Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Jason Sol Zielonka, MD, AFACC – Chief Scientific Officer (CSO)

 

Roles @ LPBI:

 

A. Scientific in 2020-2021

• CSO, Dr. Jason Zielonka, MD will be LPBI’s Lead Curator for Development of Medical Counter-measures for 2019-nCoV, CoVid19, Coronavirus on LPBI’s Coronavirus Portal
• It was launched on 3/14/2020 to cover various aspects of the viral infection pandemic
• Focusing on the following therapeutical options:

(a) Monoclonal and polyclonal antibodies

(b)  Vaccines

(c)  Small molecule treatments (e.g., chloroquinolone and derivatives), including compounds already approved for other indications 

(d)  Immuno-therapies derived from human or other sources

 

B. Pipeline Development in 2020

1. AUDIO PODCASTS with Gail
2. NLP, ML, AI algorithms applied to our English Text Analysis & Mining: Summer 2020 – Cancer Volume One and Volume Two, with

• Summer Interns – Deva and Alex and the Expert: Noam Ordan, PhD
• Cancer Expert – Dr. Williams
• Aviva – TLC
• Rick Mandahl – Client Relations Management: SelectHealth and Intermountain 

C. Global Business Development with Joel Shertok and Rick Mandahl in 2020

D. Segmentation of the Journal Archive for Outbound Micro-marketing by Theme – with Aviva in 2020

• Medical Devices = All articles in the archive
• Calcium in Cardiac function
• Genomics role in CNS Diseases

E. Cardiovascular Diseases: Six Volumes – Marketing to Big Pharma – with Aviva in 2021

• Series A: e-Books on Cardiovascular Diseases

BUNDLED BY AMAZON.COM INTO A SIX-VOLUME SERIES FOR $515

https://lnkd.in/e6WkMgF

 

Declaration of Expertise  –  Future Contributions to 12 Categories of Research:

•   Third-party IP: drug discovery
•   Autophagosomes or autophagy
•   Biosimilars
•   Gut microbiome and obesity
•   Immunotherapy
•   Nanotechnology for drug delivery
•   Nuclear medicine
•   Longevity
•   Pharmacovigilance
•   Regulated clinical trials

Jason Sol Zielonka, MD, AFACC

Fishers IN 46040

Jasonz.MIT@gmail.com

Tel.: (917) 856-4852

LinkedIn: http://www.linkedin.com/in/jason1z

 

BIO

 

1. Professional Preparation

• Massachusetts Institute of Technology  

B.S., 1970   Electrical Science & Engineering

• Yale University School of Medicine

M.D., 1974   Medicine

• University of Minnesota School of Medicine, Minneapolis

Internship, Surgical, 1974-75

Residency, Neurosurgery, 1975-76

Residency, Diagnostic Radiology, 1976-78

• Harvard University School of Medicine, Joint Program in Nuclear Medicine

Post-Doctoral Fellowships (Clinical, Research), 1978-81

 

2. Appointments

• Adjunct Faculty, Purdue University (August 2012 – present)

Executive Management, Biotechnology & Entrepreneurship Programs

• Eli Lilly & Company, Inc, Indianapolis, IN (August 2012 – December 31, 2017)

Medical Fellow, Global Patient Safety, Diabetes & AutoImmune Business Units (2012- March 2015)

Medical Fellow, Global Patient Safety, Oncology (March 2015 – Dec 2017)

