Prospects of Manufacturing Bio Technology Products in Pakistan - ZAUQ LIFT Conference Key Note 2019

Dr. Shafeeq Haider Director, Life Sciences shafeeq.haider@zauq.com www.zauq.com

Ex Senior Executive– -PKLI & RC - Pakistan Pakistan Kidney and Liver Institute & research Center Dr. Sulaiman Habib Medical Group – Saudi Arabia IGSAR Group – Canada Medical Doctor with over 30 Years international experience in Healthcare Manage Extensive cross-disciplinary knowledge of various verticals i.e. Finance, Mark Human Resource, Administration, QA, Biomedical, Project Management, Telemed Procurements, BPOs/KPOs/ITES, Clinical Research etc.

Contents Introduction Global Outlook Pakistani Context Local Manufacturing of Vaccines • Monoclonal Antibodies • Blood products • End of Presentation • • • •

Biotechnology Introduction • The art of utilizing living organisms and their products for the production of food, drink, medicine or for other benefits to the human race , or other animal science.

• 4th Industrial Revolution • OECD predicts 1/3rd of Total World Economy will be based on Biotechnology

Types of Biotechnology • Bioinformatics: biological problems using computational techniques.

• Blue biotechnology: marine and aquatic applications.

• Green biotechnology: applied to agriculture processes.

• Red biotechnology is applied to medical process. This include pharmaceutical drug discovery and production, genetic testing and pharmacogenomics.

• White biotechnology, also known as industrial biotechnology.

Difference Between Biologic And Drug Biologic Product • Manufactured in a Living System • Large Molecule • Process is the most important product • Clinical Trials are conducted for equivalence with originator

Pharmaceutical Drug • Manufactured through chemical Processes in machines • Small Molecules

• Tangible Drug is the product • Bioequivalence is done to compare with originator

Market Size Pharmaceuticals reaching 1 Trillion US$

Biotechnology Crossing 400 Billion US$

• Past Growth Dip of less than 3% but now Growth spurt of 6%+ is expected in coming years

• In Last 2 months Biotech start-ups have raised more money then in one full year in past

Potential Areas Of Interest

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WORLD FIRST CADUCEUS SHAPED BIOTECHNOLOY FACTORY (cGMP, FDA)

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Biotechnology Ecosystem In Pakistan

More than 30 Biotechnology Research Institutes More than 45 University Programs in Biotechnology

Support System Signatory WHO Convention on Biological Diversity, and Cartagena protocols.

Several legislations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have been promulgated in the country.

National Bio-safety Guidelines have been promulgated. IRBs/Ethics Committees/CRO/SMOs.

Is Pakistan Ready For Biologic Manufacturing?

History Surprisingly Biotechnology Manufacturing started in Pakistan in 1948.

Heavily Public Sector dominated sector Most Agro focused BT cotton success story; saving of 4 Billion US$.

Genome mapping of Dr. Ata Ur Rehman in 2011 in just one tenth of cost.

Current Status In Public sector, only 1 NIH Biologic Production Division working. 8% local production vs 92% imported. Very few Private Sector facilities, mostly closed (Interferon). Strategic need of Pakistan to be self reliant on biological products especially in Vaccines. We need to be prepared for Post Gavi times.

SOME SUGGESTIONS & STRATEGY Strengthen BPD NIH to produce more Turn around existing Biologic sick units

•. Initially focus on non-EPI vaccine manufacturing Gradual ToT starting with Bulk filling Halal Biologics Rejuvenation/Wellness Biologics Insulin Manufacturing Manufacturing of Monoclonal Ab, Stem Cells, etc ATMP (Advanced Therapy Medicinal Products) ie Stem cell.

SWOT Analysis Strengths Basic infrastructure (esp HR) getting available locally Diaspora support Government Support Private sector support

Weaknesses

S W O T

Opportunities Least Competition Technology could also be sourced now from various international sources

Capital Intensive HR/infrastructure needs further upgradation/training

Threats Very strict Regulatory framework (whichis good in a way) Lower cost, competitive imports (with questionable quality)

Attractive Opportunity in Vaccines Market Market for vaccines is expected to grow from USD 36.45 billion in 2018 to USD 50.42 billion by 2023, at a CAGR of 6.7% from 2018 to 2023.

High prevalence of infectious diseases, growing support for vaccine R&D, investments into vaccine development, and a rising focus on immunization.

Monoclonal Antibodies These are Antibodies which SPECIFICALLY bind to particular target proteins on cell surface and alter their effects.

They are identical clones from a single parent immune cell.

MAbs are used in the treatment of cancer, transplantation of bone marrow and organs, autoimmune diseases, cardiovascular diseases and infectious diseases.

Blood Fractionation Project

BLOOD FRACTIONATION PROJECT Total Blood Volume Collected Globally: More than 40 Million Ltr 21 Million Ltr Plasma yield (If separated) but only 12 Million Ltr Plasma separate 9 Million Ltr is discarded ( 40% loss) India, China, Korea, Japan and mostly Western countries Ref: WHO

International Contract Fractionation (ousourcing) is viable on 30,000 to 50,000 Ltr Establishment of local facility viable on 300,000 Ltr/Yr SBTP already has a network of Blood collection facilities with capacitiy exceeding 350,000 Ltr. So despite having raw material, no industrial scale fractionation is done. We still import plasma related products. Their collection system is cGMP, GLP certified and working through German Government Support.

GMP/GLP certified SBTP

Collection Screening Components

RBC

FFPs

Platelet

Refriegerate

Storage/Freeze

Agitate

Transport

Transport

Transport

Plasma-derived medicinal products (PDMP) IG

BLOOD COAGULATION

Hepatitis B

Factor VIII (Hemophilia A)

Rabies

Factor IX (Hemophilia B)

Tetanus

Von Willebrand Factor

Anti Rho

Factor XII & XI

VZ .Chicken Pox

Prothrombin

Immune deficiency (Replacement)

Fibronogen

PROTEASE INHIBITORS

ANTICOAGULANT

Antiothrombin

Protient C

Alpha 1 Antitrypsin ALBUMIN

CALL TO ACTION

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Dr. Shafeeq Haider Director, Life Sciences shafeeq.haider@zauq.com www.zauq.com Ex – Pakistan Kidney and Liver Institute -PKLI Medical Doctor with over 30 Years international experience in Healthcare Management. Extensive cross-disciplinary knowledge of various verticals i.e. Finance, Marketing, Human Resource, Administration, QA, Biomedical, Project Management, Telemedicine, Procurements, BPOs/KPOs/ITES, Clinical Research etc.