Confirmed Speakers

Expanded Access Programmes 2021

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Anne B. Cropp

Chief Scientific Officer, Early Access Care

Anne Cropp Pharm.D. is Chief Scientific Officer for Early Access Care, a company exclusively providing global Expanded Access/Compassionate Use services.  Anne has led the development of Expanded Access programs for small, mid, and large pharma companies based in the US, Europe, and Asia. Prior to founding Early Access Care, Anne was Vice President in the Global Product Development Group of Pfizer Inc responsible for Phase 2 and 3 Clinical Development Programs and Head of the Compassionate Access Group for Pfizer.  She is a globally recognized expert in expanded access and compassionate use and has over 25 years experience in early access programs. 

Marjorie Zettler

Director of Clinical Science, Regor Pharmaceuticals, Inc.

Marjorie Zettler, PhD, MPH is Director of Clinical Science at Regor Pharmaceuticals, Inc., a pioneering drug discovery and clinical-stage pharmaceutical research company. An industry veteran with more than 18 years’ experience at companies in the pharma and healthcare sector including Lilly and Cardinal Health, her work has focused on clinical research, drug development, and regulatory strategy. She has published over 100 abstracts, manuscripts, and patents. Dr. Zettler received a doctorate in physiology and a bachelor’s degree (honors) in genetics from the University of Manitoba, Canada, as well as a master’s degree in public health from the University of Manchester, United Kingdom.  

Lisa Kearns

Division of Medical Ethics, NYU Grossman School of Medicine

Awaiting bio. 

Khrystal Davis

Founder, Texas Rare Alliance

Awaiting for bio. 

Neena Nizar

President & Founder, The Jansens Foundation

Awaiting for bio. 

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Christine Von Raesfeld

Founder & CEO, People with Empathy

Awaiting for bio.

Sam Lucas

Senior VP, Expanded Access Program, Durbin

Awaiting for bio.

Kim Buchanan

Associate Director Development Quality, Merck

Mrs. Buchanan is currently the Associate Director of MRL Global Development Quality supporting Global Clinical Supplies at Merck & Co. Over the past twenty-five years, she has held commercial Quality and commercial packaging operational experience. While supporting Global Clinical Supply, she has worked in Global Clinical Supply as a program manager, Global Clinical Supply Logistics Coordinator and in Global Development Quality supporting release of Clinical Supplies and process improvements.  She was key to the development of the Expanded Access at her company.

Eugean Jiwanmall

Senior Research Analyst for Medical Policy & Technology Evaluation, Independence Blue Cross

Eugean Jiwanmall’s past professional experiences include basic science and clinical research. In his current role as a Senior Research Analyst for Medical Policy & Technology Evaluation at Independence Blue Cross’ Medical & Claim Payment Policy Department within Facilitated Health Networks and Medical Affairs, he has served as the subject-matter-expert, writer, reviewer, communicator, presenter, consultant, adviser/facilitator, and decision-maker for hundreds of medical policy topics and technology assessments within dozens of clinical disciplines and multiple business areas. Eugean has participated in numerous roles & capacities in a number of conferences, summits, and other national & international events etc. upon invitations. He has been invited by renowned organizations, evaluator bodies, & thinktanks etc. to be key informant on a variety of complex and challenging topics, and recognized in communications & publications for these works.

Eugean has taken and completed graduate coursework in bioethics at the University of Pennsylvania School of Medicine. He holds a bachelor’s degree in biological sciences with honors from Drexel University (minor was in business administration), a master’s degree of public health in evaluative clinical sciences from Dartmouth Medical School, and an MBA in healthcare management and economics with honors from Drexel University.