• Questcor Pharmaceuticals Inc, Union City, CA (2010-2010) Senior Vice President & Chief Medical Officer
• Ortho-McNeil Janssen Scientific Affairs (OMJSA), Titusville, NJ (2005-2010) Senior Medical Director, Trial Methodology, Data Generation
• Pfizer, Inc., New York, NY (2002-2005) Senior Medical Director
• Pfizer Global Pharmaceuticals (PGP), NYC, NY (Jan 2004-Aug 2005)
• Pfizer Global Research & Development (PGRD), Sandwich, UK (Jan 2002-Dec 2003) Early Therapeutic Area Lead (ETAL), CV & Non-sexual Indications, PDE-5i
• DuPont Pharmaceuticals, Inc., Wilmington, DE (2000-2002), Senior Medical Director & Head, Cardiovascular Clinical Research®)
• Independent Consultant, Philadelphia, PA (1998-2000)
• PREMIER RESEARCH WORLDWIDE, Philadelphia, PA (1995-1998), Senior Vice President, Scientific and Regulatory Services
• NYCOMED R&D INC., Collegeville, PA (1993-1995) (formerly Diagnostic Imaging Division, Sterling-Winthrop Inc. [SWPRD]) Director, Medical & Scientific Affairs
• NOVO NORDISK PHARMACEUTICALS, INC., Princeton, NJ (1992-1993), Director, Clinical Development
• BRISTOL-MYERS SQUIBB COMPANY, INC., Princeton, NJ (1987-1992)
• Pharmaceutical Research Institute (1990-1992), Director, Cardiovascular Clinical Research
• Squibb Diagnostics (1987-1990), Medical Director, Worldwide Clinical Research

• MEDICAL COLLEGE OF WISCONSIN, Milwaukee, WI (1983-1987)

1. Chief, Nuclear Medicine Service, Veterans Administration Medical Center
2. Assistant Professor, Dept of Radiology, Division of Nuclear Medicine

• MASSACHUSETTS GENERAL HOSPITAL, Boston, MA (1981-1983)

1. Staff Physician, Nuclear Medicine Division
2. Instructor, Radiology (Harvard Medical School)
3. Intern, Department of Surgery (1974-1975)
4. Resident, Department of Neurological Surgery (1975-1976)
5. Resident, Department of Diagnostic Radiology (1976-1978)

• Harvard Medical School, Boston, MA (1978-1981), Fellow, Cardiovascular Nuclear Medicine

 

3. Honors & Certifications

Associate Fellow, American College of Cardiology (ACC) (1991)

Certification, American Board of Nuclear Medicine (1981)

Diplomate, National Board of Medical Examiners (1975)

Tau Beta Pi (National Honorary Society) (1969)

Sigma Xi (National Scientific Research Honorary Society) (1969)

Eta Kappa Nu (National Electrical Engineering Honorary Society) (1968)

 

Listed in:

Directory of Medical Specialists Who’s Who in the East

Who’s Who Registry of Global Business Leaders

 

4. Biography

Dr Zielonka retired from Eli Lilly & Company at the end of December 2017, completing a 30 year career in the pharmaceutical industry and entering the next phase of his career.

Dr Zielonka has held positions with several biopharmaceutical and consulting organizations, including Bristol-Myers Squibb, Novo Nordisk, Sterling Winthrop, Dupont Pharma, Pfizer (in the UK and US), and Johnson & Johnson. He was also a full-time consultant to FDA, helping implement and manage the current Adverse Event Reporting System (AERS) and serving as FDA’s first head of clinical coding and evaluation. The roles he has held have included global patient safety, clinical research, medical affairs and exploratory medicine. During this period, he led or participated in six successful first-in-class product development teams.

Curriculum Vitae

PROFESSIONAL GOALS

• Senior leadership position in an innovative, preferably disruptive biotechnology organization
• Positive impact on human health care globally
• “To live, laugh, love and leave a legacy”

(Stephen Covey, “7 Habits of Highly Effective People”)

 

CAREER HIGHLIGHTS 

• Developed multiple first in class (FIC) or novel compounds and devices, including
  • FIC approved PET imaging radiopharmaceutical and delivery system (Squibb; CardioGen®)
  • FIC approved non-ionic, low osmolar iodinated contrast agent (Squibb; IsoVue®)
  • FIC approved macrocyclic, non-ionic gadolinium-based MR contrast imaging agent (Squibb; ProHance®)
  • FIC approved Tc-99m based myocardial perfusion imaging agent (Squibb; CardioTec®)
  • FIC generation approved MRI scanner (General Electric; Signa®)
  • FIC approved insulin biosimilar (Eli Lilly; Basaglar®)
  • Innovative (designated breakthrough therapy by FDA, EU) treatment for soft tissue sarcoma (Eli Lilly; olaratumab)
• Extensive global development & clinical strategy experience, in multiple therapeutic areas
• Extensive regulatory experience in submissions & labeling strategy (80+ regulatory submissions)
• Presentation experience before regulatory authorities and at public advisory committees
• C-suite experience (Chief Medical Officer for $5.6B company (market capitalization)

