Taking Immunotherapy to the Next Level

Transcription

1 Taking Immunotherapy to the Next Level J. Joseph Kim, Ph.D. President & CEO November 2017 NASDAQ: INO

2 Forward Looking Statement Our commentary and responses to your questions may contain forward-looking statements, including comments concerning clinical trials and product development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of Inovio s technology by potential corporate partners, capital market conditions, timing of events, cash consumption, and other information concerning factors that could cause actual results to differ materially from those set forth in our Annual Report on Form 10-K for the year ended December 31, 2016, our Form 10-Q for the period ended September 30, 2017, and other regulatory filings from time to time. 2

3 Leading the Development of DNA-based Immunotherapies to Commercialization Powerful platform, multiple product candidates Phase 3 enrolling; Four additional immunotherapy trials with efficacy endpoints Our purpose Develop immunotherapies and vaccines to fight cancers and infectious diseases Efficacy demonstrated in phase 2b study Partnerships and collaborations: MedImmune, Regeneron and Genentech 3

4 Immune Responses by Design Optimized platform: SynCon + CELLECTRA SynCon antigen genetic code enables precise targeting of cancer or pathogen Designed to break tolerance and cover mutating strains Highly optimized SynCon plasmid + novel CELLECTRA delivery generate optimal antigen production IN THE BODY Activates robust functional CD8+ killer T cell and antibody responses Phase 2b data published Favorable safety profile in over 1,500 subjects and 4,000 immunizations Significant antigen-specific immune responses in almost 1,000 patients and counting CELLECTRA 5PSP Device SynCon Immunotherapy 4

5 Inovio Product Pipeline Product Indication Preclinical Phase 1 Phase 2 Phase 3 Milestone VGX-3100 Cervical Dysplasia Vulvar Neoplasia Initiated P3 2Q17 Initiated P2 2Q17 INO-5401 INO-5150 Bladder Cancer Glioblastoma Multiforme Prostate Cancer Initiated P1/2 checkpoint combo study 4Q17 Initiated P1/2 checkpoint combo study 4Q17 Reported data 3Q17 Candidate for Outlicensing INO-1400 INO-1800 htert (Multiple Solid Tumors) Hepatitis B Report data 4Q17 Report data 1Q18 Candidate for Outlicensing Post-data MEDI0457 Head & Neck Cancer Preventive Initiated P1/2 checkpoint combo study 2Q17 PARTNER FUNDED INTERNALLY FUNDED 5

6 VGX-3100: Fulfills Unmet Treatment Needs of HPV-Related Precancers VGX-3100 is indicated for the treatment of the following precancerous diseases caused by HPV types 16 and 18: High grade Cervical Dysplasia High grade Vulvar Dysplasia High-grade Anal Dysplasia Annual Incidence (HPV 16/18+ Precancers) First-in-class HPV-specific immunotherapy Targets the major underlying cause of anogenital cancer Treats pre-cancer without invasive surgery Cervical Vulvar US: 195,000 EU: 233,000 US: 23,000 EU: 15,000 6 Anal US: 13,400 EU: 2,514

7 Vulvar Anal Cervical HPV Caused Pre-Cancers: Limitations of Surgery Loss of Reproductive Health 10% - 16% Pain 1 Recurrence of CIN2/3 3,4 after LEEP Surgical Complications 23.5% >50% 40-50% Negative Psychosocial Impact HPV-16 DNA detected in patients after LEEP 4 Recurrence post-surgery with clean margins Recurrence post-surgery 1 Massad LS, et al. Obstet Gynecol. 2013;121: Nobbenhuis MA, et al. Lancet. 2001;358: Xi LF, et al. J Infect Dis. 2007;195: Nobbenhuis MA, et al. Br J Cancer. 2001;84: Wright TC, et al. Obstet Gynecol. 1992;79: IARC.Colposcopy and Treatmetn of Cervical Intraepithelial Neoplasia: A Beginner s Manual Kyrgiou M, et al. Cochrane Database Syst Rev. 2015;CD008478

