Alternative Career Options

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Alternative Career Options

• CROs
• (Contract Research Organizations)

SuzAnn Hertzler, Ph.D. Structural
Characterization Catalent Pharma
Solutions 12-29-09
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DISCLAIMER

• The views reflected in this presentation are
  solely those of the presenter and do not
  necessarily reflect the position of my company,
  any of its clients, or any of my friends and
  colleagues that contributed to the presentation.

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Overview

• Overview of the drug development process
• Importance of CROs to drug development
• Catalent Pharma Solutions overview
• Catalent San Diego services overview
• Catalent Structural (biomolecular) services
• My roles as a Scientist and Project Director

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New Drug Development
Development
Safety
Safety and Efficacy
Approval
Sell Drug
http//www.phrma.org/publications/publications//20
05-03-17.1145.pdf
Time to Develop a Drug 10 to 15 years, all
aspects will involve CRO support
Drugs and Biologics approved in 2008
31 Compounds in development in 2009 2,900
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New Drug Development
IND Investigational New Drug
DRUG DISCOVERY
PRE-CLINICAL
CLINICAL TRAILS
MOI and MOA Mode of Interest/Action
API Development (active pharmaceutical ingredient)
GCP Safety and Efficacy
preliminary efficacy, toxicity pharmacokinetic
information
GLP Toxicology (Animal) Safety, Effectiveness,
Dose
(Healthy)
Dose-Ranging ADME Pharmacovigilance,
Tolerability, Pharmacokinetics, Pharmacodynamics
Prove identity, strength, purity, quality,
potency
NCE/NME New Chemical/Molecular Entity
http//www.phrma.org/publications/publications//20
05-03-17.1145.pdf
Time to Develop a Drug 10 to 15 years, all
aspects will involve CRO support
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New Drug Development
NDA New Drug Application (BLA - Biological
License)
Large-Scale Manufacturing
CLINICAL TRAILS
FDA REVIEW
Phase IV Post Marketing Surveillance
GCP Safety and Efficacy
Randomized (drug vs. placebo vs. gold std)
(Diseased)
IIA. Dosing Requirement IIB. Dose Efficacy (phase
where most drugs fail)
(Healthy and Diseased)
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Key Acronyms

• CRO, CMO Contract Research (Manufacturing)
  Organization
• MOI, MOA Mode of Interest, Most of Action
• NCE, NME New Chemical Entity, New Molecular
  Entity
• API Active Pharmaceutical Ingredient
• DS Drug Substance (API plus inactive ingredients
  of formulation)
• DP Drug Product Finished Dose Form (all
  ingredients, solvents, fillers, containers,
  closures, packaging, and labeling)
• IND Investigational New Drug
• NDA (BLA) New Drug (Bioloigic License)
  Application
• cGXPs current good practices according to FDA
  CFRs
• GLP laboratory (tox. and animal studies) GMP
  manufacturing (CMC, analytical testing) GCP
  clinical trials
• ADME Absorption, Distribution, Metabolism,
  Excretion

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Importance of CROs
CROs are integral to the drug development process
Develop Molecule (synthesize) (clone, harvest)
In vitro In vivo Studies
In vivo Studies Analytical
Pre-Formulation Pre-Tox.studies, Analytical
Formulation GLP Tox. PK Analytical
Define Toxicology File IND
Clinical Trials Stability Studies
Evaluate Molecule
50 mg - 2g (1L biologic)
2 25 g (10L biologic)
100 400 g (50L biologic)
1 10 kg (200L biologic)
10 - 500 kg (2,000L biologic)
Outsourced to Contract Research Organizations
(CROs)
Pharmaceutical, Biotechnology Company
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CRO Services

• Research and Development
• Analytical Testing
• Manufacturing
• Process Development
• Toxicology studies
• Pharmacokinetics and Pharmacodynamics
• Clinical Support
• Marketing and Distribution

Not an extensive list of support
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CROs in Massachusetts

• http//www.blueskybiotech.com/
• http//www.abtassociates.com/index.cfm
• http//www.apredica.com/
• http//www.asischem.com/
• http//www.biotrofix.com/
• http//www.gwathmey.com/
• http//www.idexx.com/view/xhtml/en_us/preclinical-
  research.jsf?conversationId16390
• http//neuromorphometrics.com/
• http//www.phylonix.com/
• http//www.wolfelabs.com/
• http//www.xtalbiostructures.com/
• http//www.criver.com/en-US/Pages/home.aspx
• http//www.synomicspharma.com/
• http//www.gvkbio.com/
• http//www.averionintl.com/

