HT Pharmaceuticals Clinical Research Consulting Humphrey Tebit, Principal

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Company History HT Pharmaceuticals registered as a Sole Proprietorship in 2008 HT Pharmaceuticals registered as a Sole Proprietorship in 2008 Invited to conduct a pilot study for a small pharmaceutical company in March 2008 Invited to conduct a pilot study for a small pharmaceutical company in March 2008 Selected to work on projects for two different Contract Research Organizations (CROs) in 2008 Selected to work on projects for two different Contract Research Organizations (CROs) in 2008 Currently working on 3 pivotal studies for a small pharmaceutical company, due for submission to Health Canada by the end of 2009 Currently working on 3 pivotal studies for a small pharmaceutical company, due for submission to Health Canada by the end of 2009

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Humphrey Tebit, Principal M.Sc. in Biometry (Applied Statistics) M.Sc. in Biometry (Applied Statistics) B.Sc. (Hons) Biochemistry B.Sc. (Hons) Biochemistry 15 years of pharmaceutical experience, 10 in Europe and 5 in North America 15 years of pharmaceutical experience, 10 in Europe and 5 in North America 4 years of scientific experience in Africa 4 years of scientific experience in Africa

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Industry Experience Associate Director Pharmacokinetics and Statistics, Biovail Contract Research Associate Director Pharmacokinetics and Statistics, Biovail Contract Research Director of Pharmaceutics, Cantest Director of Pharmaceutics, Cantest Clinical Development Consultant, Apotex Clinical Development Consultant, Apotex Clinical Consultant, Genpharm Clinical Consultant, Genpharm Senior Biometrics Officer and Team Leader, Merck Generics (UK) Senior Biometrics Officer and Team Leader, Merck Generics (UK) Research Assistant, Animal Research Institute Research Assistant, Animal Research Institute

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Key Strengths Full understanding of clinical trials Full understanding of clinical trials Broad and varied technical skills required for project management Broad and varied technical skills required for project management Effective liaison among product manufacturers, sponsor companies, CRO’s and sub-contractors Effective liaison among product manufacturers, sponsor companies, CRO’s and sub-contractors Excellent communication and presentation skills Excellent communication and presentation skills International experience to manage study activities for global companies International experience to manage study activities for global companies

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Services Offered Research & Planning Research & Planning CRO Selection & Management CRO Selection & Management Study Management Study Management Submission Submission

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Research & Planning Conducting feasibility studies for submission Conducting feasibility studies for submission Reviewing results to date to determine study design parameters for future studies Reviewing results to date to determine study design parameters for future studies Designing Phase I - Phase III studies Designing Phase I - Phase III studies Consulting with relevant regulatory bodies Consulting with relevant regulatory bodies Managing Pharmacokinetics BA/BE studies Managing Pharmacokinetics BA/BE studies –Designing PK studies for both BA and BE type studies –Applying understanding of PK/TK parameters to study design and interpretation of results

Copyright © 2009 All Rights Reserved HT Pharmaceuticals CRO Selection & Management CRO selection CRO selection –Applying experience working with over 50 CROs to identify those capable of conducting the studies –Obtaining quotes from multiple CROs to determine the best CRO for the project and manage costs Development of bioanalytical methods Development of bioanalytical methods –Advising on method development to ensure correlation between study designs and bioanalytical methods –Ensuring maximum study data capture Liaise between product manufacturers and study implementation CRO Liaise between product manufacturers and study implementation CRO Resolve study technical issues between CRO and pharmaceutical company Resolve study technical issues between CRO and pharmaceutical company

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Study Management Apply clinical research experience to manage project activities efficiently and effectively Apply clinical research experience to manage project activities efficiently and effectively Analysis of clinical data Analysis of clinical data Study report review and report writing Study report review and report writing –Interpreting and presenting statistical study results to non-statisticians –Writing reports for different regulatory jurisdictions

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Submission Advise on submission strategy Advise on submission strategy Review submission package and provide all required documentation Review submission package and provide all required documentation Interpret unexpected results and demonstrate relevance for submission and/or for planning future studies Interpret unexpected results and demonstrate relevance for submission and/or for planning future studies

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Completed BE Pilot Study Supporting a small size pharma company on their Abbreviated New Drug Submission (ANDS) into Health Canada Supporting a small size pharma company on their Abbreviated New Drug Submission (ANDS) into Health Canada Pilot Study activities Pilot Study activities –Designed study –Obtained quotes from 3 CROs, selected the most suitable CRO for study and contracted out the work –Significant input into the study protocol and development of study documentation –Managed study activities from pre-study through clinical and bioanalytical phases to report review

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Current BE Study Three Pivotal Studies: Three Pivotal Studies: –Performed all Pilot Study activities –Saved company over $100K on each study by selecting the best CRO and the most cost effective study design –Monitored Phase I of clinical phase of study Writing controlled correspondence for the company on study requirements Writing controlled correspondence for the company on study requirements Liaison with European product manufacturer on documentation required for study protocol approval Liaison with European product manufacturer on documentation required for study protocol approval

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Client Feedback Current client is very satisfied with the way HT Pharmaceuticals is handling their study activities Current client is very satisfied with the way HT Pharmaceuticals is handling their study activities Client has given total control and responsibility of running the studies to HT Pharmaceuticals Client has given total control and responsibility of running the studies to HT Pharmaceuticals Client has consulted HT Pharmaceuticals on additional projects Client has consulted HT Pharmaceuticals on additional projects

Copyright © 2009 All Rights Reserved HT Pharmaceuticals Why Work with HT Pharmaceuticals HT Pharmaceuticals can: Support your study requirements for a more efficient and successful submission Support your study requirements for a more efficient and successful submission Provide you with expert advice on technical issues for clinical trials Provide you with expert advice on technical issues for clinical trials Apply European and North American experience to support global implementation of clinical trials Apply European and North American experience to support global implementation of clinical trials Manage all your study activities and work independently with the CRO to assure a successful outcome Manage all your study activities and work independently with the CRO to assure a successful outcome