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Martha Arnold Principal,  PharmApprove Princeton, NJ Michael W.  Young biomedwoRx: Life Sciences Consulting San Diego, CA ...
Disclaimer <ul><li>The views discussed in this presentation given on January 21, 2010 at the Loews Hotel Philadelphia at t...
Objectives <ul><li>To provide you with: </li></ul><ul><ul><li>A better understanding of the Oncology Drugs Advisory Commit...
Your Presenters <ul><li>Martha Arnold </li></ul><ul><ul><li>Principal, PharmApprove </li></ul></ul><ul><ul><li>Regulatory ...
Insurmountable Opportunities <ul><li>In 1972, Congress   passed the  Federal Advisory Committee Act Public Law 92-963 </li...
Additional Hurdles <ul><li>Over the past decade that the advisory panel process itself has changed.  </li></ul><ul><li>Bec...
About Advisory Committees <ul><li>The Food and Drug Administration, to assist in its mission to protect and promote the pu...
Drugs Advisory Committees  <ul><li>Anesthetic and Life Support Drugs Advisory Committee   </li></ul><ul><li>Anti-Infective...
ODAC According to ODAC <ul><li>The '''Oncology Drugs Advisory Committee''' (ODAC) receives requests for technical and clin...
CDER <ul><li>The Center for Drug Evaluation and Research  (CDER, pronounced &quot;see'-der&quot;) is a division of the  U....
CBER <ul><li>The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the  U.S. Food and Dru...
ODAC Span of Influence <ul><li>Advisory   committees  are the primary means by which the   FDA obtains independent scienti...
Who is the ODAC Panel? <ul><li>Chair -- Gail Eckhardt, MD, University of Colorado (Medical Oncology) </li></ul><ul><li>Ral...
ODAC Panel  continued <ul><li>Ronald Richardson, M.D., Mayo Clinic (Medical Oncology) </li></ul><ul><li>Mikkael Sekeres, M...
Some Learnings to Share
Define Your Issues Before Messages <ul><li>Start by identifying all possible FDA and committee issues.  </li></ul><ul><li>...
Craft Your Take Home Messages:  What do the data say? <ul><li>Based on the data and outside opinion, formulate key message...
Selecting Presenters:  Credible Is More Important Than “Good” <ul><li>Assuming your pivotal clinical work has been done by...
The Real “No Spin Zone”  <ul><li>“ Let’s 'spin' that point more,” is sometimes the call to action in rehearsals or plannin...
Be Prepared to take a Direct  Approach to Uncomfortable Questions <ul><li>Counter-spin is answering every question directl...
Planning and Rehearsing Answers is as Important as Knowing the Answers <ul><li>Some ODAC  Teams have divided the team into...
Outside Experts Need to Rehearse <ul><li>“ They wouldn't be outside experts if they couldn't perform well,” is sometimes e...
Who Should Moderate Q & A? <ul><li>Logic would tell you a moderator with no responsibilities other than getting the right ...
The Argument for Outside Help <ul><li>Many journalists who cover the FDA have noted recently that the FDA has become more ...
Perspectives on ODAC <ul><li>Martha Arnold </li></ul>
Your Audience:  ODAC <ul><li>Standing membership </li></ul><ul><ul><li>Oncologists across several subspecialties, includin...
What is ODAC, not? <ul><li>They are  NOT  your KOLs </li></ul><ul><li>They may  NOT  be expert in  your  therapeutic area ...
What is Your Objective? <ul><li>Earn as many votes as possible </li></ul><ul><li>Influence the discussion </li></ul>
Influence the Discussion?  Isn’t it All About the Vote? <ul><li>“ The advisory committee is advisory. Period. It is not a ...
How much time do you have? 8:00 am Introductory comments 8:15 Sponsor Presentation 9:00  FDA Presentation 9:45 Break 10:00...
Projection Screen FDA Team Podium General Audience Videographers Additional Sponsor Seating Sponsor Team Press “ Setting t...
Who are Your Other Audiences? <ul><li>FDA </li></ul><ul><li>Attendees in the room </li></ul><ul><ul><li>Media </li></ul></...