 

PROFESSIONAL EXPERIENCE

 

Adjunct Faculty, Purdue University (August 2012 – present)

School of Pharmacy

Executive Management, Biotechnology & Entrepreneurship Programs

 

Managing Director, Shechina Consulting Services, LLC (January 2018 – present)

Responsibilities:

Assessing client needs

Delivering committed projects & tasks within time and budget targets

Accomplishments:

Support to investigative journalism unit at CBS News

 

Eli Lilly & Company, Inc, Indianapolis, IN (August 2012 – December 31, 2017)

Medical Fellow, Global Patient Safety, Diabetes & AutoImmune Business Units (2012- March 2015)

Responsibilities:

Lead Safety Physician for LY2963016 (first-in-class insulin glargine biosimilar)

• Provided support for all global phase 1-3 clinical registration studies
• Member, core team for writing US, EU, Japan submissions for marketing authorization – world’s first biosimilar insulin
• Member, core team for review & approval of all affiliate submissions for LY2963016
• Provided all “right to operate” documents (DSUR, IB, Risk Profile) as well as all required regulatory documents (RMP) for ongoing development
• Provide all periodic safety oversight for LY2963016 program (DSST; DSMT; PDSR)
• LY2963016 Core Team (Lilly / Boeringher Ingelheim Alliance governance body) Member, Global Cardiovascular Safety Advisory Committee
• Review of all CV safety issues for portfolio (marketed) and pipeline (in development) products

Member, DRA-1 Drug Monitoring & Safety Committee

• Provide independent safety oversight for this high-priority development program

Member, Large Molecule Hub; Biosimilars Working Group; SAEN (Submission & Approval Expert Network); GPS Submissions Advisory Committee

• Subject matter expert and mentor/advisor to all Lilly development and medical affairs teams across all business units and across all development stages

Co-moderator, Learning Catalyst

• Assisted in organizing and implementing a weekly teaching lecture series across the Development Center of Excellence (DCoE), broadcast to ca 1600 R&D

Accomplishments:

• BasaGlar : US, EU, Japan submissions filed and approved
• First public data disclosures at ADA (June 2014)
• Submissions & approvals now achieved in >30 jurisdictions
• 3 additional global registration & post-registration studies planned
• 3 peer-reviewed publications of clinical data from pivotal studies
• 2 peer-reviewed publications of regulatory & clinical strategies for development & approval of biosimilars in US and EU
• Scientific reviewer of FDLI publication “ A Primer on Biosimilars”

 

Medical Fellow, Global Patient Safety, Oncology (March 2015 – Dec 2017)

Responsibilities

Lead Safety Physician for Lilly Immuno-oncology early stage pipeline (Phase 1/2)

• Lead Safety Physician for multiple (9) early development & co-development oncology compounds, including immune-oncology portfolio
• Safety Physician for gemcitabine (Gemzar™) and pemetrexed (Alimta™)
• Safety Physician for necitimumab (Portrazza™) submission activities
• Safety Physician for olaratumab submission activities
• Core team member for Immuno-oncology Global Safety Team
• Supervised safety support for 2 alliance partnership programs via Lilly China
• Continuing membership in various Departmental & cross-functional committees
• Continuing Learning Catalyst & mentoring activities

Accomplishments:

• Development of Regulatory & Right to Operate packages for 2 PD-1/PDL-1 compounds, 1 CXCR4 compound and 1 drug-antibody conjugate compound
• Submission & approval (US, EU; others pending) of Portrazza® (necitumumab) for NSCLC
• Submission & approval (US, EU) of olaratumab for soft tissue sarcoma (orphan drug designation; accelerated review)

 

Independent Consultant (2011-2012)

Responsibilities:

Assessing client needs

Delivering committed projects & tasks within time and budget targets

Accomplishments:

Client base is ca 70% traditional pharmaceutical & biotechnology companies; ca 30% financial organizations

Have provided completed projects and tasks for 3 pharma/biotech clients and >20 financial clients

 

Questcor Pharmaceuticals Inc, Union City, CA (2010-2010) Senior Vice President & Chief Medical Officer

Responsibilities:

Member, Senior Management Team

Participant, Board strategic deliberations, Financial analyst calls

Provided all medical oversight, guidance for Corporate marketing and R&D activities

Headed Medical Science Liaison, Medical Information, Medical Education, Safety & Pharmacovigilance functions

Oversaw protocol review & approval for both company-sponsored and IIS activities

Accomplishments:

Assisted in advancing sNDA ( Infantile Spasms) through FDA review (PDUFA date, Sept 2010)

Reorganization, expansion of Medical Affairs functions Re-establishment of Medical Affairs/Marketing alignment

Note: QCOR was acquired by Mallinckrodt Inc in April 2014 for $5.6 Billion

 

Ortho-McNeil Janssen Scientific Affairs (OMJSA), Titusville, NJ (2005-2010) Senior Medical Director, Trial Methodology

Data Generation, (Aug 2005 – 2010) – now J&J North American Pharmaceuticals

Responsibilities:

Primary corporate review & approval for all external reports of company-sponsored studies

Included abstracts, posters, manuscripts, clinical trial disclosures

Primary corporate review & approval for all OMJSA-conducted company-sponsored protocols

Accomplishments:

Over 300 protocols reviewed and approved

Over 3200 publications reviewed, approved, and submitted

All current and legacy OMJSA protocols requiring registration successfully registered on clinicaltrials.gov

 

Pfizer, Inc., New York, NY (2002-2005) Senior Medical Director

Pfizer Global Pharmaceuticals (PGP), NYC, NY (Jan 2004-Aug 2005)

Full Development Team Lead (FDTL) & WW Medical Team Lead (WWMTL), Fragmin® 

Responsibilities:

Co-chair, Fragmin Global Strategy Group

Provide strategic, developmental and operational support for all clinical programs (phase 1-4) for Fragmin (dalteparin), through and including publication

Responsible for all IIS activities related to Fragmin

Responsible for all KOL relationships & medical support for symposia & international meetings for Pfizer thrombosis activities

Mentor to PGRD Thrombosis team developing next generation antithrombotics

Accomplishments:

Two approved US sNDA indications; multiple EU marketing approvals Numerous publications, symposia programs, maintaining high product visibility Transitioned product & group from Cardiovascular group to Oncology group Maintained revenues over a 2 year period without active sales force activity

 

Pfizer Global Research & Development (PGRD), Sandwich, UK (Jan 2002-Dec 2003) Early Therapeutic Area Lead (ETAL), CV & Non-sexual Indications, PDE-5i

Responsibilities:

Provide strategic and operational support for all translational medicine studies (phase 1- 2A) for PGRD cardiovascular compounds and for non-sexual programs for PDE-5 inhibitors

Provide a seamless transition from preclinical to clinical R&D

Provide New Business Development & Market Analytics with medical input in prioritizing candidates and programs within the CV pipeline

Accomplishments:

Managed progression and no-go decision (end of phase 1) for UK-396,082 (TAFI) Managed pre-clinical to clinical transition of oral anti-Xa inhibitor

Managed pilot programs for sildenafil in glaucoma, Raynaud’s disease, diabetes, metabolic syndrome, Alzheimer’s disease

 

DuPont Pharmaceuticals, Inc., Wilmington, DE (2000-2002)

Senior Medical Director & Head, Cardiovascular Clinical Research

Responsibilities:

Responsible for all registration and line-extension clinical strategies and execution for cardiovascular therapeutic area

Provided medical guidance to R&D and Marketing in cardiovascular arena Assisted Medical Affairs in clinical and pharmacovigilance areas as needed

Accomplishments:

Supervised global phase 2-3 trials and termination of GP 2b/3a inhibitor program Developed & executed phase 1-2 trials of oral anti-Xa inhibitor

Submitted & successfully prosecuted NDA for low molecular weight heparin Managed joint development program with Merck (Cozaar®/Hyzaar®)

 

Independent Consultant, Philadelphia, PA (1998-2000)

Responsibilities:

Fulfilled contractual arrangement between Premier Research Worldwide & PSI International to support FDA AERS platform

Accomplishments:

Created & supervised AE coding, QA groups supporting FDA AERS team Successfully coded 1300-1500 MedWatch forms per day using MedDRA (approx total: 1.2 million AE reports)

