Drug Development: New York City

Stacey Hawkins

Date: 04/27/2017
Time: 9:00 am  to  4:30 pm

Drug Development Immersion

DateApril 27-28, 2017
Time9:00 am – 4:30 pm
LocationVenable Offices, Rockefeller Center, 1270 Avenue of the Americas, 24th Floor, New York City, NY 10020
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.

All course materials are handed out at the course. There is no pre-work required. Lunch will be provided. Scroll down to view the full agenda.


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Rockefeller Center, 1270 Ave of the Americas 24th floor, NY, NY 10020


Day One
Drug Development Overview 9:00–10:00
Drug Development Process Map
Success Metrics & Chances of Success
Timelines & Costs
FDA & EMA Approvals

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

Break 10:45–11:00

Drug Discovery 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

Integrated Development & Strategic Considerations 1:00-1:30
Draft Label
Therapeutic Target Profile
Integrated Development Process
Project Teams
Stage Gates

Break 2:15-2:30

The Regulatory Process 2:30-4:15
Regulatory Agencies
FDA & EMA Mission
FDA & EMA Organization
FDA User Fees & Review Times (PDUFA, GDUFA, BsUFA)
FDA Risk Evaluation & Mitigation Strategy (REMS)
FDA & EMA Formal Meetings With Sponsors
FDA & EMA Desirable Designations
FDA & EMA Orphan Drug Designation
EMA User Fees & Review Times
EMA Risk Management Plan (RMP)
US & EU Regulatory Compliance

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 Therapeutics in Cells
Cell Line & Cell Bank Development
Upstream & Downstream Bulk Processing
Large Molecule Formulation
Stability & Analytical Testing of Protein Products
Small Molecule Manufacturing Overview
Small Molecule Formulation

Break 10:15-10:30

Preclinical Development: The IND & CTA 10:30–12:00
Mutagenicity & Carcinogenicity Testing
Reproductive & Developmental Toxicology
Safety Pharmacology
Absorption, Distribution, Metabolism, Excretion (DMPK)
Preclinical Studies Overview
IND/CTA Types & Approval Times

Lunch provided 12:00–1:00

Clinical Development 1:00–3:00
Clinical Protocols
Investigator Sites
Study Design & Endpoints
Statistical Considerations
Adaptive Designs
Phase I
Pharmacokinetics & Pharmacodynamics
Phase IIA & IIB
FDA & EMA Approval Process

Product Launch 3:00-4:15
Marketing Plans
Manufacturing & Supply Chain
Payer Strategy
Sales Force Readiness
Patient Strategy
Medical Affairs Readiness
Phase IV

Q&A|Review 4:15–4:30


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 cannot 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.

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