As You Prepare <ul><li>Messaging/Storyline is critical </li></ul><ul><ul><li>Consistency </li></ul></ul><ul><ul><li>Clarit...
Making the Most of Your Opportunities <ul><li>Briefing Package </li></ul><ul><ul><li>Brief, accessible, complete </li></ul...
Making it Happen <ul><li>The commitment </li></ul><ul><ul><li>5 to 6 months ideal timeline </li></ul></ul><ul><ul><li>For ...
Final Thoughts <ul><li>One of the hardest, most stressful and exhausting experiences you’ll ever go through </li></ul><ul>...
Recent Experience <ul><li>Steven M. Fruchtman, M.D.,  Vice President, Clinical Research, Allos Therapeutics, Inc. on succe...
Recent Experience <ul><li>Elizabeth Faust, PhD , Senior Director, Medical Affairs , Gloucester Pharmaceuticals on successf...
Upcoming ODAC <ul><li>On  February 10, 2010,  during the morning session, the committee will discuss new drug application ...
Oncology Groundshifts <ul><li>Healthcare reform will bring a number of seismic changes. These include: </li></ul><ul><ul><...
Thank you <ul><li>Preparing for Successful Interactions with ODAC 3rd Annual Forum on Oncology Commercialization Strategie...
Who is ODAC? <ul><li>Chair S. Gail Eckhardt, M.D. Expertise: Medical Oncology Term: 02/16/2006 - 06/30/2010 Professor and ...
Who is ODAC? <ul><li>Jean Grem, M.D., F.A.C.P.   Expertise: Hematology/Oncology Term: 05/05/2008 - 06/30/2011 Professor of...
Who is ODAC? <ul><li>Patrick Loehrer, Sr., M.D. Expertise: Medical Oncology Term: 05/21/2009-06/30/2012 Interim Director, ...
Additional Resources <ul><li>FDA Advisory Committee.com </li></ul><ul><li>  www.fda.gov/AdvisoryCommittees </li></ul>
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ODAC: Preparing For Successful Interactions w/ Oncology Drugs Advisory Committee

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Presentation given at CBI 3rd Annual Forum on Oncology Commercialization Strategies [Philadelphia, Jan 21, 2010]

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ODAC: Preparing For Successful Interactions w/ Oncology Drugs Advisory Committee

  1. 1. Martha Arnold Principal, PharmApprove Princeton, NJ Michael W. Young biomedwoRx: Life Sciences Consulting San Diego, CA January 21, 2010 Philadelphia, PA Preparing for Successful Interactions with ODAC 3rd Annual Forum on Oncology Commercialization Strategies
  2. 2. Disclaimer <ul><li>The views discussed in this presentation given on January 21, 2010 at the Loews Hotel Philadelphia at the CBI 3 rd Annual Forum on Oncology Commercialization Strategies are those of the presenters and do not necessarily represent the views of any associated company or client. </li></ul>
  3. 3. Objectives <ul><li>To provide you with: </li></ul><ul><ul><li>A better understanding of the Oncology Drugs Advisory Committee (ODAC) to increase your likelihood of a successful interaction. </li></ul></ul><ul><ul><li>A brief backgrounder on the function and make-up of ODAC </li></ul></ul><ul><ul><li>Key learnings from recent ODAC meetings </li></ul></ul><ul><ul><li>Suggested resources to use in preparing to meet with ODAC </li></ul></ul><ul><ul><li>A helpful review of part of the oncology drug approval process which will strengthen your commercialization skillset, even if you’re not going to ODAC in the near-term. </li></ul></ul>
  4. 4. Your Presenters <ul><li>Martha Arnold </li></ul><ul><ul><li>Principal, PharmApprove </li></ul></ul><ul><ul><li>Regulatory and Commercial Strategy Consultant </li></ul></ul><ul><ul><li>Project lead on over 25 Advisory Committee projects </li></ul></ul><ul><ul><li>Lead Commercial Officer at Anesta Corp. </li></ul></ul><ul><ul><li>Group Product Director, Johnson & Johnson </li></ul></ul><ul><li>Michael W. Young </li></ul><ul><ul><li>Principal, biomedwoRx: Life Sciences Consulting </li></ul></ul><ul><ul><li>Senior Dir., Alliance Marketing & Management, Senior Director, Global Oncology Strategy ~ Eisai Oncology Franchise </li></ul></ul><ul><ul><li>Head of Marketing ~ Ligand Pharmaceuticals, Inc. </li></ul></ul><ul><ul><li>Over 20 product launches in the oncology / supportive care / specialty markets </li></ul></ul>
