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Introduction and Capabilities

         On-demand access to expertise that helps you maintain a
                          competitive edge




244 Fifth Avenue, Suite 2988
New York, NY 10001
1.212.726.1224
Aperion On-Call Overview

                 Aperion On-Call                               Our Clients

 Leading global expert network                 Pharmaceutical, medical device, and
 Exclusively healthcare focused                 biotechnology companies
 Founded by seasoned, healthcare-industry      Institutional investment firms
  professionals                                 Business decision makers
 Primary market research firm                  Licensing executives
 Headquartered in NYC                          Market research executives
                                                Competitive intelligence professionals
                 Research Areas
                                                Global consultancy firms
   Pharmaceuticals                             Branding/ Advertising Firms
   Medical devices                             Healthcare public policy/not-for profit
                                                 organizations
   Biotechnology
   Healthcare services
   Regulatory
   Reimbursement


                                                                                           2
What We Do

•   Manage a global network of experienced healthcare professionals providing insights on
    issues affecting the pharmaceutical, biotechnology, medical device, and healthcare
    services sectors
•   Identify key opinion leaders that have the right expertise to answer our client’s
    questions
•   Provide our clients with on-demand access to our worldwide network of experts via:
     • Telephone consultations
     • One-on-one and group meeting
     • Customized market research projects




                                                                                         3
Our Network of Advisors Spans Almost All Areas of Healthcare

              Therapeutic Areas                        Reimbursement/Managed Care

Allergy/Immunology         Infectious Disease   P&T hospital formulary members
Anesthesiology             Internal Medicine    Managed care medical directors
Cardiology                 Nephrology           Pharmacists
Dentistry                  Neurology            Pricing and contracting experts
Dermatology                OB/GYN               Branding and marketing
Endocrinology              Oncology             strategists
Gastroenterology           Ophthalmology
General and                Plastic Surgery
specialized surgery        Pulmonology
Hematology                 Radiology
Hepatology                 Urology

                  Regulatory

Former FDA members        Product liability
Patent experts             lobbyists
Drug scheduling experts   Medicare/
Regulatory consultants     medicaid
Policy advisors            policy officials
                          Statisticians                                             4
Why Aperion On-Call?




                        Commercial Assessments

                         Competitive Intelligence

                 Clinical Trial/Regulatory Assessments

                        Technology Assessments

                            Branding Strategy

                        Pricing & Reimbursement

                              KOL Mapping

                       Customized Market Research




                                                         5
Questions that can be answered by using our services

          Commercial Assessments

•   Who will be the primary prescribers of the drug/device?
•   What is the unmet medical need in a particular therapeutic area?
•   Does the drug/device address the unmet medical need?
•   How can drug/device be differentiated from what is currently available?
•   How strong is the differentiation point?
•   What therapeutic position (line of therapy) can this drug/device achieve?
•   Will drug/device be put on hospital formulary?
•   What percentage of patients will the drug device be used in?
•   What type of patient is the best candidate for drug/device?
•   What percentage of patients will drug/device be used in?




                                                                                6
Questions that can be answered by using our services

           Competitive Intelligence

•   Who are your competitors?
•   What is the current competitive landscape?
•   How will the competitive landscape look in the future?
•   What is the impact of new entrants and patent expirations on your product?
•   How effective are your competitors’ sales force in marketing their products to prescribing
    physicians?
•   What are patients saying about your competitors’ treatments and their side effects?
•   What strategic marketing initiatives are my competitors implementing for their branded products?
•   How has your competitor prioritized their development stage pipeline and R&D resources?
•   What is your competitor’s strategy for lifecycle management?
•   What are the pricing/reimbursement/formulary issues for your competitors’ products?




                                                                                                   7
Questions that can be answered by using our services

    Clinical Trial/Regulatory Assessments

•   What is the best regulatory strategy of a particular drug/device/indication?
•   What is the optimal clinical trial design for an indication and phase of development?
      •   Clinical trial type
      •   Appropriate dose/schedule
      •   Appropriate controls
•   How to estimate sample size?
•   What is the ideal patient population, inclusion/exclusion criteria?
•   What is the ideal clinical endpoint form a regulatory standpoint?
•   What is the ideal clinical endpoint from a physician standpoint?
•   What endpoints are appropriate to show clinical benefit in an indication?
•   What is an acceptable safety profile for your development-stage product?
•   What should the clinical development plan for our product look like to maximize its revenue
    potential in a rapidly evolving therapeutic landscape?