8 HPV-Related Cervical HSIL Phase 3 Program VGX-3100 has the potential to be the first treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100: Targets HPV 16/18 subtypes; E6/E7 oncogenes Treats high-grade squamous intraepithelial lesions (HSIL) Consists of two studies in parallel: REVEAL I (primary) n=198 REVEAL II (confirmatory) n=198 Randomized (2:1), double-blind, placebo-controlled Dosing: month 0, 1, 3 (as in P2b) Primary endpoint: month 9 (as in P2b) REVEAL1: Study follow-up through week 88 (as in P2b) Primary Endpoint Regression of HSIL (CIN2/3) AND clearance of HPV 16/18 in the cervix Secondary Endpoints Safety/tolerability Regression of HSIL Virologic clearance of HPV- 16 and/or HPV-18 Non-progression to cancer Clearance of HPV from noncervical anatomic locations REVEAL 2: Study follow-up through week 40 Report data from both studies in

9 Phase 2b Study Primary and Secondary Efficacy Endpoints Met T Cell Responses Measured in Blood Cervical HSIL regression to low or normal AND HPV clearance VGX % Control 14.3% Difference 25.9% VGX-3100 Specific T Cells VGX-3100 Placebo * * * * Study Week Treatment at wks 0, 4, & 12 *Statistically significant; bars are 95% Cl T Cell Responses Measured in Tissue P-value 1 p=0.001 Efficacy correlates to immune responses PP and mitt p-values equal 167 subjects Paper published in The Lancet September Strata-adjusted

10 Rationale for Combinations in Immuno-Oncology: Turning Cold Tumors to Hot Tumors Tumor infiltration of antigen-specific, functional CD8+ T cells may prime patients for treatment with checkpoint inhibitors and increase response rates Checkpoint combinations Checkpoints combined with Inovio cancer vaccines Increase anti-tumor benefit, without adding toxicity Checkpoint monotherapies Durable anti-tumor benefit Low response rates; ~20% in most tumors Improved response rates Significantly increased toxicity & discontinuations Clinical studies planned for MEDI0457 with MedImmune - INO-5401 with Regeneron and Genentech 10

11 Immuno-Oncology Studies with Efficacy Endpoints MEDI0457 (licensed out to MedImmune) Metastatic HPV-related squamous cell carcinoma of the head & neck (SCCHN) with persistent or recurrent disease after chemotherapy treatment. Combination with durvalumab (IMFINZI ) PD-L1 checkpoint inhibitor Phase 1/2 open label study: safety, immunological impact, objective response rate, progression-free survival and overall survival ~ 50 subjects. Enrolling. INO-5401 (combination of 3 tumor-associated antigens: htert, PSMA, WT1) Advanced unresectable or metastatic urothelial carcinoma (bladder cancer) Combination with atezolizumab (TECENTRIQ ) PD-L1 checkpoint inhibitor Phase 1b/2 open-label trial: safety, immune response and clinical efficacy ~ 80 patients; ~ 60 will be PD-1/PD-L1 refractory patients. Enrolling. INO-5401 Newly diagnosed glioblastoma multiforme (GBM) Combination with REGN2810 PD-1 checkpoint inhibitor Phase 1b/2a open label trial: safety, tolerability, immunological impact, progression-free survival and overall survival ~ 50 patients. Enrolling. 11

12 MEDI0457: Turning Cold Tumors to Hot Tumors in Phase 1 Control: FoxP3 CD8 Before treatment with MEDI0457 Cold After treatment with MEDI0457 Hot 12

13 Platform Development Programs: Global Health Vaccines Concept to 1 st patient dosed in ~6 months. Only vaccine with clinical data 100% antibody response rates 13

