Developing A New Product
Risk Management Program
Creativity and Innovation Excellence

Presentation By Andre’ Harrell

1
This slide presentation is for
illustration purposes only and to
show how AH2 & Beyond can help
you build a Risk Managemen...
Purpose
• The purpose of this presentation is to walk through the
structure of building a “Risk Management Program” plan
w...
Risk Management Background
• US FDA Requirements of Risk Management Plans
(RMPs)
– History – Evolution of FDA Policy
– Gui...
FDA Requirements of RMPs
Evolution of FDA Policy on Risk Management

• 2003 Public Discussion
•
•

Risk Management plans f...
FDA Requirements of RMPs
Draft Guidance Documents

• Risk Assessment: Premarketing and

Pharmacovigilance
Guidance Documen...
Risk Management Guidance (1):
Premarketing Risk Assessment

• Premarketing Risk Assessment Guidance:
– Overall description...
Risk Management Guidance (2):
Risk Minimization Action Plans – “RiskMAP”

• “RiskMAP” Guidance:
“RiskMAP”:

a strategic sa...
Risk Management Guidance (2):
Risk Minimization Action Plans – “RiskMAP” (cont.)

When a “RiskMAP” should be Considered
Ap...
Risk Management Guidance (2):
Risk Minimization Action Plans – “RiskMAP” (cont.)
Category

Description

Examples

Targeted...
Risk Management Guidance (3):
Pharmacovigilance/Epidemiologic Assessment

• Draft Guidance:
– Overall description of poten...
Risk Management Guidance (3):
Pharmacovigilance Assessment (cont.)
Assessment

Draft FDA Guidance

Identifying and
Describ...
Our Proposed
Risk Management Program

13
Overall RMP Strategy
• Overall Goal:
• Develop RMP prior to Complete Response Submission so that
RMP is not rate-limiting ...
Development of the RMP
• Identify Key Safety Risks
• Class (opioid) knowledge
• Technology (e.g. IONTOPHARESIS, OROS, IV P...
RMP Process Strategy
RISKS

ASSESSMENT

MANAGEMENT

IN VITRO/
NONCLINICAL

LABELING

EDUCATION

CLINICAL
ABUSE LIABILITY

...
Sources of Potential Risk
Inappropriate Use
(Patient)

Inappropriate Use
(Physician)

Risks of Tech
System

Inappropriate ...
In-vitro Studies
-Ease of tampering
(intact & crushed; whole & portions of DF)
-Solubility & Dissolution in
aqueous & orga...
Our Draft Label Strategy
• Provide FDA only with Sections that are relevant to RMP
(mainly class specific)
• Sections were...
Highlighted Differences in Draft Label
• The following sections represent the greatest risk to
obtaining FDA agreement to ...
Surveillance Components
• Passive Surveillance
• Active Surveillance
• Epidemiology Studies
• External KOL Advisory Board
...
Surveillance Activities
Summary of planned surveillance activities by risk

Our
Database

Passive Surveillance
FDA
AERS/
S...
Educational Strategy
• The educational plan for our product is intended to
provide appropriate and accurate tools regardin...
Educational Needs
Health Care
Practitioners

Patients,
Family
Members,
Caregivers

Indication

√

√

Schedule II status

√...
Educational Needs
Health Care
Practitioners

Patients,
Family
Members,
Caregivers

Patient
Advocacy
Groups

Anti-Drug
Abus...
Educational Tactical Strategy
Strategic Priority

Leverage Point

• Exploit Uniqueness of Product
• Gain Rapid Availabilit...
Educational Strategy Background
• Developed in response to concern from FDA regarding
appropriate use of product
– Key Com...
Summary
Risk Management Program

28
Supply Chain and Initial Launch Strategy
• Our Product supply chain
– All applicable FDA and DEA regulations will be follo...
Summary (Critical Success Factors)
• Finalize RMP prior to Complete Response Submission
• Minimize potential for rate limi...
Checkout my presentation on “Global Sales &
Marketing Excellence Plan-Example”!
http://slidesha.re/1dBavAO
You can also ch...
Andre’ Harrell
AH2 & Beyond Consulting
www.ah2andbeyond.com
267-221-8529
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Developing A New Product Risk Management Program

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This slide presentation is for illustration purposes only and to show how AH2 & Beyond can help you build a Risk Management Program for your new product to aid in the regulatory approval process.

