Leaders in Pharmaceutical Business Intelligence (LPBI) Group

• Population Health Management, Genetics & Pharmaceutical
• International Global Work in Pharmaceutical
• Pharmaceutical R&D Investment
• Clinical Trials & IRB
• FDA Regulatory Affairs

Jukka Karjalainen, MD, PhD

Personal Bio

Senior Operating, Medical and Scientific Officer with over 25 years of healthcare experience spanning multiple medical specialties, academic, clinical research and pharma industry experience in US, Canada and Europe, in clinical, medical and regulatory affairs, business development, financing, M&A, and pharmaceutical and medical device development.

Successfully built basic & clinical research, medical affairs, drug safety and regulatory departments in large and mid-size pharmaceutical and biotech companies and led CMC, preclinical, regulatory and clinical drug development from Phase I to Phase IV.  Have over 20 years of experience in dealing with regulatory authorities, developing clinical and regulatory strategies, managing KOL’s, and managing local and multinational trials in various therapeutic areas.

Presently Dr. Karjalainen is President and Director of Pharma Consulting Services, Toronto, Canada, providing consulting services to biotechnology and pharmaceutical companies for clinical research, regulatory, CMC, medical affairs and business development. He also serves as Managing Director, Regulatory and Scientific Affairs, for a private global capital company.  In 2007-2009 Dr. Karjalainen was COO and CMO at Bradmer Pharmaceuticals leading company’s Phase 3 brain cancer drug development project.  Prior to that Dr. Karjalainen held a position as VP, Drug Development in Cytochroma, leading preclinical, CMC, clinical and regulatory affairs operation of the company. He provided leadership and strategic planning for the company’s dermatology, CNS, CKD, autoimmune and fungal diseases, and oncology programs.  Prior to that he served as Director, Medical & Regulatory Affairs at Biovail Pharmaceuticals, where he was responsible for managing medical operations, drug safety reporting, medical information and regulatory affairs, and assumed a leadership role of clinical trials. In 1998-2002.

Board certified in pharmaceutical medicine, pediatrics, general practice, and diabetes care.

Academic titles:  Associate Professor, Senior Lecturer, Registrar.

Core competencies:

•             Strategic Leadership
•             Drug Development Expertise
•             Medical Affairs Expertise
•             Drug Safety
•             Clinical Development
•             Process Innovation
•             BD, Financing
•             Research Expertise
•             Regulatory Compliance & Documentation

Senior R&D, Clinical, Medical & Regulatory Affairs Executive

A senior Operating, Medical and Scientific Officer with extensive healthcare experience spanning multiple medical specialties, academic and clinical research and pharma industry experience in US, Canada and Europe in clinical, medical and regulatory affairs, business development, financing, M&A, and pharmaceutical and medical device development covering CMC, preclinical, regulatory and clinical drug development from Phase I to Phase IV.

I have successfully built research, clinical and medical affairs and regulatory teams in large and mid-size pharmaceutical companies, and in small start-up biotech companies meeting the highest standards and expectations.

I negotiated agreements with FDA and Health Canada, which accelerated product development timelines and saved Millions of Dollars in development costs, and executed a product development strategy, which facilitated the first human dose within 8 months from in-vitro characterization stage of the compound.

I am high energy, proactive, communicative and enthusiastic leader with high-level strategic and managerial focus combined with hands-on operational knowledge and capabilities.

I have passion for innovation, commitment to excel, strive to win/win, take calculated risk, and solve issues creatively.

Core competencies:

Strategic Leadership Drug Development Expertise Medical Affairs Expertise

Clinical Development Process Innovation BD, Financing

Research Expertise Regulatory Compliance & Documentation

Career Highlights

• Developed clinical, medical and regulatory policies and procedures to comply with regulatory requirements within 4 months in job in a start-up company.
• Managed 100 corporate Phase 2-3 clinical registration trials and 30 local Phase 3b and 4 trials in over 150 clinical investigator sites.
• Negotiated a regulatory strategy with Health Canada for chronic kidney disease program that saved 5 months of development time to first human dose.
• Successful equity and debt financing in 3 pharmaceutical companies totaling $US100M.
• Challenged local regulatory authorities successfully to receive critical regulatory exemptions for national approval of a product, which accelerated final marketing authorization approval.
• Prepared an accelerated pre-clinical and clinical development plan for the lead dermatology compound, from compound characterization stage to the first human dose in 8 months.
• Presented a comprehensive drug safety and medical monitoring plan to management and the company Board for internalization from the clinical CRO with estimated savings of over $6 MUS.
• Designed Phase 3 clinical trial program for worldwide regulatory approval of a medical device, successfully led regulatory discussions and built infrastructure, investigator and clinical trial monitor network to initiate the program in North America, Europe and in Nordic Countries.
• Initiated and led a collaborative research project with academia, which received EU Biomed grant from the European Commission totaling $1,400,000 CAD.