14 Positive Clinical Immune Response Data from Studies in Healthy Volunteers: Emerging Infectious Diseases MERS (GLS-5300) Phase 1 High levels of binding antibodies measured (ELISA) in 92% (57 of 62) of evaluated subjects Antigen-specific cytotoxic T-lymphocyte (CTL) responses observed 98% (61 of 62) generated an antibody and/or T cell response against MERS HIV (PENNVAX-GP) Phase 1 Overall, 93% (71 of 76) evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens (env A, env C, gag, or pol) Similarly, 94% (62 of 66) evaluated participants demonstrated an env specific antibody response None of the placebo recipients (0%;0 of 9) demonstrated either a cellular or an antibody response in the study Ebola (INO-4201) Phase 1 High levels of binding antibodies measured (ELISA) in 95% (170 of 179) of evaluated subjects T cell immune responses are being evaluated Zika (GLS-5700) Phase 1 High levels of binding antibodies measured (ELISA) in 100% (39 of 39) of evaluated subjects T cell immune responses are being evaluated 14

15 2017 Value Drivers and Milestones 2Q17: VGX-3100 HSIL P3 & VIN P2 studies initiated 2H17: Advance INO-5401 bladder cancer and GBM programs with checkpoint inhibitor to P1/P2 4Q17: Report INO-1400 (htert) interim immune response and safety data 2Q17: MEDI0457 checkpoint inhibitor combo P1/P2 trial initiated 3Q17: Report INO-5150 (prostate) immune response and safety data (interim) 4Q17: Publish Zika, Ebola, MERS phase 1 immune response and safety data 15

16 Value Drivers and Milestones 1Q18: Report INO-1800 HBV immune response and safety data (interim) 2018: Initiate VGX-3100 AIN P2 study 2019: Report on interim P1/2 data from Bladder INO-5401 study 2019: Report on interim P1/2 data on MEDI0457 study 2018: Report on Zika vaccine Puerto Rico study 2019: Report on interim P1/2 MERS vaccine Korea study data 2019: Report on interim P1/2 data from GBM INO-5401 study 16

17 Management & Financials

18 Senior Management J. Joseph Kim, PhD President & CEO Peter Kies CFO Niranjan Y. Sardesai, PhD; COO Mark L. Bagarazzi, MD CMO Decades of biotechnology/ pharma management Merck: hepatitis A and B vaccines manufacturing; HIV vaccine (Ad5) R&D Ernst & Young Experience with growth companies Extensive biotech management and product development experience Led diagnostics development for mesothelioma, bladder cancer, and ovarian cancer for Fujirebio Diagnostics Clinical research experience incl. Merck Led clinical/regulatory for shingles and rotavirus vaccines; DNA vaccine expert 18

19 Board of Directors Avtar Dhillon, MD Chairman, BOD Seasoned venture capitalist and biotech entrepreneur Simon X. Benito Former Senior Vice President, Merck Vaccine Division George Bickerstaff Partner, M.M. Dillon & Co. Former CFO, Novartis Pharma AG Angel Cabrera, PhD President, George Mason University Morton Collins, PhD General Partner, Battelle Ventures and Innovations Valley Partners 19 J. Joseph Kim, PhD President & CEO, Inovio Adel Mahmoud, PhD Professor, Princeton Univ. Former President, Merck Vaccines Responsible for Gardasil, Zostavax, Proquad and Rotateq David B. Weiner, PhD Executive VP, The Wistar Institute; Director, Vaccine Center

20 Scientific Advisory Board David B. Weiner, PhD Chairman Father of DNA vaccines Executive VP, The Wistar Institute; Director, Vaccine Center Anthony W. Ford- Hutchinson, PhD Former SVP, Vaccines R&D, Merck Oversaw development: Singulair, Januvia, Gardasil,Zostavax, Proquad and Rotateq Stanley A. Plotkin, MD Developed rubella and rabies vaccines Oversaw Sanofi flu vaccine Emeritus Professor, Wistar Institute & University of Pennsylvania 20

21 Financial Information Recent share price 1 $4.59 Shares outstanding 2 Market cap 1 Cash & short-term investments 2 3 Debt M $414.5 M $141.9 M 0 M 1 November 24, September 30, Due from ApolloBio Corp: up to $50M in signing fee, milestone and equity investment, the latter two contingent upon corporate and regulatory approvals in process 21

