News and Events
Episode 21, “The Legend of I-SPY 2 - Part B”
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In this episode, Dr. Don Berry and Dr. Scott Berry provide an in-depth account of I-SPY 2, focusing on the trial’s use of the “time machine” methodology—an Bayesian solution allowing bridging across arms to inform ongoing analyses.
In Episode 21 of Berry’s “In the Interim…” Podcast, titled The Legend of I-SPY 2 - Part B, Dr. Donald Berry and Dr. Scott Berry explore the “time machine” approach at the heart of I-SPY 2.
Faced with dropping the standard control arm mid-trial a method was devised to maintain rigorous comparisons using non-concurrent controls. This solution leverages Bayesian modeling of era effects in the trial, enabling direct comparison of treatment arms enrolled at different times. The method became foundational for platform trial designs in breast cancer and shaped models now used in glioblastoma, pancreatic cancer, and ALS.
Contributions by Laura Esserman, Anna Barker, and Janet Woodcock, along with technical execution by Meredith Buxton (trial logistics), and code innovation by Ashish Sanil were critical to sustained platform operation.
Notable episode insights:
● The “time machine” enables credible analysis using non-concurrent controls
● Bayesian probabilities optimize randomization and predictive probabilities optimize graduation of therapies
● Four investigational drugs from I-SPY 2 have achieved regulatory approval
● Influence extends to complex platform trials across multiple disease areas
Listen to the full episode today: https://www.berryconsultants.com/resource/21-the-legend-of-i-spy-2-part-b
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Episode 19, “The STEP Platform with Dr. Eva Mistry and Dr. Jordan Elm”
This episode of "In the Interim..." features an in-depth discussion of the StrokeNet Thrombectomy Endovascular Platform (STEP), a multi-domain, adaptive platform trial for acute stroke, anchored in the NIH StrokeNet network.
Episode 20, “The Legend of I-SPY 2 - Part A”
In Episode 20 of Berry’s "In the Interim..." Podcast, The Legend of I-SPY 2 - Part A, Dr. Don Berry and Dr. Scott Berry discuss the origins and design of the I-SPY trials.
Episode 21, “The Legend of I-SPY 2 - Part B”
In this episode, Dr. Don Berry and Dr. Scott Berry provide an in-depth account of I-SPY 2, focusing on the trial’s use of the “time machine” methodology—an Bayesian solution allowing bridging across arms to inform ongoing analyses.
Episode 22, “The Time Machine”
Dr. Scott Berry and Dr. Kert Viele discuss the origins and implementation of the “time machine” modeling approach, beginning with sports analytics and progressing to adaptive platform clinical trials.
Episode 23, “Bayesian Approach in Clinical Trials”
This episode of "In the Interim…" features Dr. Scott Berry, Dr. Kert Viele, and Dr. Melanie Quintana of Berry Consultants dissecting the technical and operational landscape of Bayesian statistics in clinical trial design.
Episode 24, “STEP Statistical Modeling”
In this episode of "In the Interim…", Dr. Scott Berry, Dr. Elizabeth Lorenzi, and Dr. Amy Crawford discuss the STEP platform trial’s statistical methodology for evaluating which acute stroke patients benefit and which do not from endovascular therapy (EVT).
Episode 25, “A Discussion with Michael Proschan on Response-Adaptive Randomization”
In this episode of "In the Interim…", Dr. Scott Berry and NIH’s Dr. Michael Proschan conduct a detailed discussion from opposing viewpoints on response-adaptive randomization (RAR) in clinical trials.
New Publication: Dr. Donald Berry on the Evolution of Bayesian Clinical Trials
Dr. Donald Berry has published a comprehensive history from his perspective on the development of Bayesian clinical trials, entitled “Adaptive Bayesian Clinical Trials: The Past, Present, and Future of Clinical Research.” It’s available free with open access from the publisher at https://www.mdpi.com/2077-0383/14/15/5267
2025 JSM in Nashville, Tennessee
Berry Consultants is proud to sponsor next week’s American Statistical Association 2025 Joint Statistical Meetings (JSM) in Nashville, Tennessee!
Episode 11, “Implementing Adaptive Trials"
In Episode 11 of "In the Interim...", host Scott Berry discusses the nuances of implementing adaptive clinical trials with Dr. Anna McGlothlin and Dr. Michelle Detry from Berry Consultants.
