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1 Navigation instructions n this sample, the only active clickable areas are the navigation buttons marked by these shapes: which will guide you through each of our main learn products. At any point, you can return to the main menu by clicking the home button in the bottom right corner.

2 TM empower the learner

3 Key Concepts TM Product nformation ETS offers a variety of interactive products for use on touch-screen devices and/or computers. nteractive pdfs utilize basic linking to create a non-linear experience for receiving information, and allows the user easier ways to navigate intuitively to areas of information they may need. Clinical Studies Patient Case Studies NEW 1 2 3

4 TM empower the learner Key Concepts Clinical Studies Patient Case Studies Product nformation NEW 1 2 3

5 Key Concepts Clinical Studies Patient Case Studies Product nformation NEW TM empower the learner ETS offers a variety of interactive digital experience products for use on touch-screen devices and/or computers. nteractive pdfs utilize basic linking to create a non-linear experience for receiving information, and allows the user easier ways to navigate intuitively to areas of information they may need

6 CLNCAL STUDY OBJECTVE POPULATON METODS RESULTS SAFETY

7 CLNCAL STUDY POPULATON Eligibility Characteristics Age No colon cancer Chronic inflammatory bowel syndrome Treatment failure with xxxxxxxxxxx

8 CLNCAL STUDY POPULATON Eligibility Characteristics 48 ± 12 yrs of age h 9 h % white Mean OFF time Mean ON time % white ± 12 yrs of age 7 h 8 h Mean OFF time Mean ON time

9 CLNCAL STUDY POPULATON Primary endpoint Secondary measures Summary Response No response Sustained response (% of patients) Product % 99.0% Response No response Control / / 209 Product Control

10 CLNCAL STUDY POPULATON Primary endpoint Secondary measures Summary Virologic failure 1/ % product-treated Volumus fastidii sit te, nam an aperiri maiorum voluptatibus. Quo ex harum dolor corrumpit, cum modus sanctus offendit ad, malis apeirian his ne. Per eu indoctum salutandi, in illud mazim incorrupte nec, modo postea his eu. Cu pri audire verterem similique, has zril nemore id. Additional findings Product-treated Product-free P Levels less than the lower limit of normal at the end of treatment (%) 51.2% 3.4%

11 PRODUCT NFORMATON Product Overview Safety Pharmacology Efficacy Patient Counseling Full P

12 PRODUCT NFORMATON PRODUCT OVERVEW ndications and use Dosage and administration Dosage forms and strengths Description, how supplied, storage and handling ndication 1 Dosage 40 mg/kg* * every other week next ndication 2 nitial dose 80 mg/kg One week after initial dose 40 mg/kg* * every other week

13 PRODUCT NFORMATON PRODUCT OVERVEW ndications and use Dosage and administration Dosage forms and strengths Description, how supplied, storage and handling previous DOSAGE r copackaged with product tablets ndoctum corrumpit sea te, mea et homero prompta tincidunt. Quo dicam officiis suavitate ea, sit elit exerci nusquam ut, sea ut lucilius accusata. Accusam copiosae tacimates ut vis. DOSAGE Two tablets once daily (in the morning) r and one tablet twice daily (morning and evening) Both dosages should always be taken with a meal without regard to fat or calorie content

14 PRODUCT NFORMATON PRODUCT OVERVEW ndications and use Dosage and administration Dosage forms and strengths Description, how supplied, storage and handling Pen Prefilled syringe nstitutional use vial Single-use pen provides a dose of: Single-use prefilled syringe provides doses of: Single-use institutional vial provides a dose of: 40 mg (0.8 ml) 40 mg (0.8 ml) 20 mg (0.4 ml) 40 mg (0.8 ml) 10 mg (0.2 ml)

15 Oncology Backgrounder ntroduction 1 What is Cancer? 2 Diagnosis, Grading, and Staging 3 4 Treatment Options: Nonpharmacologic and Supportive Therapies Treatment Options: Pharmacologic Therapies Glossary

16 Oncology Backgrounder 1 What is Cancer? Learning Objectives Key Concepts Characteristics of Cancer Cells Malignancy Tumor Types Natural istory of Cancer Summary Review Questions

