7th Expanded Access Programmes World Congress 2024 Americas

7th Expanded Access Progammes World Congress 2024 Americas

Strategies and Considerations in Launching an Expanded Access Programmes

Boston, MA, USA

Thursday 14th - Friday 15th November 2024

KEY INDUSTRY EXPERT SPEAKERS 2024

Elsa Luna, Director, Expanded Access Operations, Pfizer
Amber Bifolck Fisher, Senior Clinical Research Manager, Expanded Access, Kura Oncology
Melanie Wolf, Associate Director, Global Early Access Programs, Sarepta Therapeutics
Christine Istanboulian, Global Medical Operations , Early Access Programs, Sanofi
Jennifer Grigonis, Sr. Director Business Development EAP, Bionical Emas
Tori Rizk, Associate Portfolio Director, Bionical Emas
Patrick Raletz, Project Manager EAP, Bionical Emas
Juan Rosario, Project Manager EAP, Bionical Emas
Monica L Weldon, President/CEO/Founder, SYNGAP1 Foundation
Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross
Chisa Nosamiefan, Co-founder, The Labalaba Foundation for Lupus
Senior Representative, Pulse Inforframe
Carlos Izquierdo, Global Pricing & Access Lead – Early Pipeline Gastrointestinal, Takeda
Siddharth Jain, Medical Director –LSDs & HAE, Global Medical Affairs, Takeda
Emily M. Parks, Founder, CEO, POP!
Rachel Harisson, Associate Director, Early Access Program, Apellis Pharmaceuticals
Jennifer M. Joe, Global Medical Strategy & Population Health Director, AstraZeneca
Norah Xiao, Director, Digital Health Partnership, Astrazeneca
Donna Cowan, Associate Director, EAP & Registry, Stealth Biotherapeutics*

Amber Bifolck Fisher

Senior Clinical Research Manager

Kura Oncology, Inc.

Amber Bifolck Fisher

Senior Clinical Research Manager

Amber Bifolck Fisher is the Senior Clinical Research Manager at Kura Oncology. She has managed Kura’s Compassionate Use and Investigator Sponsored Studies since 2022. She has been a Certified Clinical Research Professional since 2016, and a member of the Global Clinical Supplies Group Expanded Access Resource Team since January. Amber resides with her family in Cambridge, MA.

ELSA LUNA

Director, Expanded Access Operations

Pfizer

ELSA LUNA

Director, Expanded Access Operations

Available Shortly

Melanie Wolf

Associate Director, Global Early Access Programs

Sarepta Therapeutics

Melanie Wolf

Associate Director, Global Early Access Programs

People and project leader acclaimed for managing talent to achieve maximum business results. Recognized as a diversity and inclusion advocate with expertise in highly regulated pharmaceutical/biotechnology industry. Demonstrated passion for serving others and proven ability to motivate diverse groups by leveraging each individual’s unique strengths, skills, and abilities. Analytical problem solver who values creativity and innovation. Dedicated to engaging and empowering employees to move organizations toward achievement of business and financial goals. Build and deliver impactful workshops Build future standards, guidelines and policies Career coaching Increase process efficiency Build leadership skills in others Revenue-producing process improvement Balance employee behavior and results Excellent project management and technical skills

NNIFER GRIGONIS

Sr. Director Business Development EAP

Bionical Emas

NNIFER GRIGONIS

Sr. Director Business Development EAP

Jennifer Grigonis has a strong background in business development and operations. Jennifer is currently working at Bionical Emas, where they hold the position of Director of Business Development, EAP. Prior to this role, they were an Associate Director of Business Development, EAP at the same company. Jennifer also served as the Business Development Operations Lead and US Proposal and Project Manager - EAP at Bionical Emas. Before joining Bionical Emas, Jennifer worked as a Business Development Operations Consultant at Social and Scientific Systems from 2010 to 2011. Jennifer also held various positions at Medifacts International, including Associate Director of Global Business Development Operations, Senior Manager of Business Operations & Strategic Partnerships, and Senior Proposal Manager. Jennifer started their career at PAREXEL International, where they worked in client relations, specifically in the field of Clinical Pharmacology. Jennifer Grigonis earned a Bachelor of Arts degree in Sociology from Temple University. No specific dates were provided for their education at this institution.

