Biotech Primer Presents: Drug Development Immersion


Mon, November 2, 2015, 9am – Tue, November 3, 2015, 4pm




Drug Development Immersion is an intensive two-day course concentrating onthe regulatory, commercial and scientific considerations required tosuccessfully bring a drug to market. Discussion points will feature both small molecule and biologic products. Numerous personal accounts and case studies are used to illustrate the decision-making process companies use, giving participants a working knowledge of strategic development.

Day One

Introductions 9:00-9:15

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

Lunch provided 12:00–1:00

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

GeneralStrategic 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)
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

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

Lunch provided 12:00–1:00

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

ProductLaunch 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
Medical Affairs Readiness
Phase IV
Life Cycle Management

Q&A|Review 4:15–4:30

Simon J. Tulloch, MD, Drug Development Expert |Instructor

Dr. Tulloch has more than 25 years of pharmaceutical and biotech experience inclinical 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 ChiefMedical Officer at InfaCare Inc, a privately funded biotech company, and spentten years at Shire Pharmaceuticals. He moved to the USA to establish Shires U.S. research and development organization. Dr. Tulloch built the organizationin all areas of drug development, and successfully conducted the development and NDA approval of Adderall XR. During that time his organization alsodeveloped and got NDA approvals for Fosrenol (Shire's firIf there are less than 20 paying registrants by Oct 1, 2015 the Briefing will be 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 projectsin 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.

Cancellation Policy: If there are less than 20 registration by October 1, 2015, the course will be cancelled.

If there are less than 20 paying registrants by Oct 1, 2015 the Briefing will be cancelled.