17 ONCOLOGY BACKGROUNDER Characteristics of Cancer Cells Malignancy Tumor Types Natural istory of Cancer Summary Review Questions Sustained Proliferation Evading Growth Suppression Replicative mmortality Resisting Apoptosis Cells increase in number through a process referred to as proliferation, which involves progression through the cell cycle (see Figure 1). Cells proceed through the four stages of the cell cycle G 1, S, G 2, and M in response to signals that can include nutrients, hormones, and M phase growth factors. [Lodish, 2013, 15, 1113; Malumbres, 2014, 52] Figure 1 Life cycle of a cell: a cell proceeds through two gap phases (G 1 and G 2 ) while it grows, a synthesis phase (S) when it replicates its genetic material, and a mitosis phase (M) when it separates chromosomes and divides into two cells. Cells can also exit the cell cycle in a resting phase called G 0. [Lodish, 2013, 15] G 2 phase Cell growth Chromosomes separate; cell divides DNA replication Cell growth G 1 phase G0 phase = checkpoint When cells divide, the rst critical process is to replicate the genetic material (DNA) accurately. The cell copies its DNA and passes one copy to the daughter cell. f this S phase Resting phase no cell division does not occur accurately, damaged copies of genes, which accumulate in cells and can lead to cancer, are passed on.

18 ONCOLOGY BACKGROUNDER WAT S CANCER? Characteristics of Cancer Cells Malignancy Tumor Types Natural istory of Cancer Summary Review Questions Sustained Proliferation Evading Growth Suppression Replicative mmortality Resisting Apoptosis Growth factors produced by tumor Cells have surveillance pathways, called cell cycle checkpoints, that monitor for successful completion of a phase before permitting entry into the next phase. Regulated progression through the cell cycle helps maintain genome integrity. There are three DNA damage checkpoints: between G 1 /S, within S, and between G 2 /M. For instance, a checkpoint detects DNA damage and halts progression to M phase until it is repaired. [Malumbres, 2014, 52, 53, 60; Gordon, 2011, 23, 24, 26] (see Tip) Growth factor receptors Activated signaling pathway DNA Gene expression Mutation Activated signaling pathway Cancer cell membrane

19 ONCOLOGY BACKGROUNDER WAT S CANCER? Characteristics of Cancer Cells Malignancy Tumor Types Natural istory of Cancer Summary Review Questions Sustained Proliferation Evading Growth Suppression Replicative mmortality Resisting Apoptosis Cells have surveillance pathways, called cell cycle checkpoints, that monitor for successful completion of a phase before permitting entry into the next phase. Regulated progression through the cell cycle helps maintain genome integrity. There are three DNA damage checkpoints: between G 1 /S, within S, and between G 2 /M. For instance, a checkpoint detects DNA damage and halts progression to M phase until it is repaired. [Malumbres, 2014, 52, 53, 60; Gordon, 2011, 23, 24, 26] (see Tip) Tumor cells often have mutations in proto-oncogenes, which changes them into oncogenes that alter cell cycle and checkpoint pathways to sustain proliferation. Mutations can also affect pathways responsible for recognizing DNA damage, which allows other mutations to accumulate, leading to genome instability and cancer. Normally the production and release of growth factors that allow cells to progress through the cell cycle are tightly regulated. Cancer cells disrupt this by producing their own growth factors, increasing the number of growth factor receptors, and by activating signaling pathways inside the cell in the absence of growth factors (see Figure 2 on the next page). When entry into, transit through, or exit from the cell cycle is altered, cells do not differentiate. You ll learn later in this module that this is related to a tumor s grade and a patient s prognosis. [anahan, 2011, 646, 647; Atkinson, 2009, 5]

20 PATENT CASE STUDY NTRODUCTON: This interactive snapshot lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. LEARNNG OBJECTVES: 1 This interactive snapshot lorem ipsum dolor sit amet, consectetur adipiscing, sed do eiusmod. GET STARTED 2 rure dolor in reprehenderit in voluptate velit esse cillum dolore. 3 Excepteur sint occaecat cupidatat non proident.

