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Introduction and Overview

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new molecules as the starting point for innovative drugs (synthesis or isolation) ... of Innovator Companies: GlaxoSmithKline, Novartis (Ciba-Geigy and Sandoz), Wyeth ... – PowerPoint PPT presentation

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Title: Introduction and Overview


1
Pharmaceutical Industry
  • Introduction and Overview

PRA700
2
Major Players
  • General public
  • Pharmaceutical Companies
  • Physicians
  • Pharmacists
  • Governments

3
Pharmaceutical Companies
  • Innovator
  • Generic
  • Third Party
  • Ultra Generic

4
Innovator Companies
  • original research
  • new molecules as the starting point for
    innovative drugs (synthesis or isolation)
  • Preclinical studies
  • chemistry
  • physical aspects of the molecule

5
Innovator Companies (continued)
  • Biological aspects of the molecule
  • a) pharmacology, ADME i.e., absorption,
    distribution, metabolism and excretion
  • b) Toxicological properties of the new molecular
    entity
  • Formulation trials
  • biologically active molecule is processed along
    with pharmaceutical inactive ingredients to
    produce pharmaceutical dosage forms

6
Innovator Companies (continued)
  • Clinical studies
  • Phase 1 Introduction of investigational drugs
    into humans for the primary purpose of assessing
    safety and establishing tolerant dose.
  • Phase 2 Establishing the efficacy of the drug
    by using a small number of patients.
  • Phase 3 Establishing the efficacy, safety and
    all other aspects of the drug by using a thousand
    or more patients.

7
Innovator Companies (continued)
  • They are the first to make scientific
    submissions.
  • submit Clinical Trial Application (CTAs) to the
    Regulatory Authorities.
  • Conduct ongoing Clinical Trials.

8
Innovator Companies (continued)
  • In summary the innovators are the first
    pharmaceutical companies to establish the drug
    product on the market and promote its
    effectiveness to physicians thereby establishing
    demand for the drug.
  • Examples of Innovator Companies GlaxoSmithKline,
    Novartis (Ciba-Geigy and Sandoz), Wyeth-Ayerst,
    Merck, Bayer, Eli Lilly.

9
Generic Pharmaceutical Companies
  • inexpensive (or less expensive) copies of the
    innovators' product
  • scientific submissions to Regulatory Authorities
  • abbreviated compared to the innovators
  • Abbreviated New Drug Submissions (ANDS) submitted
    to Regulatory Authorities

10
Generic Pharmaceutical Companies (continued)
  • CTAs are submitted but adherence to the
    guidelines differs from the innovative companies
  • Not required to conduct phase I, II and III
    clinical trials



11
Generic Pharmaceutical Companies (continued)
  • required to formulate the product
  • approval to market a copy of an innovator's
    product involves demonstration that their copy is
    equivalent in terms of safety, efficacy and
    quality to the innovator's product
  • bioequivalency is demonstrated through a series
    of chemical and physical laboratory tests

12
Generic Pharmaceutical Companies (continued)
  • Examples of Generic Companies
  • Apotex, Novex Pharma, Torpharm
  • Novopharm
  • Genpharm Inc.

13
Third Party Pharmaceutical Companies
  • Contract laboratories
  • Raw material distributors
  • Consultants
  • participate in part of the process of drug
    development
  • conduct bioequivalence studies

14
Third Party Pharmaceutical Companies
  • Examples of Third Party Pharmaceutical Companies
    Patheon, Roberts Pharmaceuticals, Global, PDi,
    Biovail, Phoenix, CanReg, CanTox Inc.

