Keeping Small Businesses Competitive through Sharing Best Practices of Global Leaders

Keizo Koya’s & Eita Kitayama’s BIO

Keizo Koya, PhD : CEO, Founder & Producer

Dynamic leader, senior executive and unique entrepreneur with almost three decades of experience in global pharmaceutical R&D and business.

Achieved leadership positions in many multinational pharmaceutical companies.

Formed Boston Strategics Corporation in 2012, to create a next generation paradigm for global pharmaceutical R&D based on a new global/strategic/high-performance drug R&D platform free from existing infrastructures.

Prior to founding Boston Strategics, worked for Synta Pharmaceuticals for 10 years as Senior Vice President, Drug Development. Synta is a public biopharmaceutical company focused on discovering and developing novel pharmaceutical products (e.g. ganetespib, a novel Hsp90 inhibitor) for patients with severe medical conditions, including cancer.

Prior to joining Synta, led the research and development of numerous investigational cancer and autoimmune drugs at several companies including serving as Vice President, R&D of Shionogi BioResearch Corp, Director, Drug Discovery and Development at Fuji ImmunoPharmaceuticals Corp., and the Head of Pharmaceutical R&D of Fuji Film USA.

Also led the anti-cancer drug project at Harvard Medical School, DFCI to develop new cancer mitochondria-targeted drugs.

Before moving to the US in 1990, worked as a chief scientist for various projects at Main Research Institute of Fuji Film, Japan. A chemist by training with a Ph.D. in organic chemistry, Had over 45 issued and pending U.S. patents.

 

Eita Kitayama, MS : President and Founder 

Eita Kitayama is Founder & President of Boston Strategics Corporation, an integrated drug R&D company that utilizes the expertise of its highly experienced core staff to take products from Discovery through Phase II clinical testing in a highly efficient and cost effective manner.

Boston Strategics uses “True” Open Innovation™ that results in a comprehensive “Strategy–Execution–Results” approach. Boston Strategics follows global drug development standards and has strong Medical and Scientific Advisory Boards. Boston Strategics can significantly reduce the time and cost of drug development with its streamlined structure and team of experts. Core competencies include Discovery (Research), Preclinical Development, Clinical Development, IND preparation, submission, and maintenance.

Prior to establishing Boston Strategics, Eita was Senior Director of Preclinical Outsourcing/Strategy at Synta Pharmaceuticals, where he took strategic and operational leadership in all preclinical outsourcing and preclinical/nonclinical development programs including a small-molecule Hsp90 inhibitor, an mitochondrial metabolism inhibitor, a calcium release-activated calcium (CRAC) channel inhibitor, a small-molecule IL-12/23 inhibitor, and a vascular disrupting agent.

Prior to joining Synta, Eita was Senior Program Manager and Senior Scientist at Covance Laboratories (2001-2003).

He also has over 17 years of industry experience in Japan (1984-2001) as a Program Manager, Study Director, Chief of GLP Office, GLP Computer System Manager, and Laboratory Scientist. Eita was a member of Alternatives to Carcinogenicity Testing Sub-Committee (1997-1999), International Life Sciences Institute, to evaluate CB6F1-rasH2 transgenic mice model. Eita translated “100 Question and Answer about AIDS” by Michael Thomas Ford into Japanese (1996) and is a frequent author and lecturer on strategic outsourcing and establishing global partners.

http://www.bostonstrategics.com/

In the Spotlight Interview

1.Please share with us the inception of Boston Strategics Corporation.

Before starting up Boston Strategics Corporation (BSC), it was about to be “Boston Global Partners” simply to provide global/strategic outsourcing supports. However, after meeting with top management of potential Japanese clients, we learned that they need much wider strategic support for their global drug development ranging from late discovery, through translational research, first-in-man and proof-of-concept studies in a highly efficient and cost effective manner. Thus, we decided to name our company “Boston Strategics” to provide them with “strategics.”

Its mission is to continuously improve patient health care by changing the drug R&D paradigm using a“True” Open Innovation™ platform.