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Developing A New Product Risk Management Program

  1. 1. Developing A New Product Risk Management Program Creativity and Innovation Excellence Presentation By Andre’ Harrell 1
  2. 2. This slide presentation is for illustration purposes only and to show how AH2 & Beyond can help you build a Risk Management Program for your new product to aid in the regulatory approval process. 2
  3. 3. Purpose • The purpose of this presentation is to walk through the structure of building a “Risk Management Program” plan which will aid your product through the regulatory approval process. • The following presentation looks at an innovative delivery system designed for pain management and the steps taken to build a robust “Risk Management Program” plan. • There are of course a few ways to build a “Risk Management Program”, this structure I have found to be the most thorough and comprehensive approach. 3
  4. 4. Risk Management Background • US FDA Requirements of Risk Management Plans (RMPs) – History – Evolution of FDA Policy – Guidance for Industry – RMPs for Currently Marketed Opiates – Recommended “Educational Programs” that support the “Risk Management Program” plan 4
  5. 5. FDA Requirements of RMPs Evolution of FDA Policy on Risk Management • 2003 Public Discussion • • Risk Management plans for opiate analgesic products/devices Abuse liability of and risk management plan for Palladone (no longer on the market) • Key Conclusions- Risk Management Plans should include: • • • Appropriate HCP/Patient Education Surveillance of misuse, abuse, diversion Assessment of Risk Management Plan’s impact on opioid utilization practices • Educational Program • • Education and Outreach Programs required Surveillance and Monitoring Research 5
  6. 6. FDA Requirements of RMPs Draft Guidance Documents • Risk Assessment: Premarketing and Pharmacovigilance Guidance Documents • Risk Minimization: “RiskMAP” Guidance Document Risk Management = Assessment + Minimization • Risk Management is the process of: 1. Assessing a product’s benefit-risk balance 2. Developing/Implementing tools to minimize risks while preserving benefits 3. Evaluating tool effectiveness and reassessing benefit-risk balance 4. Making adjustments as appropriate to tools 6
  7. 7. Risk Management Guidance (1): Premarketing Risk Assessment • Premarketing Risk Assessment Guidance: – Overall description of potential safety assessments during drug development • Focus on late clinical development (e.g. Phase 3) • States that recommendations are not intended for all products – Specifically, the generation, acquisition, analysis, and presentation of premarketing safety data 7
  8. 8. Risk Management Guidance (2): Risk Minimization Action Plans – “RiskMAP” • “RiskMAP” Guidance: “RiskMAP”: a strategic safety program designed to meet specific goals and objectives in minimizing known risks of a product while preserving its benefits Goals: should target the achievement of particular health outcomes related to known safety risks Objectives: should result in processes or behaviors leading to achievement of goals 8
  9. 9. Risk Management Guidance (2): Risk Minimization Action Plans – “RiskMAP” (cont.) When a “RiskMAP” should be Considered Appropriate information for the determination are: 1. Data from clinical development program, post-marketing surveillance and phase 4 studies 2. The product’s intended population and use “For example, opiate products/devices have important benefits in alleviating pain but are associated with significant risk of overdose, abuse and addiction. The agency recommends that sponsors of Schedule II controlled substances, including Schedule II extended release or high concentration opiate products, considering developing RiskMAPs for these products.” 9
  10. 10. Risk Management Guidance (2): Risk Minimization Action Plans – “RiskMAP” (cont.) Category Description Examples Targeted Education and Outreach Recommended when: • Healthcare provider letters 1. Product risks cannot be minimized with risk minimization measures alone • Training programs for healthcare providers/patients & CE 2. As a component of “RiskMAPs” using reminder or performancelinked access systems Reminder Systems Recommended when targeted education and outreach are insufficient • Prominent professional or public notifications • Patient labeling or package inserts • Focused or limited promotional techniques such as product sampling or DTC advertising • Patient agreement forms • Certification program for providers • Limited amount of uses •Specialized Packaging PerformanceLinked Access Systems Recommended when: • Only by certified Healthcare providers 1. Product have significant or otherwise unique benefits in a particular patient group or condition but unusual risks exist • Product dispensing only by specially certified pharmacies 2. Above categories insufficient • Product utilization only to patients with evidence or other documentation of safe use conditions 10
  11. 11. Risk Management Guidance (3): Pharmacovigilance/Epidemiologic Assessment • Draft Guidance: – Overall description of potential safety assessments beyond approval • Focus on post marketing data collection and risk assessment • States that recommendations are not intended for all products 11