22 Investment Thesis: Inovio Positioned with Multiple Transformational Steps as an Immunotherapy Leader Taking immunotherapy to the next level Powerful technology platform with multiple cancer and infectious disease product candidates Phase 3 & phase 2 precancer studies including three P1/P2 immuno-oncology studies combining Inovio s technology with checkpoint inhibitors INO: NASDAQ Best-in-class data: phase 2b CD8 killer T cell/efficacy correlation published in The Lancet Validation: partners, publishing, grants 22

23 Appendix

24 Enhanced Cellular Delivery: Key Enabler of DNA Immunotherapies DNA plasmids must get through protective membrane into a cell to work Best method to enhance cellular uptake is electroporation SynCon DNA plasmid and CELLECTRA delivery device are phase 3 ready CELLECTRA 5PSP Device 24

25 CELLECTRA 5PSP Electroporation Delivery Device Drug Array 25

26 1 x 10-6 spleenocytes EP Optimization Design + Delivery = Improved Immune Responses T Cell Responses By ELISpot Assay Display of GFP gene expression after electroporation delivery into rabbit muscle Immunized 3x with 15ug pnp wk post Imm +EP

27 % Responders Clinical Confirmation of Inovio Electroporation Benefit HIV Antigen Response EP P= P < EP CD4 and CD8 intracellular cytokine staining (IFN-γ, IL-2) response associated with IL-12 and EP administration (2 clinical studies) with HIV gag, pol, env antigens/plasmids Dosing at 0, 4, 12 weeks Performed by independent HVTN Core Lab at University of Washington in NIH-sponsored trials Responses to three doses of vaccine delivered with EP are greater than responses to four doses of vaccine delivered IM IL-12 + IL-12 - IL-12 + IL-12 CD4+ Responders (%) CD8+ Responders (%) Spyros A. Kalams, et al., The Journal of Infectious Diseases 2013;208: HVTN 080 (N = 48 total). Responses shown against global peptides post-third dose, based on evaluable responders. HVTN 070 (N = 120 total). Responses shown against global peptides post-third dose, based on evaluable responders.

28 Demonstrated Effect in Phase 2b Trial of VGX-3100 Placebo-Controlled, Randomized, Double Blind VGX-3100 SynCon product for HPV-related pre-cancers Targets HPV 16/18 subtypes, E6/E7 oncogenes Females, age (n=167) High-grade cervical dysplasia (CIN2/3); HSIL HPV 16 and/or 18 positive 3:1 randomization Primary Endpoint Regression of CIN2/3 (HSIL) to CIN1 or normal (week 36) Secondary Endpoint Regression of CIN2/3 to CIN1 or normal and clearance of HPV (week 36) Dosing: month 0, 1, 3 28

29 Phase 2b Achieves Primary and Secondary Endpoints Groups Primary Endpoint Secondary Endpoint Primary Post Hoc Regression high grade to low grade cervical dysplasia or normal Dysplasia regression to low or normal AND HPV clearance Lesion regression to normal VGX % 40.2% 40.2% Control 30.6% 14.3% 16.7% Difference 18.9% 25.9% 23.5% P-value 1 p=0.017 p=0.001 p=0.006 Efficacy correlates to immune responses PP and mitt p-values equal 167 subjects Paper published in The Lancet September Strata-adjusted Phase 3 Primary Endpoint 29