21 PATENT CASE STUDY PATENT MEDCAL TEAM ELECTRONC MEDCAL RECORD NAME: Maureen O. AGE: RACE: FAMLY STORY OF CONDTON: SYMPTOMS: QUOTE:

22 PATENT CASE STUDY VST 1 NAME SPECALTY PATENT MEDCAL TEAM ELECTRONC MEDCAL RECORD Dr. Rebecca Lindsay, M.D. VST 2 NAME SPECALTY Dr. Jonathon Bunn, M.D. VST 3 NAME SPECALTY Dr. Diedra Parks, M.D. VST 4 NAME SPECALTY Dr. enry McMahnon, M.D.

23 PATENT CASE STUDY PATENT MEDCAL TEAM ELECTRONC MEDCAL RECORD

24 PATENT CASE STUDY ELECTRONC MEDCAL RECORD Round 1 Round 2 Round 3 Round 4 Round 5 nitial Presentation Test Results Conclusions and Plan Patient Name: Maureen O. DOB: 1/12/1969 Date: 5/30/2014 Medical Record: SP5541 Chief Complaint: Ad augue noluisse eam. Patient Diary istory of Present llness: Eum copiosae verterem ea, ut option meliore has, reque impedit eam ei. Mel ad veritus partiendo, mel modo vidit nonumes ei. usto convenire an sed. Sed dolore debitis in, qui an augue tollit nemore, his consul fastidii lobortis at. Corrumpit similique definitiones eam at. Ad augue noluisse eam, nullam invenire disputationi cu cum, an nostro adolescens complectitur pro. Ad per falli intellegebat, usu ea epicuri forensibus. Vix an qualisque similique, has no debitis accusam deterruisset, id veri sonet referrentur eum. Euismod habemus eu per. Vis saepe interesset scriptorem ut, omnesque quaestio cu mea, quo mundi possit essent ne. Te agam voluptaria vel, eu mei porro blandit. Mea id labores tractatos salutatus. At cum vide timeam, eu oratio ceteros honestatis pro. omero denique nostrum eum at. Nullam referrentur per ea. At mei animal offendit adipisci, vel ne debitis pertinax intellegebat. Pro paulo molestie te. Vis mazim cetero argumentum ut, cum te liber mucius ocurreret. Suas debet discere ius id. Nonumes detraxit qui ad, minimum voluptaria te eos. Delenit similique sit at, ad usu ceteros lucilius explicari. Molestie placerat accusamus usu eu, sea probo graeci ad. Quis facete aliquando mea. Euismod habemus eu per. Vis saepe interesset scriptorem ut, omnesque quaestio cu mea, quo mundi possit essent ne. Te agam voluptaria vel, eu mei porro blandit.

25 PATENT CASE STUDY ELECTRONC MEDCAL RECORD Round 1 Round 2 Round 3 Round 4 Round 5 nitial Presentation Test Results Conclusions and Plan Labs Additional Tests Patient Name: Maureen O. DOB: 1/12/1983 Date: 5/30/2014 Test Result Flag Normal Range (Adult Female) Units GB 11.1 L g/dl CT 36.1 L % RBC x10 6 /μl MCV fl MC pg MCC g/dl RDW % Platelets x10 9 /L WBC x10 9 /L Differential Neutrophils % Lymphocytes % Monocytes % Eosinophils % Basophils % ESR mm/hr Medical Record: SP5541 Test Result Flag Normal Range (Adult Female) Units Liver Tests Total protein g/dl Albumin g/dl Total bilirubin mg/dl Conjugated (direct) bilirubin mg/dl ALP units/l ALT units/l AST units/l GGT units/l Stool specimen C. difficile negative Enteric culture negative Ova/parasites negative Occult blood positive P

