Regulatory Affairs 2010


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Speid and Associates is a Regulatory Affairs and Drug Development Consultancy Company. (Slides produced in 2010)

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Regulatory Affairs 2010

  1. 1. Speid & Associates, Inc. Consultancy Services, Inc. Lorna Speid, Ph.D., RAC President Speeding New Drugs to Market®
  2. 2. Speid & Associates, Inc.  Speid & Associates is a regulatory affairs and drug development consultancy - Dr. Speid is the principal consultant - Associates with extensive experience in regulatory affairs and drug development are placed on projects as needed - The associates are based in different countries as well as in the United States – most have some large pharma experience
  3. 3. Speid & Associates, Inc.  The company is a US-based California corporation  The clientele is US-based and international  The company has collaborations and partnerships with other reputable companies to provide high quality services in relevant areas of drug development to Speid & Associates clients
  4. 4. Dr. Speid’s Credentials  Registered UK Pharmacist  B.Pharm.(Hons.) – King’s College, London University  Ph.D. from University of Wales & Centre for Medicines Research International (UK)  Experience working for a number of international pharmaceutical companies, including: - Sanofi-Winthrop (UK) - Ciba-Geigy/Novartis (HQ - Switzerland) - GeneMedicine/Valentis, Inc. (US) - Dir. Reg Affairs - NewBiotics (Officer of the Company), VP Regulatory Affairs & Project Management [incl. clinical & QA]) - Avera (Officer of the Company), VP Regulatory Affairs
  5. 5. Dr. Speid’s Expertise  Dr. Speid has very broad-based experience - with international pharmaceutical industry - as core team member of international project teams in large and small pharmaceutical organizations - setting up and managing project teams, including virtual teams - with FDA and health authorities worldwide (CDER & CBER) - with all major health authorities worldwide - With INDs, MAAs, NDAs, CTDs - Document management oversight experience - Appeals procedures - Has set up and monitored clinical trials in past, and therefore understands the clinical process - 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 - A summary of case studies is available towards the end of this presentation
  6. 6. Dr. Speid’s Bio Lorna Speid, B.Pharm. M.R.Pharm.S., Ph.D., RAC is President of Speid & Associates, Inc. a regulatory and drug development consultancy based in San Diego, California. She works with small and large pharmaceutical companies, assisting them at the various stages of the drug development process, including European strategic regulatory affairs. Dr. Speid began her career as a pharmacist in the UK, after which she completed a Ph.D. at the Center for Medicines Research International, into the Safety Assessment of Medicines, Pre and Post Marketing. She has worked for large as well as small pharma companies, including Sanofi Winthrop in the UK (now Sanofi- Aventis), Ciba Geigy and Novartis in Switzerland. Small companies that she has worked for include Valentis, Inc., NewBiotics, and Avera, Inc., the last two companies at Vice President of Regulatory Affairs level. She has a Bachelor of Pharmacy degree from the University of London, and a Ph.D. from the University of Wales, College Cardiff.Document management oversight experience. Dr. Speid is the author of Clinical Trials: What Patients and Healthy Volunteers Need to Know – published by Oxford University Press.
  7. 7. Associates  US and international located  Wide range of skillsets [drugs, biologics, diagnostics, devices, statistics, clinical, marketing, EU/US/international]  Experienced regulatory and drug development professionals - Most have large pharma experience - Most have achieved Vice President level or Sr. Director level  Associates are assigned to projects as needed
  8. 8. Why Hire Us? We believe that a successful development program requires more than serendipity or luck --- We have a proven track record of past achievements
  9. 9. Why Hire Us? We work with our clients to achieve successful global registration, as expeditiously as possible --- help the client to put the pieces of the development jigsaw together successfully.
  10. 10. Why Hire Us? We can help you to determine what your next move should be with a NCE or established drug, biological, device or diagnostic
  11. 11. Why Hire Us? We can ‘jump start’ a stalled program: -Clinical holds - Rejected marketing applications (for any health authority in the world) -Dr. Speid has appeals experience and a proven track record of success in this area
  12. 12. How We Work  Strategic  Tactical  Hands-on  We can work on location or remotely - Our clients are as far away as in Australia, or as local as San Diego  Dr. Speid is available to act as a consultant Vice President of Regulatory Affairs on an as needed basis
  13. 13. Types of Customers  Customer base - Small companies - Large pharma - US based companies - Companies in Canada, Europe, Australia and rest of world - Venture capital organizations - Analysts - Angel investor organizations - Financial institutions, including Wall Street
  14. 14. Overview of Services  Clinical trial applications – for individual European countries, and other countries  Investigational New Drug Applications  Orphan Drug Applications  New Drug Applications (electronic and paper Common Technical Dossier formats)  Marketing Authorization Applications (electronic and paper Common Technical Dossier formats)
  15. 15. Overview of Services cont.  Abbreviated New Drug Application (ANDA)  Premarket Approvals (PMA)  510k applications  505(b)(2) applications  Fast Track applications  Development of meeting strategy and briefing package preparation - End of Phase 1 / End of Phase 2 meetings - Pre-NDA meeting
  16. 16. Overview of Services cont.  Special Protocol Assessment strategy development  Special Protocol Assessment preparation  Pediatric strategy development - US - Europe - International  Marketed product support  Postmarketed product support  US Agent services for ex-US companies
  17. 17. Overview of Services cont.  Regulatory authority meeting strategy development - Pre-IND - Pre-IDE - End of Phase 2 meeting - Informal discussions with reviewers - Pre-NDA meeting - Meetings during NDA / Marketing Authorization Application review
  18. 18. Overview of Services – Types of Projects  Drugs (small molecule)  Biologics (large molecule)  Gene Therapy  Medical Devices  In vitro Diagnostics  Combination Products  Generics  Due Diligence  Quality Assurance including audits [through partners]  Strategic medical writing
