Hello! I am Jason Summa

I am a dedicated oncology professional with a proven record of making intricate cancer treatments and concepts accessible to wide audiences, fueled by extensive experience and a strong commitment to advancing cancer care.

Adaptable and quick to learn, I thrive in fast-paced and accelerated environments. My innate teaching skills allow me to distill complex ideas for diverse audiences by encouraging learning through creative and engaging methods promoting the advancement of critical clinical development programs.

My Journey

When I was a child and pictured what I wanted to grow up to be, I was always wearing a lab coat - not a police uniform or firefighter gear. Then again, I was also the kid with all the chemistry sets, so maybe my vision wasn’t too far-fetched. I am still, to this day, fascinated by the intersection where the worlds of chemistry and biology meet. It is at those crossroads that set the path of my professional career.

It was very late on a Friday when I received a phone call from my mother. Before answering, I knew this would not be the kind of phone call that I would want to receive. That night, she told me a lesion was imaged on her lung during a routine x-ray of her back. Understanding the type, stage, and size, I knew the median 2-year survival clock started ticking away - and I couldn’t stop it. I researched the disease tirelessly, asked my KOLs to give her the best care possible, helped her through surgery, managed her treatment options, laid an ear on her office visits, and sat in the chemotherapy unit as her hair fell away.

As many caretakers know, family and friends diagnosed with cancer can lead to a bleak future. Ultimately, she passed away 2 years and 2 months after that initial phone call.

My family members believe I did the best I could for her. But that does not satisfy me. Still, there is a lingering question that rattles around my brain. “What if I could have done better? Did I make any wrong choices along the way? What if I could have saved her?”

These questions continue to drive me in both my professional and personal journey.

Elizabeth Jane Semenza Summa

November 19, 1950 - September 20, 2015

My Mission

I'm driven to challenge norms, foster positive change, and ignite enthusiasm for innovative approaches. My exceptional communication skills, relatability, and boundary-pushing mindset are catalysts for sparking meaningful results.

Guided by the scientific method, I question, learn, hypothesize, test, analyze, and share results, contributing to the ever-evolving oncology field. Because cancer has affected me closely, paving my career path, my mission is to revolutionize cancer treatment and education, leaving a lasting impact.

My Philosophy

sage [seyj]

adjective

1: proceeding from or characterized by wisdom, prudence, and good judgment

2: wise through reflection and experience

What is truth? This is the question that keeps me up at night. A perfectionist by nature, I won’t settle for ambiguity and am always on a mission to analyze information, to find the right answer and share it with others.

PROMISE: The truth will set you free.

CORE DESIRE: The discovery of the truth

GOAL: To use intelligence to understand the world

FEAR: Being duped; ignorance

MOTIVATION: Independence and fulfillment

STRATEGY: Seek out information; understand process

My Strengths

Extensive experience in Clinical Development and Operations, particularly in oncology.
Proficiency in Medical Writing for effective communication of complex medical information.
Expertise in Drug Development, from early-stage trials to FDA reporting, indicating a thorough understanding of the pharmaceutical development process.
Strategic decision-making skills, essential for effective project management and problem-solving in clinical research.
Leadership and team management capabilities, demonstrated by experience in guiding cross-functional teams.
Educational background with an MBA and B.Sc. in Chemistry, providing a strong foundation in both business and science. Certifications in Project Management (PMP) and Regulatory Affairs (RAC), enhancing my professional qualifications.

