Speid & Associates, Inc. Consultancy Services, Inc. Lorna Speid, Ph.D., RAC President Speeding New Drugs to Market ® www.d...
Staff at Speid & Associates <ul><li>Lorna Speid, B.Pharm(Hons)., M.R.Pharm.S.,  Ph.D. </li></ul><ul><ul><li>President </li...
Staff at Speid & Associates <ul><li>Speid & Associates, Inc. has access to additional expert consultants via the San Diego...
Dr. Speid – Credentials  <ul><li>Registered UK Pharmacist </li></ul><ul><li>BPharm(Hons)  –  King ’ s College, London Univ...
Dr. Speid – Expertise <ul><li>Experience with international pharmaceutical industry </li></ul><ul><li>Broad based drug dev...
Dr. Speid – Expertise <ul><li>Document management oversight experience </li></ul><ul><li>Appeals procedures </li></ul><ul>...
Speid & Assoc. Associates <ul><li>Expert consultants (associates) work with the Company </li></ul><ul><li>Different specia...
How We Work <ul><li>Strategic </li></ul><ul><li>Tactical </li></ul><ul><li>Hands-on </li></ul><ul><li>Can work on location...
How We Work We believe that a successful development program requires more than serendipity or luck --- We have a proven t...
How We Work It is very easy to throw money away if you do not have the right people on your team --- We are experienced in...
How We Work We work with our clients to achieve successful global registration, as expeditiously as possible  --- we ident...
How We Work <ul><li>We can ‘jump start’ a stalled program: </li></ul><ul><li>Clinical holds </li></ul><ul><li>Rejected mar...
How We Work We can help you to determine what your next move should be in the drug/device/diagnostic or combination develo...
How We Work – the Starting Point Review of Regulations US Europe International Review of Guidelines US Europe Internationa...
Overview of Services - Customer Base <ul><li>Customer base  </li></ul><ul><ul><li>Small companies  </li></ul></ul><ul><ul>...
Overview of Services <ul><li>Drugs (small molecule) </li></ul><ul><li>Biologics (large molecule) </li></ul><ul><li>Gene Th...
Overview of Services <ul><li>Experience with many therapeutic areas, including: </li></ul><ul><ul><li>Anti-infective </li>...
Overview of Services – Due Diligence <ul><li>Conducted for companies, VCs and financial institutions </li></ul><ul><ul><li...
Overview of Services - Clinical <ul><li>Review of Summary Bases of Approvals </li></ul><ul><li>Preparation of INDs, CTAs, ...
Overview of Services - INDs <ul><li>Assistance and advice in clinical hold situations </li></ul><ul><li>Regulatory due dil...
Overview of Services – Clinical Trial Applications <ul><li>Expertise in new European Clinical Trial process [European Clin...
Overview of Services – Toxicology <ul><li>Review of toxicology guidelines </li></ul><ul><li>Development of toxicology stra...
Overview of Services – Applications and Reports <ul><li>Preparation and planning for Pre-IND meetings </li></ul><ul><li>Pl...
Overview of Services – eCTD Services <ul><li>Building of global eCTD strategy </li></ul><ul><li>Organization of the intern...
Overview of Services – Company Staff Development <ul><li>Training of Executive Management  </li></ul><ul><li>Provision of ...
Partnerships <ul><li>Speid & Associates, Inc. has partnered with the following organizations to bring services to the Spei...
Webinar Series <ul><li>The Regulatory Series </li></ul><ul><ul><li>A regulatory affairs series which provides an update on...
Webinar Series <ul><li>Audio Files are Now Available </li></ul><ul><ul><li>The audio files are available at  www.drugstoma...