                                                                                                  8
Questions that can be answered by using our services

           Technology Assessments

•   Is the scientific hypothesis sound?
•   Is preclinical data predictive of clinical outcome?
•   Making sense of pharmacokinetic and toxicology data
•   Does the “animal-model” data provide a good correlate for what may be observed in human clinical
    testing?
•   What does the medical community think about our drug or its MOA?
•   What is the predicted efficacy of the drug?
•   What is the predicted safety of the drug?
•   What is the predicted risk/benefit profile of the drug?
•   How does the drug compare to treatments that are currently available?
•   Have similar drugs been tested before? If so, what was the outcome?




                                                                                                  9
Questions that can be answered by using our services

               Branding Strategy

•   How to maximize the commercial value of development-stage and in-line products?
•   How differentiated is your brand from the competition?
•   What are key opinion leaders and early-adopters saying about your brand?
•   How can your sales force more effectively market to physicians? What key points should my sales
    force be emphasizing?
•   What programs or strategies have been effective for increasing patient compliance for a particular
    product?
•   How do/will prescribing physicians perceive a particular drug or brand?
•   How do/will patients perceive a particular drug or brand?
•   What gives successful pharmaceutical brands their edge?




                                                                                                    10
Questions that can be answered by using our services

           Pricing & Reimbursement

•   What is the appropriate pricing strategy for the drug/device?
•   How to reach the best pricing potential?
•   Who will be the primary payer (Medicaid/Medicare/private insurance)?
•   Are there any special reimbursement issues to consider (bundling)?
•   What tier will the drug be placed in?
•   What variables play a role in tier positioning?
•   Will the drug/device be placed on hospital formulary?
•   What will be the patient co-pay or price-share?
•   How will changes to Medicare and Medicaid program impact your sales channels?
•   How do you measure the effectiveness of your managed care contracting strategy?
•   What is the pharmacoeconomic benefit of the drug/device?




                                                                                      11
Questions that can be answered by using our services

                  KOL Mapping

•   What are the key questions that need to be addressed for a particular therapeutic area?
•   Who are the thought leaders in this therapeutic area that possess the expertise to answer these
    questions?
•   Who are the innovators and early adopters in a given therapeutic are?
•   Who are the global KOLs for brands in early development?
•   Who are the local and regional KOLs for brands nearing launch?
•   Who are the KOLs that shape treatment guidelines?
•   Who are the KOLs that would be willing to serve as advocates of our branded product to the
    medical community?




                                                                                                      12
Custom Primary Research Projects

        Customized Market Research

•   We can assemble a Target Product Profile based on available clinical data
•   We can design discussion guides for your telephone interviews
•   We can design survey questionnaires
•   We can identify the most relevant KOLs, practicing physicians and regulatory or reimbursement
    experts
•   We can conduct in-depth physician interviews over the phone




                                                                                                13
Aperion On-Call Advantage

Adhere to highest standards of client service
    • We recognize that reliable and timely information from the authoritative experts are
        indispensable in guiding decision-making.
Affordable pricing
     • We take great pride in being able to provide service that we believe is comparable to our
        competitors but is at a significantly reduced cost to our clients. With a strong emphasis on
        operational efficiency and cutting away with unnecessary "over-head" costs, we are able to
        pass on these savings to our clients and make our On-Call Advisor Network available to
        more clients with budgets large or small.
No sign-up or license fees
     • Access to our Aperion On-Call Advisor Network is on a "pay-as-you-use" basis. Upon signing
        a standard Services Agreement with our firm, each client has access to our entire On-Call
        Network and is only billed after one or more consultations are completed.
No minimum use requirements
    • Our clients may use our On-Call Advisor Network as much or as little as they wish.
Strict Confidentiality and Compliance policies
      • We protect our clients' interests by making certain that every On-Call Advisor associated with
         a Client consultation has agreed to terms and conditions that comply with industry standards
         surrounding non-disclosures, insider trading and material and non-public information rules.

