Clinical Research Organization (CRO) & Consulting Company for                                                            G...
Table of Contents                                                                                  TOPICS                 ...
About the ESTERN Medical CRO GroupThis confidential document is provided for evaluation purposes only. All intellectual pr...
Who we are?                                                                                                               ...
Our Full Range of Clinical Trials                                              Development Services                       ...
Why Go to U.S. North America & Latin AmericaThis confidential document is provided for evaluation purposes only. All intel...
Why the U.S. or Latin America?                                                                                  Our CRO Bu...
Our Global Presence & Partnership AlliancesThis confidential document is provided for evaluation purposes only. All intell...
Why U.S. or Latin America Outperforms                                                                                other...
Why U.S. or Latin America Outperforms                                                                                 othe...
Fast & Efficient Execution of Clinical Trials in the U.S. & Latin America                                                 ...
U.S. & Latin America has more than 16,000 FDA Regulated Investigators & is         also increasing rapidly across LATAM.  ...
Open Phase III Clinical Trials Sponsored by the 20 Largest U.S.-                                                    Based ...
LATAM Vs US Vs European “Review Process”: Rate Key Limiting Steps• In the “USA”, each protocol (except for Phase 1 only re...
U.S. Vs LATAM Regulatory Timelines & Patient Recruitment Rates Our Most Common Regulatory Start-Up Times in the           ...
Our Areas of Expertise & Solutions                               in Clinical Site SelectionThis confidential document is p...
Our Areas focused Expertise in “Pharmaceutical &                                               Medical Devices” Clinical T...
We offer Tailored Solutions to our Sponsors across the                                                                    ...
Our Database Process of Clinical Site Selection                                                                           ...
Our U.S. & Latin America Therapeutic Expertise / Track Record of                    Executed Clinical Trials              ...
Our Clinical Sites Database Across U.S & Latin America     ESTERN Medical CRO Proprietary Database of Clinical Sites Netwo...
Our Track Record of Executed Pharmaceutical & Medical Device                                                      Clinical...
Our Therapeutic Expertise: Cardiology &                                                                                   ...
Our Therapeutic Expertise: Oncology & CNS /                                                                             Pa...
Our U.S. & Latin American Integration of Regulatory                    Activities & Cost AnalysisThis confidential documen...
ESTERN Medical Integrated Clinical & Regulatory ActivitiesOur Key Responsibilities           • External and Internal Custo...
Our Overall Regulatory Timelines Across Latin America*Source: ESTERN Medical CRO   This confidential document is provided ...
Our Leverage Cost Savings from Executing Trials in                                                                    U.S....
Our Company Organizational Structure                                           &                          Senior Executive...
ESTERN Medical CRO Operational Organizational                                                                             ...
Our Senior Executive Management Team                                                                    Dr.	  Jorge	  L.	 ...
ESTERN Medical Senior Executive Management                                                                               D...
ESTERN Medical Senior Executive Management                                                                                ...
ESTERN Medical Senior Executive Management                                                                               C...
ESTERN Medical Senior Executive Management                                                                                ...
ESTERN Medical Senior Executive Management                                                                                ...
ESTERN Medical Senior Executive Management                                                                                ...
ESTERN Medical Senior Executive Management                                                                                ...
Our Corporate &                                          Scientific Advisory BoardThis confidential document is provided fo...
Our Corporate & Scientific Advisory Board                                                                     Dr.	  Jorge	 ...
ESTERN Medical Corporate & Scientific Advisory Board                                                                       ...
ESTERN Medical Corporate & Scientific Advisory Board                                                                       ...
Presentationemv02april2011 110503074023 Phpapp01
Presentationemv02april2011 110503074023 Phpapp01
Presentationemv02april2011 110503074023 Phpapp01
Presentationemv02april2011 110503074023 Phpapp01
Presentationemv02april2011 110503074023 Phpapp01
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Presentationemv02april2011 110503074023 Phpapp01

  1. 1. Clinical Research Organization (CRO) & Consulting Company for Global Biotechs, Pharmaceutical & Medical Device Companies for U.S. North America & Latin AmericaThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited EM-No. V. 02 / June, 2012 1