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Company Presentation Final June 2008

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Corporate Presentation - International Regulatory and Drug Development Services

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  • Company Presentation Final June 2008

    1. 1. Speid & Associates, Inc. Consultancy Services, Inc. Lorna Speid, Ph.D., RAC President Speeding New Drugs to Market ® www.drugstomarket.com
    2. 2. Staff at Speid & Associates <ul><li>Lorna Speid, B.Pharm(Hons)., M.R.Pharm.S., Ph.D. </li></ul><ul><ul><li>President </li></ul></ul><ul><li>Expert Associates are available as needed on a project and company basis </li></ul>
    3. 3. Staff at Speid & Associates <ul><li>Speid & Associates, Inc. has access to additional expert consultants via the San Diego Consultants ’ Forum, started by Speid & Associates, Inc. and Entremedica, Inc. </li></ul><ul><ul><li>A one- stop-shop can be provided for any project </li></ul></ul><ul><ul><li>See www.consultants-forum.com </li></ul></ul>
    4. 4. Dr. Speid – Credentials <ul><li>Registered UK Pharmacist </li></ul><ul><li>BPharm(Hons) – King ’ s College, London University </li></ul><ul><li>Ph.D. from University of Wales & Centre for Medicines Research International (UK) </li></ul><ul><li>Experience working for a number of international pharmaceutical companies, including: </li></ul><ul><ul><li>Sanofi-Winthrop (UK) </li></ul></ul><ul><ul><li>Ciba-Geigy/Novartis (HQ - Switzerland) </li></ul></ul><ul><ul><li>GeneMedicine/Valentis, Inc. (US) - Dir. Reg Affairs </li></ul></ul><ul><ul><li>NewBiotics (Officer of Company, VP Regulatory Affairs & Project Management [incl. clinical & QA]) </li></ul></ul><ul><ul><li>Avera (Officer of Company, VP Regulatory Affairs) </li></ul></ul>
    5. 5. Dr. Speid – Expertise <ul><li>Experience with international pharmaceutical industry </li></ul><ul><li>Broad based drug development skills </li></ul><ul><li>Experience as core team member of international project teams in large and small pharmaceutical organizations </li></ul><ul><li>Experience setting up and managing project teams, including virtual teams </li></ul><ul><li>Experience with FDA and health authorities worldwide (CDER & CBER) </li></ul><ul><li>IND, MAA, NDA, CTD experience, </li></ul>
    6. 6. Dr. Speid – Expertise <ul><li>Document management oversight experience </li></ul><ul><li>Appeals procedures </li></ul><ul><li>Has set up and monitored clinical trials in past, and therefore understands the clinical process </li></ul><ul><li>Good understanding of challenges faced by small and large companies – ability to address these to optimize the potential for success in the small company setting </li></ul>
    7. 7. Speid & Assoc. Associates <ul><li>Expert consultants (associates) work with the Company </li></ul><ul><li>Different specialities and expertises, for example: </li></ul><ul><ul><li>Regulatory Affairs </li></ul></ul><ul><ul><li>Statistics </li></ul></ul><ul><ul><li>Drug Development </li></ul></ul><ul><ul><li>Clinical Development </li></ul></ul><ul><ul><li>Therapeutic area specialists </li></ul></ul><ul><ul><li>Drug Discovery and Research </li></ul></ul>
    8. 8. How We Work <ul><li>Strategic </li></ul><ul><li>Tactical </li></ul><ul><li>Hands-on </li></ul><ul><li>Can work on location or remotely </li></ul><ul><ul><li>Our clients are as far away as in Australia, or as local as San Diego </li></ul></ul>
    9. 9. How We Work We believe that a successful development program requires more than serendipity or luck --- We have a proven track record of past achievements
    10. 10. How We Work It is very easy to throw money away if you do not have the right people on your team --- We are experienced in working with diverse teams -- We will ensure that the knowledge remains within the client company by working closely with the team