  5. 5. Insurmountable Opportunities <ul><li>In 1972, Congress passed the Federal Advisory Committee Act Public Law 92-963 </li></ul><ul><li>In 2010, getting a drug or medical device to market has never been more expensive, time-consuming, or difficult. </li></ul><ul><li>New legislation increases the likelihood that your product will wind up in front of an FDA advisory committee. </li></ul><ul><li>With the road to approval becoming even tougher, just having solid data to support your product may not be enough. </li></ul>
  6. 6. Additional Hurdles <ul><li>Over the past decade that the advisory panel process itself has changed. </li></ul><ul><li>Because of tighter conflict-of-interest rules, panelists tend to be less well-informed about your product and indication, and more concerned than ever about product safety. </li></ul><ul><li>The combination makes for a particularly challenging meeting. </li></ul><ul><li>But there are strategies and processes that can help you prepare your team, better explain the issues, and increase your chances for product approval. </li></ul>
  7. 7. About Advisory Committees <ul><li>The Food and Drug Administration, to assist in its mission to protect and promote the public health, uses 48 committees and panels to obtain independent expert advice on scientific, technical, and policy matters. </li></ul><ul><li>48 committees… </li></ul><ul><li>Advisory committees provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies.  </li></ul><ul><li>The marketing applications include data to show the safety and effectiveness of human drugs.  </li></ul><ul><li>The outside experts receive summary information about the applications and copies of  FDA's review of the application documents.   </li></ul><ul><li>Advisory committees may recommend approval or disapproval of a drug's marketing application.  FDA generally follows an advisory committee's recommendation, but is not bound to do so.  </li></ul>
  8. 8. Drugs Advisory Committees <ul><li>Anesthetic and Life Support Drugs Advisory Committee </li></ul><ul><li>Anti-Infective Drugs Advisory Committee </li></ul><ul><li>Antiviral Drugs Advisory Committee </li></ul><ul><li>Arthritis Advisory Committee </li></ul><ul><li>Cardiovascular and Renal Drugs Advisory Committee </li></ul><ul><li>Dermatologic and Ophthalmic Drugs Advisory Committee </li></ul><ul><li>Drug Safety and Risk Management Advisory Committee </li></ul><ul><li>Endocrinologic and Metabolic Drugs Advisory Committee </li></ul><ul><li>Gastrointestinal Drugs Advisory Committee </li></ul><ul><li>Nonprescription Drugs Advisory Committee </li></ul><ul><li>Oncologic Drugs Advisory Committee </li></ul><ul><li>Peripheral and Central Nervous System Drugs Advisory Committee </li></ul><ul><li>Pharmaceutical Science and Clinical Pharmacology Advisory Committee </li></ul><ul><li>Psychopharmacologic Drugs Advisory Committee </li></ul><ul><li>Pulmonary-Allergy Drugs Advisory Committee </li></ul><ul><li>Reproductive Health Drugs Advisory Committee </li></ul>
  9. 9. ODAC According to ODAC <ul><li>The '''Oncology Drugs Advisory Committee''' (ODAC) receives requests for technical and clinical evaluation of new drugs by the United States) U.S. Food and Drug Administration (FDA). </li></ul><ul><li>The committee, consisting of members from academic and clinical oncology biostatistics, the general public, and the pharmaceutical industry </li></ul><ul><li>Make non-binding recommendations to both the CDER and CBER divisions of the FDA about the advisability of approving new medications to treat cancer. </li></ul>
