CURRICULUM VITAE

Richard Graydon, MD, PhD

1202 Lexington Ave 646-732-3345
New York, NY 10028 richardgraydon2@gmail.com

Summary of Qualifications

 MD and PhD degrees - Board Certified Hematologist-Oncologist with over 14 years in clinical
development and medical monitoring in cross-functional teams developing compounds being studied
for new oncology and hematology indications. Robust knowledge of protocol design and oversight,
implementation, and execution of successful clinical trials. Active member of matrix teams dedicated
to the implementation of clinical research studies as part of global compound development programs.
 Clinical experience as an MD, and research experience as a PhD. Strong leader, strategic thinker with
background in high productivity environments. Long history of successful collaboration with KOLs.
 Meticulous and results oriented MD/PhD with extensive experience in clinical medicine, preclinical
research, clinical trials, drug development and regulatory affairs. Personally led 6 NDA and 12 IND
submissions including ciltacabtagene autoleucel (cilta-cel), quizartinib, milademetan, edoxaban,
trastuzumab deruxtecan, daratumumab, amivantamab, siltuximab, etc.
 Experienced incorporating previous medical and scientific education, clinical practice, and research
experience into clear, coherent study design and protocol writing for and operational execution of
clinical studies, including creation of submission documents for NDA.
 Frequent and regular interactions with multiple health authorities including FDA, MHRA, ANSM,
Swissmedic, BfArM, NMPA, PMDA, TGA, ANVISA for a number of regulatory queries and
submissions. Achieved approvals for INDS, NDAs, Orphan Drug and Fast Track
 Therapeutic areas: immuno–oncology, targeted molecular therapies, CAR T-cell therapy, ADC
therapies, hematology (leukemias: AML, ALL, CML, lymphomas: NHL, DLBCL and follicular and
multiple myeloma), oncology (lung, breast, prostate CRC, melanoma, etc.).

 Author- The Genetic Risks of Cancer: The Effects of DNA, Genomics and Inheritance on Aging and
Survival. 1st ed. New York, NY Amazon 2017

Professional Experience

Senior Director Clinical Development 2015-present New Jersey

Johnson & Johnson, Inc.

 Directed the strategic planning, execution and implementation of Phase I-III Clinical Development Plans
for compounds in Hematology-Oncology through product lifecycle.
 Directed adaptive and classic protocol design for proof-of-concept through pivotal trials
 Provided leadership to the clinical and global study teams for successfully advancing clinical trials.
Directed clinical development programs and medical review, analysis, and interpretation of study data.
 Successfully led development programs & launches for amivantamab (NSCLC), abiraterone (Prostate
Cancer), ibrutinib (Chronic Lymphocytic Leukemia), daratumumab & cilta-cell CAR T-cell therapy
(Multiple Myeloma). Led early phase development of JNJ-1330 (Colorectal Cancer), JNJ-7706621
(Glioblastoma), JNJ-74856665 (Acute Myeloid Leukemia), and JNJ-64619178, a PRMT5 inhibitor.
 Directed provision of scientific contributions applicable to oncology clinical research to a cross-
functional team developing compounds being studied for new oncology indications.
 Provide clinical and medical input as a key member of development program teams and sub-teams and
to evaluate potential business opportunities. Provided periodic medical monitoring as needed.
 Spearheaded the identification, recruitment and selection of appropriate clinical investigators and
contract research organizations, resulting in appropriate negotiation of contracts.
 Provided scientific and clinical input to study-related documents including INDs, NDAs, IBs, CSRs,
ISEs and ensured the timely medical review and reporting of AEs. Led IND and NDA submissions.
 Collaborated with Regulatory Affairs to ensure the timely preparation of documents to be submitted to
the FDA and other health authorities for review.
 Recurring in-person and written communications with the FDA and global regulatory pertaining to
INDs, NDAs, EMA-MAA, FDA-clinical hold, Safety Management Guidelines, ODD, DSURs, IBs, etc.
 Responsible for the timely preparation of presentations reporting results of clinical trials to internal and
external audiences. Led the interpretation and reporting of the results of the research, including
submission to health authorities. Developed, in concert with senior clinical staff, credible relationships
with key opinion leaders (KOLs), Investigators, and global clinical research staff. Directed evaluation of
scientific information and new ideas to assist in identifying new research opportunities.
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Senior Director, Clinical Development 2008-2015 New Jersey