  2. 2. Table of Contents TOPICS Slide No. About the ESTERN Medical CRO Group 3 Why Go to U.S. North America & Latin America? 6 Our Areas of Expertise & Solutions in Clinical Site Selection 16 Our U.S & Latin America Therapeutic Expertise, Track Record of Executed Clinical Trials & Our Proprietary Clinical Sites 20 Database U.S & LATAM Our U.S & Latin American Integration of Regulatory Activities & Cost Analysis 25 Our COmpany Organizational Structure & Senior Executive Management Team 29 Our Corporate & Scientific Advisory Board 39 Contact Us & Global Alliances & Partnerships 45This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 2
  3. 3. About the ESTERN Medical CRO GroupThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 3
  4. 4. Who we are? The ESTERN Medical CRO Corporation is one of the worlds leading global full Clinical Research Organizations (CRO), conducting clinical trials in the U.S. North America & the Emerging Markets across Latin America. We operate in two continents, in U.S. North America and Latin America. Our corporate office is located in Boston/Cambridge, USA and our own international subsidiary regional offices are spread across the following countries “Mexico, Colombia, Chile, Argentina & Brazil”. As an independent, privately owned corporation, since its foundation in 2002 we are passionate about being the preferred full service Contract Research Organization (CRO) partner worldwide, thus contributing to people’s health and quality of life. This leadership is built on our internal skills and competencies, and is complemented by collaboration with external partners and clients that include Global Pharmaceutical, Biotechnology, Medical Device, CROs & Academic - Government Institutions. ESTERN Medical CRO applies innovative dynamic Clinical Trial, Operational & Regulatory Development and a broad track record of diverse therapeutic expertise to our clients. We emphasize our commitment to quality to help our sponsors and partners maximize returns on their R&D investments by accelerating the delivery of safe and effective novel trial therapeutics to patients globally. ESTERN Medical provides outsourced clinical trial services across all trial phases I, II, III & IV, through its years of experience, ESTERN Medical has developed the operational and therapeutic expertise to provide high quality, global service while maintaining our differentiating personal interaction element of commitment to excellence to our sponsor.This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 4
  5. 5. Our Full Range of Clinical Trials Development Services Clinical Research Perceptive Informatics Consulting • Phase I, II, III & IV • Medical Imaging (MRI, CT, • Clinical Product/ Research • Biotech, Pharma & Medical Angio & Nuclear Medicine) Development & Regulatory Affairs Devices Trial Execution U.S. & • IWRS (Interactive Web Latin America Response) • Strategic Compliance & Risk • Project Management Management • EDC (Electronic Data Site Management, Regulatory Capture) • Clinical & Manufacturing EC/IRB & MoH Submissions, • Quality Process • Integration Services Monitoring • CTMS • Clinical Trials Development • Patient & Investigator Consulting Recruitment • ePro (Electronic Patient Diaries) •Pharma & Medical Device • EDC-Data Management Country Registration Services Biostatistics in the U.S. & LATAM. • Bioanalysis • Medical Services Product Development Process Expertise Technology Expertise ExpertiseThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 5
  6. 6. Why Go to U.S. North America & Latin AmericaThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 6
  7. 7. Why the U.S. or Latin America? Our CRO Business Model Presence • Strong academic & private clinical trials populated cities in the World yielding enrollment capabilities that generate strong enrollment efficiencies rates, with superb patient compliance and retention to availability of treatment-naive • Limited cultural & language barrier differences patients. compared to other countries as well as ethnic diversity covering most of the World’s • Top rated clinical research medical population, Large U.S. Hispanic populations as Governmental & Private Institutions. well as other European, Asian, and African populations • Physicians, Scientists and Key opinion leaders (Kols) with a broad range of expertise in clinical • Some Latin American countries provide a Fast research trials with a track record in the field Track regulatory form: Ministers of Health Biotech, Pharmaceutical and Medical Devices (MOH), IRB (Institutional Review Board) & Ethical research. Comities, FDA & EMEA quality assurance through strong adherence to GCP - ICH norms • Broad geographic patient population across 21 countries with access to 572 million population • Competitive economic cost in clinical trials in Latin America and in the U.S. 313 million. execution compared to US & Western Europe & other emerging countries • The top 20th Worlds largest and most populated metropolitan areas, provide us a broad patient concentrations in large public hospitals across the U.S. (New York, Los Angeles, Chicago, Houston etc.), Mexico City - Mexico; Buenos Aires - Argentina; Sao Paulo - Brazil; Bogota - Colombia; Lima - Peru; Rio de Janeiro - Brazil; Santiago - Chile, as some of the mostThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 7
  8. 8. Our Global Presence & Partnership AlliancesThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 8
