Raf Derhaeg

I started in 2006 as a traffic and safety regulator at Infrabel at the signal box of Brussels-North, one of the two main signal boxes of the Brussels area.

In 2010 I was promoted after internal exams and became head of the signal box.

One year later, in 2011, I was again promoted and became Safety Analyst.

In 2013 I moved back to the Brussels-North signal box as head of supervision.

From September 2014 until april I worked at the planning of infrastructure works for the Brussels area.

As of april 2018 I was transferred to the division of Emergency Planning and Tunnel Safety as Tunnel Safety Supervisor for the Brussels tunnels.

Marius Raddum

Marius Raddum is the Accident investigator for AIBN (Accident Investigation Board Norway), Road traffic, since 2011. Marius have a Civil Engineer education and has investigated 6 major tunnel fires in Norway: Oslofjordtunnelen (2011); Gudvangatunnelen I (2013); Gudvangatunnelen II (2015); Skatestraumtunnelen (2015); Fjaerlandstunnelen (2017) and Oslofjordtunnelen (2017).

Anastasia Gutierrez

Anastasia Gutierrez is a Director, Clinical Program Management at Bellicum Pharmaceuticals, where she is managing the execution of Adaptive Cell Therapy programs including timelines, deliverables, scope, risks and budget. Anastasia has almost 20 years of clinical research experience, with a focus on early phase oncology studies. Prior to joining Bellicum, Anastasia spent a number of years on the CRO side of industry where she managed a number of global Phase I-IV studies across Americas, Europe, Middle East, Africa and Asia/Pacific Rim.  She is a native of Russia and has her medical degree from Smolensk State Medical Academy. She came to the US in 2003 and settled in the Houston area, where she currently lives with her family

Alicia Kae Miller

Alicia Kae Miller is the Director, Patient Engagement, at Aeglea BioTherapeutics, Inc. Alicia has been with Aeglea since January 2017. Her work in biotechnology includes eleven years at BioMarin Pharmaceutical Inc. in varying capacities with increasing responsibilities.

 

Alicia is an accomplished patient engagement professional and versatile organizational manager with extensive training and planning experience in community-based advocacy. She obtained her BA from Dominican University of California and is currently a graduate student at St. Edward’s University in Austin, TX, and expects to receive her MSc in Leadership and Change in May 2020.

Whitnie Strauss

Whitnie is a graduate of the University of Texas with a degree in Public Relations. She lives in the beautiful Texas Hill Country with her husband, Steve. They have three children, Rhett (11), Reid (9) and Cora (7). Reid was diagnosed with CTD at 2 1⁄2 years old. Whitnie is a passionate advocate for CCDS. She has served as a panelist at the FDA Inborn Error of Metabolism public forum and is actively involved in fundraising, marketing, and other initiatives to bring heightened awareness to the CCDS community. Aside from her work with the Association for Creatine Deficiencies she also runs the graphic design company, Strauss Design Group, LLC.

Gowri Sukumar

Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the technical disciplines of CMC development as well as regulatory Affairs. She has broad responsibilities that include process development, Drug Substance and Drug Product manufacturing from the CMC side. From the Regulatory affairs perspective, she provides regulatory leadership and expertise for regulatory strategy, liaises with the regulatory agencies including FDA, Health Canada and other Health authorities. For her leadership approach, she brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture and teamwork for successfully advancing programs in an effective and efficient manner.  Gowri holds a master’s Degree in Biosciences as well as the prestigious Regulatory Affairs Certification (RAC) awarded by the Regulatory Affairs Professional Society.  She is the author or co-author of several peer-reviewed research publications as well as book chapters. Gowri has breath of experience spanning R&D, CMC and Regulatory affairs. She also serves as a reviewer for several international Bioscience Journals for providing Scientific and technical expertise.

Heather Giles

Dr. Giles has been President, CEO and Director of Vapogenix since July 2017. She joined Vapogenix in 2009 as Chief Scientific Officer and has provided scientific and drug development leadership, in addition to making significant contributions to overall company strategy and to successful fundraising. Dr. Giles has held international leadership positions in large and small pharmaceutical companies and has wide experience in drug discovery and development from target validation, through clinical studies to final regulatory submission. She recently led Vapogenix through the successful completion of a Phase II clinical trial in Australia.

 

Jay Venkatachalam

Jay joined Biogen in 2011 as an MBA Intern in the Supply Chain Group. Jay has 10 years of supply chain experience and 8 years of that has been in the Clinical Supply Industry. Prior to joining Biogen, Jay worked for a third party logistics provider that serviced clients like KFC and McDonalds where he gained his core supply chain skills as a management trainee. Through his stint at Biogen, Jay has worked in Clinical Logistics and Clinical Planning managing end to end Clinical Supply Chain Activities for a number of trials in all phases and has also been involved in a number of pre-approval regulatory inspections. Jay has also led multiple process improvement initiatives at Biogen to streamline overall clinical supply end to end processes and system integrations.

Jane M. Jacob

With over 15 years’ experience in clinical research, following 15 years in academia, Dr. Jacob ‘s experience working within the corporate infrastructure as well as establishing successful sponsor/site relationships, has allowed her to successfully develop and launch both large and small clinical trials across the research spectrum – retrospective, post market and IDE  studies.  She has been a study coordinator, then a CRA, a manager, director and is now Vice President of Research and Clinical Affairs at several medical device companies.