TORI RIZK

Associate Portfolio Director

Bionical Emas

TORI RIZK

Associate Portfolio Director

Available Shortly

PATRICK RALETZ

Project Manager EAP

Bionical Emas

PATRICK RALETZ

Project Manager EAP

Available Shortly

JUAN ROSARIO

Project Manager EAP

Bionical Emas

JUAN ROSARIO

Project Manager EAP

Available Shortly

CARLOS IZQUIERDO

Global Pricing & Access Lead – Early Pipeline Gastrointestinal

Takeda

CARLOS IZQUIERDO

Global Pricing & Access Lead – Early Pipeline Gastrointestinal

Available Shortly

Chisa Nosamiefan

Co-founder

The Labalaba Foundation for Lupus

Chisa Nosamiefan

Co-founder

Chisa Nosamiefan is Co-founder of The Labalaba Foundation for Lupus Awareness and Advocacy. With a personal experience of living with lupus, Chisa has become a global patient leader, dedicating her efforts to raising awareness, advocating for improved healthcare, and supporting individuals affected by this complex autoimmune disease. Chisa's deep-rooted passion for health equity and her drive to address the disparities faced by minorities in healthcare have been instrumental in shaping her advocacy work. She recognizes the importance of cultural competence and the role it plays in providing effective and inclusive healthcare services. Chisa firmly believes that embracing and integrating cultural diversity into healthcare practices can lead to improved outcomes and better patient experiences. Patient self-advocacy is another area that holds great significance for Chisa. She strongly believes in empowering patients to actively participate in their own care and make informed decisions. Through her advocacy and educational initiatives, Chisa aims to equip individuals with the tools and knowledge needed to advocate for themselves within the healthcare system. As a member of the Patient Advisory Board of the Brigham and Women's Hospital Lupus Center in Boston, Massachusetts and Partnership of Quality Measurements Review Board, Chisa actively contributes her patient perspective to help shape research, treatment protocols, and policies. Her unique insights and experiences provide valuable input for healthcare professionals, researchers, and pharma bridging the gap between patients, provider, industry and payer.

SIDDHART JAIN

Medical Director, Global Medical Lead

Takeda

SIDDHART JAIN

Medical Director, Global Medical Lead

Siddharth is an accomplished Medical Affairs leader (14+ years) with a diverse, multicultural experience in reputed organizations with successful stints in varied therapies (including Rare diseases). His strengths are collaborating with stakeholders from varied cultural & ethnic diversities & different work environments, reputation for agility to adapt towards rapidly evolving ecosystem, quickly earning confidence of key stakeholders and establishing a positive, growth-minded working culture by providing ongoing mentoring and support for colleagues. He has conceptualized and executed various digital, omnichannel & medical excellence projects, partnering with external societies/ patient advocacy groups, market access & leading large multi-country RWE studies and driving publications.

EUGEAN JIWANMALL

Senior Research Analyst for Medical Policy & Technology Evaluation

Independence Blue Cross

EUGEAN JIWANMALL

Senior Research Analyst for Medical Policy & Technology Evaluation

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.

