Lobbying from the Perspective of a Physician and Former State ...

  • 1,115 views
Uploaded on

 

  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
    Be the first to like this
No Downloads

Views

Total Views
1,115
On Slideshare
0
From Embeds
0
Number of Embeds
0

Actions

Shares
Downloads
5
Comments
0
Likes
0

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide
  • Amgen Corporate Template
  • Amgen Corporate Template
  • Amgen Corporate Template
  • Amgen Corporate Template
  • Amgen Corporate Template
  • Amgen Corporate Template
  • Amgen Corporate Template
  • Amgen Corporate Template
  • Amgen Corporate Template SIMILAR: Product attributes are similar enough to establish the same safety and efficacy as comparator drug. IDENTICAL: Product attributes are the same as those of comparator drug. However, Quality and consistency of biopharmaceuticals are extremely sensitive to changes in manufacturing and production. Minor variations could produce different products with clinical consequences. References : Roger SD. Biosimilars: How similar or dissimilar are they? Nephrology. 2006;11:341-3466. Power DA, et al. Biological drugs and the coming of ‘biosimilars’. J Pharm Pract Res. 2008;38:137-139.
  • Amgen Corporate Template Biopharmaceutical (protein-based) drugs differ from chemical drugs in the following areas: Molecular properties : the size and complexity of the active substance Size: biopharmaceuticals are large, chemicals are small (Molecular weight of interferon alpha: 19,000 Dalton and Aspirin: 180 Dalton) Structure: biopharmaceuticals are complex, chemicals simple and well-defined Stability: biopharmaceuticals are unstable, chemicals stable Modification: biopharmaceuticals have many options to modify, chemicals have limited Manufacturing : the nature of the starting materials (cell banks, tissues and other biological products), and the complexity of manufacturing processes Biopharmaceutical products are derived from living cells, they are complicated to produce, and nearly impossible to replicate in an identical fashion. Broadly speaking, the manufacturing and the analytical difficulties increase with the molecular weight of the protein, and with the extent of glycosylation and other post-translational modifications. Chemicals are manufactured through predictable chemical process that are relatively easy to reproduce. Simple to purify and to measure their purity with a high degree of certainty and precision. Chemists can easily reverse engineer and make nearly perfect copies. Characterization : the limitations of state-of the-art methods to fully characterise proteins and detect all product variables that can influence side effects Biopharmaceuticals difficult to characterise due to mixture of related molecules Chemicals easy to characterise Stability : Because they are natural proteins, the storage and stability conditions of biopharmaceuticals are highly sensitive in contrast to chemical drugs. Immunogenicity : Because biopharmaceuticals are exogenous molecules produced in “living” systems, they have the capacity to produce an immune response; The clinical significance of immunogenicity varies by product class and individual products. References : Sharma BG. Manufacturing challenges for biosimilars – the process defines the product. EJHP Practice. 2007;13:54-56. Prugnaud JL. Similarity of biotechnology-derived medicinal products: specific problems and new regulatory framework. Br J Clin Pharmacol . 2007;65:619-620. Roger SD. Biosimilars: How similar or dissimilar are they? Nephrology. 2006;11:341-3466. Power DA, et al. Biological drugs and the coming of ‘biosimilars’. J Pharm Pract Res. 2008;38:137-139.
  • Amgen Corporate Template In many countries, biosimilars require a different regulatory pathway Chemical drugs are relatively easy to copy and analyse because of their simple chemical ingredients and structure. In contrast, biopharmaceuticals are complicated to produce and to replicate because they are derived from living organisms. Small differences in the production process of biopharmaceuticals can yield vastly different products, whereas the manufacturing process of chemical medicines is predictable. Generic versions of chemical medicines are identical chemical copies or the original product, whereas biosimilars are not identical, only similar, to innovator products. Generic products do not require submission of clinical study data rather, only pharmacoequivalence data is required. Of note, however, EMEA recognises that the “generic pathway” is not possible for approval of biopharmaceutical products. Rather, the conduct of clinical studies are required. Reference : Rogers SD. Biosimilars: How similar or dissimilar are they? Nephrology. 2006;11:341-346. Power DA, et al. Biological drugs and the coming of ‘biosimilars’. J Pharm Pract Res. 2008;38:137-139.
  • We are all part of a unique business and industry. There are not many other industries with such high risk, with such long cycle times and that are so expensive. What you’re looking at here on the top is a representation of the number of projects/product opportunities it takes at each stage of the pipeline to eventually yield one marketed product. For example, fewer than 1 in 10 research projects make it into pre-clinical research or to become what we call a PST. At each stage of the R&D process, opportunities fall out for a variety of reasons. Human biology is extremely complex and has high variability, and truly isn’t all that well understood. It doesn’t follow the rules of math or physics. That makes developing drugs a very challenging endeavor. When you add up the time and cost, it generally takes about 15 years and counting the costs of failures, costs $1B from discovery to approval
  • Amgen Corporate Template