  9. 9. Why U.S. or Latin America Outperforms other Emerging Countries & Regions ? Eastern USA Latin America China India EuropePopulation 313 Million 572 Million 1.340 Million 1.210 Million 880 Million USD 15.094 USD 7.298 USD 1.676 USD 2.385GDP (Nominal) USD 5.16 Trillion Trillion Trillion Trillion Trillion Hindi, English • Spanish (88%) Mandarin and and 8Language • English • Portuguese 10 other other 14 languages (12%) languages languages This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 9
  10. 10. Why U.S. or Latin America Outperforms other Emerging Countries & Regions ? USA Latin America China India Eastern Europe Higher Educational Educational Standards. Educational Equals West Equals West European standards standards do not EuropeanEducation and do not correspond On the vanguard correspond to West and NorthStandards of clinical, scientific, North American to European and AmericanPhysicians ethical practices educational West European and North American educational regulated by the standards North American standards standards AMA standards •FDA full •FDA has independent •China does not • India is FDA • 47% to adhere to compliance & regional based comply with the “approved“ clinical protocol people FDA inspections •standards. Adherence to the • No acquired principles of good • FDA Regional Local •29% failure to comparable Ref. FDA.gov clinical practices Offices across Latin report adverse data (GCPs), including America events adequate human Ref. FDA.gov subject protection •63% FDA GCP/GMPFDA Compliance (HSP) is universally inspections passed •21% inadequate recognized as a with no actions clinical trial critical requirement required records to the conduct of research involving •Complies with GCPS, Ref. FDA.gov human subjects.  ICH Guidelines Ref. FDA.gov Ref. FDA.gov This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 10
  11. 11. Fast & Efficient Execution of Clinical Trials in the U.S. & Latin America Patient Recruitment for all Current Listed Clinical Trial Diseases in Latin America Across USA & Latin America USA 61.710 Effectiveness ESTERN experience: Brazil 2.822 (patients / 6-25 patients per sites) site Mexico 1.629 Argentina 1.345 Some Latin America Chile 736 Regulatory countries have fast track Peru 601 Approval Times regulatory regime Colombia 551 Grand Total 69.394 *Source: ESTERN Medical CRO Group Latin American *Source: Clinicaltrials.gov, June / 2012 Operations, 2012 Capacity Operating in Emerging Markets across Latin America can substantially increase your capacity balancing with U.S. sites. Productivity Number of patients per site is usually higher than in USA and Western Europe, and LATAM leverages the overall trial performance Quality Quality of data is in LATAM comparable or equal / superior to USA & Western Europe.This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 11
  12. 12. U.S. & Latin America has more than 16,000 FDA Regulated Investigators & is also increasing rapidly across LATAM. Annualized Percent of Percent of 1996 2006 10-year Growth Total Total Rate North America 12,174 83.65% 14,555 63.18% 1.80% Western 1,899 13.05% 3,923 17.03% 7.52% Europe Central and 56 0.38% 1,793 7.78% 41.4% Eastern Europe Latin America 98 0.67% 1,095 4.75% 27.3% Asia 108 0.74% 1,054 4.58% 25.6% Rest of World 218 1.50% 617 2.68% 11.0% TOTAL 14,574 23,089 *Source: Tufts University Center for the Study of Drug DevelopmentThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 12
  13. 13. Open Phase III Clinical Trials Sponsored by the 20 Largest U.S.- Based Pharmaceutical & Medical Device Companies as of 2009 U.S. Ranks “1st” & Latin America “3rd” place 0 100 200 300 400 * United States Western Europe Global Number of Clinical Trials * Latin AmericaEastern Europe/Russia Includes any trial conducted in a Canada country that has at least one site Southeast Asia United States ranks in 1st placeAustralia/New Zealand * Latin America ranks in 3rd India place) Middle East Africa China Japan 0 5,000 10,000 15,000 * United States Global Number of Clinical Trial Sites Western Europe Eastern Europe/Russia Includes each location where a * Latin America study is recruiting Canada United States ranks in 1st place Southeast Asia *(Latin America ranks in 4th place) Australia/New Zealand Japan India *Source: New England Journal Medicine, Vol. 360, 8 February 2009 Middle East Africa China This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 13
  14. 14. LATAM Vs US Vs European “Review Process”: Rate Key Limiting Steps• In the “USA”, each protocol (except for Phase 1 only requires submission to the FDA and in parallel an IRB review and approval. • Prior review by FDA is not required except for Phase 1. • The rate limiting step is mainly the IRB submissions and approvals process. •The IRB review is 45-60+/- days within the USA• In “Latin America” the review process is sequential: first EC/IRB and then MoH. • MoH review time varies from country to country • Local Insurance covering patients can be rate limiting as many EC/IRB require • Many EC/IRB submissions and some regulatory authorities require a signed contract •The EC/IRB with MoH review is approximately 90 days in countries within LATAM• In “EU”, there is a parallel review process, and so submissions to EC’s and Competent Authority (MoH) can be performed simultaneously. • The EC/IRB - MoH review is 60 days for countries within the EU. This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 14