 

2.Take us through a typical day, start to finish.

Keizo:

(typical weekday schedule in Boston)
5:30 am – wake up/stretch/music/walk with dog
6:30 am – breakfast/watch various news via web
7:30 am – arrive at office/meditate and karate practice at balcony with ocean view
8:30 am – brainstorm with partner
9:00 am – emails/meetings/brainstorming/discussions/teleconference
7:00 pm – complete office work and drive back home
7:30 pm – dinner/drink at home (or business dinner at restaurant)
8:30 pm – teleconference/emails/must-list prep
9:00 pm – power walk
9:45 pm – shower/stretch/meditate
10:30pm – emails/read

 

Eita:

(a typical day in Boston)
6:30 am – wake up/shower/breakfast
8:00 am – arrive at office/do nothing at balcony
8:30 am – brainstorm with partner
9:00 am – emails/meetings/discussions/listen to favorite tunes at balcony
7:30 pm – dinner/evening walk with wife/some emails/do nothing at balcony at home

(a typical day in Japan)
Seven to ten-day business trip to Japan (13:40 flight) regularly every one or two months, during while we meet with more than 50 key decision makers.
5:30 am – wake up/shower
7:00 am – breakfast meeting with a new strategic partner, who was on a business trip to Tokyo coincidentally, to discuss potential clinical study design and its feasibility for a potential oncology drug with new concept
9:00 am – visit our corporate attorneys in Japan for a final review of an in-licensing agreement
10:30 am – visit to a Japanese large pharma with the attorneys for in-licensing discussion
12:00 pm – business lunch with the attorneys (follow up meeting)
1:30 pm – visit to one of our major clients to review ongoing programs
4:00 pm – visit to an investment bank to introduce our business models and potential investment opportunities
6:00 pm – dinner with senior managements of the major client
10:00 pm – emails/phone calls

 

3. What was the best advice you received in the early stages of creating Boston Strategics Corporation?

The future belongs to those who see possibilities before they become obvious.

Listen to potential clients to identify real needs. Talk to as many experts as possible to benchmark your business model(s)/concept(s).

 

4. What are your strategies for building awareness of Boston Strategics Corporation for the short term and the long term?

Corporate website, press release, publication.  To make a real impact in helping the society.

 

5. What is your proudest achievement?

We achieved alliances/partnerships with (see respective press releases below) :
a) MD Anderson Cancer Center;
b) FUJIFILM;
c) TAPBOOST Technology;
d) In-license of E6201 from Eisai

 

a1) Boston Strategics Announces Strategic Alliance with UT MD Anderson for Oncology Drug Development

July 25, 2013

Boston Strategics Corporation (Boston Strategics), an integrated biotechnology research and development company, Boston, MA, announced today a strategic alliance with the University of Texas MD Anderson Cancer Center, Houston TX to facilitate oncology drug development integrating the translational and clinical expertise and resources of MD Anderson with the “True” Open Innovation™ network built by Boston Strategics.

Under this agreement, Boston Strategics will optimize and execute the global drug development of its pharmaceutical and biotechnology clients by leveraging its “True” Open Innovation™ network to deliver superior outcomes using its highly efficient execution strategies in partnership with MD Anderson, a leader in innovative translational and clinical oncology development.

Building truly collaborative translational and clinical development programs is one of the main tenets of Boston Strategics’ efficient approach to drug development that values the importance of the input from clinical investigators to optimize drug development.

MD Anderson leadership in translational research and in precision medicine with the newly created Institute for Personalized Cancer Therapy will permit tailoring of Boston Strategics’ cancer therapies to appropriate patient populations.

This agreement underscores Boston Strategics commitment to partnering with academic and medical institutions to build a global network of experts and institutions dedicated to improving the treatment of cancer and management of patients.

“By combining the strengths of the MD Anderson Cancer Center with the oncology drug development expertise and true open innovation™ network of Boston Strategics, we are creating a new, efficient, streamlined model for global oncology clinical development,” says Eita Kitayama, President of Boston Strategics. “This is an innovative and unique collaboration that will translate the highest-quality science into proven clinical success in an efficient and agile manner, while enhancing the competitive position of our Pharma and Biotech clients in the ever increasing challenging environment of clinical drug development.”

The ultimate goal of this partnership is to deliver new therapeutic approaches to oncology patients globally with industry benchmark-beating timelines and financial investment giving Boston Strategics’ local and global partners a fast and efficient path to developing their compounds globally.

“MD Anderson is keen on collaborating with partners willing to establish long-term commitments to the institution,” said Ferran Prat, MD Anderson vice president for strategic industry ventures. “We believe in the power of industry and academia coming together, and coming up with solutions to enhance efficiencies and achieve faster development times. This partnership allows the organizations to work closely in a collaborative fashion to reach those goals”

MD Anderson provides care for approximately 100,000 patients each year. In FY 2012, nearly 8,500 of its patients participated in clinical trials exploring novel treatments, the largest such program in the nation. Boston Strategics has established collaborations with several major Japanese pharmaceutical partners.

 

b1) Boston Strategics Announces Oncology Drug Development Partnership with FUJIFILM Pharmaceuticals U.S.A.

November 26, 2013

Boston, USA, November 26, 2013 – Boston Strategics Corporation, an integrated research and development biotechnology company, Boston, MA, today announced a new drug development partnership with FUJIFILM Pharmaceuticals U.S.A., Inc. (FPHU), Boston, MA, a global pharmaceutical development center of FUJIFILM Corporation, Tokyo, Japan. This strategic collaboration is the first of its kind between a Japanese pharmaceutical company and a pharmaceutical research and development provider, creating a novel and comprehensive approach to global pharmaceutical development.

Under this agreement, Boston Strategics will be the primary provider for FPHU global drug development services and resources for FPHU Oncology programs. This agreement will build on Boston Strategic strengths covering the spectrum from preclinical and early clinical development through Phase I and II human Proof-of-Concept (POC). Utilizing Boston Strategics’ internal oncology development expertise and ability to identify and collaborate with the best resources around the world, FPHU will expand its global reach in oncology drug development.

Boston Strategics will optimize and execute the global strategy of FPHU Oncology drug development programs. In this capacity, Boston Strategics will leverage its “True” Open Innovation™ network to deliver superior outcomes, using highly efficient execution strategies and proven partners, such as the University of Texas MD Anderson Cancer Center, Houston TX (MD Anderson).

“True Open Innovation™ overcomes any limitations by reducing the need for large infrastructure, and draws on critical drug development expertise based on the unique needs of a particular program,” says Keizo Koya, PhD, CEO of Boston Strategics. “Our strong business relationships with our global resource networks are poised to assist pharmaceutical/biotech companies with strategy and launch of quality global drug development programs, and rapidly execute them to the next decision step/value inflection point. We are deeply committed to giving a new pharmaceutical R&D platform for FPHU, which look for an innovative and efficient way of globally developing their unique oncology pipelines. Entering into a special alliance of Boston Strategics this year with MD Anderson, a world leader in cancer treatment and oncology research, Boston Strategics will use this opportunity to provide global clinical development supports for FPHU.”

The ultimate goal of this unique partnership is to develop Fujifilm’s oncology drug candidates globally using innovative approaches coupled with industry benchmark-beating timelines, quality, and financial investment.

 

c1) TAPBOOST Technology: Novel Technology to Enhance the Production of Hard-to-Produce Therapeutic Recombinant Proteins

May 5, 2014, PEGS Boston the essential protein engineering summit

Dr. Akinori Hishiya was invited to speak at 2014 PEGS Boston. Over 1,600 participants gathered in Boston for open forum discussions and collaboration at this CHI’s flagship biologics event.

Dr. Hishiya gave a presentation titled “TAPBOOST™ -Enhanced Protein Production-” and poster session titled “TAPBOOST Technology: Novel Technology to Enhance the Production of Hard-to-Produce Therapeutic Recombinant Proteins.”