Developed coding rules, training program, guidance now used as a global standard by MedDRA Support Organization

 

PREMIER RESEARCH WORLDWIDE, Philadelphia, PA (1995-1998)

Senior Vice President, Scientific and Regulatory Services

Responsibilities:

Supported New Business Development by creating medical and regulatory components of all client proposals

Provided medical support to Operations groups for all ongoing projects

Provided medical oversight (as Principal Investigator) for all studies conducted in Clinical Research Unit

Accomplishments:

Provided sufficient revenues and activities to support successful IPO Supervised over 70 phase 1 studies

Supervised over 30 phase 2-3-4 studies

Successfully organized winning bid (with PSI International) to support FDA’s AERS platform Successfully organized medical component of defense of FDA, scientific societies in pedicle screw litigation

 

NYCOMED R&D INC., Collegeville, PA (1993-1995)

(formerly Diagnostic Imaging Division, Sterling-Winthrop Inc. [SWPRD]) Director, Medical & Scientific Affairs 

Responsibilities:

Provide strategic & operational support (phase 1-3) for the development of:

1. imaging compounds (radiographic contrast agents, ultrasound compounds & MRI compounds — alliance with Nycomed AG [Norway])
2. cardiovascular compounds (alliance with Sanofi [France])

Accomplishments:

Imaging: multiple line-extension approvals for iodinated contrast agents & MRI contrast agents. Imaging: pre-registration development of ultrasound contrast agent

CV: operational support of two major programs for clopidogrel: CAPRIE & CURE

Assisted in organizational changes following Kodak divestiture and integration into Nycomed AG

 

NOVO NORDISK PHARMACEUTICALS, INC., Princeton, NJ (1992-1993)

Director, Clinical Development 

Responsibilities:

Oversight of all registration (phase 1-3) activities in North America for all Novo Nordisk compounds, including the current EU marketed portfolio as well as the R&D pipeline

Member, global clinical council (heads of the European, Asian & North American R&D centers along with the headquarters staff) – senior clinical strategic body

Accomplishments:

Diabetes: initiation of nasal insulin (recombinant human form) pre-clinical studies

Metabolism: initiation of phase 2-3 studies for recombinant human growth hormone; now approved in US

Women’s health: initiation of phase 2-3 studies for a variety of hormone replacement therapy products, including Vagifem®, now approved in US

Thrombosis: initiation of phase 1-2 studies in US for logiparin, a low molecular weight heparin, now approved in US

Hematology: initiation of phase 1 study in US for NovoSeven® (human recombinant factor VIIa), now approved in US

 

BRISTOL-MYERS SQUIBB COMPANY, INC., Princeton, NJ (1987-1992)

(Pharmaceutical Research Institute) (1990-1992) Director, Cardiovascular Clinical Research

Responsibilities:

Provide global strategic and operational support (phase 1-3b) to:

• the hypertension, congestive heart failure and anti-arrhythmia sections of the CV group
• the cardiogenic shock and trauma section of the CV group

Provide clinical guidance to the entire CV group on the use of imaging in clinical trial design

Accomplishments:

Successfully completed clinical & regulatory program leading to the approvals of 2 next- generation ACE inhibitors

Successfully completed phase 1-2 program with a thromboxane receptor antagonist

 

(Squibb Diagnostics) (1987-1990)

Medical Director, Worldwide Clinical Research

Responsibilities:

Help expand business outside of current geographic scope (US, Canada) Provide medical strategy for & implementation of:

development of new business areas, i.e., MR imaging; PET imaging; ultrasound imaging

development of new compounds, in existing and future business areas, i.e., cardiac & cerebral perfusion imaging; SPECT imaging

line extensions to current portfolio, e.g., low osmolar iodinated contrast agents

Accomplishments:

Initiated development programs in Europe and Japan, ultimately leading to product approvals in both regions

Multiple line extension approvals (sNDA) for iodinated contrast agents, radiopharmaceuticals, leading to increased revenue

Multiple new entity approvals (NDA), including the first PET pharmaceutical approved by FDA and a first-in-class radiopharmaceutical for myocardial perfusion imagi

 