Episode 12, “Platform Trial in Psychiatry with Dr. Husseini Manji"
In the latest episode of "In the Interim...", Dr. Scott Berry and Dr. Mike Krams sit down with Dr. Husseini Manji, to explore the potential of platform trials in advancing precision medicine within psychiatry, particularly in tackling complex mental illnesses.
Episode 13, “DSMBs in Adaptive Trials with Roger Lewis"
In this episode of "In the Interim…", host Dr. Scott Berry is true to the name of the podcast, as he discusses the unblinded world of adaptive clinical trials alongside Dr. Roger Lewis, a renowned expert in both statistical science and clinical medicine.
Episode 14, “Drug Developers’ Lessons from Sports: Regression-to-the-Mean"
In this engaging episode of "In the Interim...", host Dr. Scott Berry is joined by Dr. Nick Berry to explore the intriguing parallels between sports and drug development, focusing on the concept of "regression-to-the-mean."
Episode 15, “Prof Craig Ritchie: Looking Back at EPAD, Moving Forward in Alzheimer’s Disease"
Scott Berry, Founder of Berry Consultants, interviews Professor Craig Ritchie—specialist in brain health and neurodegenerative diseases, Chief Investigator of EPAD (European Prevention of Alzheimer Dementia), and CEO of Scottish Brain Sciences—for a precise analysis of platform trial methodology in Alzheimer’s research.
Episode 16, “Spending Alpha"
In this solo episode of "In the Interim...", Scott Berry, President and Senior Statistical Scientist at Berry Consultants, addresses deep-rooted confusion in the field of adaptive clinical trial design surrounding the concept of “spending alpha.”
Episode 17, “Seamless 2/3 Trial Designs"
Scott Berry convenes co-authors Kert Viele, Joe Marion, and Lindsay Berry to discuss the statistical and developmental nuances of inferentially seamless phase 2/3 clinical trial designs.
Episode 18, “A Statistician Reads JAMA"
Dr. Scott Berry applies a statistician’s review of a random trial result published in JAMA – the FAIR-HF2 clinical trial. Interrogating the frequentist paradigm and the focus on the binary outcome of the primary hypothesis test.
FACTS 7.2 Release
Berry Consultants is excited to announce the release of version 7.2 of FACTS (Fixed and Adaptive Clinical Trial Simulator) today, which now includes a broader set of dose escalation designs.
Episode 10, “Revisiting Seamless 2/3 Trial for GLP-1 Agonist"
In this episode of "In the Interim..." we revisit the ground-breaking seamless phase 2/3 clinical trial for the GLP-1 agonist, dulaglutide—better known as Trulicity.
Episode 9, “I-SPY 2 to GMB AGILE and Beyond"
In this episode of "In the Interim...," we sit down with Dr. Meredith Buxton to explore the evolution of platform trials from I-SPY 2 to GBM AGILE and Beyond.
Today’s episode, “External Data in Clinical Trials"
In this episode of "In the Interim...," Scott Berry and Kert Viele navigate the nuanced debate surrounding the integration of external data in clinical trials.
Episode 7, “Remembering Jimmie Savage"
In today's podcast episode, discover more about Jimmie Savage—the man who shaped Bayesian statistics and left an indelible mark on the field.
Today’s Episode, “The Art and Slog of Innovating"
This week Dr. Michael Krams joins the podcast to discuss the art and slog of innovation in pharmaceutical companies and clinical trials.
Episode 5 released today, "Religion, Politics, and Ordinal Outcomes"
In this latest episode of our podcast, Scott Berry discusses the controversial and vital topic of ordinal outcomes.
Episode 4, "HEALEY ALS Platform Trial with Dr. Merit Cudkowicz and Dr. Melanie Quintana"
Join us for an exploration into the HEALEY ALS Platform Trial, a pioneering effort in adaptive trial design, with Dr. Merit Cudkowicz of MGH and Dr. Melanie Quintana from Berry in today's podcast.
Episode 3, "FACTS 7.1 Release with Tom Parke" is now available!
Our latest podcast episode explores the fascinating world of clinical trial simulation, spotlighting updates to FACTS 7.1!