  12. 12. Risk Management Guidance (3): Pharmacovigilance Assessment (cont.) Assessment Draft FDA Guidance Identifying and Describing Safety Signals • Good reporting practice, case reports, assessing causality, summary Investigating a Signal • Pharmaco-epidemiologic Safety Studies, Registries, and Surveys Interpreting Safety Signals 1. Provide an assessment of the benefit-risk balance, 2. Propose steps to further investigate the signal, 3. Propose RiskMAPs if appropriate 1. Identified safety signals 2. At-risk populations not adequately studied 3. Other significant safety concerns exist Pharmacovigilance Plan • Data Mining and Safety Signals May include: AEs as expedited reports, frequent summaries, active surveillance, additional studies and surveys
  13. 13. Our Proposed Risk Management Program 13
  14. 14. Overall RMP Strategy • Overall Goal: • Develop RMP prior to Complete Response Submission so that RMP is not rate-limiting to NDA approval • Approach: • Submit draft RMP and receive FDA comments by designated date • Meet with FDA on designated date to discuss key elements • Relevant Products Used for RMP: • Product A (draft label, supply chain integrity, launch) • Product B (draft label, components of surveillance) – Note RMP is not public information 14
  15. 15. Development of the RMP • Identify Key Safety Risks • Class (opioid) knowledge • Technology (e.g. IONTOPHARESIS, OROS, IV PCA, TRANSDERMAL etc) knowledge • KOL Advisory Board Input • FDA Guidance's and Competitive Intelligence of Other Products • Develop Risk Management Strategies • • • • Design around key identified risks Take into account regulatory expectations Consider strategies beyond the standard tools, such as labeling Employ a multi-faceted approach 15
  16. 16. RMP Process Strategy RISKS ASSESSMENT MANAGEMENT IN VITRO/ NONCLINICAL LABELING EDUCATION CLINICAL ABUSE LIABILITY CLINICAL STUDIES LAUNCH/ PROMOTION SURVEILLANCE DISTRIBUTION/ SUPPLY CHAIN ACTIVE PASSIVE 16
  17. 17. Sources of Potential Risk Inappropriate Use (Patient) Inappropriate Use (Physician) Risks of Tech System Inappropriate Use (Others) Pharmacological Profile Abuse Risk Profile Preclinical/ Toxicology Studies Diversion Accidental Exposure PK or PD Interactions Special Populations Newly Identified Risks (Clinical Trials) 17
  18. 18. In-vitro Studies -Ease of tampering (intact & crushed; whole & portions of DF) -Solubility & Dissolution in aqueous & organic solvents -Ease of administration (IV & IN polyox) Human Abuse Liability Study - Overall liking in comparison to Dilaudid IR and placebo - Non-opioid dependent, poly drug abusers - Intact and tampered dosage forms Pre-marketing Risk Assessment Nonclinical Studies - Acute and sub-chronic IV toxicity in rats -Polyox and tampered Innovative Delivery System Phase 2 and 3 Human Clinical studies - Safety database ~ 1300 received our product - Our product exposure up to 21 months - Multiple population (LBP, OA, cancer etc) - Opioid naïve and tolerant - Rates of specific AE of interest (class) - Evidence of diversion, misuse, abuse etc 18
  19. 19. Our Draft Label Strategy • Provide FDA only with Sections that are relevant to RMP (mainly class specific) • Sections were updated from original NDA based on: – – – – New information to date Competitive Product A – currently approved PI Competitive Product B – currently approved PI for immediate release Competitive Product C – currently approved PI • Sections we didn’t include (e.g. Clinical trials , safety, PK & Metabolism etc) pending completion of ongoing trials • Medication guide will be provided with complete response submission 19
  20. 20. Highlighted Differences in Draft Label • The following sections represent the greatest risk to obtaining FDA agreement to the draft label & RMP • Black Box/Warnings: – Largely based on Competitive Product A, with the exception of: • IV toxicity warning (due to polyox); based on planned studies • 8 mg dose for opioid naïve & higher doses for opioid tolerant (16, 32, 64 mg) • Indication: – Opioid Naïve included (8 mg) • Physical Properties Our Product system (to deter tampering): – Inclusion of the physical features of our product that deter tampering (to be discussed with FDA at the scheduled meeting) 20
  21. 21. Surveillance Components • Passive Surveillance • Active Surveillance • Epidemiology Studies • External KOL Advisory Board • Data Review and Reporting 21
  22. 22. Surveillance Activities Summary of planned surveillance activities by risk Our Database Passive Surveillance FDA AERS/ SRS TESS NFLIS Active Surveillance IMS LRx Informant Network Impaired HCP surveys Epidemiology Studiesa Risk DAWN Abuse Overdose Misuseb Pediatric exposure Diversion Other AEs of interest DAWN: Drug Abuse Warning Network; TESS: Toxic Exposure Surveillance System; NFLIS: National Forensic Laboratory Information System a: Done on an as needed basis b: Any misuse, whether intentional or unintentional, including off-label use, by patient, health care practitioner or other individual. 22