MONICA L WELDON

President/CEO/Founder Bridge the Gap

SYNGAP Education and Research Foundation

MONICA L WELDON

President/CEO/Founder Bridge the Gap

In November of 2012, Monica’s twin son, Beckett, was the first to be diagnosed at Texas Children’s Genetics Clinic with the gene mutation SYNGAP1 (6p21.3). When Beckett was 4 months old, she noticed he was not meeting the same milestones as his twin sister. Monica then began a journey to find answers to help her son. She started to blog about his progress and this led to building a community of parents and caregivers that are now a strong support group. She is the Founder and President/CEO of Bridge the Gap – SYNGAP Education and Research Foundation. It is her passion to help support these families by raising awareness and creating a strong foundation that will accelerate a path to better therapies. She retired in 2016 after 23 years in education teaching secondary science. Her new focus is on building the programs and mission of Bridge the Gap – SYNGAP Education and Research Foundation. She is the Primary Investigator on the SYNGAP1 (MRD5) Registry and Natural History Study. She is a life member of the Worldwide Association of Female Professionals and a member of the first class of 2017 Illumina Ambassadors established in the United States. In addition to leading the foundation, she is an author, public speaker, consultant on rare disease business strategies and advocates for rare disease legislation at both the federal and state levels. Several of her authored scientific publications include Nature Neuroscience, The Journal of Neurodevelopmental Disorders, and The Journal of Pediatrics. She has authored a book about her son Beckett’s diagnostic journey called “Slow Moving Stream – My Special Boy”. She is a graduate from East Texas Baptist University with a Bachelor’s of Science in Biology/Psychology (1991) and Secondary Certification in Education (1995). She will be attending Northwestern University Pritzker School of Law in the Fall of 2020 to earn her Masters in Science Law. She has five beautiful children, Haleigh (28), Taylor, USMC (25), Sawyer (23), and the twins Beckett & Pyper (12). She was a Global Genes 2015 & 2016 RARE Champion in Advocacy Award nominee for her work in the rare disease community and WeGo Health Awards Nominee for years 2015, 2017, 2018, 2019, & 2020. She was named 2020 Global Shakers Rare Disease Champion.

EMILY M. PARKS

Founder, CEO

POP!

EMILY M. PARKS

Founder, CEO

Emily Parks is a young professional based out of the Washington D.C. area working in behavioral health and patient advocacy and student of Johns Hopkins University Carey School of Business pursuing an MBA in Healthcare Management. Emily received a small bowel transplant recipient in 2020 from MedStar Georgetown Transplant Institute after 20 years on TPN. Combining her expertise in behavioral health with her lived experience of navigating multiple tertiary hospitals firsthand has led her down the path of studying the impact of medical trauma and medical PTSD on patients and its influence on treatment outcomes. Emily founded the organization POP!, an organization dedicated to raising awareness of medical PTSD and medical trauma. In partnership with Stanford University School of Medicine and University of Washington- Seattle School of Medicine, Emily is part of a team constructing a new curriculum for budding anesthesiologists to use trauma-informed care to increase emotional intelligence in providers and decrease further retraumatization for patients living with anesthesiology related Medical PTSD. Emily is coordinating development of a new podcast in which anonymous letters from both patients and providers about their negative interactions with one another. Then, with the support of industry experts, the podcast host will examine both the facts and subjective emotions from either side to determine the tools needed to help people think and/or act differently in similar situations going forward. Lastly, she is working on a publication detailing what Medical PTSD is,common responses and/or protocols patients face in the healthcare system that leads to undermining feelings of patient empowerment, and how providers can respond to patients with Medial PTSD to promote true patient-centered care. In her free time, Emily enjoys cuddling with her cats, Sassy and Mickey, watching true crime documentaries, and sleeping. Site: popmedicalptsd.org LinkedIn: https://www.linkedin.com/in/emilyprk/

SENIOR REPRESENTATIVE

Coming Soon!

Pulse Inforframe

SENIOR REPRESENTATIVE

Coming Soon!

Roberta Smith

President

Alagille Syndrome Alliance

Roberta Smith

President

Roberta has been with ALGSA since 2013, her work in advocacy inspired by her twin daughters, one having Alagille Syndrome. Roberta has worked closely with industry through the drug development of now two FDA approved drugs for Alagille Syndrome. This has included intricate involvement in expanded access and patient recruitment, elevating the patient voice to improve access and understanding of the patient experience.

RACHEL HARISSON

Associate Director, Early Access Program

Apellis Pharmaceuticals

RACHEL HARISSON

Associate Director, Early Access Program

Early Access Program (EAP) Professional and an emerging leader in the EAP field who lived and worked overseas for 11 years. Committed to connecting individuals, motivating cross-functional teams and the pursuit of breakthroughs in medical care frontiers. Dedicated to collaborating and supporting peers and managers, have earned the trust and admiration of professionals both in America and abroad. In addition, am devoted to supporting the research, innovation and delivery of medical treatment to help professional stakeholders and patients around the world.

JENNIFER M. JOE

Global Medical Strategy & Population Health Director

AstraZeneca

JENNIFER M. JOE

Global Medical Strategy & Population Health Director

Jennifer Joe MD is the Population Health Director within global medical affairs, where she sits at the intersection of population health, digital, education, and clinical trials. Her role is disease state agnostic, and her current work is supporting the amyloidosis teams. She believes in putting the voice of the patient at the center of every discussion. Trained in nephrology at the Harvard-affiliated Mass General and Brigham and Women’s Hospital, she currently practices part-time at the Boston VA healthcare center.

Alan J. Balch

Chief Executive Officer

Patient Advocate Foundation

Alan J. Balch

Chief Executive Officer

Dr. Balch has over fifteen years of executive leadership in the non-profit sector with an emphasis on consensus-building and collaboration. He has led numerous federal advocacy efforts on a range of issues both at the legislative and regulatory level. He became the CEO of both NPAF and PAF in 2013. From 2006 - 2013, he served as the Vice President of the Preventive Health Partnership -- a national health promotion collaboration between the American Cancer Society, American Diabetes Association, and American Heart Association. Prior to 2006 Dr. Balch was the Executive Director of Friends of Cancer Research. Dr. Balch has served on the Executive Board of the Patient Advocate Foundation and National Patient Advocate Foundation since 2007. He also serves on numerous advisory boards and committees. He earned his PhD in environmental studies with a concentration in political economy in 2003 from the University of California, Santa Cruz; master’s degree in environmental sciences in 1997 from the University of Texas in San Antonio; his bachelor’s degree (cum laude) in biology in 1994 from Trinity University in San Antonio.

DONNA COWAN

Associate Director, Expanded Access Programs

Stealth BioTherapeutics

DONNA COWAN

Associate Director, Expanded Access Programs

Donna Cowan is a Certified Clinical Research Coordinator/Project Manager with more than 20 years of biopharmaceutical experience. For the past several years Donna has concentrated on the management of Investigator Initiated Studies and Expanded Access Programs (Compassionate Use, Managed Access, Named Patient), leveraging her passion for patient care into providing early access to investigational therapies to those with serious or life-threatening conditions who may have no other treatment options. She has experience in various therapeutic areas including oncology, rare and orphan disease, endocrinology, neuroendocrinology, and infectious disease, participating in several successfully executed NDA applications in these areas. Ms. Cowan is the Associate Director of the Expanded Access Programs and Investigator Initiated Studies at Stealth BioTherapeutics (SBT), a Boston area-based biopharmaceutical company developing therapies to treat the mitochondrial dysfunction associated with genetic mitochondrial diseases and many common age-related diseases.

Norah Xiao

Director, Digital Health Partnership

Astrazeneca

Norah Xiao

Director, Digital Health Partnership

Norah Xiao is the Director of Digital Health Partnership in Global Commercial Digital Health at AstraZeneca. As a digital product strategist, patients’ needs are her northstar. She leads the development of global commercial digital health strategy with Global Medical Affair and Global Brand and the implementation with marketing companies by building partnerships with external ecosystems. Amyloidosis is the rare disease she is currently working on.

Senior Representative

Available Shortly

Coming Soon!

Senior Representative

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