  10. 10. CDER <ul><li>The Center for Drug Evaluation and Research (CDER, pronounced &quot;see'-der&quot;) is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the FD&C Act. </li></ul><ul><li>The center reviews applications for new and generic pharmaceuticals, manages US cGMP regulations for pharmaceutical manufacturing, determines which medications require a medical prescription , monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market. </li></ul><ul><li>CDER reviews New Drug Applications to ensure that the drugs are safe and effective. </li></ul><ul><li>Its primary objective is to ensure that all prescription and over-the-counter (OTC) medications are safe and effective when used as directed. </li></ul>
  11. 11. CBER <ul><li>The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services . CBER is responsible for assuring the safety, purity, potency, and effectiveness of biological and related products, including: </li></ul><ul><ul><li>Blood for transfusion and as a raw material for drug products </li></ul></ul><ul><ul><li>Human cells, tissues, and cellular and tissue-based products </li></ul></ul><ul><ul><li>Vaccines for use in humans. </li></ul></ul><ul><ul><li>Allergenic extracts. </li></ul></ul><ul><ul><li>Some medical devices, specifically test kits for HIV </li></ul></ul><ul><ul><li>Xenotransplantation . </li></ul></ul><ul><ul><li>Gene therapy and Human Cloning </li></ul></ul>
  12. 12. ODAC Span of Influence <ul><li>Advisory committees are the primary means by which the FDA obtains independent scientific advice. </li></ul><ul><li>Four main assumptions </li></ul><ul><ul><li>It is independent with respect to influence by either the product sponsor or by the FDA. </li></ul></ul><ul><ul><li>It provides ‘expert scientific advice’, because the committee members are acknowledged experts in their respective fields. </li></ul></ul><ul><ul><li>It advises the FDA; however, lacks the authority to make decisions to obligate the Agency. </li></ul></ul><ul><ul><li>It often addresses specific questions drafted by the Agency's professional staff. </li></ul></ul>
  13. 13. Who is the ODAC Panel? <ul><li>Chair -- Gail Eckhardt, MD, University of Colorado (Medical Oncology) </li></ul><ul><li>Ralph Freedman, MD, PhD, MD Anderson (Gynecologic Oncology) </li></ul><ul><li>Jean Grem, MD, University of Nebraska (Hematology/Oncology) </li></ul><ul><li>William Kelley, DO, Yale (Medical Oncology) </li></ul><ul><li>Michael Link, MD, Stanford (Pediatric Oncology) </li></ul><ul><li>Patrick Loehrer, MD, Indiana University (Medical Oncology) </li></ul><ul><li>Gary Lyman, MD, Duke (Medical Oncology/Hematology, Biostats/Epidemiology) </li></ul>N.B. – Panel as of December 2009
  14. 14. ODAC Panel continued <ul><li>Ronald Richardson, M.D., Mayo Clinic (Medical Oncology) </li></ul><ul><li>Mikkael Sekeres, MD, MS; Cleveland Clinic (Medical Oncology) </li></ul><ul><li>Margaret Tempero, M.D., UCSF (Hematology/Oncology) </li></ul><ul><li>Wyndham Wilson, M.D., NCI (Lymphoma) </li></ul><ul><li>Virginia Mason, R.N. (Oncology Nurse) - Consumer Rep </li></ul><ul><li>Gregory Curt, M.D., AstraZeneca - non-voting Industry Rep </li></ul>
  15. 15. Some Learnings to Share
  16. 16. Define Your Issues Before Messages <ul><li>Start by identifying all possible FDA and committee issues. </li></ul><ul><li>Develop key messages strong enough to stand alone when compared to the data and issues. </li></ul><ul><li>This approach may seem counter-intuitive. It may appear far more logical to craft key messages first and leave the issues for later. </li></ul><ul><li>The opposite is true. Experience shows that ODAC Teams often expend too many hours getting the “perfectly worded message points,” only to discover they aren’t solidly supported by their data and the issues. </li></ul>*With acknowledgements to the Communication Council of America