30 On February 13, 2017, Inovio entered into a Collaboration and License Agreement with ApolloBio Corporation ApolloBio to receive exclusive rights to VGX-3100 within Greater China (China, Hong King, Macao, Taiwan) Potential inclusion of The Republic of Korea within three years of the Effective Date Inovio to receive upfront cash payment of $15M (1) Inovio to further receive up to $20M based upon achievement of VGX-3100 regulatory milestones (US, China, Korea), and double digit royalties on all net sales of VGX-3100 within the licensed territory Under a separate Stock Purchase Agreement, ApolloBio to purchase $35M (2) of Inovio common stock ApolloBio will pay $8.20 per share, which is based upon the 30 trading day volume weighted average price encompassing a period prior to and following FDA s lifting of the VGX-3100 clinical hold It is anticipated to close during the second half of 2017 Both agreements are subject to closing conditions including the final approval of ApolloBio s Board of Directors and shareholders, as well as regulatory and currency approvals required by The People s Republic of China 30 Inovio and ApolloBio Transaction: VGX-3100 (1) $12M of the $15M was tied to the FDA s lifting of the VGX-3100 Phase 3 pre-initiation clinical hold. The clinical hold was lifted on June 6 th (2) The amount may potentially be less than $35M, such that ApolloBio would not become the largest shareholder of Inovio.

31 First Partnership to Initiate Immuno-Oncology Strategy AstraZeneca/MedImmune (deal signed August 2015) Products Upfront Payment Development Costs Milestone Payments Royalties MEDI0457 (previously INO-3112) HPV-driven cancer immunotherapy + 2 new R&D products $27.5 million All development costs $700 million Up to double digit tiered royalties on MEDI royalties for additional cancer vaccine products MedImmune intends to study MEDI0457 in combination with selected immuno-oncology molecules within its pipeline 31

32 Granulysin Granzyme A Granzyme B MEDI0457 Drives Antigen Specific CD8+ T Cells with Lytic Phenotype in Patient with HPV16/18 Head & Neck Cancer Perforin Lytic phenotype: patient PBMCs stimulated 120 hours in vitro with antigen. No costimulation; no cytokine added at any time. Activation markers: CD38, CD69, CD137 Lytic proteins: perforin, granzyme A, granzyme B, granulysin 32

33 % C D 8 /C D 3 8 & C D 6 9 & C D Induction of CD8+ Activation, Lytic Protein Synthesis, and Humoral Immune Responses to HPV 16 and 18 in MEDI0457 Treated HNSCC Patient MEDI0457 IN O HPV 16/18 Specific CD8+ T Cell Activation BBefore e r e IN MEDI0457 O AAfter r IN MEDI0457 O HPV 16/18 Specific CD8+ T Cell Activation and Expression of Lytic Proteins 8 of 9 patients show CD8+ responses to MEDI Representative patient Before MEDI0457 After MEDI0457 Before MEDI0457 After MEDI0457

34 34

35 Emerging Infectious Disease Vaccine Opportunities Rapid response technology platform desired by health authorities to fight emerging infectious diseases Inovio DNA vaccine platform demonstrates rapid design, manufacturing, and clinical development of products for emerging diseases Commercialization drivers Grants, such as DARPA $45M Ebola award, Gates $8.8M, IVI grant for MERS Priority review voucher potential Stockpiling contracts: scale manufacturing Coalition for Epidemic Preparedness Innovations (CEPI) The coalition will also develop so-called platform technologies experimental approaches to producing new vaccines that use synthetic DNA to kick-start an immune response. MIT Technology Review Newly formed CEPI is largest-ever initiative to finance/develop new vaccines to address emerging infectious diseases Initial $540M investment: Germany, Japan, Norway, Bill & Melinda Gates Foundation and Wellcome Trust 35

36 dmab Products: Multiple Immune Mechanisms & Products Inovio s DNA-based monoclonal antibody products target: Cancers Infectious Diseases Checkpoint Inhibitors (CI) PD-1 PD-L1 4 additional CIs Herceptin Anti-Tregs Other anti-cancer pathways Influenza A Influenza B Pseudomonas MRSA/Staph Ebola MERS Dengue CHIKV Other infectious diseases 36 DARPA funded programs

