7th Expanded Access Programmes World Congress 2024 Americas

7th Expanded Access Progammes World Congress 2024 Americas

STEERING INTRICATE REGULATORY REQUIREMENTS AND CHALLENGES IN SUCCESSFULLY IMPLEMENTING EARLY ACCESS TO MEDICINES

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
Dr. Femida Gwadry-Sridhar, Founder and CEO, Pulse infoframe Inc.
Dan Lewi , Head, Business Development and Patient Advocacy, Pulse infoframe Inc., Co- founder, CATS Foundation
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
Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross
Chisa Nosamiefan, Co-founder, The Labalaba Foundation for Lupus
Carlos Izquierdo, Global Pricing & Access Lead – Early Pipeline Gastrointestinal, Takeda
Jennifer McNary, Founder, One Rare

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

JENNIFER GRIGONIS

Sr. Director Business Development EAP

Bionical Emas

JENNIFER 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.

Dr. Femida Gwadry-Sridhar

Founder and CEO

Pulse Infoframe Inc.

Dr. Femida Gwadry-Sridhar

Founder and CEO

Femida is a pharmacist, clinical epidemiologist, and methodologist with over 25 years of experience in clinical trials, patient registries, knowledge translation, health analytics and clinical disease outcomes. She was recently recognized as a lifetime fellow of the CIHR for her contributions to global research with impact. Femida has published over 200 manuscripts and abstracts in top tier journals and actively continues her professional interests in enabling technologies for better provider workflow and patient engagement. Femida is a founding member of the International Society for Pharmacoeconomics and Outcomes Research medication adherence group, which has provided an early glimpse into how to conduct research in adherence. The recipient of numerous nominations, awards, and positive press, Springboard Enterprises has recognized Femida as a leading entrepreneur in digital health. She also holds her Ph.D. in research methodology and health economics from McMaster University.

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.

Dan Lewi

Head, Business Development and Patient Advocacy

Pulse infoframe Inc., Co- founder, CATS Foundation

Dan Lewi

Head, Business Development and Patient Advocacy

Having two sons diagnosed with a rare disease (MPSII) changes your perspective and priorities in life. Having spent over 20 years in construction, many of which were at Board level, Bob decided to pursue a career in the Charity sector. At first becoming a Trustee, then progressed to Managing Director and Group CEO of various patient organisations, supporting those living with rare diseases and complex needs. Bob wanted to bring together his family experiences of a "Rare life lived" and commercial attributes in order to improve the lives of those most marginalised in society whilst, at the same time, helping to create a more sustainable financial future for patient organisations both in the UK and globally. As well as being Group CEO of the MPS Society/Rare Disease Research Partners he is proud to serve as Vice Chair of the LSD Collaborative, Board Member of the worldwide International MPS Network, Acting Chair of the New Born Screening Collaborative and work as a patient representative for MPS in various global charitable access programs that provide a possible lifeline to treatments in selected areas of the world. These are not job roles, but a way of life!

Jennifer McNary

Founder

One Rare

Jennifer McNary

Founder

Jenn McNary is a trusted voice in the rare disease community, as a mother, public speaker and fierce advocate. Her work in the rare disease space as a thought leader earned her the Ryan’s Quest Ryan’s Hero award in 2013, and the prestigious 2017 Meyer- Whalley instrument of change award. Formerly as the director of outreach and advocacy at a Massachusetts based non-profit foundation, she was responsible for the organization of the largest FDA advisory committee hearing in history, with over 1000 duchenne advocates, families, clinicians and researchers in attendance. Jenn has unique experience in the drug development field, as a parent of children enrolled in clinical trials, an advocate engaging with the regulators and as a patient engagement professional in the life sciences. Currently, Jenn is the Co-Founder and Principal of Canary Advisors, a boutique patient advocacy consulting firm with a focus on regulatory and access patient engagement. Her other activities include serving as the Founder of One Rare, a non-profit formed to meet the needs of young adults with rare and chronic conditions and raising her children in Massachusetts.

SENIOR REPRESENTATIVE

Coming Soon!

Pulse Inforframe

SENIOR REPRESENTATIVE

Coming Soon!

SENIOR REPRESENTATIVE

Coming Soon!

Coming Soon

SENIOR REPRESENTATIVE

Coming Soon!

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.