  17. 17. Craft Your Take Home Messages: What do the data say? <ul><li>Based on the data and outside opinion, formulate key messages to emphasize in the presentation. </li></ul><ul><li>If the data do not support a message, don't present it. Be rigorous. </li></ul><ul><li>Develop a data-supported message for each section of the presentation and develop a proactive and credible title slide for each section. </li></ul><ul><li>“ Easily Managed Safety Profile” vs. “Adverse Events” </li></ul><ul><li>Use the team issues list to calibrate each key message. There is little value in spending considerable time crafting an eloquently worded message if it conflicts with a previously prioritized high-risk issue. </li></ul><ul><li>In addition, decide which issues should be addressed pre-emptively in the presentation, and which should be saved for a question and answer period. </li></ul>
  18. 18. Selecting Presenters: Credible Is More Important Than “Good” <ul><li>Assuming your pivotal clinical work has been done by good researchers, it’s often puzzling to watch how presenters are selected by companies. </li></ul><ul><li>ODAC teams often spend considerable time evaluating who should present. “Dr. ‘A' is a much better presenter than Dr. ‘B'” the argument goes, but Dr. ‘A' may not know the data well or treated too few patients to be credible. </li></ul><ul><li>With appropriate coaching, a less eloquent speaker will often be the best choice. </li></ul><ul><li>Knowledge is more important than smoothness, and credibility is more important than eloquence. </li></ul>
  19. 19. The Real “No Spin Zone” <ul><li>“ Let’s 'spin' that point more,” is sometimes the call to action in rehearsals or planning meetings. Experience shows that “spin” rarely gets drugs and biologics approved. Positive statements that exceed the strength of supporting data are “spin.” </li></ul><ul><li>Don’t put your approval at risk. Agency staff and advisory committee members come prepared to be skeptical. </li></ul><ul><li>Positive positions are critically important, however it is equally important to underpin each with supporting data, literature cites, or expert opinion. </li></ul>
  20. 20. Be Prepared to take a Direct Approach to Uncomfortable Questions <ul><li>Counter-spin is answering every question directly, no matter how difficult or embarrassing. </li></ul><ul><li>This approach may not put a drug, biologic, or device in the best light 100% of the time, but it adds to your credibility – especially if seeking some latitude from the advisory committee because data may be less robust than planned. It is important to have “high ground” to move to following this kind of disclosure. </li></ul><ul><li>“ We don't currently have the data you are asking for; we do have historical data based on the literature which indicate . .” vs. “I'm sorry, we don't have that data.” </li></ul>
  21. 21. Planning and Rehearsing Answers is as Important as Knowing the Answers <ul><li>Some ODAC Teams have divided the team into specialty areas (regulatory, preclinical, efficacy, safety, biostatistics for example). Each specialty team takes one key issue to resolve. Teams develop a draft, bullet-form answer including a 1-2 sentence position (“high ground”) and corresponding supporting evidence (data, literature, or expert opinion). Upon completion, teams trade answers, conduct an informal peer review of another team's work, and return their comments to the original authoring team for refinement. </li></ul><ul><li>Once refined, to ensure other interested parties have an opportunity for input, ask a spokesperson for each specialty team to test their answer for the full team. It a quick way to get draft responses to troublesome issues within a few short hours. </li></ul>
