John Orloff
Scientific Advisory Board @ Cantai Therapeutics
About
Dr. Orloff, M.D., is a global R&D/business leader with nearly 25 years of experience in the bio-pharma industry at leading organizations with expertise in research, non-clinical/clinical development, medical affairs, health economics & outcomes research, and regulatory affairs. He currently serves in board roles and as a venture partner. He was recently Head of R&D at Alexion headquartered in Boston, MA, focused on complement-mediated disorders and rare disease targets within seven franchises: hematology, nephrology, neurology, ophthalmology, cardiology, metabolic diseases, and acute care. Over a period of 3 years, Dr. Orloff led the expansion of the development pipeline from 3 to nearly 30 programs, spanning over 80 clinical trials from Phase 1 to Phase 4, and a significant increase in productivity from internal discovery research, with the delivery of 3 novel INDs. Prior to a brief stint as Head of R&D at Novelion, where he helped to define a growth strategy in metabolic diseases, Dr. Orloff served as EVP, Global Head of R&D, and CSO at Baxalta. In this role, Dr. Orloff advanced its pipeline by employing an external innovation model; led ~1300 people spanning discovery research to LCM; and served as a Section 16 Officer, representing R&D at all Executive Committee meetings, Board interactions, and investor/external engagements. During 2 years, Dr. Orloff oversaw regulatory approval of 10 unique products and 2 devices in the U.S. and Europe. Previously, Dr. Orloff served as SVP, Global Head of Clinical Development at Merck Serono. Dr. Orloff joined Novartis Pharma in 2003 and quickly rose to positions of greater scope, including global head of Clinical Development and Medical Affairs for Arthritis, Bone Metabolism, Women's Health, and Urology. As SVP, Head, US Medical & Regulatory Affairs, he provided executive leadership of U.S. Clinical Development, Medical Affairs, and Evidence-based Medicine, and for NA Regulatory Affairs. He also served as global head of Regulatory Strategy, and oversaw the development of/received regulatory approval for a wide range of products. Dr. Orloff also served in executive positions with Merck Research Labs. Board Certified in Endocrinology & Metabolism and Internal Medicine, and a Diplomate, National Board of Medical Examiners. He has an MD from the University of Vermont and an AB from Dartmouth; completed his Internal Medicine Internship, Residency, & Chief Residency at the University of Pittsburgh, and held an Endocrinology & Metabolism Fellowship at Yale.
United States
Greater Boston
Biotechnology
Clinical Development, Pharmaceutical Industry, Drug Development, Clinical Trials, Medical Affairs, GCP, Oncology, Cardiology, Clinical Research, Regulatory Affairs, Lifesciences, Biopharmaceuticals, Biotechnology, Pharmacovigilance, Pharmacology, Medicine, CRO, Regulatory Submissions, Diabetes, Drug Discovery
Experience

Scientific Advisory Board
Waltham, MA
Cantai seeks to develop drug candidates to treat autoimmune and inflammatory disorders by developing cytokine-targeting bispecific antibodies that meaningfully improve the status quo for the millions of patients suffering from immune-mediated and autoimmune diseases.

Non Executive Director
Boston, Massachusetts, United States
Zenas BioPharma is a global biopharmaceutical company based in the USA and China committed to becoming a leader in the development and delivery of immune-based therapies for patients in the US, China and around the world. Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbiopharma.com and follow us on Twitter at @ZenasBioPharma and LinkedIn.

Venture Partner
Boston, Massachusetts, United States
Venture Partner, Agent Capital Agent Capital is an international life sciences investment firm that supports disruptive healthcare companies focusing on novel, differentiated therapeutics and treatments that address unmet patient needs. Agent Capital aligns with scientists, entrepreneurs, and other investors to develop the next generation of healthcare innovations, leverages their industry expertise and successful track record to source premier deals, accelerate value, and drive successful exits. Their first fund invested in 15 portfolio companies, the majority of which have executed collaborations with major pharmaceutical companies and successfully raised additional capital in the private or public markets. For more information, please visit Agent Capital’s website at www.agentcapital.com.

Advisor
GLG Institute
New York, United States
GLG Institute is transforming the way the world’s top executives share expertise, learn, and accelerate their development. Senior executives learn fastest through conversation with other professionals who can share relevant experience and hard-won perspectives. GLG Institute is designed to create those conversations. We recruit the world’s best operators, leaders, and policy makers to serve as Advisors to GLG Institute Members.

Non Executive Director
London, England, United Kingdom
Non-executive Director, Benevolent AI BenevolentAI combines advanced AI and machine learning with cutting edge science to decipher complex disease biology, generate novel insights and discover more effective medicines. Our unique computational R&D platform spans every step of the drug discovery process, powering an in-house pipeline of 25+ drug programmes from early discovery towards clinical phases. With several successful collaborations with leading pharmaceutical organisations, we are also the only AI-drug discovery company with a clinically validated approach, discovering a leading repurposed drug candidate for COVID-19. BenevolentAI is headquartered in London with a research facility in Cambridge (UK) and a further office in New York, with a team of over 300 world-leading scientists and technologists progressing its mission to reinvent drug discovery and advance life-changing drugs through to the clinic.

EVP, Global Head of R&D
Boston
Led a worldwide organization highly skilled in rare disease drug development with scientific expertise in complement biology. Dr. Orloff was instrumental in leading an overhaul of the R&D function, with recruitment of new talent and the re-organization of Clinical Development, Development Operations and Quantitative Sciences, Medical Affairs, Global Drug Safety, Product Development and Clinical Supply, and Program and Portfolio Management, and Discovery Research. The transformation of R&D focused internal research on complement, where Alexion is a recognized leader, and development work on both complement- and non-complement-mediated targets within seven franchises: hematology, nephrology, neurology, ophthalmology, cardiology, metabolic diseases, and acute care. Over a period of 3 years, Dr. Orloff led the expansion of the development pipeline from 3 to nearly 30 clinical-stage development programs across 12 assets, spanning over 80 clinical trials from Phase 1 to Phase 4, and expanding from 6 disease areas in 2017 to 23 in 2020. He also drove a significant increase in productivity from internal discovery research, with the delivery of 3 novel INDs, and the goal to deliver at least 5 new INDs by 2025. Dr. Orloff exited Alexion in July 2021 following the acquisition by AstraZeneca.

EVP, Global Head of R&D, and Chief Scientific Officer
Cambridge, MA
Advanced Baxalta’s pipeline by employing an external innovation model (Hematology, Immunology, and Oncology). Lead ~1300 people spanning discovery research to LCM; Section 16 Officer, representing R&D at all Executive Committee meetings, Board interactions, investor/external community engagements. During a span of 2 years, oversaw regulatory approval of 10 unique products (Adynovate, Vonvendi, Cuvitru, Rixubis, HyQvia, Oncaspar, Onivyde, Flexbumin 5%, Obizur, FEIBA prophy) and 2 devices (BaxJet III, MyPKFiT) in major markets (US and EU). Baxalta was ranked 1st overall in the Patient View Corporate Reputation of Pharma among Rare Disease Patient Groups (2015 survey).

Global Head of R&D
Cambridge, MA
Responsible for advancing the BioScience pipeline, enhancing the current R&D operating model, and pursuing additional innovative opportunities for the business, as Baxter BioSciences works toward becoming an independent global biopharmaceutical company.

Global Head Clinical Development
Billerica, MA
Led design / execution of global clinical development programs & projects, driving quality execution of the projects after proof-of-concept. Oversaw pipeline management / development, working collaboratively with research teams & commercial to drive efficient development of Merck's portfolio.
Education
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