Daniel S. Lynch joined SpringWorks Therapeutics at launch in 2017 and is currently chairman of the board of directors. Since October 2007, Dan has served as executive chairman or board member for a number of private biopharmaceutical companies, including Stromedix (until its acquisition by Biogen Idec in February 2012), Translate Bio, Nimbus Discovery, Edimer Pharmaceuticals, Ember Therapeutics, Blueprint Medicines, and Sesen Bio. He also served on the board of directors of BIND Biosciences. Previously, Dan served as chief executive and chief financial officer of ImClone Systems Corporation, or ImClone. As ImClone’s chief executive officer, he led ImClone through a significant turnaround, helping to restore the company’s reputation and to secure FDA approval of ERBITUX (cetuximab), a novel cancer treatment. As its chief financial officer, Dan led negotiations to form the major partnership between ImClone and Bristol-Myers Squibb. Earlier in his career, Dan served in various financial positions at Bristol-Myers Squibb over a 15-year tenure. He served on the board of directors and the audit committee of U.S. Oncology for five years until December 2010, when it was acquired by McKesson.
Dan received his B.A. in mathematics from Wesleyan University and his MBA from the Darden Graduate School of Business Administration at the University of Virginia.
Chief Financial Officer, Amplyx Pharmaceuticals, Inc.
Alan Fuhrman is a member of the Board of Directors for Checkmate Pharmaceuticals. Alan served on the Board of Directors and as Chair of the Audit Committee for Loxo Oncology until its sale to Eli Lilly in the first quarter of 2019. He currently serves as the Chief Financial Officer of Amplyx Pharmaceuticals, Inc. Prior to joining Amplyx, he served as CFO of Mirna Therapeutics, a publicly traded, clinical-stage microRNA company that merged with Synlogic in August 2017. Alan previously served as CFO of Ambit Biosciences, where he helped lead the company through its initial public offering and oversaw financial, investor and administrative operations until its sale to Daiichi Sankyo in 2014. Earlier in his career, Alan practiced as a certified public accountant with Coopers & Lybrand. Alan received a B.S. in both Business Administration and Agricultural Economics from Montana State University.
Julie Hambleton, M.D.
Former Chief Medical Officer, IDEAYA Biosciences
Julie Hambleton, M.D. is a senior biotechnology executive with over 20 years of experience in clinical drug development. She served as Senior Vice President, Chief Medical Officer, Head of Development at IDEAYA Biosciences, an oncology medicine company, until her retirement on April 30, 2020. Previously, she was Vice President, Head of U.S. Medical at Bristol-Myers Squibb, overseeing Medical & Health Economic and Outcomes Research activities in support of the Oncology, Immuno-Oncology, Specialty and Cardiovascular marketed portfolios. Earlier, she served as Executive Vice President and Chief Medical Officer at Five Prime Therapeutics and Vice President, Clinical Development, at Clovis Oncology. Dr. Hambleton began her industry career at Genentech, most recently as Group Medical Director, Global Clinical Development, leading a cross-functional group conducting Phase 2 and 3 trials of Avastin®.
In addition, Dr. Hambleton serves as a Director on IGM Biosciences’ and Arch Oncology’s Board of Directors.
Dr. Hambleton completed her medical and hematology-oncology training at the University California, San Francisco, where she then served on faculty from 1993 to 2003. She received a B.S. from Duke University, and M.D. from Case Western Reserve University School of Medicine and was Board-certified in Hematology and Internal Medicine.
Saqib Islam, J.D.
Chief Executive Officer
Saqib Islam was appointed chief executive officer of SpringWorks Therapeutics in 2018. He was a founding member of the company’s executive team since its launch in 2017 and previously served as chief financial officer and chief business officer. Prior to joining SpringWorks Therapeutics, Saqib was chief business officer at Moderna Therapeutics, where he oversaw critical aspects of the company’s growth, including global strategic planning, corporate development and business development. Prior to joining Moderna, Saqib served as executive vice president, chief strategy and portfolio officer at Alexion Pharmaceuticals, executing the company’s corporate growth strategies and contributing to its assessment and management of global operations. Saqib has over 25 years of international business management experience and an extensive background in the healthcare banking sector, having held managing director positions in the investment banking divisions of Morgan Stanley and Credit Suisse Securities. He currently serves on the Board of Directors of Passage Bio, a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders with limited or no approved treatment options.