  22. 22. Outside Experts Need to Rehearse <ul><li>“ They wouldn't be outside experts if they couldn't perform well,” is sometimes expressed by sponsor teams. That is not the point. It is important to know what an expert will say under pressure in the presence of his or her peers. </li></ul><ul><li>That pressure can be simulated by having all team members questioned by mock committees including outside experts and company representatives. </li></ul><ul><li>Discussions with an expert asked to sit with you at committee are valuable, but they may not reveal what that individual will actually say at the meeting. </li></ul><ul><li>Mock committee rehearsals, although not real life, reflect with some accuracy how team members will perform in the “real thing.” </li></ul>
  23. 23. Who Should Moderate Q & A? <ul><li>Logic would tell you a moderator with no responsibilities other than getting the right question to the right person is the best approach. However, advisory committees would rather just go to the person who will answer the question. </li></ul><ul><li>A clinical lead who is close to the data often makes the best moderator. True, it is a heavy burden to answer questions as well as triage multi-part questions, but many former advisory committee members have expressed that since time is short, they prefer to deal with “a moderator who can address many of the issues.” </li></ul><ul><li>The goal: get information to the committee as directly and quickly as possible. </li></ul>
  24. 24. The Argument for Outside Help <ul><li>Many journalists who cover the FDA have noted recently that the FDA has become more cautious and sometimes “harsh” in agency reviews of drug/biologic safety and efficacy data. </li></ul><ul><li>Professionalism in the presentation of data and responses to division staff and advisory committee questions, therefore, has become critically important. </li></ul><ul><li>Get Help. You wouldn’t necessarily go to a Level 3 Trauma Center to get your appendix out. Your chance of a successful routine surgery is greater with a team that does those procedures every day. </li></ul>
  25. 25. Perspectives on ODAC <ul><li>Martha Arnold </li></ul>
  26. 26. Your Audience: ODAC <ul><li>Standing membership </li></ul><ul><ul><li>Oncologists across several subspecialties, including pediatrics </li></ul></ul><ul><ul><li>Statisticians, epidemiologists </li></ul></ul><ul><ul><li>Consumer/Patient representatives </li></ul></ul><ul><ul><li>Industry representatives (nonvoting) </li></ul></ul><ul><li>Temporary members as chosen by FDA </li></ul>
  27. 27. What is ODAC, not? <ul><li>They are NOT your KOLs </li></ul><ul><li>They may NOT be expert in your therapeutic area </li></ul><ul><li>They are NOT FDA </li></ul>
  28. 28. What is Your Objective? <ul><li>Earn as many votes as possible </li></ul><ul><li>Influence the discussion </li></ul>
  29. 29. Influence the Discussion? Isn’t it All About the Vote? <ul><li>“ The advisory committee is advisory. Period. It is not a judge and jury. It is not the O.J. trial. It is not: ‘If the glove fits, you must acquit. It is the advice we are looking at, not the vote. We are more interested in the reasons why people are voting.” </li></ul><ul><li>Richard Pazdur BusinessWeek.com (May 2008) </li></ul>
  30. 30. How much time do you have? 8:00 am Introductory comments 8:15 Sponsor Presentation 9:00 FDA Presentation 9:45 Break 10:00 Questions from the Committee to Presenters 10:45 Public Comment Session 11:15 Questions to the ODAC and ODAC discussion Noon Adjourn
  31. 31. Projection Screen FDA Team Podium General Audience Videographers Additional Sponsor Seating Sponsor Team Press “ Setting the Stage”
  32. 32. Who are Your Other Audiences? <ul><li>FDA </li></ul><ul><li>Attendees in the room </li></ul><ul><ul><li>Media </li></ul></ul><ul><ul><li>Advocacy/citizens’ groups </li></ul></ul><ul><ul><li>Competitors </li></ul></ul><ul><ul><li>Financial analysts </li></ul></ul><ul><ul><li>General public </li></ul></ul><ul><li>Unseen viewers of webcasts </li></ul><ul><ul><li>Real time and post-meeting </li></ul></ul><ul><li>Visitors to the FDA website </li></ul>