My Knowledge

My Therapeutic Areas

Oncology
Immuno-oncology
Hematology
Neurology
Infection Diseases and Vaccines
Dermatology
Immunology
Metabolism and Endocrinology
Ophthalmology

My Regulatory Experience

Australia (TGA), Austrian (AGES), Belgium (FAMHP), Canada (HC), Denmark (DKMA), Europe (EMEA), France (ANSM), Germany (BfArM), Hong Kong (DH), Ireland (HRPA), Italy (AIFA), Netherlands (IGZ), Japan (NIHS), Netherlands (MEB), Norway (NoMA), Portugal (Infarmed), Russia (Minzdrav), South Korea (MFDS), Spain (AEMPS), Sweden (MPA), Switzerland (Swissmedic), Taiwan (TSFA), UK (MHRA), US (FDA)

My Functional Expertise

Clinical Development
Clinical Science
Clinical Operations
Medical Writing
Project/Program Leadership
Competitive Intelligence
Regulatory Affairs and Operations
Chemistry, Manufacturing, and Controls
Nonclinical Pharmacology
Nonclinical Toxicology
Process Development
Quality Control (SOP Development)

My Medical Writing

Pre-IND Meeting Requests Pre-IND Briefing Books

FDA Comments and Requests NDAs/BLAs
Clinical Protocols and Amendments
Breakthrough Designations
Investigator's Brochures
Informed Consent Forms ICFs
Clinical Study Reports (CSRs)
Clinical Development Plans (CDPs)
Annual Safety Reports (DSURs)
Technical Papers and Manuscript