  19. 19. Overview of Services – Therapeutic Areas  Experience with many therapeutic areas, including: - Anti-infective - Oncology – gastric, colorectal, pancreatic, head and neck, hematological - Respiratory - Women’s health - Dermatology - Anti-inflammatory and immunological diseases - Central nervous system - Bone
  20. 20. Overview of Services – Due Diligence  Conducted for companies, VCs and financial institutions - Review of company strategy - Review of the compounds  Extensive review of documents, including regulatory correspondence  Review of regulatory actions, e.g. warning letters - Assessment of the company systems and management team - Assessment of risk and probability of success - Assessment of the regulatory hurdles, and time to market - Preparation of report
  21. 21. Overview of Services - Clinical  Review of Summary Bases of Approvals  Preparation of INDs, CTAs, IDEs  Set up clinical trials  Writing of Investigator’s Brochures  Writing, editing or review of Protocols  Submissions to IRBs and FDA  Preparation of Informed Consent Documents  Writing, editing and/or review of clinical study reports
  22. 22. Overview of Services – Devices and Diagnostics  Strategic and hands-on  US and European - Relationship building with FDA - Relationship building with Notified Bodies  Rest of the world  Health authority meeting requests and preparations - Briefing package preparations  Clinical protocol design and preparation  IRB/ethics committee liaison
  23. 23. Overview of Services - INDs  Assistance and advice in clinical hold situations  Regulatory due diligence for licensing-in or licensing-out situations  Preparation of IND Annual Reports  Advice regarding Quality Assurance issues  Preparation of IND safety reports  Preparation of INDs in the new eCTD format  Preparation of INDs in the older 9 section format
  24. 24. Overview of Services – Clinical Trial Applications  Expertise in new European Clinical Trial process [European Clinical Trial Directive] - Conversion of US IND to European Clinical Trial Application - Clinical trials for Russia and other Eastern European countries via partners - Clinical trial applications for China via partners
  25. 25. Overview of Services – Toxicology  Review of toxicology guidelines  Development of toxicology strategy - Acute toxicology study designs - Sub-chronic toxicology study designs - Chronic toxicology study designs - Reproductive toxicology study designs - Carcinogenicity study designs and strategy  Liaison with major toxicology houses  Preparation of toxicology protocols  Review of toxicology reports  Development of Pre-IND meeting strategy and discussions with health authorities around the toxicology issues
  26. 26. Overview of Services – electronic CTDs  Building of global eCTD strategy  Organization of the internal and external project teams  Interpretation of the guidelines for the compound in question  Organization of discussions with Health Authorities  Publishing strategy derivation  Expert writing
  27. 27. Global and International Regulatory Affairs  See separate presentation about this service offering: - Europe Japan - USA - South Africa - Australia - Eastern Europe - South America - Africa and Middle East - Asia including China and India
  28. 28. Partnerships  Speid & Associates, Inc. has partnered with several organizations in various parts of the world to bring services to our clients. Please ask if you would like additional information about the following: - Life science services based in China – all aspects are available - Document management services - Clinical Research Organizations - GLP toxicology services - Analytical services - Bankers, auction specialists, and fund raising specialists – preclinical - Phase 2 data - Specialized predictive individualized therapy services – for oncology and non oncology drugs - Notified Bodies
  29. 29. Case Studies  Dr. Speid worked with a small virtual organization to develop the regulatory strategy for a combination product . This involved being the main point of contact for the Division Head at FDA. Dr. Speid was instrumental in ensuring that the virtual team understood the requirements for the product development concept. She wrote the Pre- Investigational Drug Exemption meeting request and the Pre- Investigational Drug Exemption briefing document. ------------------------------------------------------------------------------------------------------  Dr. Speid worked with a late stage company that was licensing in a drug with a large amount of disorganized documentation. She created an internal document that identified the document management needs of the organization. Several vendors were brought into the company to present their services. The best document management vendor was selected after internal support was garnered for the document management system.
  30. 30. Case Studies  Dr. Speid created an NDA plan for a pharmaceutical company which had licensed in a late stage haematological drug. Detailed operating plans were put into place which included expert author meetings to assure the creation of effectively written sections of the New Drug Application in eCTD format. ------------------------------------------------------------------------------------------------------  Dr. Speid worked on a regulatory and development strategy for an ocular implant combination product. This involved liaising with the combination division and the drug division within the FDA to seek advice on the appropriate registration pathway in the absence of guidelines. Clear guidance was provided to the client to clarify the development and registration pathway.
  31. 31. Case Studies  Negotiated with health authorities as part of key regulatory meetings to avoid the need to repeat or to conduct new toxicological studies. This saved the company at least 6 months and approximately 500, 000 USD. --------------------------------------------------------------------------------------------------  Acted as the US Agent for a German company. Filed safety reports to the FDA for two studies that were ongoing in Germany. -----------------------------------------------------------------------------------------------------  Developed a regulatory strategy for a pediatric development which involved US and European pediatric development for a monoclonal antibody. This included consideration of the use of a parallel advice procedure between the US and Europe. --------------------------------------------------------------------------------------------
  32. 32. Case Studies  Wrote a strategic briefing document for a large and mid-size pharmaceutical company for a drug intended for an autoimmune disease. This document was used as the basis for a meeting with the FDA. The meeting was successful and opened the way for a potential approval.
  33. 33. Contact Information  Dr. Lorna Speid - Telephone 858 793 1295 - Cellphone 858 531 6640 - Email: