Itzchak Angel, Ph.D.

 Private/Business: 22 Lotus Street, Nes-Ziona, Israel 74045 ► Telephone +972-8-9380323

► Mobile: +972-544-300795 ► email: angelpct@gmail.com   ► www.angelpct.com

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 Qualifications:

Accomplished executive in the Pharmaceutical Industry, with over 30 years experience in guiding strategic drug- and business- development in both large and emerging Companies. Effectively established Discovery, Research and Development Teams and Projects and brought several pharmaceutical drugs to market. Excellent communicator and negotiator who led international projects and interfaced with high profile regulatory, government and industry leaders. Have been involved in raising venture and strategic partner financing. Have extensive relationships and contacts in the pharmaceutical industry, academia, and professional organizations.

Areas of Expertise:

• Ethical Drug Development
• Discovery, Research & Development
• Human Resource Management
• Small molecules, biologics, drug delivery and medical devices
• Strategic Planning
• Risk assessment strategies
• Business Development
• Critical Company and Product review
• Instruction and education in Drug Development
• Personnel, Budget, Time-line Management & Control
• International Regulatory Affairs
• National & International Project Management
• Multilingual Communication & Negotiation Skills

Accomplishments:

• Initiated and built research programs in several therapeutic fields, research structures and facilities.
• Contributed to the discovery, research, optimization, development, and marketing of numerous drug leads and marketed pharmaceuticals (including zolpidem (Ambien®), alfuzosine (Xatral®, UroXtral®), mizolastine (Mizollen®) and Migpriv®) as well as to the development of numerous compounds across all phases of drug development.
• Developed, managed and supervised budgets, time-lines and personnel in both international and emerging Pharmaceutical Organizations.
• Successfully involved in initiation, discussion, negotiation and completion of several in- and out-licensing activities, asset evaluation and of corporate and scientific partnerships.
• Successfully transformed a Discovery- and Technology-oriented company into a fully integrated Drug Development Company
• Involved in raising venture and strategic partner financing.
• Created the Israeli Pharmalogica Consortium, which assembles some of the key players of Israeli Pharmaceutical Industry with Academia and Governmental Institution
• Serving as President and Chairman of the Israeli Pharmalogica Consortium
• Served as consultant for the Israeli Chief Scientist.
• Gives courses in Drug development and regulatory affairs to executives in Life Sciences
• Elected to represent the Israeli Biotechnology in the High Level French-Israeli Advisory Committee and serves as an active member
• Consult to Israeli and European drug, biotechnology and device companies.

Professional Experience:

July 2005 – Present

President and CEO, Angel Pharmaceutical Consulting & Technologies (A.P.C.T.) Ltd., Nes-Ziona, Israel.

Give Consultation to and assist Life Sciences companies in Strategic and Operational issues related to Ethical Drug Development (from Research through Preclinical and Clinical, up to marketing), Regulatory Affairs, Business Development and Planning and Organization

• Expertise in Small molecules, Biotechnology product, delivery system, medical devices and drug device combinations.
• Planning and assistance in organization of meetings with FDA or other Regulatory Authorities
• Assistance in the evaluation, selection and negotiation with CROs
• Assist companies in Fund Raising, Licensing activities and Scientific collaborations
• Interacts with Investors and Venture Capital companies in the assessment of investments and in Business Development activities
• Interfaces with European, Asian and US companies on potential Business, Collaborative and Scientific Activities inIsrael
• Give courses (public and company based) on Drug development, Risk assessment strategies, Regulatory affairs and optimal company organization strategies

February  2014 – Present

Founder and CEO, Novitero Ltd. Nes-Ziona, Israel.

• A new company established by Dr. Itzchak Angel to design and develop new small molecule drugs based on validated novel targets and using computer based dynamic molecular and structural design.

November 2012-January 2017

Director and CEO, Accellta Ltd., Israel

• A new company established by the Technion and the Alfred Mann Institute at the Technion (AMIT) to commercialize stem cell technologies that were developed in the last decade by Professor Joseph Itskovitz-Eldor, a pioneer and world leader in the stem cell filed.

September 2007 – August 2013
Vice President, Business Development, Cardiamit Ltd., Israel (part-time).

•  Reporting to the CEO and part of the Executive Management Team, having responsibility for the overall management of Regulatory affairs & Business Development
• Actively involved in the identification and screening of companies for out-licensing opportunities, collaborative agreements and in-licensing actions
• Hold overall management responsibility for development, pre-clinical and clinical activities at Cardiamit Ltd.
• Selects, manage and in-charge of all outsourcing activities in Cardiamit Ltd

December 2006 – February 2012
Vice President, Drug & Business Development, GalMed Medical Research, Israel(part-time).

•  Reporting to the CEO and part of the Executive Management Team, having responsibility for the overall management of Business Development

• Developed the lead compound Aramchol successfully from early pre-clinical studies up to Phase-II clinical trials
• Actively involved in the identification and screening of companies for out-licensing opportunities, collaborative agreements and in-licensing actions
• Hold overall management responsibility for development, pre-clinical and clinical activities at GalMed.
• Selects, manage and in-charge of all outsourcing activities in GalMed.
• Involved in research and development in several areas such as Cholesterol reduction, Fatty Liver and Gallstone management.

December 2006 – September 2012
Vice President, Drug & Business Development, Novotyr Therapeutics Ltd., Israel

 (part-time).

• Reporting to the CEO and part of the Executive Management Team, having responsibility for the overall management of Business Development
• Actively involved in the identification and screening of companies for out-licensing opportunities, collaborative agreements and in-licensing actions
• Hold overall management responsibility for development, pre-clinical and clinical activities at Novotyr Therapeutics Ltd.
• Selects, manage and in-charge of all outsourcing activities in Novotyr Therapeutics Ltd.

January 2007 – August 2007
Chief Technology Officer, BioVent Ltd, Israel (part-time).

• Reporting to the CEO and part of the Executive Management Team, having responsibility for the overall management of Research and Development at BioVent.
• Hold overall management responsibility for development, pre-clinical and clinical activities at BioVent.
• Select, manage and in-charge of all outsourcing activities in BioVent.
• Involved in research and development in several areas such as Influenza and Bird Flu management.

January 2006 – December 2006

Vice President, Research and Development, Proteologics Ltd., Rehovot, Israel

(part-time).

• Reporting to the CEO with regular interface with the Board of Directors and Scientific Advisory Board (Including Nobel Laureates Profs. Hershko and Chiechanover).
• Hold overall management responsibility for screening, compound selection and development activities at Proteologics
• Responsible for the discovery, identification, optimization and development of novel, ethical and proprietary compounds in diverse therapeutic fields.

• As support of Business Development, actively involved in the identification and screening of opportunities, out-licensing activities of clinical compounds and drug delivery technologies, collaborative agreements and in-licensing actions.
• Involved in research and development in several areas such as Anti-virals and Cancers.

March 1998 – August 2005

Vice President, Research and Development, D-Pharm Ltd.,Rehovot,Israel.

• Reporting to the CEO and part of the Executive Management Team, with regular interface with the Board of Directors and Scientific Advisory Board.
• Hold overall management responsibility for discovery, pre-clinical and clinical activities at D-Pharm.
• Responsible for the discovery, identification, optimization and development of novel, ethical and proprietary compounds in diverse therapeutic fields.
• Involved in two financial rounds, totaling $45M.
• Assemble the research and development team and successfully brought the company from a staff of 20 to 120, organized to GLP, GMP and GCP standards in a multi-functional, fully integrated, ethical and regulatory-compliant pharmaceutical company.

• As support of Business Development, actively involved in the identification and screening of opportunities, out-licensing activities of clinical compounds and drug delivery technologies, collaborative agreements and in-licensing actions.
• Involved in research and development in several areas such as Stroke, Epilepsy, Alzheimer’s’ Disease, Parkinson’s disease, Blood and Tumor Brain Barriers, Brain and Gastrointestinal transport mechanisms, psoriasis and Cancers.

January 2002 – September 2005

President and Chairman, Pharmalogica Consortium, Israel

• Created and served as President and Chairman of the Israeli Pharmalogica Consortium, which assembled some of the key players of Israeli Pharmaceutical Industry with Academia and Governmental Institution targeting optimal and collaborative Predictive ADME-Tox in Drug Development
• Led the capture, implementation and management of >$12 M government support
• Interacted with high profile government, academia and industry leaders to lead, coordinate and optimize function of the Consortium
• Timely met Industry and Government Goals and Milestones for the development of innovative ADME-T technologies

February 1996 – March 1998

Department Head of Pharmacology, Internal Medicine, Synthelabo Recherche

(now Sanofi-Aventis), France.

