Dr. Kumar Gadamasetti, Short CV

May ****, San Francisco, CA

1

Biographical Sketch

Dr. KUMAR GADAMASETTI, Ph.D.

CONTACT:

**** **** ******** ***

Belmont, CA 94002

(San Francisco Bay Area)

650-***-**** c; 650-***-**** land line

acuzct@r.postjobfree.com

Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. Over the past 25 years he has been working in pharmaceutical preclinical and clinical drug dev. (Chemistry of API: Process R&D and Manufacturing) in key therapeutic areas of cancer, CV, CNS and Infectious diseases and familiarity with regulatory compliance (IND-CMC & Clinical supplies). He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen Inc, CA-USA) as well as mid-size and start-up companies (Discovery Partners International, CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). HIGHLIGHTS:

Areas of Leadership, General Management

Leadership, strategic Vision, analytical mind-set / skills and Matrix Management

Strong in Operations, Cost containment, Productivity and Budget Management

Project, program and portfolio management (lean methods)

building with consensus and mentoring

Fund raising, building infrastructure and value creation with start-up companies Areas of Technical Expertise and Management

Pharmaceutical Dev. (preclinical-clinical) (cancer, CV, CNS etc) of chemistry of drugs

API Process R&D (optimizing synthetic routes and Kilo-labs scale-up) of Small molecules

Manufacturing of API (cGMP Kilo-labs and scale-up)

Outsourcing (preclinical & clinical supplies) of API

Regulatory Aspects (CMC-IND, NDA docs, DMF and ANDA filing familiarity, QbD:QC-QA)

Intimate knowledge of Lead candidates to clinical candidates; and formulations (DP)

Publications and presentations in national and global pharma/biotech conferences Areas of Editorial, Academic, Global Discovery-Development Conferences and Workshops

Chairmanship of global conf.: ‘Process Chemistry in the Pharmaceutical Industry’

Int Editorial Board member, ‘Organic Process Res & Dev. (ACS Process J., 2001-2015)

Visiting professor (Catholic U., Louvain, Belgium; U. Pittsburgh, PA, USA)

Edited two volumes on, Process Chemistry in the Pharmal Industry (see p6 - 1999, 2008)

Founder & Chairman, ‘ACSProspectives, ‘Chemistry in the Pharma Industry’ (2002-2004)

Conduct workshops (QbD and Project Management of DSDdev.) [2010-current] HIGHLIGHTS: API Process R&D /Manuf., Regulatory Compliance and Project Mgmt Proficiency

AMGEN: CinacalcetTM (SensiparTM; in Market)- API (small molecules) Process R&D and Manufacturing Regulatory Compliance – IND/ Phase 0 –Ph I; IND-CMC; FDA-1998. Clinical – cGMP Kilo-labs, IND & Clinical supplies of API (AMG073; outsourced in Japan)

Bristol-Myers Squibb Co.: API Process R&D and Manufacturing: Small Molecules

(Cancer, CNS, CV and infectious diseases and Biologics-mAb & ADCs (BR96 DOXTM)- Paclitaxel®(Blockbuster in Market)–Process R&D, DS Final form., and Manuf. Ph1 NDA

Certum LLC.: Biologics mAb process familiarity; Sepsis (mAb) Diagnostic Kits and 510K appln. Consulting on API (small molecules) process and manufacturing

Discovery Partners International: Multi-PM of drug-like small molecules – Development, Manufacturing of API (Process R&D and Manuf.); marketed internationally.

Delphian Pharmaceuticals: Cancer Drugs - Ph-0; Drug Dev and API (PR&D and Manuf.). Dr. Kumar Gadamasetti, Short CV

Apr 24, 2015, San Francisco, CA

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INDUSTRIAL (PHARMA & BIOTECH) EXPERIENCE

Certum LLC – Belmont, CA Operating Officer

[Oct 2011 – Current] – A Biologics Drug Development and a Consulting Company A pharmaceutical and biopharmaceutical drug development and a consulting company focused in screening/selecting and licensing-in projects/programs (Industry, NIH/NCI and academia) in the areas of cancer therapeutics (Antibody Drug Conjugates-ADCs and small molecules) and diagnostic kits (sepsis mAb biologic kits; 510K). Drug Development, process R&D and Manufacturing of API and outsourcing. Projects:

Biologic drugs (Cancer target identification, mAbs and Antibody Drug Conjugates - ADCs). Sepsis Diagnostic Kits (R&D and manufacturer; familiarity with mAbs and 510K appln. process Small Molecules (proprietary conventional small molecule cancer drugs) API and ADC linkers. Activities:

Strategy-planning and Analytics

Identifying CROs and CMOs for outsourcing of API

Outsourcing (pre-clinical and clinical cGMP supplies of API) Matrix management of various CRO personnel

Project Management (MS Project and MS Excel for PM) Regulatory (CMC-IND documents) compliance

Team & Personnel:

Based on the project(s) hire the consultants and work in teams with expert-specific groups Accomplishments:

Actively consulting on, discovery and development of Antibody Drug Conjugates (ADCs) Actively consulting on, small molecules process optimization, scale-up and regulatory aspects Sepsis diagnostic kits (mAb based) business to Asia for development, manuf. and marketing. Consulting and Project Management

API Process Dev.– (Malvern, PA); DP Formulations – Horizon Therapeutics (CA) Delphian Pharmaceuticals Inc., South San Francisco, CA Operating Officer

[2003-2010]

A Pharmaceutical Cancer Drug Discovery and Development Company Projects:

Therapeutic Areas

Class MOA Cancer Non-Cancer

1. Anti-tubulins Tumor Vascular Ovarian, Breast

Disruption (TVDA) Leukemia

Tumor Stem Cells Various cancers

2. Anti-angiogenesis Dual Inhibition Solid Tumors Rheumatoid Arthritis, and Cytotoxic VEGF/PDGF & DHFR AMD Macular Degeneration 3. Anti-Folates DHFR / TS Inhibition NSCLC, Lever Psoriasis, Renal, Leukemia Rheumatoid Arthritis

Investors: Japanese private investors

Activities:

Strategy-planning and Analytics

In Licensing projects from Academia and NIH/NCI

Cancer Drugs - Multi-PM of Ph 0 Drug Dev and API

Dr. Kumar Gadamasetti, Short CV

Apr 24, 2015, San Francisco, CA

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Outsourcing of API process / manuf. to CROs and Academia for chemistry and biological testing Multi-Project Management (MS Project and MS Excel for PM) Team & Personnel:

Executives (3), consultants (3) and work in teams with expert-specific groups (up to 8-10) Accomplishments:

Cancer drug leads were promoted to Japanese drug developers X-Mine Inc., Brisbane, CA Chief Operating Officer

[2002-2003]

(The Company is a joint venture of talents between Stanford University and MIT Whitehead Institute). X-Mine Inc. in 2002- licensed-out Opus and X-Miner to Isis Pharmaceuticals in CA. Opus is a biological knowledge database developed and X-Miner is a gene expression analysis system developed by X-Mine. X-Miner is distinguished by a number of supervised learning tools which allow researchers to pose biologically relevant questions when analyzing large and complex data sets with emphasis on rigorous statistical validations.

Projects:

Study on NCI cell lines, Biomarkers, Leads from Gene expression and relate to NCEs/Drugs Team & Personnel: 25-30

Accomplishments:

Licensing-out Opus and X-Miner to Isis Pharmaceuticals in CA. Road shows at Eli Lilly, Bristol-Myers Squibb Co and other companies for potential deals. Discovery Partners International Inc., [CRO], South San Francisco, CA Senior Director

[2000-2002]

A CRO focused in discovery and development of ‘Drug-like Combinatorial Chemical Library of small molecules’; highly systems-managed and productivity oriented group management of scientific teams encompassing process R&D, manufacturing, cold-packaging and shipping to companies, globally. Revenue:

$12-15M annually; Revenue generation was reviewed on quarterly basis. Projects:

Combinatorial Libraries of Small Molecules (CV, CNS, Cancer and other therapeutic areas) Multi-projects and Protocols for revenue generation Activities:

Small Molecules Chemistry: ‘drug-like small molecules – Dev., Manufacturing and Marketing internationally.

Contract services of combinatorial ‘drug-like compound’ libraries and training customers. Strategy and planning

Budget & Scientific Team Management

Team & Personnel:

40-50 total (Development); direct reports (7 managers); 30-35 (Manufacturing). Accomplishments:

Multiple deals closed globally with large pharma, mid size and small biotech companies. AMGEN Inc., Thousand Oaks, CA Group Head

[1997-2000]

A leading Biotech company. Drug Discovery support group, API process R&D of small molecules, cGMP Kilo Laboratories, Clinical supplies manufacturing. Highlights:

Dr. Kumar Gadamasetti, Short CV

Apr 24, 2015, San Francisco, CA

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API: Process R&D (route selection, optimization, scale-up), cGMP Kilo lab and manufacturing

Lead candidate from NPS was Developed (Process R&D / Manuf.) and Marketed – CinacalcetTM Projects:

AMG-073 (Calcimimetics drug optimization of large scale API route; outsourced clinicals of API. Development of NPY drug leads, multi-analogs

-secretase Drug lead development and multi-analogs V 3 Drug lead development and multi-analogs

Activities:

Strategy and planning and Budget Management

Project Management and CMC key member for CinacalcetTM IND and Regulatory work API Process R&D and optimization of processes for Clinical manufacturing Kilo-lab and Manufacturing (cGMP material)

Outsourcing clinical cGMP campaigns (Japan and Eu) In-Licensing small molecules program (Team lead member) Team Management and Mentoring

Team & Personnel:

In the laboratories (8); CMO and CRO Outsourced (15-20) Accomplishments:

Building Kilo-labs first of its kind in CA for small molecules ($15-20M project) Optimizing the lead to drug AMG-073, Kilo scale and eventually clinical supplies of CinacalcetTM IND filing (CMC) and launch of CinacalcetTM

Bristol-Myers Squibb Co., New Brunswick, NJ Senior Scientist

[1991-1997]

A fortune 500 major Drug Discovery and Development Multi-National Company. API Chemical Process R&D and manufacturing (mostly Small Molecules and Biologics – ADCs) Highlights:

Taxol, licensed-in from NCI was developed to be a Blockbuster Drug (Marketed) – Paclitaxel®

Biologics-mAb & ADCs (BR96 DOXTM)-chemistry, analyses, scale-up and Regulatory Compliance Projects:

Therapeutic Areas - Small molecules and monoclonal antibodies and mAb-drug conjugates Anti-Cancer Taxol (Paclitaxel®) New Process; Campaign in multi-ton scale Biologics mAb Adriamycin Conjugates cGMP batches, Synthesis & Purification Drugs ADCs (BR96 DOXTM) handling; Patent filed

(Magic Bullets) Clinical Phase

Cardiovascular Endothelin antagonists Phase I/II clinical, Final Form Thromboxane Antagonist Process optimizations & method dev. CNS Anti-Migraine Substituted Indoles optimizations and scale up Infectious- Broad-Spectrum Carbapenem Cyclization - method development & Diseases Antibiotic, optimization

Anti-HIV Chiral synthesis–optimizations/scale up

Activities & Team & Personnel:

API Process R&D (several projects: route scouting, final route selection and scale-up) and manufacturing. Of note-worthy is Paclitaxel® (process development of final route for manufacturing of clinical campaign)

Managing one junior scientist (Team of 2)

Presenting papers in global scientific conferences, publishing and book writing. Dr. Kumar Gadamasetti, Short CV

Apr 24, 2015, San Francisco, CA

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Accomplishments:

Several small molecules synthetic route selection & optimization of routes in several therapeutic areas (Cancer, CV, CNS, Infectious diseases)

Commercial process of DS, Paclitaxel®and final crystallization of single desired morph (powder x-ray).

Taxol was licensed from NCI, developed and marketed as the Blockbuster drug, Paclitaxel®. Antibody Drug Conjugate (ADC), BR96DOX - Development of first Biologics Drug in Pharma EDUCATION

Ph.D. (1987) - U. of Vermont, Burlington, VT. Organic Chemistry - Total Synthesis of Aspidospema alkaloids leading to cancer drugs (Blockbuster drugs: Vinblastine and Vincristine).

Post Doctoral (1989-1991) – U. of Virginia, Charlottesville, VA; Medicinal Chemistry and Organic Chemistry – Synthesis, analyses and biological testing of Vinblastine analogs for cancer. PUBLICATIONS, PATENTS & BOOKS

Available on request

PROFESSIONAL EXPERIENCE (SNAPSHOT)

BOOKS: ‘Process Chemistry in the Pharmaceutical Industry’, on next page (p6) Dr. Kumar Gadamasetti, Short CV

Apr 24, 2015, San Francisco, CA

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PUBLISHED BOOKS ON, ‘PROCESS CHEMISTRY IN THE PHARMACEUTICAL INDUSTRY’

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