William Richard Light

Chief Scientific Officer, VirTech Bio

As a biochemist and senior executive with over 30 years of process/analytical/regulatory development experience in cGMP commercialization of blood-related biopharmaceutical products, I have the knowledge, experience, collaborations, leadership and motivation required to successfully complete this proposed research (development of a new hemoglobin based oxygen carrier (HBOC) for ex-vivo medical device platforms.)  I am uniquely qualified, as I have had the fortune of following over my career two commercial HBOC products (Hemopure® and Oxyglobin®, Biopure Corporation and then OPK Biotech) from the bench top to the sales force, through all the lengthy phases of their development, gaining expertise as they matured.  I have been responsible for process development on the bench top, to technology transfer into the pilot plant, to development of analytical assays, writing the Chemistry Manufacturing and Control sections for regulator submissions (Clinical and Marketing), and sitting on committees to design the manufacturing centers and product distribution.  I hold numerous patents in this field from composition to process and use.   My dealings with Contract Manufacturing Organizations give me insight into what they need for a commercial process.  But I never lost sight of my scientific roots, and it was this science that led to the successful development of an in vivo oxygen transport solution.  HBOCs had a colorful past competing in vivo against blood transfusion, but the experience and research from those times can contribute to its success ex vivo where blood has its own complications.  All things do come full circle, and what we have learned ex vivo, I have applied to our novel in vivo solution as well.   Namely, a new focus on fluid properties as well as oxygenation properties.

Trinayan Kashyap

Director, Global Expanded Access Lead and Research & Translational Development, Karyopharm Therapeutics Inc

I am currently serving as the Director of Translational Research and Global Expanded Access Lead at Karyopharm Therapeutics. I have been with Karyopharm Therapeutics for 10+ years and was involved with the discovery of the first-in-class oral selective inhibitor of nuclear export (SINE) compound, selinexor (XPOVIO). Subsequently, I led the pre-clinical efforts in the discovery of the second generation SINE compound, which is currently being tested in phase 1 and 2 clinical studies. I have also been involved with clinical development programs at Karyopharm. Since 2019, I have been assigned to lead the Expanded Access Program at Karyopharm. Prior to Karyopharm, I was working at Beth Israel Deaconess Medical Center, Boston. I received by master’s degree in Biological Sciences from the University of Massachusetts, Lowell.

John Lagus

Executive Vice President, Business Development, Tanner Pharma Group

John Lagus is the Executive Vice President of Business Development for Tanner Pharma Group. John spent more than a decade at Orphan Medical where he held various roles in development, commercial, corporate development, and oversight of international. Prior to joining, John worked for 12 years at Idis (and subsequently Clinigen) with roles in commercial, operations, and general management. John has a BA in mathematics from St Olaf College and a MS in statistics from Iowa State University.
 

Dana Dunne

Expanded Access Program Director, Tanner Pharma Group

Dana Dunne is the Expanded Access Program Director at Tanner Pharma Group. Prior to joining Tanner, Dana worked for 13+ years at mid- to large-size CROS, holding various clinical operational roles including clinical management of both local and global clinical trials. Dana has a BS in Dental Hygiene from the University of North Carolina at Chapel Hill and a Clinical Trials Research Associate (AAS) Degree from Durham Technical Community College.

Oliver White

Senior Program Manager, Tanner Pharma Group

Oliver White serves as Senior Program Manager for the Managed Access Programs (TannerMAP) division of Tanner Pharma Group. During his tenure with the company, Oliver has led the design and set-up of several Managed Access Programs for rare disease and oncology products. Oliver holds a master’s degree in chemistry from Durham University, England, and has undertaken pharmaceutical research placements at Vertex Pharmaceuticals and Université Grenoble Alpes, France.

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Robert Keel

Executive Vice President, Managed Access Programs, Tanner Pharma Group

Rob Keel is the Executive Vice President of Managed Access Programs (TannerMAP) and Managing Director in Switzerland for Tanner Pharma Group. He has lived and worked extensively on an international basis and feels it is a privilege to be able to help others. He has held global general management, supply chain and finance roles within the airline, agriculture, and pharmaceutical industries across the EMEA and Asia-Pacific regions. Prior to joining Tanner, Rob was part of the EMEA senior management team at AstraZeneca and held various positions at Alliance Boots (now Walgreens) and Genentech. Rob holds an Industrial Engineering and Management Sciences degree from Northwestern University and an MBA from Harvard Business School.

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