  23. 23. Educational Strategy • The educational plan for our product is intended to provide appropriate and accurate tools regarding the balance of the benefits and risks of our product. • The objectives of this plan will be to: – Educate key stakeholders on the benefits and risks associated with our product – Provide key stakeholder identified with the information and tools necessary to ensure that our product is utilized appropriately • Key Stakeholders – – – – – – – Health care practitioners Patients, family members, caregivers Patient advocacy groups Anti-drug abuse organizations Third party payers Law enforcement Our sales force 23
  24. 24. Educational Needs Health Care Practitioners Patients, Family Members, Caregivers Indication √ √ Schedule II status √ Precautions/Warnings/ Contraindications √ √ Side Effect / AEs √ √ Proper Pat. Selection √ Dosage & Admin. √ Conversion Ratios √ Our Technology – Physical properties √ Our Technology – Pk properties √ Recognize abuse / minimize diversion Patient Advocacy Groups Anti-Drug Abuse Organizations Third Party Payers Law Enforcement Our Sales Force √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ INFORMATION NEEDS √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Mechanisms for Reducing Abuse √ √ √ √ √ √ Instruction if abuse / diversion is occurring √ √ √ √ For patient use only √ √ √ √ √ √ Storage conditions √ √ √ √ √ √ Instructions if problem occurs √ √ √ √ √ √ √ 24
  25. 25. Educational Needs Health Care Practitioners Patients, Family Members, Caregivers Patient Advocacy Groups Anti-Drug Abuse Organizations Third Party Payers Law Enforcement Our Sales Force √ √ √ √ √ √ √ √ KEY TOOLS Approved professional labeling Patient labeling (medication guide and PPI) Educ Program Support √ √ √ Product & disease info via various media √ Website - Professional √ √ √ Patient Starter Kit √ √ Website – non professional Toll Free number to report problems √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Ongoing Sales Training √ Access to our Medical Affairs √ 25
  26. 26. Educational Tactical Strategy Strategic Priority Leverage Point • Exploit Uniqueness of Product • Gain Rapid Availability and Generate Positive Initial Product Experience • • Target Audience • Nurses (DON, Med/Surg, PACU, CNE), Pharmacists and Patients Rationale • Description • Rep, HCP & Multi-media delivered training program designed to fully prepare HCPs on the preparation, administration, and disposal of our product. • Includes an optional certification component Get physicians to try our product Get physicians to utilize our product instead of IV PCA, IM analgesia and IV basal / bolus analgesia • • Provide clear, simple and easy-to-use instructions that insure appropriate use of our product Facilitates training of hospital staff according to hospital policies by providing flexible and customizable framework Key component of Risk Management Plan 26
  27. 27. Educational Strategy Background • Developed in response to concern from FDA regarding appropriate use of product – Key Component of our product Risk Management Plan • Educational program content developed based on comprehensive review of: – Key learnings from KOL Advisory Boards – Market research with nurses, pharmacists and patients • • • • • Two rounds of qualitative market research in 6 cities Quant study with a total of 400 nurses, pharmacists and patients Surveys included in phase IIIb trials Focus Groups with phase IIIb trial nurses and patients Telephone interviews with phase IIIb trial nurses – FDA feedback on Package insert 27
  28. 28. Summary Risk Management Program 28
  29. 29. Supply Chain and Initial Launch Strategy • Our Product supply chain – All applicable FDA and DEA regulations will be followed – Additional corporate policies and procedures • Ensure distributors are in good standing with HDMA • Direct purchasing customers must procure corporate products through our distribution network • Initial launch strategy – Pain & Hospital Sales Forces – Audience comparable to our current product portfolio • Anesthesiologists, Neurologists, Oncologists, Select Primary Care and allied health professionals (pharmacists, nurses, nurse practitioners, phys. asst.) – Information will be available for other health care practitioners via the internet, PDR, medical education and support of various third party organizations 29
  30. 30. Summary (Critical Success Factors) • Finalize RMP prior to Complete Response Submission • Minimize potential for rate limiting step in approval process • Our product’s RMP compares favorably to other competing RMP’s • Robust Educational Program Platform • Strong collaboration between Medical, Regulatory/Compliance/Legal and Marketing required • Refined cost estimates continue to be evaluated 30
  31. 31. Checkout my presentation on “Global Sales & Marketing Excellence Plan-Example”! http://slidesha.re/1dBavAO You can also checkout my background/work by clicking on the following links: http://www.slideshare.net/aharrell2000 www.linkedin.com/pub/andre-d-harrell/5/13/382/ http://thesalesprofessionalnetwork.blogspot.com/ www.ah2andbeyond.com https://www.facebook.com/pages/Sales-MarketingManagement-Consulting/267898536570725
  32. 32. Andre’ Harrell AH2 & Beyond Consulting www.ah2andbeyond.com 267-221-8529

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