  15. 15. U.S. Vs LATAM Regulatory Timelines & Patient Recruitment Rates Our Most Common Regulatory Start-Up Times in the Variation in Global Patient Recruitment U.S. & Latin America Rates Regulatory Start-Up Population Average Number of Country Startup rank Time Region (2010) Patients Enrolled Per Site Overview (Months) U.S.A. 1st Tier 313,637 Million 2 Asia - Pacific 5.78 Mexico 1st Tier 110.6 Million 4 Latin America 4.56 Colombia 1st Tier 46.3 Million 4 Central & 6.27 Eastern Europe Chile 1st Tier 17.1 Million 4-5 Western Europe 3.08 Argentina 2nd Tier 40.6 Million 4-5 U.S. 1.92 Brazil 3rd Tier 195.4 Million 6-8 *Sources: Lehman Brothers Biopharmaceuticals R&D Statistical Sourcebook 2009 & *LATAM Clinical Trial Authorizations: Overview and update; Regulatory Focus, June Source: ESTERN Medical Latin American Operations 2012 2009• Latin American recruitment is well known to be of greater efficiency than other traditional regionsAs clinical trial sponsors increasingly shift their radars towards the emerging economies of Latin America, ESTERN Medical, garners localknowledge from key industry figures in the region, uncovering some countries initiatives aimed at bringing their regulatory processes in linewith traditional markets in the west. This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 15
  16. 16. Our Areas of Expertise & Solutions in Clinical Site SelectionThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 16
  17. 17. Our Areas focused Expertise in “Pharmaceutical & Medical Devices” Clinical Trials in the U.S. & Latin America Medical DeviceApproval Process ESTERN Medical Areas of ExpertisePharmaceuticalDrug Approval Process This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 17
  18. 18. We offer Tailored Solutions to our Sponsors across the U.S. & Latin AmericaOur Premium Quality Overall Services• Clinical Development and Design of Clinical Studies across U.S. &Latin America• Expertise in Biotech, Pharmaceutical & Medical Device ClinicalTrials• Efficient Patient Recruitment in the U.S. & Latin America in highlyqualified sites• Regulatory Strategies Dossiers Submissions (IRB/EC, MOH) in theU.S. & 21 Latin American countries.• *Monitoring, *Project Management, *Biostatistics, *MedicalWriting, *Translations, *Streamlined Site Selection & RecruitmentProcess, *Logistics, *EDC-Data Management, *AuditsOur Regulatory Services• Thorough knowledge of regulatory environment in U.S. & LatinAmerican countries.• Regulatory approval process (Ethics Committees & MOH) morestreamlined & predictable in the U.S. and LATAM.• Customized Regulatory Strategy per country to expedite approvaltimelines. This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 18
  19. 19. Our Database Process of Clinical Site Selection in the U.S. & Latin AmericaESTERN Medical Employs its Proprietary Database of HighProfile Clinical Sites across U.S. & Latin America ESTERN Medical proprietary database includes, hospitals, patientStep 1: ESTERN Medical creates database population, diseases specific, Key Opinion Leaders, country inconsidering Clinical Trial Specific Criteria the U.S. & LATAM specific Ministry of Health regulations, etc. ESTERN Medical Preliminary assessment Based on top-level information. Criteria can include:Step 2: ESTERN Medical filters into long U.S. & Latin America geographic location;list of candidates Clinical Trial region capabilities. ESTERN Medical Detailed assessment The criteria used in detailed assessments and proposal stages are based on:Step 3: ESTERN Medical filters into shortlist of candidates Intangible factors: Tangible factors: Financial stability • Reliability • Patient population Request proposals • Reputation • Disease Specific • Type of vendor • Experience • Capacity • Cultural fitFinal Selection • LocationSteps • Timescale • Commitment to project • Cost • Management strategy This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 19
  20. 20. Our U.S. & Latin America Therapeutic Expertise / Track Record of Executed Clinical Trials & Our Proprietary Clinical Sites Database U.S. & LATAMThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 20
  21. 21. Our Clinical Sites Database Across U.S & Latin America ESTERN Medical CRO Proprietary Database of Clinical Sites Network across U.S. North America & Latin America by Country and Therapeutic Area USA Mexico Colombia Brazil Argen1na ChileThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited *Source: ESTERN Medical CRO 21
  22. 22. Our Track Record of Executed Pharmaceutical & Medical Device Clinical Trials Phases I, II, III through IV Across USA & Latin America*Source: ESTERN Medical CRO This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 22
  23. 23. Our Therapeutic Expertise: Cardiology & Infectious DiseasesThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 23
  24. 24. Our Therapeutic Expertise: Oncology & CNS / Pain Management & PsychiatryThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 24
  25. 25. Our U.S. & Latin American Integration of Regulatory Activities & Cost AnalysisThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 25
  26. 26. ESTERN Medical Integrated Clinical & Regulatory ActivitiesOur Key Responsibilities • External and Internal Customer Advice, Guidance & Support • Feasibility, Proposals, Budgets • Regulatory Risk Analysis and Strategies • Regulatory Requirements Compliance for U.S. & LATAM • Regulatory Start-up - Documents Compilation and Review • Independent Ethics Committee and LATAM MoH Submissions • Follow-up and Reports • Import/Export processes U.S. & LATAM • CTM Delivery, Logistic, Storage and DestructionOur Regulatory Department- Interactions Clinical Monitoring Laboratory Services Operations Client Finance Department Regulatory Affairs Business Development Department Information Technology - IRB/EC (Institutional Review Board - U.S & LATAM (Clinical SItes) - LATAM MoH (Ministry of Health) Quality Assurance Drug Safety This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 26
  27. 27. Our Overall Regulatory Timelines Across Latin America*Source: ESTERN Medical CRO This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 27
