Available Shortly - Featuring 30 + Key Industry Expert speakers

Expanded Access Programmes 2022 Europe

  • Martine Zimmermann, PharmD, SVP, Head Regulatory Affairs, R&D & Commercial Quality, Alexion
  • Wendy Erler, VP, Global Head Patient Experience, STAR and Patient Advocacy, Alexion
  • Ramona Reichenbach, Head of Managed Access Center of Excellence, Novartis
  • Nicola Gillott, Head of Expanded Access, Amryt Pharma plc
  • Pascal King, Market Access Lead, International and Partner Markets, Jazz Pharmaceuticals
  • Sjaak Vink, Chief Executive Officer, The SocialMedwork
  • Robert Donnell , Executive Vice President, Medicines Access, Smartway Pharma
  • Tom Smith, Program Management Director, Expanded Access, Durbin PLC - Uniphar Group
  • Eugean Jiwanmall , Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross
  • Graham Sidorowicz, EVP Commercial, Bionical Emas
  • Rakesh Davda, Head of Real World Data & Market Access, Bionical Emas
  • Richard Klein, Director, Expanded Access Programs & Policy, GE2P2*
  • Joshua Vecht, Medical Affairs Operations and Governance Lead, Kyowa Kirin International
  • Susanne Alden, Regulatory Affairs Associate Director, Abbvie*
  • Georges France, Quality Expert, Consultant for GSK
  • Christine MacCracken, Head, Patient Strategy & Solution, Janssen Pharmaceuticals, J&J Company
  • Katrin Schepp, General Counsel, The SocialMedwork
  • Josie Godfrey, Co-Founder and CEO, Realise Advocacy
  • Lindsay Birrell, Co-Founder & CEO, Realise Advocacy , Trustee, Medics 4 Rare Diseases
  • Paolo Morgese, EU Director Market Access & Member Relations, Alliance for Regenerative Medicine
  • Sara Radenovic, Associate Director, Managed Access, GSK*
  • Magali Taiel, Chief Medical Officer, Gensight Biologics
  • And many many more...

Ramona Reichenbach

Head of Managed Access Center of Excellence, Novartis

Pascal King

Market Access Lead, International and Partner Markets, Jazz Pharmaceuticals

Josie Godfrey

Co-Founder and CEO, Realise Advocacy

Nicola Gillott

Head of Expanded Access, Amryt Pharma plc

Tom Smith

Program Management Director, Expanded Access, Durbin PLC – part of the Uniphar Group

Sjaak Vink

Chief Executive Officer, The SocialMedwork

Graham Sidorowicz

Senior Vice President, Business Development, Bionical Emas

Eugean Jiwanmall

Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross

Richard Klein

Director, Expanded Access Programs & Policy, GE2P2

Rakesh Davda

Head of Real World Data & Market Access, Bionical Emas

Christine MacCracken

Head, Patient Strategy & Solution, Janssen Pharmaceuticals, J&J Company

Magali Taiel

Chief Medical Officer, Gensight Biologics

Martine Zimmermann, PharmD

SVP, Head Regulatory Affairs, R&D & Commercial Quality, Alexion

Wendy Erler

VP, Global Head Patient Experience, STAR and Patient Advocacy, Alexion

Georges France

Quality Expert, Consultant for GSK

Paolo Morgese

EU Director Market Access & Member Relations, Alliance for Regenerative Medicine

Lindsay Birrell

Co-Founder & CEO, Realise Advocacy, Trustee, Medics 4 Rare Diseases

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Ramona Reichenbach

Head of Managed Access Center of Excellence, Novartis

Available Shortly… 

Pascal King

Market Access Lead, International and Partner Markets, Jazz Pharmaceuticals

Lindsay Birrell

Co-Founder & CEO, Realise Advocacy, Trustee, Medics 4 Rare Diseases

Lindsay is the former CEO of MSUK where she served for 6 years and is a trustee at Medics 4 Rare Diseases. Lindsay also served as NHS England Metabolic Clinical Reference Group Patient and Public Voice member for over 4 years. During her time working in rare diseases, she has developed knowledge of the challenges that all stakeholders face in participating in NICE and NHS England access processes for new treatments.

Lindsay has become a strong advocate for supporting patient groups in access and has seen first-hand that well-supported patient advocates can have an impact on decision-making.

Nicola Gillott

Head of Expanded Access, Amryt Pharma plc

Tom Smith

Program Management Director, Expanded Access, Durbin PLC – part of the Uniphar Group

Tom Smith, Program Management Director, Expanded Access Programs, Durbin PLC
 
Tom Smith is the Program Management Director, Expanded Access Programs at Durbin PLC (part of the Uniphar Group). As part of this role, Tom is responsible for Durbin’s portfolio of EAPs including program design and implementation, global supply of unlicensed medicines, client relations and project management. His program management and operational team span sites in the UK, USA and Ireland. During his tenure at Durbin Tom has experience in a range of therapeutic areas and product classifications, including gene therapy and rare diseases and has developed novel strategies to facilitate access to specialist medicines. Tom has a BSc (Hons) in Pharmaceutical Sciences from the University of Nottingham and has contributed to published research within the School of Pharmacy.