Career Experience

President, Director                                                                                  

March 2009 -Present

PHARMA CONSULTING SERVICES, CANADA 

Provide consulting services to biotechnology and pharmaceutical companies for medical affairs, clinical research, regulatory, CMC and business development.

• Assigned to lead and structure merger between two biotechnology companies both valued at over $100M.
• Contracted by biotechnology company to negotiate a deal for out licensing their lead oncology compound.
• Designed drug development plans from preclinical to Phase 2 for small molecules and biologics  (oncology, dermatology, diagnostics) for 4 biotech companies.
• Designed a Phase1 and 2 oncology clinical program for a biotechnology company for investor presentations, and represented the company on road shows.
• Designed a BA/BE program for an extended release formulation product for treatment of ADHD.
• Provided consultation services through consultant networks in US and Canada for various clients (product evaluations, management consulting, business efficiency, company assessments, product development plans).
• Consulted for several private investment, venture capital and institutional investors. Key projects: Evaluations of their clients and company valuations, pipeline products, writing business plans and clinical and regulatory development plans, and providing expert reports.

Managing Director, Scientific and Regulatory Affairs: INVICTUS GLOBAL CAPITAL,
BVI, NEW YORK, ZURICH,  TORONTO 

Consultant for HEALTHXCEL CORPORATION, USA AND CANADA                                                                     

• Finalized business plan for acquire of profitable pharmaceutical companies in US and South-America in 4 months.
• Developed company business plan and initiated financing of $US30-40 million.
• Identified acquisition targets and entered in negotiations to acquire their assets.
• Led on-site negotiations and preliminary due-diligence activities.
• Negotiated and completed financing agreements and obtained funding commitment letters from 2 investor groups.
• Hired management team and prepared an operational plan for the company.

Chief Operating and Medical Officer

Dec 2007- Feb 2009

BRADMER PHARMACEUTICALS, USA and CANADA

Provide leadership for the Company’s pivotal Phase III registration programs with targeted monoclonal antibody therapies, specifically central nervous system cancers, and responsibility for the day-to-day operations of a publicly-traded, rapidly evolving company.  Provide overall direction to all functional medical, clinical and regulatory activities in the US and Canada and to the global strategic medical plan.  Provide strategic direction by leading the assessment of the Company’s clinical assets, ensure aggressive and sophisticated extraction of full commercial value from the Company’s technology and work with the senior management to successfully execute on a plan to strategically monetize assets by negotiating and closing multiple corporate collaborations.   Establish and maintain collaborations with partners and update management of competitors and other clinical developments which may affect the company.  Plan and provide oversight the pivotal Phase III clinical trial within approved timeline and budget. Accompany CEO in road shows and give business presentations to partners, investors, and Board. Integral member of the senior management team and a key advisor to the CEO. Reported to the CEO.

• Prepared the clinical development plan for the lead oncology product.
• Led CMC and clinical IND serial update preparation and submission to FDA within 4 months and received approval for both within 5 months.
• Prepared protocol amendment and received FDA’s written approval.
• Prepared Annual Report.
• Developed all required clinical, medical and regulatory policies and procedures to comply with local and global requirements for a late-stage development company within 5 months in job.
• Presented a comprehensive drug safety and medical monitoring plan to management and the Board to internalize these functions from the clinical CRO with estimated savings of over $6MUS of the budget.
• From the time of approval of the internalization plan hired key staff (Medical Monitor, Drug Safety Manager and Drug Safety Assistant) within 4 weeks and led execution of the plan with all functions operational in-house within 2 months.
• Led preparation of all study documents (over 50) for a multidisciplinary oncology trial in 4 months.
• Led site selection and qualification process and activated the first leading US oncology sites in less than 6 months.
• Prepared pre-CTA meeting documents and led the meeting with Health Canada for expansion of the trial to Canada.

 

Vice President, Drug Development                                                                

February 2004- December 2007

CYTOCHROMA INC, Canada

Provided strategic leadership and planning for the company’s dermatology, chronic kidney disease, autoimmune diseases, and oncology programs with a pivotal role in the company’s next stage of growth to develop Medical, Regulatory and Clinical Research organization and lead company’s compounds to clinic and to market.

