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April 30 – May 2, 2018

Boston, MA
The Countdown Is On – 1 Week To Go!

Morning Workshops
Monday, April 30 2018

09.00 - 12.00
Workshop A: Enhancing the Outsourcing Process: How to Select and Use Contract Manufacturing Services and the Broader Contract Services Ecosystem Effectively

Gene therapies have made significant progress in the rare disease space, and as commercialization draws closer, particularly in indications like haemophilia which require high doses of therapeutic, the outsourcing and contract service environment becomes more essential than ever before.

Attendees will learn about:

• The criteria you should be using to adequately assess potential partners to outsource projects to in the gene therapy space
• The broader contract infrastructure – understand how to improve interactions with CMOs, CROs, contract testing firms and contract shipping and transportation
companies
• Key factors impacting the decision to develop in-house capabilities or outsource services to third parties

Workshop Leader: Scott Burger, Principal, Advanced Gene & Cell Therapy

09.00 - 12.00
Workshop B: Discussing Novel Technologies With the Potential to Impact the Gene Therapy Field in 2018

[SOLD OUT]

Clearly the use of AAV vectors has had a significant impact on the field, as demonstrated by their continued use in the pioneering clinical trials currently reaching maturity. However, these vectors still encounter significant challenges that impact on their efficacy and safety. Attend this workshop to get up to speed on the latest developments in vector technology.

Attendees will learn about:

• The degree to which the current suite of AAV vectors are able to affect the expression levels of a transgene at a therapeutic level
• Next generation delivery technologies with improved tissue targeting and the ability to deliver larger genes to the target tissue
• Novel technology to avoid immune response complications associated with re-dosing

Workshop Leader: Casey Maguire, Assistant Professor of Neurology, Harvard Medical School

Afternoon Workshops
Monday, April 30 2018

12.30 - 15.30
Workshop C: Investigating the Unique Regulatory Landscape of the Gene Therapy Field

[SOLD OUT]

As the gene therapy space advances and clinical investigations continue to produce promising results, uncertainty about the regulatory frameworks and procedures in place needs to be addressed. Attend this workshop to gain an in-depth understanding of the regulatory landscape at this pivotal time for the gene therapy field.

Attendees will learn about:

• What the regulators are looking for in every stage of development – from preclinical investigations, through clinical development, manufacturability and reimbursement
• The availability of regulatory incentives for the development of gene therapies in the rare disease space
• In-depth case studies, guiding you through regulatory strategy and decision making throughout the development process

Workshop Leaders: Gopalan Narayanan, Vice President, Disruptive Biologics, Voisin Consulting
Francois Gianelli, Senior Scientist, Regulatory, Voisin Consulting

12.30 - 15.30
Workshop D: Intellectual Property & Licensing: Navigating the Landscape

[10 Places Remaining]

As gene therapy products continue to progress through clinical trials, commercial entities begin to focus on the intellectual property associated with the methods and specific compositions used in these therapies.

This workshop will provide a valuable insight into the topic of IP and licensing of gene therapy products.

Attendees will learn about:

• Practical strategies to transform discoveries and new vectors into IP
• Short and long-term IP issues confronting gene therapy products
• A case study of a hypothetical gene therapy product
• Approaches to improve interactions with business people and their attorneys

Workshop Leader: Richard Emmons, Partner, Burns & Levinson LLP