  28. 28. Our Leverage Cost Savings from Executing Trials in U.S. & Latin American Countries• Patient recruiting is up to ten times more efficient Patient concentration e.g. in Mexico, Colombia, Chile and Argentina.• Treatment costs 30% less than in the US/Europe Lower costs for medication, investigations and hospitalization• Cost reduction due to domestic travel in Latin American Countries Urban concentration of sites Regional & Local Representative in each Office• Support Services - Less Expensive Printing, translation, local courier Data Management• Regulatory - Less Expensive Lower costs and fees in Latin America vs. US and Europe regulatory agencies• ESTERN Medical takes advantage of the higher recruitment rates expected in LATAM & higher advantage with combine U.S. or EU trial: • Compensates for delayed start-up due to the regulatory process • Allows to gain efficiencies by concentrating a higher number of patients in a reduced number of sites: • Lower overall study costs for sponsors • May enable to complete recruitment ahead of plan. This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 28
  29. 29. Our Company Organizational Structure & Senior Executive Management TeamThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 29
  30. 30. ESTERN Medical CRO Operational Organizational Flowchart U.S. & LATAM USA GLOBAL  CORPORATE  OFFICES U.S.  &  LATIN  AMERICAN  CRO  OPERATIONS CLINICAL   CLINICAL  RESEARCH   DATA   US  /  LA  LEGAL    &   REGULATORY DEVELOPMENT &  OPERATIONS MANAGEMENT  /    IT FINANCE DIRECTOR DIRECTOR DIRECTOR DIRECTOR DIRECTOR SENIOR  MANAGERS   FINANCE  &  LEGAL   SENIOR  MANAGERS SENIOR  MANAGERS SENIOR  CRA  &   SENIOR  MANAGERS MANAGERS   REGIONAL  CRAS  This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 30
  31. 31. Our Senior Executive Management Team Dr.  Jorge  L.  Estrella,  M.D. President  &  Chief  Medical  Officer Boston,  MA  USAThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 31
  32. 32. ESTERN Medical Senior Executive Management Dr. Jorge L. Estrella, M.D. President & Chief Medical Officer Dr. Estrella brings broad experience in the field of clinical Research development of cardiovascular and interventional medical devices, working previously as the Senior Physician Director-Clinical Trials Coordination at TheEducation Guidant Corporation - (ACS) Advanced Cardiovascular Systems in Santa Clara, California, Peripheral and Stent Division, having culminating with Guidant Corporation, with the “RX - HERCULINK®, 1st Renal and Peripheral Stent system1994-1996 Internal Medicine and Infectious Diseases - Molecular Biology platforms. Dr. Estrella also acquired extensive knowledge working in the clinical Research & Clinical Training at The National Institute of development of the CNS with RISPERDAL® (risperidone) indicated for treatment Nutrition, (INNSZ), Mexico City. Schizophrenia as a Senior Director Clinical Research at “Janssen1993-1994 Medical Internship at The Institute of Medical Security and Pharmaceuticals”. Services of the State Employees (ISSSTE), Mexico City.1989-1992 Medical Doctor. Dr. Estrella is internationally recognized for his broad expertise in clinical trials Autonomous University of Guadalajara (UAG), & research development in the pharmaceutical and medical device scientific Guadalajara, Mexico community in some of the most prestigious medical institutions, pharmaceutical and medical device companies. He has extensive expertise in the fields of cardiovascular, peripheral vascular diseases, interventional cardiology, CNS, infectious diseases and Diagnostic Imaging, bringing those clinical development products to future global market approvals.Track Record Professional ExperienceDr. Estrella is the Founder of ESTERN Medical Clinical Research Organization& Consulting Group and current President & Chief Medical Officer. 2002-Present ESTERN Medical CRO Global Group, LLC. Boston - Cambridge, Massachusetts, USAHe is responsible for overall corporate management and evaluating new President & Chief Medical Officer.clinical trials pipelines as well as sponsors relationships withPharmaceutical, Biotech & Medical Device Companies. 2002 -2005 EPIX Pharmaceuticals, Inc & Schering AG Pharma - “now known as Bayer Schering Pharma AG”Dr. Estrella brings to ESTERN Medical extensive experience in the Cambridge, Massachusetts, USACardiovascular, CNS, Infectious Diseases and MRI Diagnostic Radiological Director Clinical DevelopmentImaging therapeutic areas from EPIX Pharmaceutical Inc., in Cambridge, MAUSA as the Director Clinical Development, his Clinical R&D culminated with 1999-2002 GUIDANT Corporation / ACS Advanced Cardiovascular System“Vasovist” (gadofosveset trisodium) “First Imaging Agent Approved For -”now known as Boston Scientific Inc & Abbott Vascular”.Magnetic Resonance Angiography (MRA) In The US-FDA & EU-EMEA” a novel Santa Clara, California, USAblood pool magnetic resonance angiography (MRA & MRI) agent, Vasovist®. Senior Director Clinical Trials Coordinator Physician.Dr. Estrella brings a unique combination of entrepreneurial, scientific andbusiness expertise, encompassing both pharmaceutical and medical device 1998-1999 Janssen Pharmaceuticalsclinical trials development. North Carolina., USA Associate Director of Clinical Research 32