37 Tumor Clearance (%) Protection in Challenge with Dengue Virus (%) Promising Preclinical dmab Data Cancer dmab Prostate cancer model in mice (Unpublished data) Dengue dmab (Nature Scientific Reports 2015) 100% 80% 100% 80% 100% 60% 70% 60% 40% 40% 20% 20% 0% 0% 0% 0% dmab (7 of 10) Control (0 of 10) dmab (10 of 10) Control (0 of 10) DARPA awards $57M to advance dmab application and develop products for Ebola, influenza and antibiotic resistant bacteria 37

38 38 Successful start of phase 3 studies

39 Expansion Into Brand New Facilities at Both SD and PHL to Support Next Phase of Growth Completed/Planned next wave of expansion New device manufacturing facility in San Diego (~52,000 sq. ft). Build out and move in 07/17/2017; ~30,000 sq. ft additional space leased in Plymouth Mtg HQ. Consolidated operations by functional areas in San Diego (2 sites) and Plymouth Mtg 39

40 The People Who Make it Happen Board of Directors J. Joseph Kim President & CEO Rami Kim-Ko Administrative Manager Peter Kies CFO Thomas Kim Sr VP Gen Counsel & Corp Secretary Mark Bagarazzi CMO Niranjan Y. Sardesai COO Matthew Morrow Director Immunology & Kim Kraynyak Lead, Immunology David Frantz, PM, Preclinical Dawson Knoblock Prod Dev Scientist Nikki Marshall Product Dev Scientist Naseem Prostak Product Dev Assoc Li Liu Product Dev Scientist Albert Sylvester Product Dev Assoc Charles Reed Protein Engineer Maggie Campbell Dir Acct & FInance Lynn Ngo Mgr, Financial Reporting Ruthie DeGuzman Sr Accountant Emily Miles AP Clerk (Contractor) Amir Khan Sr Dir Product Devel Jian Yan Assoc Dir Antigen Design & Discovery Anna Slager Product Dev Scientist Neil Cooch Product Dev Scientist Jing Chen Product Dev Scientist Bradley Garman Product Dev Assoc Angela Brakhop Scientific Writer (Part-time) Jeffrey Allen Assoc Dir, Pharmacology/ Toxicology Megan Wise Postdoctoral Fellow Catherine Ha Controller Ann Hartman Sr Financial Analyst Guadalupe Cajica Accounting Assoc Erin Butler Asst Controller Ronnie Wen Sr. Mrg, Acct, VGXP Joan Coyle Sr Acct Contractor Iris Rico Mgr, Accounting Urthelyn Addae- Mensah Sr Accountant Lan Cao Staff Accountant Carolina Garcia AP Clerk Emma Masteller Sr. Dir, Immuno- Oncology Bernadette Ferraro Sr Scientist Phoebe Valdes RA II Justin Arndt RA I Aleksandr Dolgoter Assoc Scientist Jewell Walters Scientist Lannie Nguyen RA I Anna Pyzel RA I Jeff Richardson VP, Strategic Relations Lisa Daniels Assoc Dir, Human Resources Charles Hagan Talent Acquisition Partner Linda McLaughlin Manager, HR Lucy Omar HR Assistant Denise Wescott Office Manager Shanjida Sharna Receptionist Glenda Didienne Manager, General Operations Angelica Chavez Office Coordinator Victoria Akpan Office Coordinator Marvin Bautista Facilities Supervisor Thomas Hong Comm Associate Kristine Germar Scientist David Valenta Sr Mgr, Analytical Immunology Mina Naji Clin Immunological Coordinator Jocelyn Cheung Associate Scientist Sophie Tan RA II Karlie Berg RA II Lindsay Sakata Associate Scientist Kelsie Dickerson RA I Loubna Mameza RA I Laurent Humeau VP R&D Jean Boyer Sr Dir, Analytical Sciences