                                                                                                       14
Contact Us




                  244 Fifth Avenue, Suite 2988
                      New York, NY 10001
                       Tel: 212-726-1224
             Email: clientservices@aperiononcall.com

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Aperion On Call Capabilities

  • 1. Introduction and Capabilities On-demand access to expertise that helps you maintain a competitive edge 244 Fifth Avenue, Suite 2988 New York, NY 10001 1.212.726.1224
  • 2. Aperion On-Call Overview Aperion On-Call Our Clients  Leading global expert network  Pharmaceutical, medical device, and  Exclusively healthcare focused biotechnology companies  Founded by seasoned, healthcare-industry  Institutional investment firms professionals  Business decision makers  Primary market research firm  Licensing executives  Headquartered in NYC  Market research executives  Competitive intelligence professionals Research Areas  Global consultancy firms  Pharmaceuticals  Branding/ Advertising Firms  Medical devices  Healthcare public policy/not-for profit organizations  Biotechnology  Healthcare services  Regulatory  Reimbursement 2
  • 3. What We Do • Manage a global network of experienced healthcare professionals providing insights on issues affecting the pharmaceutical, biotechnology, medical device, and healthcare services sectors • Identify key opinion leaders that have the right expertise to answer our client’s questions • Provide our clients with on-demand access to our worldwide network of experts via: • Telephone consultations • One-on-one and group meeting • Customized market research projects 3
  • 4. Our Network of Advisors Spans Almost All Areas of Healthcare Therapeutic Areas Reimbursement/Managed Care Allergy/Immunology Infectious Disease P&T hospital formulary members Anesthesiology Internal Medicine Managed care medical directors Cardiology Nephrology Pharmacists Dentistry Neurology Pricing and contracting experts Dermatology OB/GYN Branding and marketing Endocrinology Oncology strategists Gastroenterology Ophthalmology General and Plastic Surgery specialized surgery Pulmonology Hematology Radiology Hepatology Urology Regulatory Former FDA members Product liability Patent experts lobbyists Drug scheduling experts Medicare/ Regulatory consultants medicaid Policy advisors policy officials Statisticians 4
  • 5. Why Aperion On-Call? Commercial Assessments Competitive Intelligence Clinical Trial/Regulatory Assessments Technology Assessments Branding Strategy Pricing & Reimbursement KOL Mapping Customized Market Research 5
  • 6. Questions that can be answered by using our services Commercial Assessments • Who will be the primary prescribers of the drug/device? • What is the unmet medical need in a particular therapeutic area? • Does the drug/device address the unmet medical need? • How can drug/device be differentiated from what is currently available? • How strong is the differentiation point? • What therapeutic position (line of therapy) can this drug/device achieve? • Will drug/device be put on hospital formulary? • What percentage of patients will the drug device be used in? • What type of patient is the best candidate for drug/device? • What percentage of patients will drug/device be used in? 6
  • 7. Questions that can be answered by using our services Competitive Intelligence • Who are your competitors? • What is the current competitive landscape? • How will the competitive landscape look in the future? • What is the impact of new entrants and patent expirations on your product? • How effective are your competitors’ sales force in marketing their products to prescribing physicians? • What are patients saying about your competitors’ treatments and their side effects? • What strategic marketing initiatives are my competitors implementing for their branded products? • How has your competitor prioritized their development stage pipeline and R&D resources? • What is your competitor’s strategy for lifecycle management? • What are the pricing/reimbursement/formulary issues for your competitors’ products? 7
  • 8. Questions that can be answered by using our services Clinical Trial/Regulatory Assessments • What is the best regulatory strategy of a particular drug/device/indication? • What is the optimal clinical trial design for an indication and phase of development? • Clinical trial type • Appropriate dose/schedule • Appropriate controls • How to estimate sample size? • What is the ideal patient population, inclusion/exclusion criteria? • What is the ideal clinical endpoint form a regulatory standpoint? • What is the ideal clinical endpoint from a physician standpoint? • What endpoints are appropriate to show clinical benefit in an indication? • What is an acceptable safety profile for your development-stage product? • What should the clinical development plan for our product look like to maximize its revenue potential in a rapidly evolving therapeutic landscape? 8
  • 9. Questions that can be answered by using our services Technology Assessments • Is the scientific hypothesis sound? • Is preclinical data predictive of clinical outcome? • Making sense of pharmacokinetic and toxicology data • Does the “animal-model” data provide a good correlate for what may be observed in human clinical testing? • What does the medical community think about our drug or its MOA? • What is the predicted efficacy of the drug? • What is the predicted safety of the drug? • What is the predicted risk/benefit profile of the drug? • How does the drug compare to treatments that are currently available? • Have similar drugs been tested before? If so, what was the outcome? 9
  • 10. Questions that can be answered by using our services Branding Strategy • How to maximize the commercial value of development-stage and in-line products? • How differentiated is your brand from the competition? • What are key opinion leaders and early-adopters saying about your brand? • How can your sales force more effectively market to physicians? What key points should my sales force be emphasizing? • What programs or strategies have been effective for increasing patient compliance for a particular product? • How do/will prescribing physicians perceive a particular drug or brand? • How do/will patients perceive a particular drug or brand? • What gives successful pharmaceutical brands their edge? 10
  • 11. Questions that can be answered by using our services Pricing & Reimbursement • What is the appropriate pricing strategy for the drug/device? • How to reach the best pricing potential? • Who will be the primary payer (Medicaid/Medicare/private insurance)? • Are there any special reimbursement issues to consider (bundling)? • What tier will the drug be placed in? • What variables play a role in tier positioning? • Will the drug/device be placed on hospital formulary? • What will be the patient co-pay or price-share? • How will changes to Medicare and Medicaid program impact your sales channels? • How do you measure the effectiveness of your managed care contracting strategy? • What is the pharmacoeconomic benefit of the drug/device? 11
  • 12. Questions that can be answered by using our services KOL Mapping • What are the key questions that need to be addressed for a particular therapeutic area? • Who are the thought leaders in this therapeutic area that possess the expertise to answer these questions? • Who are the innovators and early adopters in a given therapeutic are? • Who are the global KOLs for brands in early development? • Who are the local and regional KOLs for brands nearing launch? • Who are the KOLs that shape treatment guidelines? • Who are the KOLs that would be willing to serve as advocates of our branded product to the medical community? 12
  • 13. Custom Primary Research Projects Customized Market Research • We can assemble a Target Product Profile based on available clinical data • We can design discussion guides for your telephone interviews • We can design survey questionnaires • We can identify the most relevant KOLs, practicing physicians and regulatory or reimbursement experts • We can conduct in-depth physician interviews over the phone 13
  • 14. Aperion On-Call Advantage Adhere to highest standards of client service • We recognize that reliable and timely information from the authoritative experts are indispensable in guiding decision-making. Affordable pricing • We take great pride in being able to provide service that we believe is comparable to our competitors but is at a significantly reduced cost to our clients. With a strong emphasis on operational efficiency and cutting away with unnecessary "over-head" costs, we are able to pass on these savings to our clients and make our On-Call Advisor Network available to more clients with budgets large or small. No sign-up or license fees • Access to our Aperion On-Call Advisor Network is on a "pay-as-you-use" basis. Upon signing a standard Services Agreement with our firm, each client has access to our entire On-Call Network and is only billed after one or more consultations are completed. No minimum use requirements • Our clients may use our On-Call Advisor Network as much or as little as they wish. Strict Confidentiality and Compliance policies • We protect our clients' interests by making certain that every On-Call Advisor associated with a Client consultation has agreed to terms and conditions that comply with industry standards surrounding non-disclosures, insider trading and material and non-public information rules. 14
  • 15. Contact Us 244 Fifth Avenue, Suite 2988 New York, NY 10001 Tel: 212-726-1224 Email: clientservices@aperiononcall.com