Smith, M.R., Fizazi, K., Sandhu, S.K., Kelly, W.K., Efstathiou, E., Lara, P., Yu, E.Y., George, D.J., Chi, K.N., Saad, F. and Summa, J., 2020. Niraparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD): Correlative measures of tumor response in phase II GALAHAD study. Journal of Clinical Oncology, 38(6_suppl), pp.118-118.
Smith, M.R., Sandhu, S.K., Kelly, W.K., Scher, H.I., Efstathiou, E., Lara, P., Yu, E.Y., George, D.J., Chi, K.N., Summa, J. and Kothari, N., 2019. Phase II study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD): preliminary results of GALAHAD. Journal of Clinical Oncology, 37(7_suppl), pp.202-202.
Smith, M.R.., Sandhu, S.K., Kelly, W.K., Scher, H.I., Efstathiou, E., Lara, P.N., Yu, E.Y., George, D.J., Chi, K.N., Saad, F. and Summa, J., 2019. Pre-specified interim analysis of GALAHAD: A phase II study of niraparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD). Annals of Oncology, 30, pp.v884-v885.
Smith MR, Sandhu S, Kelly WK, Smith, M.R.Scher HI, Efstathiou E, Lara P, Yu EY, George DJ, Chi KN, Saad F, Summa J, Freedman JM, Mason GE, Zhu E, Ricci DS, Simon JS, Cheng S, Fizazi K. Pre-specified interim analysis of GALAHAD: A phase 2 study of niraparib in patients with metastatic castration-resistant prostate cancer and biallelic DNA-repair gene defects. ESMO Congress Abstract LBA50, Smith, M.R.Smith, M.R.2019 European Society of Medical Oncology Congress. Barcelona, Spain, Sept. 2019. Poster presentation at ESMO Congress, Barcelona, Spain, Sept. 2019
Smith MR, Sandhu SK, Kelly WK, Scher HI, Efstathiou E, Lara P, Yu EY, George DJ, Chi KN, Summa J, Kothari N, Zhao X, Espina BM, Ricci DS, Simon JS, Tran N, Fizazi K, GALAHAD Investigators. Phase II study of niraparib in patients with metastatic castration-resistant prostate cancer and biallelic DNA-repair gene defects: Preliminary results of GALAHAD. J Clin Oncol 37, 2019 (suppl 7S; abstr 202). Poster presentation at Genitourinary Cancers Symposium, San Francisco, CA, Feb. 2019
Smith, M.R.; Sandhu, S.K.; Kelly, W.K.; Scher, H.I.; Efstathiou, E.; Lara, P.; Yu, E.Y.; George, D.J.; Chi, K.N.; Summa, J.; et al. Phase II study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD): Preliminary results of GALAHAD. J. Clin. Oncol. 2019, 37, 202
Smith, M.R.; Sandhu, S.K.; Kelly, W.K; Scher, H.I.; Efstathiou, E.; Lara, P.; Yu, E.Y.; George, D.J.; Chi, K.N.; Summa, J.; et al. Pre-specified interim analysis of GALAHAD: A phase II study of niraparib in patients(pts) with metastatic castration-resistant prostate cancer(mCRPC)and biallelic DNA-repair gene defects(DRD). Ann. Oncol. 2019, 30, v884–v885.
Autio KA, Dreicer R, Anderson J, Garcia JA, Alva A, Hart LL, Milowsky MI, Posadas EM, Ryan CJ, Graf RP, Dittamore R, Schreiber NA, Summa JM, Youssoufian H, Morris MJ, Scher HI. Safety and Efficacy of BIND-014, a Docetaxel Nanoparticle Targeting Prostate-Specific Membrane Antigen for Patients With Metastatic Castration-Resistant Prostate Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1344-1351. doi: 10.1001/jamaoncol.2018.2168. PMID: 29978216; PMCID: PMC6233779..
Von Hoff DD, Mita MM, Ramanathan RK, Weiss GJ, Mita AC, LoRusso PM, Burris HA 3rd, Hart LL, Low SC, Parsons DM, Zale SE, Summa JM, Youssoufian H, Sachdev JC. Phase I Study of PSMA-Targeted Docetaxel-Containing Nanoparticle BIND-014 in Patients with Advanced Solid Tumors. Clin Cancer Res. 2016 Jul 1;22(13):3157-63. doi: 10.1158/1078-0432.CCR-15-2548. Epub 2016 Feb 4. PMID: 26847057..
Autio, K.A., Garcia, J.A., Alva, A.S., Hart, L.L., Milowsky, M.I., Posadas, E.M., Ryan, C.J., Summa, J.M., Youssoufian, H., Scher, H.I. and Dreicer, R., 2016. A phase 2 study of BIND-014 (PSMA-targeted docetaxel nanoparticle) administered to patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Journal of Clinical Oncology, 34(2_suppl), pp.233-233.
Summa, J.M., Von Hoff, D.D., Sachdev, J.C., Mita, M.M., LoRusso, P.M., Eisenberg, P.D., Burris, H.A., Hart, L.L., Youssoufian, H., Parsons, D.M. and Low, S.C., 2015. Abstract B144: Evaluation of total and encapsulated drug pharmacokinetics for BIND-014 (docetaxel nanoparticles for injectable suspension) in a phase 1 study. Molecular Cancer Therapeutics, 14(12_Supplement_2), pp.B144-B144.