  33. 33. As You Prepare <ul><li>Messaging/Storyline is critical </li></ul><ul><ul><li>Consistency </li></ul></ul><ul><ul><li>Clarity </li></ul></ul><ul><ul><li>Brevity </li></ul></ul><ul><li>Three opportunities to tell your story </li></ul><ul><ul><li>Briefing Package </li></ul></ul><ul><ul><li>Core Presentation </li></ul></ul><ul><ul><li>Q&A </li></ul></ul>
  34. 34. Making the Most of Your Opportunities <ul><li>Briefing Package </li></ul><ul><ul><li>Brief, accessible, complete </li></ul></ul><ul><ul><li>Due a month prior to the meeting </li></ul></ul><ul><ul><li>2 per meeting, 4 per ODAC day </li></ul></ul><ul><li>Core Presentation </li></ul><ul><ul><li>Up to 45 minutes </li></ul></ul><ul><ul><li>External experts and sponsor speakers </li></ul></ul><ul><li>Q&A </li></ul><ul><ul><li>Opportunities abound, if you prepare appropriately </li></ul></ul><ul><ul><li>High expectations for data and retrieval </li></ul></ul>
  35. 35. Making it Happen <ul><li>The commitment </li></ul><ul><ul><li>5 to 6 months ideal timeline </li></ul></ul><ul><ul><li>For key people – 80+% time </li></ul></ul><ul><li>Set a clear project plan </li></ul><ul><ul><li>Responsibilities, deliverables </li></ul></ul><ul><ul><li>Help to guide and manage the process </li></ul></ul><ul><li>Focus on the strategy and messaging </li></ul><ul><li>Welcome tough feedback, get it early </li></ul>
  36. 36. Final Thoughts <ul><li>One of the hardest, most stressful and exhausting experiences you’ll ever go through </li></ul><ul><ul><li>Also, one of the most rewarding and personally satisfying </li></ul></ul><ul><li>Our favorite wise words: </li></ul><ul><li>“ Rehearse, rehearse, rehearse, and when you’re sick of it, rehearse again” </li></ul><ul><li>Andrew Whelton </li></ul>
  37. 37. Recent Experience <ul><li>Steven M. Fruchtman, M.D., Vice President, Clinical Research, Allos Therapeutics, Inc. on successful ODAC with Pralatrexate </li></ul><ul><ul><li>Know your own data! </li></ul></ul><ul><ul><ul><li>Backwards </li></ul></ul></ul><ul><ul><ul><li>Forwards </li></ul></ul></ul><ul><ul><ul><li>Any which way </li></ul></ul></ul><ul><ul><li>Practice. It gets tense in there. No matter how good a public speaker you think you are; have prepared remarks so important points are highlighted </li></ul></ul><ul><ul><li>Practice with mock committees including statisticians, clinicians, industry consultants, etc.. This should reflect the make up of the ODAC panel (i.e. if ODAC includes a peds heme/onc, practice with a peds heme/onc). </li></ul></ul><ul><ul><li>Have your company experts with you in case an unanticipated question is asked that you are not expert in answering </li></ul></ul><ul><ul><li>ODAC members are not restricted to asking any question, even if you think a SPA discussion already covered the material, or that you have an understanding with the agency </li></ul></ul>
  38. 38. Recent Experience <ul><li>Elizabeth Faust, PhD , Senior Director, Medical Affairs , Gloucester Pharmaceuticals on successful ODAC with romidepsin. </li></ul><ul><ul><li>Just know that regardless of how much you’ve prepared questions and answers, something is likely to come up that wasn’t anticipated. Your answer must be based on data and responded to in an authoritative manner so knowing WHO will field certain types of questions before going into the meeting is key. </li></ul></ul><ul><ul><li>Plan backups for logistical and electronic breakdowns. If it happens (which it does), you won’t be thrown off. </li></ul></ul><ul><ul><li>You don’t know the territory well enough…get help. Talk with people who have done this many times. </li></ul></ul>
  39. 39. Upcoming ODAC <ul><li>On February 10, 2010, during the morning session, the committee will discuss new drug application (NDA) 022-481, proposed trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by Cell Therapeutics, Inc.  The proposed indication (use) for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive non-Hodgkin’s lymphoma (NHL) who have received two or more prior lines of therapy. </li></ul><ul><li>During the afternoon session, the committee will discuss NDA 022-374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for injection, manufactured by ChemGenex Pharmaceuticals.  The proposed indication (use) for this product is for the treatment of adults with chronic myeloid leukemia (CML) bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib. </li></ul>