Although many therapeutic recombinant proteins are produced in mammalian expression systems in order to ensure adequate post translational modification and protein folding, some are hard to fold, and are confined in the endoplasmic reticulum where they are degraded, resulting in poor expression and process yields. We have developed a novel technology called TAPBOOST™, which significantly enhances the production of many therapeutic recombinant proteins. A proprietary protein (TAPBOOSTER) is expressed together with the therapeutic protein. The TAPBOOSTER protein binds to targeted proteins and enhances its production specifically. TAPBOOSTER has successfully enhanced the production of many therapeutic recombinant proteins including monoclonal antibodies and Fc fusion proteins. The technology is particularly effective in enhancing the production of proteins where incorrect folding may result in limited expression or degradation. Examples include IL13Ralpha2-Fc or Factor VIII-Fc. By using TAPBOOST™ technology, the productivity of IL13Ralpha2-Fc and Factor VIII-Fc were improved more than 20 fold. The unique mechanism of action enables this technology to combine with other existing expression technologies to enhance the production of therapeutic protein with synergistic effect.

 

d1) Boston Strategics Corporation Announces Licensing Deal with Eisai Co., Ltd.

June 30, 2014

Boston Strategics Corporation (BSC), an integrated clinical-stage drug research and development (R&D) company, Boston, MA, today announced that it has entered into an exclusive licensing and development agreement with Japanese global pharmaceutical company Eisai Co., Ltd., for Eisai’s oncology drug, E6201.

E6201 is a dual-targeted FLT3 and MEK inhibitor which has completed a Phase1 clinical trial showing preliminary antitumor activity and an acceptable safety profile. Building on a strong scientific rationale supported by recent preclinical data, BSC will undertake a clinical Proof of Concept (PoC) trial in the high unmet need FLT3 mutated AML patients.
Under this agreement with Eisai, BSC has worldwide rights to develop and commercialize E6201 for all Oncology indications.

This collaboration is a prime example of BSC applying its “True” Open Innovation™ platform to develop drug candidates with potential to significantly improve patients’ health care. As such it represents the next step toward BSC’s vision to create a novel and comprehensive approach to global pharmaceutical development.

“This is a critical milestone for BSC to validate our concept to move drug development programs forward by increasing the Probability of Success (PoS) and sharing risks with key strategic partners,” says Eita Kitayama, President of Boston Strategics. “Eisai recognized the value of this approach and entrusted BSC with the development of E6201 for cancer indications to build on the foundation of this new platform. At BSC, we are deeply committed to proving that our innovative approaches can deliver breakthrough therapies with industry benchmark-beating timelines, quality, and financial investments, thus limiting the ever increasing costs of pharmaceutical innovation and development.”

 

6. What are Your Top 3 book recommendations?

Keizo:
1. Ivan the fool: Lev Nikolayevich Tolstoy
2. A Calendar of Wisdom: Lev Nikolayevich Tolstoy
3. On Happiness: Émile-Auguste Chartier (Alain)
Eita:
1. Galapagos: Kurt Vonnegut
2. The Metamorphosis: Franz Kafka
3. Blue Ocean Strategy: W. Chan Kim and Renée Mauborgne
What other charitable causes are most meaningful to you and why?

Our mission is to continuously improve patient health care by changing the drug R&D paradigm using “True” Open Innovation™ platform.

 

7. Who has been most influential toward your career successes with Boston Strategics Corporation?

“Blue Ocean Strategy,” proposed by Professors W. Chan Kim and Renée Mauborgne, is an impressive concept for us because it suggests that current drug development is using a typical Red Ocean Strategy and our “True” Open Innovation™ platform may enable us to do it in the Blue Ocean.

 

8. What is your advice for entrepreneurs who are 1-3 months away from launching their business?

Have clear business concepts and vision to achieve them.

Continue to ask yourself why, for what, for whom.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Tag Cloud

%d bloggers like this: