Previous Speakers

3rd Expanded Access Programmes Global Congress 2022

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

Lisa Kearns, MS, MA, is a senior researcher in the Division of Medical Ethics at NYU Grossman School of Medicine. She is a member of the Division’s working groups on Compassionate Use and Preapproval Access (CUPA) and Pediatric Gene Therapy and Medical Ethics (PGTME). For the past six years she has studied the ethical issues surrounding pre approval/expanded access to investigational drugs, including state and federal “right to try” legislation. More recently she has been studying the ethics of “bespoke” N-of-1 gene therapies and of pre approval access to gene therapies. Since March she has been researching the ethical allocation of drugs, vaccines, and medical equipment during the novel coronavirus pandemic and access to investigational and unproven therapies for Covid-19. She is the deputy chair of the Compassionate Use Advisory Committees (CompAC), which advise Janssen Pharmaceuticals on the ethical allocation of its investigational drugs.

Jean Godin

Head, Global Access Programme, Sanofi

Jean Godin holds a Doctorate in Medicine (MD) from the University of Montreal, a post Graduate diploma in Family Medicine from the University of Montreal and a MBA in Business Administration from McGill University. He is a licensed physician of the Quebec College of Physician & Medical Council of Canada (LMCC). He practiced medicine full time in the Montreal area in both university and community hospitals until he joined the pharmaceutical industry in December of 1999.

Jean headed scientific affairs in Canada at Teva Pharmaceuticals (innovative division) from 1999 to 2007. In June 2007, he became General Manager for the branded activities of Teva in Canada; he was then responsible for the development and commercialization of the innovative portfolio. In July 2012, Jean joined Novartis Canada in the position of Chief Scientific Officer and Vice-President, Clinical and Regulatory Affairs, reporting to the CEO. Jean joined Sanofi in May 2016.  He is currently the Head of Global Access Programs.

Jean currently lives in Cambridge, Massachusetts and maintains a part-time medical practice in Montreal.

Neena Nizar

President & Founder, The Jansens Foundation

Dr. Nizar serves as Founder and Executive Director of the Jansen’s Foundation. She is a rare disease advocate and Change Leader in the rare disease community, specifically in the field of ultra-rare skeletal dysplasias. Dr. Nizar has a Doctoral degree in Educational Leadership from Creighton University, Nebraska, is a TEDx speaker, a blogger and passionate voice for the special needs community. She is a Trailblazer for the Rare Advocacy Movement (RAM) and Nebraska’s Mother of The Year, 2018. Dr. Nizar is also a rare disease patient and a mother to two boys with Jansen’s Metaphyseal Chondrodysplasia – a disease that affects less than 30 people worldwide.

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.

Michelle Clausen

Senior Director, Expanded Access (Compassionate Use) & Enterprise Medical Community, Pfizer

Michelle began her career at Pfizer in 2001 as part of the Medical Information Team and has continued roles within the Chief Medical Office throughout her 21+ years at the company.  Currently she leads Expanded Access & Enterprise Medical Community, within Global Medical Operations, Governance and Community, a part of Pfizer Worldwide Medical & Safety.  Medical Community focuses on internal medical functions, creating efficiencies to increase the flow of knowledge across Pfizer’s medical lines. Expanded Access (often called compassionate use) provides access to investigational medicines to patients who have exhausted all standard of care treatment and are not eligible for a clinical trial for a life-threatening or serious illness.  Michelle leads the Global Expanded Access Team and is the business process owner for the related standard operating procedure which provides global access to investigational products to patients with life-threatening conditions.  Michelle has her Doctor of Pharmacy from Shenandoah School of Pharmacy and BS in Pharmacy from Rutgers College of Pharmacy. Michelle lives in NJ with her husband, and 3 teenage children, and their Chow Chow dog.  She enjoys traveling, baking, and trying new activities.
 

Christine Von Raesfeld

Founder & CEO, People with Empathy

As Founder/CEO of People with Empathy, Christine Von Raesfeld is a leader in bringing a critically needed patient perspective to cutting-edge medical innovations. Committed to providing patients with chronic and rare diseases with the support they need, Christine works with patient advocacy organizations, industry representatives, and individual patients and their loved ones. Living with many rare and chronic diseases, she believes that the only way to ensure health equity is to leverage one’s own data. As a patient involved in Stanford’s Humanwide program, she speaks on the benefits and advantages of precision medicine, with a special interest in pharmacogenomics. 