  40. 40. Oncology Groundshifts <ul><li>Healthcare reform will bring a number of seismic changes. These include: </li></ul><ul><ul><li>the emergence of a comparative effectiveness model </li></ul></ul><ul><ul><li>for cancer patients, an increased focus on personalized medicine </li></ul></ul><ul><ul><li>improved screening and earlier diagnosis </li></ul></ul><ul><ul><li>highly motivated patient advocacy communities committed to making sure that patients get the best treatments for their cancer </li></ul></ul><ul><ul><li>a very challenging communications environment which will include Social Media. </li></ul></ul>
  41. 41. Thank you <ul><li>Preparing for Successful Interactions with ODAC 3rd Annual Forum on Oncology Commercialization Strategies </li></ul>
  42. 42. Who is ODAC? <ul><li>Chair S. Gail Eckhardt, M.D. Expertise: Medical Oncology Term: 02/16/2006 - 06/30/2010 Professor and Division Head, Medical Oncology University of Colorado Health Sciences Center </li></ul><ul><li>Designated Federal Official Nicole Vesely, Pharm.D. Advisors and Consultants Staff (HFD-21) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland, 20857 (301) 827-7001 Fax: (301) 827-6776 E-mail: [email_address] </li></ul><ul><li>** Gregory Curt, M.D. Expertise: Clinical Oncology Term: 06/10/2008 -10/31/2011 U.S. Medical Science Lead, Emerging Products AstraZeneca Oncology </li></ul><ul><li>Ralph Freedman, M.D., Ph.D. Expertise: Gynecologic Oncology Term: 05/21/2009 – 06/30/2012 Clinical Professor Department of Gynecologic Oncology The University of Texas </li></ul>
  43. 43. Who is ODAC? <ul><li>Jean Grem, M.D., F.A.C.P. Expertise: Hematology/Oncology Term: 05/05/2008 - 06/30/2011 Professor of Medicine Department of Internal Medicine Section of Hematology/Oncology University of Nebraska Medical Center </li></ul><ul><li>William Kelly, D.O. Expertise: Medical Oncology Term: 05/21/2009 – 06/30/2012 Associate Professor of Medicine and Surgery Yale University </li></ul><ul><li>Michael Link, M.D . Expertise: Pediatric Oncology Term: 11/15/2006 - 06/30/2010 Chief, Division of Hem/Onc Stanford University School of Medicine </li></ul><ul><li>Virginia Mason, R.N. Expertise: Oncology Nursing Term: 07/01/2007 - 06/30/2011 Executive Director Inflammatory Breast Cancer Research Foundation </li></ul><ul><li>Ronald Richardson, M.D. Term: 02/21/2007 - 06/30/2010 Expertise: Medical Oncology Consultant Department of Medical Oncology Mayo Clinic </li></ul><ul><li>Mikkael Sekeres, M.D., M.S. Expertise: Medical Oncology Term: 05/21/2009 – 06/30/2012 Associate Professor of Medicine Cleveland Clinic Taussig Cancer Institute </li></ul>
  44. 44. Who is ODAC? <ul><li>Patrick Loehrer, Sr., M.D. Expertise: Medical Oncology Term: 05/21/2009-06/30/2012 Interim Director, Melvin and Bren Simon Cancer Center Indiana University </li></ul><ul><li>Gary Lyman, M.D. M.P.H., FRCP (Edin) Expertise: Med.Onc/Hem, Biostats/Epid. Term: 02/21/2007 - 06/30/2010 Director Health Services and Outcomes Research Program-Oncology Duke University Medical Center </li></ul><ul><li>Margaret Tempero, M.D. Term: 05/05/2008 - 06/30/2011 Expertise: Hematology/Oncology University of California, San Francisco - UCSF Cancer Center </li></ul><ul><li>Wyndham Wilson, M.D. Term: 05/05/2008 - 06/30/2011 Expertise: Lymphoma/Neurobiology Chief, Lymphoma Therapeutics Section National Cancer Institute </li></ul>
  45. 45. Additional Resources <ul><li>FDA Advisory Committee.com </li></ul><ul><li>  www.fda.gov/AdvisoryCommittees </li></ul>

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