  33. 33. ESTERN Medical Senior Executive Management Robert Morgan, J.D., M.S. & B.S. Head of Scientific Regulatory Legal Affairs & Quality He drafted proposed FDA legislation Reform, including the drafting as well a members of the US-Congress. Mr. Morgan has held diverse executiveEducation positions in some of the top and most prestigious Medical Research & Clinical Regulatory Global Companies with EPIX Pharma, Inc, DuPont Pharma Company, Genzyme Corp., PAREXEL International Corp. & Theseus Imaging1992-1995 Massachusetts School of Law. Corp. before joining ESTERN Medical CRO Group & ZIOPHARM Oncology, Inc.1980-1982 University of Kansas, Masters in Radiation Biophysics.1973-1978 University of Massachusetts BS, in Zoology. Mr. Morgan is a Adjunct Faculty Member of The Healthcare Drug Development for the Graduate School of Engineering at Northeastern University in Boston.Track Record Professional ExperienceMr. Robert Morgan, is the Head of Scientific Regulatory Legal Affairs &Quality at ESTERN Medical CRO Global Group. He is also one of the key 2009-Present ESTERN Medical CRO Global Group, LLC.senior executive members of ESTERN’S Corporate Scientific Advisory Board Boston - Cambridge, Massachusetts, USAsince April 2009. Mr. Morgan also serves as the Senior Excecutive Vice Head of Scientific Regulatory Legal Affairs & QualityPresident, Regulatory Affairs, Quality, and Clinical Development and hasserved in that capacity since June 2006 at ZIOPHARM Oncology, Inc. 2006-Present Ziopharm Oncology, Inc. Boston, MA USA.During his career he has submitted and maintained multiple IND, NDA and Senior Vice President, Regulatory Affairs - Quality PharmaceuticalInternational regulatory filings. He also filed the first electronic IND Development & Drug Safety.application accepted by the FDA in the new international standard CommonTechnical Document format. 2003 -2006 EPIX Pharmaceuticals, Inc & Schering AG Pharma - now known asMr. Morgan, has over 25 years experience in all areas of drug development, Bayer Schering Pharma AGin the United States, Canada, Europe, India, Pacific Rim and Latin America. Cambridge, Massachusetts, USAAuthor of numerous successful IND, NDA and Orphan Drug submissions, Executive Director Regulatory Affairs & Quality.specializing in innovative treatments across multiple therapeutic areas,particularly Oncology, Interventional/Peripheral Cardiology and DiagnosticRadiological Imaging. 2001-2003 Theseus Imaging Corp. Subsidiary North America Scientific, Inc. Boston, MA USA.His effectiveness, hands-on direction: design early phase clinical studies, Vice President, Regulatory Affairsdraft regulatory submissions, including US and European Orphan Drugapplications, draft abstracts and manuscripts for publication in professional 1994-2001 Dupont Pharmaceuticals Companyjournals. Boston, MA USA Senior Director Regulatory Affairs 33
  34. 34. ESTERN Medical Senior Executive Management Claudia Hernandez-E., B.S., RPT., & MRI-Tech. Director Clinical Operations U.S. North America & Latin AmericaEducation Prior to joining Medrad Inc., she was the senior MRI manager clinician specialist for Siemens Medical in South America with diverse responsibilities from clinical training through operational commercialization support. Previous to her experience in the pharmaceutical & medical device industry1993 – 1994Masters Clinical Radiology at the (UDES) Universidad she endure her clinical experience as a chief clinical MRI technologist at a Santander, Bogota, Colombia South American university hospital in Bogota, Colombia and as a clinical physical therapist as clinician for more than 10 years.1985 – 1988 .S., Clinical Physical Therapy at the Universidad del B Rosario, Bogota, Colombia Mrs. Hernandez - E. is internationally well recognized for her broad expertise as a clinician and scientific researcher in some of the most prestigious medical institutions in the fields of cardiovascular, peripheral vascular diseases, interventional cardiology and diagnostic CT, MRITrack Record radiological imagingMrs. Hernandez, joined ESTERN Medical in April 2008 with an extensive Professional Experienceclinical research and clinical technical support training in the fields ofcardiology & interventional diagnostic imaging areas. Ms. Hernandez she 2008 to Present ESTERN Medical CRO, Global Group, LLC.brings a wide combination of scientific and business entrepreneurial hands on Boston - Cambridge, Massachusetts, USAknowledge and expertise to the ESTERN Medical CRO Group. Director Clinical Operations U.S. & Latin AmericaMrs. Hernandez - E. was previously the Senior Manager Clinical Research &Support Clinical Specialist for Latin American & Caribbean for Medrad Inc. a 1999 - 2008 Senior Manager Clinical Research & Support Clinicalsubsidiary of Bayer-Schering Pharma AG, where she initiated a strategy that Specialist for Latin American & Caribbeanhelped transform Medrad Inc. in Latin America from a distribution platform Medrad Inc, a subsidiary of Bayer Schering Pharma, AG.company to a fully independent clinical and training research networkstructure in South America. 1996 – 1999 Senior Manager Clinical MRI Specialist for Siemens Medical, for South America.Mrs. Hernandez - E. spent 10 years with Medrad Inc. culminating in her rolewith two of the most important company platforms, the Avanta cardiovascular 1995 – 1999 Chief Clinical MRI Imaging technologist at the Universityinterventional radiology MRI/CT diagnostic imaging injectors and most Hospital San Jose Bogota, Colombiaimportant the Stellant Dual Injector System for Multi-slice CT as a clinicalresearch support training for the Latin American region. 1989 – 1995 Independent Physical Clinical Therapist, (RPT). 34