Podcast Episode 2, "When Should You Use Adaptive Design Clinical Trials?" is live!
Join President, Dr. Scott Berry, and Director of Research, Dr. Kert Viele, as they unravel the nuances of adaptive design in clinical trials.
Berry Releases New Podcast Series, “In the Interim…”
In 2025 Berry will be celebrating 25 groundbreaking years in the field of statistical and adaptive clinical trials, and today we're excited to announce the launch of Berry's "In the Interim..." podcast.
February 2025 FACTS Webinar
This month’s webinar will be on the topic, “Why simulate? Can clinical trial simulation really improve the strategic decision making in drug development?”
Mike Krams, M.D. joins the Berry Consultants Team
Berry Consultants has hired Dr. Mike Krams as a Senior Medical Scientist in Europe, bringing extensive experience in clinical development strategy and adaptive trials to the team.
FACTS 7.1 Release
Berry Consultants has released FACTS 7.1, featuring enhancements such as concurrent control comparisons, conditional power calculations, new analysis options for dichotomous endpoints, integration with the R package "Airship" for flexible graphing, improved Bayesian dose escalation consistency, and various interface improvements.
FACTS Webinar Series in Oct. and Nov.
Berry Consultants is hosting a free 6-week public webinar series on "Case Studies in using FACTS to design Clinical Trials" from October 17th to November 21st, 2024, featuring live demonstrations of trial design using their simulation software, with registration available for each session at their website.
ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
Berry Consultants is proud to be a Principal Sponsor of the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop in Rockville, MD from September 25th-27th, and invites attendees to visit their exhibit booth to discover their trial design, implementation, and software solutions.
External Podcast: Innovative Clinical Trial Design Identifies Effective Drug and Its Most Efficacious Dose for Treating Early Alzheimer Disease
In the September 6, 2024 episode of SciPod Health and Medicine, the podcast discusses a paper on Lecanemab for early Alzheimer’s disease by Dr.
August 2024 FACTS Webinar
Join us on August 23rd at 11am EDT for a public webinar led by FACTS developer Elias Meyer, focusing on interactive results exploration and visualization using the R Shiny App AIRSHIP; register in advance at the provided Zoom link.
ASA JSM 2024
Berry Consultants will sponsor the ASA JSM next week, inviting attendees to visit booth #101 for insights on adaptive clinical trial design, software demos, and to catch Dr. Joseph Marion's presentation on innovative clinical trial solutions for pediatric neurodevelopmental disorders on August 4.
July 2024 FACTS Webinar
Join the Berry Consultants software team on July 26 at 11am EDT for a public webinar exploring the open enrollment option in the FACTS Dose Escalation N-CRM module, including its functionality, benefits, and comparison to the BOIN "backfill" option; register in advance at the provided Zoom link.
PSI: Statisticians in the Pharmaceutical Industry Conference
Berry Consultants will sponsor and present at the PSI Conference in Amsterdam from June 16-19, featuring team members who will discuss various topics related to adaptive designs and clinical trials; visit booth #12 to learn more about their consulting and software solutions.
Summer Biometric Seminar of the Viennese Section of the International Biometric Society
The Berry Consultants team is thrilled to present at the free Summer Biometric Seminar on June 21st at the Medical University of Vienna, focusing on "Bridging the Gap between Bayesian & Frequentist Approaches in Clinical Trials for Drug Development," with options to attend in person or online via WebEx.
June 2024 FACTS Webinar
Join the June 14th FACTS Software Webinar at 11am EDT for an exclusive preview of the new features in the upcoming FACTS 7.1 release, including enhanced simulators, new statistical analyses, improved graphing capabilities, and user-friendly tooltips—register in advance at the provided Zoom link.
45th Annual Meeting of the Society for Clinical Trials
The Berry Consultants team is eager to present at the 45th Annual Meeting of the Society for Clinical Trials in Boston, MA, with sessions on patient-centered trial design, predictive probabilities, and the HEALEY ALS Platform Trial scheduled for May 21st and 22nd.
April 2024 FACTS Webinar
Join the Berry Consultants Software team for an April 26 webinar at 11am EDT, where they will showcase an optimization project focused on automated design evaluation and extracting early stopping boundaries for adaptive designs; register here: https://us02web.zoom.us/webinar/register/WN_mAEuXVOATGqJE44JSrMu2w.
