Negotiating with Industry: What They Want vs. What We Need

Transcription

1 Negotiating with Industry: What They Want vs. What We Need Presented At: Massachusetts General Hospital October 19, 2017 Presented By: Partners Clinical Trials Office Maureen Lawton, Pharm.D., J.D. Michael Canova, J.D.

2 Introduction Description of the Clinical Trials Office ( CTO ) Other Teams with Contract Responsibilities Conflicts of Interest Academic & Industry Perspectives Conclusion & Questions

3 CTO Responsibilities The CTO negotiates corporate sponsored clinical research contracts with Partners-affiliated institutions. Agreement Associates review and negotiate: Clinical Trial Agreements Confidentiality Agreements Services Agreements Clinical Research Support Agreements Research Collaboration Agreements (e.g., biomarker analysis) ARO Agreements (TIMI,CTNI, NCRI) Amendments Research Gifts Financial Analysts are responsible for: Budget review, negotiation, approval and fund activation Petition Medicare for Pre-Approval of Category B Device Trials Medicare Coverage Analysis (MCAs)

4 Other Teams That Handle Contracts Innovation Reviews and negotiates agreements involving basic bench research (non-human, pre-clinical) Sponsored Research Agreements, Licensing Agreements, Option Agreements, Confidentiality Agreements, Material Transfer Agreements, and Amendments Research Management Reviews and negotiates agreements for government, non-profit, and foundation-funded research (i.e. NIH grants) Development Office When a sponsor gives a gift to the hospital or a department; contact the Development Office

5 Other Teams That Handle Contracts Supply Chain (formerly Materials Management) Reviews contracts when the Institution purchases equipment as part of sponsored research Reviews and negotiates procurement agreements (Partners is making payment) Office of General Counsel Negotiates and reviews contracts that require senior management authorization; performs all legal work arising from the activities of Partners and its affiliated entities Office of Interactions with Industry (OII) handles personal consulting agreements Outside Counsel Litigation, Patents, etc.

6 Conflicts of Interest Academic-Industry relationships are essential to our mission, but may introduce bias and undermine public trust These relationships must be fully disclosed, reviewed, and appropriately managed Partners Commission on Interactions with Industry Recommendations took effect on October 1, 2009 Resources: OII Website Compliance Officers at each Institution

7 Conflicts of Interest Equity in Company Consulting for Company Not allowed (1a) Allowed, but must be less than $25,000/yr

8 Recent Developments: The Sunshine Act Physician Payment Sunshine Act Effective August 1, 2013 Requires manufacturers of drugs, biologics, and medical devices to report transfers of value over $10 made to physicians and teaching hospitals Direct and indirect payments ( in-kind transfers) Royalty and equity payments Aims to decrease improper influence on research, education, and clinical decision making as a result of payments from manufacturers Transfers of Value in Support of Research: Reporting of research payments may be delayed due to clinical investigational status of product Request that payments be reported as research payments made to the institution Provides for fines for industry non-compliance

9 Recent Developments: Anti-Bribery/Anti-Corruption The US Foreign Corrupt Practices Act (FCPA) prohibits bribery of government employees, public officials, or a political party for the purpose of obtaining, directing, or retaining business or securing an unfair advantage Recordkeeping Provision--to prevent the concealment of bribes Government employee: any person who receives any part of his or her salary from the government; includes educators or others at government-run universities any other person who performs a governmental function with or without pay Provides for criminal and civil penalties, including fines and prison time

10 Clinical Trials vs. Basic Research Industry-funded Basic Research: Pre-clinical or non-clinical research Advances fundamental knowledge May lead to clinical research Industry-funded Clinical Trials: Designed to contribute to the science around a compound or technology Focus on safety and/or efficacy of drugs, devices, or methods to prevent, diagnose, or treat disease Prospective recruitment of human subjects

11 Company-Initiated vs. Investigator-Initiated Clinical Trials Company-Initiated Clinical Trials: Company wrote the Protocol Study of Company s drug or device Company owns the data/results and IP Investigator-Initiated Clinical Trials: Investigator wrote the Protocol Usually a Phase IV study of Company s product Institution owns data/results and IP not directly related to Company s product

12 Academic Site Priorities The Academic Site wants: To protect the rights of the Patient, Investigator, and Institution To improve patient care A well-managed trial Data integrity Cover costs Dissemination of data and publication of results Indemnification and subject injury coverage

13 Industry Priorities Industry wants: Protection of the Company s confidential information and IP To improve patient care A well-managed trial Data integrity Manage costs Dissemination of data and publication of results To limit indemnification and subject injury obligations Product improvement to maximize profits