  35. 35. ESTERN Medical Senior Executive Management Dr. John Jairo Hernandez, M.D. Director CNS & Pain ManagementEducation Professional Experience1995 Neuro-Magnetic Resonance Imaging. Biomagnetic - Intitute for Dr. Hernandez serves also as a professor at the School of Medicine and the Magnetic Resonance Imaging Director Medicine Pain Management and clinical research at the Universidad Caracas (Venezuela) del Rosario in Bogota, Colombia, with more than 20 years of experience in1987 Neurosurgery Spine and Pain this field. Centre Hospitalier Universitaire “La Timone”, Marseille (France)1983-1988 Post-Graduate Degree in Neurosurgery He is one of the top senior clinical advisors & Key Opinion Leaders ( KOL) for major Colegio Mayor de Nuestra Senora del Rosario global Pharmaceutical & Medical Device companies across the U.S, EU & Latin St. Joseph Hospital, Bogota (Colombia) America such as Grunenthal Laboratories, Pfizer, Novartis, Medtronic, Janssen1982 Medical Degree Cilag, Wyeth, Eli Lilly , Sanofi- Aventis in the fields of clinical research University of Rosario, School of Medicine pharmacology and medical device pain management, neurology & Bogota (Colombia) neurosurgery.Dr. Hernandez obtained his medical degree from the Universidad del Rosario He is also one of the first physician and (PIs) that implanted the first patientin Bogota, Colombia. He completed his internship and residency training in neurostimulators across Latin America and the first one in Colombia as wellNeurosurgery at the Colegio Mayor de Nuestra Señora del Rosario, Bogota, as broad experience in pharma drug-pumps in Pain-ManagementColombia, and continued his postgraduate studies in vertebral column andspinal medulla pain management in France at La Timone in Marseille. Dr. Hernandez has published numerous clinical journal and medical books publications in CNS and Pain Management.His third postgraduate training was done in Neuro-Imaging in MRI at theInstituto de Resonancia Magnética Biomagnética in Caracas, Venezuela His strengths are backed by 26 years of experience, a great academic background as university professor. Dr. Hernandez has published over 100 clinical articles on pain management diverse medical books & journals andTrack Record broad experienced management and clinical marketing Active Member, “Founder and Former President of the Colombian Association for the Study of Pain” (ACED) and active member of theDr. Hernandez joined ESTERN Medical in 2007 with extensive expertise in International Association for the Study of Pain (IASP).the clinical, academia and clinical trials research in Neurosurgery, MagneticResonance Imaging and Pain Management.Dr. Hernandez is involved in clinical and research as one of the top key This confidential document is provided for evaluation purposes only. All intellectualopinion leader and medical speaker for ESTERN Medical in his field of property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this informationexpertise in academia in the pharmaceutical and medical device industry. or any part thereof is strictly prohibited 35
  36. 36. ESTERN Medical Senior Executive Management Dr. Hernan Dario Hernandez C., D.D.S Director Operations South AmericaEducation Track Record & Professional Experience1978-1982 Surgeon in Dentistry Dr. Hernandez joined ESTERN Medical in June 2006 and serves as our UNICOC - Universitaria Colegios de Colombia, School Director of Operations for South America. of Dentistry (Colegio Odontologico Colombiano) Bogota, Colombia Before joining ESTERN Medical he worked in the Private & Health Government agencies across South America. He has a vast experience the EU, Spanish healthcare R&D industry as an executive & clinician, where he did acquired his clinical, regulatory and operational expertise on a global basis for major pharmaceutical, medical device companies & CROs in Seville, Spain. Dr. Hernandez brings abroad experience in the clinical operations for pharmaceutical & medical device healthcare industry across South America including a vast strategic operational finance/accounting & legal business development planning expertise from his broad knowledge & experience working as a senior executive member at AFIDRO (Association of Pharmaceutical Research & Development) in Colombia. Dr. Hernandez strengths are backed more than 20 years of experience an academic background as university clinician school of dentistry professor. This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 36
  37. 37. ESTERN Medical Senior Executive Management Dr. Jorge E. Estrella Sr., M.D. Director Medical AffairsEducation Professional ExperienceDr. Estrella obtained his Medical Degree from the Universidad Dr. Estrella is a Clinician and Researcher with a broad knowledgeAutónoma de México, UNAM, in Mexico City. gerontology and geriatrics were he has worked on cellular enzymatic therapy antibodies and protein therapeutics in MexicoHe completed his internship and residency training in Internal in the vanguard of medicine novel treatments.Medicine Geriatrics at the National Institute of Gerontology andGeriatrics, Bucharest, Romania, with international renowned Dr. Estrella brings a track record of experiences bringing theProfessor, Dr. Ana Aslan, MD. first novel wave of early geriatrics and gerontology clinical trials treatments to Latin America from Europe to present novel ones. Dr. Estrella was previously the Medical Director of DistribuidoraTrack Record Imperial de Mexico previously part of a major European distribution company in Mexico Pharmaceutical field for moreDr. Estrella is one of the Co-Founder of ESTERN Medical Mexico than 20 years. Dr. Estrella is key opinion leader for new noveland was appointed Director of Medical Affairs for ESTERN CRO in emerging global pharmaceutical companies in the field geriatric2002. compounds.Dr. Estrella has over 47 years of experience as a clinician andacademic university professor of internal medicine & geriatricsat the University of Mexico. As a clinical researcher and he is akey asset member at ESTERN Medical with broad knowledge inthe fields geriatric and cell therapy pharmaceuticals. Dr. Estrellabrings a wealth of business development in the Latin Americanand European pharma markets. This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 37