March 2024 FACTS Webinar
Join the FACTS Software March Webinar on March 22 at 11am EDT to explore Response Adaptive Randomization (RAR) through practical insights, misconceptions, and simulated examples in R and FACTS—register now!
Berry Consultants Releases New Version of ADDPLAN
The Berry Consultants Software team has released ADDPLAN NEO version 10.2, which introduces new features including a graph for Group Sequential designs, stopping boundaries, interim test statistic estimates from simulated trials, and illustrative examples to enhance understanding for non-statisticians.
International Society for Biopharmaceutical Statistics Symposium March 6th-9th
Berry Consultants will present at the ISBS Symposium this week, featuring Dr. Christina Saunders on March 8th at 2pm EST and Dr. Kert Viele on March 9th at 1:30pm EST, with details available at the ISBS program link.
2024 ENAR Spring Meeting March 10th-13th
Berry Consultants will present two topics at the 2024 ENAR Spring Meeting on March 11, featuring Joe Marion, Ph.D., discussing "Borrowing Phase 2 Data in Phase 3" at 9:20am EST, and Amy Crawford, Ph.D., presenting on "Identifying Patients Who Benefit from EVT" at 10:55am EST.
February 2024 QUOTES Webinar
Berry Consultants will host a free webinar on February 23 at 11:00 AM EST, focusing on optimizing clinical trial design and estimating the expected net present value of drug development programs using the QUOTES software, particularly addressing the trade-offs in phase 2 trials.
January 2024 FACTS Webinar
Join the Berry Consultants software team for their January FACTS webinar on January 19th at 11am EST to learn about the upcoming addition of an ordinal endpoint option to the trial simulator via Zoom at the provided link.
ASA Women in Statistics and Data Science Conference 2023
Join Dr. Cora Allen-Savietta from Berry Consultants on October 25 for a presentation on a platform trial in Parkinson's disease.
New Public Webinar Series: Introduction to Adaptive Trial Designs using FACTS
Public live Zoom webinars on "Introduction to Adaptive Trial Designs using FACTS" are scheduled for October and November.
ASA Biopharmaceutical Industry Statistics Workshop
Berry Consultants is sponsoring the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop from September 27-29 in Rockville, MD, where several team members will be presenting, and attendees can find more information and register on the ASA Workshop Website.
Futility in Clinical Trials
The new JAMA Guide to Statistics and Methods by Dr. Barbara Wendelberger and Dr. Roger Lewis examines the concept of futility in clinical trials.
PSI 2023 Conference June 11-June 14
Visit the Berry Consultants booth to meet our team and experience demos of our latest software products: FACTS 7, ADDPLAN, and QUOTES.
44th Annual SCT Meeting
The Berry Consultants team will present sessions on May 22 at 2:45 PM EST and May 23 at 4:15 PM EST.
FDA/AdvaMed Medical Device Statistical Issues Conference
On May 12, Dr. Amy Crawford and Dr. Joe Marion from Berry Consultants will present at the FDA/AdvaMed Conference.
Applied Probability Conference
Peter Jacko will present "Bandit Procedures for Designing Patient-Centric Clinical Trials" on April 21.
Berry Consultants Releases FACTS 7 Clinical Trial Simulator
FACTS 7 introduces a new module specifically for Platform Trial designs.
Advanced Statistical Methods to Borrow External Information
Dr. Ben Saville will present at the DIA/FDA Biostatistics Industry & Regulator Forum on March 30.
JAMA releases paper on Lecanemab for Patients With Early Alzheimer Disease
The study employs Bayesian analysis to evaluate dose-finding in a Phase 2b randomized clinical trial.
Adaptive Designs and Multiple Testing Procedures Workshop
Join Tom Parke for the ADMTP 2023 Workshop in Basel, Switzerland.
Complex Innovative Trials Designs: Current Perspectives & Future Directions
Register now to attend Dr. Melanie Quintana's presentation at the DIA/FDA Biostatistics Industry & Regulator Forum on March 29.
Accelerating ALS Drug Development Through an Innovative Clinical Trial Design
Dr. Melanie Quintana will be presenting at the MDA Clinical & Scientific Conference on March 21 at 4:30 PM CT.
