Drug Development: SSF, CA

Stacey Franklin

Date: June 1, 2017
Time: 9:00 am  to  4:30 pm

Drug Development Immersion

DateJune 1-2, 2017
Time9:00 am – 4:30 pm
Fee$1390 USD | CLSA Member Discount $1290 USD
LocationCLSA Event Center, 250 East Grand Ave Suite 26, South San Francisco, CA 94080
ExtrasLunch and all course materials included
Drug Development Immersion

Drug Development Immersion is a two-day, intensive course focused on the regulatory, commercial and scientific considerations required to bring a drug successfully to market. Discussion points feature both small molecule and biologic products. Post-approval commercial considerations and risk management are also discussed. Numerous personal accounts and war stories are used to illustrate the decision-making process companies use, giving participants a working knowledge of strategic development. Learn what it takes to get a molecule from the bench into the marketplace by an industry expert who has received drug approvals in both the US and Europe.

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Location

250 East Grand Ave Suite 26, S. San Francisco, CA 94080

Agenda

Day One
Introductions 9:00-9:15

Drug Development Overview 9:15–10:00
Success Metrics & Chances of Success
Timelines & Costs
FDA Approvals

Drugs Defined 10:00–10:45
Drug Defined
Types of Drugs
Product & Data Exclusivity
Approval Process for Generics: FDA & EMA
Approval Process for Biosimilars: FDA & EMA

Break 10:45–11:00

Where Do Drugs Come From? 11:00-12:00
Target Identification
Potential Targets: Pharmacology
Target Validation
Assay Development
Screening
Animal Models
Lead Optimization
Case Study: Multiple Sclerosis
Drug Development Organizations

Lunch provided 12:00–1:00

Global Integrated Development 1:00-1:30
Integrated Development Process
Project Teams
Stage Gates

General Strategic Development Considerations 1:30–2:15
Draft Label
Therapeutic Target Profile

Break 2:15–2:30

The FDA & EMA Regulatory Process 2:30-4:15
History of Regulation
FDA Mission & Organization
EMA Mission & Organization
International Conference on Harmonization (ICH)
PDUFA
REMS
FDA Formal Meetings With Sponsors
EMA Formal Meetings With Sponsors
Briefing Pack
Special Protocol Assessment (SPA)
Regulatory Interactions & Tools
Generics & Biosimilars
Orphan Drugs
Regulatory Compliance
Regulatory Compliance: Case Study

Q&A|Review 4:15-4:30

 

 

 

Day Two
Product Design & Manufacturing 9:00-10:15
Chemical Manufacturing Controls
Product Design
Routes of Administration
Making Proteins in Cells
Biomanufacturing Overview
Cell Line & Cell Bank Development
Upstream & Downstream Bulk Processing
Formulation, Fill & Finish
Stability & Analytical Testing of Protein Products
Small Molecule Manufacturing Overview
Small Molecule Formulation
Label, Package & Distribution

Break 10:15-10:30

Preclinical Development: The IND & CTA 10:30–12:00
Preclinical Development Pre-IND|CTA
Mutagenicity & Carcinogenicity Testing
Toxicology
Reproductive & Developmental Toxicology
Safety Pharmacology
Absorption, Distribution, Metabolism, Excretion
Preclinical Trials Overview
Preclinical Development Post IND|CTA

Lunch provided 12:00–1:00

Clinical Development 1:00–3:00
Ethical Considerations
Clinical Protocols
Investigator Sites
Study Design Considerations
Study Design Choices
Endpoint Choices
Statistical Considerations
ANOVA & ACOVA
Phase I
Phase IIA & IIB
Phase IIIA & IIIB
Adaptive Design
NDA & MAA Approval Process Overviews

Product Launch 3:00-4:15
Launch Overview & Teams
Core Product Strategy
Manufacturing & Supply Chain
Payer Strategy
Value Proposition
Value Based Pricing
Sales Force Readiness
Healthcare Professional Strategy
Patient Strategy
Compliance
Medical Affairs Readiness
Pharmacovigilance
Phase IV
Life Cycle Management

Q&A|Review 4:15–4:30

Instructor

SimonTulloch grey backgroundSimon J. Tulloch, MD, Drug Development Expert | Instructor

Dr. Tulloch has more than 25 years of pharmaceutical and biotech experience in clinical development, R&D management, and business roles, both in Europe and the USA. He consults to the industry on strategic R&D issues, clinical development and medical issues.

He has been the Chief Medical Officer at InfaCare Inc, a privately funded biotech company, and spent ten years at Shire Pharmaceuticals. He moved to the USA to establish Shires U.S. research and development organization. Dr. Tulloch built the organization in all areas of drug development, and successfully conducted the development and NDA approval of Adderall XR. During that time his organization also developed and got NDA approvals for Fosrenol (Shire’s first global NCE) and Equetro, as well as providing CMC, preclinical, and marketing medical support to all of Shire’s U.S. products. Latterly, he assumed the role of head of the global CNS Business Unit.

Prior to his time at Shire, Dr. Tulloch spent eight years with Johnson and Johnson companies, including five years as clinical research director for R.W. Johnson PRI’s European R&D facility in Zurich, Switzerland, working on multiple projects in various therapeutic areas and stages of development.

He trained in medicine at Oxford University, has a degree in physiology and a diploma in pharmaceutical medicine, and worked for a number of years for the UK National Health Service in hospital posts.

Refund Policy

All courses and products are final sale. No refunds, exchanges or transfers. If you can not attend your purchased event, you may send someone in your place by notifying Sheila Wagner, Wagner@BiotechPrimer.com, no later than one week before the start date of the class. With the purchase of this course, you will automatically be registered for our WEEKLY. You will receive this free educational newsletter, conveying the science behind the headlines, every Thursday. You may unsubscribe with one click at anytime.

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