Not an extensive list. There are many with a
range of support services
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Catalent Pharma Solutions

• Employs approximately 10,000 at more than 30
  facilities worldwide
• Drug Delivery Systems (oral, inhaled, sterile)
• Manufacturing (oral dose and sterile)
• Packaging (contract, printed, specialty)
• Development (biopharm, product, clinical supply)
• Biopharm Gene exp, Bio Mfg, Analytical,
  Biosafety, Bioassay,

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Catalent Pharma Solutions

• San Diego Analytical Services
• Originated as the Analytical Development
  Laboratory of Amylin Pharmaceuticals

Facility is 21 CFR 210 and 211 (cGMP) and 21 CFR
58 (GLP) compliant
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Catalent San Diego Offerings

• Formulation Development
• Analytical Development Validation
• Structural Biomolecular Characterization
• Quality Control (QC) / Stability
• with Quality Assurance (QA) oversight

excipients, solutions, stabilizers, emulsions,
powders, solubility, stability, aggregation
chromatography, electrophoresis, spectrometry,
spectroscopy methods
proof of structure, monitor modifications,
support mfg, authentication, qualification
stability storage testing, release testing,
cGLP, cGMP, ICH USP guidelines
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Catalent San Diego Offerings

• API, DS, DP Characterization Quality
• Every Lot (phase 0 to phase IV) prove Identity,
  Purity, Potency, Strength, Safety

IDENTITY NMR, MS, IR, WB, characterization
assays, appearance
PURITY RP, SEC, SDS-PAGE, SDS-CGE, CZE, IEF,
LC-MS, GC-MS, MP, KF, Particles
POTENCY activity assays, concentration, ELISA
SAFETY Bioburden, Endotoxin, Particulate,
Sterility, Residuals
Assays will vary by compound client
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Structural Characterization Services

• Structural characterization analysis of
  proteins, peptides, small molecules and
  oligonucleotides

• Glycosylation analysis (Quantitative
  Monosaccharide and Sialic acid analysis,
  Oligosaccharide profiling, Glycoprofiling
  including site occupancy by LC-MS)

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Structural Characterization Services

• Peptide Mapping, Disulfide Bond Mapping, Analysis
  of PTMs, and Intact Molecular Weight by LC-MS
• Small molecule elemental composition and impurity
  analysis by LC-MS and GC-MS

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Structural Characterization Services

• Capillary Electrophoresis (cIEF, SDS-CGE, CZE),
  Circular Dichroism, Amino Acid Analysis,
  Extinction Coefficient Determination, and
  N-terminal Sequencing
• Method Development and Validation

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Catalent Project Work Flow
Administrative Responsibilities of a Project
Director

• Monthly Responsibilities
• Client Deadlines
• (Lot Release, Stability, IND, NDA)
• Catalent Financial Goals
• Approve Analyst Work Hours
• Monitor Analyst Efficiency (time money)

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Project Director/Manager

• Point of Contact for the Client
• Participate in project planning, decision-making,
  developing implementation strategies, and leading
  efforts for projects (quoting prices for
  services writing protocols, methods, SOPs, and
  analysis reports)
• Work with team to create maintain project plans
  and timelines
• Direct analyst to deliver projects on track on
  budget
• Direct OOS or Aberrant Data Investigations

Responsibilities Project director ( 40),
Analytical lab work ( 60)
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Suggested Courses (online)

• UCSD Extension Program
• Regulatory Affairs Essentials (6 courses)
• Regulatory Requirements for Drugs Biologics
• Regulatory Compliance for Drugs Biologics
• Good Clinical Practices
• Good Laboratory Practices
• Good Manufacturing Practices
• Overview of Regulatory Affairs for Medical
  Devices
• Biotech Pharmaceutical Manufacturing courses
• Drug Discovery Development Courses
• www.fda.gov/cder or /cber or /chrh

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QA

• Thank you for you attention
• Contact Information
• SuzAnn Hertzler, Ph.D.
• Scientist, Project Director
• Catalent Pharma Solutions
• 9240 Trade Place
• San Diego, CA 92126
• [phone]
• suzann.hertzler_at_catalent.com

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