Register Now • 888-224-2480 • AmericanConference.com/ClinicalTrials Earn CLE ETHICS Credits Clinical Trials Ensuring Safe and Compliant Domestic and International Clinical Trials American Conference Institute’s 14 th Advanced Summit on Current and former government regulators and enforcers unite with preeminent biopharmaceutical and medical device experts to give you the practical tools to: • UNDERSTAND FDA’s current clinical trials enforcement priorities to minimize potential for warning letters stemming from post-marketing studies and investigator reporting • PINPOINT common clinical trial activities which may raise a red flag to enforcers and prepare for continued intense DOJ scrutiny • MINIMIZE FCPA and anti-corruption risks and enhance human subject protection when conducting international clinical trials • SIMPLIFY the informed consent process to be in accordance with good clinical practices (GCPs) when recruiting trial subjects • GUARD against litigation risks and class actions stemming from clinical studies through careful trial design • AVOID common pitfalls when disclosing clinical trials results and working within the bounds of FDAAA and Sunshine • IMPROVE conflict of interest disclosure and management when working with independent review boards (IRBs) • REVAMP corporate social media policies to minimize liability while expanding your trial’s online presence • CONDUCT safe and effective biosimilars clinical trials Plus TWO interactive half-day sessions designed to give you the edge in designing and conducting clinical trials A. Pre-Conference Workshop A: The Nuts-and-Bolts of Structuring and Carrying Out Large Scale International Clinical Trials B. Device Manufacturers’ Working Group Session: Clinical Trials for Medical Device Companies Benefit from direct FDA and DOJ insight into structuring and conducting compliant clinical trials: Karena Cooper Senior Counsel Office of Regulatory Policy (ORP), CDER Food and Drug Administration (FDA) Mary E. Crawley AUSA Eastern District of Pennsylvania Network with an exceptional faculty of industry experts including: Abbott Laboratories Duke University School of Medicine GE Healthcare Emory University Endo Pharmaceuticals Hospital Corporation of America Johnson & Johnson The Medicines Company MedStar Health Mitsubishi Tanabe Novartis Institutes for BioMedical Research Prometheus Laboratories Rigel Pharmaceuticals University of California, Davis University of Pennsylvania Vidox Willis And many more… July 17 – 18, 2012 | Omni Parker House | Boston, MA Media Partners:
Transcript
Register Now • 888-224-2480 • AmericanConference.com/ClinicalTrials
EarnCLE
ETHICSCredits
Clinical TrialsEnsuring Safe and Compliant Domestic and International Clinical Trials
American Conference Institute’s 14th Advanced Summit on
Current and former government regulators and enforcers unite with preeminent biopharmaceutical and medical device experts to give you the practical tools to:
• UNDERSTAND FDA’s current clinical trials enforcement priorities to minimize potential for warning letters stemming from post-marketing studies and investigator reporting
• PINPOINT common clinical trial activities which may raise a red flag to enforcers and prepare for continued intense DOJ scrutiny
• MINIMIZE FCPA and anti-corruption risks and enhance human subject protection when conducting international clinical trials
• SIMPLIFY the informed consent process to be in accordance with good clinical practices (GCPs) when recruiting trial subjects
• GUARD against litigation risks and class actions stemming from clinical studies through careful trial design
• AVOID common pitfalls when disclosing clinical trials results and working within the bounds of FDAAA and Sunshine
• IMPROVE conflict of interest disclosure and management when working with independent review boards (IRBs)
• REVAMP corporate social media policies to minimize liability while expanding your trial’s online presence
• CONDUCT safe and effective biosimilars clinical trials
Plus TWO interactive half-day sessions designed to give you the edge in designing and conducting clinical trials
A. Pre-Conference Workshop A: The Nuts-and-Bolts of Structuring and Carrying Out Large Scale International Clinical Trials
B. Device Manufacturers’ Working Group Session: Clinical Trials for Medical Device Companies
Benefit from direct FDA and DOJ insight into structuring and conducting compliant clinical trials:
Karena CooperSenior CounselOffice of Regulatory Policy (ORP), CDERFood and Drug Administration (FDA)
Mary E. CrawleyAUSAEastern District of Pennsylvania
Network with an exceptional faculty of industry experts including:
Abbott Laboratories Duke University School of MedicineGE HealthcareEmory UniversityEndo PharmaceuticalsHospital Corporation of AmericaJohnson & JohnsonThe Medicines CompanyMedStar HealthMitsubishi TanabeNovartis Institutes for BioMedical ResearchPrometheus Laboratories Rigel PharmaceuticalsUniversity of California, DavisUniversity of PennsylvaniaVidoxWillisAnd many more…
July 17 – 18, 2012 | Omni Parker House | Boston, MA
Media Partners:
WHO YOU WILL MEET
• Pharma, Medical Device
and Biotech companies:
– General Counsel
– Regulatory Aff airs
– Director of Clinical Research
– Scientifi c Aff airs
– Compliance Offi cers
– QA/QC Directors
• Clinical Researchers
• Members of IRBs
• CROs
– Counsel
– Regulatory Aff airs
– Scientifi c Aff airs
• Hospitals and Research
Institutions
• Products Liability Attorneys
• Health Care Attorneys
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education
requirements. Th is course is identifi ed as nontransitional for the purposes of CLE accreditation.
ACI certifi es that the activity has been approved for CLE credit by the New York State Continuing Legal Education Board in the amount of 15.0 hours, of which 1.0 will apply to Ethics. An additional 4.0 credit hours will apply to workshop A participation and 3.5 credit hours will apply to workshop B participation.
ACI certifi es that this activity has been approved for CLE credit by the State Bar of California in the amount of 12.75 hours, of which 1.0 will apply to Ethics. An additional 3.5 credit hours will apply to workshop A participation and 3.0 credit hours will apply to workshop B participation.
You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processed in 4-8 weeks aft er a conference is held.
ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every eff ort to process your request.
Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/CLE
The FDA recognizes that there have been “dramatic changes” in how clinical trials are conducted and monitored.
Modernize your company’s policies and protocols to place your company at the forefront of the quickly evolving clinical trials landscape
In the last year, between the issuance of fi nal and proposed regulations on clinical trials conduct and unprecedented government and public scrutiny of trials, structuring and conducting safe and compliant clinical trials has never been a more diffi cult task. Undoubtedly, there will be even more challenges and new demands on even the most seasoned clinical trials professionals in the months to come. In light of the complexity facing the clinical trials world, ACI’s 14th Advanced Forum on Clinical Trials provides a comprehensive forum for the key stakeholders — current and former government enforcers, top in-house counsel from sponsor biopharmaceutical and medical device companies, CROS, hospitals, universities, and research institutions — to unite and share best practices when structuring a safe and compliant clinical trials program which maximizes data integrity and human subject protection.
More is at stake than ever with record-breaking fi nes and criminal and civil liability.
Th e continued and steady stream of high-profi le investigations into biopharmaceutical and device companies’ clinical studies data integrity makes it abundantly clear that it is imperative to have triage plans in place to weather the storm of criminal and civil liability stemming from clinical trial research.
Successful clinical trials are essential to a company’s pipeline and market share. Attendees of this event will:
Hear directly from the FDA and DOJ and several former federal prosecutors on how to guard proactively against impermissible behavior during a clinical trial
Heighten patient protection throughout your clinical trials by learning inside compliance tips and strategies from counsel from Hospital Corporation of America, University of Pennsylvania, and more…
Facilitate drug approval and protect market share as you share best practices with the experts who already have put established large-scale trials together including representatives from Abbott Laboratories, GE Healthcare, Johnson & Johnson, Th e Medicines Company, Prometheus Laboratories, Rigel Pharmaceuticals and more…
Gain insider tips to ensure compliance, minimize liability, and adhere to good clinical practices when conducting clinical trials domestically and internationally in the face of new developments with informed consent, post-marketing studies, risk-based monitoring
Find out best practices for keeping up to date with numerous scientifi c and technical advances including the cultural permeation of social media and the reality of biosimilar clinical trials
Over the years, previous attendees have demanded even more in-depth information on the logistical and practical challenges of running a trial, so this year we are pleased to present two highly in-depth sessions run by practitioners in the trenches: Th e Nuts-and-Bolts of Structuring and Carrying Out Large Scale International Clinical Trials and Clinical Trials for Medical Device Companies.
Don’t hesitate- streamlined and safe clinical trials are crucial to the continued success of your company. Call 888-224-2480, fax your registration form to 877-927-1563 or register on-line at www.AmericanConference.com/ClinicalTrials to ensure that you have a spot among your peers at this summit of the leaders in the clinical trials industry.
Earn
CLECredits
Each year more than 21,000 in-house counsel, attorneys in private practice and other senior executives participate in ACI events – and the numbers keep growing.
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Unparalleled Learning and Networking
ACI understands that gaining perspectives from – and building relationships with – your fellow delegates during the breaks can be just as valuable as the structured conference sessions. ACI strives to make both the formal and informal aspects of your conference as productive as possible.
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As a member of our sponsorship faculty, your organization will be deemed as a partner. We will work closely with your organization to create the perfect business development solution catered exclusively to the needs of your practice group, business line or corporation.
For more information about this program or our global portfolio of events, please contact:
Wendy Tyler Head of Sales, American Conference InstituteTel: 212-352-3220 x5242 | Fax: 212-220-4281 [email protected]
Global Sponsorship Opportunities
The Nuts-and-Bolts of Structuring and Carrying Out Large Scale International Clinical Trials
Preventing delays in start dates through a global •controlled master program
Determining where to locate the trial –What are the drop-dead dates for starting the trial? –
Getting beyond the clinical trial agreement: handling •the somewhat voluminous paperwork necessary to get a clinical trial up and running
Negotiating IRB and site agreements –Negotiating data agreements –Negotiating EU representative agreements in –international clinical trials
Putting compliance and training mechanisms in place •to avoid FDA and FCPA enforcement when working with subcontractors and vendors Finding and recruiting required numbers of patients •with adequate health profi le at reasonable costEnsuring data privacy under HIPPA: Protecting the •security of protected health information (PHI) in the digital age
Abiding by the new EU data privacy directive –Managing recordkeeping including clinical trial –registries and study data
Including key insurance provisions and essential •contractual indemnity to minimize liability when conducting clinical trials
Complying with disparate insurance requirements: –a country-by-country guide to what sponsors must have in place
Working with CROs in designing, implementing and •managing clinical trials
Negotiating with CROs when contracting with sites, –investigators, and vendorsDoing more with less resources: a look at the business –basics in vendor/CRO relationshipsManaging expectations in advance in order to protect –parties’ respective rights in the contractWho has access to the results? –Who ultimately bears the responsibility for errors? –
Th is workshop aims to give practitioners in the trenches the crucial information necessary to combat logistical and practical problems inherent in being responsible for organization and execution of large-scale clinical trials.
PRE‐CONFERENCE PRIMER Monday, July 16, 2012 | 1:30 pm – 5:00 pm (Registration begins at 1:00 pm)
Harvey J. Altman, Ph.D. Executive Director and Head, Clinical OperationsMitsubishi Tanabe Pharma Development America, Inc. (Warren, NJ)J. Benneville (Ben) HaasPartnerLatham & Watkins LLP (Washington, DC)
Marialuisa S. Gallozzi PartnerCovington & Burling LLP (Washington, DC)David E. Shuey, ARMNorth America Practice Leader — Life SciencesWillis (Radnor, PA)
Whether you are new to clinical trials or need a refresher, this course will give you the practical knowledge necessary to combat the logistical diffi culty in organizing large-scale operations and master the myriad of rules and requirements associated with running clinical trials across multiple jurisdictions. In this highly interactive guided pre-conference workshop, hear expert practitioners give concrete and practical tips to get clinical trials up and running smoothly, quickly, and most importantly, successfully. Get a jump-start on the issues that will be addressed in even greater depth throughout the conference such as:
J. Benneville (Ben) HaasPartnerLatham & Watkins LLP (Washington, DC)Priya Mannan JD LLMExecutive DirectorAssociate General Counsel & Global Compliance Offi cerNovartis Institutes for BioMedical Research, Inc.(Cambridge, MA)
8:30 Maintaining FDA Audit Readiness: Compliance in Post-Marketing Studies, Investigator Reporting and Beyond
Karena Cooper, J.D., M.S.W. Acting Associate Director of Policy and Communication and Regulatory CounselOffi ce of Scientifi c Investigations (OSI), CDERUnited Stated Food and Drug Administration (FDA) (Silver Spring, MD)Katherine O’BrienCounselAbbott Laboratories (Chicago, IL)Maria Kennedy Assistant General CounselOffi ce of the General Counsel Johnson & Johnson (New Brunswick, NJ)
Exercise of FDA’s authority to enforce requirements •that sponsors conduct FDCA Section 505(o)(3) postmarket studies and clinical trials
FDA/CDER’s February 2012 Notice to Industry –FDA/CDER Warning Letter citing sponsor for –noncompliance with FDCA Section 505(o)(3) postmarketing requirement
FDA’s draft guidance on risk-based approaches •to monitoring clinical investigationsDemonstrating your compliance initiatives in managing •relationships and record keeping and responding to warning letters about your clinical investigations
9:45 Morning Networking Break
10:00 Promoting Transparency in Clinical Trials: Bracing for the Dual Impact of Sunshine and FDAAA on Disclosure and Reporting
Christopher EliopulosAssociate General Counsel GE Healthcare (Wauwatosa, WI)Robyn S. Shapiro PartnerDrinker Biddle & Reath LLP (Milwaukee, WI)
Exploring the diffi culties in complying with clinical trial •results disclosure requirements
Determining who is a responsible party for reporting –under FDAAA rulesDetermining and complying with ICMJE clinical trial –disclosure requirements
Determining and complying with state clinical trial –result disclosure requirementsSetting a timeline for results disclosure –Adopting audit and monitoring processes for –results posting
Exploring the diffi culties in complying with payment •disclosure requirements
Preparing for large-scale reporting of payments –to healthcare professionals under the Sunshine Act
When must you report a clinical trial payment •to a physician or investigator?Creating a consistent system to track the myriad •payments to healthcare providers during a trial in order to track potential confl ictsWho in your organization is responsible •for reporting?Avoiding the auspices of impropriety when •disclosing payments to physicians and investigators
Determining when to report payments to physicians –under the particular challenges of Massachusetts, Vermont and Maine state lawsReconciling varying and sometimes confl icting –state law disclosure requirements regarding payments made during clinical trialsComplying with NIH Final Rule disclosure –requirements and lowered monetary threshold
11:15 Complying with Revamped FDA Confl icts of Interest Guidance When Selecting and Working with Independent Review Boards
Angelique P. Dorsey, J.D., CHRC Research Compliance DirectorMedStar Health (Columbia, Maryland)
Preparing for continuing IRB review post-clinical trial •approval in keeping with the FDA’s fi nal guidance post-clinical investigation approval
What will be required from sponsors and researchers –in terms of criteria and frequency of post-approval review? When will expedited review be possible? –Communicating with IRBs throughout the continuing –review period
Exploring potential red fl ags for enforcement: an overview •of recent FDA warning letters to IRBs
Properly and thoroughly vetting potential IRBs –Examining the trend towards for-profi t IRBs –How are independent and for-profi t IRBs taking steps –to reduce confl ict?
Complying with the lowered NIH monetary threshold •for investigator confl icts of interest disclosure
Determining when to disclose a potential confl ict –Ascertaining and diff erentiating between actual and –perceived fi nancial confl icts of interest when working with IRBs
What is considered fair market value when compensating •IRBs?Arguing against the appearance of impropriety when •working with one IRB on many studiesObtaining AAHRP accreditation for an IRB •
1:45 Identifying Potential High-Risk Areas to Minimize Future Products Liability Stemming from Clinical Trials
Loren H. Brown PartnerDLA Piper (New York, NY)Charlene A. Gallagher PrincipalGallagher Consulting (Philadelphia, PA)
Limiting litigation exposure: what can sponsors do •to protect themselves during their clinical trial to avoid product liability later?
Assessing potential product liability when analyzing –reported adverse events during a clinical trialWill the fi nancial interest of doctors conducting –the study withstand a close look?Strategies for defeating failure to warn cases premised –on clinical trials data
Examining the trend of subpoenaing clinical trial records •for products liability causes of action
Discovery in the electronic age: how to best structure –your emails and prepare CR&D staff to anticipate such review
Potential exposure arising out of globalization of clinical •trials — current trendsCombating a PR nightmare in the case of a clinical trial •incident or scenerioMonitoring the safety of study participants: structuring •and facilitating oversight of and communication with CROs and sites
Brian J. MalkinPartnerFrommer Lawrence & Haug LLP (New York, NY)
How will FDA take “a selective and targeted approach” •to requiring clinical trials?
How much and what kind of data should prudent –companies generate and include?
Demonstrating biosimilarity: what will the FDA require •from trials?
Extrapolating data obtained in clinical trials for –a reference product to support biosimilar applications Relying on clinical trial data provided by ex-U.S. –companies for comparator products
Evaluating the potential for citizens’ suits when evaluating •safety and effi cacy for complex and multifaceted molecules Biosimilar reviews: anticipating what’s new in the clinical •trials arena and what is familiar
How FDA will review a 351(k) submission? –Following a hypothetical 351(k) submission –
Framing the risks and benefi ts in this nascent area •
3:30 Afternoon Refreshment Break
3:45 Working with Academic Medical Centers on Clinical Trial Agreements
Andrew JonesClinical Trials Contracts Analyst, Health System ContractsUniversity of California, Davis (Sacramento, CA)
S. David McLean, Jr.Associate General Counsel, Offi ce of the General CounselEmory University (Atlanta, GA)Adam P. Rifk indAssociate Director, Pre-awardOffi ce of Research ServicesUniversity of Pennsylvania (Philadelphia, PA)H. Gilbert Smith, Ph.DAssociate Dean & Managing DirectorOffi ce of Corporate Research CollaborationsDuke University School of Medicine (Durham, NC)
Understanding the diff ering missions and goals between •industry and academiaFactoring in universities’ charitable and academic missions •Safeguarding IP protection and ownership rights for data •gathered during clinical trials
Understanding the obligations of a non-profi t under –the Internal Revenue CodeStructuring your clinical trial agreement so that –ownership of intellectual property is clearAllocating data ownership and use rights –Addressing ownership and access to biological samples –Disposition of rights to inventions –Considerations around publication –
Negotiating confi dentiality agreements for potential •principal investigators to review the protocol to determine whether to participate in the clinical trial
5:15 Conference Adjourns to Day 2
DAY TWO: Wednesday, July 18, 2012
8:00 Continental Breakfast
8:45 Co-Chairs’ Opening Remarks and Recap of Day 1
9:00 DOJ Enforcement Spotlight: Steering Clear of Corporate and Individual Liability When Conducting Clinical Trials in an Era of Heightened Scrutiny
Mary E. CrawleyAssistant United States AttorneyEastern District of Pennsylvania (Philadelphia, PA)Deborah A. Logan, Esq. Sr. Counsel, Research & DevelopmentEndo Pharmaceuticals Inc. (Chadds Ford, PA)
Anticipating which activities during a clinical trial may •raise a red fl ag to enforcers based on recent investigations
Failing to report adverse events during a trial –Falsifi cation of clinical trial data in new drug –applications (NDAs)Falsifying medical research –Engaging in promotional activities relating to –the clinical trialKickbacks to clinical trials investigators –
Examining the incentive for whistleblowers suits •in the pharmaceutical and biotech industryExamining the trend towards individual rather than •corporate accountability
Subcontractors’ and investigators’ potential liability –
Exploring prosecutorial tools to pursue False Claims •Act liability for wrongful conduct in connection with clinical trialsWhen does a misstatement of clinical trial data about •the effi cacy of a drug for off -label use become criminal?
How does this intersect with First Amendment –rights post Sorrell & Coronia?
Implementing compliance plans to guard against •corporate and individual liability
Training employees and contractors about the –ins-and-outs of compliance with good clinical practices Coordinating your legal, compliance and audit –departments to have internal investigation mechanisms in placeSelf-reporting of problem data –
10:00 Morning Coff ee Break
SPOTLIGHT SESSIONS: Conducting Clinical Trials Internationally: Protecting Human Subject and Data Integrity in Emerging and Established Markets
10:15 Minimizing Risk and Adhering to the FCPA Mandates when Conducting Clinical Trials Abroad Sergei Drapkin, MD, PhD, MBASenior DirectorVidox Consulting (Luxembourg, EU)Daniel KaufmanSenior DirectorGlobal Contracting and Business EthicsTh e Medicines Company (Parsippany, NJ)Steven S. MichaelsPartnerDebevoise & Plimpton LLP (New York, NY)
Complying with anti-corruption and anti-kickback •laws when running clinical trials in a state-owned economic sector
Identifying who may be considered a government offi cial –Increasing study enrollment while steering clear –of FCPA impropriety with the commonly accepted practice of referral payments to physiciansGiving gift s and adhering to culturally accepted –standards for politeness without violating anti-corruption laws
Including provisions in the clinical trial agreement •to structure funding and payments in accordance with FCPA requirementsStrengthening your compliance program when working •in high risk markets
Understanding the evolving regulatory framework –companies conducting clinical trials in emerging markets must abide with in:
Russia •India •China •Latin America •
Diligently monitoring CROs and other third parties –Overcoming the diffi culties inherent to performing •clinical trials in rural areas
Understanding cultural diff erences and obtaining –informed consent for women in traditionally patriarchal culture Recruiting patients in light of negative publicity –surrounding trials
11:30 Focus on Established Markets: Conducting Clinical Trials in the EU
Complying with revamped data protection laws •and privacy policies under the EU directive
Registering foreign trials –Appointing a legal representative to establish –a local presence
Communicating with both the FDA and the EMA when •monitoring foreign clinical trials to ensure that all required procedures are followed to protect data integrity
Avoiding duplicative eff orts in your disclosures –to both authoritiesUnderstanding the certain prospect of increased –monitoring and OIG oversight for trials conducted abroad
Working in countries with a robust anti-corruption •scheme in place
Examining the implications of the UK anti-bribery –statute in the clinical trials arenaDetermining whether parent companies or sister –affi liates will be covered under the UK Bribery Act if they have matrix organizations
Understanding the individual country requirements •when conducting trials in the EU
Update on new regulatory developments aff ecting –clinical trials in the EUCoordinating trials and understanding timelines –in multiple EU countries concurrently
12:15 Networking Luncheon
1:30 Understanding the Nuances of Medicare Secondary Payor Rules Relating to Injuries Arising out of Clinical Trials
Ryan D. MeadePartnerMeade & Roach LLP (Chicago, IL)Eve M. BruntsPartnerRopes & Gray LLP (Boston, MA)
Understanding how Medicare secondary payer rules apply •to research sponsors and clinical sites
What type of “injury” or “complication” triggers –the rules?What type of subject injury language can have –unintended consequences for clinical sites?
Reporting payments for subject injuries under new •reporting obligations
Who qualifi es as a responsible reporting entity (RRE) –to trigger the rules?What guidance has CMS provided on meeting RRE –obligations?
Incorporating subject injury language responsive •to Medicare MSP rules in clinical trial agreements and informed consent documents
What should research sponsors be doing to ensure –that clinical sites and subjects provide the information needed to meet obligations?
Device Manufacturers’ Working Group Session Thursday, July 19, 2012 | 9 am – 12 pm (Registration 8:30 am)
Clinical Trials for Medical Device Companies In this highly collaborative session exclusive to medical device manufacturers, attendees will have the unique opportunity to interact with their device peers and colleagues to apply the concepts learned over the past two days and delve more deeply into the specifi c concerns and challenges that arise during a medical device clinical trial. Points of discussion include:
Analyzing how changes to the 510(k) process and the •increased clinical studies therein will impact your current clinical trials procedures and protocolsExploring the EMA’s new approaches to clinical trials •for devices Defi ning the scope of permissible Medicare coverage •for subject injuries arising out of device trials
Mastering the CMS code system to meet technological –advances in invasive and non-invasive devices
Responding to CDRH’s increased post-market vigor •and avoiding fi nes and penalties through compliant post-market studies and policiesAddressing specifi c privacy and patient recruitment •concerns associated with device clinical trialsOverview of the international regulations, customs •and best practices relevant for medical devices in order to reduce risks and produce meaningful reliable date for marketing approvalIdentifying key provisions to include in the clinical trial •agreement that address the particular concerns of a device companyBest practices for managing a device clinical trial from •start to fi nish
2:30 “Friending” Your Clinical Study Subjects: Exploring Social Media as a Platform for Patient Recruitment
Maria D. BuckleyOf CounselNutter McClennen & Fish LLP (Boston, MA)Priya Mannan JD LLMExecutive DirectorAssociate General Counsel & Global Compliance Offi cerNovartis Institutes for BioMedical Research, Inc.(Cambridge, MA)
Utilizing Facebook and other social networking sites •to increase visibility of your trial and apply to a broader range of potential study subjects
What can you say without entering the realm –of marketing (on-label and off -label)?Weighing the eff ect of comments made on Facebook –group message boards regarding effi cacy of the drugShould this count as knowledge of adverse events? –
Factoring in FDA’s draft guidelines on responding •to unsolicited requests via social media
Using classifi ed ads on web sites to recruit participants –for clinical trialsAvoiding the perception of soliciting clinical trials –study subjects with coercion of payment
Exchanging ideas about using Twitter as a means •for recruitmentCreating a virtual presence and putting a comprehensive •social media policy for the trial
Using clinicaltrials.gov eff ectively to register both –the trial and the results under FDAAANavigating and utilizing the new NIH “Clinical Trials –and You” website Creating a policy about participants’ use of Facebook –and Twitter during the trial
3:30 Afternoon Refreshment Break
3:45 Complying with Good Clinical Practices When Conducting Clinical Trials: Informed Consent, Secondary Use of Data and Beyond
Adela C. Enochs-Ochoa Executive Director, Legal Rigel Pharmaceuticals, Inc. (San Francisco, CA)Jenny AlonsoSenior Director, Clinical Aff airs and Compliance Offi cerPrometheus Laboratories (San Diego, CA) David Vulcano, LCSW, MBA, CIP, RACAVP & Responsible Executive for Clinical ResearchHospital Corporation of America, Inc. (Nashville, TN)
Mitigating risk and minimizing exposure to liability •by properly obtaining informed consent
Beyond the form itself: understanding the process –of informed consentHow can sponsors protect themselves from risk –when not directly obtaining consent?Securing informed consent in traditionally patriarchal –and tribal culturesObtaining proper informed consent to facilitate –pediatric drug discovery
Pledging human subject protection and data validity •when conducting international clinical trials
Demonstrating drug effi cacy in a variety of treatment- –naïve ethnic populations and the ensuing benefi ts to your research and development pipelineUsing translation services for informed consent –forms: the importance of steering clear of meaningful diff erences in dialect
What risks do companies face if the consent is not •informed?Secondary use of specimens and data- what is legal •and what is ethical?
What is your obligation to identify or strip data –garnered in a clinical trial?
Identifying the rights of the clinical trial subject as •to biobanking and incidental fi ndings in clinical research in light of increased sophistication in genetic testing and unprecedented access to genetic material
What is your obligation to tell a subject that you have –made a fi nding incidental to research?If there is an obligation to disclose how long does –this last?
5:00 Main Conference Adjourns
R E G I S T R A T I O N F O R M
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Clinical TrialsEnsuring Safe and Compliant Domestic and International Clinical Trials
American Conference Institute’s 14th Advanced Summit on
July 17 – 18, 2012 | Omni Parker House | Boston, MAAbbott Laboratories
The Clinical Technology Transfer Group
Covington & Burling LLP
Debevoise & Plimpton
DLA Piper
Emory University
Endo Pharmaceuticals Inc.
Frommer Lawrence & Haug
Gallagher Consulting
GE Healthcare
Hospital Corporation of America
Johnson & Johnson
Latham & Watkins LLP
Meade & Roach
The Medicines Company
MedStar Health
Mitsubishi Tanabe
Novartis Institutes for BioMedical Research, Inc.
Nutter McClennen & Fish LLP
Prometheus Laboratories
Rigel Pharmaceuticals
Ropes & Gray LLP
University of California, Davis
University of Pennsylvania
Vidox
Willis
Hear from an unparalleled faculty of legal and regulatory clinical research professionals:
Registration FeeThe fee includes the conference‚ all program materials‚ continental breakfasts‚ lunches and refreshments.
Payment PolicyPayment must be received in full by the conference date. All discounts will be applied to the Conference Only fee (excluding add-ons), cannot be combined with any other offer, and must be paid in full at time of order. Group discounts available to individuals employed by the same organization.
Cancellation and Refund PolicyYou must notify us by email at least 48 hrs in advance if you wish to send a substitute participant. Delegates may not “share” a pass between multiple attendees without prior authorization. If you are unable to find a substitute, please notify American Conference Institute (ACI) in writing up to 10 days prior to the conference date and a credit voucher valid for 1 year will be issued to you for the full amount paid, redeemable against any other ACI conference. If you prefer, you may request a refund of fees paid less a 25% service charge. No credits or refunds will be given for cancellations received after 10 days prior to the conference date. ACI reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or other costs incurred by registrants. No liability is assumed by ACI for changes in program date‚ content‚ speakers‚ or venue.
Hotel InformationAmerican Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a preferential rate. Please contact the hotel directly and mention the “ACI-Clinical Trials” conference to receive this rate:Venue: Omni Parker House, BostonAddress: 60 School Street, Boston MA, 02108Reservations: (617) 227-8600 or (800) THE-OMNI
Incorrect Mailing InformationIf you would like us to change any of your details please fax the label on this brochure to our Database Administrator at 1-877-927-1563, or email [email protected].
