. J Pharm Pract Res. 2008;38:137-139.
ManufacturingUnique line of living cells;Impossible to ensure identical copy
Predictable chemical processIdentical copy can be made
CharacterisationImpossible to characterise fully due to a mixture of related molecules
Easy to fully characterise
StabilitySensitive to storage and handling conditions
More stable
Immunogenicity Higher potential Lower potential
Structure Complex Simple
Stability Unstable Stable
Modification Many options Well-defined
Biologics(Protein-based drugs)
Generics(Chemically-based drugs)
Size Large SmallNeupogen Aspirin
Pro
per
ties
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Why do Biosimilars require a different regulatory pathway?1,2
Chemical drugs are relatively easy to copy and analyse because of their simple chemical ingredients and structure
Biopharmaceuticals are complicated to produce and to replicate because they are derived from living organisms
Manufacturing process of chemical medicines is predictable
Small differences in the production process of biopharmaceuticals can yield vastly different products
Generic versions of chemical medicines are identical chemical copies
Biosimilars are not identical to innovator products
Generic products do not require submission of clinical efficacy and safety data
EMEA recognises that the “generic pathway” is not possible for approval of biosimilar products
Chemical drugs Biopharmaceuticals
EMEA, European Medicines Agency
1Roger SD. Nephrology. 2006;11:341-344;2Power DA, et al. J Pharm Prac Res. 2008;38:137-139.
Biopharmaceutical R&D is a High-Risk, Long-Cycle, and Expensive Business
Research Preclinical P1 P2 P3 Approval
Years 6 1.5 1.5 1.5 2.5 1.5
Costs $150M $200M $80M $120M $250M $130M
2913~ 150 5 1
R&D Projects by Phase to Generate One Drug
~ 15 Years and $1B
Amgen supports a responsible, science-basedlegal & regulatory pathway for biosimilars
that meets our guiding principles of:
Amgen’s position on biosimilars is based in sound science, patient focus and fair competition
21Amgen Policy Discussion. Kim Greco/Kiki Traylor, 6/21/10
Outcome of the Advocacy Efforts in the US
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PPACA passed and included a biosimilars pathway that focused on patient safety, sound science,
and continued innovation
So the Work is Done on the Biosimilars Issue?
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• No, implementation has only just begun…
Interchangeability/Substitution
Patient Safety / Pharmacovigilance
Distinct Naming
Data ExtrapolationTransparentLabelling
Questions
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