ENRICH: A Novel Approach to Clinical Trials in ICH
Dr. Ben Saville of Berry Consultants will explore essential elements of the ENRICH randomized adaptive clinical trial.
NIH Announces ALS Innovative Research Initiative
The partnership between Berry Consultants and the NIH on the ALS Innovative Research Initiative is a remarkable endeavor aimed at advancing research in ALS.
2020 JSM Virtual Conference
Berry Consultants will sponsor and present at the virtual American Statistical Association's Joint Statistical Meetings from August 2-6, 2020, with more details available on the JSM website.
Los Angeles County Modeling Updates
Since March 2020, Berry Consultants LLC has been collaborating with the Los Angeles County Department of Health Services to develop COVID-19 hospital demand modeling projections, utilizing an SEIR epidemiologic model to predict hospital needs and assess the impact of physical distancing measures, with their findings prominently featured in various media outlets.
LA County COVID-19 Modeling Presentation
The Los Angeles County Department of Health Services has released a COVID-19 hospital demand modeling presentation, with assistance from Berry Consultants, along with a complete press release available online.
REMAP-CAP Study: Rationale and Design
Berry Consultants and the international REMAP-CAP team detail the Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia (REMAP-CAP) study in a manuscript published in the Annals of the American Thoracic Society.
REMAP-CAP Trial's latest information
Visit REMAPCAP.org for the latest updates and responses from the REMAP-CAP Trial regarding the COVID-19 pandemic.
2019 JSM in Denver, Colorado
Berry Consultants will sponsor and host an exhibit booth at the American Statistical Association's Joint Statistical Meetings in Denver from July 27 to August 1, 2019, where they will also present in various sessions.
New Materials Released for the NHLBI ICTR Project
Berry Consultants has launched a series of informative videos and webinars on clinical trial topics, including disease progression modeling and innovative designs, available on the ICTR website, and invites readers to register for updates and share feedback.
Upcoming NHLBI ICTR Webinar, September 20, 2018
In a public webinar on September 20, 2018, Berry Consultants' Kert Viele will explore the key components and trade-offs of gold standard randomized clinical trials versus innovative trial designs, discussing techniques such as flexible sample sizes and novel endpoints.
ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
Berry Consultants will prominently participate in the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop in Washington, D.C. from September 12-14, 2018, with team members Scott Berry, Melanie Quintana, and Tom Parke presenting on various innovative topics related to clinical trial designs.
2018 JSM in Vancouver
Berry Consultants will sponsor the Joint Statistical Meetings in Vancouver from July 28 to August 2, showcasing their new software FACTS 6.2 and QUOTES at exhibit booth #324, while also participating in various sessions throughout the event.
The Release of FACTS 6.1 Software
Berry Consultants is excited to announce the release of FACTS 6.1, which introduces new Dose Escalation simulation types, enhanced functionality with 'Design Variants' across all FACTS engines, and maintains full compatibility with previous versions, making it easier to estimate sample sizes and analyze trial outcomes.
Berry Consultants Welcomes New Clinical Trial Strategy Team
Berry Consultants has launched a Clinical Trial Strategy Team, led by Dr. Meredith Buxton and Dr. Melissa Paoloni, to enhance the design and implementation of innovative platform and adaptive clinical trials across all therapeutic areas, aiming to advance precision medicine through expert guidance and comprehensive services.
ARLG ADAPT Platform Trial Public Meeting
Duke Clinical Research Institute is hosting a public meeting on December 7th from 9am-3pm to discuss the results of the NIH-funded ADAPT project, which aims to create a more efficient and cost-effective clinical trial design for testing new antibiotics against highly resistant bacterial pathogens.
CTTI's New Recommendations for Data Monitoring Committees
The Clinical Trials Transformation Initiative (CTTI) has released new recommendations and best practices for Data Monitoring Committees (DMCs), with contributions from Berry Consultants' Dr. Roger Lewis and Dr. Jason Connor.
2016 JSM in Chicago
Berry Consultants will prominently sponsor and participate in the Joint Statistical Meetings (JSM) from July 30 to August 4 in Chicago, featuring an exhibit booth (#529) and various sessions, inviting attendees to meet the team.