26 PATENT CASE STUDY ELECTRONC MEDCAL RECORD Round 1 Round 2 Round 3 Round 4 Round 5 nitial Presentation Test Results Conclusions and Plan Patient Name: Maureen O. DOB: 1/12/1969 Date: 5/30/2014 Medical Record: SP5541 Chief Complaint: Ad augue noluisse eam. Reviewing Physician Notes/Plan: Eum copiosae verterem ea, ut option meliore has, reque impedit eam ei. Mel ad veritus partiendo, mel modo vidit nonumes ei. usto convenire an sed. Sed dolore debitis in, qui an augue tollit nemore, his consul fastidii lobortis at. Corrumpit similique definitiones eam at. Ad augue noluisse eam, nullam invenire disputationi cu cum, an nostro adolescens complectitur pro. Signed: Larry Friedman, MD Date: 5/30/2014 BD Specialist Perspective Apply Your Knowledge

27 ELECTRONC MEDCAL RECORD Patient Diary m Maureen. am 45 years old, married, and work as an occupational therapist. love my job, but some days can t even make it to work. This diarrhea has made it hard for me to function normally. t s been a lot worse lately, and now m having cramps and even seeing blood in my bowel movements. ve tried to improve my diet by eating more fruits and vegetables and cutting out red meat. exercise and even quit smoking, but none of this has helped. Now wake up in the middle of the night having to go to the bathroom, my stomach hurts all the time, and never feel rested. don t know what s wrong with me! So m going to see a gastroenterologist, and hopefully ll get some answers and some relief. X

28 NEW TM PRODUCTS BOLOGCS VRTUAL PRECEPTORSP FOLLOW TE SCRPT NFOGRAPC ELEMENTS

29 Biologics OVERVEW MANUFACTURNG REGULATORY PATWAY MARKETPLACE EMERGNG SSUES

30 Biologics OVERVEW What are biologics? BPC DEFNTONS BOLOGC AGENT VS SMALL-MOLECULE DRUG POST-TRANSLATONAL MODFCATONS MMUNOGENCTY QUZ

31 Biologics OVERVEW BPC Definitions Biologic Agent vs Post-translational mmunogenicity Small-molecule Drug Modifications QUZ BOLOGC AGENT MOLECULAR WEGT Approximately STRUCTURE Complex and not always well defined with many options for posttranslational modification OW SYNTESZED Unique living cell lines next SMALL MOLECULE DRUG Approximately Simple and well-defined; not as sensitive to or dependent on small changes in the manufacturing processes Predictable chemical reactions

32 Biologics OVERVEW BPC Definitions Biologic Agent vs Post-translational mmunogenicity Small-molecule Drug Modifications QUZ back SMALL MOLECULE SMALL MOLECULE BOLOGC AGENT DRUG BOLOGC AGENT DRUG PURFCATON Desired product is often present in low quantity; impurities may vary by process and product. Standardized procedures; desired product is often a main component of the chemical synthesis. STABLTY Sensitive to storage and handling conditions Relatively stable MMUNE REACTONS G POTENTAL Due to patient- and product-related factors LOW POTENTAL

33 Biologics OVERVEW KNOWLEDGE CECK A biologic agent differs from a small-molecule drug in which of the following ways? (a) how it s synthesized (b) potential for eliciting an immune reaction (c) structural complexity (d) all of the above

34 Biologics OVERVEW KNOWLEDGE CECK A biologic agent differs from a small-molecule drug in which of the following ways? (a) how it s synthesized (b) potential for eliciting an immune reaction (c) structural complexity (d) all of the above

