Peter H. Kalinka

EXTERNAL CONSULTANT – BIOPHARMACEUTICALS DEVELOPMENT AND MANUFACTURING

• Extensive knowledge of

Biologics,Vaccines, Pharmaceuticals

and Class III Medical Device

Development from Lab to

Manufacturing Scale.

• Establishment of a Clinical Research

Organisation and global Clinical Trial

Direction

• Extensive understanding of regulatory

requirements in highly regulated

markets (FDA, EMA, Health Canada,

Anvisa, etc.)

• Manufacturing facility planning and

construction (USA, Brasil, Canada,

China)

• Extensive experience in budgeting

development projects and facilities

• Consulting and Project Direction

Experience in the across the globe

including MENA, China, India, Taiwan

• Global level networking across the

entire Biopharmaceutical Industry

• Diversified experience across

Pharmaceuticals and

Biopharmaceuticals Space

− Biologics, Vaccines, Gene and Cell

Therapy

− Pharmaceuticals

− Medical Devices

− Facility Planning and

implementation

− Budgeting

• Executive Industry Positions at

• Sandoz

• Ares Serono

• Novartis

• Biopartners

• Establishment of own

Biopharmaceutical Consulting

Companies ad CRO’s

• Presently: Longmore 60

Biotech Inc.

• 30+ years of expertise ranging across

Biopharmaceutical Drug development, including but

not limited to Biologics, Biosimilars, Vaccines GCT and Medical Devices. Process Development of

pharmaceutical Macromolecules such as Collagen

and Hyaluronic acid.

• Cloning, Process Development, Scale Up, Tech.

Transfer, Clinical Trials, Regulatory Affairs (FDA, EMA, Health Canada, Anvisa etc.)

• Candidate Evaluation and Selection

• Manufacturing Facility planning, construction,

implementation and operation. Budgeting,

Equipment, Vendor Selection

• Due Diligence – Investors, Partnering, Acquisitions, Joint Ventures

• Selection, Hiring and Management of relevant

Personnel

• Expert Witness – technical, patent litigations

• Establishment of complete

Biopharmaceutical Divisions at

Novartis/Sandoz and Apotex

• Direction of the Development of more

than 20 Biopharmaceuticals with

several approvals in the EU, US, Canada

and Australia.

• Development of Pharmaceuticals and

Medical Devices

• Planning and Set-Up of Manufacturing

Plants (Biopharmceuticals,

Pharmacceuticals, Vaccines, GCT) in

Europe, Canada, USA, Brasil and China.

• Lecturer at Universities in Europe and

the US.

• Successful involvement an Expert

Witness in high level patent disputes

Held Executive Positions at high level Pharmaceutical Organisations such as Sandoz, Novartis, Ares-Serono, Bio Partners, etc. Established Consulting Firms and CRO’s latest Longmore 60 Biotech Inc., Palm Springs, USA

Dr. Peter H. Kalinka

• PH.D.

Education

What I bring to the Team

Industry Expertise

Functional Expertise Career Highlights

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