Case Studies

Below you will find examples of projects we have carried out over the years covering a wide range of tasks across the life science industry.

PHARMA & MEDICAL DEVICE COMBO;  Partnering in Japan and Korea

Scandinavian public listed drug and medical device development company with its lead oncology candidate (ODD in EU and Korea) in pivotal clinical trials in Europe and Asia.

Find potential partners in Japan and Korea for the lead drug & device combination candidate as well as the delivery / potentiator platform technology.
  • Review of 100 companies, reaching out to > 40 companies in both countries.
  • The Covid-19 pandemic first delayed partnering interactions as a planned road-show in both countries were cancelled. It was mitigated by ABD’s presence in both countries working semi-virtually.
  • Non-confidential presentations were made for 10 companies, some with ABD’s local representative participating on site.
  • CDA signed with several companies for detailed presentations, leading to negotiations in Japan and Korea with one Material Transfer & Collaboration Agreement signed with a Korean C&GT company.
Project Lead & project coordination, contacts, “door-opening”, reputational insight and analysis, interactions, and presentations on behalf of the client, and negotiations with companies in both Japan and Korea. Project documentation and oral presentations.

PHARMA; Out-licensing Women’s Health asset in China

VC-funded Scandinavian Biopharma SME with a Women’s Health asset in EU Phase II clinical trial.

Business Development, partnering and out-licensing in China.

  • Search & Evaluation of potential Chinese partners.
  • Onsite introduction of the client company and its Women’s Health clinical stage asset to the potential partner.
  • Personal introduction of the client company CEO and its Chairman, initiating and facilitating negotiations face-to-face.
  • Thorough negotiation support and strategic advice during onsite meetings in China and online throughout the process until deal closure.
Search & Evaluation, personal “door-opening”, onsite meeting prescence, intercultural business advice and strategy througout the negotiation process until closure including recommendation of local legal expertise by recommendation and introduction to highly reputable local law office.

PHARMA; Search & Evaluation China and Korea

NASDAQ-listed large US biotech company with blockbuster drug, coming off patent in 5-6 years, with no Asian presence, having closed several collaboration deals with major Chinese pharma companies.
S&E of innovative Chinese and Korean clinical stage oncology, auto-immune disease and inflammation assets being developed with promising efficacy data and USD 300M-400M sales potential.
  • Information gathering through local newsletters, online partnering conferences and investor presentations and clinical trial databases. Combined with 20 years of ABD’s interactions with local companies and domestic industry insiders.
  • Evaluated 190 clinical assets from 90 Chinese and 45 Korean companies.
  • 60 assets from 40 companies were selected for oral presentations, whereof 33% were investigated further saving time and money for the client to thoroughly review clinical opportunities in the targeted countries.
Project Lead, Search & Evaluation, In-depth investigations, including reputational insight and assessments giving bi-weekly oral presentations to the client.

PHARMA; Market assessment & entry China

US-based pharma company with limited local presence in China having no experience and time to conduct this specific project.
Market Assessment with a China Entry strategy for an innovative dermatology clinical stage asset.
  • Assessment of patient population for the specific indication and possibilities for off-label prescription.
  • Competitor analysis, including interviews of local distributors, pharmacies, and hospitals.
  • Assessment of client’s asset, developing Chinese questionnaire, conducting KOL interviews at selected hospitals in key provincial cities, as well as with patients, patient organisations and provincial health insurance offices.
  • Developing an entry strategy for the Chinese market.

Project Lead & Coordination, strategy development, project documentation and oral presentation to the client.

The B-Core Consulting team in Beijing carried out all interviews and provided additional analysis.

BIOTECH; Distribution, Marketing & Sales of bioprocessing products in Asia-Pacific

Scandinavian listed biotech company.

Regional coordination, Distribution, Marketing & Sales of bioprocessing products.

