1. Alternative Career Options
CROs
(Contract Research Organizations)
SuzAnn Hertzler, Ph.D.
Structural Characterization
Catalent Pharma Solutions

2. 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.

3. 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

4. New Drug Development
Development
Safety
Safety and Efficacy
Approval
Sell Drug
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

5. New Drug Development DRUG DISCOVERY PRE-CLINICAL CLINICAL TRAILS
IND = Investigational New Drug
DRUG DISCOVERY
PRE-CLINICAL
CLINICAL TRAILS
MOI and MOA = Mode of Interest/Action
API Development
(active pharmaceutical ingredient)
preliminary efficacy, toxicity & pharmacokinetic information
GCP: Safety and Efficacy
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
Time to Develop a Drug = 10 to 15 years, all aspects will involve CRO support

6. New Drug Development CLINICAL TRAILS FDA REVIEW
NDA = New Drug Application; (BLA - Biological License)
Large-Scale Manufacturing
CLINICAL TRAILS
FDA REVIEW
GCP: Safety and Efficacy
Phase IV
Post Marketing Surveillance
Randomized
(drug vs. placebo vs. gold std)
(Diseased)
IIA. Dosing Requirement
IIB. Dose Efficacy (phase where most drugs fail)
(Healthy and Diseased)

7. 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

8. Importance of CROs CROs are integral to the drug development process
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) kg
(2,000L biologic)
Outsourced to Contract Research Organizations (CROs)
Pharmaceutical, Biotechnology Company

9. 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

10. CROs in Massachusetts*
* Not an extensive list. There are many with a range of support services

11. 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,

12. Catalent Pharma Solutions
San Diego Analytical Services
Originated as the Analytical Development Laboratory of Amylin Pharmaceuticals
Cabrillo
1999
2002
2006
Magellan
Cardinal
Health
Catalent
Pharma
Solutions
Facility is 21 CFR 210 and 211 (cGMP) and 21 CFR 58 (GLP) compliant

13. 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

14. 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

15. 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)

16. Structural Characterization Services
Peptide Mapping, Disulfide Bond Mapping, Analysis of PTM’s, and Intact Molecular Weight by LC-MS
Small molecule elemental composition and impurity analysis by LC-MS and GC-MS

17. 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

18. Catalent Project Work Flow
Write TTP/ATM
Sample Receipt & Tracking
Paper & Electronic Archival
Write Technical Report
QA Audit
Testing & Analysis
Direct Analyst
Request Notebooks
(TTP, ATM, Phase)
Data Review Compare, Critic Results
Report sent to Customer
Generate Quotes
Customer Signature
Write SOPS
TTP: Protocol
ATM: Method
SOP: standard operating procedures
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)

19. 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%)

20. 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
or /cber or /chrh

21. Thank you for you attention
Q&A
Thank you for you attention
Contact Information
SuzAnn Hertzler, Ph.D.
Scientist, Project Director
Catalent Pharma Solutions
9240 Trade Place
San Diego, CA 92126
(858)