Summa, J., Kung, J., Adams, L.K., Zale, S.E. and Youssoufian, H., 2015. Abstract A161: Cardiovascular safety profile of BIND-014 (docetaxel nanoparticles for injectable suspension) evaluated in phase 1 and 2 studies. Molecular Cancer Therapeutics, 14(12_Supplement_2), pp.A161-A161.
Summa, J., Von Hoff, D., Sachdev, J., Mita, M., LoRusso, P., Eisenberg, P., Burris, H., Hart, L., Youssoufian, H., Parsons, D. and Low, S., 2015. Pharmacokinetics of BIND-014 (docetaxel nanoparticles for injectable suspension) in preclinical species and patients with advanced solid tumors. Cancer Research, 75(15_Supplement), pp.5514-5514.
Low, S., Hoff, D.V., Mita, M., Burris, H., Eisenberg, P., Hart, L., LoRusso, P., Weiss, G., Sachdev, J., Mita, A. Summa, J., and Ramanathan, R., 2014. Prostate-specific membrane antigen (PSMA) expression as a potential patient selection marker in patients with refractory solid tumors administered BIND-014, a PSMA-targeted nanoparticle containing docetaxel. Cancer Research, 74(19_Supplement), pp.911-911.
Mita, M., Burris, H., LoRusso, P., Hart, L., Eisenberg, P., Mita, A., Low, S., Summa, J., Berk, G. and Sachdev, J., 2014. Abstract CT210: A phase 1 study of BIND-014, a PSMA-targeted nanoparticle containing docetaxel, administered to patients with refractory solid tumors on a weekly schedule. Cancer Research, 74(19_Supplement), pp.CT210-CT210.
Von Hoff, D.D.., Mita, M., Eisenberg, P., LoRusso, P., Weiss, G., Sachdev, J., Mita, A., Low, S., Hrkach, J., Summa, J. and Berk, G., 2013. Abstract LB-203: A phase I study of BIND-014, a PSMA-targeted nanoparticle containing docetaxel, in patients with refractory solid tumors. Cancer Research, 73(8_Supplement), pp.LB-203
Summa, J., LoRusso, P.M., Eisenberg, P., Hrkach, J., Schnipper, E. and Hoff, D.V., 2012. Abstract LB-452: A phase I, open label, safety, pharmacokinetic and pharmacodynamic dose escalation study of BIND-014 given by IV infusion to patients with advanced or metastatic cancer. Cancer Research, 72(8_Supplement), pp.LB-452.
A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers (ClinicalTrials.gov Identifier: NCT04292197)
A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma (ClinicalTrials.gov Identifier: NCT03288480)
A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors (ClinicalTrials.gov Identifier: NCT02266745)
A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab (PAVE-1) (ClinicalTrials.gov Identifier: NCT03409458)
Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer (ClinicalTrials.gov Identifier: NCT03871816)
An Efficacy and Safety Study of Niraparib in men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies (GALAHAD) (ClinicalTrials.gov Identifier: NCT02854436)
A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men with Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) (ClinicalTrials.gov Identifier: NCT02924766)
A Phase 2 Study to Determine the Efficacy and Safety of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) in Patients with Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer, and Squamous Cell Carcinoma of the Head and Neck (ClinicalTrials.gov Identifier: NCT02479178)
A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients with KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer (ClinicalTrials.gov Identifier: NCT02283320)
An Open-Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Administered to Patients with Metastatic Castration-Resistant Prostate Cancer (ClinicalTrials.gov Identifier: NCT01812746)
An Open-Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy to Patients with Non-Small Cell Lung Cancer (ClinicalTrials.gov Identifier: NCT01792479)
A Phase 1 Open-Label, Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Given by Intravenous Infusion to Patients with Advanced or Metastatic Cancer (ClinicalTrials.gov Identifier: NCT01300533)
Methods of treating cancers with therapeutic nanoparticles
US Patent Number: 20170151181A1
Nanoparticles comprising docetaxel for treating cancers having a k-ras mutation
Canadian Patent Number: CA2946155A1
Inhalable Epinephrine
US Patent Number: 7947742