2015 JSM in Seattle
Berry Consultants is sponsoring the Joint Statistical Meetings (JSM) from August 8-13 in Seattle, where they will host an exhibit booth (#533) and have team members presenting, with more details available in the provided summary.
Energy & Commerce Committee releases document for better and faster cures
The House Energy and Commerce Committee has released a discussion document proposing measures to accelerate cures in the U.S., focusing on modernizing clinical trials through Bayesian statistics and adaptive trial designs.
Dr. Donald Berry named amongst Thomson Reuters Highly Cited Researchers
Dr. Donald Berry has been recognized as one of Thomson Reuters' Highly Cited Researchers in Clinical Medicine, ranking among the top 1% for most cited documents, and is also listed in "The World's Most Influential Scientific Minds: 2014."
Berry Consultants a lead partner for the EPAD Initiative
The European Prevention of Alzheimer’s Dementia (EPAD) Initiative, involving 35 partners from industry and academia, aims to collaboratively research and test innovative treatments to prevent Alzheimer’s dementia by establishing a European-wide register of 24,000 participants over five years.
2014 ASA Biopharmaceutical Section FDA-Industry Workshop
Berry Consultants will actively participate in the 2014 ASA Biopharmaceutical Section FDA-Industry Statistics Workshop in Washington D.C. from September 22-24, with team members Jason Connor, Kert Viele, and Scott Berry presenting on topics including comparative effectiveness, historical borrowing in clinical trials, and trial simulation for adaptive designs.
2014 JSM in Boston
Berry Consultants will prominently sponsor and participate in the Joint Statistical Meetings (JSM) from August 2-7 in Boston, featuring an exhibit booth (#118) and various sessions, inviting attendees to meet their team.
Congratulations to Dr. Jason Connor - Appointed to Clinical Trial Advisory Panel
Dr. Jason Connor, Director & Senior Statistical Scientist at Berry Consultants, has been selected as one of ten members of The Patient-Centered Outcomes Research Institute's Advisory Panel on Clinical Trials.
Upcoming June 2014 Conference Presentations by Kristine Broglio
Kristine Broglio, Statistical Scientist for Berry Consultants, will present at two conferences in June 2014: the ISPOR 19th Annual International Meeting on May 31-June 4, discussing "Determining Comparative Effectiveness Benchmarks for Emerging Treatments for Hepatitis C Virus," and the DIA 2014 50th Annual Meeting on June 15-19.
Berry Consultants Acquires FACTS
Berry Consultants has acquired full ownership of the FACTS clinical trial simulation software from Tessella, enhancing its capabilities in designing advanced clinical trials while Tessella will continue to provide IT support during the transition.
Berry Consultants in the News
Our News & Events section now features two new articles on adaptive design for trials, including "Adaptive Clinical Design Addresses the Uncertainties" and "How Math Can Improve Drug Trials and Save Lives," with direct links available.
Upcoming 2014 Conferences in London
Berry Consultants will present at two London conferences in 2014: "Adaptive Designs in Clinical Trials" on March 24-25 featuring Dr. Roger Lewis, and "Smart Trials 2014" on April 9-10 with Anna McGlothlin, focusing on innovative approaches in clinical development.
JSM 2013, August 3-8
Berry Consultants will sponsor and host an exhibit booth at the Joint Statistical Meetings (JSM) in Montreal from August 3-8, 2013, where team members will participate in various sessions, with more details available on their website.
Upcoming Transforming Drug Development Conference
Berry Consultants is co-sponsoring the "Transforming Drug Development" conference on October 22nd in Bethesda, Maryland, featuring key presentations from team members on adaptive clinical trials, and interested attendees can register at http://www.InnovationsInClinicalTrials.com/.
Upcoming April 2013 Events
In April, Berry Consultants will participate in several events, including conferences and webinars on adaptive designs and comparative effectiveness trials, taking place in London, Bethesda, and Arlington.
Upcoming Transforming Drug Development Conference
Berry Consultants is co-sponsoring the "Transforming Drug Development" conference on October 22nd in Bethesda, Maryland, featuring key presentations from team members on adaptive clinical trials, and interested attendees can register at http://www.InnovationsInClinicalTrials.com/.