Saqib received his bachelor’s degree from McGill University, graduating as a Faculty and University Scholar, and a J.D. from Columbia Law School, where he was a Harlan Fiske Stone Scholar.
Freda Lewis-Hall, M.D., DFAPA
Former Chief Medical Officer, Pfizer
Freda Lewis-Hall served as executive vice president and chief patient officer at Pfizer. In this role, Freda worked to extend the reach of Pfizer’s patient-facing health information and education and amplify the voice of the patient inside and outside Pfizer. From 2009-2018 Freda served as Pfizer’s chief medical officer, responsible for the safe, effective and appropriate use of Pfizer medicines and vaccines, and in this role she reshaped Pfizer’s medical policies and practices to intensify the company’s focus on patient engagement and inclusion.
Before joining Pfizer, Freda held senior leadership positions in medical affairs and product development with Vertex, Bristol-Myers Squibb, Pharmacia and Eli Lilly and Company. Prior to joining the biopharmaceutical industry, she served as vice chairperson and associate professor in the Department of Psychiatry at Howard University College of Medicine and was an advisor to the National Institute of Mental Health. She graduated from Johns Hopkins and earned her medical doctorate at Howard University College of Medicine. She launched her medical career as a practicing physician and then focused her academic research on the effects of health care disparities and the impact of mental illness on families and communities.
Freda is a distinguished fellow of the American Psychiatric Association. She is a frequent speaker on issues such as improving patient safety and outcomes and reducing stigma and healthcare disparities. She appears regularly on health-related television programs in major global markets, including CBS-syndicated shows such as The Doctors and Dr. Phil. She also shares health and medical information through gethealthystayhealthy.com.
Managing Director, Bain Capital Life Sciences
Jeffrey Schwartz is a managing director of Bain Capital Life Sciences, where he is a founding member of the team. Prior to founding Bain Capital Life Sciences in 2016, he was a leader within the healthcare vertical of Bain Capital Private Equity. Since joining the firm, Jeffrey has been actively involved in and served on the board of directors for a wide spectrum of healthcare companies in which Bain Capital Private Equity has made investments including: Air Medical Group Holdings, Beacon Health Options, CRC Health, HCA, Lake Region Medical, Quintiles, QuVa Pharma and Warner Chilcott. Prior to joining Bain Capital, Jeffrey served as an equity research analyst at Lehman Brothers, working in both New York and London.
Jeffrey received an MBA from The Wharton School at the University of Pennsylvania, where he was a Palmer Scholar. He graduated magna cum laude from Yale University with a B.A. in economics.
Stephen Squinto, Ph.D.
Executive Partner, OrbiMed
Stephen Squinto, Ph.D., joined SpringWorks Therapeutics at launch in 2017 and is acting head of research and development. Steve is a venture partner with OrbiMed who brings over 25 years of biotechnology industry experience. Steve was a co-founder of Alexion Pharmaceuticals and recently served as its executive vice president and chief global operations officer. Prior to 2013, he was Alexion’s global head of research and development. From 1988 to 1992, Steve held various positions at Regeneron Pharmaceuticals. Prior to Regeneron, he held a joint academic position at both the Tulane University and LSU Medical Schools. He is a recipient of numerous honors and awards from academic and professional organizations for his scientific work. Steve received his B.A. in chemistry and Ph.D. in biochemistry and biophysics from Loyola University of Chicago.
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Investigator-Initiated Research Terms and Conditions
All submitted proposals and related documents, including study concepts and protocols, shall be deemed Non-Conﬁdential. No conﬁdential relationship shall be established or implied by SpringWorks' acceptance of such materials.
