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HT Pharmaceuticals Clinical Research Consulting

HT Pharmaceuticals Clinical Research Consulting. Humphrey Tebit, Principal. Company History. HT Pharmaceuticals registered as a Sole Proprietorship in 2008 Invited to conduct a pilot study for a small pharmaceutical company in March 2008

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HT Pharmaceuticals Clinical Research Consulting

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  1. HT PharmaceuticalsClinical Research Consulting Humphrey Tebit, Principal

  2. Company History • HT Pharmaceuticals registered as a Sole Proprietorship in 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 • Currently working on 3 pivotal studies for a small pharmaceutical company, due for submission to Health Canada by the end of 2009 HT Pharmaceuticals

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

  4. Industry Experience • Associate Director Pharmacokinetics and Statistics, Biovail Contract Research • Director of Pharmaceutics, Cantest • Clinical Development Consultant, Apotex • Clinical Consultant, Genpharm • Senior Biometrics Officer and Team Leader, Merck Generics (UK) • Research Assistant, Animal Research Institute HT Pharmaceuticals

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

  6. Services Offered • Research & Planning • CRO Selection & Management • Study Management • Submission HT Pharmaceuticals

  7. Research & Planning • Conducting feasibility studies for submission • Reviewing results to date to determine study design parameters for future studies • Designing Phase I - Phase III studies • Consulting with relevant regulatory bodies • 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 HT Pharmaceuticals

  8. CRO Selection & Management • 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 • 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 • Resolve study technical issues between CRO and pharmaceutical company HT Pharmaceuticals

  9. Study Management • Apply clinical research experience to manage project activities efficiently and effectively • Analysis of clinical data • Study report review and report writing • Interpreting and presenting statistical study results to non-statisticians • Writing reports for different regulatory jurisdictions HT Pharmaceuticals

  10. Submission • Advise on submission strategy • Review submission package and provide all required documentation • Interpret unexpected results and demonstrate relevance for submission and/or for planning future studies HT Pharmaceuticals

  11. Completed BE Pilot Study • Supporting a small size pharma company on their Abbreviated New Drug Submission (ANDS) into Health Canada • 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 HT Pharmaceuticals

  12. Current BE Study • 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 • Liaison with European product manufacturer on documentation required for study protocol approval HT Pharmaceuticals

  13. Client Feedback • 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 consulted HT Pharmaceuticals on additional projects HT Pharmaceuticals

  14. Why Work with HT Pharmaceuticals HT Pharmaceuticals can: • Support your study requirements for a more efficient and successful submission • Provide you with expert advice on technical issues for 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 HT Pharmaceuticals

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