Christine’s drive to make lives better for patients has been nationally recognized. In 2019, she spoke on stage at the Startup Health Festival as an invited guest of Sanguine Biosciences. In 2018, Christine served on the Team of Patient Advisors for PatientsLikeMe. She has been nationally recognized for her work in advocacy and when several awards including Silicon Valley Business Journal’s100 Women of Influence, 2019 and a 2020 Community Hero by Assemblyman Kansen Chu. In addition, Christine serves as a Virtual Advisor Team member for the All of Us research program, a Technical Expert Panelists for CMS and a patient advisor/consultant or multiple pharmaceuticals off branded campaigns and startup ventures.

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.

Robert Donnell

Executive Vice President, Medicines Access, Smartway Pharma

Robert has designed and led some of the most innovative and largest EAPs in recent years including in rare diseases and gene therapy. He has experience across Europe, USA and globally and has advised major blue-chip Pharma as well as smaller biotech companies. He started his career at P&G and AZ before moving to a number of international service providers working with pharma and biotech companies on supply chain solutions. He currently leads all global development and implementation of EAPs at Smartway where he specializes in working with manufacturers to develop the best Medicines Access plan for them.

Richard Klein

Director, Expanded Access Programs & Policy, GE2P2 Global Foundation

Richard Klein, an internationally recognized expert in expanded access to unapproved therapeutic agents, worked at the FDA for more than 40 years, before leaving the agency in 2017. While there he helped develop the revised expanded access regulations and guidelines, led the creation of the FDA expanded access website, and helped develop the streamlined application for individual patient access and the Reagan Udall Foundation Expanded Access Navigator. He also spearheaded the effort to waive full-board IRB review for individual patient access to unapproved drugs and biologics. As director of the FDA’s Patient Liaison Program, he interacted extensively with outside communities and the agency’s scientific and policy offices to advocate for patient interests and facilitate patient engagement in regulatory activities. He worked closely with patient communities in a variety of areas, including treatment access to unapproved drugs, product safety, and clinical trial design. Before taking on that role, he created the FDA’s HIV/AIDS program, working with AIDS activists and advocates to coordinate their input and participation in regulatory policy and decision-making related to HIV/AIDS. Prior to working in patient engagement, he helped develop policies and regulations for the protection of human research subjects, both at FDA and HHS, including the original Common Rule, and provided guidance for institutional review boards (IRBs).

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.
 

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.

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.

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.

Rachel Harrison

Associate Director, Early Access Program, Apellis Pharmaceuticals

Skilled at cross-functional collaboration between teams and driven to communicate successfully to obtain optimal results for the Expanded Access Programs I manage.  Successfully opened and closed an Early Access Program and currently manage a robust on-going Global Compassionate Use Program.   Knowledgeable in navigating the intricacies of Global Early Access Programs including Clinical Supply, Regulatory Requirements, Patient Access Portals, development of Physician facing materials, and submissions to the Institutional Review Board (IRB).  Proven success as an Alliance Manager with a demonstrated history of working in international settings. Thus far, was a team member for the launch of 2 FDA approved Orphan Drugs: COPIKTRA (duvelisib) and EMPAVELI (pegcetacoplan). Skilled in Communications, Global Alliance Management, Cross-functional Coordination, Corporate Development, Strategic Alliances, and Database Administration.  

Misty Gravelin, MPH, RAC

Project Lead, Expanded Access Support Unit, University of Michigan

Misty Gravelin, MPH, RAC, is the lead for expanded access support at the University of Michigan, as part of the Michigan Institute for Clinical and Health Research (MICHR). She has provided regulatory support or institutional coordination for hundreds of single-patient requests and dozens of multi-patient programs. In addition to this role, she is the project lead for Transforming Expanded Access to Maximize Support and Study (TEAMSS), an NIH-funded Collaborative Innovation Project to develop and disseminate resources for expanded access at academic medical centers. She has authored multiple papers on expanded access, including articles in the Journal of Clinical and Translational Science, the American Journal of Bioethics, and the Hastings Center Report.

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