  • Expanded the market coverage to India and Australia & New Zeeland by bringing in local bioprocessing advisors and negotiating and closing deals with distributors.
  • Restructured and brought in new distributors for Hong Kong, China, and Taiwan.
  • Designed and implemented operational reporting and supporting processes in Asia Pacific.
  • Developed educational material in bioprocessing and carried out training with distributors and partners on site and on-line.
  • Provided marketing & sales support to all distributors and agents in Asia Pacific, including roadshows meeting old and new customers. Online and in person seminars and workshops at conferences and exhibitions.
  • Doubled regional revenues over a two-year period.

Business Development, Marketing & Sales development and support, Operational support.

C> Mapping Japanese Cell & Gene Therapy influencers, and decision makers

Global MNC pharma company
Business intelligence by mapping of public affairs stake holders in the ATMP-space and conducting face-to-face interviews in Japan, resulting in a local public affairs plan as a part of a global plan for CAR-T and Cell & Gene Therapies.
  • In depth review of the recent PMDA regulation changes and investigation of on-going regulatory and policy activities pertaining to ATMP to develop a suitable public affairs strategy.
  • Review of price and re-imbursement regulations and practises for ATMP in Japan.
  • In depth investigation of both academic (universities, research institutes and hospitals) and industry (activities in SME-biotech companies, domestic pharma companies and competing MNCs).

Solely responsible for Japan investigations, Search & Evaluation, mapping KOL (universities, hospitals, research and policy institutes, ministries such as MHLW with PMDA, industry organisation such as FIRM, JBA, JPMA, JSHCT, NCCHD etc), and corporation like Fuji Film, conducting face-to-face interviews, development of public affairs strategy Japan as a part of the global strategy envisioned by the Team.

Worked as 1 of 5 consultants in a global team with the other team members based in EU and US.

DIA; Licensing IPR from Korea

Scandinavian biotech company, publicly listed at Nasdaq, Stockholm.
Securing access to IPR from Korean medical conglomerate to ensure FTO.
  • In-depth review of the pharmaceutical company and its subsidiary, including top manager’s decision-making practises, corporate culture, cross border business experiences, staff turn-over, domestic reputation, R&D track record, etc.
  • Established direct contact with subject matter project leader, BD&L management at Korean mother company and its subsidiary.
  • Negotiations were carried out through TEAMS with ABD’s local partner present both online and with on-site follow-up bridging East and West until successful closure of agreement in less than one year.

Business Intelligence, cross-cultural project coordination (translations of language / business cultural/behavioural aspects), introduction / “door”-opening, strategic negotiations advice, project documentation and oral presentation.

MEDICAL DEVICE; Market Entry Asia

Scandinavian based Med. Tech. SME.
Entry strategy for main Asian markets.
  • Brief market review of the segment targeted with the Medical Device in the largest markets, India, Hong Kong, China, Japan, and Korea.
  • Review of Price & Re-imbursement for Medical Devices in targeted countries.
  • Review of Regulatory requirements for CE-marked Medical Devices in targeted countries.
  • Developed a general strategy for market entry based on the device particular Key Differentiating Factors and local market requirements prioritising ease of access for CE-marked products such as India and Hong Kong as well as selected provinces in China such as Guangdong Province via the “Greater Bay Area” Initiative in Hong Kong and Hainan Province via the “Medical Tourism Zone” scheme. While Japan and Korea would have lower priority as local clinical studies are most likely required.
Project Lead, information gathering, strategy development, project documentation and oral presentation.

BIOTECH; Global bioreactor market assessment and evaluation of acquisition targets

US public listed global Life Science firm.

Review and assessment of global bioreactor market with evaluation of acquisition targets and competitor analysis .

  • Global bioreactor market assessment, by detailed review of commercial market reports, combined with in-depth interviews of industry insiders through AlphaSight, GLG and ABD’s network in EU, US, and Asia.
  • Deep dive into potential acquisition targets in Europe and US, including global top tier firms.
  • Global competitor analysis with SWOT, workflow value creation charts, entry barriers, differentiation, etc
  • Detailed review of single-use technology pertaining to upstream bioprocessing.
  • Decision making material prior to a major acquisition.