Daiichi-Sankyo, Inc

 Directed adaptive and classic design of Phase I-III clinical trial protocols and produced Clinical
Development Plans for in Hematology-Oncology compounds.
 Provided scientific and clinical input to study-related documents including IBs, CSRs, ICFs, CRFs, ISEs
and ensured the timely medical review and reporting of AEs
 Served as Medical Monitor of assigned clinical studies. Directed protocol development from POC to
pivotal trials. Medical review, analysis, and interpretation of data from clinical studies.
 Served as Medical Monitor of assigned clinical studies. Directed medical review, analysis, and
interpretation of data from clinical studies.
 Directed formulation of strategic portfolio development across programs and within individual programs
as appropriate which included evaluation of agents for potential collaboration.
 Successfully led ADC trastuzumab deruxtecan (Breast Cancer), quizartinib and milademetan (AML,
NHL, DLBCL) edoxaban (Atrial fibrillation, DVT) IND and NDA filings and development programs.
 Responsible for providing leadership to the clinical and global study teams, and for successfully
advancing clinical trials. Provided clinical and medical input as a key member of development program
teams and sub-teams and to evaluate potential business opportunities.
 Responsible for the timely preparation of presentations reporting results of clinical trials to internal and
external audiences.
 Served as a liaison between the company and clinical investigators.
 Supported medical affairs activities involving product evaluation, labeling and surveillance.
 Assessed external clinical research proposals involving company products and manuscripts being
prepared for publication
 Developed, in concert with senior clinical staff, credible relationships with Investigators and key opinion
leaders in many countries.
 Led the Clinical Development line function on multidisciplinary project teams. Worked with marketing
to evaluate product candidates, determine product indications and design post-marketing studies, as
appropriate.
 Continuous interactions with global health authorities including the FDA, PMDA, MHRA, for
multiple regulatory queries and submissions. Presented in-person at ODAC for Quizartinib review.
Achieved approvals for INDS, NDAs, MAAs, Orphan Drug and Fast Track designations.

Clinical Practice

 Harvard University Medical Center Boston

 Massachusetts General Hospital 1999 - 2008
 Associate Professor of Medicine
 Attending Physician
 Department Hematology & Oncology

Education

Harvard University Medical Center 1994-1999 Boston

Massachusetts General Hospital

 Oncology/Hematology
Clinical Fellowship, 1997-1999

 Internal Medicine
Clinical Residency, 1994-1997
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Stanford University 1987-1994 Stanford

School of Medicine
M.D. Degree, Doctor of Medicine, 1994
Graduated Magna Cum Laude

 Ph.D. Degree, Molecular Genetics, 1994

Thesis - transcription factors, RNA polymerase, and restriction
endonuclease cleavage site selection of cloned protein coding sequences

Cornell University New York

School of Biological & Health Sciences
1983-1987

 B.S. Degree 1988

Chemical Engineering
Pre-medical curriculum
Graduated Magna Cum Laude

Publications

• A Phase 1 Study of Milademetan in Combination with Quizartinib in Patients with Newly Diagnosed
(ND) or Relapsed/Refractory (R/R) FLT3-ITD Acute Myeloid Leukemia (AML). Naval Guastad
Daver, Weiguo Zhang, Richard Graydon, Vikas Dawra, Jingdong Xie, Prasanna Kumar, Michael
Andreeff; November 2019Blood 134:1389-1389
• Exposure-Response (E-R) Analysis in the Absence of Pharmacokinetic Data: Comparison of Efficacy
From Two Different Dosing Regimens of Bortezomib in Transplant-Ineligible Newly Diagnosed
Multiple Myeloma Patients. Parasrampuria D, He J, Zhang L, Heeg B, Hu P, Nemat S, Graydon R,
Lam A, Appiani C, et al. Submitted to British Journal of Haematology 2019

• Graydon R. The Genetic Risks of Cancer: The Effects of DNA, Genomics and Inheritance on Aging
and Survival. 1st ed. New York, NY Amazon 2017

• A Phase IIA Exploratory Study of Oral Milciclib Maleate in Patients with Unresectable or Metastatic
Hepatocellular Carcinoma. Richard Graydon, Jules Jacob, Vaseem Palejwala, Kunwar Shailubhai.
Cancer Research 2021 (in press)

