1 9. Mitgliederversammlung CONELIS e.V. 18.10.2013.

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9. Mitgliederversammlung CONELIS e.V.

18.10.2013

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Agenda13:00 Introduction New Members, Voting Astrid Schott

13:20 Welcome and introduction round Astrid Schott, all

13:40 Election New CONELIS BoardIntroduction candidatesElectionTalk of the New Chairperson of the boardStrategy Meeting 2014

Michael Hildebrand

14:15 Conelis Questionnaire Results Michael Hildebrand

15:15 Break

15:45 Budget Christian Wolf

16:00 Conelis 5-year Celebration Michael Hildebrand

16:30 Product Development Group Result of Customer Interviews Next Steps

Astrid Schott

17:00 Conelis Participation in Meetings 2014 Michael Hildebrand

Miscellaneous All

18:00 Dinner All

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New Members

Full Member

Name Area of Expertise ReferencesSilke Sittner Marketing and distribution Board

Nils Matzen Marketing and distribution Board

„Interest“

Name/company Area of ExpertiseXenia von Maltzan Xendo Regulatory CRO

Heike Schön Lumis International,

Leaving ConelisBioscentia Clinical trial laboratory

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Michael Hildebrand


15:15 Break




Astrid Schott


Miscellaneous All

18:00 Dinner All

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Aus der Satzung…..

• Der Vorstand im Sinne des § 26 BGB besteht aus:– dem Vorsitzenden, dem stellvertretenden Vorsitzenden und dem Schatzmeister. – Beisitzern, die durch den Vorstand berufen werden können.

• Der Vorstand vertritt den Verein gerichtlich und außergerichtlich durch wenigstens zwei Mitglieder des Vorstands, darunter der Vorsitzende oder der stellvertretende Vorsitzende.

• Der Vorstand wird von der Mitgliederversammlung für die Dauer von 2 Jahren gewählt.

• Die Wiederwahl der Vorstandsmitglieder ist möglich. Der Vorsitzende ist nur einmalig in direkter Folge wieder wählbar. Die jeweils amtierenden Vorstandsmitglieder bleiben nach Ablauf ihrer Amtszeit im Amt, bis Nachfolger gewählt sind.

• Das Amt eines Vorstandsmitgliedes endet:– durch Ablauf der Amtszeit- mit der Niederlegung des Amtes durch schriftliche Mitteilung an

den Vorstand,– durch Abberufung seitens der Mitgliederversammlung (einfache Mehrheit) oder– wenn das Vorstandsmitglied nicht mehr Mitglied des Vereins ist.

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CONELIS SURVEY 2013

Members‘ MeetingBerlin

18-10-2013

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Survey 2013

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Survey 2013

Other:

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Survey 2013

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Survey 2013

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Survey 2013

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Survey 2013

Other:

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Survey 2013

D:

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Survey 2013

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Survey 2013

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Survey 2013

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What kind of CONELIS activities would you like to contribute to?

No * Topic Comments3 + 6 ?/ no time/

no commentDepends on options, no clear suggestions right now/ currently no time/currently none

6 Expertise related Improvement of the medical chemistry platform/ medical devices, RA and clinical/ medical devices / preclinical development / complete clinical trial development support / business projects

5 Conference attendance

(3) Conference attendance / participation in scientific meetings / talks on conferences on medical device + VD topics

3 Booth duty/events

Help in organizing special events / social events / booth duty

3 Seminars Workshops - seminars on selected aspects in Pharma R&D led by Conelis or having a strong Conelis touch / organization of workshop / seminars, conferences but not direct BD activities

2 Networking (external)

Representative of Conelis in Bio-Deutschland/the existing regional collaboration with BioTop etc should be expanded to other organizers with visibility beyond Berlin-Brandenburg

1 Strategy discussions

1 Product development

*of members commenting

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Survey 2013

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Survey 2013

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Survey 2013

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Survey 2013

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Survey 2013

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Survey 2013

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Survey 2013

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Survey 2013

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Conelis Members should do more of the following:

No * Topic Comments7 Interaction interacting with one another, too much top down driven right now /

develop Conelis group feeling through more informal networking (Stammtisch)/ direct interaction / information on their expertise (2)/contact each other/participate in meetings

4 Projects Discussion about interesting projects/look for synergies in the “areas of expertise”/involve other members in projects/collaborative projects

4 Marketing, BD help with staffing and organizing congresses and meetings/ active search for projects/more external presence like newsletter etc/ promotion of services

3(2 external1 Internal)

Seminars Own medical scientific seminars on selected topics (eg MD reimbursement, clinical trials pharma vc. MD, reg. requirements Pharma vs. MD, post market clinical follow up, principles of risk management, tools of due diligence…/workshop, seminars on selected aspects in pharma R&D led by Conelis or having a strong Conelis touch/internal seminars once or twice a year

2 other Bring new ideas into the association/ Take advantage of member network

*No of members commenting, 10 members had no comment, 1 of them “too early as recently joined”

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The contact persons/board members should do more of the following:

No of members commenting

Topic Comments

7 Fine as is

2 Contact Persons Regular meetings or TCs / contact persons should organize at least 1 meeting in area of expertise per year and join forces for seminars or trainings

2 Information information / regular update on projects of Conelis members

1 Seminars contact persons should …. join forces for seminars/trainings

1 Marketing/BD Promotion of services

12 members had no comment

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The following topic(s) should be covered at the next members’ meeting/ strategy meeting (please specify)

No MM StM Topic Comments

5 1 Marketing/BD

Improvement of the visibility of CONELIS/ reassessing of the topic “CROs as clients”/brainstorming for a re-newed web presence / presence at scientific meetings? / realize a real 1-stop-shop from pre-clinics to market access and joint cooperation for a “cat walk” of the complete CONELIS group / Business development

3 2 Products More clear definition of the CONELIS “Products”/ Conelis Product Development/definition of the CONELIS “Products”

2 1 Information Short verbal presentation of consultancy projects members are involved in/ statistics of projects coming through Conelis to the members, i.e. efficiency of outreach efforts by Conelis

2 Interaction Interaction between members / collaborative projects

1 Networking Discussion about a network with other groups/institutions1 Planning of the next strategy meeting

1 1 Competence centers

Creation of competence centers (ie clinical trials, trial conduct, medical writing, statistical expertise center…)

1 Regulation New MD regulation

* Of members commenting, 11 members had no comment, MM Members´meeting, StM Strategy Meeting

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Additional issues/comments/suggestionsNo of members commenting

Topic Comments

5 Question-naire related

Questions 17, 18, 26 could not be answered due to bugs in document/ item 30:never/ Q12: response don’t know, have no information have never attended, Q 13 don’t know, have no information have never attended/ have never attended strategy meeting, rated them 100% as I could not leave them blank/ what is meant by “support”? Being present at the booth of CONELIS or making other colleagues, clients and participants at other meetings aware of CONELIS, which I do, Q9: difficult living outside Germany, Q12: what do you mean? Q19-21 not applicable, 25: good to know each other and the expertise but what is intense contact?

3 Fine as is So far so good/continue your excellent work!/super idea the survey!

1 Meeting Meeting outside Berlin

1 Marketing/BD

We used to present CONELIS at MEDICA, the information material need more clear statements on CONELIS products, we used to present the current material at MEDICA and always got understanding questions

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Action Issues from Survey

Topic: Information on activities

Proposal:Each Contact Person (CP) should give some written infoon some important activities in the respective groupto be placed in the CONELIS Newsletter

Joint TCs (at least twice a year) of Board and CPs

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Action Issues from Survey

Topic: Promotion of services

Task Force: Who ?

Topic: Information on fields of expertiseVerbal presentation on projects members are involved in

- Use individual profile description on CONELIS homepage- Establish informal round table ?

Task force: Who ?

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Topics for Strategy Meeting

• How to improve the visibility of CONELIS ?

• Is there a need and an option to establish a One-stop-shop for our customers ?

• How to facilitate/generate more collaborative projects ?

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BREAK

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Michael Hildebrand


15:15 Break




Astrid Schott


Miscellaneous All

18:00 Dinner All

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Budget – Einnahmen

Ist Plan

Beitrag OM 7.984,50 500,00

- davon Aufnahmegebühr 2013 500,00

Beitrag FM 6.250,00

- davon Aufnahmegebühr 2013 250,00

- davon Beiträge/Gebühren 2012 1.750,00

Spende 500,00

Zinsen 19,35 5,00

Gesamt 14.753,85 505,00

Plan: budgetierte Einnahmen• Aufnahme von 2 ordentlichen Mitgliedern (Aufnahmegebühr erlassen)• übliche Zinsen auf DKB-Konto• Einnahmeplanung Mai 2013: € 15.480,50 vs 15.258,85 im Nov 2013

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Budget – Ausgaben

Ist Plan

Externe Veranstaltungen -2.095,59 -2.095,00

Werbemittel (inkl. Webseite) -1.880,77

Geschäftsstelle -1.071,00 -357,00

Interne Veranstaltungen -443,37 -1.500,00

Gesamt -5.490,73 -3.952,00

Plan: budgetierte Ausgaben• Sponsoring eines Conelis-Teilnehmers bei der BioEurope (Wien, Nov 2013)• Zahlungen für 3 Monate Betreuung der Geschäftsstelle• MV und Abendveranstaltung; GLS-Sprachenschule (Okt 2013)• Ausgabenplanung Mai 2013: € 11.700,00 vs 9.442,73 im Nov 2013 (beide Beträge

ohne im Mai vorgeschlagene Rückstellung von € 3.500 für 5er-Jubiläum)

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Budget – Saldo 2013 und Ausblick

Einnahmen 2013 15.258,85

Ausgaben 2013 -9.442,73

Saldo 2013 5.816,12

Ausblick 2014• 2 neue ordentliche Mitglieder• Ausfall von 2 Fördermitgliedern: BioScientia und NisiPharm• Geplante Einnahmen

- 32 ordentliche Mitglieder x € 250 = € 8.000- 6 Fördermitglieder = € 2.250

• Geplante Ausgaben- ca. € 10.000 (ohne 5er Jubiläum)

• Saldo- ca. € 5.250

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5 - year celebration

• Type of event ?

Based on survey an event with external guests either in combination with science or art was favourite.

• Who will be on the team to organize the event?

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Michael Hildebrand


15:15 Break




Astrid Schott


Miscellaneous All

18:00 Dinner All

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Product Development Group

Interdisciplinary services in “Current Services A-Z”– Due diligence*– Portfolio Assessment– “Preclinical development”*– R&D Strategies

What should be developed into a CONELIS Product?

*have been conducted by Conelis teams

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Conelis Product Development Group

Conrad- Kintzel- Lampe –Matzen –Schott (+ Hildebrand, Wolf)

• What could reasonable CONELIS products be– “Zweitmeinung” – “2nd opinion”

• Analyse the need – Customer Interviews partly done– Competitor analysis

• Clarify liability issues. – “Bietergemeinschaft” – Other forms of organization/company

• Product Specification• Testrun

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Customer Interviews “2nd opinion” Demographics

Target identifica-tion

Preclinical Phase I Phase II Phase III Postmarketing, Vertrieb

Other

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3 3 3

2

4

1

Planned Done

Pharma/Biotech 11 5

Venture Capital 2 1

Medical Device -

Academia -

Company Size 17.000

600

150

72

60

5 (VC)

117%

233%

350%

Hierachy level

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“I would like to have a 2nd opinion for….”

Customers were asked the open question,if they ever had thought, they would like to have a 2nd opinion (if>1 numbers in brackets) – what was the topic? :

• Clinical development plans (3), Study design • CMC data• Regulatory framework in different (exotic) regions, special regulations• Health Economics• Market Development in the future (2) (depending on health policies and generic competition)• Produkt evaluation (2), „Wirtschaflichkeisberechnung“, „Potential“, Business-case• Partnering opportunities, risks• Launch strategies, • Marketing• Market access/reimbursement (2)

Further comments: • „Zweitmeinung“ ist ein super Name!• So was gibt es evt. für Due Diligence- sonst jedoch noch nicht• Zweitmeinung wurde schon eingeholt wenn:

– man sich selber nicht gut fühlt mit der 1. Meinung– wenn 1. Meinung nicht der eigenen Position entspricht („paßt nicht in meine Strategie“)– man den Experten der 1. Meinung nicht voll vertraut.

• Das ist ein sequentieller Prozess – Entscheidung für Zweitmeinung fällt nach der Ersten Meinung!

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What is you potential interest in a “2nd opinion” concerning the following topics (1 no interest to 5 very high interest)

Topic 1 2 3 4 5

Decision to move a product into the next phase of development (ie preclinical to clinical testing)

Milestone planning (preclinical or clinical development plans)

Concerning documents (IB, protocols or reports)

Concerning internal decisions (portfolio assessment, termination of projects)

Support of in-licensing (due diligence, as 2nd opinion, not due diligence itself)

.

External validation is

standard

Clinical Development Clinical Dev.,

CMC

Risks , strategy

Study protocols,

dossier

2x Not applicable For small

companies

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Team “2nd opinion”

Customers were asked the open question, which characteristics they would deem necessary for team members in a “2nd opinion team/Sparringboard”:

• Erfahrung im Gebiet, wirklicher Experte (5)• Sind auf der Höhe der aktuellen Entwicklungen • Netzwerke /aktuelle Kontakte • Industry background• Offenheit und Kreativität• Guter Mix- Senior + Querdenker/Methodiker• Können Wirtschaftlichkeit einschätzen

Nein Ja Comment, or undecidedWould you appreciate if experts from Industry would be part of the team?

1 4 1 “depending on Question/ problem, could be a chance”,” I assume Conelis members to have an industrial background”

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Please rate characteristics for an interdisciplinary team giving a 2nd opinion(1 not important, 5 very important)

Topic 1 2 3 4 5

Seniority (was defined differently by interview partners – age not important, experience)Continuity (always same team members

Flexibility – team members according to need

Always the same person organizing the “2nd opinion”

Independence of experts (no experts from industry)

If Quality ok

Should be part of the team

If confidentiality is guaranteed

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Costs – Example 1

Participants were asked what the prize for a typical “2nd opinion” should be

Consultancy Fees (without travel costs, costs for room…) in T€:

1. Sparringboard Development PlanTeam with 5 interdisciplinary experts:• Pharmacology• Toxicology• Clinical development• Market expert• Regulatory expert

1 day review of development plan and IB per consultant, product is a small molecule phase Ib, 4 hours discussion with company

2010 155

Including Report

*“Hochrechnung marktüblicher Tagessätze” of max. 20T€

0 T€

*

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Participants were asked what the prize for a typical “2nd opinion” should be

Consultancy fees:

10 155

Study protocol, no interest in IB

review

0 0,8-1T€

Costs – Example 2

2. Document ReviewReview Investigator brochure before Phase I4 experts:• Toxicology• Pharmacology• Clinical development• Regulatory Input in writing , document has 30 pages

(2) According to daily rates

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Next Steps

1. Brainstorming2. Product taskforce identified3. Need analysis

1. Customer interviews - continue2. Competitor analyses

4. Product specification5. Product Development and “Testrun”

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Michael Hildebrand


15:15 Break




Astrid Schott


Miscellaneous All

18:00 Dinner All

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Conelis Participation in Meetings 2013/2014

• Bio-Europe Wien 2013• Deutsche BiotechnologieTage April 9 and 10 in

Hamburg• DIA Europe Wien 24-27. März• International Conference of Pharmaceutical Medicine

(ICPM) 2014: Berlin 20-21. März

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Michael Hildebrand


15:15 Break




Astrid Schott


Miscellaneous All

18:00 Dinner All

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Miscellaneous

• BIO EUROPE In Vienna (4 – 6 Nov 2013).• Medtech within CONELIS

– Currently Lampe, Zimmermann and Zanker are working in the Medical Device area

– proposal how the Medtech area can be strengthened within CONELIS– Extra group/division ?

• Outcome research and Pricing within Conelis• Membership “Bio Deutschland” , fee around 1000€ a year

– Should be decided by vote

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