15
Ultra Generic Pharmaceutical Companies
  • Market a product that is manufactured by
    innovator companies
  • Minimal research and development
  • Reference to innovators approval by regulatory
    body
  • Also called Super Generic
  • began 1997
  • Example of Ultra Generic AltiMed

16
Departments within a Pharmaceutical Company
  • Marketing/Sales Department
  • Product selection criteria
  • sales volume b
  • potential sales volume based on the number of
    people who are afflicted by a particular disease
    for which the drug product is designed to relieve
    (innovators)
  • level of difficulty involved in the processing or
    product formulation

17
Departments (continued)
  • availability of adequate amounts of raw material
  • product exclusivity/patent protection
  • therapeutic niches

18
Departments (continued)
  • Formulation or Product Development Department
  • Pre-formulation dosage strength, dosage form,
    development and manufacturing process
  • Formulation direct compression, dry granulation,
    wet granulation

19
Departments (continued)
  • Stability Testing (or New Product Testing)
    Laboratory
  • before being approved for distribution and sale a
    product must be tested for stability
  • stability of the drug refers to its ability to
    maintain its physical, chemical (and
    microbiological for drugs other than solid
    dosage forms) integrity or wholesomeness over a
    period.

20
Departments (continued)
  • stability testing provides the following
    information
  • stability of drug substance in the presence of
    light, heat, moisture, packaging, excipients,
    etc.
  • storage conditions (including packaging material)
  • duration of formulation stability
  • product expiry dates

21
Departments (continued)
  • Bio-analytical Laboratory (Biolab)
  • innovator and generic drugs require different
    levels of bioanalytical testing of the drug
    product.
  • All tests conducted on analytes (drug substances,
    metabolites, impurities, etc.) in the biological
    system (i.e., blood, urine, etc.) are performed
    by the Bio-analytical Laboratory.

22
Departments (continued)
  • Innovator drug plasma concentration of the drug
    related to clinical response (i.e., the
    therapeutic and adverse effect of the drug on a
    healthy or subject patient)
  • innovator is also expected measure the impurity
    (including metabolites) plasma concentration to
    assess their toxicological impact on the study
    subject

23
Departments (continued)
  • Generics required to demonstrate bioequivalency
    of their product when compared with the innovator
    product

24
Departments (continued)
  • Manufacturing
  • unlike the Formulation or Product/Process
    Development Departments which are working with
    small scale trial batches, Manufacturing deals
    with the routine production of large scale
    (usually in excess of 100,000 tablets)
    pharmaceutical products

25
Departments (continued)
  • Quality Control Department
  • During manufacturing it is imperative that
    physical and chemical (also microbiological for
    liquids, semisolids and preservatives) testing be
    continued, on a regular basis, to monitor the
    quality of the drug product
  • This is achieved by the Quality Control (QC)
    Department using physical and chemical methods
    (stability-indicating methods)

26
Departments (continued)
  • Quality Assurance
  • responsible for documentation
  • involved in inspections by regulatory bodies

27
Role of Regulatory Affairs in Pharmaceutical
Industry
  • Regulatory Affairs Department
  • Pharmaceutical companies are required to submit
    scientific data regarding their product to
    Regulatory Authorities
  • Examples of Canadian submissions are Clinical
    Trial Application (CTA), New Drug Submission
    (NDS), Abbreviated New Drug Submission (ANDS),
    Supplemental New Drug Submission (SNDS) and
    Abbreviated Supplemental New Drug Submission
    (ASNDS)

28
Role of Regulatory Affairs in Pharmaceutical
Industry
  • Regulatory Affairs is the department of a
    Pharmaceutical company that deals with all
    aspects relating to the submission
  • collect scientific data from the many labs
  • collate this information onto the submission
    forms provided by the regulatory body

29
Role of Regulatory Affairs in Pharmaceutical
Industry
  • RA receive the letters of approval (called Notice
    of Compliance) from the regulatory body giving
    permission to sell its product
  • RA is the department that may receive letters of
    non-approval (NON) which means the contents of
    the submission are not sufficient to support
    approval of the drug product
  • Clarifaxes NOD are also received by RA to
    address issues in the submission

30
Role of Regulatory Affairs in Pharmaceutical
Industry
  • RA personnel are at the forefront of regulatory
    issues they inform the rest of the company about
    any new Good Manufacturing Practice (GMP)
    requirements
  • RA can therefore be viewed as a facilitator they
    facilitate communications between the many
    pharmaceutical departments and the regulatory
    bodies

31
Summary
  • Large industry
  • Extensive documentation
  • Many opportunities
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