KENTRON BIOTECHNOLOGY PVT LTD · feasibility studies ( for medical devices), phase II and III clinical trials (for drugs). In addition to implementing high quality studies with novel

KENTRON BIOTECHNOLOGY PVT LTD

KENTRON - OBJECTIVE

Kentron provides support to the pharmaceutical and biotechnology industries in the

form of outsourced pharmaceutical research services in India (for both drugs and

medical devices).

We offer our clients the experience of moving a new drug or device from its conception

to regulatory marketing approval without the drug sponsor having to maintain a staff for

these services.

CUSTOMER AND MARKET SIZE The global pharmaceutical market will grow at about a 15% rate in 2019 to over $820 billion

and be worth over $ 5 trillion by 2020 and eventually worth over $ 50 trillion by 2030

Pharmaceutical and biotechnology companies in the US spent approximately $259 billion on R&D in 2019, which equates to roughly 18% of their sales and is a 5% increase from the previous year.

A significant portion of R&D budgets are used for the outsourcing services offered by the CRO industry, approximately $ 60 billion in 2019.

This figure is expected to grow at 15% over the next seven years and should increase further with the broadening of the spectrum of services outsourced to cover the entire value chain.

As outsourced services in developing countries such as India and china move up the value chain to cover phase 1 / 2 trials, the total contracts value may go up to $ 50 billion by 2020.

KENTRON PRESENCE

USA

Nanjing, China

Bangalore, India

Beijing, China

UK

MISSION & VALUESMission:

Provide high quality clinical research with an acute focus on patient safety, emerging technologies

and new research processes to build synergy between sponsors and patients We accomplish our

mission by identifying our customer’s needs, supporting the values of their organization, and

focusing on providing the best cost-efficient solution available.

Values:

Our corporate philosophy is centered on the idea that our people are our ultimate driving force.

Therefore, personal and professional development and employee satisfaction is an important aspect

of our operations. As a result, we have well-rounded team of experienced professionals in the

research industry to guide and execute a variety of customer engagements.

VISION

Generating value by delivering global excellence in clinical drug and medical device

development. To be the most admired outsourced Biotechnology / pharmaceutical

research service providers, based upon outstanding clinical drug development

programme planning, translational medicine expertise and paradigm shifts in clinical

study design and execution.

STRATEGY

Kentron edge arises from its outstanding technical assessment and product

development support capability.

An emphasis on technical assessment by world-class scientists within Kentron is

complemented by input from physicians who have held senior positions in global

pharmaceutical companies and been associated with the development of globally

prominent products.

KENTRON STRENGTHS

Experienced Management Team

India and China Cost Advantage

Strong Relationships with hospitals and research facilities throughout India

Cardiovascular Studies

Oncology Studies

Scientific Advisory Board comprised of World Leading Professors

Broad Services offering

Ability to Commercialize existing products for sale in the Indian and Chinese

marketplace

OPERATIONAL PRINCIPLES

Operate according to standard western practices. Manage the Company on basis of maximizing value creation Strategic management according to Igor Ansoff’s approach Directors responsible for in-country business success of Company Director Operations responsible for in-country medical and scientific excellence of

Company Weekly management meeting with the clients Low attrition of staff

KENTRON - ORIENTATION

Kentron provides support to the pharmaceutical and biotechnology industries in the

form of outsourced Biotechnology / pharmaceutical research services (for both drugs

and medical devices).

We offer our clients the experience of moving a new drug or device from its conception

to regulatory marketing approval without the drug sponsor having to maintain a staff for

these services.

We provide services to clinically develop the product candidates exclusively in Asia

We emphasize the design and conduct of clinical studies to western standards and

acceptance while leveraging the advantages of the territory (treatment naïve pts, large

pts population, low costs, etc.)

Our unique drug development programme is an exciting initiative, focusing on pilot

feasibility studies ( for medical devices), phase II and III clinical trials (for drugs). In

addition to implementing high quality studies with novel therapeutic agents, we will

continue to ensure optimal patient care.

90% Employees are postgraduates in clinical research & all employees are trained in

US FDA/ ICH GCP / EMEA (EU)/Schedule Y requirements

Employees have US FDA audit experience in India.

Our team is dedicated to help you take your product candidate from discovery through to

proof of concept and beyond.

Unique Risk Sharing Model

Unique Risk Sharing Model

Kentron brings the resources our partners need to progress their

programs through clinical development rapidly and provides them the

opportunity to participate in the value created as a result.

Our risk-sharing model is unique because our focus is to derisk

compounds for our partners with the option of delivering the compound

back to them for the next stages of development.

MANAGEMENT

Kentron is led by a management team that possesses extensive

experience of conceiving and executing entire clinical product

development programs for global registration purposes, as well as

substantial hands-on operational experience in the relevant territory for

over 31 years

Extensive experience in growing and positioning CRO’s for international

success

A focus on strategic outsourcing behavior

QUALITY RESEARCH FAST

The Key to Successful Clinical Research

Quality Research Fast: Staff Experience

Oncology Medical Devices Psychiatry Ophthalmology Infectious diseases including HIV Gynecology & Obstetrics Neurology Dermatology Endocrinology / Metabolic disorders Cardiology Gastroenterology Immunology Respiratory

Quality Research Fast: Compliance

All employees are trained in US FDA/ ICH GCP/ EMEA (EU)/ SFDA (China)

requirements

Employees have US FDA audit experience conducting studies in India

90% of all employees have earned postgraduates degrees in clinical research

and / or clinical research related field

Quality Research Fast: Staff Training

Induction program

ICH GCP training is delivered by our In-house qualified trainer Mr.

Subbarayan Head QA& Training and Dr Varada, Director Clinical Operations.

Training on Kentron SOP’s

Continuous training program ranges from technical to non-technical topics

internally or by qualified trainers

Regulatory scenario in India

Lean Six Sigma

Soft skill development program

Quality Research Fast: Staff Training (Cont.)

Study specific training is conducted during kick-off meeting / Investigator meetings and ad hoc meetings as and when required

India has a large patient pool with a diverse selection of diseases prevalent

Source: The Global Metamorphosis , Compelling Reasons for Doing Clinical Research in India,

Ernst & Young 2009

Quality Research Fast: Large Patient Pool

PARTNERSHIP SERVICES

Emerging Market Opportunities

Few companies are poised to take advantage of the rapidly growing Indian and

Chinese markets for Pharmaceutical Drugs and Devices

Kentron has strong relationships with Indian regulators, manufacturers and

pharmaceutical companies

Kentron also has strong relationships in China with two companies that have large

sales forces and excess plant capacity

Kentron is experienced in this arena and is well connected with banks and

consultancies experienced in this space

LICENSING & TECHNOLOGY TRANSFER

Indian patent law and its policies in response to the requirements of the Trade- Related

Aspects of Intellectual Property (TRIPS) -

Kentron is attractive collaborator to their western counterparts.

We provide diversified solutions to their sponsors in the areas of intellectual property

protection rights and enforcement

We assist the developer of technology to exploit the technology through Kentron as a

commercial partner

We also help in forming alliances with partners that can progress the development of the

technology to take it to market.

We provide the resources to take the technology through its clinical and regulatory

phases, and also provide partner with another organization to take it through these

phases, and into the market.

QUALITY RESEARCH AND TIMELINES EFFICIENT TIMELINES – CASE STUDY

ENSURING CLINICAL SUCCESS IN INDIA

A detailed feasibility is conducted on all new projects in order to gather information on the:

Standard of patient care (India vs West)

Recruitment potential

Clinical site infrastructure

Experienced Principal Investigators’ insight is gathered prior to protocol finalization to ensure an

Asian-centric protocol that will maximize recruitment potential and minimize protocol amendments.

Therapeutic indication feasibility

Inclusion & exclusion criteria

Treatment regimes

Informed consent questions

KENTRON MANAGEMENT TEAM

Dr P A Patil is the Chairman and Chief scientific director for Kentron Biotechnology. He proactivelyworks with senior management team for ongoing projects and provide specific scientific information required for the product development programmes He was professor and chair of department of clinical pharmacology in Jawaharlal Nehru Medical College. Currently he is the Joint Director of Research Foundation for KLE University and also Adjunct Professor of Pharmacology at KLE Institute of Dental Sciences Bangalore, India.

His other assignments in the past include member of Board of Post graduate teaching & Research and Research Recognition committee, Member of Board of Society for Clinical Research, MPH and Nano-Medicine, and member of Research Grants Committee, and Chair of EC in Regional Medical Research centre(ICMR)

During his 37 year career, Dr Patil has gathered extensive experience in the areas of drug development and has been involved in the discovery and development of a diverse array of drugs that have reached advanced preclinical and clinical evaluation. He has published 77 peer reviewed scientific papers in the various national and international journals. He has guided more than 15 post doctoral research and more than 40 masters in pharmacy dissertations.

Dr P A Patil MBBS, MD (Clinical Pharmacology)Chairman

Dr Carole McArthur is scientific Director of the Kentron Team. She is a Professor of Oral Biology in the School of Dentistry at the University of Missouri-Kansas City and a Clinical Professor in the Department of Pathology at Truman Medical Centre, Kansas City, Missouri, USA. She is the director of US-Cameroon Health Program (US-CAM). US-CAM is a humanitarian and research effort to reduce HIV transmission in Developing Countries, especially Africa where Dr Carole has developed a laboratory for HIV and TB research and carrying out clinical diagnostic trials. She has extensive experience in both the academic and private sector in the development of diagnostic systems for the detection of a wide range of substances. Her current research focuses on AIDS and TB in Africa, particularly in seeking novel therapies for TB.

Prior to joining Truman Medical centre in 1997, she served as consulting Director for Abbott Laboratories African HIV clinical field trial in Cameroon (1997-2005) besides consulting for International Rotary Health, Hunger and Humanity Project, National Institute of Dental and Biomedical Research, Great Lakes, Chicago, QBC Diagnostic, Port Matilda Pennsylvania and Oasis Diagnostics, Seattle, WA for Salivary assay evaluation.

Dr. Carole has a Ph.D. in the field of immunology with a minor in biochemistry from the University of Otago in New Zealand. She also has a M.D. degree from the University of Missouri-Kansas City (UMKC) and is a clinical and anatomic pathologist. Dr. Carole also directs residency research in the pathology Department at Truman Medical Center in Kansas City and is an adjunct faculty member in the University Of Missouri School Of Medicine and in UMKC’s women’s and gender studies. Her 30 years of research in the biological sciences span the fields murine tumor immunogenetics, human, fish and veterinary immunoparasitology, tropical medicine and human and veterinary diagnostic system development and evaluation.

Dr Carole McArthur Scientific Director

Dr Gopal Palepu MD (Anesthesiology)Member, Scientific Advisory Board

Dr. Gopal Palepu is a Member of scientific advisory board of Kentron. He provides scientific and technical inputs on existing and new product development programmes for our clients. His advice on scientific data, analyses, and interpretations help kentron to make a positive difference in the clinical programmes at an early stage.

He brings in expertise in the Haemo-dynamic monitoring in critically ill subjects, Intensive care for Liver Disease & transplanation,and infectious diseases. His scientific direction and inputs on conduct of clinical study in India for the western medical device companies add value to our clients.His advise on program evaluation is used as a decision support tool by investors prior to investment or as a guide to investment decisions in pharmaceutical /Biotech companies.

He is currently one of the most senior consultant in the Department of Critical care medicine in CARE Hospital Nampally, Hyderabad ,India.He has rich experience of management and general administration for more than two decades being functioned across multiple hospitals across India and United Kingdom.From 1992 to 2001,he was special registrar Kings college hospitals,south thames Deanery & London UK.

Dr Gopal graduated in Medicine from Andhra University, AP,India and Doctrate of Medicine from PGI Chandigarh. Eventually he was awarded fellowship from Royal college of Anaesthetists London,UK and CCST in 2001.

During his 25 years of long career, Dr. Gopal has been awarded many membership of European Soc of Intensive Care Medicine (ESICM) , Society of Critical Care Medicine (SCCM, USA), European Society of Clin. Micro & Inf. Diseases (ESCMID), Liver Intensive Care Group of Europe (LICAGE), International Trauma Care (ITC),etc..He is also examiner for Indian Diploma in Critical Care (IDCC) by ISCCM, India and Diploma in Emergency Medicine, conducted by Royal College of Emergency Medicine, UK.

He is also a part of several institutional committees in India and review panels and also participated in few clinical studies in ICU set up for western sponsors besides publishing few hundred international publications and presentations.

Dr Shailendra Shettennavar, MD (Physician) , MBA, D pharma QA/QC

Director and Chief Executive Officer

Dr. Shailendra Shettennavar joined Kentron Biotechnology Private Limited India., as Director & Chief Operating Officer and eventually promoted as Chief Executive Officer since Jan 2014. He is responsible for adminstartion,finance and corporate governance of Indian and collaborative Chinese operations. Before joining Kentron he was Chief Operating Officer for a multinational CRO based out of India,UK & China and was responsible for Global BD & Operations. He graduated in medicine from Jawaharlal Nehru Medical College, Belgaum, Karnataka and a postgraduate degree in Clinical Research. He has more than 25 years of clinical experience and more than 20 years in the global biopharmaceutical industry. He has participated in various global clinical trials in diverse capacities. With his extensive knowledge and interest in anthropology and Indian history he has completed projects on Indian tribes such as the Toda and Khasi and emphasized on applied anthropology.

Dr.Shailendra is recognized for his administrative capabilities as he served in the prestigious Civil Services for the State of Karnataka. He did his Post Graduation in Business Management from the Regional Institute of Cooperative Management in Bangalore and Pharma Quality Assurance and Compliance from the Bioinformatics Institute of India. A quality oriented person himself; he motivates the organization to follow the mission, “Provide high quality clinical research with an acute focus on patient safety, emerging technologies and new research processes” to the core.

He was honored with prestigious “Business Leadership Award for Industrial Development”-2014 by IEDR (Indian Economic Development & Research), an award which recognizes individuals nationally who inspire others through their vision and leadership and for the outstanding contributions to the industry and economy of India.

He was also honored with doctorate in clinical Research by St Paul University Argentina and Soborn University France in 2016 and 2018 respectively. He was honored with multiple awards in economic development and social responsibility by Global Achievers federation Tashkent ,Uzbekistan and Moscow Russia and Vietnam

Dr. Varada Bidargaddi joined Kentron Biotechnology Pvt Ltd., as Director. Clinical operations and medical affairs. She has over 25 years of clinical experience in academia and the pharmaceutical industry.Before joining Kentron Biotechnology she worked with Infinitus clinical research private limited as director ,clinical operations and was responsible for execution of studies from preclinical to final clinical study report.

She has successfully recruited and resourced key personnel and overseen the internal and external operations of clinical trials. Further, Varada is a veteran project manager with experiences ranging from staffing and vendor management to clinical trial logistics.

Varada has an outstanding track record of success in clinical operations, her experience and leadership will be instrumental to Kentron as we continue to grow as an organisation dedicated to helping patients and generation of quality data for the sponsors.

As a Medicine Graduate from Jawaharlal Medical College Belgaum, Karnataka, India with Post Graduation in Clinical Research and Master’s in Business Administration she will bring proven leadership in quality to Kentron.

Varada has been involved with many national and international companies and provided the excellent services in Management of clinical operations as per the regulatory requirements. She has designed & developed unique Project Management System for the appropriate conduct of clinical trials.Lastly, her experience in managing and coordinating Sponsor and FDA Audits in India is an additional advantage to Kentron

Dr Varada Bidargaddi, Director Clinical Operations & Medical Affairs

Mr. P S Subbarayan, MSc (Medical Science)consultant Quality Assurance and Training

Mr Subbarayan is M.Sc in Pharmacology. He has worked with HMR Ltd as Research Pharmacologist, Aventis Pharma as Clinical Research Associate and later as Specialist, Medical Knowledge Management. He has published scientific papers in international journals, monitored phase III and IV studies. Trained and certified as an auditor by Aventis GCP QA, European Drug Development Centre, Paris.

He has trumendous experience of international audits

Currently he is Heading Quality Assurance at Kentron Biotechnology Pvt Ltd.,He brings in expertise in Conducting Compliance/Quality Control activities including (but not limited to) process reviews, vendor assessments, essential document and project file reviews and compliance/co-monitoring visits for Indian sites, East Asia and across other GC countries as required.Verifying the implementation of corrective and preventive actions identified during conduct of internal and external compliance activities and other performance monitoring activities.Monitoring and delivering continuous improvements to all Kentron standard operating procedures under guidance from the Director, Operations.He also involved in Training staff in appropriate procedures, processes and systems where required Implementation of the training programme and framework including delivery and some development of training modules as required.

He reports directly to CEO in all quality related concern's and process modifications.

Mr.Ganesh K J , Director – Marketing -Medical devices

Mr Ganesh has joined Kentron as Director Marketing and will be responsible for Global marketing of Kentron’s and their clients products with prime focus on Indian market. Designated as Marketing Director, will oversee all operation under Sales and Marketing. He is leading a sales force of more than 500 spread across India on diversified products.

He is a management graduate from TAPMI, has been a business leader with over 28 years of global, award winning experience across FMCG, Hospitality, Telecom and Device companies such as Gillette, Bajaj Electrical, Sterling & Mahindra Holidays, Bharti Airtel, Digibee Microsystems & Vodafone. His last assignment was as National Business Head for Vodafone Global Enterprise in India.

Has turned around fledgling businesses/brands to positions of market dominance & leadership through strategic product launches, innovative distribution /channel mechanisms, business alliances, expansion & development; has led successful organizational change management processes, innovation as well as business acceleration across and within challenging market environments. Consistently delivered exceptional business results on key metrics – market share and P&L.

Currently, he is been supported by well established sales force and a team of professionals who bring in expertise in Branding ,marketing and sales. They work in the areas of Business consulting, Partner search and Execution, their assignments include various facets of business management in the areas of Education, Healthcare, HR, Technology and Marketing. Besides Kentron, they are associated with companies like Cumulus Technologies (Viceroy) and Smart Minds, Discovery Kids Scienceadda & Martrikz.

Dr. Penny Kumar brings to Kentron a very rich experience of the bio-pharmaceutical industry focusing on clinical operations and management of large international clientele.

Most recently Dr. Kumar was the Head of Business Development wing, Global Drug Development Experts, India, a US and India based Clinical Research company. He is the pioneer person in bringing multinational clinical studies to Central India and able to successfully establish clinical operations in those regions. Dr. Kumar’s career has spanned in various multinational CROs at various levels of operations and management. Dr. Kumar conducted his Medical degree at Nagpur University, India.and masters in business administration from Manipal University Bangalore.

He brings in expertise in developing and maintaining existing client contacts, establishing new clients and productive business relationships especially for Asia and European region.

He Prepares and issue accurate and appropriate proposals in response to client requests and also maintaining communication with the clients with regards to potential clinical studies and proposals, thus brings awareness of current developments within clinical research and relevant therapeutic areas.

Dr Penny Kumar MBBS ,MBA Associate Director – Business Development

(Asia-Pacific)

COMPANY GROWTH STRATEGY

As a new company, Kentron’s growth strategy has been designed to ensure

that all projected studies are effectively resourced throughout their duration.

As necessary, additional staff are recruited and trained prior to the start of all

new projects in order to ensure that all projects are appropriately supported.

All employees have stock options in the company, thereby ensuring greater

employee dedication, commitment, and retention.

ORGANOGRAM Board of Directors

Dr Shailendra Chief Executive

officer

Mr SubbarayanQual ity

assurance and compliance

D r Penny Kumar

Associate director –BD

Ma na ger fo r

c o rpo rate

i n ter fac e

Finance & HR

Finance Manager

HNM Prasad Legal Advisor

Dr Varada Bidargaddidirector -

Operations

Regulatory partners

Dr Ashwini KumarRegulatory affairs

Regulatory Associate

Clinical trial supply

management

Coordinator CTSM

Project Management

Assistant Project managers

Lead CRA Project Specific

Clinical Research associate

Clinical Trial administrator

Clinical Research associate

Clinical Research AssociateFeasibility

coordinator

Clin ical data management

Data Manager and statisticians

Licensing & Technology

transfer

Mr /madhusudanCorpora te af fa irs

Secre ta ry & IPR expert

Pre clinical & CRM

Strategic partner

Medical Monitoring

Safety coordinator

investors Pruthvi associates Company Auditors

Scientific directors

Product development programs• Study design• Protocol drafting• Study feasibility• Regulatory approvals• Clinical trial supplies management• Project management• Patient recruitment• Clinical monitoring• Quality assurance & compliance• Medical Monitoring• Clinical Data Management Evaluation of existing product development programsRescue programs Co-development programs

KENTRON – CAPABILITIES

KENTRON - PIPELINE

#. Indication Phase Sites Total Target Sponsor - country Functions of Kentron Status

1 NSCLC II 20 100 USA DCGI Approval to Final CSR Completed

2 Glucose monitoring device studyR&D study to FDA study I 6 400 - 1000 UK

Protocol designing ,Clinical Monitoring & Project

management, Medical Monitoring, Data

management

completed

3 Solid Tumor and NHL 1a 2 6 USA Medical Monitoring & Project management Completed

4 Cardiac Stent PMS 1 100 India Clinical monitoring and project management completed

5 Contrast imaging study – Breast Cancer II 1 10 USA Clinical development and marketing completed

6 Breath Analyser medical device II 1 32 Israel Clinical Development Completed

#. Indication Phase Sites Total Target Sponsor - country Functions of Kentron Status

7 Benign Prostatic Hypertrophy IV 18 Part of enrollment and Follow up US

Monitoring of US sites, Project Management, Data Management and Safety

ManagementOngoing

8 Breath Analyser study II 01 100 ISRAELClinical Monitoring and

project management and data management

completed

9 Ovarian cancer I TBD 40 UK Clinical monitoring and project management Under discussion

10 Infrascan NA NA NA Israel Marketing Completed

11 Diabetes II 2 50 USA Clinical Monitoring & Project management Under discussion

12 HIV II 10 100 New ZealandClinical Monitoring & Project

management Under discussion

13 Epilepsy I & II TBD 135 IsraelClinical Monitoring & Project

management Study not approved by DCGI

14 FLEXOR TENDON SURGERY III 07 200 SwedenProtocol Writing to Final

Clinical study report including Global

ManagementOngoing

CONTACT DETAILS

Company website : www.kentron.co

Business Related Enquiry: [email protected]

Registered office:

202, 2nd Floor stanberry court, 60 feet Road Sanjay Nagar

Bangalore 560094,Karnataka,India

Contact Persons

Dr Shailendra Shettennavar +918431510518

[email protected]

Thank you