SpringWorks shall have the right to retain any such materials. SpringWorks will only consider unsolicited IIR proposals submitted in writing by external investigators interested in studying SpringWorks drug candidates in therapeutic areas of interest. Support from SpringWorks, if any, will be granted on the basis of scientiﬁc merit. IIR budgets must be reasonable and appropriate for the proposed study.
Acceptance of the submission of a study concept or protocol does not constitute approval. SpringWorks reserves the right to decline support of a proposal any time after submission.
Following review by SpringWorks, the submitter will be notiﬁed as to whether the IIR proposal has been approved or denied, or if additional information is required. Approval of a study concept does not guarantee approval of a study protocol. SpringWorks shall have no obligation to give the reasons for its decisions.
SpringWorks support of an IIR will be subject to the execution of a written agreement which shall include terms aligned with the following principles:
Conduct of the Study. The IIR will be conducted in accordance with the ﬁnal protocol as approved by SpringWorks, International Conference on Harmonization Good Clinical Practice (ICH GCP) guidelines, and all applicable governmental laws, rules, and regulations. Also, if study drug is supplied by SpringWorks as part of an IIR, the Institution is expected to follow SpringWorks instructions such as those regarding proper handling of study drug (e.g., storage and handling, expiration of drug notices, drug disposal or destruction).
Sponsorship. The Institution, not SpringWorks, will be the sponsor of the IIR. The Institution, the Principal Investigator and the Institution staff will not represent to any third party, including IIR subjects, that SpringWorks is a sponsor.
Regulatory. The Institution will be solely responsible for any and all safety reporting and regulatory obligations associated with the conduct of the IIR, including, but not limited to, obtaining and maintaining an Investigational New Drug application (IND), if required.
IRB/IACUC Approval. The Principal Investigator will ensure that the IIR is approved by and subject to continuing oversight by an appropriate Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), and shall provide to SpringWorks a copy of such approval, and any extensions or renewals.
Informed Consent. For clinical studies, the Principal Investigator will obtain informed consent for each IIR subject in accordance with 21 Code of Federal Regulations Part 50 (unless an exemption under such part has been approved by the IRB and documentation of same can be provided), and will inform IIR subjects that SpringWorks is providing support for the IIR. SpringWorks shall have the right to review and comment on the informed consent form.
Registration of Study. For clinical studies, the Principal Investigator shall register the IIR at either (i)https://www.clinicaltrials.gov, or (ii) any other registry the requirements of which are consistent with the guidelines of the International Committee of Medical Journal Editors ("ICMJE") on trial registrations, in each case to the extent required by the ICMJE guidelines (as in effect at the time the IIR begins) in order for the IIR results to be eligible for publication in an ICMJE journal.
Reporting of Serious Adverse Events. For clinical studies utilizing a SpringWorks study drug product, within 24 hours of ﬁrst awareness of the event (immediately if the event is fatal or life-threatening), the Principal Investigator will report to SpringWorks by email any Serious Adverse Event ("SAE") that occurs during the SAE reporting period (as deﬁned in the agreement) in an IIR subject assigned to receive the SpringWorks study drug. The Principal Investigator will report to the appropriate Regulatory Authority (e.g., FDA) such SAEs using an FDA MEDWATCH form, and shall do so within the time frames set forth by FDA regulations. SAEs should be reported as soon as they are determined to meet the deﬁnition, even if complete information is not yet available.
Disclosure. SpringWorks will publicly disclose at its discretion, and in accordance with the information maintained in its internal business records, the name of the Institution and/or the Principal Investigator and certain information relating to the agreement including, but not limited to, any ﬁnancial and in-kind payments received under the agreement, the nature of the engagement and any other payment or service-related information as may be deemed appropriate by SpringWorks or as may be dictated by applicable law. Payments to the Institution for work done by speciﬁed individuals may reference both the Institution and the individual.