Project Lead, Business Intelligence and analysis, conducting telephone interviews, projects documentation and presentation.

TECHNOLOGY; Strategy development & global commercialisation of platform

Japanese MNC.

Business Development Ex-Japan; Global commercialisation and Operational strategy for an innovative technology platform

  • Gap-analysis with a business feasibility study for commercial use in diagnostics and analytical R&D.
  • SWOT analysis with mitigation strategies filling perceived gaps, suggesting world-wide partnering, global KOLs and development of “killer” applications.
  • Development of commercialisation strategy to reach sales of USD50M in 3 years.
  • Operational strategy to establish a new Life Sciences Business Unit, with the necessary in-house competences and tie-up with partner companies, the potential users of the technology developing diagnostic and analytical applications and products.
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DERMATOLOGY,  Partnering strategy Korea and Regulatory Affairs review

Scandinavian public listed mid-size Pharma/OTC company
Developing a partnering strategy for Korea and reviewing regulatory affairs allowing to register and market a dermatology asset locally.
  • Reviewing and providing advice for the regulatory pathway in Korea for a dermatology product considering the differences between EMA and Korean MFDS regulations, which had caused some concern. Several alternatives registration pathways were investigated, as a cosmetic, pharma, OTC, or medical device.
  • Partnering strategy and selection criteria for a local partner taking care of registration and distribution.
  • Review and list of potential partners considering reputation, financial strength, experiences, strategic fit, etc
Project Lead & coordination, Search & Evaluation, regulatory review, reputational insight and analysis, report writing and oral presentation.

WOMENS HEALTH, Regulatory pathway + China Customs & Quarantine Control

Public listed Scandinavian SME healthcare company.

Feasibility study to get a probiotic women’s healthcare product imported in compliance with testing procedures by China Customs & Quarantine Control and duly registered in China.

  • Review of previous failed attempts to get the product into China and suggest legally complaint procedures.
  • Review of registration options in accordance with regulatory procedures at the Ministry of Health proposing a strategy for regulatory administrative filing at the provincial level.
  • Development of a strategy for China Customs & Quarantine Control by co-developing testing procedures with them, a local university, and the client for the product to be imported to China. Such strategy has proved to be successful in the past
  • Recommendation which province and port to be used for importation with a high chance of success.
  • Suggestion of a distribution, marketing, and sales strategy.

Project Lead & Project Coordination, fact finding, regulatory review, strategy development, project documentation and presentation to the client. This projects was carried out together with a Sr Regulatory Affairs expert in Beijing.

BIOTECH; Market development, distribution of R&D reagents in Asia

A privately held innovative Scandinavian life science reagents company.

Further market development in China and Japan including securing new distributors.

  • Development of market strategies for China and Japan.
  • Adding distribution and sales channels.
  • New marketing plans to improve local brand and product awareness.
  • Search & Evaluation of additional distributors in China, Hong Kong and Japan utilising internal knowledge and contacts with industry insiders, meeting with potential candidates at their HQs.
  • Leading negotiations and closure of distribution deals in Hong Kong/China and Japan.
  • Marketing and sales support in China and in Japan during a 12 months start-up period.
  • Design and participation of a seminar tour in Japan together with a Scandinavian KOL.

Project Lead & Project Coordination, Strategy development, Search & Evaluation, on-site meetings and negotiations with Japanese and Chinese distributors. Road-show support in Japan. Meeting Minutes, report writing and oral presentations.