Sjaak Vink

Chief Executive Officer, The SocialMedwork

Sjaak Vink, CEO, TheSocialMedwork.com
As a social innovator committed to the UN Sustainable Development Goals 2030, Sjaak aims to create a more equal and fair healthcare system that gives everyone access to the medicines they need, no matter where they live.

After a successful entrepreneurial career, he in 2011 set out to dedicate his time towards social good in various industries. He founded TheSocialMedwork in 2015 with the sole mission to contribute to better health outcomes by helping patients and physicians all over the world to get access to the newest treatments not approved or available in their home countries. He was in 2012 the founding CEO of myTomorrows and is currently a board member of  a number of patient advocate groups such as the Abigail Alliance for Better Access to Developmental Drugs in Washington D.C. (who is one of the initiators of the US Right to Try Act) and Chicago based Cures Within Reach. Sjaak is since 2016 a Global Ambassador of the Inspiring Rare Birds which promotes female entrepreneurship in Australia and all over Asia.

Sjaak and TheSocialMedwork are solely backed by social impact investors, amongst which Esther Dyson (named by Forbes to be one of the most powerful women of Silicon Valley and ao co-founder of 23AndMe) and Jamie Heywood (ao founder of PatientsLikeMe and ALS-Technical Development Institute).

TheSocialMedwork platform has so far connected patients and physicians from over 90 countries to more than 15,000 elsewhere approved medicines for life debilitating illnesses. Currently TheSocialMedwork receives over a thousand requests for access to unapproved medicines a month and the numbers are growing fast. For 4 years in a row patients and physicians value TheSocialMedwork platform and expertise 5 out of 5 stars.  
https://thesocialmedwork.com/. 

Graham Sidorowicz

Senior Vice President, Business Development, Bionical Emas

Eugean Jiwanmall

Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross

Richard Klein

Director, Expanded Access Programs & Policy, GE2P2

Rakesh Davda

Head of Real World Data & Market Access, Bionical Emas

Rakesh has extensive pharmaceutical industry experience working across Commercial, Medical Affairs and Market Access roles, including supporting Clinical Audit, Global Value Dossiers and Observational Studies. He has advanced knowledge in International Health Technology Assessment, Pricing and Reimbursement (MSc), with practical experience gained through working on NICE technology appraisals.  Rakesh is focused on providing innovative RWD solutions aimed at improving access to medicines in areas of unmet clinical need, with the goal of generating insights capable of adding value to Regulatory, Pricing and Reimbursement processes.

Christine MacCracken

Head, Patient Strategy & Solution, Janssen Pharmaceuticals, J&J Company

Christine MacCracken is Head, Patient Strategies & Solutions at the Janssen Pharmaceutical Companies of Johnson and Johnson where she leads strategic identification and implementation of patient-centered programs such as pre-approval access.  A pediatric oncology nurse by training, Christine has held multiple roles within academia, non-profit and industry, all with a keen focus on elevating the voice of patients.
 
Prior to joining the Johnson & Johnson Family of Companies in 2015, Christine was Senior Director, Business Insights at the National Comprehensive Cancer Network (NCCN). In support of people with cancer and the providers who treat them, she closely collaborated with industry, state oncology societies and advocacy groups to disseminate NCCN treatment information through health technology platforms as well as market and outcome research programs. 
 
Her focus is on raising awareness around hearing and heeding the voice of the patient, as well as  recognizing “Every Patient is a Person First”. 

Magali Taiel

Chief Medical Officer, Gensight Biologics

Dr. Taiel completed her doctorate in Medicine with board certified in Ophthalmology from Lariboisiere Saint Louis University, Paris, France, in 1993, and her Associate Professor degree in 1998. Dr Taiel completed her internship at academic Paris hospitals, was an Associate Professor of Ophthalmology, served as an Ophthalmology Department Head, and ran Surgical and Medical Ophthalmology private practice. After 13 years of Ophthalmology public and private practice, Dr Taiel has been engaged in the Pharma Industry for 20 years; she brings extensive experience and expertise in drug clinical development, gene therapy, and medical affairs. She started her carrier at Servier company headquarter, and then worked in Ophthalmology area at Pfizer for several years; she then held international and management positions in various therapeutic areas, including both technical and supervision duties, at Eli Lilly Company for many years. Then, as VP Clinical Development, she led Clinical Development and Operations, to develop antisense oligonucleotides in Inherited Retinal diseases at ProQR Therapeutics. She then moved to GenSight-Biologics in 2018, to supervise the Medical Department and lead Gene Therapy programs in Inherited Retinal and Neuro-Ophthalmology diseases, as the CMO of the company.

Dr. Taiel has authored numerous protocols and articles published in peer reviewed journals, and made critical contributions to successful clinical development and launch of many products. She brings extensive years of experience from both academic medicine and pharma industry.

Martine Zimmermann, PharmD

SVP, Head Regulatory Affairs, R&D & Commercial Quality, Alexion

Martine Zimmermann is Senior Vice President and Head of Regulatory Affairs, R&D & Commercial Quality at Alexion, AstraZeneca Rare Disease. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of the regulatory environment for medicines under development for rare diseases. Prior to Alexion, Dr Zimmermann held numerous R&D and regulatory roles in companies such as Aventis (now Sanofi), Servier and H. Lundbeck A/S. Dr Zimmermann also serves currently as a Director in the Board Inventiva Pharma.

From 2019 to 2021 she served as a Director in the Board for CAELUM Bioscience.
She received her PharmD from the University Louis Pasteur in Strasbourg, France, and is based in Zurich, Switzerland. Martine has been a champion of diversity, equality, inclusion and belonging, having been recognized by the Healthcare Businesswoman’s Association as a Luminary in 2020, and efforts by serving as an executive sponsor for Alexion’s flagship Women In Leadership (WIL) employee resource group.

Wendy Erler

VP, Global Head Patient Experience, STAR and Patient Advocacy, Alexion

Wendy has built her patient advocacy career in many rare disease communities and oncology. Wendy Erler is the VicePresident of Patient Experience, STAR and Advocacy at AstraZeneca in Alexion’s rare disease, where she is responsible for leading the enterprise innovation model to gather and incorporate patient insights throughout the drug development and commercialization processes. She leads the Global PatientAdvocacy function and has responsibility the rare disease patient advocacy team. Previously, Ms. Erler was on the executive leadership team at Wave LifeSciences where she led Patient Advocacy and Commercial. Wendy graduated from Miami University and earned her MBA from St. Joseph’s University. 

Georges France

Quality Expert, Consultant for GSK

Georges L. FRANCE, Ph D, Individual Senior Quality Consultant (GFQE), Former GSK-CH VP Global Quality lead
Former Pfizer VP Global Quality Strategy, ICH Quality Expert (EWG-ICH Q10; IWG-ICH Q8,9 &10; EWG-ICH Q12)

Georges is Individual Senior Quality consultant for GFQE after retiring from GSK. He closed his activities at GSK as VP Quality integration process lead (GSK-Pfizer JV CH), previously he led Quality globally for Local Operating Companies (LOC). Prior to GSK, he led the quality integration for Novartis-GSK JV and was with Novartis CH since March 2012.
He previously worked with Pfizer as a VP Global Quality Strategy and Global Affiliates Quality and prior to that, worked with Wyeth for 12 years.

For the International Conference of Harmonization (ICH), He was EPFIA topic leader in the Expert working Group for the ICH Q10 guidelines (Pharmaceutical Quality System), as in the ICH Q8, Q9 and Q10 Implementation Working Group.
 
Today he is an EFPIA Expert for ICH Q12 (Life Cycle Management) guideline Expert Working Group
Georges holds a Doctorate in Pharmacy and a Post-Graduate Degree in Pharmacology and completed the INSEAD Advanced Management Program. 

Paolo Morgese

EU Director Market Access & Member Relations, Alliance for Regenerative Medicine

Paolo is a healthcare investment and market access professional with more than 15 years of experience in both assessing and supporting access to innovative healthcare technologies. Paolo is currently VP Market Access at Alira Health a healthcare advisory company and EU Director Market Access and Member Relations at the Alliance for Regenerative Medicine (ARM). Between 2012 and 2017 he worked at Deerfield Management, a healthcare investment company, where he was Director of EU Research and Market Access. Prior to that, he worked at Merck Serono for five years, Kyphon, which became Medtronic, and also spent several years with the Italian HTA Agency Agenas. Paolo’s interests and expertise are centred around healthcare technology value assessment and maximization, with a particular interest in the early stages of product development.

Lindsay Birrell

Co-Founder & CEO, Realise Advocacy, Trustee, Medics 4 Rare Diseases

Lindsay is the former CEO of MSUK where she served for 6 years and is a trustee at Medics 4 Rare Diseases. Lindsay also served as NHS England Metabolic Clinical Reference Group Patient and Public Voice member for over 4 years. During her time working in rare diseases, she has developed knowledge of the challenges that all stakeholders face in participating in NICE and NHS England access processes for new treatments.

Lindsay has become a strong advocate for supporting patient groups in access and has seen first-hand that well-supported patient advocates can have an impact on decision-making.

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