Specific responsibilities: Establish and maintain collaborations with strategic partners and maintain an understanding of competitors and other clinical developments which may affect the company. Oversee drug development and budget of ~ $20M. Develop clinical strategies to address proof-of-principle in the most time- and cost-effective manner. Oversee preclinical studies for IND candidates. Develop regulatory strategies, and coordinate and prepare documents for submissions to regulatory authorities. Audit and inspection readiness. Interact with regulatory authorities regarding all aspects of drug development and approval. Plan, organize and manage in-house activities, external collaborations and CROs to advance lead compounds into clinical trials and through clinical development. Supervise clinical trial document’s preparation, investigator and site selection, patient recruitment, study initiation, coordination and monitoring. Oversee study data management and statistical analysis. Support CEO in road shows and give business presentations to partners, investors, and Board. Integral member of the senior management team and a key advisor role to the CEO. Reported to the CEO. From July 2006 with the acquisition of Proventiv Pharmaceuticals, Madison, Wisconsin, USA, the position was changed to Vice President, Clinical Affairs.

• Reviewed and revised budget and timelines for clinical development of dermatology and oncology compounds by May 2004.
• Presented and received approval of CTA018 drug development plan to the company board in May 2004.
• Led preparation of Pre-IND and Pre-CTA briefing documents to US and Canadian authorities for the lead dermatology compound in July-August 2004.
• Prepared an accelerated pre-clinical and clinical development plan for the lead dermatology compound, from compound characterization stage to the first human dose in 8 months.
• Filed regulatory applications for Phase 1 clinical trials for the lead dermatology compound in October 2004.
• Negotiated a regulatory strategy with Health Canada for chronic kidney disease program that saved 5 months of development time to first human dose in May 2005.
• Completed successfully 2 Phase I studies in psoriatic subjects in June 2005.
• Prepared and filed an IND at FDA for a Phase II clinical study in psoriasis in December 2005. Approval in January 2006.
• Prepared 2 Canadian CTAs for Phase I trials in Chronic Kidney Disease.
• Prepared a clinical development plan and regulatory plan for a medical food product.
• Requested and prepared a pre-IND meeting with FDA for a Phase II clinical study in CKD in November 2006.
• A successful Pre- IND meeting for a CKD product in 2006.
• Completed successfully a large Phase II trial in 2007.
• Frequent presentations to potential business partners and negotiations for out-licensing and co-development deals.

Director of Medical and Regulatory Affairs & Corporate Vice President

BIOVAIL Pharmaceuticals, Canada 

August 2002- January 2004

General Medical and Regulatory Management responsibility including strategic business plans, budget and metrics with $10 million operating budget. Leader of Medical and Regulatory staff of 9 local professionals and 12 project staff. Responsible for staff recruitment, retainment and training of medical staff. Responsible for marketing and sales support, medical training of marketing/sales staff. National responsibility for medical information, drug safety reporting, regulatory affairs and communication with regulatory authorities. International and national leadership of registration and local clinical trials with $20 million budget. Provided scientific, clinical research and regulatory expertise including review and approval of marketing communications in four main therapeutic areas (CV, CNS, Skin & Metabolic diseases including Diabetes). Member of Biovail Executive Board, R&D Steering Committee, Management Team and Therapeutic Advisory Boards. Reporting to General Manager of Canadian operations and corporate CSO.

• Performed a deficiency analysis, presented an action plan and timetable, then executed the plan leading to re-structuring of medical, regulatory and marketing policies and procedures in compliance with local/global requirements within 4 months in job (Development of a Master SOP, Sampling, Archiving, CRO, Marketing & Sales and Training SOPs).
• Developed company strategy for design and quality execution of corporate and local clinical trials in compliance with international guidelines and regulations.
• Leadership role of two key registration trials.
• Re-designed medical information services for Canadian customers.
• Ensured staff compliance and training with local, regional and global demands, including sales and marketing personnel training, promotional material design and approval of external communications.
• Networked and negotiated with TPD and FDA to receive critical exemptions from ICH for regulatory approval of 2 new indications for significant benefit to the company.
• Took clinical development of a topical cream for hypertrofic scars to Phase II.
• Took responsibility of NCE and other compound evaluation for Biovail, Canada.

Medical Director, Corporate Endocrinology Product Team Advisor            

June 1998 – June 2002

ELI LILLY AND COMPANY, FINLAND  

Leader of 25 medical and regulatory professionals of the Finnish affiliate to work to high expectations as teams in national, regional or global environments. Provided strong leadership in medical and regulatory strategy planning, input to the marketing plans, and medical and scientific expertise to support local marketing and sales organizations.  Established cross-functional, multicultural, and international teams to manage 30-40 corporate, multicentre Phase 1-4 clinical registration trials and 20 local Phase 1, 3b and 4 trials in over 150 clinical investigator sites fulfilling speed and quality criteria of Eli Lilly and Company in various therapeutic areas (cardiology, oncology, women’s health care, sexual dysfunction, urology, and infectious diseases) with a budget of $40 million. Developed local clinical programs to create significant additional revenue. Ensured staff compliance to local, regional and global requirements including sales and marketing personnel training, promotional material design and approval. Negotiated with regulatory authorities and was responsible for external media communications. Developed medical, marketing and sales operations policies and procedures to meet with local and corporate demands. Ensured on-time and high quality drug safety reporting including SAEs and annual safety reports. Member of the Executive Board, Member of European Endocrine Research Team, Chair of the diabetes advisory board, secretary of the Lilly Foundation and member of all medical and marketing advisory boards in different therapeutic areas. Reported to Managing Director and corporate Regional Head of R&D.

• Expanded medical and regulatory organization from 6 to 25 professionals over 3 years including 3 CRPs, Team Leader, CTMs, CRAs, regulatory manager, medical information and drug safety staff.
• Insourced and trained 4 CRO CRA’s to temporarily cover resource gaps and provide back-up support when needed.
• Expanded medical information services and developed a new technical standard and tool for maximizing efficiency of services.
• Re-structured all medical, regulatory and marketing SOPs to meet with local and global regulations.
• Took strong leadership of corporate multicentre trials in cardiology (Raloxifen (RUTH), Moxonidine and abxicimab trials (ReoPro AMI I and II), endocrinology (insulin and pioglitatsone trials, osteoporosis trials with raloxifen, PKC inhibitor in prevention of diabetes complications, growth retardation disorders with Humatrope), CNS (olanzapine in psychosis and bipolar disorder trials, fluoxetine 1-weekly formulation in depression, ADHD trials (Strattera) and Parkinson’s disease), oncology (Gemcitabine (Gemzar), MTA (Alimta), Specific Receptor Antagonist Trials and uterine and breast cancer trials with SERM III) women’s health care (PTH and Raloxifen trials), sexual dysfunction (Tadalafil (IC-351) trials), urology (Duloxetin trials) and infectious diseases (antibiotic trials, APC)
• Developed new project management tools to improve consistency, quality, speed and tracking of clinical trials.
• Established cross-functional, multicultural, and international teams with corporate recognition as staff nominations to international study management teams.
• Was rewarded 5 corporate prices and certificates for the best country worldwide and exceeding expectations in clinical trial management in RUTH, Pioglitatsone, Gemzar, Raloxifen and PTH trials.
• Networked actively with local authorities to comply with local regulations but also challenged and negotiated with authorities to accept some critical exemptions, which benefited the company.
• Wrote 2 health outcome reports for regulatory filing of human recombinant insulin (Humalog), and olanzapine (Zyprexa).

Core Clinician                                                                                                 

September 1996 – July 1998

SCHERING AG, HELSINKI, FINLAND AND BERLIN, GERMANY

Recruited to develop international clinical research team of 25 clinical research professionals to design Phase 3 clinical trial program for worldwide regulatory approval of an Intrauterine Menopausal Levonorgestrel Delivery System (MLS) including 3 international, multicentre, comparative clinical trials. Budget $ 60 million. Reported to VP of R&D.

• Built infrastructure, investigator and clinical trial monitor network to initiate Phase 3 clinical trial program in North America, Europe and in Nordic Countries.
• Conducted a successful pre-IND meeting with FDA (1997)
• Compiled an IND submission (1997-1998)
• Completed Phase 3 clinical trial reports of topical estrogen gel (Leiras Study Report 122-94573-01, 1998, Leiras Final Study Report 122-94573-01, 1999)

 

Medical Advisor/Research Manager                                                               

June 1995 – August 1996

LEIRAS INC., HELSINKI, FINLAND

Recruited from academia and previous consultant role to design 3 clinical research projects and develop clinical research teams for 3 clinical research programs.  Budget $ 12 million. Reported to Director of R&D.

