Drug Approval PlanFebruary 15, 2017

RibofadeTM (Medizolid)TheNewGoldStandard

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● IPhO Case Representative: Samie Ahmed● Fellow Advisor: Arielle Gabarda● General Body Members divided into Functional Groups:

○Clinical Development■Members: Chris Boutari, Greg Butler, Lusik Agazaryan & Jasmine King

○Regulatory Affairs■Members: Samie Ahmed & WonWoo Chung

○Medical Affairs■Members: Adaku Egwuonwu & Jamal Salah

○Marketing/Commercial ■Members: Chinwe Oparaocha, Miriam Danquah, Tara Roy, Ishrat Raji, Jenel Clement, Allison Wong, Beyang Kima-Tabong

TheTeam

●Dr. Daenerys Targaryan, MD, PhDDirector of Infectious Disease Department at the Iron Throne General Hospital

●Dr. Jon Snow, MD, MPHAssistant Director of Infectious Disease Department at the King of the North Hospital

●Dr. Bran Stark, PharmDClinical Coordinator and P&T Member at the House of Stark Hospital

KeyOpinionLeaders

● Explore the comprehensive drug development plan for our assigned hypothetical drug.

● Highlight the four key functional strategies – Clinical Development, Regulatory Affairs, Medical Affairs, and Marketing.

●Highlight the Value of Industrial Pharmacist in each functional strategy.

AimsandObjectives

MissionStatement● At McUred, Inc. our mission is to deliver life-changing therapies for

people living with infectious disease, and particularly to patients with the greatest medical needs.

● Clinical Development● Regulatory Affairs● Medical Affairs● Marketing/Commercial

OurCompanyStrategy

Successful product launching depends on coordination and cross-functional

preparation.

●Patient Population - Adults with serious gram-positive infections

●Indications○Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia

○Community or hospital-acquired pneumonia caused by Streptococcus pneumoniae or Staphylococcus aureus

○Complicated and uncomplicated skin and skin structure infections caused by S. aureus(methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae

○New: Active and latent pulmonary infections caused by Mycobacterium tuberculosis.

RibofadeTM(Medizolid)- Purpose

● In the last 3 decades antibiotic development has drastically reduced, due to big pharma companies not having enough incentive to produce antibiotics

● Medizolid has an advantage with key opinion leaders because it is a new antibiotic produced during a time that antibiotic production is at a historical low

WhydevelopanewAntibiotic?

● IND Application (Form FDA 1571) ● Purpose:

○ Protect the investigators and test subjects.○ Under federal law, a drug must be the subject of an approved marketing application before it is

distributed across state lines. ● Timeframe:

○ Pre-IND Process○ Initial IND Submission ○ FDA Response ○ IND Maintenance

● IND Maintenance: ○ IND Safety Reports○ IND Annual Reports

InvestigationNewDrugApplicationProcess-RegulatoryAffairs

RibofadeTM Lifecycle

PhaseI

● Lead Study Design: Refer to next slide○ Phase 1 Clinical Study for Medizolid – “Pharmacokinetics, Safety, and

Tolerability" for the outline of the trial○ Purpose: Evaluates the pharmacokinetics, safety and tolerability of

Medizolid in healthy volunteers○ Coordinate clinical supply operations○ Initiation and coordination of clinical trial studies

Phase I-ClinicalDevelopmentStrategy

● Regulatory Affairs Strategy○ Preparation, review, and maintenance of regulatory submissions○ Compliance with FDA authorities and agencies○ Provide support for clinical development

● Medical Affairs Strategy○ Contributes to patient enrollment and general support of clinical trials○ Review trial results and information on the pharmacologic profile of the drug and communicate

this to internal stakeholders

● Marketing Strategy○ Market need for new products and estimate annual earnings○ Analyze financial burden of the targeted disease with cost of illness and cost of care data○ Potential countries to market compound○ Other products on the market and their market share○ Clinical trials needed to establish non-inferiority

Phase I

PhaseIMarketing- GlobalDrugResistantDeathsperYear

PhaseIMarketing- CostofIllnessandCare

● Analyze direct and indirect costs of infection control for MRSA infections.

● Average costs per patient: $60,000● Average costs per hospitals:

$14,000● Average third-party payer costs:

$2,277- $3,200 per case; $478 million- $2.2 billion annually

● Costs for society: $7,070- $20,489 per case; $1.4 billion- 13.8 billion annually

● Hospital-Acquired Condition (HAC) Reduction Program

● Utilize pre-clinical and Phase I clinical data results to estimate cost-minimizing benefits gained from treatment by our drug in target populations.

Community and health-care acquired methicillin-resistant Staphylococcus aureus infection

Centers for Disease Control and Prevention. “Active Bacterial Core Surveillance (ABCs) Report Emerging Infections Program Network Methicillin-

Resistant Staphylococcus aureus”, 2014

PhaseII

● Regulatory Affairs Strategy ○Preparation, review, and maintenance of regulatory submissions○Compliance with FDA authorities and agencies○Provide support for clinical development

●Medical Affairs Strategy○Collaborate with Clinical Development to assess the efficacy and safety of the drug○Communicate these findings with KOLs and internal stakeholders and solicit feedback about trial strengths and weaknesses

PhaseII

PhaseIIMarketing- SWOTAnalysisHELPFUL TO SALES HARMFUL TO SALES

INTERNAL STRENGTHS● QD - reduced consumer cost● 3-5 day administration period - reduced hospital stay● No weekly lab draws as compared to vancomycin● Reduced mortality rate compared to Zyvox● Reduced development spending - increased marketing

potential● First and only MDR TB indication

WEAKNESSES● Physician hesitation due to

novelty● Formulary conflict - MDR

agents not currently first line● Zyvox patent ended 2015

EXTERNAL OPPORTUNITIES● Increased use of Vancomycin and decreased use of

Zyvox● MDR agents to become more popular in use -

projected future sale increase● Little competition on pneumonia and VRE indication● Cost-effectiveness incentive ● GAIN Act

THREATS● Potential to increase antibiotic

resistance

PhaseIII

● Regulatory Affairs Strategy○Develop and review product labeling○Filing update and assure compliance with FDA ○Support all global and domestic activity○Support clinical trial documentation and medical affair activities ○Support Marketing Strategy - Review advertising, promotional materials, and labeling to comply with FDA or Federal Trade Commission Standards

●Medical Affairs Strategy ○Coordinate with Regulatory Affairs and Clinical Development to review trial data and assess accuracy

○Update KOL and internal stakeholders with accurate information on trial results

PhaseIII

PhaseIII- Marketing

PhaseIII- Marketing

"Pfizer Reports First-Quarter 2016 Results"http://www.pfizer.com/system/files/presentation/Q1_2016_PFE_Earnings_Press_Release_nvewlnavd.pdf

Phase III- Marketing

Chart of Antibiotic Use by Resistance Map Site Tool on Center for Disease Dynamics, Economics & Policy

https://resistancemap.cddep.org/AntibioticUse.php

PhaseIV

●Regulatory Affairs Strategy ○Filing Update ○Continuation of support for marketing○Periodic Safety Reports (post-marketing)■Med Watch

●Medical Affairs Strategy ○Coordinate with Marketing to ensure accurate post-marketing surveillance○Educate the sales force with accurate information on the drug’s use, side effects and trial results○Solicit feedback about our product to KOLs around the world and respond to physician and patient inquiries

○Utilize MSLs to engage on off-label indications

PhaseIV– Post-MarketingSurveillance

Marketing&MedicalAffairsgoHand-in-Hand

● Marketing and Medical Affairs will work together to

use social media outlets enhance presentation and

communication with not only KOLs within our country

but with also those around the world.

● We will share our story of our drug by utilizing Hashtags

such as #TreatMRSA&VRE & #NewGoldStandard

MarketingStrategy

● Clinical Development○Being the drug experts, pharmacists have the sound scientific judgement necessary to designexperimental protocol, determining specific parameters and dealing with potential problems

● Regulatory Affairs○Our extensive knowledge of pharmacology can be utilized as a concrete resource for human clinical trial studies when implemented according to the sponsor’s independent consultant SOP

● Medical Affairs○With the patient in mind, and with the extensive knowledge and understanding of therapeutics and diseases, we provide the integrity and insight to deliver scientifically accurate data to our internal and external stakeholders

● Marketing Development○Pharmacists provide an in depth perception of the needs and expectations of both the patient and the provider, allowing for a greater focus on the target audience and how to best serve them.

ValueofanIndustrialPharmacist

References1. https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf

2. http://www.who.int/mediacentre/factsheets/fs194/en/3. Sannazzaro, A. “MRSA: the superbug poised to cost hospitals super sums.” Infection Control Today. Retrieved from

http://www.infectioncontroltoday.com/news/2015/12/mrsa-the-superbug-poised-to-cost-hospitals-super-sums.aspx. Dec 29 2015.

4. Sutton, J.P., Steiner, C.A. “ Hospital-, health care-, and community-acquired MRSA: estimates from California hospitals, 2013.” Healthcare Cost and Utilization Project. Retrieved from https://www.hcup-us.ahrq.gov/reports/statbriefs/sb212-MRSA-Hospital-Stays-California-2013.pdf. 2016http://www.grandviewresearch.com/industry-analysis/antibiotic-market

5. Taylor, M. “Just what do you do: Medical Affairs Job Description” Bio Careers Blog. Nov 10th 2011. http://biocareers.com/bio-careers-blog/just-what-do-you-do-medical-affairs-job-description Accessed Jan 5th 2017.

6. MCPHS University. “Biopharmaceutical Industry Fellowship Program”. MCPHS University Brochure. 20167. Tyson, G;Culer, D. “Preparing the Market for a New Drug with an Effective Medical Affairs Launch”. Pharmaceutical

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8. Ventola, C. Lee. “Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic?” Pharmacy and Therapeutics 36.10 (2011): 669–684. Print.

9. Lau, Virginia. “8 ways for Pharma to improve the way it uses Twitter”. Medical, Marketing, & Media. July 28, 2016. http://www.mmm-online.com/technology/8-ways-for-pharma-to-improve-the-way-it-uses-twitter/article/512377/Accessed December 3rd 2016.

10. "The Antibacterials Market Outlook to 2016", Business Insiderhttp://download.bioon.com.cn/view/upload/201303/16084001_7254.pdf

11. Chart of Antibiotic Use by Resistance Map Site Tool on Center for Disease Dynamics, Economics & Policy https://resistancemap.cddep.org/AntibioticUse.php

12. "Pfizer Reports First-Quarter 2016 Results"http://www.pfizer.com/system/files/presentation/Q1_2016_PFE_Earnings_Press_Release_nvewlnavd.pdf

13. Lee, B. Y., Singh, A., David, M. Z., Bartsch, S. M., Slayton, R. B., Huang, S., …Daum, R.S. (2013). The economic burden of community-associated methicillin-resistant staphylococcus aureus (ca-mrsa). Clinical Microbiolgy and Infection. 19(6), 528–536. doi: 10.1111/j.1469-0691.2012.03914.x

14. “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” FDA. Website http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf. Accessed Jan 1st 2017.

References

Thankyou.