35

36 PRESCRPTON FLOW

37 PATENT PROVDER PAYER PARMACY MANUFACTURER

38 PATENT + PATENT + PROVDER + PAYER + PARMACY MANUFACTURER

39 PATENT + NTERACTONS Cu est tritani luptatum. Quo an dicat sapientem constituam, id mel duis graeci. An mei solum error nonumy, veritus elaboraret definitiones vel ei. Est nonumy oblique convenire ei. Unum conceptam est et, vocibus nostrum deterruisset. PROVDER PATENT At aeterno placerat his, et his eruditi voluptatibus. Mei dicunt deleniti ex, id cum quas explicari adolescens. Dicta legimus ei eum, omnes tibique interpretaris et mei. d vix apeirian reprehendunt. CALLENGES PROVDER + Eu officiis inciderint duo, inimicus democritum efficiantur per an. d vis consul utamur. Eu doctus evertitur per, vel dictas comprehensam at. Agam cetero virtute. At paulo concludaturque duo. Nec dicat paulo ut, sed cu dico repudiare argumentum. Ex vix quod eirmod reprehendunt, impetus denique ex pro. Graeco virtute torquatos ne duo, ne mel nobis mollis integre. + PAYER Ad sed clita voluptua. An sea mundi expetendis, in his praesent evertitur. Ex exerci patrioque usu, etiam periculis adipiscing te vix, ex solet legere vel. + PARMACY Reque viderer an mel, vel ex alterum civibus. Ubique periculis et vix, aliquip graecis vulputate eu vim. Vis ad ullum pertinacia, sed ei augue aliquid complectitur, at hinc singulis forensibus quo. Dico elitr vix at. An mel quidam nostrud, modus tamquam repudiandae ea usu. Noster definiebas vel ne. MANUFACTURER AUDO

40 Clinical Particulars Safety nteractive SmPC Pharmacolo g y Efficacy Full SmPC

41 Clinical Particulars Safety MOA Pharmacokinetics Preclinical Safety Pharmacolo g y Efficacy Full SmPC

42 Pharmacology nteractive SmPC MOA Pharmacokinetics Preclinical Safety Summary MOA Resistance Persistence Entry Budding Numquam insolens suscipiantur eos cu. Ea has esse integre civibus, cetero veritus pro id. Oratio appellantur philosophia no mel. Eam eros vivendo et, nec in quot intellegebat deterruisset, causae docendi quo ei. Fastidii persecuti adipiscing eu mea, ne cum soluta tempor platonem, labore essent ea vix. Est case choro et, nam vulputate temporibus ea, munere concludaturque cum at. Replication Assembly Replication

43 Pharmacology nteractive SmPC MOA Pharmacokinetics Preclinical Safety Summary MOA Resistance Persistence Numquam insolens suscipiantur eos cu. Ea has esse integre civibus, cetero veritus pro id. Oratio appellantur philosophia no mel. Eam eros vivendo et, nec in quot intellegebat deterruisset, causae docendi quo ei. Ad duo illum similique. Sonet doming ad est, vim nobis urbanitas reformidans eu. Tale possim mea et. Cu qui enim admodum periculis. Recteque constituam vim an, virtute dolorem vel id. Mean Sonet doming ad est, vim nobis Genotype Recteque Mean values (range) Constituam 1a 7.7 nm 39 nm 1b 1.8 nm 8 nm 1a (treatment-naïve panel) 1b (treatment-naïve panel) 0.77 nm (0.4 to 2.1 nm; n=11) 0.46 nm (0.2 to 2 nm; n=10)

44 Pharmacology nteractive SmPC MOA Pharmacokinetics Preclinical Safety Summary MOA Resistance Persistence Treatment-emergent amino acid substitutions in the pooled analysis (N = 2510) Target Emergent Amino Acid Substitutions Genotype 1a N = 67 Genotype 1b N = 7 NS3 V55 c 6 (4) Y56 c 9 (6) 42.9 (3) d 132V c 6 (4) R155K 13.4 (9) D168A 6 (4) D168V 50.7 (34) 42.9 (3) d D168Y 7.5 (5) V36A c, V36M c, F43L c, D168, E357K c <5% NS5A M28T 20.9 (14) M28V e 9 (6) Q30R e 40.3 (27) Y (2) 58D, 58P, Y93N <5% NS5B A553T 6.1 (4) S556G 33.3 (22) C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561 <5%

45 Pharmacology nteractive SmPC MOA Pharmacokinetics Preclinical Safety Summary MOA Resistance Persistence During treatment S556G S556G S556G Persistence of resistance-associated substitutions Ad duo illum similique. Sonet doming ad est, vim nobis urbanitas reformidans eu. Tale possim mea et. Cu qui enim admodum periculis. Recteque constituam vim an, virtute dolorem vel id. Ad duo illum Sonet doming ad est, vim nobis urbanitas reformidans eu. Tale possim mea et. Post-treatment week 48 S556G