Under several capacities during the 12 years at Synthelabo:

• Directed all facets of scientific, developmental, P&L, project management and marketing support in various therapeutic areas.
• Initiated and subsequently expanded activities in the areas of Metabolic Disorders (Type-II diabetes, Obesity), Gastroenterology; Urology; Allergy, Pain and Inflammation and anti-histamines.
• In-charged of the pre- and clinical development of prokinetic 5-HT₄ agents, anti-emetic 5-HT₃ antagonists and combination products.
• Established new research and development units in Urology and in charged of research and development of compounds for BPH and Urinary Incontinence.
• Established novel research methodologies in the fields of erectile dysfunction and urinary incontinence.
• Created scientific teams investigating the pre- and post-synaptic regulation of monoamine functions.
•  Initiated and advanced to clinical development novel SSRIs for obesity and depression and anti-diabetic compounds acting on alpha-2 adrenoceptors.
• Participated in asset evaluation and in- and out-licensing activities of compounds in the filed of expertise.

• Contributed to the discovery, research, optimization, development, and marketing of numerous drug leads and marketed pharmaceuticals (including zolpidem (Ambien®), alfuzosine (Xatral®, UroXtral®), mizolastine (Mizollen®) and Migpriv®) as well as to the development of numerous compounds across all phases of drug development.

Jan. 1995 – Feb. 1996            Section Head of Internal Medicine, Synthelabo Recherche (L.E.R.S.), France.

Dec. 1993 – Dec. 1994            Chief, Urology, Gastro-Enterology and Metabolic Disorders Group, Synthelabo Recherche (L.E.R.S.), France.

June 1992 – Dece 1993          Chief, Metabolism and General Pharmacology Group, Synthelabo Recherche (L.E.R.S.), France.

July 1990 – June 1992          Group Leader, Metabolism and General Pharmacology Group, Synthelabo Recherche (L.E.R.S.), France.

May 1986 – June 1990          Chief, Neurohormonal Receptor Unit.

Synaptic Receptors Group, Synthelabo Recherche (L.E.R.S.),France.

Nov. 1985 – Apr. 1986           Visiting Associate, Clinical Neuroscience Branch, National Institute of Mental Health,Bethesda,Maryland,USA.

• In-charged of initiating and conducting research in the field of regulation of body weight, gluco-receptors, monoamine uptake, anti-depressant drug action, dopamiergic neurotransmission and search for endogenous modulators of these processes.
• Expertise in brain functions, receptor and transporter physiology and pharmacology, HPLC methodologies.

Education:                     

1982 – 1985                              Post Doctoral Fellowship – Clinical Neuroscience Branch, National Institute of Health, Bethesda, Maryland, USA.

Advisor:  Steven M. Paul

1980 – 1982                              Ph.D. – Hamburg University,Germany: Neurochemistry.  Subject of Ph.D. Thesis: “Calcium Control of GABA Synthesis and Uptake in Synaptic Vesicles and in Reconstituted Phospholipid Vesicles System”.

Advisor:  Alfred Fleissner

1979 – 1980                     M.Sc. – Tel-Aviv University,Israel: Biochemistry.

Subject of Master Thesis: “Mechanisms of Storage and Uptake of Acetylcholine in Torpedo Synaptic Vesicles”.

Advisor:  Daniel M. Michaleson

1976 – 1979                          B.Sc. – Tel-Aviv University,Israel: Biology.

Taking part in a special curriculum for outstanding students.

Honors and Awards:

1976 – 1978                              Honor Programs for Outstanding Students

1978                                                   Rector’s Award for Outstanding Achievements

1980 – 1982                                      DAAD Fellowship,HamburgUniversity

1982  –1985                              Fogarty Post-Doctoral Fellowship, National Institute of Mental Health NIH.

Society Memberships:

• New YorkAcademyof Science
• BIO
• American Association of Pharmaceutical Sciences
• European Association for the Study of Diabetes
• European Association of Urology
• American Heart Association
• American Epilepsy Society
• Society for Neurosciences
• American Diabetes Association
• French Pharmacological Society
• Society for the Study Ingestive Behavior

Journal Refereed:

• Life Sciences
• European Journal of Pharmacology
• Diabetologia
• American Journal of Physiology
• Fundamental and Clinical Pharmacology
• Drug Investigation

Languages:

Hebrew:         Mother Tongue

English:         Spoken and Written

French:          Spoken and Written

German:        Spoken and Written

Computer skills:

Microsoft:      PowerPoint, Excel, Project, Word; Several Photo-editing programs