Transcript

  • 1. Lobbying from the Perspective of a Physician and Former State Senator * Kathleen (Kiki) Traylor MD, Amgen State Government Affairs Society of Utah Medical Oncologists Fall Meeting, October 3, 2010 * 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
    The views expressed herein are those of the speaker and not necessarily those of Amgen
  • 3. What I Already Knew as a Physician
    • We don’t practice in a vacuum
    • Legislation can dramatically affect our world
    • You can react to legislation that already passed (not ideal)
    The views expressed herein are those of the speaker and not necessarily those of Amgen Or you can proactively get involved in legislation from the beginning (ideal)
  • 4. What I Learned as a State Senator
    • 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 views expressed herein are those of the speaker and not necessarily those of Amgen The relationship between policy and politics is incredibly complex. Be patient.
  • 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
    The views expressed herein are those of the speaker and not necessarily those of Amgen
  • 6. As a Physician and Former Senator who Now Lobbies: You can make a difference
    • 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
    The views expressed herein are those of the speaker and not necessarily those of Amgen
  • 7. Talking Points One-Pager Example from the American Academy of Pediatrics’ 2010 legislation (Shown with permission)
  • 8. If You Testify
    • 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
    The views expressed herein are those of the speaker and not necessarily those of Amgen
  • 9. Stay involved
    • 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
    The views expressed herein are those of the speaker and not necessarily those of Amgen
  • 10. Grassroots Mobilization Example of an URGENT ACTION email from Colorado Medical Society (Shown with permission)
  • 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 views expressed herein are those of the speaker and not necessarily those of Amgen
  • 12. THE BIOSIMILARS PATHWAY Example of recent lobbying on a bioscience health care issue
  • 13. Remember…
    • … 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
    The views expressed herein are those of the speaker and not necessarily those of Amgen
  • 14. Amgen’s position on biosimilars is based in sound science, patient focus and fair competition Amgen Policy Discussion. Kim Greco/Kiki Traylor, 6/21/10 Amgen supports a responsible, science-based legal & regulatory pathway for biosimilars that meets our guiding principles of:
  • 15. Biosimilars Endorsements Political/Congressional House New Democrat Coalition New Democrat Coalition Third Way California State Assembly California State Senate WA State House and Senate Economic Development Committee Physicians Alliance 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 Patients AIDS 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/Innovation Amarillo 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 Organizations Council 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
  • 16. Biosimilars are similar, not identical to original biopharmaceutical products Different cell lines Different manufacturing processes 1 Roger SD. Nephrology. 2006;11:341-346; 2 Power DA, et al. J Pharm Pract Res. 2008;38:137-139. ....but not identical Biosimilars are similar... Impact of small differences in either biological or manufacturing process could lead to different clinical efficacy and safety for patients 1,2
  • 17. Biologics are larger & more complex than chemical medicines Aspirin ~180 daltons Insulin 51 amino-acids ~5,800 daltons Somatropin 191 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
  • 18. Biosimilars differ from generics in molecular properties and complex manufacturing 1–4 1 Sharma BG. EJHP Practice. 2007;13:54-56; 2 Prugnaud JL. Br J Clin Pharmacol. 2007;65:619-620; 3 Roger SD. Nephrology. 2006;11:341-346; 4 Power DA, et al. J Pharm Pract Res. 2008;38:137-139. Neupogen Aspirin Properties Manufacturing Unique line of living cells; Impossible to ensure identical copy Predictable chemical process Identical copy can be made Characterisation Impossible to characterise fully due to a mixture of related molecules Easy to fully characterise Stability Sensitive 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 Small
  • 19. Why do Biosimilars require a different regulatory pathway? 1,2 EMEA, European Medicines Agency 1 Roger SD. Nephrology. 2006;11:341-344; 2 Power DA, et al. J Pharm Prac Res. 2008;38:137-139. 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
  • 20. Biopharmaceutical R&D is a High-Risk, Long-Cycle, and Expensive Business 2 9 13 ~ 150 5 1 R&D Projects by Phase to Generate One Drug ~ 15 Years and $1B 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
  • 21. Amgen’s position on biosimilars is based in sound science, patient focus and fair competition Amgen Policy Discussion. Kim Greco/Kiki Traylor, 6/21/10 Amgen supports a responsible, science-based legal & regulatory pathway for biosimilars that meets our guiding principles of:
  • 22. Outcome of the Advocacy Efforts in the US PPACA passed and included a biosimilars pathway that focused on patient safety, sound science, and continued innovation
  • 23. So the Work is Done on the Biosimilars Issue?
    • No, implementation has only just begun…
    Interchangeability/ Substitution Patient Safety / Pharmacovigilance Distinct Naming Data Extrapolation Transparent Labelling
  • 24. Questions