Patrick Pezzoli Dir, Product Characterization Joseph Agnes Sr. Scientist Dinah Amante Assoc Scientist Dennis van de Goor RA II Christian Roh RA I Shane Desfor RA I Aubree Anton RA I Alexander Quach RA I Thomas Mancini Sr. IP Counsel Paul Irvine IP Paralegal Rebecca Piranian Paralegal Ann Hastings Asst, Contract Mgmt Maggie Hewlett PT, File Clerk Trevor Smith Associate Dir, R&D Katherine Schultheis Scientist Holly Pugh RA II Bryan Yung RA II Nina Schommer Scientist Jacklyn Nguyen RA I Jacklyn Nguyen RA I Scott White VP CD Infectious Diseases Prakash Bhuyan VP, Clinical Dev Jeff Skolnik VP, Clin Dev, Oncology Ildiko Csiki VP, Clin Dev, Oncology Stephanie Ramos Associate Dir, R&D JingJing Jiang Scientist Preeti Bangalore RA II Ghiabe Guibinga Scientist Xinggang Liu RA II Sergey Lyubinetsky Cloning Scientist Dustin Elwood Scientist Robert Juba VP, Bio Mfg/Clinical Supplies Mgmt Chalise Jackson Clin Supplies Mngr Mike Dallas Sr. Dir Biostatistics Trevor McMullan Sr Biostatistician Susan Duff Director, Data Mgmt Kate Broderick Sr. Director, R&D Meredith Landau Mngr Data Mgmt Timothy Herring Epidemiologist Xiaoyun Zhang Sr Biostatistician Sandra Oyola Mngr Data Mgmt Gabrielle Farrell CoOp Jay McCoy Assoc Dir, Device R&D Alison Generotti Bioengineer RA I Paul Fisher Bioengineering Scientist Eric Schade Bioengineer RA I Maria Yang Production Scientist Roi Ferrer RA I Joseph Fader RA I Ami Shah Brown VP, Reg Affairs Lester Gibbs Dir, Regulatory Affairs Maurice Briggs Director, Reg Affairs Tracy Janus Dir, Reg Affairs, CMC Heather L. Sinsel Mngr, Reg Ops and Submissions Renuka Krishnan Dir, Reg Affairs, Medical Devices David Gramse Manager, Reg Affairs, Medical Devices Cheng Zhang Assoc Dir, Reg Affairs, Medical Devices Samantha Rosencranz CTA Amanda Busch Associate Scientist Janess Mendoza Operations Group Lead Lauren Gites RA II Melissa Gutierrez RA II Brian Lee RA I Francisco Vega Vega RA I Alicia Menendez Assoc. Scientist Nathan Keys RA I Alysha Vu RA I Matthew Parris Dir Clinical Ops Maureen O Connell CS Grace Warkulwiz Assoc Scientist Brian Sacchetta Assoc. CS Kamal Bhatt Assoc Clinical Prog Director Nicholas Carroll Assoc CS Drishty Mangrolia Sr CS Robin Elder Mgr, Pharmacovigilance Tamara Howard Sr CS Patricia Campbell Drug Safety Associate Bryan Stone CTA Jessica Lee VP, Clinical Ops & Global Integration Kimberly Hunsicker Patricia Green- Sr. Dir, Clinical Ops Amsler Sr Dir, Clin Compli Diane Stinson Pamela Bachman Sr Outsourcing Mgr Sr Clin Comp Assoc Nick Jeffers Carol Helper Outsourcing Mgr Sr Mgr, Clin Comp Robert E. Samuels Ashley Popelik Assoc Clin Prog Dir Sr Mgr, Clin Comp Clay Churchill Deborah Carman CPM Associate, Clin Comp Kathleen Thomas Pitman Marcozzi-Pierce Technical Writer Sr. CPM Helaine Zwanger Mary Giffear CS Assoc Dir, Clin Stu Ashley Santo Malissa Diehl Associate Scientist Sr CS Percilla Chang Michele Bialecki CTA CTA Divya Shah Amy Scheeler Sr CS Sr. CS Sybil Varghese Clinical Scientist Lizbeth Romero Clinical Trial Assoc Marie Leimkuhler Dir, Clinical Ops Noel Rolon Sr. Dir, Clinical Ops Elliott Blackwood Clinical Device