14 Four Contentious Contract Issues Intellectual Property Publication Indemnification Subject Injury

15 Intellectual Property Academic Perspective Each party owns its pre-existing IP Company-Initiated Clinical Trials: Company owns what is generated in the performance of the Protocol Trial data/results Discoveries, developments or inventions ( Inventions ) Academic Site assigns Inventions to Company Academic Site retains right to use Trial data/results and any Invention for its internal, non-commercial research and education purposes Investigator-Initiated Clinical Trials: Academic Site owns Trial data/results Academic Site retain rights to all Inventions not directly related to Company s product

16 Intellectual Property Industry Perspective Company must protect its investments in its compound/technology Company-Initiated Clinical Trials: Company owns IP because Company developed, owns, and paid for all aspects of protocol execution Investigator-Initiated Clinical Trials: Company owns IP related to Company s product Company retains an option to negotiate an exclusive license to use IP not related to Company s product

17 Publication Academic Perspective Necessary for the Academic Site to fulfill its academic mission Disseminate unbiased information for public good in a timely manner Disclose research results Preserve tax-exempt status

18 Elements of Publication Publish methods, data, and results If Company-initiated, multi-site clinical trial, then Academic Site requires the right to publish its individual results by some data certain (usually 12 to 24 months after conclusion of the trial) Company granted initial review period to review and comment on proposed publications (usually 30 days for manuscripts and 14 days for abstracts) Additional delay, if requested, to protect IP, but total delay may not exceed 120 days No editorial control by Company except for deletion of Confidential Information and IP

19 Publications Industry Perspective Company-Initiated Clinical Trials: As trial sponsor, Company is responsible for ensuring accuracy of data Company owns data and can use for its own publication purposes Company-initiated, multi-center studies: Company plays role in determining if and when there will be multi-center publication Company is committed to sharing meaningful results of controlled trials with the medical community in a timely manner; posting requirements (clinicaltrials.gov) Company has right to review any data disclosures to protect its confidential information

20 Indemnification Academic Perspective When a third party asserts a claim against the Academic Site or Company Company-Initiated Clinical Trials: Company indemnifies Academic Site for injuries arising from subject s participation in the trial Company provides indemnification in consideration for Academic Site conducting the trial Investigator-Initiated Clinical Trials: Remain silent Indemnification commitment waives statutory charitable cap

21 Exceptions to Indemnification Company s obligation shall not apply to the extent that Principal Investigator and/or Academic Site: Failed to follow the protocol or written instructions, unless deviation is to protect the safety of subject; Failed to comply with applicable laws or regulations; or Acted in negligent or reckless manner.

22 Indemnification Industry Perspective Company wants Academic Site to indemnify, defend and hold harmless the Company for the Academic Site s willful misconduct, negligence, and/or intentional acts because it is not possible for Company to prevent such acts Company is willing to indemnify, defend, and hold harmless the Academic Site for injuries to patients resulting from the Company s protocol Industry will typically ask for indemnification commitment from Academic Site in Investigator-Initiated Clinical Trials

23 Subject Injury Academic Perspective Company-Initiated Clinical Trial: Company agrees to pay Academic Site (or otherwise pay) for the costs of diagnosis and treatment of any injury or illness to a patient caused by the trial Exceptions: no payment to the extent injury caused by Academic Site s negligence, willful malfeasance, or failure to follow protocol Investigator-Initiated Clinical Trial: Seek subject injury commitment to the extent the injury is caused by defect in Company s drug or device

24 Subject Injury Industry Perspective Appropriate to provide reasonable medical treatment when a patient is injured as a direct result of the Company s drug or device or protocol treatment which the patient would not have undergone in usual clinical practice Not responsible for injuries due to standard of care treatment Not responsible for subject fault, e.g., failure to follow directions

25 Overview of CTO s Agreement Process Presently, all new CTAs and CRSAs must be entered in InfoEd PD: Components: Agreement, Protocol, PIQ, and Cover Sheet Principal Investigator s Questionnaire (PIQ): Documents characteristics of study, e.g., study design, PI- or Company-initiated, provision of equipment, export control questions Conflict of interest questions After all documents received through PD, Agreement Associate & Financial Analyst negotiate Agreement and Budget Will seek input from PI on various contract and budget issues Agreement Associates work closely with Financial Analyst on budget development and negotiation

26 Conclusion Contact the CTO when you are engaged in or have questions about corporate sponsored or funded clinical research. Questions?