Testimonials

"Having worked with Jason over the last 20 years, I saw him develop into a motivated and knowledgeable pharmaceutical product leader. He has a unique set of skills that enable him to integrate the CMC, non-clinical and clinical disciplines needed to move complex projects forward. Because of his strong communication and leadership skills he is able to use his talents and knowledge to guide drug development project teams to success."

James Wright, Ph.D.
"I've worked with Jason in three different companies over the past 20 years. I have been so impressed with the evolution of Jason's growth. From starting out as a lab scientist, to becoming an early stage program leader in charge of the early regulatory and clinical aspects for an IND submission and then continuing to grow into clinical operations and taking leadership of relationships clinical investigators, external KOLs and our CAB. Jason faces every new challenge and opportunity with a hunger to learn, humility to appreciate what he knows or doesn't know and, most of all, as a leader who brings people together in a collaborative and productive manner focused upon shared success and always with an eye toward helping patients."

Jeff Hrkach, Ph.D.
“Working with Jason is like a breath of fresh air: he brings new ideas to the table that are inventive and scientifically sound. His work on a daily basis demonstrates his experience with issue resolution and his integrity.”

Géralyn Trudel, Ph.D.
"Jason is one of the best clinical leaders I have had the pleasure of working with. He is driven, adaptable, dependable, and a natural leader and teacher. Jason is the quintessential professional and has integrity and a passion for working on innovative cancer treatments. He is a true asset to any organization."

Jamie Freedman
"I had the enjoyment of working with Jason on several oncology clinical programs. He continuously provided me with actionable advice that was invaluable to me and the study's success. His clinical development insights were invaluable and allowed me to operate and make decisions that I thought were best for the trial while knowing that he was always available when I needed support."

Meaghan Elliott
"I've had the pleasure of working with Jason for the past several months as his career coach, where together we were able to identify the key motivations that are at the heart of his professional ambition. He approached the process like a job, giving it 200%, which resulted in us quickly uncovering his core ideals and uniqueness, identifying areas of strength, and creating a richer representation of who he is as an individual."

Felicia Zigman
"I have known Jason for over ten years and worked with him for five of them. Jason has always been an incredibly high performer and a cross-functional leader, and he will add instant value to any organization he joins."

Max Mahoney
"I have had the pleasure of working with Jason and can attest to the wealth of knowledge he brings in areas from Clinical Research to Clinical Operations to Medical Writing. He is a compassionate and supportive leader who is always willing to share his knowledge and it was a privilege to work with and learn from him."

Elizabeth Staron
"I have seen Jason translate complex medical concepts and technologies and distill them into understandable concepts based on his audience. Whether it be physicians, hospital clinical staff, patient advocacy groups, or internal teams, he can always strike the right tone and rhythm. Jason is also a very related individual capable of drumming up excitement around our work, even during difficult times.”

Monica Jackson
“Jason was always a great person to work with, easy to talk to, and fantastic collaborator. He has a unique combination of personal, business, scientific, and technical skills that allowed him to bridge so many areas of the biotech community from formulations and chemistry to clinical and regulatory."

Greg Troiano, M.S.
"I’ve seen Jason in action in various roles from scientist, project leader to head of clinical & regulatory operations. He is passionate about drug discovery and bringing new therapeutics to patients. A life-long learner with incredible diplomatic skills, he always succeeds in bringing people together and guiding them to a common goal. Jason is detail-oriented with a strong work ethic, and can always be counted on to get the job done."

Beadle Retnarajan, M.S.
“I worked with Jason for six years and witnessed firsthand how his entrepreneurial drive, creativity, and problem-solving capability came together to drive our small company forward in new directions. Jason was a pleasure to work with, and always willing to tackle the next challenge - and was consistently effective in doing so.”

Donald Parsons, Ph.D.
"Jason's personality draws team members together to achieve aggressive milestones while demonstrating how important these milestones are and maintaining a collective atmosphere."

Omid Farohzad, M.D.
"Jason excels in oncology drug development, combining technical expertise with strategic leadership. His ability to steer complex projects through regulatory challenges has contributed significantly to advancing patient care. Jason's clear communication and mentorship have greatly benefited our team, inspiring excellence and innovation. His integrity and commitment to scientific rigor distinguish him as a notable leader in the life sciences."

Edwina S. Baskin-Bey, M.D.
"Jason brings extensive experience in biopharmaceuticals, significantly contributing to drug development and clinical research. His practical approach and regulatory knowledge have made him key in advancing therapies and projects. With a strong foundation in science and business, plus leadership across teams, Jason effectively tackles medical science challenges, showing a steadfast commitment to enhancing healthcare outcomes."

Adrian Senderowicz, M.D.
“Working with Jason at BIND Therapeutics was a privilege. His expertise in clinical development and hands-on approach enabled our team to remain agile and adaptable. Jason fosters an environment of innovation and collaboration, allowing us to thrive. His guidance and passion for making a difference positively impacted our work, and I'm grateful for the opportunity to have been part of his team at BIND Therapeutics.”List Item

Jean Kung, M.B.A.