Trainer Hedieh Badie Clinical Device Trainer Rachel Elward Lead, Med Device Teresa Leano Device Trainer Bridgette White Sr. CPM Jeff Smith CTA Linda Peterson Assoc Dir, Oncology Sharon Morgan Sr. Exec Admin Bill Ruggerio Director of IT Christian Flocco Sr Mgr IT CSV Greg Pearl Sr. Mgr, BSA Kevin Helmbold IT Site Support III Dan Markle Applicant Specialist (Contractor) Denise Hurley IT Business Analyst (Contractor) Gonzalo Pacheco IT Systems Admin Mark Sturrock Sr Systems Engineer Mark Labelle Sr. Mgr, Infrastructure Architecture Daniel Jordan VP, Device Mfg Operations Brian Waterman Assoc Dir, Mfg/Eng Kevin Kirby Sr Mfg Project Eng Felipe Buenrostro Distribution Assoc Kevin Wyrwich Mfg Electrical Eng David Dinubilo Mfg Project Eng Alison Riley Mfg Eng I Gordon Jung Sr Mfg Eng Linda Campbell Sr. Technical Writer Luis Ramos Production Supervisor Anjovel Castro Assembler Lead Ismael Cardenas- Lopez Elec Test Tech Lead Tap Truong Sr Electrical Tech Jeffrey Sanchez Assembler II Jestoni Canlas Assembler II Joel Lorenzo Assembler II Eric Cochran Electrical Test Tech. Tommy Phothirath Assembler II (Contractor) EJ Brandreth VP, Quality Karen Roycroft Dir, Clinical QA Michelle Beveridge Mgr, Clinical QA Nathan Manczarek Director, Device Quality; Mgmt Rep Robert Wixey Sr Sup, Compliance/ Lead Auditor Yumi Nakamura QA System Admin William Ray Mgr, Quality Eng/QC Matthew Gephart Quality Engineer Thanh Le QC Technician Jose Gaston QC Technician Tina Gutierrez QC Technician Sopida Injun QC Technician Luigi Tamburro Quality Engineer Jose Luis Hernandez Mgr, Quality Sys/ Doc Control Saul Rodriguez Doc Control Specialist Bentley Tam Quality Systems Specialist Janet Nelson Assoc Dir, Device Quality John Vaught RA/QA Associate Ravinder Singh Sr Mfg & Service Technician Brian Burton Device Service Tech (Contractor) John Bates QC Technician (Contractor) Ronald Smith Sr Supervisor, Bioanalytics QA Nhi Tsan QA Sample Inventory Specialist Stephen Kemmerrer VP, Engineering Development Beat Stadelmann Director, Electrical Engineering Michael Mai Sr Electrical Eng Charu Mather Principal Elec Eng Kevin Kemmerer Mechanical Eng II Gabriel Tobias Eng Elec Tech Victor Covarrubias Electrical Eng Dinh Winter Eng Tech Jasmin Gamilla Senior Systems Engineer Jeby Macaraeg Eng Tech Michael Mai Sr Electrical Eng Sree Chandrasenan Software Manager Michael Mai Sr Electrical Eng Anu Soundarajan SW Validation Engineer (Contractor) Brad Fisher V&V Engineer (Contractor) Daniel Unger SW Validation Engineer (Contractor) Brad Fisher V&V Engineer (Contractor) Jennifer Laux VP, Commercial Mark Twyman Sr. Dir, Commercial James Barlow Sr. Dir,Commercial Chelsey Nehila Sr.Assoc.Commercial Keiko Simon VP, Alliance and Program Mgmt Jennifer Lata Associate Director PM Sandra Lee Program Manager Paul Stead VP, BD Aug 2014: Total 86 [PM (36); SD (45); Contractors (2); Interns (3)] Aug 2015: Total 135 [PM (57); SD (64); Contractors (5); Interns (9)] Aug 2016: Total 214 [PM (83); SD (102); Contractors/Interns (29)] Jul 2017: Total 271 [PM (116); MR (83); WR (59); Contractors (13)] Joseph Hess QA Associate