Mary Bea Harding « ISCTM | The International Society for CNS Clinical Trials and Methodology

Thank you for agreeing to participate as a presenter and/or chairperson at the upcoming ISCTM 2017 ‘Autumn’ Conference, which includes a Joint Day with ECNP. This page contains all the links you will need for submitting information to the ISCTM, as well as information we hope you find helpful for your planning.

Dates/Location
31 Aug – 2 Sept 2016
Le Meridien Etoile
Paris, France
(Housing to be booked through the ISCTM. Do not contact the hotel directly.
Details below)

STEP 1: Complete the Online Confirmation and Agreement

STEP 2: Please Email Biographical Paragraph

2500 characters max (including spaces)

STEP 3: Register for the Meeting

Registration will open mid-April. All speakers and chairs MUST process online registration. You will be able to access the fee-waived Speaker Registration path by selecting above link and inserting your ISCTM email of record on the Identity Confirmation page. You will have the opportunity to book your housing during the registration process. Do not contact the hotel.

STEP 4: Please Email Abstract

Abstract, for inclusion in the program book, should be submitted after the session development call with chairs (no later than Monday 19 June). Abstract should be in paragraph form,
< 300 words and contain no tables.

STEP 5: Presentation Submission Schedule

— Draft: Chairs will advise according to each segment’s agenda development telecon schedule.
— Final: Bring flash drive to onsite registration desk the morning of your session, no later than 30 minutes prior to the start of the meeting day.

STEP 6: Chairs – Publication Information

ISCTM strongly encourages dissemination of information discussed during ISCTM meetings through publication. At the minimum, we ask chairs to encourage speakers to release slide and video presentations for posting on the ISCTM website. (Output category specifications)

Travel Arrangements:
In order to meet ISCTM’s fiscal responsibilities, the Society endeavors to operate its meetings as close to break even as possible, hopefully in the black. The Executive does not wish to raise additional revenue through increasing registration fees, so we must keep a close watch on expenses. Therefore, we ask speakers who will request reimbursement to keep this in mind when arranging travel, specifically, if at all possible, to book flights enough ahead of travel dates to take advantage of the lower fares. (2017 Autumn Reimbursement Policy)

Agenda at a Glance:

Day 1: Thursday, 31 August 2017
16:00-19:30 Onsite Registration Open
18:45-20:00 Welcome Cocktail Reception

Day 2: Friday, 1 September 2017 – Joint Day with ECNP
7:30 Registration Opens / Continental Breakfast
8:15 Welcome from ISCTM/ECNP Presidents
8:30-10:15 Beyond efficacy: Hard outcomes in treatment studies (Schooler/Goodwin)
10:30-12:15 Clinician reported outcomes in multinational CNS trials: Practical guidance on translation and cultural adaptation (Kalali/Vieta)
12:15-13:45 Lunch
13:45-17:30 Drug development for negative symptoms in schizophrenia: What have we learned? What can we do better? (Umbricht, Arango)
17:30 Joint Sessions Adjourn
17:30-19:00 Reception/Poster Session

Day 3: Saturday, 2 September 2017
7:30 Registration Opens / Continental Breakfast
8:30 Behavioral and psychiatric symptoms in dementia (BPSD) (Ereshefsky/Pani)
13:00 Meeting Adjourns

ISCTM Contact Information

Georg Haig – 2017-2019 Chair, Scientific Program Committee
Carlotta McKee – Executive Director, ISCTM
Mary Bea Harding – Executive Assistant, ISCTM

Phone: +1.615.383.7688

2017 Autumn Conference – Speaker Online Confirmation and Agreement

Friday, December 9th, 2016

2017 Executive Committee Nomination

Thursday, November 17th, 2016

Call for Nominations Letter
(Includes criteria for service on the Executive Committee)

To complete this form you will need:

1) If nominating someone other than yourself, your endorsement alone is sufficient, UNLESS the nominee is someone from within your organization, then a second endorsement from someone outside of your organization is required. One person may fill out on behalf of both people in this instance.
2) If you are self-nominating, you will need endorsement from two people, not from the same group.
3) Short bio of nominee

Advantages and Challenges of Adaptive CNS Trials: Real World Lessons

Friday, November 4th, 2016

Co-Chairs: Ron Marcus, MD; Judith Kando, PharmD

The Adaptive Design Working Group (ADWG) hosted a scientific session during the 2015 annual meeting that focused primarily on dose response adaptation in Phase 2 clinical studies. The current Adaptive Design Scientific session will start off with an update on the expansion of adaptive design methodology in neuroscience clinical trials and then focus on different topics. Session will begin with a presentation of a comparative effectiveness study in status epilepticus followed by a discussion of an adaptation of dose and/or endpoint in a range of age-related disease characteristics in a Phase 2 proof-of-concept rare disease pediatric epilepsy study. An adaptation of the primary endpoint in a Phase 2 cognitive impairment associated with schizophrenia study will be presented, and lastly, attendees will hear an exploration of the multiple layers of considerations, that one may encounter, in the development of a confirmatory, adaptive trial having multiple endpoints and multiple adaptive features (e.g., sample size adaptation and treatment allocation adaptation). An FDA statistician will comment on the presentations as well as participate in the panel discussion. During the discussion, panelists will provide answers to questions that emerge during the session as well as answer questions raised during the 2016 webinar series.

Optimizing Use of ‘Big Data’ for Patient Identification and Disease Management

Wednesday, October 26th, 2016

Co-Chairs: Larry Alphs, MD, PhD; Gayle Wittenberg, PhD

‘Big data’ has become a buzz word referring to extremely large data sets that can be analyzed to reveal patterns, trends, and relationships among data elements. Despite the overuse of the term, the value that big data can bring to public health questions, its limitations and how to harness its use for clinical trial design, regulatory and public policy use remain incompletely addressed. This day-long session will focus on 1) different sources of big data and the questions they address; 2) challenges involved in aggregating and analyzing these data; 3) how their value can be harnessed to impact CNS clinical trials; 4) identifying and outlining current gaps towards use in regulatory, payer, and public health settings.

Silver Linings Playbook: The Positive Side of Negative Trials

Monday, October 24th, 2016

Co-chairs: Richard Keefe, PhD; Steven Romano, MD

Late phase clinical trials are conducted to confirm results from earlier phase activities and are thus expected to have a substantially higher probability of success. But failures in these pivotal registration trials do occur, and often lead to program cancellation. Regardless of whether a particular program advances or is discontinued following negative trial results, there are important methodological lessons that can be extracted to inform future research endeavors. This session will first highlight the need to adhere to disciplined early phase drug development fundamentals in order to diffuse risk and increase probability of later phase success. Next, specific results and challenges from a number of late phase programs in both psychiatry and neurology will be discussed, with opportunities to review what was learned and what options can be considered for future investment. A panel discussion will cover a range of stakeholder viewpoints, including regulatory, industry sponsors and clinical research organizations.