MEDICAL COLLEGE OF WISCONSIN, Milwaukee, WI (1983-1987)

Chief, Nuclear Medicine Service, Veterans Administration Medical Center Assistant Professor, Dept of Radiology, Division of Nuclear Medicine 

Responsibilities:

Typical senior academic and clinical role at a university-based, tertiary referral center

Member, Service Chiefs’ Committee, headed by Chief of Staff of Medical Center – senior operational and policy making body

Patient care: providing nuclear medicine (including cardiovascular nuclear medicine, SPECT and PET) imaging clinical services, as well as supervising the radioimmunoassay lab, providing diagnostic services

Teaching: Lectures, clinical supervision for medical students, residents, fellows, as well as faculty for MCW-sponsored symposia and guest faculty for other sponsored symposia

Research: Human and preclinical research involving novel imaging compounds (radiopharmaceuticals, contrast agents) and novel devices (single-photon, PET, and SPECT imagers)Accomplishments:

Provided clinical services to 35-50 patients/day, including teaching responsibilities

Conducted research resulting in multiple presentations at national & international meetings and in multiple manuscripts published in peer-reviewed journals

 

MASSACHUSETTS GENERAL HOSPITAL, Boston, MA (1981-1983)

Staff Physician, Nuclear Medicine Division & Instructor, Radiology (Harvard Medical School) 

Responsibilities:

Typical academic and clinical role at a university-based, tertiary referral center

Patient care: providing nuclear medicine (including cardiovascular nuclear medicine, SPECT and PET) imaging clinical services

Teaching: Lectures, clinical supervision for medical students, residents, fellows, as well as faculty for Harvard/MGH CME symposia

Research: Human and preclinical research involving novel imaging compounds (radiopharmaceuticals, contrast agents) and novel devices (single-photon, PET, and SPECT imagers)

Accomplishments:

Provided clinical services to 40-55 patients/day, including teaching responsibilities

Conducted research resulting in multiple presentations at national & international meetings and in multiple manuscripts published in peer-reviewed journals

 

EDUCATION

 

Massachusetts Institute of Technology, Cambridge, MA

BS (Electrical Science & Engineering), 1970

 

Yale University School of Medicine, New Haven, CT

MD, 1974

 

University of Minnesota, Minneapolis, MN (1974-1978)

Intern, Department of Surgery (1974-1975)

Resident, Department of Neurological Surgery (1975-1976)

Resident, Department of Diagnostic Radiology (1976-1978)

 

Harvard Medical School, Boston, MA (1978-1981)

Fellow, Cardiovascular Nuclear Medicine (1978-1979)

Fellow, Joint Program in Nuclear Medicine (1979-1981), (First Fellow with joint research appointment in Cardiology and Nuclear Medicine) Resident,

 

LICENSURE & CERTIFICATION

Diplomate, National Board of Medical Examiners (1975) Certification, American Board of Nuclear Medicine (1981)

Licensure: Massachusetts (1978-1984), Wisconsin (1983-1988); Pennsylvania (1988-2000)

 

AWARDS & HONORS

Eta Kappa Nu (National Electrical Engineering Honorary Society) (1968) Tau Beta Pi (National Honorary Society) (1969)

Sigma Xi (National Scientific Research Honorary Society) (1969)

Associate Fellow, American College of Cardiology (ACC) (1991)

Listed in:

Directory of Medical Specialists Who’s Who in the East

Who’s Who Registry of Global Business Leaders

 

MEMBERSHIPS

American College of Cardiology (ACC) American College of Nuclear Physicians (ACNP) American College of Radiology (ACR) Association for Computing Machinery (ACM) Drug Information Association (DIA)

Food, Drug & Law Institute (FDLI)

Member, Drugs & Biologics Committee (2012- present) Institute of Electrical and Electronics Engineers (IEEE) International Society of Thrombosis & Hemostasis (ISTH) New York Academy of Sciences (NYAS)

Radiological Society of North America (RSNA) Society of Magnetic Resonance in Medicine (SMRM) Society of Nuclear Medicine (SNM)

 

PUBLICATIONS

6 book chapters

1 commercially distributed software package

45 presentations at national meetings

>100 abstracts and scientific exhibits

40 published articles in peer-reviewed journals.