Speaker Opportunities at VIBpharma

• A - Z
• Subject
• Company

Nigel Baker

I am currently a director of biostatistics in the department of Global Biostatistics and Epidemiology with Amgen Ltd, based in Cambridge in the UK.  In this role I head up a group of statisticians who work on project teams developing oncology therapeutics.  I have been with Amgen since 1996, in positions of increasing responsibility, contributing to the development of many of Amgen’s products.

Prior to Amgen, I worked for a contract company who run toxicology studies.  Before that I was with Pfizer for a number of years.  Initially I worked on phase 2 and 3 clinical trials and later worked in Pfizer’s non-clinical area offering statistical support to pharmacologists and drug metabolism staff.

I am married with two sons.  When not working I do some running, play a little golf with my younger son, support my older son when he is playing rugby and enjoy dingy sailing.

Caroline Borremans

Caroline Borremans joined J&J - Belgium in the Drug Evaluation, Pharmaceutical Sciences Group in September 1997. She worked in discovery research on the development of new in vitro techniques for the determination of permeation profiles of new compounds. Caroline joined Quality Assurance – Compliance in 2004, where she was responsible for quality systems in the Clinical Supplies Unit, Clinical Distribution Services and Pharmaceutical Product Development. In 2005 she participated in a GMP-GCP exchange project that was set up to facilitate the exchange of expertise between clinical QA and GMP QA. This enabled her to become an expert on all issues arising in the grey area in which GMP and GCP activities overlap.

In 2007, Caroline joined the Customer Relationship Management Group as a Global Clinical Supplies Manager where she is the link between the clinical and chemical-pharmaceutical development teams with regard to medication management in clinical trials.

Caroline holds a degree in Biochemistry. She wrote a thesis at the University of Porto (Portugal) dealing with a new method for pesticide determination. She has co-authored eleven publications mainly on the development of new in vitro permeation techniques

Danny Lee-Frost

Head of Operations for the Enforcement & Intelligence Group of the MHRA. Been with the agency for 13 years, having joined as an investigator from Social Security fraud. Danny gained an MSc in Criminal Justice in 1998.
Has conducted investigations involving counterfeits, illegal wholesaling, illegal manufacturing and diversion. Danny represents the UK on the Permanent Forum for International Pharmaceutical Crime (PFIPC) which sits on the sub group of the WHO IMPACT (International Medical Products Anti-Counterfeiting Taskforce) Enforcement Group.

Now in overall charge of all investigations within the group with special responsibility as Senior Investigating Officer for complex and sensitive cases including counterfeits

Fiona Guillard

After leaving university Fiona Guillard spent several years working in Contract Research Organisations before moving to GlaxoSmithKline in 2000 to work in the clinical pharmacology statistics group, predominantly supporting compounds in the neurology and gastrointestinal areas.

In October 2007 Fiona moved into a new role supporting adaptive designs and Bayesian methodology across the biostatistics community at GSK, covering all therapeutic areas and phases of development.

Fiona holds an MSc in Applied Statistics from Sheffield Hallam University, UK, and a BSc(Honours) in Statistics and Operational Research from Coventry University, UK.

Raja Velagapudi, M. Pharm., M.S., Ph D

Dr. Velagapudi received his Bachelor of Pharmacy and Master of Pharmacy degrees from Andhra University in India.  He received his M.S. degree in Pharmaceutics from Duquesne University in Pittsburg and a PhD in Biopharmaceutics from the University of Texas at Austin, USA.  He worked in the Division of Biopharmaceutics at the Food and Drug Administration, USA, from 1983 to 1992 in different capacities performing pharmacokinetic review. 

For the last 16 years, he worked in the pharmaceutical industry providing pharmacokinetic support for regulatory submissions of chemical entities as well as therapeutic proteins.  Currently, he is a Director of Pharmacokinetics / Bioequivalence at Barr Laboratories, Inc, USA, and providing pharmacokinetic support for generic and new drug applications for chemical entities as well as for generic protein product development. 

He is an active speaker, organizer and participant advocating numerous topics related to follow-on-biologics/biosimilars/subsequent entry biologics in the US, Canada and Europe