BIOPHARMA; GMP Audit in China

Large Chinese generic pharmaceutical group belonging to an industrial conglomerate having embarked on biosimilar and innovative biologics development and manufacturing.
GMP-audit according to PIC/S and EMA regulations of a large-scale biosimilar drug substance manufacturing facility with fed-batch prokaryotic upstream bioprocessing with stainless steel equipment, traditional centrifugations, filtration, and downstream bioprocessing.
  • Off-site preparations and then four days on-site at plant inland China (Hubei Province)
  • Detailed review of documentation, interviews with key personnel and two days with walk-through and inspections of the full product flow from goods arrival to warehousing and all utilities.
  • Deep analysis of bioprocess flow, performance, and operational outcome.
  • GMP-report containing observed deviations and deficiency according to Eudralex with suggestions to rectify and improve GMP-compliance
Bioprocessing expertise and auditing in GMP-environment under the Project Lead of Mr Magnus Jahnsson, former EMA inspector and educator, at the time working for Pharmadule. Project documentation and oral presentation.

Biotech – Distribution of reagents for R&D and bioprocessing QA/QC in Asia

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Pharma – Partnering feasibility review & strategy Japan

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Partnering & Distribution strategy China for Dermatology asset (OTC / Pharma Rx / Med. Dev.)

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Partnering Asia of clinical stage oncology asset

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Design, Engineering & Build of a modular BSL-2 animal laboratory in East Timor

United Nations (UN), Food & Agricultural Organisation (FAO).

Design, Lay-out, Engineering & Construction of a turnkey modular BSL-2 laboratory built-up in Dili, East Timor.

  • Coordination between FAO’s representatives in Dili, East Timor, and Green Cross Engineering & Maintenance in Korea both on-line and on site in Dili.
  • Facilitating and resolving intercultural communication and technical issues between the Government of East Timor, the European (Italy, Portugal, and Australia) leadership of FAO in Dili and the engineering company in Korea.
  • Ensuring acceptance of facility design and lay-out, shipping schedule of the modular facility from Korea by boat to East Timor.
  • Negotiated project extension due to local delays and ensured completion with full project payment.

Project Lead & Coordination.

This project was carried out together with GCEM from Korea.

C&GT: GMP-compliance of a Cell & Gene Therapy manufacturing facility

Chinese listed Cell & Gene Therapy company.

GMP gap-analysis and compliance support with QA & Validation Management.

  • GMP review and audit of design, lay-out, engineering and documentation system of a cell and gene therapy manufacturing facility under construction, providing second opinion, list of deficiencies and suggested remedies with an GMP-coordination action plan.
  • Developed Project Quality Assurance Plan (PQAP)
  • Developed SOPs and templates for Audits, Design reviews, FAT, SAT, Receipt Verification (RV), IQ and OQ.
  • Developed Validation Master Plan (VMP).
  • Carried out Quality Risk Management for the intended manufacturing processes according to USFDA, EMA and PIC/S GMP guidelines identifying Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) resulting in a control strategy for the facility in accordance with ICH Q8-9 and a start-up plan for testing the facility.

Project Lead & Project Coordination, on-site GMP-audits, QA and Validation Management together with Mr Magnus Jahnsson and the team in Sweden and China.

Business Development & Commercialization strategy ex-Japan for a novel analytical instrument for tissue samples

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Business Development, strategy and business intelligence paving the way for the establishment of a new business unit in life science focusing on analysis of biological samples and in vitro diagnostics.
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Business Development in-licensing half-life extension technology and out-licensing pre-clinical assets.

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Business Development, strategy and business intelligence paving the way for the establishment of a new business unit in life science focusing on analysis of biological samples and in vitro diagnostics.
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Outsourcing mAb manufacturing in Asia + COGs analysis mAb-production

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Business Development, strategy and business intelligence paving the way for the establishment of a new business unit in life science focusing on analysis of biological samples and in vitro diagnostics.
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Outsourcing mAb manufacturing in Asia + COGs analysis mAb-production

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Business Development, strategy and business intelligence paving the way for the establishment of a new business unit in life science focusing on analysis of biological samples and in vitro diagnostics.
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Outsourcing mAb manufacturing in Asia + COGs analysis mAb-production

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Business Development, strategy and business intelligence paving the way for the establishment of a new business unit in life science focusing on analysis of biological samples and in vitro diagnostics.
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