  38. 38. ESTERN Medical Senior Executive Management Antonio Ley Estrella, J.D. Director Legal & FinanceEducation Mr Ley strengths are also supported by more than 35 years of experience an academic background as university professor*Masters Degree in Legal Finance school of Law & Finance at the Universidad Autónoma de MexicoUniversidad Autónoma de Mexico (UNAM) (UNAM) & (UABC).*Law Degree, Universidad Autónoma de Mexico (UNAM) Some of his past legal & finance clients are Merck & Pfizer Pharmaceuticals, Aeroméxico Airlines, Coca Cola of Mexico, MoH of Mexico bringing that bast experience of knowledge to ESTERN Medical CRO under his belt of expertise and knowledge in theTrack Record legal and finance area.Mr. Ley-E. is a Co-Founder at ESTERN Medical Mexico S.A. andjoin the company in 2002 as the Director Legal & Finance. Professional ExperienceMr. Ley is responsible for maintaining in accordance all legal & 2002-Present ESTERN Medical - Director Legal & Financefinance Business Development with sponsors eitherPharmaceutical & Medical Device companies and CRO partners 1978 - 2008 President & L.E. Associates Legal Firm - Mexicoacross Latin America.30 years of experience as an attorney in the legal and financebusiness development as the previous the President at the legalfirm L.E. Associates, in Mexico. This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 38
  39. 39. Our Corporate & Scientific Advisory BoardThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 39
  40. 40. Our Corporate & Scientific Advisory Board Dr.  Jorge  L.  Estrella,  M.D. President  &  Chief  Medical  Officer Boston,  MA  USAThis confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 40
  41. 41. ESTERN Medical Corporate & Scientific Advisory Board Michael Webb, M.B.A. Head Of Corporate Advisory BoardMr. Michael D. Webb was appointed Head of Corporate Mr. Webb holds Bachelors degrees in Biochemistry andAdvisory Board since March 2009. Economics from the University of Kansas, Summa Cum Laude and an MA in International Relations from Sussex University inHe is currently the President & CEO at Allegro Diagnostics the UK, completing his thesis on "Pharmaceuticals Policy andCorp. in New England, Massachusetts. the World Health Organization." In addition, Mr. Webb holds an MBA degree with honors from the Kellogg Graduate School ofMr. Webb has more than 25 years of experience in Management at Northwestern University. He is a past chairmanhealthcare and life sciences. Most recently, he was the of the Massachusetts Biotechnology Council and currentlyfounder and CEO of Anchor Therapeutics, a venture-backed serves on the boards of Anchor and Virtify, where he iscompany focusing on developing pepducins, a new biology Chairman of the Board. He also serves on the advisory boardsplatform for drug discovery. Prior to founding Anchor, he of Deuteria Pharmaceuticals, ESTERN Medical CRO, Wolfewas the CEO of EPIX Pharmaceuticals, Inc. from 1994 Laboratories, the Kellogg Center for Biotechnology atthrough 2005. During this period, EPIX grew from a venture- Northwestern, the Institute for Advancing Medical Innovation atbacked startup to the world leader in discovery and the University of Kansas and is a Senior Advisor to Johnstondevelopment of pharmaceuticals for diagnostic imaging with Blakely, a life sciences investment banking firm.MRl, achieving worldwide approval for its lead product andcompleting numerous financings and corporate partnerships He currently serves on the boards of the Massachusettsincluding an IPO on NASDAQ. Mr. Webb joined EPIX from Biotechnology Council, where he is past Chairman, the KelloggCIBA, where he was most recently Senior Vice President, Center for Biotechnology at Northwestern and is a SeniorWorldwide Marketing and Strategic Planning of CIBA Advisor to Johnston and Blakely, a life sciences investmentDiagnostics, responsible for global marketing, program banking firm.management, corporate planning, business developmentand licensing. Prior to CIBA, Mr. Webb was a seniorconsultant at Booz, Allen & Hamilton, specializing inhealthcare and life sciences. This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 41
  42. 42. ESTERN Medical Corporate & Scientific Advisory Board Dr. John Amedio, PhD. Senior Corp. R&D Scientific Advisory BoardDr. John Amedio was appointed Member of the Corporate Most recently Dr. Amedio was Vice President, Manufacturing &Advisory Board since July 2009. Process Development, ZIOPHARM Oncology, Inc., (2006-2009); Executive Director, Analytical and Chemical R&D, EPIXDr. John Amedio is Vice President, Manufacturing & Process Pharmaceuticals Inc., (1995-2006) and Unit Leader, ChemicalDevelopment at Seaside Therapeutics LLC., serving in that Research and Development Department, Sandoz Researchcapacity since 2009. John has twenty years of experience in Institute (1989-1995)(currently Novartis Pharmaceuticals)major and start-up pharmaceutical companies. He has extensiveexperience in all aspects of Chemistry, Manufacturing and Dr. Amedio holds a Post-Doctoral, in Natural Product Synthesis/Controls (CMC), including regulatory agency document Organic Chemistry from the State University of Oregon andpreparation, quality assurance, active pharmaceutical ingredient completed his Ph.D., in Organic Chemistry (Synthesis, Isolationsynthesis, drug product pre-formulation and formulation, of Natural Products, Transition Metals) from the University ofanalytical methods development and the preparation of clinical Delaware and B.S, Chemistry from the Manhattan College in Newtrial material for the appropriate developmental stage York.worldwide. Dr. Amedio has delivered numerous profitable andpatented manufacturing processes (API and finished drugproduct, injectable and oral dosage forms). This confidential document is provided for evaluation purposes only. All intellectual property contained herein remains the property of ESTERN Medical, LLC. Any unauthorized use, review, retransmission, distribution, copying or other dissemination of this information or any part thereof is strictly prohibited 42

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