    11. 11. How We Work We work with our clients to achieve successful global registration, as expeditiously as possible --- we identify the pieces of the jigsaw and help the client to work out how they fit together
    12. 12. How We Work <ul><li>We can ‘jump start’ a stalled program: </li></ul><ul><li>Clinical holds </li></ul><ul><li>Rejected marketing applications (for any health authority in the world) </li></ul><ul><ul><li>Dr. Speid has appeals experience and a proven track record of success </li></ul></ul>
    13. 13. How We Work We can help you to determine what your next move should be in the drug/device/diagnostic or combination development program
    14. 14. How We Work – the Starting Point Review of Regulations US Europe International Review of Guidelines US Europe International Review of ICH guidelines Development of global and US regulatory and development strategy
    15. 15. Overview of Services - Customer Base <ul><li>Customer base </li></ul><ul><ul><li>Small companies </li></ul></ul><ul><ul><li>Large pharma </li></ul></ul><ul><ul><li>US based companies </li></ul></ul><ul><ul><li>Companies in Canada, Europe, Australia and rest of world </li></ul></ul><ul><ul><li>Venture capital organizations </li></ul></ul><ul><ul><li>Analysts </li></ul></ul><ul><ul><li>Angel investor organizations </li></ul></ul><ul><ul><li>Financial institutions, including Wall Street </li></ul></ul>
    16. 16. Overview of Services <ul><li>Drugs (small molecule) </li></ul><ul><li>Biologics (large molecule) </li></ul><ul><li>Gene Therapy </li></ul><ul><li>Medical Devices </li></ul><ul><li>In vitro Diagnostics </li></ul><ul><li>Combination Products </li></ul><ul><li>Generics </li></ul><ul><li>Due Diligence </li></ul><ul><li>Quality Assurance including audits [through partners] </li></ul><ul><li>Strategic medical writing </li></ul>
    17. 17. Overview of Services <ul><li>Experience with many therapeutic areas, including: </li></ul><ul><ul><li>Anti-infective </li></ul></ul><ul><ul><li>Oncology </li></ul></ul><ul><ul><li>Respiratory </li></ul></ul><ul><ul><li>Women ’ s health </li></ul></ul><ul><ul><li>Dermatology </li></ul></ul><ul><ul><li>Anti-inflammatory </li></ul></ul><ul><ul><li>Central nervous system </li></ul></ul><ul><ul><li>Bone </li></ul></ul>
    18. 18. Overview of Services – Due Diligence <ul><li>Conducted for companies, VCs and financial institutions </li></ul><ul><ul><li>Review of company strategy </li></ul></ul><ul><ul><li>Review of the compounds </li></ul></ul><ul><ul><ul><li>Extensive review of documents, including regulatory correspondence </li></ul></ul></ul><ul><ul><ul><li>Review of regulatory actions, e.g. warning letters </li></ul></ul></ul><ul><ul><li>Assessment of the company systems and management team </li></ul></ul><ul><ul><li>Assessment of risk and probability of success </li></ul></ul><ul><ul><li>Assessment of the regulatory hurdles, and time to market </li></ul></ul><ul><ul><li>Preparation of report </li></ul></ul>
    19. 19. Overview of Services - Clinical <ul><li>Review of Summary Bases of Approvals </li></ul><ul><li>Preparation of INDs, CTAs, IDEs </li></ul><ul><li>Set up clinical trials </li></ul><ul><li>Writing of Investigator ’ s Brochures </li></ul><ul><li>Writing, editing or review of Protocols </li></ul><ul><li>Submissions to IRBs and FDA </li></ul><ul><li>Preparation of Informed Consent Documents </li></ul><ul><li>Writing, editing and/or review of clinical study reports </li></ul>
    20. 20. Overview of Services - INDs <ul><li>Assistance and advice in clinical hold situations </li></ul><ul><li>Regulatory due diligence for licensing-in or licensing-out situations </li></ul><ul><li>Preparation of IND Annual Reports </li></ul><ul><li>Advice regarding Quality Assurance issues </li></ul><ul><li>Preparation of IND safety reports </li></ul><ul><li>Preparation of INDs in the new eCTD format </li></ul><ul><li>Preparation of INDs in the older 9 section format </li></ul>