• Developed 3 clinical research teams of clinical trial management professionals including CTMs, CRAs, clinical monitors, statistician and data management personnel.
• Completed Phase 2 clinical trial reports for worldwide regulatory purposes on intrauterine hormone delivery system (Leiras Study Report 116-90526-01, 1996; Leiras Study Report 118-90513-02, 1997; Leiras Study Report 116-90526-02, 1997; Leiras Study Report 116-95536-01, 1997; Leiras Final Study Report 116-95536-02, 1999; Leiras Final Study Report 116-90526-03, 1999)
• Took the initiative of building a basic research network, which led to design of a collaborative research project with four reputed universities in Finland and Sweden. This initiative was presented to European Commission as a shared cost (SC) 3-year EU Biomed-2 research project in 1996. European Commission approved the application and granted funding for 3 years (project PL 96 3422, 850,000 E, C$ 1,400,000).

 

Academic Experience

Various Senior and Junior Academic and Clinical Position, 1981-1995 

Teaching Assignments 1981 – 2000

UNIVERSITY OF OULU, FINLAND

Eighteen years in academia, Ph.D., Associate Professor and Senior Lecturer. Basic research (Junior and Senior Scientist positions) and clinical positions (Specialist in Pediatrics and General Medicine) including junior and senior scientist roles with an extensive international network. Private practitioner as pediatrician and GP for 7 years. Continued position as senior lecturer till 2000 and annual lectures as Associate Professor.

• Involved in the design of the nationwide study on “Childhood Diabetes in Finland” and worked subsequently as a senior investigator and consultant in the project for 8 years (from 1986 to 1994) to ensure quality of immunological methods used.
• Coordinated 3 academic dissertations (the last one in 2000).
• Research achievements awards during Postdoctoral Research Fellowship in Toronto, 1990-1992 (part of 1993 and 1994).
• Received 4 international scientific awards.
• Recipient of multiple national and international research grants between 1985-2000. Total value ~ $9 million.
• Member of multiple medical and scientific associations.
• External reviewer for several international medical journals.

Nominations

• Chief Pediatrician, Department of Pediatrics, District Hospital, Kristinestad, Finland, 20.9.1995 
• Chief Physician, Public Health Care, City of Vantaa, Finland, 8.12.2009 

 

Publications

• 47 original publications in top-rated international medical journals, over 40 clinical study reports, 2 health outcome reports, 11 review articles and numerous abstracts.

Board memberships, awards and honors

• Board Director, Healthxcel Corporation, 2010-.
• Young Investigator’s Award, Medical Association Duodecim 1992
• Alma och K.A. Snellman’s Doctoral Price, given for the best academic dissertation in Finland 1987-1991, the Alma and K.A. Snellman Foundation, Oulu, Finland.
• Postdoctoral Fellow Trainees Research Reward, Toronto Diabetes Association, Toronto, Canada 1992
• Young Investigators Award, Scandinavian Society for the Study of Diabetes 1993
• Member of  the Board of Finnish Association of Pharmaceutical Physicians and Chairman of the Educational Board 1999-2002
• Biltmore’s Who’s Who, VIP Honored Lifetime Member, Executive Of The Year 2011.
• Cambridge Who’s Who, Honored Lifetime Member.

Education

• Specialist License in Pharmaceutical Medicine (6-year training under IFAPP training program)  – 2001
• Associate Professor, University of  Oulu, Oulu, Finland  – 1996
• Senior Registrar and Lecturer in Pediatrics, University of Oulu, Oulu, Finland – 1996
• Specialist license in Pediatrics (6-year program), University of Oulu, Oulu, Finland – 1995
• Specialist license in General Practice (6-year program), University of Oulu, Oulu, Finland  – 1994
• Ph.D. – 1989
• M.D., University of Oulu, Oulu, Finland  – 1983
• Multiple training courses in pharmaceutical development, clinical development, medico-marketing 1995-2003
• Executive leadership, people management, performance management, negotiation skills, self-awareness, situational leadership, social styles, cultural awareness.

Selected professional associations

• Society of Neuro-Oncology 2007-present
• International Science Advisory Board, member 2006-present
• American Academy of Dermatology, member 2005-2008
• National Kidney Foundation, member  2005-2008
• American Society of Nephrology, member  2005-2008
• National Psoriasis Foundation, member 2005-2008
• ASCO, member 2004-present
• Chair of the Educational Board of the Finnish Pharmaceutical Physicians Association 2000-2002
• International Pharmaceutical Physicians Association 1996-present
• Finnish Pharmaceutical Physicians Association 1995-2002
• Canadian Diabetes Association (CDA) 1990-2000
• American Diabetes Association (ADA) 1990-Present
• Council of Epidemiology & Immunology, ADA, USA 1986-2000
• Council of Diabetes in Youth, ADA, USA 1986-Present