• Efficacy and tolerability of rifaximin in combination with lactulose in end-stage liver disease patients
with MELD greater than 20. P.S.Mantry, A.Mehta, R. Graydon. Transplantation Proceedings Volume
46, Issue 10, December 2014

• Pharmacological cardioversion of atrial fibrillation with vernakalant: evidence in support of the ESC
Guidelines. Irene Savelieva, Richard Graydon, A. John Camm. EP Europace, Volume 16, Issue 2,
February 2014

Skills

 Board Certified Hematologist-Oncologist

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 Clinical experience as an MD/research experience as a PhD

 Superior communication skills, outstanding time management and organizational abilities. Extensive
knowledge of FDA, EMA, ICH, GCP, GVP and CIOMS guidelines and regulations. Track record of
successful interactions with FDA and other global health authorities.

 Experienced in use of applied statistics, epidemiology, evidence-based medicine, medical decision-

making, and critical appraisal and interpretation of clinical and research data
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 Familiar with industry principles of drug safety, US and international regulatory guidelines, drug
development, biostatistics, pharmacology, clinical trial methodology, epidemiology, and oncology.

 Knowledge of interpretation & presentation of aggregate safety data, signal recognition & statistical
techniques, safety data capture in CT & PM settings

 Appreciation of the global safety environment, international regulations & guidance documents

Experienced with, AERS, VAERs, Argus the Active Post-market Risk Identification and Analysis
system (ARIA) and the SENTINEL Common Data Model. Clintrace, and multiple in-house databases.

 Appreciation of working as part of a cross-functional team

 Experience and working knowledge of advanced biostatistics, MedDRA, CTCAE, eDMS, and
analytical biochemical technologies such as immunoassay, ELISA, PCR, and DNA analysis.

 Proficiency and knowledge of AMA style, familiarity with ACCME guidelines, and FDA/DDMAC
regulations.

 Top-notch collaborator with thought leaders for developing clinical information programs. A
relationship builder with internal and external colleagues.

Broad knowledge of biotech & pharmaceutical industries, large-molecule biologic and small-molecule
pharmaceutical development processes, and medical-regulatory environment.

 Knowledge of EU (EMEA) and Canadian and regulatory requirements, as well as ICH E2 and E6 plus
CFR 312 and 314. EMEA filing experience.

 General knowledge of applied clinical medicine and laboratory interpretation. Ability to act as
"consultant" with clients: attend meetings, develop relationships, formulate suggestions

 Understanding of characteristics of various physician target audiences: concerns, sensitivities,

challenges to practice, especially as they relate to communicating with these groups

 Ability to prioritize work and execute on several projects simultaneously. Strong computer skills,

Recent Meeting Attendance, Professional Development and Continuing Education

 Emerging Safety Science Workshop - William DuMouchel, PhD Chief Statistical Scientist FDA White
Oak Conference Center, Silver Spring, MD April 23-24, 2007

 Drug Information Association (DIA) - 44th Annual Meeting, Boston, MA June 2008

 American Society Clinical Oncology (ASCO) Annual Meeting. Chicago, IL June 2010

 American College of Cardiology Annual Meeting ACC.11 & i2 Summit New Orleans, LA — April 2–
5, 2011

Sixth Annual Pacific Drug Safety Summit, San Francisco, CA September 20-21, 2012

 American Society Clinical Oncology (ASCO) Annual Meeting. Chicago, IL June 2013
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 4th Annual Pharmacovigilance & Risk Management Strategies Forum, Amsterdam, Netherlands.
January 2014

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 Recent Meeting Attendance, Professional Development and Continuing Education (cont.)
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 Biotechnology Industry Organization (BIO) - 16th Annual Meeting, International Biotechnology
Investor Conference, New York February 2016

 Drug Information Association (DIA), June 18-22, 2017 Chicago, IL

 American Society Clinical Oncology (ASCO) Annual Meeting. Chicago, IL June 2019
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 Biotechnology Industry Organization (BIO) - 19th Annual Meeting, International Biotechnology
Conference, New York February 2020

 American Society of Hematology (ASH) - 63rd ASH Annual Meeting Atlanta, GA December 2021

 American Society for Transplantation and Cellular Therapy, Tandem Meetings, Salt Lake City, Utah,
April 2022

 American Society of Gene & Cell Therapy 25th Annual Meeting, Washington, DC May 2022