    21. 21. Overview of Services – Clinical Trial Applications <ul><li>Expertise in new European Clinical Trial process [European Clinical Trial Directive] </li></ul><ul><ul><li>Conversion of US IND to European Clinical Trial Application </li></ul></ul><ul><li>Gaining experience working with Russia and other Eastern European countries </li></ul><ul><li>Gaining experience with India and developing countries </li></ul>
    22. 22. Overview of Services – Toxicology <ul><li>Review of toxicology guidelines </li></ul><ul><li>Development of toxicology strategy </li></ul><ul><ul><li>Acute toxicology study designs </li></ul></ul><ul><ul><li>Sub-chronic toxicology study designs </li></ul></ul><ul><ul><li>Chronic toxicology study designs </li></ul></ul><ul><ul><li>Reproductive toxicology study designs </li></ul></ul><ul><ul><li>Carcinogenicity study designs and strategy </li></ul></ul><ul><li>Liaison with major toxicology houses </li></ul><ul><li>Preparation of toxicology protocols </li></ul><ul><li>Review of toxicology reports </li></ul><ul><li>Development of Pre-IND meeting strategy and discussions with health authorities around the toxicology issues </li></ul>
    23. 23. Overview of Services – Applications and Reports <ul><li>Preparation and planning for Pre-IND meetings </li></ul><ul><li>Planning for major filings (eg CTD, NDAs) </li></ul><ul><li>Writing of major filings, CTDs, NDAs </li></ul><ul><li>Writing of expert reports </li></ul><ul><li>Planning and implementation of document management systems </li></ul><ul><li>Reimbursement strategies (via collaborator) </li></ul>
    24. 24. Overview of Services – eCTD Services <ul><li>Building of global eCTD strategy </li></ul><ul><li>Organization of the internal and external project teams </li></ul><ul><li>Interpretation of the guidelines for the compound in question </li></ul><ul><li>Organization of discussions with Health Authorities </li></ul><ul><li>Publishing strategy derivation </li></ul><ul><li>Expert writing </li></ul>
    25. 25. Overview of Services – Company Staff Development <ul><li>Training of Executive Management </li></ul><ul><li>Provision of advice to Executive Management Team </li></ul><ul><li>Provision of advice to Board of Directors </li></ul><ul><li>Provision of input to investors (potential and current) </li></ul>
    26. 26. Partnerships <ul><li>Speid & Associates, Inc. has partnered with the following organizations to bring services to the Speid & Associates clients expeditiously and cost effectively: </li></ul><ul><ul><li>Organization that publishes and hosts electronic submissions </li></ul></ul><ul><ul><li>A Phase 1 unit in the UK </li></ul></ul><ul><ul><li>An expanding global CRO </li></ul></ul><ul><ul><li>A CRO organization that delivers services in Russia and the former Soviet Union countries </li></ul></ul><ul><ul><li>An organization that can act as the Legal Representative for European Clinical Trial Applications </li></ul></ul>
    27. 27. Webinar Series <ul><li>The Regulatory Series </li></ul><ul><ul><li>A regulatory affairs series which provides an update on the key regulatory issues that companies face, including the changing regulatory environment, preparing for an electronic Common Technical Dossier submission, pediatric regulations, and others. </li></ul></ul><ul><li>The Diabetes Series 2008 </li></ul><ul><ul><li>This webinar series of 6 webinars was attended by companies involved in the development of diabetes and metabolic therapeutics. An overview of the issues involved with the development of these therapeutics is presented </li></ul></ul>
    28. 28. Webinar Series <ul><li>Audio Files are Now Available </li></ul><ul><ul><li>The audio files are available at www.drugstomarket.com </li></ul></ul><ul><ul><li>The slides are available free from this site with the audio files </li></ul></ul>

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